CFR 2019 Title21 Vol1

Title 21
Food and Drugs

Parts 1 to 99
Revised as of April 1, 2019
Containing a codification of documents

of general applicability and future effect
As of April 1, 2019
Published by the Office of the Federal Register

National Archives and Records Administration
as a Special Edition of the Federal Register
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Table of Contents
Page
Explanation ................................................................................................ v
Title 21:
Chapter I—Food and Drug Administration, Department of Health

and Human Services .................................................................... 3
Finding Aids:
Table of CFR Titles and Chapters ....................................................... 551
Alphabetical List of Agencies Appearing in the CFR ......................... 571
List of CFR Sections Affected ............................................................. 581

iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 21 CFR 1.1
refers to title 21, part 1,
section 1.
iv
Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially noticed (44
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PAST PROVISIONS OF THE CODE
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1963, 1964-1972, 1973-1985, and 1986-2000.
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vi
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OLIVER A. POTTS,
Director,
Office of the Federal Register
April 1, 2019.
vii
THIS TITLE
Title 21—FOOD AND DRUGS is composed of nine volumes. The parts in these
volumes are arranged in the following order: Parts 1–99, 100–169, 170–199, 200–299,
300–499, 500–599, 600–799, 800–1299 and 1300 to end. The first eight volumes, con-
taining parts 1–1299, comprise Chapter I—Food and Drug Administration, Depart-
ment of Health and Human Services. The ninth volume, containing part 1300 to
end, includes Chapter II—Drug Enforcement Administration, Department of Jus-
tice, and Chapter III—Office of National Drug Control Policy. The contents of
these volumes represent all current regulations codified under this title of the
CFR as of April 1, 2019.
For this volume, Kenneth R. Payne was Chief Editor. The Code of Federal
Regulations publication program is under the direction of John Hyrum Martinez,
assisted by Stephen J. Frattini.
ix
Title 21—Food and
Drugs
(This book contains parts 1 to 99)
Part
CHAPTER I—Food and Drug Administration, Department of

Health and Human Services ............................................... 1
CHAPTER I—FOOD AND DRUG
ADMINISTRATION, DEPARTMENT OF HEALTH
AND HUMAN SERVICES
EDITORIAL NOTE: Nomenclature changes to chapter I appear at 66 FR 56035, Nov. 6, 2001, 69

FR 13717, Mar. 24, 2004, and 69 FR 18803, Apr. 9, 2004.
SUBCHAPTER A—GENERAL
Part Page
1 General enforcement regulations ............................ 5
2 General administrative rulings and decisions ......... 123
3 Product jurisdiction ................................................ 128
4 Regulation of combination products ....................... 133
5 Organization ............................................................ 139
7 Enforcement policy ................................................. 150
10 Administrative practices and procedures ................ 160
11 Electronic records; electronic signatures ............... 197
12 Formal evidentiary public hearing ......................... 201
13 Public hearing before a public board of inquiry ...... 219
14 Public hearing before a public advisory committee 223
15 Public hearing before the Commissioner ................ 251
16 Regulatory hearing before the Food and Drug Ad-
ministration ......................................................... 253
17 Civil money penalties hearings ............................... 260
19 Standards of conduct and conflicts of interest ....... 273
20 Public information .................................................. 275
21 Protection of privacy .............................................. 306
25 Environmental impact considerations .................... 323
26 Mutual recognition of pharmaceutical good manu-
facturing practice reports, medical device qual-
ity system audit reports, and certain medical de-
vice product evaluation reports: United States
and the European Community ............................. 335
50 Protection of human subjects ................................. 365
54 Financial disclosure by clinical investigators ........ 377
56 Institutional Review Boards ................................... 381
58 Good laboratory practice for nonclinical labora-

tory studies .......................................................... 391
3
21 CFR Ch. I (4–1–19 Edition)
Part Page
60 Patent term restoration .......................................... 404
70 Color additives ........................................................ 411
71 Color additive petitions .......................................... 419
73 Listing of color additives exempt from certifi-
cation ................................................................... 426
74 Listing of color additives subject to certification .. 480
80 Color additive certification ..................................... 518
81 General specifications and general restrictions for
provisional color additives for use in foods,
drugs, and cosmetics ............................................ 524
82 Listing of certified provisionally listed colors and
specifications ....................................................... 531
83–98 [Reserved]
99 Dissemination of information on unapproved/new
uses for marketed drugs, biologics, and devices ... 537
SUBCHAPTER A—GENERAL
PART 1—GENERAL ENFORCEMENT Subpart H—Registration of Food Facilities

REGULATIONS GENERAL PROVISIONS
1.225 Who must register under this subpart?
Subpart A—General Provisions 1.226 Who does not have to register under
this subpart?
Sec. 1.227 What definitions apply to this sub-
1.1 General. part?
1.3 Definitions.
1.4 Authority citations. PROCEDURES FOR REGISTRATION OF FOOD
FACILITIES
Subpart B—General Labeling Requirements 1.230 When must you register or renew your
registration?
1.20 Presence of mandatory label informa- 1.231 How and where do you register or
tion. renew your registration?
1.21 Failure to reveal material facts. 1.232 What information is required in the
1.23 Procedures for requesting variations registration?
and exemptions from required label 1.233 Are there optional items included in
statements. the registration form?
1.24 Exemptions from required label state- 1.234 How and when do you update your fa-
ments. cility’s registration information?
1.235 How and when do you cancel your fa-
Subpart C [Reserved] cility’s registration information?
ADDITIONAL PROVISIONS
Subpart D—Electronic Import Entries
1.240 What other registration requirements
1.70 Scope. apply?
1.71 Definitions. 1.241 What are the consequences of failing
1.72 Data elements that must be submitted to register, update, renew, or cancel your
in ACE for articles regulated by FDA. registration?
1.242 What does assignment of a registra-
1.73 Food.
tion number mean?
1.74 Human drugs. 1.243 Is food registration information avail-
1.75 Animal drugs. able to the public?
1.76 Medical devices. 1.245 Waiver request.
1.77 Radiation-emitting electronic prod-
ucts. Subpart I—Prior Notice of Imported Food
1.78 Biological products, HCT/Ps, and re-
lated drugs and medical devices. GENERAL PROVISIONS
1.79 Tobacco products. 1.276 What definitions apply to this sub-
1.80 Cosmetics. part?
1.81 Rejection of entry. 1.277 What is the scope of this subpart?
REQUIREMENTS TO SUBMIT PRIOR NOTICE OF
Subpart E—Imports and Exports IMPORTED FOOD
1.83 Definitions. 1.278 Who is authorized to submit prior no-
1.90 Notice of sampling. tice?
1.91 Payment for samples. 1.279 When must prior notice be submitted
1.94 Hearing on refusal of admission or de- to FDA?
1.280 How must you submit prior notice?
struction.
1.281 What information must be in a prior
1.95 Application for authorization to relabel notice?
and recondition. 1.282 What must you do if information
1.96 Granting of authorization to relabel changes after you have received con-
and recondition. firmation of a prior notice from FDA?
1.97 Bonds.
1.99 Costs chargeable in connection with re- CONSEQUENCES
labeling and reconditioning inadmissible 1.283 What happens to food that is imported
imports. or offered for import without adequate
1.101 Notification and recordkeeping. prior notice?

1.284 What are the other consequences of
Subparts F–G [Reserved] failing to submit adequate prior notice
Pt. 1 21 CFR Ch. I (4–1–19 Edition)
or otherwise failing to comply with this Subpart K—Administrative Detention of
subpart? Food for Human or Animal Consumption
1.285 What happens to food that is imported
or offered for import from unregistered GENERAL PROVISIONS
facilities that are required to register 1.377 What definitions apply to this sub-
under subpart H of this part? part?
1.378 What criteria does FDA use to order a
Subpart J—Establishment, Maintenance, detention?
and Availability of Records 1.379 How long may FDA detain an article
of food?
GENERAL PROVISIONS 1.380 Where and under what conditions
must the detained article of food be held?
1.326 Who is subject to this subpart? 1.381 May a detained article of food be de-
1.327 Who is excluded from all or part of the livered to another entity or transferred
regulations in this subpart? to another location?
1.328 What definitions apply to this sub- 1.382 What labeling or marking require-
part? ments apply to a detained article of food?
1.329 Do other statutory provisions and reg- 1.383 What expedited procedures apply when
ulations apply? FDA initiates a seizure action against a
1.330 Can existing records satisfy the re- detained perishable food?
quirements of this subpart? 1.384 When does a detention order termi-
nate?
REQUIREMENTS FOR NONTRANSPORTERS TO ES-
HOW DOES FDA ORDER A DETENTION?
TABLISH AND MAINTAIN RECORDS TO IDEN-
TIFY THE NONTRANSPORTER AND TRANS- 1.391 Who approves a detention order?
PORTER IMMEDIATE PREVIOUS SOURCES OF 1.392 Who receives a copy of the detention
FOOD order?
1.393 What information must FDA include
1.337 What information must nontrans- in the detention order?
porters establish and maintain to iden-
tify the nontransporter and transporter WHAT IS THE APPEAL PROCESS FOR A
immediate previous sources of food? DETENTION ORDER?
1.401 Who is entitled to appeal?

REQUIREMENTS FOR NONTRANSPORTERS TO ES- 1.402 What are the requirements for submit-
TABLISH AND MAINTAIN RECORDS TO IDEN-
ting an appeal?
TIFY THE NONTRANSPORTER AND TRANS- 1.403 What requirements apply to an infor-
PORTER IMMEDIATE SUBSEQUENT RECIPIENTS mal hearing?
OF FOOD 1.404 Who serves as the presiding officer for
1.345 What information must nontrans- an appeal and for an informal hearing?
1.405 When does FDA have to issue a deci-
porters establish and maintain to iden-
sion on an appeal?
tify the nontransporter and transporter
1.406 How will FDA handle classified infor-
immediate subsequent recipients of food?
mation in an informal hearing?
REQUIREMENTS FOR TRANSPORTERS TO
ESTABLISH AND MAINTAIN RECORDS
Subpart L—Foreign Supplier Verification
Programs for Food Importers
1.352 What information must transporters
establish and maintain? 1.500 What definitions apply to this sub-
part?
GENERAL REQUIREMENTS 1.501 To what foods do the requirements in
this subpart apply?
1.360 What are the record retention require- 1.502 What foreign supplier verification pro-
ments? gram (FSVP) must I have?
1.361 What are the record availability re- 1.503 Who must develop my FSVP and per-
quirements? form FSVP activities?
1.362 What records are excluded from this 1.504 What hazard analysis must I conduct?
subpart? 1.505 What evaluation for foreign supplier
1.363 What are the consequences of failing approval and verification must I con-
to establish or maintain records or make duct?
them available to FDA as required by 1.506 What foreign supplier verification and
this subpart? related activities must I conduct?
1.507 What requirements apply when I im-
COMPLIANCE DATES port a food that cannot be consumed
without the hazards being controlled or

1.368 What are the compliance dates for this for which the hazards are controlled
subpart? after importation?
Food and Drug Administration, HHS Pt. 1
1.508 What corrective actions must I take 1.625 What records requirements must an
under my FSVP? accreditation body that has been recog-
1.509 How must the importer be identified nized meet?
at entry?
1.510 How must I maintain records of my PROCEDURES FOR RECOGNITION OF
FSVP? ACCREDITATION BODIES UNDER THIS SUBPART
1.511 What FSVP must I have if I am im- 1.630 How do I apply to FDA for recognition
porting a food subject to certain require- or renewal of recognition?
ments in the dietary supplement current 1.631 How will FDA review my application
good manufacturing practice regulation? for recognition or renewal of recognition
1.512 What FSVP may I have if I am a very and what happens once FDA decides on
small importer or if I am importing cer- my application?
tain food from certain small foreign sup- 1.632 What is the duration of recognition?
pliers? 1.633 How will FDA monitor recognized ac-
1.513 What FSVP may I have if I am import- creditation bodies?
ing certain food from a country with an 1.634 When will FDA revoke recognition?
officially recognized or equivalent food 1.635 What if I want to voluntarily relin-
safety system? quish recognition or do not want to
1.514 What are some consequences of failing renew recognition?
to comply with the requirements of this 1.636 How do I request reinstatement of rec-
subpart? ognition?
Subpart M—Accreditation of Third-Party ACCREDITATION OF THIRD-PARTY

Certification Bodies To Conduct Food CERTIFICATION BODIES UNDER THIS SUBPART
Safety Audits and To Issue Certifi- 1.640 Who is eligible to seek accreditation?
cations 1.641 What legal authority must a third-
party certification body have to qualify
1.600 What definitions apply to this sub- for accreditation?
part? 1.642 What competency and capacity must a
1.601 Who is subject to this subpart? third-party certification body have to
qualify for accreditation?
RECOGNITION OF ACCREDITATION BODIES
1.643 What protections against conflicts of
UNDER THIS SUBPART
interest must a third-party certification
1.610 Who is eligible to seek recognition? body have to qualify for accreditation?
1.611 What legal authority must an accredi- 1.644 What quality assurance procedures
tation body have to qualify for recogni- must a third-party certification body
tion? have to qualify for accreditation?
1.612 What competency and capacity must 1.645 What records procedures must a third-
an accreditation body have to qualify for party certification body have to qualify
recognition? for accreditation?
1.613 What protections against conflicts of
interest must an accreditation body have REQUIREMENTS FOR THIRD-PARTY CERTIFI-
to qualify for recognition? CATION BODIES THAT HAVE BEEN ACCRED-
1.614 What quality assurance procedures ITED UNDER THIS SUBPART
must an accreditation body have to qual- 1.650 How must an accredited third-party
ify for recognition? certification body ensure its audit agents
1.615 What records procedures must an ac- are competent and objective?
creditation body have to qualify for rec- 1.651 How must an accredited third-party
ognition? certification body conduct a food safety
audit of an eligible entity?
REQUIREMENTS FOR ACCREDITATION BODIES 1.652 What must an accredited third-party
THAT HAVE BEEN RECOGNIZED UNDER THIS certification body include in food safety
SUBPART audit reports?
1.620 How must a recognized accreditation 1.653 What must an accredited third-party
body evaluate third-party certification certification body do when issuing food
bodies seeking accreditation? or facility certifications?
1.621 How must a recognized accreditation 1.654 When must an accredited third-party
body monitor the performance of third- certification body monitor an eligible en-
party certification bodies it accredited? tity that it has issued a food or facility
1.622 How must a recognized accreditation certification?
body monitor its own performance? 1.655 How must an accredited third-party
1.623 What reports and notifications must a certification body monitor its own per-
recognized accreditation body submit to formance?
FDA? 1.656 What reports and notifications must

1.624 How must a recognized accreditation an accredited third-party certification
body protect against conflicts of inter- body submit?
est?
7
1.657 How must an accredited third-party records requirements of part 11 of this
certification body protect against con- chapter?
flicts of interest? 1.695 Are the records obtained by FDA
1.658 What records requirements must a under this subpart subject to public dis-
third-party certification body that has closure?
been accredited meet?
REQUIREMENTS FOR USER FEES UNDER THIS
PROCEDURES FOR ACCREDITATION OF THIRD- SUBPART
PARTY CERTIFICATION BODIES UNDER THIS
SUBPART 1.700 Who is subject to a user fee under this
subpart?
1.660 Where do I apply for accreditation or 1.705 What user fees are established under
renewal of accreditation by a recognized this subpart?
accreditation body and what happens 1.710 How will FDA notify the public about
once the recognized accreditation body the fee schedule?
decides on my application? 1.715 When must a user fee required by this
1.661 What is the duration of accreditation subpart be submitted?
by a recognized accreditation body? 1.720 Are user fees under this subpart re-
1.662 How will FDA monitor accredited fundable?
third-party certification bodies? 1.725 What are the consequences of not pay-
1.663 How do I request an FDA waiver or ing a user fee under this subpart on
waiver extension for the 13-month limit time?
for audit agents conducting regulatory
audits?
Subpart N [Reserved]
1.664 When would FDA withdraw accredita-
tion?
1.665 What if I want to voluntarily relin-
Subpart O—Sanitary Transportation of
quish accreditation or do not want to Human and Animal Food
renew accreditation? GENERAL PROVISIONS
1.666 How do I request reaccreditation?
1.900 Who is subject to this subpart?
ADDITIONAL PROCEDURES FOR DIRECT ACCRED- 1.902 How do the criteria and definitions in
ITATION OF THIRD-PARTY CERTIFICATION this subpart apply under the Federal
BODIES UNDER THIS SUBPART Food, Drug, and Cosmetic Act?
1.670 How do I apply to FDA for direct ac- 1.904 What definitions apply to this sub-
creditation or renewal of direct accredi- part?
tation?
1.671 How will FDA review my application VEHICLES AND TRANSPORTATION EQUIPMENT
for direct accreditation or renewal of di- 1.906 What requirements apply to vehicles
rect accreditation and what happens and transportation equipment?
once FDA decides on my application?
1.672 What is the duration of direct accredi- TRANSPORTATION OPERATIONS
tation? 1.908 What requirements apply to transpor-
REQUIREMENTS FOR ELIGIBLE ENTITIES UNDER tation operations?
THIS SUBPART
TRAINING
1.680 How and when will FDA monitor eligi-
1.910 What training requirements apply to
ble entities?
carriers engaged in transportation oper-
1.681 How frequently must eligible entities
ations?
be recertified?
RECORDS
GENERAL REQUIREMENTS OF THIS SUBPART
1.690 How will FDA make information 1.912 What record retention and other
about recognized accreditation bodies records requirements apply to shippers,
and accredited third-party certification receivers, loaders, and carriers engaged
bodies available to the public? in transportation operations?
1.691 How do I request reconsideration of a WAIVERS
denial by FDA of an application or a
waiver request? 1.914 Under what circumstances will we
1.692 How do I request internal agency re- waive a requirement of this subpart?
view of a denial of an application or 1.916 When will we consider whether to
waiver request upon reconsideration? waive a requirement of this subpart?
1.693 How do I request a regulatory hearing 1.918 What must be included in the State-
on a revocation of recognition or with- ment of Grounds in a petition requesting
drawal of accreditation? a waiver?

1.694 Are electronic records created under 1.920 What information submitted in a peti-
this subpart subject to the electronic tion requesting a waiver or submitted in
Food and Drug Administration, HHS § 1.4
comments on such a petition is publicly ments for net quantity declaration in
available? §§ 101.7(i), 201.62(h), 501.105(i), 701.13(i)
1.922 Who will respond to a petition request-
and 801.62(h) of this chapter, to initial
ing a waiver?
1.924 What process applies to a petition re- statement of ounces in the dual dec-
questing a waiver? laration of net quantity in §§ 101.7(j)
1.926 Under what circumstances may we and (m), 201.62(i) and (k), 501.105(j) and
deny a petition requesting a waiver? (m), 701.13(j) and (m) and 801.62(i) and
1.928 What process will we follow when (k) of this chapter, to initial statement
waiving a requirement of this subpart on
our own initiative? of inches in declaration of net quantity
1.930 When will a waiver that we grant be- in §§ 201.62(m), 701.13(o) and 801.62(m) of
come effective? this chapter, to initial statement of
1.932 Under what circumstances may we square inches in declaration of net
modify or revoke a waiver? quantity in §§ 201.62(n), 701.13(p) and
1.934 What procedures apply if we determine
801.62(n) of this chapter, to prohibition
that a waiver should be modified or re-
voked? of certain supplemental net quantity
statements in §§ 101.7(o), 201.62(o),
Subpart P [Reserved] 501.105(o), 701.13(q) and 801.62(o) of this
chapter, and to servings representa-
Subpart Q—Administrative Detention of tions in § 501.8 of this chapter are pro-
Drugs Intended for Human or Animal Use vided for solely by the Fair Packaging
1.980 Administrative detention of drugs. and Labeling Act. The other require-
AUTHORITY: 15 U.S.C. 1333, 1453, 1454, 1455,
ments of this part are issued under
4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, both the Fair Packaging and Labeling
332, 333, 334, 335a, 342, 343, 350c, 350d, 350e, Act and the Federal Food, Drug, and
350j, 350k, 352, 355, 360b, 360ccc, 360ccc–1, Cosmetic Act, or by the latter act sole-
360ccc–2, 362, 371, 373, 374, 379j–31, 381, 382, ly, and are not limited in their applica-
384a, 384b, 384d, 387, 387a, 387c, 393; 42 U.S.C. tion by section 10 of the Fair Pack-
216, 241, 243, 262, 264, 271; Pub. L. 107–188, 116
Stat. 594, 668–69; Pub. L. 111–353, 124 Stat. aging and Labeling Act.
3885, 3889. [42 FR 15553, Mar. 22, 1977, as amended at 58
SOURCE: 42 FR 15553, Mar. 22, 1977, unless FR 17085, Apr. 1, 1993; 75 FR 73953, Nov. 30,
otherwise noted. 2010; 78 FR 69543, Nov. 20, 2013; 81 FR 59131,
Aug. 29, 2016]
Subpart A—General Provisions § 1.3 Definitions.
§ 1.1 General. (a) Labeling includes all written,
(a) The provisions of regulations pro- printed, or graphic matter accom-
mulgated under the Federal Food, panying an article at any time while
Drug, and Cosmetic Act with respect to such article is in interstate commerce
the doing of any act shall be applicable or held for sale after shipment or deliv-
also to the causing of such act to be ery in interstate commerce.
done. (b) Label means any display of writ-
(b) The definitions and interpreta- ten, printed, or graphic matter on the
tions of terms contained in sections 201 immediate container of any article, or
and 900 of the Federal Food, Drug, and any such matter affixed to any con-
Cosmetic Act (21 U.S.C. 321 and 387) sumer commodity or affixed to or ap-
shall be applicable also to such terms pearing upon a package containing any
when used in regulations promulgated consumer commodity.
under that act.
(c) The definition of package in § 1.20 § 1.4 Authority citations.
and of principal display panel in §§ 101.1,
201.60, 501.1, 701.10 and 801.60 of this (a) For each part of its regulations,
chapter; and the requirements per- the Food and Drug Administration in-
taining to uniform location, lack of cludes a centralized citation of all of
qualification, and separation of the net the statutory provisions that provide
quantity declaration in §§ 101.7(f), authority for any regulation that is in-
201.62(e), 501.105(f), 701.13(f) and 801.62(e) cluded in that part.

of this chapter to type size require-
§ 1.20 21 CFR Ch. I (4–1–19 Edition)
(b) The agency may rely on any one which any food, drug, device, or cos-
or more of the authorities that are list- metic is enclosed for use in the deliv-
ed for a particular part in imple- ery or display of such commodities to
menting or enforcing any section in retail purchasers, but does not include:
that part. (a) Shipping containers or wrappings
(c) All citations of authority in this used solely for the transportation of
chapter will list the applicable sections any such commodity in bulk or in
in the organic statute if the statute is quantity to manufacturers, packers,
the Federal Food, Drug, and Cosmetic processors, or wholesale or retail dis-
Act, the Public Health Service Act, or tributors;
the Fair Packaging and Labeling Act. (b) Shipping containers or outer
References to an act or a section there- wrappings used by retailers to ship or
of include references to amendments to deliver any such commodity to retail
that act or section. These citations customers if such containers and wrap-
will also list the corresponding United pings bear no printed matter per-
States Code (U.S.C.) sections. For ex- taining to any particular commodity;
ample, a citation to section 701 of the or
Federal Food, Drug, and Cosmetic Act (c) Containers subject to the provi-
would be listed: Sec. 701 of the Federal sions of the Act of August 3, 1912 (37
Food, Drug, and Cosmetic Act (21 Stat. 250, as amended; 15 U.S.C. 231–
U.S.C. 371). 233), the Act of March 4, 1915 (38 Stat.
(d) If the organic statute is one other 1186, as amended; 15 U.S.C. 234–236), the
than those specified in paragraph (c) of Act of August 31, 1916 (39 Stat. 673, as
this section, the citations of authority amended; 15 U.S.C. 251–256), or the Act
in this chapter generally will list only of May 21, 1928 (45 Stat. 635, as amend-
the applicable U.S.C. sections. For ex- ed; 15 U.S.C. 257–257i).
ample, a citation to section 552 of the (d) Containers used for tray pack dis-
Administrative Procedure Act would be plays in retail establishments.
listed: 5 U.S.C. 552. The agency may, (e) Transparent wrappers or con-
where it determines that such meas- tainers which do not bear written,
ures are in the interest of clarity and printed, or graphic matter obscuring
public understanding, list the applica- the label information required by this
ble sections in the organic statute and part.
the corresponding U.S.C. section in the
same manner set out in paragraph (c) A requirement contained in this part
of this section. References to an act or that any word, statement, or other in-
a section thereof include references to formation appear on the label shall not
amendments to that act or section. be considered to be complied with un-
(e) Where there is no U.S.C. provi- less such word, statement, or informa-
sion, the agency will include a citation tion also appears on the outer con-
to the U.S. Statutes at Large. Cita- tainer or wrapper of the retail package
tions to the U.S. Statutes at Large will of the article, or, as stated in para-
refer to volume and page. graph (e) of this section, such informa-
(f) The authority citations will in- tion is easily legible by virtue of the
clude a citation to executive delega- transparency of the outer wrapper or
tions (i.e., Executive Orders), if any, container. Where a consumer com-
necessary to link the statutory author- modity is marketed in a multiunit re-
ity to the agency. tail package bearing the mandatory
label information as required by this
[54 FR 39630, Sept. 27, 1989] part and the unit containers are not in-
tended to be sold separately, the net
Subpart B—General Labeling weight placement requirement of
Requirements § 101.7(f) applicable to such unit con-
tainers is waived if the units are in
§ 1.20 Presence of mandatory label in- compliance with all the other require-
formation. ments of this part.
In the regulations specified in § 1.1(c)
[42 FR 15553, Mar. 22, 1977, as amended at 75

of this chapter, the term package FR 73953, Nov. 30, 2010; 78 FR 69543, Nov. 20,
means any container or wrapping in 2013; 81 FR 59131, Aug. 29, 2016]
10
§ 1.21 Failure to reveal material facts. Section 502(b) of the act provides for
(a) Labeling of a food, drug, device, the establishment by regulation of rea-
cosmetic, or tobacco product shall be sonable variations and exemptions for
deemed to be misleading if it fails to small packages from the required dec-
reveal facts that are: laration of net quantity of contents.
(1) Material in light of other rep- Section 602(b) of the act provides for
resentations made or suggested by the establishment by regulation of rea-
statement, word, design, device or any sonable variations and exemptions for
combination thereof; or small packages from the required dec-
(2) Material with respect to con- laration of net quantity of contents.
sequences which may result from use of Section 5(b) of the Fair Packaging and
the article under: (i) The conditions Labeling Act provides for the establish-
prescribed in such labeling or (ii) such ment by regulation of exemptions from
conditions of use as are customary or certain required declarations of net
usual. quantity of contents, identity of com-
(b) Affirmative disclosure of material modity, identity and location of manu-
facts pursuant to paragraph (a) of this facturer, packer, or distributor, and
section may be required, among other from declaration of net quantity of
appropriate regulatory procedures, by servings represented, based on a find-
(1) Regulations in this chapter pro- ing that full compliance with such re-
mulgated pursuant to section 701(a) of quired declarations is impracticable or
the act; or not necessary for the adequate protec-
(2) Direct court enforcement action. tion of consumers, and a further find-
(c) Paragraph (a) of this section does ing that the nature, form, or quantity
not: of the packaged consumer commodity
(1) Permit a statement of differences or other good and sufficient reasons
of opinion with respect to warnings (in- justify such exemptions. The Commis-
cluding contraindications, precautions, sioner, on his own initiative or on peti-
adverse reactions, and other information of an interested person, may pro-
tion relating to possible product haz- pose a variation or exemption based
ards) required in labeling for food, upon any of the foregoing statutory
drugs, devices, cosmetics, or tobacco provisions, including proposed findings
products under the Federal Food, Drug, if section 5(b) of the Fair Packaging
and Cosmetic Act. and Labeling Act applies, pursuant to
(2) Permit a statement of differences
parts 10, 12, 13, 14, 15, 16, and 19 of this
of opinion with respect to the effective-
chapter.
ness of a drug unless each of the opin-
ions expressed is supported by substan- § 1.24 Exemptions from required label
tial evidence of effectiveness as defined statements.
in sections 505(d) and 512(d) of the act.
The following exemptions are grant-
[42 FR 15553, Mar. 22, 1977, as amended at 77 ed from label statements required by
FR 5176, Feb. 2, 2012]
this part:
§ 1.23 Procedures for requesting vari- (a) Foods. (1) While held for sale, a
ations and exemptions from re- food shall be exempt from the required
quired label statements. declaration of net quantity of contents
Section 403(e) of the act (in this part specified in this part if said food is re-
1, the term act means the Federal ceived in bulk containers at a retail es-
Food, Drug, and Cosmetic Act) pro- tablishment and is accurately weighed,
vides for the establishment by regula- measured, or counted either within the
tion of reasonable variations and ex- view of the purchaser or in compliance
emptions for small packages from the with the purchaser’s order.
required declaration of net quantity of (2) Random food packages, as defined
contents. Section 403(i) of the act pro- in § 101.7(j) of this chapter, bearing la-
vides for the establishment by regula- bels declaring net weight, price per
tion of exemptions from the required pound or per specified number of
declaration of ingredients where such pounds, and total price shall be exempt
declaration is impracticable, or results from the type size, dual declaration,

in deception or unfair competition. and placement requirements of § 101.7
11
§ 1.24 21 CFR Ch. I (4–1–19 Edition)
of this chapter if the accurate state- declaration regarding name and place
ment of net weight is presented con- of business required by § 101.5 of this
spicuously on the principal display chapter if the package does not obscure
panel of the package. In the case of the declaration on unit containers or if
food packed in random packages at one it bears a statement that the declara-
place for subsequent shipment and sale tion can be found on the unit con-
at another, the price sections of the tainers and the declaration on the unit
label may be left blank provided they containers complies with § 101.5 of this
are filled in by the seller prior to retail chapter. The declaration required by
sale. This exemption shall also apply to § 101.5 of this chapter may appear on
uniform weight packages of cheese and the top or side of the closure of bottled
cheese products labeled in the same soft drinks if the statement is con-
manner and by the same type of equip- spicuous and easily legible.
ment as random food packages exempt-
(iii) Soft drinks packaged in bottles
ed by this paragraph (a)(2) except that
which display other required label in-
the labels shall bear a declaration of
formation only on the closure shall be
price per pound and not price per speci-
fied number of pounds. exempt from the placement require-
(3) Individual serving-size packages ments for the declaration of contents
of foods containing less than 1⁄2 ounce prescribed by § 101.7(f) of this chapter if
or less than 1⁄2 fluid ounce for use in the required content declaration is
restaurants, institutions, and pas- blown, formed, or molded into the sur-
senger carriers, and not intended for face of the bottle in close proximity to
sale at retail, shall be exempt from the the closure.
required declaration of net quantity of (iv) Where a trademark on a soft
contents specified in this part. drink package also serves as, or is, a
(4) Individually wrapped pieces of statement of identity, the use of such
penny candy and other confectionery of trademark on the package in lines not
less than one-half ounce net weight per parallel to the base on which the pack-
individual piece shall be exempt from age rests shall be exempted from the
the labeling requirements of this part requirement of § 101.3(d) of this chapter
when the container in which such con- that the statement be in lines parallel
fectionery is shipped is in conformance to the base so long as there is also at
with the labeling requirements of this least one statement of identity in lines
part. Similarly, when such confec- generally parallel to the base.
tionery items are sold in bags or boxes, (v) A multiunit retail package for
such items shall be exempt from the la- soft drinks in cans shall be exempt
beling requirements of this part, in- from the declaration regarding name
cluding the required declaration of net and place of business required by § 101.5
quantity of contents specified in this of this chapter if the package does not
part when the declaration on the bag
obscure the declaration on unit con-
or box meets the requirements of this
tainers or if it bears a statement that
part.
the declaration can be found on the
(5)(i) Soft drinks packaged in bottles
shall be exempt from the placement re- unit containers and the declaration on
quirements for the statement of iden- the unit containers complies with
tity prescribed by § 101.3 (a) and (d) of § 101.5 of this chapter. The declaration
this chapter if such statement appears required by § 101.5 of this chapter may
conspicuously on the bottle closure. appear on the top of soft drinks in cans
When such soft drinks are marketed in if the statement is conspicuous and
a multiunit retail package, the multi- easily legible, provided that when the
unit retail package shall be exempt declaration is embossed, it shall appear
from the statement of identity declara- in type size at least one-eighth inch in
tion requirements prescribed by § 101.3 height, or if it is printed, the type size
of this chapter if the statement of iden- shall not be less than one-sixteenth
tity on the unit container is not ob- inch in height. The declaration may
scured by the multiunit retail package. follow the curvature of the lid of the
(ii) A multiunit retail package for can and shall not be removed or ob-
soft drinks shall be exempt from the scured by the tab which opens the can.
12
(6)(i) Ice cream, french ice cream, ice (iii) The foods named in paragraph
milk, fruit sherbets, water ices, quies- (a)(6)(i) of this section, when measured
cently frozen confections (with or with- by and packaged in 1⁄2-liquid pint, 1–liq-
out dairy ingredients), special dietary uid pint, 1–liquid quart, 1⁄2-gallon, and
frozen desserts, and products made in 1–gallon measured-containers, as de-
semblance of the foregoing, when fined in the ‘‘Measure Container Code
measured by and packaged in 1⁄2-liquid of National Bureau of Standards Hand-
pint and 1⁄2-gallon measure-containers, book 44,’’ Specifications, Tolerances,
as defined in the ‘‘Measure Container and Other Technical Requirements for
Code of National Bureau of Standards Weighing and Measuring Devices, Sec.
Handbook 44,’’ Specifications, Toler- 4.45 ‘‘Measure-Containers,’’ which is in-
ances, and Other Technical Require- corporated by reference, are exempt
ments for Weighing and Measuring De- from the requirement of § 101.7(f) of this
vices, Sec. 4.45 ‘‘Measure-Containers,’’ chapter that the declaration of net
which is incorporated by reference, are contents be located within the bottom
exempt from the requirements of 30 percent of the principal display
§ 101.7(b)(2) of this chapter to the extent panel. Copies are available from the
that net contents of 8–fluid ounces and Center for Food Safety and Applied Nu-
64–fluid ounces (or 2 quarts) may be ex- trition (HFS–150), Food and Drug Ad-
pressed as 1⁄2 pint and 1⁄2 gallon, respec- ministration, 5001 Campus Dr., College
tively. Copies are available from the Park, MD 20740, or at the National Ar-
chives and Records Administration
Center for Food Safety and Applied Nu-
(NARA). For information on the avail-
trition (HFS–150), Food and Drug Ad-
ability of this material at NARA, call
ministration, 5001 Campus Dr., College
202–741–6030, or go to: http://
Park, MD 20740, or at the National Ar-
www.archives.gov/federallregister/
chives and Records Administration
codeloflfederallregulations/
(NARA). For information on the avail- ibrllocations.html.
ability of this material at NARA, call (7)(i) Milk, cream, light cream, coffee
202–741–6030, or go to: http:// or table cream, whipping cream, light
www.archives.gov/federallregister/ whipping cream, heavy or heavy whip-
codeloflfederallregulations/ ping cream, sour or cultured sour
ibrllocations.html. cream, half-and-half, sour or cultured
(ii) The foods named in paragraph half-and-half, reconstituted or recom-
(a)(6)(i) of this section, when measured bined milk and milk products, con-
by and packaged in 1–liquid pint, 1–liq- centrated milk and milk products,
uid quart, and 1⁄2-gallon measure-con- skim or skimmed milk, vitamin D milk
tainers, as defined in the ‘‘Measure and milk products, fortified milk and
Container Code of National Bureau of milk products, homogenized milk, fla-
Standards Handbook 44,’’ Specifica- vored milk and milk products, butter-
tions, Tolerances, and Other Technical milk, cultured buttermilk, cultured
Requirements for Weighing and Meas- milk or cultured whole buttermilk,
uring Devices, Sec. 4.45 ‘‘Measure-Con- low-fat milk (0.5 to 2.0 percent but-
tainers,’’ which is incorporated by ref- terfat), and acidified milk and milk
erence, are exempt from the dual net- products, when packaged in containers
contents declaration requirement of of 8- and 64-fluid-ounce capacity, are
§ 101.105(j) of this chapter. Copies are exempt from the requirements of
available from the Center for Food § 101.7(b)(2) of this chapter to the extent
Safety and Applied Nutrition (HFS– that net contents of 8 fluid ounces and
150), Food and Drug Administration, 64 fluid ounces (or 2 quarts) may be ex-
5001 Campus Dr., College Park, MD pressed as 1⁄2 pint and 1⁄2 gallon, respec-
20740, or at the National Archives and tively.
Records Administration (NARA). For (ii) The products listed in paragraph
information on the availability of this (a)(7)(i) of this section, when packaged
material at NARA, call 202–741–6030, or in glass or plastic containers of 1⁄2-pint,
go to: http://www.archives.gov/ 1–pint, 1–quart, 1⁄2-gallon, and 1–gallon
federallregister/ capacities are exempt from the place-
codeloflfederallregulations/ ment requirement of § 101.7(f) of this

ibrllocations.html. chapter that the declaration of net
13
§ 1.24 21 CFR Ch. I (4–1–19 Edition)
contents be located within the bottom context of the content declaration is

30 percent of the principal display destroyed upon division of the carton.
panel, provided that other required (10) Butter as defined in 42 Stat. 1500
label information is conspicuously dis- (excluding whipped butter):
played on the cap or outside closure (i) In 8–ounce and in 1–pound pack-
and the required net quantity of con- ages is exempt from the requirements
tents declaration is conspicuously of § 101.7(f) of this chapter that the net
blown, formed, or molded into or per- contents declaration be placed within
manently applied to that part of the the bottom 30 percent of the area of the
glass or plastic container that is at or principal display panel;
above the shoulder of the container. (ii) In 1–pound packages is exempt
(iii) The products listed in paragraph from the requirements of § 101.7(j)(1) of
(a)(7)(i) of this section, when packaged this chapter that such declaration be
in containers of 1–pint, 1–quart, and 1⁄2- in terms of ounces and pounds, to per-
gallon capacities are exempt from the mit declaration of ‘‘1–pound’’ or ‘‘one
dual net-contents declaration require- pound’’; and
ment of § 101.7(j) of this chapter. (iii) In 4–ounce, 8–ounce, and 1–pound
(8) Wheat flour products, as defined packages with continuous label copy
by §§ 137.105, 137.155, 137.160, 137.165, wrapping is exempt from the require-
137.170, 137.175, 137.180, 137.185, 137.200, ments of §§ 101.3 and 101.7(f) of this
and 137.205 of this chapter, packaged: chapter that the statement of identity
(i) In conventional 2–, 5–, 10–, 25–, 50– and net contents declaration appear in
, and 100–pound packages are exempt lines generally parallel to the base on
from the placement requirement of which the package rests as it is de-
§ 101.7(f) of this chapter that the dec- signed to be displayed, provided that
laration of net contents be located such statement and declaration are not
within the bottom 30 percent of the so positioned on the label as to be mis-
area of the principal display panel of leading or difficult to read as the pack-
the label; and age is customarily displayed at retail.
(ii) In conventional 2–pound packages (11) Margarine as defined in § 166.110
are exempt from the dual net-contents of this chapter and imitations thereof
declaration requirement of § 101.105(j) in 1–pound rectangular packages, ex-
of this chapter provided the quantity of cept for packages containing whipped
contents is expressed in pounds. or soft margarine or packages that
(9)(i) Twelve shell eggs packaged in a contain more than four sticks, are ex-
carton designed to hold 1 dozen eggs empt from the requirement of § 101.7(f)
and designed to permit the division of of this chapter that the declaration of
such carton by the retail customer at the net quantity of contents appear
the place of purchase into two portions within the bottom 30 percent of the
of one-half dozen eggs each are exempt principal display panel and from the
from the labeling requirements of this requirement of § 101.7(j)(1) of this chap-
part with respect to each portion of ter that such declaration be expressed
such divided carton if the carton, when both in ounces and in pounds to permit
undivided, is in conformance with the declaration of ‘‘1-pound’’ or ‘‘one
labeling requirements of this part. pound,’’ provided an accurate state-
(ii) Twelve shell eggs packaged in a ment of net weight appears conspicu-
carton designed to hold 1 dozen eggs ously on the principal display panel of
are exempt from the placement re- the package.
quirements for the declaration of con- (12) Corn flour and related products,
tents prescribed by § 101.7(f) of this as they are defined by §§ 137.211, 137.215,
chapter if the required content declara- and §§ 137.230 through 137.290 of this
tion is otherwise placed on the prin- chapter, packaged in conventional 5–,
cipal display panel of such carton and 10–, 25–, 50–, and 100–pound bags are ex-
if, in the case of such cartons designed empt from the placement requirement
to permit division by retail customers of § 101.7(f) of this chapter that the dec-
into two portions of one-half dozen laration of net contents be located
eggs each, the required content dec- within the bottom 30 percent of the
laration is placed on the principal dis- area of the principal display panel of
play panel in such a manner that the the label.
14
(13)(i) Single strength and less than (iii) Each unit container is labeled
single strength fruit juice beverages, with the statement ‘‘This Unit Not La-
imitations thereof, and drinking water beled For Retail Sale’’ in type size not
when packaged in glass or plastic con- less than one-sixteenth of an inch in
tainers of 1⁄2-pint, 1–pint, 1–quart, 1⁄2- height. The word ‘‘Individual’’ may be
gallon, and 1–gallon capacities are ex- used in lieu of or immediately pre-
empt from the placement requirement ceding the word ‘‘Retail’’ in the state-
of § 101.7(f) of this chapter that the dec- ment.
laration of net contents be located (b) Drugs. Liquid over-the-counter
within the bottom 30 percent of the veterinary preparations intended for
principal display panel: Provided, That injection shall be exempt from the dec-
other required label information is laration of net quantity of contents in
conspicuously displayed on the cap or terms of the U.S. gallon of 231 cubic
outside closure and the required net inches and quart, pint, and fluid-ounce
quantity of contents declaration is subdivisions thereof as required by
conspicuously blown, formed, or mold- § 201.62 (b), (i), and (j) of this chapter,
ed into or permanently applied to that and from the dual declaration require-
part of the glass or plastic container ments of § 201.62(i) of this chapter, if
that is at or above the shoulder of the such declaration of net quantity of
container. contents is expressed in terms of the
(ii) Single strength and less than sin- liter and milliliter, or cubic centi-
gle strength fruit juice beverages, imi- meter, with the volume expressed at 68
tations thereof, and drinking water °F (20 °C).
when packaged in glass, plastic, or (c) Cosmetics. Cosmetics in packages
paper (fluid milk type) containers of 1– containing less than one-fourth ounce
pint, 1–quart, and 1⁄2-gallon capacities avoirdupois or one-eighth fluid ounce
are exempt from the dual net-contents shall be exempt from compliance with
declaration requirement of § 101.7(j) of the requirements of section 602(b)(2) of
this chapter. the Federal Food, Drug, and Cosmetic
(iii) Single strength and less than Act and section 4(a)(2) of the Fair
single strength fruit juice beverages, Packaging and Labeling Act:
imitations thereof, and drinking water (1) When such cosmetics are affixed
when packaged in glass, plastic, or to a display card labeled in conform-
paper (fluid milk type) containers of 8- ance with all labeling requirements of
and 64-fluid-ounce capacity, are exempt this part; or
from the requirements of § 101.7(b)(2) of (2) When such cosmetics are sold at
this chapter to the extent that net con- retail as part of a cosmetic package
tents of 8 fluid ounces and 64 fluid consisting of an inner and outer con-
ounces (or 2 quarts) may be expressed tainer and the inner container is not
as 1⁄2 pint (or half pint) and 1⁄2 gallon for separate retail sale and the outer
(or half gallon), respectively. container is labeled in conformance
(14) The unit containers in a multi- with all labeling requirements of this
unit or multicomponent retail food part.
package shall be exempt from regula-
tions of section 403 (e)(1), (g)(2), (i)(2), [42 FR 15553, Mar. 22, 1977, as amended at 47
(k), and (q) of the act with respect to FR 946, Jan. 8, 1982; 47 FR 32421, July 27, 1982;
49 FR 13339, Apr. 4, 1984; 54 FR 9033, Mar. 3,
the requirements for label declaration
1989; 58 FR 2174, Jan. 6, 1993; 61 FR 14478, Apr.
of the name and place of business of 2, 1996; 66 FR 56035, Nov. 6, 2001; 81 FR 49895,
the manufacturer, packer, or dis- July 29, 2016; 81 FR 59131, Aug. 29, 2016]
tributor; label declaration of ingredi-
ents; and nutrition information when:
(i) The multiunit or multicomponent
Subpart C [Reserved]
retail food package labeling meets all
the requirements of this part; Subpart D—Electronic Import
(ii) The unit containers are securely Entries
enclosed within and not intended to be
separated from the retail package SOURCE: 81 FR 85870, Nov. 29, 2016, unless
under conditions of retail sale; and otherwise noted.
15
§ 1.70 21 CFR Ch. I (4–1–19 Edition)
§ 1.70 Scope. Food means food as defined in section

201(f) of the Federal Food, Drug, and
This subpart specifies the data ele-
Cosmetic Act.
ments that are required by the Food
and Drug Administration (FDA) to be Food contact substance means any
included in an electronic import entry substance, as defined in section
submitted in the Automated Commer- 409(h)(6) of the Federal Food, Drug, and
cial Environment (ACE) system or any Cosmetic Act, that is intended for use
other U.S. Customs and Border Protec- as a component of materials used in
tion (CBP)-authorized electronic data manufacturing, packing, packaging,
interchange (EDI) system, which con- transporting, or holding food if such
tains an article that is being imported use is not intended to have any tech-
or offered for import into the United nical effect in such food.
States and that is regulated by FDA. HCT/Ps means human cells, tissues,
or cellular or tissue-based products, as
§ 1.71 Definitions. defined in § 1271.3(d) of this chapter.
Low-acid canned food means a ther-
For purposes of subpart D:
mally processed low-acid food (as de-
ACE filer means the person who is au- fined in § 113.3(n) of this chapter) in a
thorized to submit an electronic im- hermetically sealed container (as de-
port entry for an FDA-regulated prod- fined in § 113.3(j) of this chapter), and
uct in the Automated Commercial En- subject to the requirements in parts 108
vironment or any other CBP-author- and 113 of this chapter.
ized EDI system.
Medical device means a device as de-
Acidified food means acidified food, as fined in section 201(h) of the Federal
defined in § 114.3(b) of this chapter, and Food, Drug, and Cosmetic Act, that is
subject to the requirements in parts 108 intended for use in humans.
and 114 of this chapter.
Radiation-emitting electronic product
Automated Commercial Environment or means an electronic product as defined
ACE means the automated and elec- in section 531 of the Federal Food,
tronic system for processing commer- Drug, and Cosmetic Act.
cial importations that is operated by Tobacco product means a tobacco
U.S. Customs and Border Protection in product as defined in section 201(rr) of
accordance with the National Customs the Federal Food, Drug, and Cosmetic
Automation Program established in Act.
Subtitle B of Title VI—Customs Mod-
ernization, in the North American Free § 1.72 Data elements that must be sub-
Trade Agreement Implementation Act mitted in ACE for articles regulated
(Pub. L. 103–182, 107 Stat. 2057, 2170, De- by FDA.
cember 8, 1993) (Customs Modernization General. When filing an entry in ACE,
Act), or any other CBP-authorized EDI the ACE filer shall submit the fol-
system. lowing information for food contact
Biological product means a biological substances, drugs, biological products,
product as defined in section 351(i)(1) of HCT/Ps, medical devices, radiation-
the Public Health Service Act. emitting electronic products, cos-
Cosmetic means a cosmetic as defined metics, and tobacco products.
in section 201(i) of the Federal Food, (a) Product identifying information for
Drug, and Cosmetic Act. the article that is being imported or of-
CBP or U.S. Customs and Border Pro- fered for import. This consists of:
tection means the Federal Agency that (1) FDA Country of Production, which
is primarily responsible for maintain- is the country where the article was
ing the integrity of the borders and last manufactured, processed, or grown
ports of entry of the United States. (including harvested, or collected and
Drug means those articles meeting readied for shipment to the United
the definition of a drug in section States). The FDA Country of Produc-
201(g)(1) of the Federal Food, Drug, and tion for an article that has undergone
Cosmetic Act. any manufacturing or processing is the
FDA or Agency means the U.S. Food country where that activity occurred
and Drug Administration. provided that the manufacturing or
16
processing had more than a minor, neg- ported or offered for import into the
ligible, or insignificant effect on the United States is required to register
article. and list the drug under part 207 of this
(2) The Complete FDA Product Code, chapter. For the purposes of this sec-
which must be consistent with the in- tion, the Drug Registration Number
voice description of the product. that must be submitted at the time of
(3) The Full Intended Use Code. entry in ACE is the unique facility
(b) Importer of record contact informa- identifier of the foreign establishment
tion, which is the telephone and email where the human drug was manufac-
address of the importer of record. tured, prepared, propagated, com-
pounded, or processed before being im-
§ 1.73 Food. ported or offered for import into the
(a) Food contact substances. An ACE United States. The unique facility
filer must submit the information identifier is the identifier submitted by
specified in § 1.72 at the time of filing a registrant in accordance with the
entry in ACE for food that is a food system specified under section 510(b) of
contact substance. the Federal Food, Drug, and Cosmetic
(b) Low-acid canned food. For an arti- Act. For the purposes of this section,
cle of food that is a low-acid canned the Drug Listing Number is the Na-
food, the ACE filer must submit at the tional Drug Code number of the human
time of filing entry the Food Canning drug article being imported or offered
Establishment Number and the Sub- for import.
mission Identifier, and can dimensions (b) Drug application number. For a
or volume, except that the ACE filer drug intended for human use that is
does not need to submit this informa- the subject of an approved application
tion in ACE at the time of entry if the under section 505(b) or 505(j) of the Fed-
article is being imported or offered for eral Food, Drug, and Cosmetic Act, the
import for laboratory analysis only number of the new drug application or
and will not be taste tested or other- abbreviated new drug application. For
wise ingested. a biological product regulated by the
(c) Acidified food. For an article of FDA Center for Drug Evaluation and
food that is an acidified food, the ACE Research that is required to have an
filer must submit at the time of filing approved new drug application or an
entry the Food Canning Establishment approved biologics license application,
Number and the Submission Identifier, the number of the applicable applica-
and can dimensions or volume, except tion.
that the ACE filer does not need to (c) Investigational new drug application
submit this information in ACE at the number. For a drug intended for human
time of entry if the article is being im- use that is the subject of an investiga-
ported or offered for import for labora- tional new drug application under sec-
tory analysis only and will not be taste tion 505(i) of the Federal Food, Drug,
tested or otherwise ingested. and Cosmetic Act, the number of the
investigational new drug application.
§ 1.74 Human drugs.
In addition to the data required to be § 1.75 Animal drugs.
submitted in § 1.72, an ACE filer must In addition to the data required to be
submit the following information at submitted in § 1.72, an ACE filer must
the time of filing entry in ACE for submit the following information at
drugs, including biological products, the time of filing entry in ACE for ani-
intended for human use that are regu- mal drugs:
lated by the FDA Center for Drug Eval- (a) Registration and listing. For a drug
uation and Research. intended for animal use, the Drug Reg-
(a) Registration and listing. For a drug istration Number and the Drug Listing
intended for human use, the Drug Reg- Number if the foreign establishment
istration Number and the Drug Listing where the drug was manufactured, pre-
Number if the foreign establishment pared, propagated, compounded, or
where the human drug was manufac- processed before being imported or of-
tured, prepared, propagated, com- fered for import into the United States
pounded, or processed before being im- is required to register and list the drug
17
§ 1.76 21 CFR Ch. I (4–1–19 Edition)
under part 207 of this chapter. For the Center for Devices and Radiological
purposes of this section, the Drug Reg- Health.
istration Number that must be sub- (a) Registration and listing. For a med-
mitted in ACE is the Unique Facility ical device, the Registration Number
Identifier of the foreign establishment for Foreign Manufacturers, Foreign Ex-
where the animal drug was manufac- porters, and/or Domestic Manufactur-
tured, prepared, propagated, com- ers, and the Device Listing Number, re-
pounded, or processed before being im- quired under section 510 of the Federal
ported or offered for import into the Food, Drug, and Cosmetic Act and part
United States. The Unique Facility 807 of this chapter.
Identifier is the identifier submitted by (b) Investigational devices. For an in-
a registrant in accordance with the vestigational medical device that has
system specified under section 510(b) of an investigational device exemption
the Federal Food, Drug, and Cosmetic granted under section 520(g) of the Fed-
Act. For the purposes of this section, eral Food, Drug, and Cosmetic Act, the
the Drug Listing Number is the Na-
Investigational Device Exemption
tional Drug Code number of the animal
Number. For an investigational med-
drug article being imported or offered
ical device being imported or offered
for import.
for import for use in a nonsignificant
(b) New animal drug application num-
risk or exempt study, ‘‘NSR’’ to be en-
ber. For a drug intended for animal use
tered in the Affirmation of Compliance
that is the subject of an approved ap-
for the ‘‘investigational device exemp-
plication under section 512 of the Fed-
tion’’ that identifies the device as
eral Food, Drug, and Cosmetic Act, the
being used in a nonsignificant risk or
number of the new animal drug appli-
cation or abbreviated new animal drug exempt study.
application. For a drug intended for (c) Premarket number. For a medical
animal use that is the subject of a con- device that has one, the Premarket
ditionally approved application under Number. This is the Premarket Ap-
section 571 of the Federal Food, Drug, proval Number for those medical de-
and Cosmetic Act, the application vices that have received premarket ap-
number for the conditionally approved proval under section 515 of the Federal
new animal drug. Food, Drug, and Cosmetic Act; the
(c) Veterinary minor species index file Product Development Protocol Number
number. For a drug intended for use in for those medical devices for which
animals that is the subject of an Index FDA has declared the product develop-
listing under section 572 of the Federal ment protocol complete under section
Food, Drug, and Cosmetic Act, the 515(f) of the Federal Food, Drug, and
Minor Species Index File number of the Cosmetic Act; the De Novo number for
new animal drug on the Index of Le- those medical devices granted mar-
gally Marketed Unapproved New Ani- keting authorization under section
mal Drugs for Minor Species. 513(f)(2) of the Federal Food, Drug, and
(d) Investigational new animal drug Cosmetic Act; the Premarket Notifica-
number. For a drug intended for animal tion Number for those medical devices
use that is the subject of an investiga- that received premarket clearance
tional new animal drug or generic in- under section 510(k) of the Federal
vestigational new animal drug applica- Food, Drug, and Cosmetic Act; or the
tion under part 511 of this chapter, the Humanitarian Device Exemption Num-
number of the investigational new ani- ber for those medical devices for which
mal drug or generic investigational an exemption has been granted under
new animal drug file. section 520(m) of the Federal Food,
Drug, and Cosmetic Act.
§ 1.76 Medical devices. (d) Component. If applicable for a
In addition to the data required to be medical device, an affirmation identi-
submitted in § 1.72, an ACE filer must fying that the article being imported
submit the following information at or offered for import is a component
the time of filing entry in ACE for that requires further processing or in-
medical devices regulated by the FDA clusion into a finished medical device.
18
(e) Lead wire/patient cable. For elec- Compliance with the applicable re-
trode lead wires and patient cables in- quirements of part 1271 of this chapter.
tended for use with a medical device, (c) Licensed biological products. For a
an Affirmation of Compliance with the biological product that is the subject of
applicable performance standard under an approved biologics license applica-
§ 898.12 of this chapter. tion under section 351 of the Public
(f) Impact resistant lens. For impact Health Service Act, the Submission
resistant lenses in eyeglasses and sun- Tracking Number of the biologics li-
glasses, an Affirmation of Compliance cense application and/or the Biologics
with the applicable requirements of License Number.
§ 801.410 of this chapter. (d) Drug registration. For a drug in-
(g) Convenience kit. If applicable for a tended for human use, the Drug Reg-
medical device, an Affirmation of Com- istration Number if the foreign estab-
pliance that the article imported or of- lishment where the human drug was
fered for import is a convenience kit or manufactured, prepared, propagated,
part of a convenience kit. compounded, or processed before being
imported or offered for import into the
§ 1.77 Radiation-emitting electronic United States is required to register
products. the drug under part 207 or part 607 of
In addition to the data required to be this chapter as applicable. For the pur-
submitted in § 1.72, an ACE filer must poses of this section, the Drug Reg-
submit all of the declarations required istration Number that must be sub-
in Form FDA 2877 electronically in mitted at the time of entry in ACE is
ACE at the time of filing entry for the unique facility identifier of the for-
products subject to the standards eign establishment where the human
under parts 1020–1050 of this chapter. drug was manufactured, prepared,
propagated, compounded, or processed
§ 1.78 Biological products, HCT/Ps, and before being imported or offered for im-
related drugs and medical devices. port into the United States. The
In addition to the data required to be unique facility identifier is the identi-
submitted in § 1.72, an ACE filer must fier submitted by a registrant in ac-
submit the following information at cordance with the system specified
the time of filing entry in ACE for bio- under section 510(b) of the Federal
logical products, HCT/Ps, and related Food, Drug, and Cosmetic Act.
drugs and medical devices regulated by (e) Drug application number. For a
the FDA Center for Biologics Evalua- drug intended for human use that is
tion and Research. the subject of an approved application
(a) Product name which identifies the under section 505(b) or 505(j) of the Fed-
article being imported or offered for eral Food, Drug, and Cosmetic Act, the
import by the name commonly associ- number of the new drug application or
ated with that article including the es- the abbreviated new drug application.
tablished name, trade name, brand (f) Investigational new drug application
name, proper name, or product descrip- number. For a drug intended for human
tion if the article does not have an es- use that is the subject of an investiga-
tablished name, trade name, brand tional new drug application under sec-
name, or proper name. tion 505(i) of the Federal Food, Drug,
(b) HCT/P registration and affirmation. and Cosmetic Act, the number of the
(1) For an HCT/P regulated solely investigational new drug application.
under section 361 of the Public Health (g) Medical device registration and list-
Service Act and the regulations in part ing. For a medical device subject to the
1271 of this chapter that is manufac- registration and listing procedures con-
tured by an establishment that is retained in part 807 of this chapter, the
quired to be registered under part 1271 Registration Number for Foreign Man-
of this chapter, the HCT/P Registration ufacturers, Foreign Exporters, and/or
Number; and Domestic Manufacturers, and the De-
(2) For an HCT/P regulated solely vice Listing Number, required under
under section 361 of the Public Health section 510 of the Federal Food, Drug,
Service Act and the regulations in part and Cosmetic Act and part 807 of this
1271 of this chapter, an Affirmation of chapter.
19
§ 1.79 21 CFR Ch. I (4–1–19 Edition)
(h) Investigational devices. For an in- ACE filer must submit a commercial
vestigational medical device that has name for the brand name. This data
an investigational device exemption element is not applicable to those
granted under section 520(g) of the Fed- products solely intended either for fur-
eral Food, Drug, and Cosmetic Act, the ther manufacturing or as investiga-
Investigational Device Exemption tional tobacco products.
Number. For an investigational med- (b) [Reserved]
ical device being imported or offered
for import for use in a nonsignificant § 1.80 Cosmetics.
risk or exempt study, ‘‘NSR’’ to be en-
tered in the Affirmation of Compliance An ACE filer must submit the data
for the ‘‘investigational device exemp- specified in § 1.72 at the time of filing
tion’’ that identifies the device as entry in ACE.
being used in a nonsignificant risk or
§ 1.81 Rejection of entry filing.
exempt study.
(i) Medical device premarket number. FDA may reject an entry filing for
For a medical device that has one, the failure to provide complete and accu-
Premarket Number. This is the Pre- rate information that is required pur-
market Approval Number for those suant to this subpart.
medical devices that have received pre-
market approval under section 515 of Subpart E—Imports and Exports
the Federal Food, Drug, and Cosmetic
Act; the Product Development Pro- § 1.83 Definitions.
tocol Number for those medical devices
for which FDA has declared the prod- For the purposes of regulations pre-
uct development protocol complete scribed under section 801(a), (b), and (c)
under section 515(f) of the Federal of the Federal Food, Drug, and Cos-
Food, Drug, and Cosmetic Act; the De metic Act:
Novo number for those medical devices (a) The term owner or consignee
granted marketing authorization under means the person who makes entry
section 513(f)(2) of the Federal Food, under the provisions of section 484 of
Drug, and Cosmetic Act; the Pre- the Tariff Act of 1930, as amended (19
market Notification Number for those U.S.C. 1484), namely, the ‘‘importer of
medical devices that received pre- record.’’
market clearance under section 510(k) (b) The term district director means
of the Federal Food, Drug, and Cos- the director of the district of the Food
metic Act; or the Humanitarian Device and Drug Administration having juris-
Exemption Number for those medical diction over the port of entry through
devices for which an exemption has
which an article is imported or offered
been granted under section 520(m) of
for import, or such officer of the dis-
trict as he may designate to act in his
Act.
(j) Medical device component. If appli- behalf in administering and enforcing
cable for a medical device, an affirma- the provisions of section 801 (a), (b),
tion identifying that the article being and (c).
imported or offered for import is a [42 FR 15553, Mar. 22, 1977, as amended at 81
component that requires further proc- FR 85872, Nov. 29, 2016]
essing or inclusion into a finished med-
ical device. § 1.90 Notice of sampling.
§ 1.79 Tobacco products. When a sample of an article offered
for import has been requested by the
In addition to the data required to be
district director, FDA shall provide to
submitted in § 1.72, an ACE filer must
the owner or consignee prompt notice
submit the following information at
of delivery of, or intention to deliver,
the time of filing entry in ACE.
(a) Brand name of an article that is a such sample. Upon receipt of the no-
tobacco product that is being imported tice, the owner or consignee shall hold
or offered for import. If the article does such article and not distribute it until
not have a specific brand name, the
20
further notice from the district direc- to the hearing on refusal of admission,
tor or U.S. Customs and Border Protec- the district director shall specify a
tion of the results of examination of time limit, reasonable in the light of
the sample. the circumstances, for filing such ap-
[81 FR 85872, Nov. 29, 2016]
plication.
(c) If the article is a drug that may
§ 1.91 Payment for samples. be subject to destruction under section
The Food and Drug Administration 801(a) of the Federal Food, Drug, and
will pay for all import samples which Cosmetic Act, the district director may
are found to be in compliance with the give the owner or consignee a single
requirements of the Federal Food, written or electronic notice that pro-
Drug, and Cosmetic Act. Billing for re- vides the notice of refusal of admission
imbursement should be made by the and the notice of destruction of an ar-
owner or consignee to the Food and ticle described in paragraph (a) of this
Drug Administration district head- section. The district director may also
quarters in whose territory the ship- combine the hearing on refusal of ad-
ment was offered for import. Payment mission with the hearing on destruc-
for samples will not be made if the ar- tion of the article described in para-
ticle is found to be in violation of the graph (a) of this section into a single
act, even though subsequently brought proceeding.
into compliance under the terms of an [80 FR 55242, Sept. 15, 2015, as amended at 81
authorization to bring the article into FR 85873, Nov. 29, 2016]
compliance or rendered not a food,
drug, device, or cosmetic as set forth in § 1.95 Application for authorization to
§ 1.95. relabel and recondition.
Application for authorization to
§ 1.94 Hearing on refusal of admission
or destruction. relabel or perform other action to
bring the article into compliance with
(a) If it appears that the article may the act or to render it other than a
be subject to refusal of admission, or food, drug, device or cosmetic may be
that the article is a drug that may be filed only by the owner or consignee,
subject to destruction under section and shall:
801(a) of the Federal Food, Drug, and
(a) Contain detailed proposals for
Cosmetic Act, the district director
bringing the article into compliance
shall give the owner or consignee a
with the act or rendering it other than
written or electronic notice to that ef-
a food, drug, device, or cosmetic.
fect, stating the reasons therefor. The
notice shall specify a place and a pe- (b) Specify the time and place where
riod of time during which the owner or such operations will be carried out and
consignee shall have an opportunity to the approximate time for their comple-
introduce testimony. Upon timely re- tion.
quest giving reasonable grounds there- § 1.96 Granting of authorization to
for, such time and place may be relabel and recondition.
changed. Such testimony shall be con-
fined to matters relevant to the admis- (a) When authorization contemplated
sibility or destruction of the article, by § 1.95 is granted, the district director
and may be introduced orally or in shall notify the applicant in writing,
writing. specifying:
(b) If such owner or consignee sub- (1) The procedure to be followed;
mits or indicates his or her intention (2) The disposition of the rejected ar-
to submit an application for authoriza- ticles or portions thereof;
tion to relabel or perform other action (3) That the operations are to be car-
to bring the article into compliance ried out under the supervision of an of-
with the Federal Food, Drug, and Cos- ficer of the Food and Drug Administra-
metic Act or to render it other than a tion or the U.S. Customs Service, as
food, drug, device, or cosmetic, such the case may be;
testimony shall include evidence in (4) A time limit, reasonable in the
support of such application. If such ap- light of the circumstances, for comple-
plication is not submitted at or prior tion of the operations; and
21
§ 1.97 21 CFR Ch. I (4–1–19 Edition)
(5) Such other conditions as are nec- unless the district director is in full
essary to maintain adequate super- agreement with the action.
vision and control over the article.
(b) Upon receipt of a written request § 1.99 Costs chargeable in connection
for extension of time to complete such with relabeling and reconditioning
operations, containing reasonable inadmissible imports.
grounds therefor, the district director The cost of supervising the relabeling
may grant such additional time as he or other action in connection with an
deems necessary. import of food, drugs, devices, or cos-
(c) An authorization may be amended metics which fails to comply with the
upon a showing of reasonable grounds Federal Food, Drug, and Cosmetic Act
therefor and the filing of an amended shall be paid by the owner or consignee
application for authorization with the who files an application requesting
district director. such action and executes a bond, pursu-
(d) If ownership of an article covered ant to section 801(b) of the act, as
by an authorization changes before the amended. The cost of such supervision
operations specified in the authoriza- shall include, but not be restricted to,
tion have been completed, the original the following:
owner will be held responsible, unless (a) Travel expenses of the supervising
the new owner has executed a bond and officer.
obtained a new authorization. Any au- (b) Per diem in lieu of subsistence of
thorization granted under this section the supervising officer when away from
shall supersede and nullify any pre- his home station, as provided by law.
viously granted authorization with re-
(c) The charge for the services of the
spect to the article.
supervising officer, which shall include
[42 FR 15553, Mar. 22, 1977, as amended at 54 administrative support, shall be com-
FR 9033, Mar. 3, 1989] puted at a rate per hour equal to 266
percent of the hourly rate of regular
§ 1.97 Bonds. pay of a grade GS–11/4 employee, except
(a) The bonds required under section that such services performed by a cus-
801(b) of the act may be executed by toms officer and subject to the provi-
the owner or consignee on the appro- sions of the act of February 13, 1911, as
priate form of a customs single-entry amended (sec. 5, 36 Stat. 901, as amend-
or term bond, containing a condition ed (19 U.S.C. 267)), shall be calculated
for the redelivery of the merchandise as provided in that act.
or any part thereof upon demand of the (d) The charge for the service of the
collector of customs and containing a analyst, which shall include adminis-
provision for the performance of condi- trative and laboratory support, shall be
tions as may legally be imposed for the computed at a rate per hour equal to
relabeling or other action necessary to 266 percent of the hourly rate of reg-
bring the article into compliance with ular pay of a grade GS–12/4 employee.
the act or rendering it other than a The rate per hour equal to 266 percent
food, drug, device, or cosmetic, in such of the equivalent hourly rate of regular
manner as is prescribed for such bond pay of the supervising officer (GS–11/4)
in the customs regulations in force on and the analyst (GS–12/4) is computed
the date of request for authorization. as follows:
The bond shall be filed with the col-
lector of customs. Hours
(b) The collector of customs may can- Gross number of working hours in 52 40–hr weeks 2,080
cel the liability for liquidated damages Less:
incurred under the above-mentioned 9 legal public holidays—New Years Day, Wash-
provisions of such a bond, if he receives ington’s Birthday, Memorial Day, Independ-
ence Day, Labor Day, Columbus Day, Vet-
an application for relief therefrom, erans Day, Thanksgiving Day, and Christmas
upon the payment of a lesser amount Day .................................................................. 72
or upon such other terms and condi- Annual leave—26 d ............................................ 208
tions as shall be deemed appropriate Sick leave—13 d ................................................ 104
under the law and in view of the cir-
Total ..................................................... 384

cumstances, but the collector shall not Net number of working hours .............. 1,696
act under this regulation in any case Gross number of working hours in 52 40-hr weeks .. 2,080
22
Hours an inspection for review and copying
Working hour equivalent of Government contribu-
by FDA.
tions for employee retirement, life insurance, and (1) Records demonstrating that the
health benefits computed at 81⁄2 pct. of annual product meets the foreign purchaser’s
rate of pay of employee ......................................... 176
specifications: The records must con-
Equivalent annual working hours ......... 2,256 tain sufficient information to match
the foreign purchaser’s specifications
Support required to equal to 1 man-year .................. 2,256 to a particular export;
Equivalent gross annual working hours
charged to Food and Drug appro-
(2) Records demonstrating that the
priation .............................................. 4,512 product does not conflict with the laws
of the importing country: This may
NOTE: Ratio of equivalent gross annual
number of working hours charged to Food
consist of either a letter from an ap-
and Drug appropriation to net number of an- propriate foreign government agency,
nual working hours 4,512/1,696 = 266 pct. department, or other authorized body
stating that the product has marketing
(e) The minimum charge for services approval from the foreign government
of supervising officers and of analysts or does not conflict with that country’s
shall be not less than the charge for 1 laws, or a notarized certification by a
hour, and time after the first hour responsible company official in the
shall be computed in multiples of 1 United States that the product does
hour, disregarding fractional parts less not conflict with the laws of the im-
than 1⁄2 hour. porting country and that includes a
statement acknowledging that he or
§ 1.101 Notification and recordkeeping. she is subject to the provisions of 18
(a) Scope. This section pertains to no- U.S.C. 1001;
tifications and records required for (3) Records demonstrating that the
human drug, biological product, device, product is labeled on the outside of the
animal drug, food, cosmetic, and to- shipping package that it is intended for
bacco product exports under sections export: This may consist of copies of
801 or 802 of the Federal Food, Drug, any labels or labeling statements, such
and Cosmetic Act or (21 U.S.C. 381 and as ‘‘For export only,’’ that are placed
382) or section 351 of the Public Health on the shipping packages or, if the ex-
Service Act (42 U.S.C. 262). ported product does not have a ship-
(b) Recordkeeping requirements for ping package or container, on shipping
human drugs, biological products, devices, invoices or other documents accom-
animal drugs, foods, cosmetics, and to- panying the exported product; and
bacco products exported under or subject (4) Records demonstrating that the
to section 801(e)(1) of the Federal Food, product is not sold or offered for sale in
Drug, and Cosmetic Act. Persons export- the United States: This may consist of
ing an article under section 801(e)(1) of production and shipping records for the
the act or an article otherwise subject exported product and promotional ma-
to section 801(e)(1) of the act shall terials.
maintain records as enumerated in (c) Additional recordkeeping require-
paragraphs (b)(1) through (b)(4) of this ments for partially processed biological
section demonstrating that the product products exported under section 351(h) of
meets the requirements of section the Public Health Service Act. In addi-
801(e)(1) of the act. Such records shall tion to the requirements in paragraph
be maintained for the same period of (b) of this section, persons exporting a
time as required for records subject to partially processed biological product
good manufacturing practice or quality under section 351(h) of the Public
systems regulations applicable to the Health Service Act shall maintain, for
product, except that records pertaining the same period of time as required for
to the export of foods and cosmetics records subject to good manufacturing
under section 801(e)(1) of the act shall practice or quality systems regulations
be kept for 3 years after the date of ex- applicable to the product, and make
portation. The records shall be made available to FDA, upon request, during
available to the Food and Drug Admin- an inspection for review and copying
istration (FDA), upon request, during by FDA, the following records:
23
§ 1.101 21 CFR Ch. I (4–1–19 Edition)
(1) Records demonstrating that the (2) The notification shall be sent to
product for export is a partially proc- the following addresses:
essed biological product and not in a (i) For biological products and de-
form applicable to the prevention, vices regulated by the Center for Bio-
treatment, or cure of diseases or inju- logics Evaluation and Research—Food
ries of man; and Drug Administration, Center for
(2) Records demonstrating that the Biologics Evaluation and Research,
partially processed biological product Document Control Center, 10903 New
was manufactured in conformity with Hampshire Ave., Bldg. 71, Rm. G112,
current good manufacturing practice Silver Spring, MD 20993–0002.
requirements; (ii) For human drug products, bio-
(3) Records demonstrating the dis- logical products, and devices regulated
tribution of the exported partially by the Center for Drug Evaluation and
processed biological products; and Research—Division of New Drugs and
(4) Copies of all labeling that accom- Labeling Compliance, Center for Drug
panies the exported partially processed Evaluation and Research, Food and
biological product and other records Drug Administration, 10903 New Hamp-
demonstrating that the exported par- shire Ave., Silver Spring, MD 20993–
tially processed biological product is 0002.
intended for further manufacture into (iii) For devices—Food and Drug Ad-
ministration, Center for Devices and
a final dosage form outside the United
Radiological Health, Division of Pro-
States; this may include a container
gram Operations, 10903 New Hampshire
label with the statement, ‘‘Caution:
Ave., Bldg. 66, rm. 5429, Silver Spring,
For Further Manufacturing Use Only’’
MD 20993–0002.
and any package insert.
(e) Recordkeeping requirements for
(d) Notification requirements for drugs, products subject to section 802(g) of the
biological products, and devices exported act. (1) Any person exporting a product
under section 802 of the act. (1) Persons under any provision of section 802 of
exporting a human drug, biological the act shall maintain records of all
product, or device under section 802 of drugs, biological products, and devices
the act, other than a drug, biological exported and the countries to which
product, or device for investigational the products were exported. In addition
use exported under section 802(c) of the to the requirements in paragraph (b) of
act, or a drug, biological product, or this section, such records include, but
device exported in anticipation of mar- are not limited to, the following:
keting authorization under section (i) The product’s trade name;
802(d) of the act, shall provide written (ii) If the product is a drug or biologi-
notification to FDA. The notification cal product, the product’s abbreviated
shall identify: or proper name or, if the product is a
(i) The product’s trade name; device, the type of device;
(ii) If the product is a drug or biologi- (iii) If the product is a drug or bio-
cal product, the product’s abbreviated logical product, a description of its
or proper name or, if the product is a strength and dosage form and the prod-
device, the type of device; uct’s lot or control number or, if the
(iii) If the product is a drug or bio- product is a device, the product’s
logical product, a description of the model number;
product’s strength and dosage form or, (iv) The consignee’s name and ad-
if the product is a device, the product’s dress; and
model number; and (v) The date on which the product
(iv) If the export is to a country not was exported and the quantity of prod-
listed in section 802(b)(1) of the act, the uct exported.
country that is to receive the exported (2) These records shall be kept at the
article. The notification may, but is site from which the products were ex-
not required to, identify countries list- ported or manufactured, and be main-
ed in section 802(b)(1) of the act or tained for the same period of time as
state that the export is intended for a required for records subject to good
listed country without identifying the manufacturing practice or quality sys-

listed country. tems regulations applicable to the
24
product. The records shall be made (e) Nonprofit food establishments in

available to FDA, upon request, during which food is prepared for, or served di-
an inspection for review and copying rectly to, the consumer;
by FDA. (f) Fishing vessels, including those
[66 FR 65447, Dec. 19, 2001, as amended at 69 that not only harvest and transport
FR 48774, Aug. 11, 2004; 70 FR 14980, Mar. 24, fish but also engage in practices such
2005; 74 FR 13112, Mar. 26, 2009; 75 FR 20914, as heading, eviscerating, or freezing in-
Apr. 22, 2010; 77 FR 5176, Feb. 2, 2012; 80 FR tended solely to prepare fish for hold-
18090, Apr. 3, 2015] ing on board a harvest vessel. However,
those fishing vessels otherwise engaged
Subparts F–G [Reserved] in processing fish are subject to this
subpart. For the purposes of this sec-
Subpart H—Registration of Food tion, ‘‘processing’’ means handling,
Facilities storing, preparing, shucking, changing
into different market forms, manufac-
turing, preserving, packing, labeling,
SOURCE: 68 FR 58960, Oct. 10, 2003, unless
dockside unloading, holding, or head-
otherwise noted.
ing, eviscerating, or freezing other
GENERAL PROVISIONS than solely to prepare fish for holding
on board a harvest vessel;
§ 1.225 Who must register under this (g) Facilities that are regulated ex-
subpart? clusively, throughout the entire facil-
(a) You must register your facility ity, by the U.S. Department of Agri-
under this subpart if you are the culture under the Federal Meat Inspec-
owner, operator, or agent in charge of tion Act (21 U.S.C. 601 et seq.), the Poul-
either a domestic or foreign facility, as try Products Inspection Act (21 U.S.C.
defined in this subpart, and your facil- 451 et seq.), or the Egg Products Inspec-
ity is engaged in the manufacturing/ tion Act (21 U.S.C. 1031 et seq.);
processing, packing, or holding of food
for consumption in the United States, § 1.227 What definitions apply to this
subpart?
unless your facility qualifies for one of
the exemptions in § 1.226. The definitions of terms in section
(b) If you are an owner, operator, or 201 of the Federal Food, Drug, and Cos-
agent in charge of a domestic facility, metic Act apply to such terms when
you must register your facility wheth- used in this subpart. In addition, for
er or not the food from the facility en- the purposes of this subpart:
ters interstate commerce. Calendar day means every day shown
(c) If you are the owner, operator, or on the calendar.
agent in charge of a facility, you may Facility means any establishment,
authorize an individual to register structure, or structures under one own-
your facility on your behalf. ership at one general physical location,
or, in the case of a mobile facility,
§ 1.226 Who does not have to register traveling to multiple locations, that
under this subpart? manufactures/processes, packs, or
This subpart does not apply to the holds food for consumption in the
following facilities: United States. Transport vehicles are
(a) A foreign facility, if food from not facilities if they hold food only in
such facility undergoes further manu- the usual course of business as carriers.
facturing/processing (including pack- A facility may consist of one or more
aging) by another facility outside the contiguous structures, and a single
United States. A facility is not exempt building may house more than one dis-
under this provision if the further man- tinct facility if the facilities are under
ufacturing/processing (including pack- separate ownership. The private resi-
aging) conducted by the subsequent fa- dence of an individual is not a facility.
cility consists of adding labeling or any Nonbottled water drinking water col-
similar activity of a de minimis nature; lection and distribution establishments
(b) Farms; and their structures are not facilities.
(c) Retail food establishments; (1) Domestic facility means any facil-
(d) Restaurants; ity located in any State or Territory of
25
§ 1.227 21 CFR Ch. I (4–1–19 Edition)
the United States, the District of Co- additional manufacturing/processing is

lumbia, or the Commonwealth of Puer- irradiation); or
to Rico that manufactures/processes, (2) Secondary activities farm. A sec-
packs, or holds food for consumption in ondary activities farm is an operation,
the United States. not located on a primary production
(2) Foreign facility means a facility farm, devoted to harvesting (such as
other than a domestic facility that hulling or shelling), packing, and/or
manufactures/processes, packs, or holding of raw agricultural commod-
holds food for consumption in the ities, provided that the primary pro-
United States. duction farm(s) that grows, harvests,
Farm means: and/or raises the majority of the raw
(1) Primary production farm. A pri- agricultural commodities harvested,
mary production farm is an operation packed, and/or held by the secondary
under one management in one general activities farm owns, or jointly owns, a
(but not necessarily contiguous) phys- majority interest in the secondary ac-
ical location devoted to the growing of tivities farm. A secondary activities
crops, the harvesting of crops, the rais- farm may also conduct those addi-
ing of animals (including seafood), or tional activities allowed on a primary
any combination of these activities. production farm as described in para-
The term ‘‘farm’’ includes operations graphs (1)(ii) and (iii) of this definition.
that, in addition to these activities: Food has the meaning given in sec-
(i) Pack or hold raw agricultural tion 201(f) of the Federal Food, Drug,
commodities; and Cosmetic Act:
(ii) Pack or hold processed food, pro- (1) Except for purposes of this sub-
vided that all processed food used in part, it does not include:
such activities is either consumed on (i) Food contact substances as de-
that farm or another farm under the fined in section 409(h)(6) of the Federal
same management, or is processed food Food, Drug, and Cosmetic Act; or
identified in paragraph (1)(iii)(B)(1) of (ii) Pesticides as defined in 7 U.S.C.
this definition; and 136(u).
(iii) Manufacture/process food, pro- (2) Examples of food include: Fruits,
vided that: vegetables, fish, dairy products, eggs,
(A) All food used in such activities is raw agricultural commodities for use
consumed on that farm or another as food or as components of food, ani-
farm under the same management; or mal feed (including pet food), food and
(B) Any manufacturing/processing of feed ingredients, food and feed addi-
food that is not consumed on that farm tives, dietary supplements and dietary
or another farm under the same man- ingredients, infant formula, beverages
agement consists only of: (including alcoholic beverages and bot-
(1) Drying/dehydrating raw agricul- tled water), live food animals, bakery
tural commodities to create a distinct goods, snack foods, candy, and canned
commodity (such as drying/dehy- foods.
drating grapes to produce raisins), and Harvesting applies to farms and farm
packaging and labeling such commod- mixed-type facilities and means activi-
ities, without additional manufac- ties that are traditionally performed
turing/processing (an example of addi- on farms for the purpose of removing
tional manufacturing/processing is raw agricultural commodities from the
slicing); place they were grown or raised and
(2) Treatment to manipulate the rip- preparing them for use as food. Har-
ening of raw agricultural commodities vesting is limited to activities per-
(such as by treating produce with formed on raw agricultural commod-
ethylene gas), and packaging and label- ities, or on processed foods created by
ing treated raw agricultural commod- drying/dehydrating a raw agricultural
ities, without additional manufac- commodity without additional manu-
turing/processing; and facturing/processing, on a farm. Har-
(3) Packaging and labeling raw agri- vesting does not include activities that
cultural commodities, when these ac- transform a raw agricultural com-
tivities do not involve additional man- modity into a processed food as defined
ufacturing/processing (an example of in section 201(gg) of the Federal Food,
26
Drug, and Cosmetic Act. Examples of tivities that are part of harvesting,
harvesting include cutting (or other- packing, or holding.
wise separating) the edible portion of Mixed-type facility means an estab-
the raw agricultural commodity from lishment that engages in both activi-
the crop plant and removing or trim- ties that are exempt from registration
ming part of the raw agricultural com- under section 415 of the Federal Food,
modity (e.g., foliage, husks, roots or Drug, and Cosmetic Act and activities
stems). Examples of harvesting also in- that require the establishment to be
clude cooling, field coring, filtering, registered. An example of such a facil-
gathering, hulling, shelling, sifting, ity is a ‘‘farm mixed-type facility,’’
threshing, trimming of outer leaves of, which is an establishment that is a
and washing raw agricultural commod- farm, but also conducts activities out-
ities grown on a farm. side the farm definition that require
Holding means storage of food and the establishment to be registered.
also includes activities performed inci- Nonprofit food establishment means a
dental to storage of a food (e.g., activi- charitable entity that prepares or
ties performed for the safe or effective serves food directly to the consumer or
storage of that food, such as fumigat- otherwise provides food or meals for
consumption by humans or animals in
ing food during storage, and drying/de-
the United States. The term includes
hydrating raw agricultural commod-
central food banks, soup kitchens, and
ities when the drying/dehydrating does
nonprofit food delivery services. To be
not create a distinct commodity (such
considered a nonprofit food establish-
as drying/dehydrating hay or alfalfa)).
ment, the establishment must meet the
Holding also includes activities per-
terms of section 501(c)(3) of the U.S. In-
formed as a practical necessity for the
ternal Revenue Code (26 U.S.C.
distribution of that food (such as 501(c)(3)).
blending of the same raw agricultural Packaging (when used as a verb)
commodity and breaking down pallets), means placing food into a container
but does not include activities that that directly contacts the food and
transform a raw agricultural com- that the consumer receives.
modity into a processed food as defined Packing means placing food into a
in section 201(gg) of the Federal Food, container other than packaging the
Drug, and Cosmetic Act. Holding facili- food and also includes re-packing and
ties could include warehouses, cold activities performed incidental to
storage facilities, storage silos, grain packing or re-packing a food (e.g., ac-
elevators, and liquid storage tanks. tivities performed for the safe or effec-
Manufacturing/processing means mak- tive packing or re-packing of that food
ing food from one or more ingredients, (such as sorting, culling, grading, and
or synthesizing, preparing, treating, weighing or conveying incidental to
modifying or manipulating food, in- packing or re-packing)), but does not
cluding food crops or ingredients. Ex- include activities that transform a raw
amples of manufacturing/processing ac- agricultural commodity, as defined in
tivities include: Baking, boiling, bot- section 201(r) of the Federal Food,
tling, canning, cooking, cooling, cut- Drug, and Cosmetic Act, into a proc-
ting, distilling, drying/dehydrating raw essed food as defined in section 201(gg)
agricultural commodities to create a of the Federal Food, Drug, and Cos-
distinct commodity (such as drying/de- metic Act.
hydrating grapes to produce raisins), Restaurant means a facility that pre-
evaporating, eviscerating, extracting pares and sells food directly to con-
juice, formulating, freezing, grinding, sumers for immediate consumption.
homogenizing, irradiating, labeling, ‘‘Restaurant’’ does not include facili-
milling, mixing, packaging (including ties that provide food to interstate
modified atmosphere packaging), pas- conveyances, central kitchens, and
teurizing, peeling, rendering, treating other similar facilities that do not pre-
to manipulate ripening, trimming, pare and serve food directly to con-
washing, or waxing. For farms and sumers.
farm mixed-type facilities, manufac- (1) Entities in which food is provided

turing/processing does not include ac- to humans, such as cafeterias,
27
§ 1.227 21 CFR Ch. I (4–1–19 Edition)
lunchrooms, cafes, bistros, fast food es- (iii) At other such direct-to-consumer
tablishments, food stands, saloons, tav- sales platforms, including door-to-door
erns, bars, lounges, catering facilities, sales; mail, catalog and Internet order,
hospital kitchens, day care kitchens, including online farmers markets and
and nursing home kitchens are res- online grocery delivery; religious or
taurants; and other organization bazaars; and State
(2) Pet shelters, kennels, and veteri- and local fairs.
nary facilities in which food is pro- (2) Sale of food directly to consumers
vided to animals are restaurants. by a farm-operated business includes
Retail food establishment means an es- the sale of food by that farm-operated
tablishment that sells food products di- business directly to consumers:
rectly to consumers as its primary (i) At a roadside stand (a stand situ-
function. The term ‘‘retail food estab- ated on the side of or near a road or
lishment’’ includes facilities that man- thoroughfare at which a farmer sells
ufacture, process, pack, or hold food if food from his or her farm directly to
the establishment’s primary function consumers) or farmers’ market (a loca-
is to sell from that establishment food, tion where one or more local farmers
including food that it manufactures, assemble to sell food from their farms
processes, packs, or holds, directly to directly to consumers);
consumers. A retail food establish- (ii) Through a community supported
ment’s primary function is to sell food agriculture program. Community sup-
directly to consumers if the annual ported agriculture (CSA) program
monetary value of sales of food prod- means a program under which a farmer
ucts directly to consumers exceeds the or group of farmers grows food for a
annual monetary value of sales of food group of shareholders (or subscribers)
products to all other buyers. The term who pledge to buy a portion of the
‘‘consumers’’ does not include busi- farmer’s crop(s) for that season. This
nesses. A ‘‘retail food establishment’’ includes CSA programs in which a
includes grocery stores, convenience group of farmers consolidate their
stores, and vending machine locations. crops at a central location for distribu-
A ‘‘retail food establishment’’ also in- tion to shareholders or subscribers; and
cludes certain farm-operated busi- (iii) At other such direct-to-consumer
nesses selling food directly to con- sales platforms, including door-to-door
sumers as their primary function. sales; mail, catalog and Internet order,
(1) Sale of food directly to consumers including online farmers markets and
from an establishment located on a online grocery delivery; religious or
farm includes sales by that establish- other organization bazaars; and State
ment directly to consumers: and local fairs.
(i) At a roadside stand (a stand situ- (3) For the purposes of this defini-
ated on the side of or near a road or tion, ‘‘farm-operated business’’ means
thoroughfare at which a farmer sells a business that is managed by one or
food from his or her farm directly to more farms and conducts manufac-
consumers) or farmers’ market (a loca- turing/processing not on the farm(s).
tion where one or more local farmers Trade name means the name or names
assemble to sell food from their farms under which the facility conducts busi-
directly to consumers); ness, or additional names by which the
(ii) Through a community supported facility is known. A trade name is asso-
agriculture program. Community sup- ciated with a facility, and a brand
ported agriculture (CSA) program name is associated with a product.
means a program under which a farmer U.S. agent means a person (as defined
or group of farmers grows food for a in section 201(e) of the Federal Food,
group of shareholders (or subscribers) Drug, and Cosmetic Act (21 U.S.C.
who pledge to buy a portion of the 321(e))) residing or maintaining a place
farmer’s crop(s) for that season. This of business in the United States whom
includes CSA programs in which a a foreign facility designates as its
group of farmers consolidate their agent for purposes of this subpart. A
crops at a central location for distribu- U.S. agent may not be in the form of a
tion to shareholders or subscribers; and mailbox, answering machine or service,
28
or other place where an individual act- year. You may authorize an individual
ing as the foreign facility’s agent is not to renew a facility’s registration on
physically present. your behalf. If the individual submit-
(1) The U.S. agent acts as a commu- ting the registration renewal is not the
nications link between FDA and the owner, operator, or agent in charge of
foreign facility for both emergency and the facility, the registration renewal
routine communications. The U.S. must also include a statement in which
agent will be the person FDA contacts the individual certifies that the infor-
when an emergency occurs, unless the mation submitted is true and accurate,
registration specifies another emer- certifies that he/she is authorized to
gency contact. submit the registration renewal, and
(2) FDA will treat representations by identifies by name, address, and tele-
the U.S. agent as those of the foreign phone number, the individual who au-
facility, and will consider information thorized submission of the registration
or documents provided to the U.S. renewal. In addition, the registration
agent the equivalent of providing the renewal must also identify the indi-
information or documents to the for- vidual who authorized submission of
eign facility. FDA will consider the the registration renewal by email ad-
U.S. agent the equivalent of the reg- dress, unless FDA has granted a waiver
istrant for purposes of sharing informa- under § 1.245. Each registration renewal
tion and communications. The U.S. must include the name of the indi-
agent of a foreign facility may view the vidual submitting the registration re-
information submitted in the foreign newal, and the individual’s signature
facility’s registration. (for the paper option). Each electronic
(3) Having a single U.S. agent for the registration renewal must include the
purposes of this subpart does not pre- name of the individual submitting the
clude facilities from having multiple renewal.
agents (such as foreign suppliers) for (c) Abbreviated registration renewal
other business purposes. A firm’s com- process. If you do not have any changes
mercial business in the United States to the information required under
need not be conducted through the U.S. § 1.232 since you submitted the pre-
agent designated for purposes of this ceding registration, registration re-
subpart. newal, or update for your facility, you
You or registrant means the owner, may use the abbreviated registration
operator, or agent in charge of a facil- renewal process. If you use the abbre-
ity that manufactures/processes, packs, viated registration renewal process,
or holds food for consumption in the you must confirm that no changes have
United States. been made to the information required
under § 1.232 since you submitted the
[80 FR 56141, Sept. 17, 2015, as amended at 81
FR 3715, Jan. 22, 2016; 81 FR 45950, July 14, preceding registration, registration re-
2016] newal or update, and you must certify
that the information submitted is
PROCEDURES FOR REGISTRATION OF FOOD truthful and accurate. Each abbre-
FACILITIES viated registration renewal must in-
clude the name of the individual sub-
§ 1.230 When must you register or mitting the abbreviated renewal, and
renew your registration? the individual’s signature (for the
(a) Registration. You must register be- paper option). Each electronic abbre-
fore your facility begins to manufac- viated registration renewal must in-
ture, process, pack, or hold food for clude the name of the individual sub-
consumption in the United States. You mitting the abbreviated renewal. For
may authorize an individual to register abbreviated registration renewals not
the facility on your behalf. submitted by the owner, operator, or
(b) Registration renewal. You must agent in charge of the facility, the ab-
submit a registration renewal con- breviated renewal must provide the
taining the information required under email address of the individual who au-
§ 1.232 every other year, during the pe- thorized submission of the abbreviated
riod beginning on October 1 and ending renewal, unless FDA has granted a
on December 31 of each even-numbered waiver under § 1.245. You must use
29
§ 1.231 21 CFR Ch. I (4–1–19 Edition)
Form FDA 3537 to submit abbreviated (4) For electronic registrations not
registration renewals to FDA. submitted by the owner, operator, or
agent in charge of the facility, after
[81 FR 45950, July 14, 2016]
submission of the registration, FDA
§ 1.231 How and where do you register will verify that the individual identi-
or renew your registration? fied as having authorized submission of
the registration in fact authorized the
(a) Electronic registration and registra- submission on behalf of the facility.
tion renewal. (1) To register or renew a FDA will not confirm the registration
registration electronically, you must or provide a registration number until
go to http://www.fda.gov/furls, which is that individual confirms that he or she
available for registration 24 hours a authorized the submission. With re-
day, 7 days a week. This Web site is spect to electronic registration renew-
available from wherever the Internet is als, after completion of the electronic
accessible, including libraries, copy registration renewal, FDA will provide
centers, schools, and Internet cafes. An an electronic confirmation of the reg-
individual authorized by the owner, op- istration renewal. For electronic reg-
erator, or agent in charge of a facility istration renewals not submitted by
may also register a facility electroni- the owner, operator, or agent in charge
cally. of the facility, FDA will verify that the
(2) Beginning on January 4, 2020, you individual identified as having author-
must submit your registration or reg- ized submission of the registration re-
istration renewal to FDA electroni- newal in fact authorized the submis-
cally, unless FDA has granted you a sion on behalf of the facility. FDA will
waiver under § 1.245. not provide an electronic confirmation
(3) After you submit your electronic of the registration renewal until that
registration, FDA will verify the accu- individual confirms that he or she au-
racy of your unique facility identifier thorized the submission.
(UFI) recognized as acceptable by FDA (5) For a foreign facility, after you
and will also verify that the facility- submit your electronic registration,
specific address associated with the FDA will verify that the person identi-
UFI is the same address associated fied as the U.S. agent for your foreign
with your registration. FDA will not facility has agreed to serve as your
confirm your registration or provide U.S. agent. FDA will not confirm your
you with a registration number until registration or provide you with a reg-
FDA verifies the accuracy of your fa- istration number until that person con-
cility’s UFI and verifies that the facil- firms that the person agreed to serve
ity-specific address associated with the as your U.S. agent. With respect to
UFI is the same address associated electronic registration renewals, after
with your registration. With respect to you complete your electronic registra-
electronic registration renewals, after tion renewal, FDA will provide you
you submit your electronic registra- with an electronic confirmation of
tion renewal, FDA will provide you your registration renewal. When you
with an electronic confirmation of update information about your U.S.
your registration renewal. When you agent as part of your electronic reg-
update your facility’s UFI as part of istration renewal, FDA will verify that
your electronic registration renewal, the person identified as the U.S. agent
FDA will verify the accuracy of your for your foreign facility has agreed to
facility’s UFI and will also verify that serve as your U.S. agent. FDA will not
the facility-specific address associated provide you with an electronic con-
with the UFI is the same address asso- firmation of your registration renewal
ciated with your registration. FDA will until that person confirms that the
not provide you with a confirmation of person agreed to serve as your U.S.
your registration renewal until FDA agent.
verifies the accuracy of your UFI and (6) If any information you previously
verifies that the facility-specific ad- submitted was incorrect at the time of
dress associated with the UFI is the submission, you must immediately up-
same address associated with your reg- date your facility’s registration as
istration. specified in § 1.234.
30
(7) You will be considered registered firmation of your registration renewal.

once FDA electronically sends you When you update your facility’s UFI as
your confirmation and registration part of your registration renewal, FDA
number. will verify the accuracy of your facili-
(b) Registration or registration renewal ty’s UFI and will also verify that the
by mail or fax. Beginning January 4, facility-specific address associated
2020, you must submit your registra- with the UFI is the same address asso-
tion or registration renewal to FDA ciated with your registration. FDA will
electronically, unless FDA has granted not provide you with a confirmation of
you a waiver under § 1.245. If FDA has your registration renewal until FDA
granted you a waiver under § 1.245, you verifies the accuracy of your UFI and
may register or renew a registration by verifies that the facility-specific ad-
mail or by fax. dress associated with the UFI is the
(1) You must register or renew a reg- same address associated with your reg-
istration (including abbreviated registration.
istration renewals) using Form FDA (6) For registrations not submitted
3537. You may obtain a copy of this by the owner, operator, or agent in
form by writing to the U.S. Food and charge of the facility, after submission
Drug Administration, Center for Food of the registration by mail or fax, FDA
Safety and Applied Nutrition, 5001 will verify that the individual identi-
Campus Dr. (HFS–681), College Park, fied as having authorized submission of
MD 20740 or by requesting the form by the registration in fact authorized the
phone at 1–800–216–7331 or 301–575–0156. submission on behalf of the facility.
(2) When you receive the form, you FDA will not confirm the registration
must fill it out completely and legibly or provide a registration number until
and either mail it to the address in that individual confirms that he or she
paragraph (b)(1) of this section or fax it authorized the submission. With re-
to 301–436–2804. spect to registration renewals, after
(3) If any required information on the completion of the registration renewal
form is incomplete or illegible when by mail or fax, FDA will provide a con-
FDA receives it, FDA will return the firmation of the registration renewal.
form to you for revision, provided that For registration renewals not sub-
your mailing address or fax number is mitted by the owner, operator, or
legible and valid. When returning a agent in charge of the facility, FDA
registration form for revision, FDA will verify that the individual identi-
will use the means by which the form fied as having authorized submission of
was received by the Agency (i.e., by the registration renewal in fact author-
mail or fax). ized the submission on behalf of the fa-
(4) FDA will enter complete and leg- cility. FDA will not provide a con-
ible mailed and faxed registration sub- firmation of the registration renewal
missions into its registration system, until that individual confirms that he
as soon as practicable, in the order or she authorized the submission.
FDA receives them. (7) For a foreign facility, after you
(5) After you submit your registra- submit your registration by mail or
tion, FDA will verify the accuracy of fax, FDA will verify that the person
your facility’s UFI and will also verify identified as the U.S. agent for your
that the facility-specific address asso- foreign facility has agreed to serve as
ciated with the UFI is the same address your U.S. agent. FDA will not confirm
associated with your registration. FDA your registration or provide you with a
will not confirm your registration or registration number until that person
provide you with a registration number confirms that the person agreed to
until FDA verifies the accuracy of your serve as your U.S. agent. With respect
facility’s UFI and verifies that the fa- to registration renewals, after you
cility-specific address associated with complete your registration renewal by
the UFI is the same address associated mail or fax, FDA will provide you with
with your registration. With respect to a confirmation of your registration re-
registration renewals, after you submit newal. When you update information
your registration renewal by mail or about your U.S. agent as part of your
fax, FDA will provide you with a con- registration renewal, FDA will verify
31
§ 1.232 21 CFR Ch. I (4–1–19 Edition)
that the person identified as the U.S. tion, the email address of the owner,
agent for your foreign facility has operator, or agent in charge is re-
agreed to serve as your U.S. agent. quired, unless FDA has granted you a
FDA will not provide you with a con- waiver under § 1.245;
firmation of your registration renewal (7) The applicable food product cat-
until that person confirms that the egories of any food manufactured/proc-
person agreed to serve as your U.S. essed, packed, or held at the facility as
agent. identified on Form FDA 3537;
(8) FDA will mail or fax you a copy of (8) The type of activity conducted at
the registration as entered, confirma- the facility for each food product cat-
tion of registration, and your registra- egory identified. You may select more
tion number. When responding to a reg- than one activity type for each food
istration submission, FDA will use the product category identified. The activ-
means by which the registration was ity type options are as follows:
received by the Agency (i.e., by mail or (i) Ambient human food storage
fax). warehouse/holding facility;
(9) If any information you previously (ii) Refrigerated human food ware-
submitted was incorrect at the time of house/holding facility;
submission, you must immediately up- (iii) Frozen human food warehouse/
date your facility’s registration as holding facility;
specified in § 1.234. (iv) Interstate conveyance caterer/ca-
(10) Your facility is considered reg- tering point;
istered once FDA enters your facility’s (v) Contract sterilizer;
registration data into the registration (vi) Labeler/relabeler;
system and the system generates a reg- (vii) Manufacturer/processor;
istration number. (viii) Acidified food processor;
(c) Fees. No registration fee is re- (ix) Low-acid food processor;
quired. (x) Farm mixed-type facility;
(d) Language. You must submit all (xi) Packer/repacker;
registration information in the English (xii) Salvage operator (recondi-
language except an individual’s name, tioner);
the name of a company, the name of a (xiii) Animal food warehouse/holding
street, and a trade name may be sub- facility;
mitted in a foreign language. All infor- (xiv) Other activity.
mation, including these items, must be (9) A statement in which the owner,
submitted using the Latin (Roman) al- operator, or agent in charge provides
phabet. an assurance that FDA will be per-
[81 FR 45950, July 14, 2016] mitted to inspect the facility at the
times and in the manner permitted by
§ 1.232 What information is required in the Federal Food, Drug, and Cosmetic
the registration? Act;
(a) For a domestic and foreign facil- (10) A statement in which the owner,
ity, the following information is re- operator, or agent in charge certifies
quired: that the information submitted is true
(1) The name, full address, and phone and accurate. If the individual submit-
number of the facility; ting the form is not the owner, oper-
(2) Beginning October 1, 2020, the fa- ator, or agent in charge of the facility,
cility’s UFI recognized as acceptable the registration must also include a
by FDA; statement in which the individual cer-
(3) The preferred mailing address, if tifies that the information submitted
different from that of the facility; is true and accurate, certifies that he/
(4) The name, full address, and phone she is authorized to submit the reg-
number of the parent company, if the istration, and identifies by name, ad-
facility is a subsidiary of the parent dress, and telephone number, the indi-
company; vidual who authorized submission of
(5) All trade names the facility uses; the registration. In addition, the reg-
(6) The name, full address, and phone istration must identify the individual
number of the owner, operator, or who authorized submission of the reg-

agent in charge of the facility. In addi- istration by email address, unless FDA
32
has granted a waiver under § 1.245. Each the new owner must submit a new reg-
registration must include the name of istration for the facility as specified in
the individual submitting the registra- § 1.231. The former owner may author-
tion, and the individual’s signature (for ize an individual to cancel a facility’s
the paper option). registration.
(b) For a domestic facility, the fol- (c) Electronic update. (1) To update
lowing additional information is re- your registration electronically, you
quired: must update at http://www.fda.gov/furls.
(1) The email address for the contact (2) After you submit your electronic
person of the facility; update, FDA will provide you with an
(2) An emergency contact phone electronic confirmation of your update.
number and email address if different When updating UFI information, FDA
from the email address for the contact will verify the accuracy of your facili-
person in paragraph (b)(1) of this sec- ty’s UFI and will also verify that the
tion. facility-specific address associated
(c) For a foreign facility, the fol- with the UFI is the same address asso-
lowing additional information is re- ciated with your registration. FDA will
quired: not provide you with an electronic con-
(1) The name, full address, phone firmation of your registration update
number, and email address of the for- until FDA verifies the accuracy of your
eign facility’s U.S. agent; facility’s UFI and verifies that the fa-
(2) An emergency contact phone cility-specific address associated with
number and email address. the UFI is the same address associated
with your registration. For foreign fa-
[81 FR 45951, July 14, 2016]
cilities, when updating information
§ 1.233 Are there optional items in- about your U.S. agent, FDA will verify
cluded in the registration form? that the person identified as the U.S.
agent for your foreign facility has
Yes. FDA encourages, but does not agreed to serve as your U.S. agent.
require, you to submit items that are FDA will not provide you with an elec-
indicated as optional on the Form FDA tronic confirmation of your registra-
3537 that you submit. tion update until that person confirms
[81 FR 45952, July 14, 2016] that the person agreed to serve as your
U.S. agent.
§ 1.234 How and when do you update (3) For electronic updates not sub-
your facility’s registration informa- mitted by the owner, operator, or
tion? agent in charge of the facility, after
(a) Update requirements. You must up- submission of the electronic update,
date a facility’s registration within 60 FDA will verify that the individual
calendar days of any change to any of identified as having authorized submis-
the information previously submitted sion of the update in fact authorized
under § 1.232 (e.g., change of operator, the submission on behalf of the facil-
agent in charge, or U.S. agent), except ity. FDA will not confirm the update
a change of the owner. You may au- to the registration until that indi-
thorize an individual to update a facili- vidual confirms that he or she author-
ty’s registration on your behalf. For ized the submission.
updates not submitted by the owner, (4) Your registration will be consid-
operator, or agent in charge of the fa- ered updated once FDA sends you your
cility, the update must provide the update confirmation, unless notified
email address of the individual who au- otherwise.
thorized submission of the update, un- (d) Update by mail or fax. Beginning
less FDA has granted a waiver under January 4, 2020, you must submit your
§ 1.245. update electronically, unless FDA has
(b) Cancellation due to ownership granted you a waiver under § 1.245. If
changes. If the reason for the update is FDA has granted you a waiver under
that the facility has a new owner, the § 1.245, you may update your facility’s
former owner must cancel the facility’s registration by mail or by fax.
registration as specified in § 1.235 with- (1) You must update your registra-
in 60 calendar days of the change and tion using Form FDA 3537. You may
33
§ 1.235 21 CFR Ch. I (4–1–19 Edition)
obtain a copy of this form by writing agent in charge of the facility, after
to the U.S. Food and Drug Administra- submission of the registration update
tion, Center for Food Safety and Ap- by mail or fax, FDA will verify that
plied Nutrition, 5001 Campus Dr. (HFS– the individual identified as having au-
681), College Park, MD 20740 or by re- thorized submission of the update in
questing the form by phone at 1–800– fact authorized the submission on be-
216–7331 or 301–575–0156. half of the facility. FDA will not con-
(2) When you receive the form, you firm the registration update until that
must legibly fill out the sections of the individual confirms that he or she au-
form reflecting your updated informa- thorized the update.
tion and either mail it to the address (7) If any update information you
in paragraph (d)(1) of this section or previously submitted was incorrect at
fax it to 301–436–2804. the time of submission, you must im-
(3) If the information on the form is mediately resubmit your update.
incomplete or illegible when FDA re- (8) Your registration will be consid-
ceives it, FDA will return the form to ered updated once FDA enters your fa-
you for revision, provided that your cility’s update data into the registra-
mailing address or fax number is leg- tion system and the system generates
ible and valid. When returning a reg- an update confirmation.
istration form for revision, FDA will [81 FR 45952, July 14, 2016]
use the means by which the registra-
tion was received by the Agency (i.e., § 1.235 How and when do you cancel
by mail or fax). your facility’s registration informa-
(4) FDA will enter complete and leg- tion?
ible updates into its registration sys- (a) Notification of registration cancella-
tem as soon as practicable, in the order tion. You must cancel a registration
FDA receives them. within 60 calendar days of the reason
(5) FDA will then mail to the address for cancellation (e.g., your facility
or fax to the fax number on the reg- ceases operations, ceases providing
istration form a copy of the update as food for consumption in the United
entered and confirmation of the up- States, or is sold to a new owner).
date. When responding to an update (b) Cancellation requirements. The can-
submission, FDA will use the means by cellation of a facility’s registration
which the form was received by the must include the following informa-
Agency (i.e., by mail or fax). After you tion:
submit your update by mail or fax, (1) The facility’s registration num-
FDA will verify the accuracy of your ber;
facility’s UFI and will also verify that (2) Whether the facility is domestic
the facility-specific address associated or foreign;
with the UFI is the same address asso- (3) The facility name and address;
ciated with your registration. FDA will (4) The name, address, and email ad-
not provide a confirmation of your reg- dress (if available) of the individual
istration update until FDA verifies the submitting the cancellation;
accuracy of your facility’s UFI and (5) For registration cancellations not
verifies that the facility-specific ad- submitted by the owner, operator, or
dress associated with the UFI is the agent in charge of the facility, the
same address associated with your reg- email address of the individual who au-
istration. For foreign facilities, when thorized submission of the registration
updating information about your U.S. cancellation, unless FDA has granted a
agent, FDA will verify that the person waiver under § 1.245; and
identified as the U.S. agent for your (6) A statement certifying that the
foreign facility has agreed to serve as information submitted is true and ac-
your U.S. agent. FDA will not provide curate, and that the person submitting
you with a confirmation of your reg- the cancellation is authorized by the
istration update until that person con- facility to cancel its registration.
firms that the person agreed to serve (c) Electronic cancellation. (1) To can-
as your U.S. agent. cel your registration electronically,
(6) For registration updates not sub- you must cancel at http://www.fda.gov/
mitted by the owner, operator, or furls.
34
(2) Once you complete your elec- entered and confirmation of the can-
tronic cancellation, FDA will provide cellation. When responding to a can-
you with an electronic confirmation of cellation, FDA will use the means by
your cancellation. which the form was received by the
(3) For registration cancellations not Agency (i.e., by mail or fax).
submitted by the owner, operator, or (6) For registration cancellations not
agent in charge of the facility, after submitted by the owner, operator, or
submission of the registration can- agent in charge of the facility, after
cellation, FDA will verify that the in- submission of the registration can-
dividual identified as having author- cellation by mail or fax, FDA will
ized submission of the cancellation in verify that the individual identified as
fact authorized the submission on be- having authorized submission of the
half of the facility. FDA will not con- cancellation in fact authorized the sub-
firm the registration cancellation until mission on behalf of the facility. FDA
that individual confirms that he or she will not confirm the registration can-
authorized the registration cancella- cellation until that individual confirms
tion. that he or she authorized the registra-
(4) Your registration will be consid- tion cancellation.
ered cancelled once FDA sends you (7) Your registration will be consid-
your cancellation confirmation. ered cancelled once FDA enters your
(d) Cancellation by mail or fax. Begin- facility’s cancellation data into the
ning January 4, 2020, you must cancel registration system. FDA will send you
your registration electronically, unless your cancellation confirmation.
FDA has granted you a waiver under
§ 1.245. If FDA has granted a waiver [81 FR 45952, July 14, 2016]
under § 1.245, you may cancel your fa-
cility’s registration by mail or fax. ADDITIONAL PROVISIONS
(1) You must cancel your registration
using Form FDA 3537a. You may obtain § 1.240 What other registration re-
quirements apply?
a copy of this form by writing to the
U.S. Food and Drug Administration, In addition to the requirements of
Center for Food Safety and Applied Nu- this subpart, you must comply with the
trition, 5001 Campus Dr. (HFS–681), Col- registration regulations found in part
lege Park, MD 20740 or by requesting 108 of this chapter, related to emer-
the form by phone at 1–800–216–7331 or gency permit control, and any other
301–575–0156. Federal, State, or local registration re-
(2) When you receive the form, you quirements that apply to your facility.
must completely and legibly fill out
the form and either mail it to the ad- § 1.241 What are the consequences of
dress in paragraph (d)(1) of this section failing to register, update, renew, or
or fax it to 301–436–2804. cancel your registration?
(3) If the information on the form is (a) Section 301 of the Federal Food,
incomplete or illegible when FDA re- Drug, and Cosmetic Act (21 U.S.C. 331)
ceives it, FDA will return the form to prohibits the doing of certain acts or
you for revision, provided that your causing such acts to be done. Under
mailing address or fax number is leg- section 302 of the Federal Food, Drug,
ible and valid. When returning a can- and Cosmetic Act (21 U.S.C. 332), the
cellation form for revision, FDA will United States can bring a civil action
use the means by which the cancella- in Federal court to enjoin a person who
tion was received by the Agency (i.e., commits a prohibited act. Under sec-
by mail or fax). tion 303 of the Federal Food, Drug, and
(4) FDA will enter complete and leg- Cosmetic Act (21 U.S.C. 333), the United
ible mailed and faxed cancellations States can bring a criminal action in
into its registration system as soon as Federal court to prosecute a person
practicable, in the order FDA receives who is responsible for the commission
them. of a prohibited act. Under section 306 of
(5) FDA will mail to the address or the Federal Food, Drug, and Cosmetic
fax to the fax number on the cancella- Act (21 U.S.C. 335a), FDA can seek de-
tion form a copy of the cancellation as barment of any person who has been
35
§ 1.242 21 CFR Ch. I (4–1–19 Edition)
convicted of a felony relating to impor- be governed by the procedures set out

tation of food into the United States. in subpart I of this part.
Failure of an owner, operator, or agent
[81 FR 45953, July 14, 2016]
in charge of a domestic or foreign facil-
ity to register its facility, renew the § 1.242 What does assignment of a reg-
registration of its facility, update re- istration number mean?
quired elements of its facility’s reg-
Assignment of a registration number
istration, or cancel its registration in
to a facility means that the facility is
accordance with the requirements of registered with FDA. Assignment of a
this subpart is a prohibited act under registration number does not in any
section 301(dd) of the Federal Food, way convey FDA’s approval or endorse-
Drug, and Cosmetic Act. ment of a facility or its products.
(b) FDA will consider a registration
for a food facility to be expired if the § 1.243 Is food registration information
registration is not renewed, as required available to the public?
by § 1.230(b). Thus, if you previously (a) The list of registered facilities
submitted a registration to FDA, but and registration documents submitted
do not submit a registration renewal to under this subpart are not subject to
FDA during the period beginning on disclosure under 5 U.S.C. 552 (the Free-
October 1 and ending on December 31 of dom of Information Act). In addition,
each even-numbered year, FDA will any information derived from such list
consider the registration for the facil- or registration documents that would
ity to be expired. FDA will consider a disclose the identity or location of a
food facility with an expired registra- specific registered person, is not sub-
tion to have failed to register in ac- ject to disclosure under 5 U.S.C. 552
cordance with section 415 of the Fed- (the Freedom of Information Act).
eral Food, Drug, and Cosmetic Act. (b) Paragraph (a) of this section does
(c) FDA will cancel a registration if not apply to any information obtained
FDA independently verifies that the fa- by other means or that has previously
cility is no longer in business or has been disclosed to the public as defined
changed owners, and the owner, oper- in § 20.81 of this chapter.
ator, or agent in charge of the facility
fails to cancel the registration, or if § 1.245 Waiver request.
FDA determines that the registration Under §§ 1.231(a)(2) and (b), 1.234(d),
is for a facility that does not exist, is and 1.235(d), beginning January 4, 2020,
not required to register, or where the you must submit your registration,
information about the facility’s ad- registration renewal, updates, and can-
dress was not updated in a timely man- cellations to FDA electronically unless
ner in accordance with § 1.234(a) or the FDA has granted a waiver from such
registration was submitted by a person requirement. Under § 1.232(a)(6), you
not authorized to submit the registra- must provide the email address of the
tion under § 1.225. Also, FDA will cancel owner, operator, or agent in charge of
a registration if the facility’s registra- the facility unless FDA has granted a
tion has expired because the facility waiver from such requirement. In addi-
has failed to renew its registration in tion, under §§ 1.230(b) and (c),
accordance with § 1.230(b). If FDA can- 1.232(a)(10), 1.234(a), and 1.235(b)(5), reg-
cels a facility’s registration, FDA will istration renewals, abbreviated reg-
send a confirmation of the cancellation istration renewals, registrations, up-
using contact information submitted dates, and cancellations not submitted
by the facility in the registration data- by the owner, operator, or agent in
base. charge must include the email address
(d) If an article of food is imported or for the individual who authorized the
offered for import into the United submission, unless FDA has granted a
States and a foreign facility that man- waiver. To request a waiver from these
ufactured/processed, packed, or held requirements, you must submit a writ-
that article of food has not registered ten request to FDA that explains why
in accordance with this subpart, the it is not reasonable for you to submit
disposition of the article of food shall your registration, registration renewal,
36
update, or cancellation to FDA elec- where the article was made; except
tronically or to provide the email ad- that, if an article of food is made from
dress of the owner, operator, or agent wild fish, including seafood, aboard a
in charge of the facility. You must sub- vessel, the FDA Country of Production
mit your request to: U.S. Food and is the country in which the vessel is
Drug Administration, Center for Food registered. If an article of food that is
Safety and Applied Nutrition, 5001 no longer in its natural state was made
Campus Dr. (HFS–681), College Park, in a Territory, the FDA Country of
MD 20740. Production is the United States.
[81 FR 45953, July 14, 2016] (5) Food has the meaning given in
section 201(f) of the act, except as pro-
Subpart I—Prior Notice of vided in paragraph (b)(5)(i) of this sec-
Imported Food tion.
(i) For purposes of this subpart, food
SOURCE: 73 FR 66402, Nov. 7, 2008, unless does not include:
otherwise noted. (A) Food contact substances as de-
fined in section 409(h)(6) of the act (21
GENERAL PROVISIONS U.S.C. 348(h)(6)); or
§ 1.276 What definitions apply to this (B) Pesticides as defined in 7 U.S.C.
subpart? 136(u).
(ii) Examples of food include fruits,
(a) The act means the Federal Food,
Drug, and Cosmetic Act. vegetables, fish, including seafood,
(b) The definitions of terms in sec- dairy products, eggs, raw agricultural
tion 201 of the act (21 U.S.C. 321) apply commodities for use as food or as com-
when the terms are used in this sub- ponents of food, animal feed (including
part, unless defined in this section. pet food), food and feed ingredients,
(1) Calendar day means every day food and feed additives, dietary supple-
shown on the calendar. ments and dietary ingredients, infant
(2) Country from which the article origi- formula, beverages (including alcoholic
nates means FDA Country of Produc- beverages and bottled water), live food
tion. animals, bakery goods, snack foods,
(3) Country from which the article is candy, and canned foods.
shipped means the country in which the (6) Full address means the facility’s
article of food is loaded onto the con- street name and number; suite/unit
veyance that brings it to the United number, as appropriate; city; Province
States or, in the case of food sent by or State as appropriate; mail code as
international mail, the country from appropriate; and country.
which the article is mailed. (7) Grower means a person who en-
(4) FDA Country of Production means: gages in growing and harvesting or col-
(i) For an article of food that is in its lecting crops (including botanicals),
natural state, the country where the raising animals (including fish, which
article of food was grown, including includes seafood), or both.
harvested or collected and readied for
(8) International mail means foreign
shipment to the United States. If an
national mail services. International
article of food is wild fish, including
seafood that was caught or harvested mail does not include express consign-
outside the waters of the United States ment operators or carriers or other pri-
by a vessel that is not registered in the vate delivery services unless such serv-
United States, the FDA Country of ice is operating under contract as an
Production is the country in which the agent or extension of a foreign mail
vessel is registered. If an article of food service.
that is in its natural state was grown, (9) Manufacturer means the last facil-
including harvested or collected and ity, as that word is defined in § 1.227,
readied for shipment, in a Territory, that manufactured/processed the food.
the FDA Country of Production is the A facility is considered the last facility
United States. even if the food undergoes further man-
(ii) For an article of food that is no ufacturing/processing that consists of

longer in its natural state, the country adding labeling or any similar activity
37
§ 1.277 21 CFR Ch. I (4–1–19 Edition)
of a de minimis nature. If the food un- carriers or other private delivery serv-
dergoes further manufacturing/proc- ice to the United States.
essing that exceeds an activity of a de (15) United States means the Customs
minimis nature, then the subsequent fa- territory of the United States (i.e., the
cility that performed the additional 50 States, the District of Columbia, and
manufacturing/processing is considered the Commonwealth of Puerto Rico),
the manufacturer. but not the Territories.
(10) No longer in its natural state (16) You means the person submitting
means that an article of food has been the prior notice, i.e., the submitter or
made from one or more ingredients or the transmitter, if any.
synthesized, prepared, treated, modi-
fied, or manipulated. Examples of ac- [73 FR 66402, Nov. 7, 2008, as amended at 80
tivities that render food no longer in FR 56143, Sept. 17, 2015]
its natural state are cutting, peeling,
trimming, washing, waxing, evis- § 1.277 What is the scope of this sub-
part?
cerating, rendering, cooking, baking,
freezing, cooling, pasteurizing, homog- (a) This subpart applies to all food
enizing, mixing, formulating, bottling, for humans and other animals that is
milling, grinding, extracting juice, dis- imported or offered for import into the
tilling, labeling, or packaging. Crops United States for use, storage, or dis-
that have been cleaned (e.g., dusted, tribution in the United States, includ-
washed), trimmed, or cooled attendant ing food for gifts and trade and quality
to harvest or collection or treated assurance/quality control samples, food
against pests, or polished are still in for transshipment through the United
their natural state for purposes of this States to another country, food for fu-
subpart. Whole fish headed, evis- ture export, and food for use in a U.S.
cerated, or frozen attendant to harvest Foreign Trade Zone.
are still in their natural state for pur- (b) Notwithstanding paragraph (a) of
poses of this subpart. this section, this subpart does not
(11) Port of arrival means the water, apply to:
air, or land port at which the article of (1) Food for an individual’s personal
food is imported or offered for import use when it is carried by or otherwise
into the United States. For an article accompanies the individual when arriv-
of food arriving by water or air, this is ing in the United States;
the port of unloading. For an article of (2) Food that was made by an indi-
food arriving by land, this is the port vidual in his/her personal residence and
where the article of food first crosses
sent by that individual as a personal
the border into the United States. The
gift (i.e., for nonbusiness reasons) to an
port of arrival may be different than
individual in the United States;
the port where consumption or ware-
house entry or foreign trade zone ad- (3) Food that is imported then ex-
mission documentation is presented to ported without leaving the port of ar-
the U.S. Customs and Border Protec- rival until export;
tion (CBP). (4) Meat food products that at the
(12) Port of entry, in section 801(m) time of importation are subject to the
and (l) of the act (21 U.S.C. 381(m) and exclusive jurisdiction of the U.S. De-
(l)), means the port of entry as defined partment of Agriculture (USDA) under
in 19 CFR 101.1. the Federal Meat Inspection Act (21
(13) Registration number means the U.S.C. 601 et seq.);
registration number assigned to a facil- (5) Poultry products that at the time
ity by FDA under section 415 of the act of importation are subject to the exclu-
(21 U.S.C. 350d) and subpart H of this sive jurisdiction of USDA under the
part. Poultry Products Inspection Act (21
(14) Shipper means the owner or ex- U.S.C. 451 et seq.);
porter of the article of food who con- (6) Egg products that at the time of
signs and ships the article from a for- importation are subject to the exclu-
eign country or the person who sends sive jurisdiction of USDA under the
an article of food by international mail Egg Products Inspection Act (21 U.S.C.
or express consignment operators or 1031 et seq.); and
38
(7) Articles of food subject to Article you must submit the prior notice be-
27(3) of The Vienna Convention on Dip- fore the article of food is sent to the
lomatic Relations (1961), i.e., shipped as United States.
baggage or cargo constituting the dip- (d) FDA will notify you that your
lomatic bag. prior notice has been confirmed for re-
view with a reply message that con-
REQUIREMENTS TO SUBMIT PRIOR NOTICE tains a Prior Notice (PN) Confirmation
OF IMPORTED FOOD Number. Your prior notice will be con-
sidered submitted and the prior notice
§ 1.278 Who is authorized to submit
prior notice? time will start when FDA has con-
firmed your prior notice for review.
A prior notice for an article of food (e) The PN Confirmation Number
may be submitted by any person with must accompany any article of food ar-
knowledge of the required information. riving by international mail. The PN
This person is the submitter. The sub- Confirmation Number must appear on
mitter also may use another person to the Customs Declaration (e.g., CN22 or
transmit the required information on CN23 or U.S. equivalent) that accom-
his/her behalf. The person who trans- panies the package.
mits the information is the trans- (f) A copy of the confirmation, in-
mitter. The submitter and transmitter cluding the PN Confirmation Number,
may be the same person. must accompany any article of food
§ 1.279 When must prior notice be sub- that is subject to this subpart when it
mitted to FDA? is carried by or otherwise accompanies
an individual when arriving in the
(a) Except as provided in paragraph United States. The copy of the con-
(c) of this section, you must submit the firmation must be provided to U.S.
prior notice to FDA and the prior no- Customs and Border Protection (CBP)
tice submission must be confirmed by or FDA upon arrival.
FDA for review as follows:
(g) The PN Confirmation Number
(1) If the article of food is arriving by
must accompany any article of food for
land by road, no less than 2 hours be-
which the prior notice was submitted
fore arriving at the port of arrival;
through the FDA PNSI when the arti-
(2) If the article of food is arriving by cle arrives in the United States and
land by rail, no less than 4 hours before must be provided to CBP or FDA upon
arriving at the port of arrival; arrival.
air, no less than 4 hours before arriving [73 FR 66402, Nov. 7, 2008, as amended at 82
at the port of arrival; or FR 15629, Mar. 30, 2017]
water, no less than 8 hours before ar- § 1.280 How must you submit prior no-
tice?
riving at the port of arrival.
(b) Except in the case of an article of (a) You must submit the prior notice
food imported or offered for import by electronically to FDA. You must sub-
international mail: mit all prior notice information in the
(1) If prior notice is submitted via the English language, except that an indi-
Automated Broker Interface/Auto- vidual’s name, the name of a company,
mated Commercial Environment/Inter- and the name of a street may be sub-
national Trade Data System (ABI/ACE/ mitted in a foreign language. All infor-
ITDS), you may not submit prior no- mation, including the items listed in
tice more than 30-calendar days before the previous sentence, must be sub-
the anticipated date of arrival. mitted using the Latin (Roman) alpha-
(2) If prior notice is submitted via the bet. Unless paragraph (c) of this sec-
FDA Prior Notice System Interface tion applies, you must submit prior no-
(FDA PNSI), you may not submit prior tice through:
notice more than 15-calendar days be- (1) The U.S. Customs and Border Pro-
fore the anticipated date of arrival. tection (CBP) Automated Broker Inter-
(c) Notwithstanding paragraphs (a) face/Automated Commercial Environ-
and (b) of this section, if the article of ment/International Trade Data System
food is arriving by international mail, (ABI/ACE/ITDS); or
39
§ 1.281 21 CFR Ch. I (4–1–19 Edition)
(2) The FDA PNSI at https:// CBP entry number or in-bond number),
www.access.fda.gov/. You must submit if available;
prior notice through the FDA Prior No- (5) The identity of the article of food
tice System Interface (FDA PNSI) for being imported or offered for import,
articles of food imported or offered for as follows:
import by international mail, and (i) The complete FDA product code;
other transaction types that cannot be (ii) The common or usual name or
made through ABI/ACE/ITDS. market name;
(b) If a customhouse broker’s or self-
(iii) The estimated quantity of food
filer’s system is not working or if the
ABI/ACE/ITDS interface is not work- that will be shipped, described from
ing, prior notice must be submitted largest container to smallest package
through the FDA PNSI. size; and
(c) If FDA determines that FDA (iv) The lot or code numbers or other
PNSI or the Operational and Adminis- identifier of the food if required by the
tration System for Import Support act or FDA regulations, e.g., low-acid
(OASIS) is not working, FDA will post canned foods, by § 113.60(c) of this chap-
prominent notification and instruc- ter; acidified foods, by § 114.80(b) of this
tions at http://www.fda.gov. FDA will chapter; and infant formula, by § 106.90
accept prior notice submissions in the of this chapter;
format it deems appropriate during the (6) For an article of food that is no
system(s) outage. longer in its natural state, the identity
[73 FR 66402, Nov. 7, 2008, as amended at 82
of the manufacturer, as follows:
FR 15629, Mar. 30, 2017] (i) The name of the manufacturer;
and
§ 1.281 What information must be in a (ii) Either the registration number,
prior notice? city, and country of the manufacturer
(a) General. For each article of food or both the full address of the manufac-
that is imported or offered for import turer and the reason the registration
into the United States, except by inter- number is not provided;
national mail, you must submit the in- (7) For an article of food that is in its
formation for the article that is re- natural state, the name and growing
quired in paragraphs (a)(1) through (18) location address of the grower, if
of this section: known. If the submitter does not know
(1) The name of the individual sub- the identity of the grower or, if the ar-
mitting the prior notice and his/her ticle has been consolidated and the
business address, phone number, and e- submitter does not know the identity
mail address, and the name and address of any of the growers, you may provide
of the submitting firm, if applicable. If the name and address of the firm that
the business address of the individual has consolidated the articles of food
submitting the prior notice is a reg- from different growers or different
istered facility, then the facility’s reg- growing locations;
istration number, city, and country (8) The FDA Country of Production;
may be provided instead of the facili- (9) If the shipper is different from the
ty’s full address; manufacturer, the identity of the ship-
(2) If different from the submitter, per, as follows:
the name of the individual and firm, if
(i) The name of the shipper; and
applicable, transmitting the prior no-
tice on behalf of the submitter and his/ (ii) The full address of the shipper. If
her business address, phone number, the address of the shipper is a reg-
and e-mail address. If the business ad- istered facility, you also may submit
dress of the individual transmitting the registration number of the ship-
the prior notice is a registered facility, per’s registered facility;
then the facility’s registration number, (10) The country from which the arti-
city, and country may be provided in- cle is shipped;
stead of the facility’s full address; (11) Anticipated arrival information
(3) The entry type; about the article of food being im-
(4) The U.S. Customs and Border Pro- ported or offered for import, as follows:
tection (CBP) entry identifier (e.g., (i) The anticipated port of arrival;
40
(ii) The anticipated date on which port of arrival, or if this code is not ap-
the article of food will arrive at the an- plicable, then the name of the carrier.
ticipated port of arrival; If the carrier is a privately owned vehi-
(iii) The anticipated time of that ar- cle, the license plate number of the ve-
rival; and hicle and the State or Province that
(iv) Notwithstanding paragraphs issued the license plate number;
(a)(11) introductory text and (a)(11)(i) (17) Planned shipment information,
through (iii) of this section, if the arti- as applicable to the mode of transpor-
cle of food is arriving by express con- tation and when it exists:
signment operator or carrier, the ex- (i) The Airway Bill number(s) or Bill
press consignment operator or carrier of Lading number(s), as applicable.
tracking number may be submitted in This information is not required for an
lieu of the information required in article of food when carried by or oth-
paragraphs (a)(11) introductory text erwise accompanying an individual
and (a)(11)(i) through (iii) of this sec- when entering the United States. If the
tion. article of food is arriving by express
(12) The name and full address of the consignment operator or carrier, the
importer. If the business address of the express consignment operator or car-
importer is a registered facility, you rier tracking number may by sub-
also may submit the registration num- mitted in lieu of the Airway Bill num-
ber of the importer’s registered facil- ber(s) or Bill of Lading number(s), as
ity. The identity of the importer is not applicable;
required for an article of food that is (ii) For food arriving by ocean vessel,
imported or offered for import for the vessel name and voyage number;
transshipment through the United (iii) For food arriving by air carrier,
States under a Transportation and Ex- the flight number. If the article of food
portation entry; is arriving by express consignment op-
(13) The name and full address of the erator or carrier, the express consign-
owner if different from the importer or ment operator or carrier tracking num-
ultimate consignee. If the business ad- ber may be submitted in lieu of the
dress of the owner is a registered facil- flight number;
ity, you also may submit the registra- (iv) For food arriving by truck, bus,
tion number of the owner’s registered or rail, the trip number;
facility. The identity of the owner is (v) For food arriving as containerized
not required for an article of food that cargo by water, air, or land, the con-
is imported or offered for import for tainer number(s). This information is
transshipment through the United not required for an article of food when
States under a Transportation and Ex- carried by or otherwise accompanying
portation entry; an individual when entering the United
(14) The name and full address of the States; and
ultimate consignee. If the business ad- (vi) For food arriving by rail, the car
dress of the ultimate consignee is a number. This information is not re-
registered facility, you also may sub- quired for an article of food when car-
mit the registration number of the ul- ried by or otherwise accompanying an
timate consignee’s registered facility. individual.
The identity of the ultimate consignee (18) Any country to which the article
is not required for an article of food has been refused entry.
that is imported or offered for import (b) Articles arriving by international
for transshipment through the United mail. For each article of food that is
States under a Transportation and Ex- imported or offered for import into the
portation entry; United States by international mail,
(15) The mode of transportation; you must submit the information for
(16) The Standard Carrier Abbrevia- the article that is required in para-
tion Code (SCAC) or International Air graphs (b)(1) through (12) of this sec-
Transportation Association (IATA) tion:
code of the carrier which is, or will be, (1) The name of the individual sub-
carrying the article of food from the mitting the prior notice and his/her
country from which the article is business address, phone number, and e-
shipped to the United States to the mail address, and the name and address
41
§ 1.281 21 CFR Ch. I (4–1–19 Edition)
of the submitting firm, if applicable. If (7) The FDA Country of Production;

the business address of the individual (8) If the shipper is different from the
submitting the prior notice is a reg- manufacturer, the identity of the ship-
istered facility, then the facility’s reg- per, as follows:
istration number, city, and country (i) The name of the shipper; and
may be provided instead of the facili- (ii) The full address of the shipper. If
ty’s full address; the address of the shipper is a reg-
(2) If different from the submitter, istered facility, you also may submit
the name of the individual and firm, if the registration number of the ship-
applicable, transmitting the prior no- per’s registered facility;
tice on behalf of the submitter and his/ (9) The country from which the arti-
her business address, phone number, cle is shipped (i.e., mailed);
and e-mail address. If the business ad-
(10) The anticipated date of mailing;
dress of the individual transmitting
and
the prior notice is a registered facility,
(11) The name and address of the U.S.
then the facility’s registration number,
recipient.
city, and country may be provided in-
stead of the facility’s full address; (12) Any country to which the article
(3) The entry type (which will be a has been refused entry.
mail entry); (c) Refused articles. If the article of
(4) The identity of the article of food food has been refused under section
being imported or offered for import, 801(m)(1) of the act and under this sub-
as follows: part, you must submit the information
(i) The complete FDA product code; for the article that is required in para-
(ii) The common or usual name or graphs (c)(1) through (19) of this sec-
market name; tion. However, if the refusal is based on
(iii) The estimated quantity of food § 1.283(a)(1)(iii) (Untimely Prior No-
that will be shipped, described from tice), you do not have to resubmit any
largest container to smallest package information previously submitted un-
size; and less it has changed or the article has
(iv) The lot or code numbers or other been exported and the original prior
identifier of the food if required by the notice was submitted through ABI/
act or FDA regulations, e.g., low-acid ACE/ITDS. If the refusal is based on
canned foods, by § 113.60(c) of this chap- § 1.283(a)(1)(ii), you should cancel the
ter; acidified foods, by § 114.80(b) of this previous submission per § 1.282(b) and
chapter; and infant formula, § 106.90 of (c).
this chapter; (1) The name of the individual sub-
(5) For an article of food that is no mitting the prior notice and his/her
longer in its natural state, the identity business address, phone number, and e-
of the manufacturer, as follows: mail address, and the name and address
(i) The name of the manufacturer; of the submitting firm, if applicable. If
and the business address of the individual
(ii) Either the registration number, submitting the prior notice is a reg-
city, and country of the manufacturer istered facility, then the facility’s reg-
or both the full address of the manufac- istration number, city, and country
turer and the reason the registration may be provided instead of the facili-
number is not provided; ty’s full address;
(6) For an article of food that is in its (2) If different from the submitter,
natural state, the name and growing the name of the individual and firm, if
location address of the grower, if applicable, transmitting the prior no-
known. If the submitter does not know tice on behalf of the submitter and his/
the identity of the grower or, if the ar- her business address, phone number,
ticle has been consolidated and the and e-mail address. If the business ad-
submitter does not know the identity dress of the individual transmitting
of any of the growers, you may provide the prior notice is a registered facility,
the name and address of the firm that then the facility’s registration number,
has consolidated the articles of food city, and country may be provided in-
from different growers or different stead of the facility’s full address;

growing locations; (3) The entry type;
42
(4) The CBP entry identifier (e.g., (iii) Notwithstanding paragraphs

CBP entry number or in-bond number), (c)(11) introductory text and (c)(11)(i)
if available; and (ii) of this section, if the article of
(5) The identity of the article of food food arrived by express consignment
being imported or offered for import, operator or carrier, the express con-
as follows: signment operator or carrier tracking
(i) The complete FDA product code; number may be submitted in lieu of the
(ii) The common or usual name or information required in paragraphs
market name; (c)(11) introductory text and (c)(11)(i)
(iii) The quantity of food that was and (ii) of this section.
shipped, described from largest con- (12) The name and full address of the
tainer to smallest package size; and importer. If the business address of the
(iv) The lot or code numbers or other
importer is a registered facility, you
identifier of the food if required by the
also may submit the registration num-
act or FDA regulations, e.g., low-acid
ber of the importer’s registered facil-
canned foods, by § 113.60(c) of this chap-
ity. The identity of the importer is not
ter; acidified foods, by § 114.80(b) of this
chapter; and infant formula, by § 106.90 required for an article of food that is
of this chapter; imported or offered for import for
(6) For an article of food that is no transshipment through the United
longer in its natural state, the identity States under a Transportation and Ex-
of the manufacturer, as follows: portation entry;
(i) The name of the manufacturer; (13) The name and full address of the
and owner, if different from the importer or
(ii) Either the registration number, ultimate consignee. If the business ad-
city, and country of the manufacturer dress of the owner is a registered facil-
or both the full address of the manufac- ity, you also may submit the registra-
turer and the reason the registration tion number of the importer’s reg-
number is not provided; istered facility. The identity of the
(7) For an article of food that is in its owner is not required for an article of
natural state, the name and growing food that is imported or offered for im-
location address of the grower, if port for transshipment through the
known. If the submitter does not know United States under a Transportation
the identity of the grower or, if the ar- and Exportation entry;
ticle has been consolidated and the (14) The name and full address of the
submitter does not know any of the ultimate consignee. If the business ad-
growers, you may provide the name dress of the ultimate consignee is a
and address of the firm that has con- registered facility, you also may sub-
solidated the articles of food from dif- mit the registration number of the ul-
ferent growers or different growing lo- timate consignee’s registered facility.
cations;
The identity of the ultimate consignee
(8) The FDA Country of Production;
is not required for an article of food
(9) If the shipper is different from the
that is imported or offered for import
manufacturer, the identity of the ship-
per, as follows: for transshipment through the United
(i) The name of the shipper; and States under a Transportation and Ex-
(ii) The full address of the shipper. If portation entry;
the address of the shipper is a reg- (15) The mode of transportation;
istered facility, you also may submit (16) The SCAC or IATA code of the
the registration number of the ship- carrier which carried the article of
per’s registered facility; food from the country from which the
(10) The country from which the arti- article is shipped to the United States
cle is shipped; to the port of arrival, or if this code is
(11) Arrival information about the ar- not applicable, then the name of the
ticle of food being imported or offered carrier. If the carrier is a privately
for import, as follows: owned vehicle, the license plate num-
(i) The port of arrival; and ber of the vehicle and the State or
(ii) The date on which the article of Province that issued the license plate
food arrived at the port of arrival. number;
43
§ 1.282 21 CFR Ch. I (4–1–19 Edition)
(17) Shipment information, as appli- (i) Section 1.281(a)(5)(iii) (quantity),

cable to the mode of transportation (ii) Section 1.281(a)(11) (anticipated
and when it exists: arrival information), or
(i) The Airway Bill number(s) or Bill (iii) Section 1.281(a)(17) (planned ship-
of Lading number(s), as applicable; ment information), changes after you
however, this information is not re- receive notice that FDA has confirmed
quired for an article of food when car- your prior notice submission for re-
ried by or otherwise accompanying an view, you must resubmit prior notice
individual when entering the United in accordance with this subpart unless
States. If the article of food arrived by the article of food will not be offered
express consignment operator or car- for import or imported into the United
rier, the express consignment operator States.
or carrier tracking number may be sub- (2) If any of the information required
mitted in lieu of the Airway Bill num- in § 1.281(b), except the information re-
ber(s) or Bill of Lading number(s), as quired in § 1.281(b)(10) (the anticipated
applicable; date of mailing), changes after you re-
(ii) For food that arrived by ocean ceive notice that FDA has confirmed
vessel, the vessel name and voyage your prior notice submission for re-
number; view, you must resubmit prior notice
(iii) For food that arrived by air car- in accordance with this subpart, unless
rier, the flight number. If the article of the article of food will not be offered
food arrived by express consignment for import or imported into the United
operator or carrier, the express con- States.
signment operator or carrier tracking
(b) If you submitted the prior notice
number may be submitted in lieu of the
via the FDA PNSI, you should cancel
flight number;
the prior notice via the FDA PNSI.
(iv) For food that arrived by truck,
bus, or rail, the trip number; (c) If you submitted the prior notice
(v) For food that arrived as contain- via ABI/ACE/ITDS, you should cancel
erized cargo by water, air, or land, the the prior notice via ACE by requesting
container number(s); however, this in- that CBP cancel the entry.
formation is not required for an article [73 FR 66402, Nov. 7, 2008, as amended at 82
of food when carried by or otherwise FR 15629, Mar. 30, 2017]
accompanying an individual when en-
tering the United States; and CONSEQUENCES
(vi) For food that arrived by rail, the
car number; however, this information § 1.283 What happens to food that is
is not required for an article of food imported or offered for import
without adequate prior notice?
when carried by or otherwise accom-
panying an individual; (a) For each article of food that is
(18) The location and address where imported or offered for import into the
the article of refused food will be or is United States, except for food arriving
being held, the date the article has ar- by international mail or food carried
rived or will arrive at that location, by or otherwise accompanying an indi-
and identification of a contact at that vidual, the consequences are:
location. (1) Inadequate prior notice—(i) No prior
(19) Any country to which the article notice. If an article of food arrives at
has been refused entry. the port of arrival and no prior notice
has been submitted and confirmed by
FR 25545, May 5, 2011; 82 FR 15629, Mar. 30, FDA for review, the food is subject to
2017] refusal of admission under section
801(m)(1) of the act (21 U.S.C. 381(m)(1)).
§ 1.282 What must you do if informa- If an article of food is refused for lack
tion changes after you have re- of prior notice, unless U.S. Customs
ceived confirmation of a prior no- and Border Protection (CBP) concur-
tice from FDA? rence is obtained for export and the ar-
(a)(1) If any of the information re- ticle is immediately exported from the
quired in § 1.281(a), except the informa- port of arrival under CBP supervision,
tion required in: it must be held within the port of entry
44
for the article unless directed by CBP outside a port, the food must be taken
or FDA. directly to that secure facility.
(ii) Inaccurate prior notice. If prior no- (3) Segregation of refused foods. If an
tice has been submitted and confirmed article of food that is refused is part of
by FDA for review, but upon review of a shipment that contains articles of
the notice or examination of the arti- food that have not been placed under
cle of food, the notice is determined to hold or other merchandise not subject
be inaccurate, the food is subject to re- to this subpart, the refused article of
fusal of admission under section food may be segregated from the rest of
801(m)(1) of the act. If the article of the shipment. This segregation must
food is refused due to inaccurate prior take place where the article is held.
notice, unless CBP concurrence is ob- FDA or CBP may supervise segrega-
tained for export and the article is im- tion. If FDA or CBP determines that
mediately exported from the port of ar- supervision is necessary, segregation
rival under CBP supervision, it must be must not take place without super-
held within the port of entry for the ar- vision.
ticle unless directed by CBP or FDA. (4) Costs. Neither FDA nor CBP are
(iii) Untimely prior notice. If prior no- liable for transportation, storage, or
tice has been submitted and confirmed other expenses resulting from refusal.
by FDA for review, but the full time (5) Export after refusal. An article of
that applies under § 1.279 for prior no-
food that has been refused under para-
tice has not elapsed when the article of
graph (a) of this section may be ex-
food arrives, the food is subject to re-
ported with CBP concurrence and
fusal of admission under section
under CBP supervision unless it is
801(m)(1) of the act, unless FDA has al-
seized or administratively detained by
ready reviewed the prior notice, deter-
FDA or CBP under other authority. If
mined its response to the prior notice,
an article of food that has been refused
and advised CBP of that response. If
admission under paragraph (a) of this
the article of food is refused due to un-
section is exported, the prior notice
timely prior notice, unless CBP concur-
should be cancelled within 5-business
rence is obtained for export and the ar-
ticle is immediately exported from the days of exportation.
port of arrival under CBP supervision, (6) No post-refusal submission or request
it must be held within the port of entry for review. If an article of food is re-
for the article unless directed by CBP fused under section 801(m)(1) of the act
or FDA. and no prior notice is submitted or re-
(2) Status and movement of refused submitted, no request for FDA review
food. (i) An article of food that has is submitted in accordance with para-
been refused under section 801(m)(1) of graph (d) of this section, or export has
the act and paragraph (a) of this sec- not occurred in accordance with para-
tion shall be considered general order graph (a)(5) of this section, the article
merchandise as described in section 490 of food shall be dealt with as set forth
of the Tariff Act of 1930, as amended (19 in CBP regulations relating to general
U.S.C. 1490). order merchandise (19 CFR part 127),
(ii) Refused food must be moved except that, unless otherwise agreed to
under appropriate custodial bond un- by CBP and FDA, the article may only
less immediately exported under CBP be sold for export or destroyed.
supervision. If the food is to be held at (b) Food carried by or otherwise accom-
the port, FDA must be notified of the panying an individual. If food carried by
location where the food is held at that or otherwise accompanying an indi-
port before the food is moved there. If vidual arriving in the United States is
the food is to be held at a secure facil- not for personal use and does not have
ity outside the port, FDA must be noti- adequate prior notice or the individual
fied of the location of the secure facil- cannot provide FDA or CBP with a
ity before the food is moved there. The copy of the prior notice (PN) confirma-
refused food shall not be entered and tion, the food is subject to refusal of
shall not be delivered to any importer, admission under section 801(m)(1) of
owner, or ultimate consignee. If the the act. If before leaving the port, the
food is to be held at a secure facility individual does not arrange to have the
45
§ 1.283 21 CFR Ch. I (4–1–19 Edition)
food held at the port or exported, FDA the food is no longer subject to refusal
or CBP may destroy the article of food. under section 801(m)(1) of the act.
(c) Post-Refusal prior notice submis- (e) International mail. If an article of
sions. (1) If an article of food is refused food arrives by international mail with
under paragraph (a)(1)(i) of this section inadequate prior notice or the PN con-
(no prior notice) and the food is not ex- firmation number is not affixed as re-
ported, prior notice must be submitted quired, the parcel will be held by CBP
in accordance with §§ 1.280 and 1.281(c). for 72 hours for FDA inspection and
(2) If an article of food is refused disposition. If FDA refuses the article
under paragraph (a)(1)(ii) of this sec- under section 801(m)(1) of the act and
tion (inaccurate prior notice) and the there is a return address, the parcel
food is not exported, the prior notice may be returned to sender marked ‘‘No
should be canceled in accordance with Prior Notice—FDA Refused.’’ If the ar-
§ 1.282 and you must resubmit prior no- ticle is refused and there is no return
tice in accordance with §§ 1.280 and address or FDA determines that the ar-
1.281(c). ticle of food in the parcel appears to
(3) Once the prior notice has been present a hazard, FDA may dispose of
submitted or resubmitted and con- or destroy the parcel at its expense. If
firmed by FDA for review, FDA will en- FDA does not respond within 72 hours
deavor to review and respond to the of the CBP hold, CBP may return the
prior notice submission within the parcel to the sender or, if there is no
timeframes set out in § 1.279. return address, destroy the parcel, at
(d) FDA review after refusal. (1) If an FDA expense.
article of food has been refused admis- (f) Prohibitions on delivery and trans-
sion under section 801(m)(1) of the act, fer. (1) Notwithstanding section 801(b)
a request may be submitted asking of the act, an article of food refused
FDA to review whether the article is under section 801(m)(1) of the act may
subject to the requirements of this sub- not be delivered to the importer,
part under § 1.277, or whether the infor- owner, or ultimate consignee until
mation submitted in a prior notice is prior notice is submitted to FDA in ac-
complete and accurate. A request for cordance with this subpart, FDA has
review may not be used to submit prior examined the prior notice, FDA has de-
notice or to resubmit an inaccurate termined that the prior notice is ade-
prior notice. quate, and FDA has notified CBP and
(2) A request may be submitted only the transmitter that the article of food
by the carrier, submitter, importer, is no longer refused admission under
owner, or ultimate consignee. A re- section 801(m)(1) of the act.
quest must identify which one the re- (2) During the time an article of food
quester is. that has been refused under section
(3) A request must be submitted in 801(m)(1) of the act is held, the article
writing to FDA and delivered by fax or may not be transferred by any person
e-mail. The location for receipt of a re- from the port or other designated se-
quest is listed at http://www.fda.gov— cure facility until prior notice is sub-
see Prior Notice. A request must in- mitted to FDA in accordance with this
clude all factual and legal information subpart, FDA has examined the prior
necessary for FDA to conduct its re- notice, FDA has determined that the
view. Only one request for review may prior notice is adequate, and FDA has
be submitted for each refused article. notified CBP and the transmitter that
(4) The request must be submitted the article of food no longer is refused
within 5-calendar days of the refusal. admission under section 801(m)(1) of
FDA will review and respond within 5- the act. After this notification by FDA
calendar days of receiving the request. to CBP and transmitter, entry may be
(5) If FDA determines that the article made in accordance with law and regu-
is not subject to the requirements of lation.
this subpart under § 1.277 or that the (g) Relationship to other admissibility
prior notice submission is complete decisions. A determination that an arti-
and accurate, it will notify the re- cle of food is no longer refused under
quester, the transmitter, and CBP that section 801(m)(1) of the act is different
46
than, and may come before, determina- (b) Hold. Unless CBP concurrence is
tions of admissibility under other pro- obtained for export and the article is
visions of the act or other U.S. laws. A immediately exported from the port of
determination that an article of food is arrival, if an article of food has been
no longer refused under section placed under hold under section 801(l)
801(m)(1) of the act does not mean that of the act, it must be held within the
it will be granted admission under port of entry for the article unless di-
other provisions of the act or other rected by CBP or FDA.
U.S. laws. (c) Status and movement of held food.
(1) An article of food that has been
§ 1.284 What are the other con- placed under hold under section 801(l)
sequences of failing to submit ade- of the act shall be considered general
quate prior notice or otherwise fail- order merchandise as described in sec-
ing to comply with this subpart?
tion 490 of the Tariff Act of 1930, as
(a) The importing or offering for im- amended (19 U.S.C. 1490).
port into the United States of an arti- (2) Food under hold under section
cle of food in violation of the require- 801(l) of the act must be moved under
ments of section 801(m) of the act, inappropriate custodial bond unless im-
cluding the requirements of this sub- mediately exported under CBP super-
part, is a prohibited act under section vision. If the food is to be held at the
301(ee) of the act (21 U.S.C. 331(ee)). port, FDA must be notified of the loca-
(b) Section 301 of the act prohibits tion where the food is held at the port
the doing of certain acts or causing before the food is moved there. If the
such acts to be done. food is to be held at a secure facility
(1) Under section 302 of the act (21 outside the port, FDA must be notified
U.S.C. 332), the United States can bring of the location of the secure facility
a civil action in Federal court to en- before the food is moved there. The
join persons who commit a prohibited food subject to hold shall not be en-
act. tered and shall not be delivered to any
(2) Under sections 301 and 303 of the importer, owner, or ultimate con-
act (21 U.S.C. 331 and 333), the United signee. If the food is to be held at a se-
States can bring a criminal action in cure facility outside a port, the food
Federal court to prosecute persons who must be taken directly to that secure
are responsible for the commission of a facility.
prohibited act. (d) Segregation of held foods. If an arti-
(c) Under section 306 of the act (21 cle of food that has been placed under
U.S.C. 335a), FDA can seek debarment hold under section 801(l) of the act is
of any person who has been convicted part of a shipment that contains arti-
of a felony relating to importation of cles that have not been placed under
food into the United States or any per- hold, the food under hold may be seg-
son who has engaged in a pattern of regated from the rest of the shipment.
importing or offering for import adul- This segregation must take place
terated food that presents a threat of where the article is held. FDA or CBP
serious adverse health consequences or may supervise segregation. If FDA or
death to humans or animals. CBP determine that supervision is nec-
essary, segregation must not take
§ 1.285 What happens to food that is place without supervision.
imported or offered for import from (e) Costs. Neither FDA nor CBP will
unregistered facilities that are re- be liable for transportation, storage, or
quired to register under subpart H other expenses resulting from any hold.
of this part? (f) Export after hold. An article of food
(a) Consequences. If an article of food that has been placed under hold under
from a foreign facility that is not reg- section 801(l) of the act may be ex-
istered as required under section 415 of ported with CBP concurrence and
the act (21 U.S.C. 350d) and subpart H of under CBP supervision unless it is
this part is imported or offered for im- seized or administratively detained by
port into the United States, the food is FDA or CBP under other authority.
subject to being held under section (g) No registration or request for review.
801(l) of the act (21 U.S.C. 381(l)). If an article of food is placed under
47
§ 1.285 21 CFR Ch. I (4–1–19 Edition)
hold under section 801(l) of the act and mitted to obtain a registration num-
no registration number or request for ber.
FDA review is submitted in accordance (2) A request may be submitted only
with paragraph (j) of this section or ex- by the carrier, submitter, importer,
port has not occurred in accordance owner, or ultimate consignee of the ar-
with paragraph (f) of this section, the ticle. A request must identify which
food shall be dealt with as set forth in one the requestor is.
CBP regulations relating to general (3) A request must be submitted in
order merchandise, except that, unless writing to FDA and delivered by fax or
otherwise agreed to by CBP and FDA, e-mail. The location for receipt of a re-
the article may only be sold for export quest is listed at http://www.fda.gov—
or destroyed. see Prior Notice. A request must in-
(h) Food carried by or otherwise accom- clude all factual and legal information
panying an individual. If an article of necessary for FDA to conduct its re-
food carried by or otherwise accom- view. Only one request for review may
panying an individual arriving in the be submitted for each article under
United States is not for personal use hold.
and is placed under hold under section (4) The request must be submitted
801(l) of the act because it is from a for- within 5-calendar days of the hold.
eign facility that is not registered as FDA will review and respond within 5-
required under section 415 of the act calendar days of receiving the request.
and subpart H of this part, the indi- (5) If FDA determines that the article
vidual may arrange to have the food is not from a facility subject to the re-
held at the port or exported. If such ar- quirements of section 415 of the act, it
rangements cannot be made, the arti- will notify the requestor and CBP that
cle of food may be destroyed. the food is no longer subject to hold
(i) Post-hold submissions. (1) To re- under section 801(l) of the act.
solve a hold, if an article of food is held (k) International mail. If an article of
under paragraph (b) of this section be- food that arrives by international mail
cause it is from a foreign facility that is from a foreign facility that is not
is not registered, the facility must be registered as required under section 415
registered and a registration number of the act and subpart H of this part,
must be obtained. the parcel will be held by CBP for 72
(2) The FDA Division of Food Defense hours for FDA inspection and disposi-
Targeting must be notified of the ap- tion. If the article is placed under hold
plicable registration number in writ- under section 801(l) of the act and there
ing. The notification must provide the is a return address, the parcel may be
name and contact information for the returned to sender marked ‘‘No Reg-
person submitting the information. istration—No Admission Permitted.’’ If
The notification may be delivered to the article is under hold and there is no
FDA by fax or e-mail. The contact in- return address or FDA determines that
formation for these delivery methods is the article of food in the parcel appears
listed at http://www.fda.gov—see Prior to present a hazard, FDA may dispose
Notice. The notification should include of or destroy the parcel at its expense.
the applicable CBP entry identifier. If FDA does not respond within 72
(3) If FDA determines that the article hours of the CBP hold, CBP may return
is no longer subject to hold, it will no- the parcel to the sender marked ‘‘No
tify the person who provided the reg- Registration—No Admission Per-
istration information and CBP that the mitted’’ or, if there is no return ad-
food is no longer subject to hold under dress, destroy the parcel, at FDA ex-
section 801(l) of the act. pense.
(j) FDA review after hold. (1) If an ar- (l) Prohibitions on delivery and trans-
ticle of food has been placed under hold fer. Notwithstanding section 801(b) of
under section 801(l) of the act, a re- the act, while an article of food is
quest may be submitted asking FDA to under hold under section 801(l) of the
review whether the facility associated act, it may not be delivered to the im-
with the article is subject to the reporter, owner, or ultimate consignee. If
quirements of section 415 of the act. A an article of food is no longer subject

request for review may not be sub- to hold under section 801(l) of the act,
48
entry may be made in accordance with consumption are more than 90 percent
law and regulation. of its total food sales.
(m) Relationship to other admissibility (c) Fishing vessels, including those
provisions. A determination that an ar- that not only harvest and transport
ticle of food is no longer subject to fish but also engage in practices such
hold under section 801(l) of the act is as heading, eviscerating, or freezing in-
different than, and may come before, tended solely to prepare fish for hold-
determinations of admissibility under ing on board a harvest vessel, are ex-
other provisions of the act or other cluded from all of the requirements in
U.S. laws. A determination that an ar- this subpart, except §§ 1.361 and 1.363.
ticle of food is no longer under hold However, those fishing vessels other-
under section 801(l) of the act does not wise engaged in processing fish are sub-
mean that it will be granted admission ject to all of the requirements in this
under other provisions of the act or subpart. For the purposes of this sec-
other U.S. laws. tion, ‘‘processing’’ means handling,
storing, preparing, shucking, changing
FR 15629, Mar. 30, 2017]
into different market forms, manufac-
turing, preserving, packing, labeling,
dockside unloading, holding or head-
Subpart J—Establishment, Mainte- ing, eviscerating, or freezing other
nance, and Availability of than solely to prepare fish for holding
Records on board a harvest vessel.
(d) Persons who distribute food di-
SOURCE: 69 FR 71651, Dec. 9, 2004, unless rectly to consumers are excluded from
otherwise noted. the requirements in § 1.345 to establish
and maintain records to identify the
GENERAL PROVISIONS nontransporter and transporter imme-
diate subsequent recipients as to those
§ 1.326 Who is subject to this subpart? transactions. The term ‘‘consumers’’
(a) Persons who manufacture, proc- does not include businesses.
ess, pack, transport, distribute, re- (e) Persons who operate retail food
ceive, hold, or import food in the establishments that distribute food to
United States are subject to the regu- persons who are not consumers are sub-
lations in this subpart, unless you ject to all of the requirements in this
qualify for one of the exclusions in subpart. However, the requirements in
§ 1.327. If you conduct more than one § 1.345 to establish and maintain
type of activity at a location, you are records to identify the nontransporter
required to keep records with respect and transporter immediate subsequent
to those activities covered by this sub- recipients that are not consumers ap-
part, but are not required by this sub- plies as to those transactions only to
part to keep records with respect to ac- the extent the information is reason-
tivities that fall within one of the ex- ably available.
clusions in § 1.327. (1) For purposes of this section, retail
(b) Persons subject to the regulations food establishment is defined to mean
in this subpart must keep records an establishment that sells food prod-
whether or not the food is being offered ucts directly to consumers as its pri-
for or enters interstate commerce. mary function. The term ‘‘consumers’’
does not include businesses.
§ 1.327 Who is excluded from all or (2) A retail food establishment may
part of the regulations in this sub- manufacture/process, pack, or hold
part? food if the establishment’s primary
(a) Farms are excluded from all of function is to sell from that establish-
the requirements in this subpart. ment food, including food that it man-
(b) Restaurants are excluded from all ufactures/processes, packs, or holds, di-
of the requirements in this subpart. A rectly to consumers.
restaurant/retail facility is excluded (3) A retail food establishment’s pri-
from all of the requirements in this mary function is to sell food directly to
subpart if its sales of food it prepares consumers if the annual monetary

and sells to consumers for immediate value of sales of food products directly
49
§ 1.328 21 CFR Ch. I (4–1–19 Edition)
to consumers exceeds the annual mone- ceive, hold, or import the finished con-
tary value of sales of food products to tainer that directly contacts the food
all other buyers. are excluded from the requirements of
(4) A ‘‘retail food establishment’’ in- this subpart as to the finished con-
cludes grocery stores, convenience tainer, except §§ 1.361 and 1.363.
stores, and vending machine locations. (l) Nonprofit food establishments are
(f) Retail food establishments that excluded from all of the requirements
employ 10 or fewer full-time equivalent in this subpart, except §§ 1.361 and 1.363.
employees are excluded from all of the (m) Persons who manufacture, proc-
requirements in this subpart, except ess, pack, transport, distribute, re-
§§ 1.361 and 1.363. The exclusion is based ceive, hold, or import food for personal
on the number of full-time equivalent consumption are excluded from all of
employees at each retail food estab- the requirements of this subpart.
lishment and not the entire business, (n) Persons who receive or hold food
which may own numerous retail stores. on behalf of specific individual con-
(g) Persons who manufacture, proc- sumers and who are not also parties to
ess, pack, transport, distribute, re- the transaction and who are not in the
ceive, hold, or import food in the business of distributing food are ex-
United States that is within the exclu- cluded from all of the requirements of
sive jurisdiction of the U.S. Depart- this subpart.
ment of Agriculture (USDA) under the
Federal Meat Inspection Act (21 U.S.C. § 1.328 What definitions apply to this
601 et seq.), the Poultry Products In- subpart?
spection Act (21 U.S.C. 451 et seq.), or The definitions of terms in section
the Egg Products Inspection Act (21 201 of the Federal Food, Drug, and Cos-
U.S.C. 1031 et seq.) are excluded from all metic Act (the act) (21 U.S.C. 321) apply
of the requirements in this subpart to such terms when used in this sub-
with respect to that food while it is part. In addition, for the purposes of
under the exclusive jurisdiction of this subpart:
USDA.
Farm means:
(h) Foreign persons, except for for-
eign persons who transport food in the (1) Primary production farm. A pri-
United States, are excluded from all of mary production farm is an operation
the requirements of this subpart. under one management in one general
(i) Persons who manufacture, proc- (but not necessarily contiguous) phys-
ess, pack, transport, distribute, re- ical location devoted to the growing of
ceive, hold, or import food are subject crops, the harvesting of crops, the rais-
to §§ 1.361 and 1.363 with respect to its ing of animals (including seafood), or
packaging (the outer packaging of food any combination of these activities.
that bears the label and does not con- The term ‘‘farm’’ includes operations
tact the food). All other persons who that, in addition to these activities:
manufacture, process, pack, transport, (i) Pack or hold raw agricultural
distribute, receive, hold, or import commodities;
packaging are excluded from all of the (ii) Pack or hold processed food, pro-
requirements of this subpart. vided that all processed food used in
(j) Persons who manufacture, proc- such activities is either consumed on
ess, pack, transport, distribute, re- that farm or another farm under the
ceive, hold, or import food contact sub- same management, or is processed food
stances other than the finished con- identified in paragraph (1)(iii)(B)(1) of
tainer that directly contacts food are this definition; and
excluded from all of the requirements (iii) Manufacture/process food, pro-
of this subpart, except §§ 1.361 and 1.363. vided that:
(k) Persons who place food directly in (A) All food used in such activities is
contact with its finished container are consumed on that farm or another
subject to all of the requirements of farm under the same management; or
this subpart as to the finished con- (B) Any manufacturing/processing of
tainer that directly contacts that food. food that is not consumed on that farm
All other persons who manufacture, or another farm under the same man-
process, pack, transport, distribute, re- agement consists only of:
50
(1) Drying/dehydrating raw agricul- claiming the exemption. The number of

tural commodities to create a distinct full-time equivalent employees is de-
commodity (such as drying/dehy- termined by dividing the total number
drating grapes to produce raisins), and of hours of salary or wages paid di-
packaging and labeling such commod- rectly to employees of the person and
ities, without additional manufac- of all of its affiliates by the number of
turing/processing (an example of addi- hours of work in 1 year, 2,080 hours
tional manufacturing/processing is (i.e., 40 hours × 52 weeks).
slicing); Harvesting applies to farms and farm
(2) Treatment to manipulate the rip- mixed-type facilities and means activi-
ening of raw agricultural commodities ties that are traditionally performed
(such as by treating produce with on farms for the purpose of removing
ethylene gas), and packaging and label- raw agricultural commodities from the
ing treated raw agricultural commod- place they were grown or raised and
ities, without additional manufac- preparing them for use as food. Har-
turing/processing; and vesting is limited to activities per-
(3) Packaging and labeling raw agri- formed on raw agricultural commod-
cultural commodities, when these ac- ities, or on processed foods created by
tivities do not involve additional man- drying/dehydrating a raw agricultural
ufacturing/processing (an example of commodity without additional manu-
additional manufacturing/processing is facturing/processing, on a farm. Har-
irradiation); or vesting does not include activities that
(2) Secondary activities farm. A sec- transform a raw agricultural com-
ondary activities farm is an operation, modity into a processed food as defined
not located on a primary production in section 201(gg) of the Federal Food,
farm, devoted to harvesting (such as Drug, and Cosmetic Act. Examples of
hulling or shelling), packing, and/or harvesting include cutting (or other-
holding of raw agricultural commod- wise separating) the edible portion of
ities, provided that the primary pro- the raw agricultural commodity from
duction farm(s) that grows, harvests, the crop plant and removing or trim-
and/or raises the majority of the raw ming part of the raw agricultural com-
agricultural commodities harvested, modity (e.g., foliage, husks, roots, or
packed, and/or held by the secondary stems). Examples of harvesting also in-
activities farm owns, or jointly owns, a clude cooling, field coring, filtering,
majority interest in the secondary ac- gathering, hulling, shelling, sifting,
tivities farm. A secondary activities threshing, trimming of outer leaves of,
farm may also conduct those addi- and washing raw agricultural commod-
tional activities allowed on a primary ities grown on a farm.
production farm as described in para- Holding means storage of food and
graphs (1)(ii) and (iii) of this definition. also includes activities performed inci-
Food has the meaning given in sec- dental to storage of a food (e.g., activi-
tion 201(f) of the Federal Food, Drug, ties performed for the safe or effective
and Cosmetic Act. Examples of food in- storage of that food, such as fumigat-
clude, but are not limited to fruits; ing food during storage, and drying/de-
vegetables; fish; dairy products; eggs; hydrating raw agricultural commod-
raw agricultural commodities for use ities when the drying/dehydrating does
as food or as components of food; ani- not create a distinct commodity (such
mal feed, including pet food; food and as drying/dehydrating hay or alfalfa)).
feed ingredients and additives, includ- Holding also includes activities per-
ing substances that migrate into food formed as a practical necessity for the
from the finished container and other distribution of that food (such as
articles that contact food; dietary sup- blending of the same raw agricultural
plements and dietary ingredients; in- commodity and breaking down pallets),
fant formula; beverages, including al- but does not include activities that
coholic beverages and bottled water; transform a raw agricultural com-
live food animals; bakery goods; snack modity into a processed food as defined
foods; candy; and canned foods. in section 201(gg) of the Federal Food,
Full-time equivalent employee means Drug, and Cosmetic Act. Holding facili-
all individuals employed by the person ties could include warehouses, cold
51
§ 1.328 21 CFR Ch. I (4–1–19 Edition)
storage facilities, storage silos, grain food before transferring it to another

elevators, and liquid storage tanks. nontransporter.
Manufacturing/processing means mak- Nontransporter immediate subsequent
ing food from one or more ingredients, recipient means a nontransporter that
or synthesizing, preparing, treating, acquires food from another nontrans-
modifying or manipulating food, in- porter.
cluding food crops or ingredients. Ex- Packaging (when used as a noun)
amples of manufacturing/processing ac- means the outer packaging of food that
tivities include: Baking, boiling, bot- bears the label and does not contact
tling, canning, cooking, cooling, cut- the food. Packaging does not include
ting, distilling, drying/dehydrating raw food contact substances as they are de-
agricultural commodities to create a fined in section 409(h)(6) of the Federal
distinct commodity (such as drying/de- Food, Drug, and Cosmetic Act.
hydrating grapes to produce raisins), Packaging (when used as a verb)
evaporating, eviscerating, extracting means placing food into a container
juice, formulating, freezing, grinding, that directly contacts the food and
homogenizing, irradiating, labeling, that the consumer receives.
milling, mixing, packaging (including Packing means placing food into a
modified atmosphere packaging), pas- container other than packaging the
teurizing, peeling, rendering, treating food and also includes re-packing and
to manipulate ripening, trimming, activities performed incidental to
washing, or waxing. For farms and packing or re-packing a food (e.g., ac-
farm mixed-type facilities, manufac- tivities performed for the safe or effec-
turing/processing does not include active packing or re-packing of that food
tivities that are part of harvesting, (such as sorting, culling, grading, and
packing, or holding. weighing or conveying incidental to
Mixed-type facility means an estab- packing or re-packing)), but does not
include activities that transform a raw
lishment that engages in both activi-
agricultural commodity, as defined in
ties that are exempt from registration
section 201(r) of the Federal Food,
under section 415 of the Federal Food,
Drug, and Cosmetic Act, into a proc-
Drug, and Cosmetic Act and activities
essed food as defined in section 201(gg)
that require the establishment to be
of the Federal Food, Drug, and Cos-
registered. An example of such a facil-
metic Act.
ity is a ‘‘farm mixed-type facility,’’
Person includes individual, partner-
which is an establishment that is a
ship, corporation, and association.
farm, but also conducts activities out-
Recipe means the formula, including
side the farm definition that require
ingredients, quantities, and instruc-
the establishment to be registered. tions, necessary to manufacture a food
Nonprofit food establishment means a product. Because a recipe must have all
charitable entity that prepares or three elements, a list of the ingredients
serves food directly to the consumer or used to manufacture a product without
otherwise provides food or meals for quantity information and manufac-
consumption by humans or animals in turing instructions is not a recipe.
the United States. The term includes Restaurant means a facility that pre-
central food banks, soup kitchens, and pares and sells food directly to con-
nonprofit food delivery services. To be sumers for immediate consumption.
considered a nonprofit food establish- ‘‘Restaurant’’ does not include facili-
ment, the establishment must meet the ties that provide food to interstate
terms of section 501(c)(3) of the U.S. In- conveyances, central kitchens, and
ternal Revenue Code (26 U.S.C. other similar facilities that do not pre-
501(c)(3)). pare and serve food directly to con-
Nontransporter means a person who sumers.
owns food or who holds, manufactures, (1) Facilities in which food is directly
processes, packs, imports, receives, or provided to humans, such as cafeterias,
distributes food for purposes other lunchrooms, cafes, bistros, fast food es-
than transportation. tablishments, food stands, saloons, tav-
Nontransporter immediate previous erns, bars, lounges, catering facilities,

source means a person that last had hospital kitchens, day care kitchens,
52
and nursing home kitchens, are res- § 1.330 Can existing records satisfy the
taurants. requirements of this subpart?
(2) Pet shelters, kennels, and veteri- The regulations in this subpart do
nary facilities in which food is directly not require duplication of existing
provided to animals are restaurants. records if those records contain all of
Transporter means a person who has the information required by this sub-
possession, custody, or control of an part. If a covered person keeps records
article of food in the United States for of all of the information as required by
the sole purpose of transporting the this subpart to comply with other Fed-
food, whether by road, rail, water, or eral, State, or local regulations, or for
air. Transporter also includes a foreign any other reason, then those records
person that transports food in the may be used to meet these require-
United States, regardless of whether ments. Moreover, persons do not have
that foreign person has possession, cus- to keep all of the information required
tody, or control of that food for the by this rule in one set of records. If
sole purpose of transporting that food. they have records containing some of
Transporter’s immediate previous source the required information, they may
means a person from whom a trans- keep those existing records and keep,
porter received food. This source can be either separately or in a combined
either another transporter or a non- form, any new information required by
transporter. this rule. There is no obligation to cre-
Transporter’s immediate subsequent re- ate an entirely new record or compila-
cipient means a person to whom a tion of records containing both exist-
transporter delivered food. This recipi- ing and new information, even if the
ent can be either another transporter records containing some of the re-
or a nontransporter. quired information were not created at
You means a person subject to this the time the food was received or re-
subpart under § 1.326. leased.
[69 FR 71651, Dec. 9, 2004, as amended at 80
FR 56143, Sept. 17, 2015; 81 FR 3715, Jan. 22, REQUIREMENTS FOR NONTRANSPORTERS
2016] TO ESTABLISH AND MAINTAIN RECORDS
TO IDENTIFY THE NONTRANSPORTER
§ 1.329 Do other statutory provisions AND TRANSPORTER IMMEDIATE PRE-
and regulations apply? VIOUS SOURCES OF FOOD
(a) In addition to the regulations in
this subpart, you must comply with all § 1.337 What information must non-
transporters establish and maintain
other applicable statutory provisions to identify the nontransporter and
and regulations related to the estab- transporter immediate previous
lishment and maintenance of records sources of food?
for foods except as described in para-
graph (b) of this section. For example, (a) If you are a nontransporter, you
the regulations in this subpart are in must establish and maintain the fol-
addition to existing recordkeeping reg- lowing records for all food you receive:
ulations for low acid canned foods, (1) The name of the firm, address,
juice, seafood, infant formula, color ad- telephone number and, if available, the
ditives, bottled water, animal feed, and fax number and e-mail address of the
medicated animal feed. nontransporter immediate previous
(b) Records established or maintained source, whether domestic or foreign;
to satisfy the requirements of this sub- (2) An adequate description of the
part that meet the definition of elec- type of food received, to include brand
tronic records in § 11.3(b)(6) (21 CFR 11.3 name and specific variety (e.g., brand x
(b)(6)) of this chapter are exempt from cheddar cheese, not just cheese; or ro-
the requirements of part 11 of this maine lettuce, not just lettuce);
chapter. Records that satisfy the re- (3) The date you received the food;
quirements of this subpart but that are (4) For persons who manufacture,
also required under other applicable process, or pack food, the lot or code
statutory provisions or regulations re- number or other identifier of the food

main subject to part 11 of this chapter. (to the extent this information exists);
53
§ 1.345 21 CFR Ch. I (4–1–19 Edition)
(5) The quantity and how the food is REQUIREMENTS FOR TRANSPORTERS TO
packaged (e.g., 6 count bunches, 25 ESTABLISH AND MAINTAIN RECORDS
pound (lb) carton, 12 ounce (oz) bottle,
100 gallon (gal) tank); and § 1.352 What information must trans-
porters establish and maintain?
(6) The name of the firm, address,
telephone number, and, if available, If you are a transporter, you must es-
the fax number and e-mail address of tablish and maintain the following
the transporter immediate previous records for each food you transport in
source (the transporter who trans- the United States. You may fulfill this
requirement by either:
ported the food to you).
(a) Establishing and maintaining the
REQUIREMENTS FOR NONTRANSPORTERS following records:
TO ESTABLISH AND MAINTAIN RECORDS (1) Names of the transporter’s imme-
TO IDENTIFY THE NONTRANSPORTER diate previous source and transporter’s
immediate subsequent recipient;
AND TRANSPORTER IMMEDIATE SUBSE-
(2) Origin and destination points;
QUENT RECIPIENTS OF FOOD
(3) Date shipment received and date
§ 1.345 What information must non- released;
transporters establish and maintain (4) Number of packages;
to identify the nontransporter and (5) Description of freight;
transporter immediate subsequent (6) Route of movement during the
recipients of food? time you transported the food; and
(7) Transfer point(s) through which
(a) If you are a nontransporter, you
shipment moved; or
must establish and maintain the fol- (b) Establishing and maintaining
lowing records for food you release: records containing the following infor-
(1) The name of the firm, address, mation currently required by the De-
telephone number, and, if available, partment of Transportation’s Federal
the fax number and e-mail address of Motor Carrier Safety Administration
the nontransporter immediate subse- (of roadway interstate transporters (49
quent recipient, whether domestic or CFR 373.101 and 373.103) as of December
foreign; 9, 2004:
(2) An adequate description of the (1) Names of consignor and consignee;
type of food released, to include brand (2) Origin and destination points;
name and specific variety (e.g., brand x (3) Date of shipment;
cheddar cheese, not just cheese; or ro- (4) Number of packages;
maine lettuce, not just lettuce); (5) Description of freight;
(3) The date you released the food; (6) Route of movement and name of
(4) For persons who manufacture, each carrier participating in the trans-
process, or pack food, the lot or code portation; and
(7) Transfer points through which
number or other identifier of the food
shipment moved; or
(to the extent this information exists);
(c) Establishing and maintaining
(5) The quantity and how the food is records containing the following infor-
packaged (e.g., 6 count bunches, 25 lb mation currently required by the De-
carton, 12 oz bottle, 100 gal tank); partment of Transportation’s Surface
(6) The name of the firm, address, Transportation Board of rail and water
telephone number, and, if available, interstate transporters (49 CFR 1035.1
the fax number and e-mail address of and 1035.2) as of December 9, 2004:
the transporter immediate subsequent (1) Date received;
recipient (the transporter who trans- (2) Received from;
ported the food from you); and (3) Consigned to;
(b) Your records must include infor- (4) Destination;
mation reasonably available to you to (5) State of;
identify the specific source of each in- (6) County of;
gredient used to make every lot of fin- (7) Route;
(8) Delivering carrier;
ished product.
(9) Car initial;
(10) Car no;
54
(11) Trailer initials/number; formation is contained in existing

(12) Container initials/number; records.
(13) No. packages; and (b) If you are a nontransporter, you
(14) Description of articles; or must retain for 6 months after the
(d) Establishing and maintaining dates you receive and release the food
records containing the following infor- all required records for any food having
mation currently required by the War- a significant risk of spoilage, loss of
saw Convention of international air value, or loss of palatability within 60
transporters on air waybills: days after the date you receive or re-
(1) Shipper’s name and address; lease the food.
(2) Consignee’s name and address; (c) If you are a nontransporter, you
(3) Customs reference/status; must retain for 1 year after the dates
(4) Airport of departure and destina- you receive and release the food all re-
tion; quired records for any food for which a
(5) First carrier; and significant risk of spoilage, loss of
(6) Description of goods; or value, or loss of palatability occurs
(e) Entering into an agreement with only after a minimum of 60 days, but
the nontransporter immediate previous within 6 months, after the date you re-
source located in the United States ceive or release the food.
and/or the nontransporter immediate (d) If you are a nontransporter, you
subsequent recipient located in the must retain for 2 years after the dates
United States to establish, maintain, you receive and release the food all re-
or establish and maintain, the informa- quired records for any food for which a
tion in § 1.352(a), (b), (c), or (d). The significant risk of spoilage, loss of
agreement must contain the following value, or loss of palatability does not
elements: occur sooner than 6 months after the
(1) Effective date; date you receive or release the food, in-
(2) Printed names and signatures of cluding foods preserved by freezing, de-
authorized officials; hydrating, or being placed in a her-
(3) Description of the records to be metically sealed container.
established and/or maintained; (e) If you are a nontransporter, you
(4) Provision for the records to be must retain for 1 year after the dates
maintained in compliance with § 1.360, you receive and release the food all re-
if the agreement provides for mainte- quired records for animal food, includ-
nance of records; ing pet food.
(5) Provision for the records to be (f) If you are a transporter or non-
available to FDA as required by § 1.361, transporter retaining records on behalf
if the agreement provides for mainte- of a transporter, you must retain for 6
nance of records; months after the dates you receive and
(6) Acknowledgement that the non- release the food all required records for
transporter assumes legal responsi- any food having a significant risk of
bility under § 1.363 for establishing and/ spoilage, loss of value, or loss of palat-
or maintaining the records as required ability within 60 days after the date
by this subpart; and the transporter receives or releases the
(7) Provision that if the agreement is food. If you are a transporter, or non-
terminated in writing by either party, transporter retaining records on behalf
responsibility for compliance with the of a transporter, you must retain for 1
applicable establishment, mainte- year after the dates you receive and re-
nance, and access provisions of this lease the food, all required records for
subpart reverts to the transporter as of any food for which a significant risk of
the date of termination. spoilage, loss of value, or loss of palat-
ability occurs only after a minimum of
GENERAL REQUIREMENTS 60 days after the date the transporter
receives or releases the food.
§ 1.360 What are the record retention (g) You must retain all records at the
requirements? establishment where the covered ac-
(a) You must create the required tivities described in the records oc-
records when you receive and release curred (onsite) or at a reasonably ac-
food, except to the extent that the in- cessible location.
55
§ 1.361 21 CFR Ch. I (4–1–19 Edition)
(h) The maintenance of electronic verification or copying of any such re-

records is acceptable. Electronic quired record is a prohibited act under
records are considered to be onsite if section 301 of the Federal Food, Drug,
they are accessible from an onsite loca- and Cosmetic Act.
tion. (b) The failure of a nontransporter
immediate previous source or a non-
§ 1.361 What are the record avail-
ability requirements? transporter immediate subsequent re-
cipient who enters an agreement under
When FDA has a reasonable belief
§ 1.352(e) to establish, maintain, or es-
that an article of food, and any other
tablish and maintain, records required
article of food that FDA reasonably be-
lieves is likely to be affected in a simi- under § 1.352(a), (b), (c), or (d), or the re-
lar manner, is adulterated and presents fusal to permit access to or
a threat of serious adverse health con- verification or copying of any such re-
sequences or death to humans or ani- quired record, is a prohibited act under
mals, or when FDA believes that there section 301 of the Federal Food, Drug,
is a reasonable probability that the use and Cosmetic Act.
of or exposure to an article of food, and (c) The failure of any person to make
any other article of food that FDA rea- records or other information available
sonably believes is likely to be affected to FDA as required by section 414 or
in a similar manner, will cause serious 704(a) of the Federal Food, Drug, and
adverse health consequences or death Cosmetic Act and this regulation is a
to humans or animals, any records and prohibited act under section 301 of the
other information accessible to FDA Federal Food, Drug, and Cosmetic Act.
under section 414 or 704(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 [80 FR 56144, Sept. 17, 2015
U.S.C. 350c and 374(a)) must be made
COMPLIANCE DATES
readily available for inspection and
photocopying or other means of repro- § 1.368 What are the compliance dates
duction. Such records and other infor- for this subpart?
mation must be made available as soon
as possible, not to exceed 24 hours from The compliance date for the require-
the time of receipt of the official re- ments in this subpart is December 9,
quest, from an officer or employee duly 2005. However, the compliance dates for
designated by the Secretary of Health small and very small businesses are
and Human Services who presents ap- contained in paragraphs (a) and (b) of
propriate credentials and a written no- this section. The size of the business is
tice. determined using the total number of
[77 FR 10662, Feb. 23, 2012]
full-time equivalent employees in the
entire business, not each individual lo-
§ 1.362 What records are excluded cation or establishment. A full-time
from this subpart? employee counts as one full-time
The establishment and maintenance equivalent employee. Two part-time
of records as required by this subpart employees, each working half time,
does not extend to recipes for food as count as one full-time equivalent em-
defined in § 1.328; financial data, pricing ployee.
data, personnel data, research data, or (a) The compliance date for the re-
sales data (other than shipment data quirements in this subpart is June 9,
regarding sales). 2006, for small businesses employing
fewer that 500, but more than 10 full-
§ 1.363 What are the consequences of time equivalent employees.
failing to establish or maintain
records or make them available to (b) The compliance date for the re-
FDA as required by this subpart? quirements in this subpart is December
11, 2006, for very small businesses that
(a) The failure to establish or main-
employ 10 or fewer full-time equivalent
tain records as required by section
employees.
414(b) of the Federal Food, Drug, and
Cosmetic Act and this regulation or [69 FR 71651, Dec. 9, 2004, as amended at 70
the refusal to permit access to or FR 8727, Feb. 23, 2005]
56
Subpart K—Administrative Deten- § 1.378 What criteria does FDA use to

tion of Food for Human or Ani- order a detention?
mal Consumption An officer or qualified employee of
FDA may order the detention of any
article of food that is found during an
SOURCE: 69 FR 31701, June 4, 2004, unless
otherwise noted.
inspection, examination, or investiga-
tion under the act if the officer or
GENERAL PROVISIONS qualified employee has reason to be-
lieve that the article of food is adulter-
§ 1.377 What definitions apply to this ated or misbranded.
subpart? [76 FR 25541, May 5, 2011]
The definitions of terms that appear
in section 201 of the act (21 U.S.C. 321) § 1.379 How long may FDA detain an
apply when the terms are used in this article of food?
subpart. In addition, for the purposes (a) FDA may detain an article of food
of this subpart: for a reasonable period that may not
Act means the Federal Food, Drug, exceed 20 calendar days after the deten-
and Cosmetic Act. tion order is issued. However, an arti-
Authorized FDA representative means cle may be detained for 10 additional
an FDA District Director in whose dis- calendar days if a greater period of
time is required to institute a seizure
trict the article of food involved is lo-
or injunction action. The authorized
cated or an FDA official senior to such
FDA representative may approve the
director.
additional 10-calendar day detention
Calendar day means every day shown period at the time the detention order
on the calendar. is issued, or at any time within the 20-
Food has the meaning given in sec- calendar day period by amending the
tion 201(f) of the act (21 U.S.C. 321(f)). detention order.
Examples of food include, but are not (b) The entire detention period may
limited to, fruits, vegetables, fish, not exceed 30 calendar days.
dairy products, eggs, raw agricultural (c) An authorized FDA representative
commodities for use as food or compo- may, in accordance with § 1.384, termi-
nents of food, animal feed, including nate a detention order before the expi-
pet food, food and feed ingredients and ration of the detention period.
additives, including substances that
migrate into food from food packaging § 1.380 Where and under what condi-
and other articles that contact food, tions must the detained article of
food be held?
dietary supplements and dietary ingre-
dients, infant formula, beverages, in- (a) You must hold the detained arti-
cluding alcoholic beverages and bottled cle of food in the location and under
water, live food animals, bakery goods, the conditions specified by FDA in the
snack foods, candy, and canned foods. detention order.
Perishable food means food that is not (b) If FDA determines that removal
heat-treated; not frozen; and not other- to a secure facility is appropriate, the
article of food must be removed to a se-
wise preserved in a manner so as to
cure facility. A detained article of food
prevent the quality of the food from
remains under detention before, dur-
being adversely affected if held longer
ing, and after movement to a secure fa-
than 7 calendar days under normal cility. FDA will also state in the deten-
shipping and storage conditions. tion order any conditions of transpor-
We means the U.S. Food and Drug tation applicable to the detained arti-
Administration (FDA). cle.
Working day means any day from (c) If FDA directs you to move the
Monday through Friday, excluding detained article of food to a secure fa-
Federal holidays. cility, you must receive a modification
You means any person who received of the detention order under § 1.381(c)
the detention order or that person’s before you move the detained article of
representative. food to a secure facility.
57
§ 1.381 21 CFR Ch. I (4–1–19 Edition)
(d) You must ensure that any re- (d) You must submit your request for
quired tags or labels under § 1.382 ac- modification of the detention order in
company the detained article during writing to the authorized FDA rep-
and after movement. The tags or labels resentative who approved the detention
must remain with the article of food order. You must state in your request
until FDA terminates the detention the reasons for movement; the exact
order or the detention period expires, address of and location in the new fa-
whichever occurs first, unless other- cility (or the new location within the
wise permitted by the authorized FDA same facility) where the detained arti-
representative. cle of food will be transferred; an ex-
(e) The movement of an article of planation of how the new address and
food in violation of a detention order location will be secure, if FDA has di-
issued under § 1.393 is a prohibited act rected that the article be detained in a
under section 301 of the act (21 U.S.C. secure facility; and how the article will
331). be held under any applicable conditions
described in the detention order. If you
§ 1.381 May a detained article of food
are requesting modification of a deten-
be delivered to another entity or
transferred to another location? tion order for the purpose of destroying
the detained article of food, you also
(a) An article of food subject to a de- must submit a verified statement iden-
tention order under this subpart may tifying the ownership or proprietary
not be delivered under the execution of interest you have in the detained arti-
a bond. Notwithstanding section 801(b) cle of food, in accordance with Supple-
of the act (21 U.S.C. 381(b)), while any mental Rule C to the ‘‘Federal Rules of
article of food is subject to a detention
Civil Procedure.’’
order under section 304(h) of the act (21
(e) If FDA approves a request for
U.S.C. 334(h)), it may not be delivered
modification of a detention order, the
to any of its importers, owners, or con-
signees. This section does not preclude article may be transferred but remains
movement at FDA’s direction of im- under detention before, during, and
ported food to a secure facility under after the transfer. FDA will state any
an appropriate Customs’ bond when conditions of transportation applicable
that bond is required by Customs’ law to the detained article. You may not
and regulation. transfer a detained article of food with-
(b) Except as provided in paragraph out FDA supervision unless FDA has
(c) of this section, no person may declined in writing to supervise the
transfer a detained article of food with- transfer. If FDA has declined in writing
in or from the place where it has been to supervise the transfer of a detained
ordered detained, or from the place to article, you must immediately notify
which it was removed, until an author- in writing the authorized FDA rep-
ized FDA representative releases the resentative who approved the modifica-
article of food under § 1.384 or the de- tion of the detention order that the ar-
tention period expires under § 1.379, ticle of food has reached its new loca-
whichever occurs first. tion, and the specific location of the
(c) The authorized FDA representa- detained article within the new loca-
tive may approve, in writing, a request tion. Such written notification may be
to modify a detention order to permit in the form of a fax, e-mail, or other
movement of a detained article of food form as agreed to by the authorized
for any of the following purposes: FDA representative.
(1) To destroy the article of food, (f) You must ensure that any re-
(2) To move the detained article of quired tags or labels under § 1.382 ac-
food to a secure facility under the company the detained article during
terms of a detention order, and after movement. The tags or labels
(3) To maintain or preserve the integ- must remain with the article of food
rity or quality of the article of food, or until FDA terminates the detention
(4) For any other purpose that the order or the detention period expires,
authorized FDA representative believes whichever occurs first, unless other-

is appropriate in the case. wise permitted by the authorized FDA
58
representative who approves the modi- firmatory testing or other evidentiary

fication of a detention order under this development requires more than 4 cal-
section. endar days to complete.
(g) The transfer of an article of food
in violation of a detention order issued § 1.384 When does a detention order
under § 1.393 is a prohibited act under terminate?
section 301 of the act. If FDA terminates a detention order
§ 1.382 What labeling or marking re- or the detention period expires, an au-
quirements apply to a detained arti- thorized FDA representative will issue
cle of food? a detention termination notice releas-
The officer or qualified employee of ing the article of food to any person
FDA issuing a detention order under who received the detention order or
§ 1.393 may label or mark the detained that person’s representative and will
article of food with official FDA tags remove, or authorize in writing the re-
or labels that include the following in- moval of, the required labels or tags. If
formation: FDA fails to issue a detention termi-
(a) A statement that the article of nation notice and the detention period
food is detained by FDA in accordance expires, the detention is deemed to be
with section 304(h) of the act; terminated.
(b) A statement that the article of
food must not be consumed, moved, al- HOW DOES FDA ORDER A DETENTION?
tered, or tampered with in any manner
for the period shown, without the writ- § 1.391 Who approves a detention
ten permission of an authorized FDA order?
representative; An authorized FDA representative,
(c) A statement that the violation of i.e., the FDA District Director in whose
a detention order or the removal or al-
district the article of food involved is
teration of the tag or label is a prohib-
located or an FDA official senior to
ited act, punishable by fine or impris-
onment or both; and such director, must approve a deten-
(d) The detention order number, the tion order. If prior written approval is
date and hour of the detention order, not feasible, prior oral approval must
the detention period, and the name of be obtained and confirmed in writing
the officer or qualified employee of as soon as possible.
FDA who issued the detention order.
§ 1.392 Who receives a copy of the de-
§ 1.383 What expedited procedures tention order?
apply when FDA initiates a seizure
action against a detained perish- (a) FDA must issue the detention
able food? order to the owner, operator, or agent
in charge of the place where the article
If FDA initiates a seizure action
of food is located. If the owner of the
under section 304(a) of the act against
a perishable food subject to a detention article of food is different from the
order under this subpart, FDA will send owner, operator, or agent in charge of
the seizure recommendation to the De- the place where the article is detained,
partment of Justice (DOJ) within 4 cal- FDA must provide a copy of the deten-
endar days after the detention order is tion order to the owner of the article of
issued, unless extenuating cir- food if the owner’s identity can be de-
cumstances exist. If the fourth cal- termined readily.
endar day is not a working day, FDA (b) If FDA issues a detention order
will advise the DOJ of its plans to rec- for an article of food located in a vehi-
ommend a seizure action on the last cle or other carrier used to transport
working day before the fourth calendar the detained article of food, FDA also
day and send the recommendation as must provide a copy of the detention
soon as practicable on the first work- order to the shipper of record and the
ing day that follows. For purposes of owner and operator of the vehicle or
this section, an extenuating cir-
other carrier, if their identities can be

cumstance includes, but is not limited determined readily.
to, instances when the results of con-
59
§ 1.393 21 CFR Ch. I (4–1–19 Edition)
§ 1.393 What information must FDA in- WHAT IS THE APPEAL PROCESS FOR A
clude in the detention order? DETENTION ORDER?
(a) FDA must issue the detention § 1.401 Who is entitled to appeal?
order in writing, in the form of a deten-
tion notice, signed and dated by the of- Any person who would be entitled to
ficer or qualified employee of FDA who be a claimant for the article of food, if
has reason to believe that such article seized under section 304(a) of the act,
of food is adulterated or misbranded. may appeal a detention order as speci-
(b) The detention order must include fied in § 1.402. Procedures for estab-
the following information: lishing entitlement to be a claimant
(1) The detention order number; for purposes of section 304(a) of the act
are governed by Supplemental Rule C
(2) The date and hour of the deten-
to the ‘‘Federal Rules of Civil Proce-
tion order;
dure.’’
(3) Identification of the detained arti-
cle of food; § 1.402 What are the requirements for
(4) The period of the detention; submitting an appeal?
(5) A statement that the article of (a) If you want to appeal a detention
food identified in the order is detained order, you must submit your appeal in
for the period shown; writing to the FDA District Director,
(6) A brief, general statement of the in whose district the detained article of
reasons for the detention; food is located, at the mailing address,
(7) The address and location where e-mail address, or fax number identi-
the article of food is to be detained and fied in the detention order according to
the appropriate storage conditions; the following applicable timeframes:
(8) Any applicable conditions of (1) Perishable food: If the detained ar-
transportation of the detained article ticle is a perishable food, as defined in
of food; § 1.377, you must file an appeal within 2
(9) A statement that the article of calendar days of receipt of the deten-
food is not to be consumed, moved, al- tion order.
tered, or tampered with in any manner (2) Nonperishable food: If the detained
during the detention period, unless the article is not a perishable food, as de-
detention order is first modified under fined in § 1.377, you must file a notice of
§ 1.381(c); an intent to request a hearing within 4
(10) The text of section 304(h) of the calendar days of receipt of the deten-
act and §§ 1.401 and 1.402; tion order. If the notice of intent is not
(11) A statement that any informal filed within 4 calendar days, you will
hearing on an appeal of a detention not be granted a hearing. If you have
order must be conducted as a regu- not filed a timely notice of intent to
latory hearing under part 16 of this request a hearing, you may file an ap-
chapter, with certain exceptions de- peal without a hearing request. Wheth-
scribed in § 1.403; er or not it includes a request for hear-
(12) The mailing address, telephone ing, your appeal must be filed within 10
number, e-mail address, and fax num- calendar days of receipt of the deten-
ber of the FDA district office and the tion order.
name of the FDA District Director in (b) Your request for appeal must in-
whose district the detained article of clude a verified statement identifying
food is located; your ownership or proprietary interest
in the detained article of food, in ac-
(13) A statement indicating the man-
cordance with Supplemental Rule C to
ner in which approval of the detention
the ‘‘Federal Rules of Civil Procedure.’’
order was obtained, i.e., verbally or in
writing; and (c) The process for the appeal of a de-
tention order under this section termi-
(14) The name and the title of the au-
nates if FDA institutes either a seizure
thorized FDA representative who ap-
action under section 304(a) of the act or
proved the detention order. an injunction under section 302 of the
[69 FR 31701, June 4, 2004, as amended at 76 act (21 U.S.C. 276) regarding the article
FR 25541, May 5, 2011] of food involved in the detention order.
60
(d) As part of the appeals process, cer must prepare a written report of
you may request an informal hearing. the hearing. All written material pre-
Your request for a hearing must be in sented at the hearing will be attached
writing and must be included in your to the report. The presiding officer
request for an appeal specified in para- must include as part of the report of
graph (a) of this section. If you request the hearing a finding on the credibility
an informal hearing, and FDA grants of witnesses (other than expert wit-
your request, the hearing will be held nesses) whenever credibility is a mate-
within 2 calendar days after the date rial issue, and must include a proposed
the appeal is filed. decision, with a statement of reasons.
The hearing participant may review
§ 1.403 What requirements apply to an and comment on the presiding officer’s
informal hearing? report within 4 hours of issuance of the
If FDA grants a request for an infor- report. The presiding officer will then
mal hearing on an appeal of a deten- issue the final agency decision.
tion order, FDA must conduct the (i) Section 16.80(a)(4) of this chapter
hearing in accordance with part 16 of does not apply to a regulatory hearing
this chapter, except that: under this subpart. The presiding offi-
(a) The detention order under § 1.393, cer’s report of the hearing and any
rather than the notice under § 16.22(a) comments on the report by the hearing
of this chapter, provides notice of op- participant under § 1.403(h) are part of
portunity for a hearing under this sec- the administrative record.
tion and is part of the administrative (j) No party shall have the right,
record of the regulatory hearing under under § 16.119 of this chapter to petition
§ 16.80(a) of this chapter; the Commissioner of Food and Drugs
(b) A request for a hearing under this for reconsideration or a stay of the pre-
section must be addressed to the FDA siding officer’s final agency decision.
District Director in whose district the (k) If FDA grants a request for an in-
article of food involved is located; formal hearing on an appeal of a deten-
(c) The provision in § 16.22(b) of this tion order, the hearing must be con-
chapter, providing that a person not be ducted as a regulatory hearing pursu-
given less than 3 working days after re- ant to regulation in accordance with
ceipt of notice to request a hearing, part 16 of this chapter, except that
does not apply to a hearing under this § 16.95(b) does not apply to a hearing
subpart; under this subpart. With respect to a
(d) The provision in § 16.24(e) of this regulatory hearing under this subpart,
chapter, stating that a hearing may the administrative record of the hear-
ing specified in §§ 16.80(a)(1), (a)(2),
not be required to be held at a time
(a)(3), and (a)(5), and 1.403(i) constitutes
less than 2 working days after receipt
the exclusive record for the presiding
of the request for a hearing, does not
officer’s final decision on an adminis-
apply to a hearing under this subpart;
trative detention. For purposes of judi-
(e) Section 1.406, rather than § 16.24(f)
cial review under § 10.45 of this chapter,
of this chapter, describes the state-
the record of the administrative pro-
ment that will be provided to an appel-
ceeding consists of the record of the
lant where a detention order is based
hearing and the presiding officer’s final
on classified information;
decision.
(f) Section 1.404, rather than § 16.42(a)
of this chapter, describes the FDA em- [69 FR 31701, June 4, 2004, as amended at 82
ployees, i.e., Office of Regulatory Af- FR 14144, Mar. 17, 2017]
fairs Program Directors or other offi-
§ 1.404 Who serves as the presiding of-
cials senior to a District Director, who ficer for an appeal and for an infor-
preside at hearings under this subpart; mal hearing?
(g) The presiding officer may require
that a hearing conducted under this The presiding officer for an appeal,
section be completed within 1 calendar and for an informal hearing, must be
day, as appropriate; an Office of Regulatory Affairs Pro-
(h) Section 16.60(e) and (f) of this gram Director or another FDA official
chapter does not apply to a hearing senior to an FDA District Director.

under this subpart. The presiding offi- [82 FR 14144, Mar. 17, 2017]
61
§ 1.405 21 CFR Ch. I (4–1–19 Edition)
§ 1.405 When does FDA have to issue a is classified under the applicable Exec-
decision on an appeal? utive order as requiring protection
(a) The presiding officer must issue a from unauthorized disclosure in the in-
written report that includes a proposed terest of national security (‘‘classified
decision confirming or revoking the de- information’’), FDA will not provide
tention by noon on the fifth calendar you with this information. The pre-
day after the appeal is filed; after your siding officer will give you notice of
4 hour opportunity for submitting com- the general nature of the information
ments under § 1.403(h), the presiding of- and an opportunity to offer opposing
ficer must issue a final decision within evidence or information, if he or she
the 5-calendar day period after the ap- may do so consistently with safe-
peal is filed. If FDA either fails to pro- guarding the information and its
vide you with an opportunity to resource. If classified information was
quest an informal hearing, or fails to used to support the detention, then any
confirm or terminate the detention confirmation of such detention will
order within the 5-calendar day period, state whether it is based in whole or in
the detention order is deemed termi- part on that classified information.
nated.
(b) If you appeal the detention order,
but do not request an informal hearing,
Subpart L—Foreign Supplier
the presiding officer must issue a deci- Verification Programs for Food
sion on the appeal confirming or revok- Importers
ing the detention within 5 calendar
days after the date the appeal is filed. SOURCE: 80 FR 74340, Nov. 27, 2015, unless
If the presiding officer fails to confirm otherwise noted.
or terminate the detention order dur-
ing such 5-calendar day period, the de- § 1.500 What definitions apply to this
tention order is deemed terminated. subpart?
(c) If you appeal the detention order The following definitions apply to
and request an informal hearing and words and phrases as they are used in
your hearing request is denied, the pre- this subpart. Other definitions of these
siding officer must issue a decision on terms may apply when they are used in
the appeal confirming or revoking the other subparts of this part.
detention within 5 calendar days after Adequate means that which is needed
the date the appeal is filed. If the pre- to accomplish the intended purpose in
siding officer fails to confirm or termi- keeping with good public health prac-
nate the detention order during such 5- tice.
calendar day period, the detention
Audit means the systematic, inde-
order is deemed terminated.
pendent, and documented examination
(d) If the presiding officer confirms a
(through observation, investigation,
detention order, the article of food con-
tinues to be detained until we termi- discussions with employees of the au-
nate the detention under § 1.384 or the dited entity, records review, and, as ap-
detention period expires under § 1.379, propriate, sampling and laboratory
whichever occurs first. analysis) to assess an audited entity’s
(e) If the presiding officer terminates food safety processes and procedures.
a detention order, or the detention pe- Dietary supplement has the meaning
riod expires, FDA must terminate the given in section 201(ff) of the Federal
detention order as specified under Food, Drug, and Cosmetic Act.
§ 1.384. Dietary supplement component means
(f) Confirmation of a detention order any substance intended for use in the
by the presiding officer is considered a manufacture of a dietary supplement,
final agency action for purposes of 5 including those that may not appear in
U.S.C. 702. the finished batch of the dietary sup-
plement. Dietary supplement compo-
§ 1.406 How will FDA handle classified nents include dietary ingredients (as
information in an informal hearing? described in section 201(ff) of the Fed-
Where the credible evidence or infor- eral Food, Drug, and Cosmetic Act) and
mation supporting the detention order other ingredients.
62
Environmental pathogen means a (2) Has otherwise been designated by

pathogen capable of surviving and per- such food safety authority as being in
sisting within the manufacturing, proc- good compliance standing.
essing, packing, or holding environ- Harvesting applies to applies to farms
ment such that food may be contami- and farm mixed-type facilities and
nated and may result in foodborne ill- means activities that are traditionally
ness if that food is consumed without performed on farms for the purpose of
treatment to significantly minimize removing raw agricultural commod-
the environmental pathogen. Examples ities from the place they were grown or
of environmental pathogens for the raised and preparing them for use as
purposes of this part include Listeria food. Harvesting is limited to activities
monocytogenes and Salmonella spp. but performed on raw agricultural com-
do not include the spores of pathogenic modities, or on processed foods created
sporeforming bacteria. by drying/dehydrating a raw agricul-
Facility means a domestic facility or tural commodity without additional
a foreign facility that is required to manufacturing/processing, on a farm.
register under section 415 of the Fed- Harvesting does not include activities
eral Food, Drug, and Cosmetic Act, in that transform a raw agricultural com-
accordance with the requirements of modity into a processed food as defined
subpart H of this part. in section 201(gg) of the Federal Food,
Farm means farm as defined in § 1.227. Drug, and Cosmetic Act. Examples of
Farm mixed-type facility means an es- harvesting include cutting (or other-
tablishment that is a farm but that wise separating) the edible portion of
also conducts activities outside the the raw agricultural commodity from
farm definition that require the estab- the crop plant and removing or trim-
lishment to be registered under section ming part of the raw agricultural com-
415 of the Federal Food, Drug, and Cos- modity (e.g., foliage, husks, roots, or
metic Act. stems). Examples of harvesting also in-
Food has the meaning given in sec- clude cooling, field coring, filtering,
tion 201(f) of the Federal Food, Drug, gathering, hulling, shelling, sifting,
and Cosmetic Act, except that food threshing, trimming of outer leaves of,
does not include pesticides (as defined and washing raw agricultural commod-
in 7 U.S.C. 136(u)). ities grown on a farm.
Food allergen means a major food al- Hazard means any biological, chem-
lergen as defined in section 201(qq) of ical (including radiological), or phys-
the Federal Food, Drug, and Cosmetic ical agent that is reasonably likely to
Act. cause illness or injury.
Foreign supplier means, for an article Hazard requiring a control means a
of food, the establishment that manu- known or reasonably foreseeable haz-
factures/processes the food, raises the ard for which a person knowledgeable
animal, or grows the food that is ex- about the safe manufacturing, proc-
ported to the United States without essing, packing, or holding of food
further manufacturing/processing by would, based on the outcome of a haz-
another establishment, except for fur- ard analysis (which includes an assess-
ther manufacturing/processing that ment of the probability that the hazard
consists solely of the addition of label- will occur in the absence of controls or
ing or any similar activity of a de measures and the severity of the illness
minimis nature. or injury if the hazard were to occur),
Good compliance standing with a for- establish one or more controls or meas-
eign food safety authority means that ures to significantly minimize or pre-
the foreign supplier— vent the hazard in a food and compo-
(1) Appears on the current version of nents to manage those controls or
a list, issued by the food safety author- measures (such as monitoring, correc-
ity of the country in which the foreign tions or corrective actions,
supplier is located and which has regu- verification, and records) as appro-
latory oversight of the supplier, of food priate to the food, the facility, and the
producers that are in good compliance nature of the control or measure and
standing with the food safety author- its role in the facility’s food safety sys-
ity; or tem.
63
§ 1.500 21 CFR Ch. I (4–1–19 Edition)
Holding means storage of food and enizing, irradiating, labeling, milling,

also includes activities performed inci- mixing, packaging (including modified
dental to storage of a food (e.g., activi- atmosphere packaging), pasteurizing,
ties performed for the safe or effective peeling, pelleting (of animal food), ren-
storage of that food, such as fumigat- dering, treating to manipulate rip-
ing food during storage, and drying/de- ening, trimming, washing, or waxing.
hydrating raw agricultural commod- For farms and farm mixed-type facili-
ities when the drying/dehydrating does ties, manufacturing/processing does
not create a distinct commodity (such not include activities that are part of
as drying/dehydrating hay or alfalfa)). harvesting, packing, or holding.
Holding also includes activities per- Microorganisms means yeasts, molds,
formed as a practical necessity for the bacteria, viruses, protozoa, and micro-
distribution of that food (such as scopic parasites and includes species
blending of the same raw agricultural that are pathogens.
commodity and breaking down pallets), Packing means placing food into a
but does not include activities that container other than packaging the
transform a raw agricultural com- food and also includes re-packing and
modity into a processed food as defined activities performed incidental to
in section 201(gg) of the Federal Food, packing or re-packing a food (e.g., ac-
Drug, and Cosmetic Act. Holding facili- tivities performed for the safe or effec-
ties could include warehouses, cold tive packing or re-packing of that food
storage facilities, storage silos, grain (such as sorting, culling, grading, and
elevators, and liquid storage tanks. weighing or conveying incidental to
Importer means the U.S. owner or packing or re-packing)), but does not
consignee of an article of food that is include activities that transform a raw
being offered for import into the agricultural commodity into a proc-
United States. If there is no U.S. owner essed food as defined in section 201(gg)
or consignee of an article of food at the of the Federal Food, Drug, and Cos-
time of U.S. entry, the importer is the metic Act.
U.S. agent or representative of the for- Pathogen means a microorganism of
eign owner or consignee at the time of public health significance.
entry, as confirmed in a signed state- Qualified auditor means a person who
ment of consent to serve as the im- is a qualified individual as defined in
porter under this subpart. this section and has technical expertise
Known or reasonably foreseeable haz- obtained through education, training,
ard means a biological, chemical (in- or experience (or a combination there-
cluding radiological), or physical haz- of) necessary to perform the auditing
ard that is known to be, or has the po- function as required by § 1.506(e)(1)(i) or
tential to be, associated with a food or § 1.511(c)(5)(i)(A). Examples of potential
the facility in which it is manufac- qualified auditors include:
tured/processed. (1) A government employee, includ-
Lot means the food produced during a ing a foreign government employee;
period of time and identified by an es- and
tablishment’s specific code. (2) An audit agent of a certification
Manufacturing/processing means mak- body that is accredited in accordance
ing food from one or more ingredients, with subpart M of this part.
or synthesizing, preparing, treating, Qualified individual means a person
modifying, or manipulating food, in- who has the education, training, or ex-
cluding food crops or ingredients. Ex- perience (or a combination thereof)
amples of manufacturing/processing ac- necessary to perform an activity re-
tivities include: Baking, boiling, bot- quired under this subpart, and can read
tling, canning, cooking, cooling, cut- and understand the language of any
ting, distilling, drying/dehydrating raw records that the person must review in
agricultural commodities to create a performing this activity. A qualified
distinct commodity (such as drying/de- individual may be, but is not required
hydrating grapes to produce raisins), to be, an employee of the importer. A
evaporating, eviscerating, extracting government employee, including a for-
juice, extruding (of animal food), foreign government employee, may be a
mulating, freezing, grinding, homog- qualified individual.
64
Raw agricultural commodity has the United States and to the importers of
meaning given in section 201(r) of the such food.
Federal Food, Drug, and Cosmetic Act. (b) Exemptions for juice and seafood—
Ready-to-eat food (RTE food) means (1) Importers of certain juice and seafood
any food that is normally eaten in its products. This subpart does not apply
raw state or any food, including a proc- with respect to juice, fish, and fishery
essed food, for which it is reasonably products that are imported from a for-
foreseeable that the food will be eaten eign supplier that is required to com-
without further processing that would ply with, and is in compliance with,
significantly minimize biological haz- the requirements in part 120 or part 123
ards. of this chapter. If you import juice or
Receiving facility means a facility fish and fishery products that are sub-
that is subject to subparts C and G of ject to part 120 or part 123, respec-
part 117 of this chapter, or subparts C tively, you must comply with the re-
and E of part 507 of this chapter, and quirements applicable to importers of
that manufactures/processes a raw ma- those products under § 120.14 or § 123.12
terial or other ingredient that it re- of this chapter, respectively.
ceives from a supplier. (2) Certain importers of juice or seafood
U.S. owner or consignee means the raw materials or other ingredients subject
person in the United States who, at the to part 120 or part 123 of this chapter.
time of U.S. entry, either owns the This subpart does not apply with re-
food, has purchased the food, or has spect to any raw materials or other in-
agreed in writing to purchase the food. gredients that you import and use in
Very small importer means: manufacturing or processing juice sub-
(1) With respect to the importation of ject to part 120 or fish and fishery prod-
human food, an importer (including ucts subject to part 123, provided that
any subsidiaries and affiliates) aver- you are in compliance with the require-
aging less than $1 million per year, ad- ments in part 120 or part 123 with re-
justed for inflation, during the 3-year spect to the juice or fish or fishery
period preceding the applicable cal- product that you manufacture or proc-
endar year, in sales of human food ess from the imported raw materials or
combined with the U.S. market value other ingredients.
of human food imported, manufac- (c) Exemption for food imported for re-
tured, processed, packed, or held with- search or evaluation. This subpart does
out sale (e.g., imported for a fee); and not apply to food that is imported for
(2) With respect to the importation of research or evaluation use, provided
animal food, an importer (including that such food:
any subsidiaries and affiliates) aver- (1) Is not intended for retail sale and
aging less than $2.5 million per year, is not sold or distributed to the public;
adjusted for inflation, during the 3- (2) Is labeled with the statement
year period preceding the applicable ‘‘Food for research or evaluation use’’;
calendar year, in sales of animal food (3) Is imported in a small quantity
combined with the U.S. market value that is consistent with a research,
of animal food imported, manufac- analysis, or quality assurance purpose,
tured, processed, packed, or held with- the food is used only for this purpose,
out sale (e.g., imported for a fee). and any unused quantity is properly
disposed of; and
You means a person who is subject to
(4) Is accompanied, when filing entry
some or all of the requirements in this
with U.S. Customs and Border Protec-
subpart.
tion, by an electronic declaration that
[80 FR 74340, Nov. 27, 2015, as amended at 81 the food will be used for research or
FR 25327, Apr. 28, 2016] evaluation purposes and will not be
sold or distributed to the public.
§ 1.501 To what foods do the require- (d) Exemption for food imported for per-
ments in this subpart apply? sonal consumption. This subpart does
(a) General. Except as specified other- not apply to food that is imported for
wise in this section, the requirements personal consumption, provided that
in this subpart apply to all food im- such food is not intended for retail sale
ported or offered for import into the and is not sold or distributed to the
65
§ 1.502 21 CFR Ch. I (4–1–19 Edition)
public. Food is imported for personal in accordance with § 117.5(i) of this

consumption only if it is purchased or chapter.
otherwise acquired by a person in a (f) Inapplicability to food that is trans-
small quantity that is consistent with shipped or imported for processing and ex-
a non-commercial purpose and is not port. This subpart does not apply to
sold or distributed to the public. food:
(e) Exemption for alcoholic beverages. (1) That is transshipped through the
(1) This subpart does not apply with re- United States to another country and
spect to alcoholic beverages that are is not sold or distributed to the public
imported from a foreign supplier that in the United States; or
is a facility that meets the following (2) That is imported for processing
two conditions: and future export and that is not sold
(i) Under the Federal Alcohol Admin- or distributed to the public in the
istration Act (27 U.S.C. 201 et seq.) or United States.
chapter 51 of subtitle E of the Internal (g) Inapplicability to U.S. food re-
Revenue Code of 1986 (26 U.S.C. 5001 et turned. This subpart does not apply to
seq.), the facility is a foreign facility of food that is manufactured/processed,
a type that, if it were a domestic facil- raised, or grown in the United States,
ity, would require obtaining a permit exported, and returned to the United
from, registering with, or obtaining ap- States without further manufacturing/
proval of a notice or application from processing in a foreign country.
the Secretary of the Treasury as a con- (h) Inapplicability to certain meat,
dition of doing business in the United poultry, and egg products. This subpart
States; and does not apply with respect to:
(ii) Under section 415 of the Federal (1) Meat food products that at the
Food, Drug, and Cosmetic Act, the fa- time of importation are subject to the
cility is required to register as a facil- requirements of the U.S. Department
ity because it is engaged in manufac- of Agriculture (USDA) under the Fed-
turing/processing one or more alcoholic eral Meat Inspection Act (21 U.S.C. 601
beverages. et seq.);
(2) This subpart does not apply with (2) Poultry products that at the time
respect to food that is not an alcoholic of importation are subject to the re-
beverage that is imported from a for- quirements of the USDA under the
eign supplier described in paragraph Poultry Products Inspection Act (21
(e)(1) of this section, provided such U.S.C. 451 et seq.); and
food: (3) Egg products that at the time of
(i) Is in prepackaged form that pre- importation are subject to the require-
vents any direct human contact with ments of the USDA under the Egg
such food; and Products Inspection Act (21 U.S.C. 1031
(ii) Constitutes not more than 5 per- et seq.).
cent of the overall sales of the facility, [80 FR 74340, Nov. 27, 2015, as amended at 81
as determined by the Secretary of the FR 25327, Apr. 28, 2016]
Treasury.
(3) This subpart does not apply with § 1.502 What foreign supplier
respect to raw materials and other in- verification program (FSVP) must I
gredients that are imported for use in have?
alcoholic beverages provided that: (a) General. Except as specified in
(i) The imported raw materials and paragraph (b) of this section, for each
other ingredients are used in the manu- food you import, you must develop,
facturing/processing, packing, or hold- maintain, and follow an FSVP that
ing of alcoholic beverages; provides adequate assurances that your
(ii) Such manufacturing/processing, foreign supplier is producing the food
packing, or holding is performed by the in compliance with processes and pro-
importer; cedures that provide at least the same
(iii) The importer is required to reg- level of public health protection as
ister under section 415 of the Federal those required under section 418 (re-
Food, Drug, and Cosmetic Act; and garding hazard analysis and risk-based
(iv) The importer is exempt from the preventive controls for certain foods)
regulations in part 117 of this chapter or 419 (regarding standards for produce
66
safety), if either is applicable, and the cordance with § 117.135 or § 507.34 of this
implementing regulations, and is pro- chapter;
ducing the food in compliance with sec- (2) You are not required to imple-
tions 402 (regarding adulteration) and ment a preventive control under
403(w) (if applicable) (regarding mis- § 117.136 or § 507.36 of this chapter with
branding with respect to labeling for respect to the food; or
the presence of major food allergens) of (3) You have established and imple-
the Federal Food, Drug, and Cosmetic mented a risk-based supply-chain pro-
Act. gram in compliance with subpart G of
(b) Low-acid canned foods—(1) Import- part 117 or subpart E of part 507 of this
ers of low-acid canned foods not subject to chapter with respect to the food.
further manufacturing or processing.
With respect to those microbiological § 1.503 Who must develop my FSVP
hazards that are controlled by part 113 and perform FSVP activities?
of this chapter, if you import a ther- (a) Qualified individual. A qualified
mally processed low-acid food pack- individual must develop your FSVP
aged in a hermetically sealed container and perform each of the activities re-
(low-acid canned food), you must verify quired under this subpart. A qualified
and document that the food was pro- individual must have the education,
duced in accordance with part 113. With training, or experience (or a combina-
respect to all matters that are not con- tion thereof) necessary to perform
trolled by part 113, you must have an their assigned activities and must be
FSVP as specified in paragraph (a) of able to read and understand the lan-
this section. guage of any records that must be re-
(2) Certain importers of raw materials or viewed in performing an activity.
other ingredients subject to part 113 of (b) Qualified auditor. A qualified audi-
this chapter. With respect to micro- tor must conduct any audit conducted
biological hazards that are controlled in accordance with § 1.506(e)(1)(i) or
by part 113, you are not required to § 1.511(c)(5)(i)(A). A qualified auditor
comply with the requirements of this must have technical expertise obtained
subpart for raw materials or other in- through education, training, or experi-
gredients that you import and use in ence (or a combination thereof) nec-
the manufacturing or processing of essary to perform the auditing func-
low-acid canned food provided that you tion.
are in compliance with part 113 with
respect to the low-acid canned food § 1.504 What hazard analysis must I
that you manufacture or process from conduct?
the imported raw materials or other in- (a) Requirement for a hazard analysis.
gredients. With respect to all hazards Except as specified in paragraph (d) of
other than microbiological hazards this section, you must conduct a haz-
that are controlled by part 113, you ard analysis to identify and evaluate,
must have an FSVP as specified in based on experience, illness data, sci-
paragraph (a) of this section for the im- entific reports, and other information,
ported raw materials and other ingredi- known or reasonably foreseeable haz-
ents that you use in the manufacture ards for each type of food you import
or processing of low-acid canned foods. to determine whether there are any
(c) Importers subject to section 418 of hazards requiring a control. Your haz-
the Federal Food, Drug, and Cosmetic ard analysis must be written regardless
Act. You are deemed to be in compli- of its outcome.
ance with the requirements of this sub- (b) Hazard identification. (1) Your
part for a food you import, except for analysis of the known or reasonably
the requirements in § 1.509, if you are a foreseeable hazards in each food must
receiving facility as defined in § 117.3 or include the following types of hazards:
§ 507.3 of this chapter and you are in (i) Biological hazards, including
compliance with the following require- microbiological hazards such as
ments of part 117 or part 507 of this parasites, environmental pathogens,
chapter, as applicable: and other pathogens;
(1) You implement preventive con- (ii) Chemical hazards, including radi-
trols for the hazards in the food in ac- ological hazards, pesticide and drug
67
§ 1.505 21 CFR Ch. I (4–1–19 Edition)
residues, natural toxins, decomposi- (x) Any other relevant factors, such
tion, unapproved food or color addi- as the temporal (e.g., weather-related)
tives, food allergens, and (in animal nature of some hazards (e.g., levels of
food) nutrient deficiencies or natural toxins).
toxicities; and (d) Review of another entity’s hazard
(iii) Physical hazards (such as stones, analysis. If another entity (including
glass, and metal fragments). your foreign supplier) has, using a
(2) Your analysis must include known qualified individual, analyzed the
or reasonably foreseeable hazards that known or reasonably foreseeable haz-
may be present in a food for any of the ards for the food to determine whether
following reasons: there are any hazards requiring a con-
(i) The hazard occurs naturally; trol, you may meet your requirement
(ii) The hazard may be unintention- to determine whether there are any
ally introduced; or hazards requiring a control in a food by
(iii) The hazard may be intentionally reviewing and assessing the hazard
introduced for purposes of economic analysis conducted by that entity. You
gain. must document your review and assess-
(c) Hazard evaluation. (1) Your hazard ment of that hazard analysis, including
analysis must include an evaluation of documenting that the hazard analysis
the hazards identified in paragraph (b) was conducted by a qualified indi-
of this section to assess the probability vidual.
that the hazard will occur in the ab- (e) Hazards in raw agricultural com-
sence of controls and the severity of modities that are fruits or vegetables. If
the illness or injury if the hazard were you are importing a raw agricultural
to occur. commodity that is a fruit or vegetable
(2) The hazard evaluation required by that is ‘‘covered produce’’ as defined in
paragraph (c)(1) of this section must in- § 112.3 of this chapter, you are not re-
clude an evaluation of environmental quired to determine whether there are
pathogens whenever a ready-to-eat any biological hazards requiring a con-
food is exposed to the environment be- trol in such food because the biological
fore packaging and the packaged food hazards in such fruits or vegetables re-
does not receive a treatment or other- quire a control and compliance with
wise include a control or measure (such the requirements in part 112 of this
as a formulation lethal to the patho- chapter significantly minimizes or pre-
gen) that would significantly minimize vents the biological hazards. However,
the pathogen. you must determine whether there are
(3) Your hazard evaluation must con- any other types of hazards requiring a
sider the effect of the following on the control in such food.
safety of the finished food for the in- (f) No hazards requiring a control. If
tended consumer: you evaluate the known and reason-
(i) The formulation of the food; ably foreseeable hazards in a food and
(ii) The condition, function, and de- determine that there are no hazards re-
sign of the establishment and equip- quiring a control, you are not required
ment of a typical entity that manufac- to conduct an evaluation for foreign
tures/processes, grows, harvests, or supplier approval and verification
raises this type of food; under § 1.505 and you are not required
(iii) Raw materials and other ingredi- to conduct foreign supplier verification
ents; activities under § 1.506. This paragraph
(iv) Transportation practices; (f) does not apply if the food is a raw
(v) Harvesting, raising, manufac- agricultural commodity that is a fruit
turing, processing, and packing proce- or vegetable that is ‘‘covered produce’’
dures; as defined in § 112.3 of this chapter.
(vi) Packaging and labeling activi-
ties; § 1.505 What evaluation for foreign
(vii) Storage and distribution; supplier approval and verification
(viii) Intended or reasonably foresee- must I conduct?
able use; (a) Evaluation of a foreign supplier’s
(ix) Sanitation, including employee performance and the risk posed by a food.
hygiene; and (1) Except as specified in paragraphs (d)
68
and (e) of this section, in approving under paragraph (d) of this section, and
your foreign suppliers and determining document your approval.
the appropriate supplier verification (c) Reevaluation of a foreign supplier’s
activities that must be conducted for a performance and the risk posed by a food.
foreign supplier of a type of food you (1) Except as specified in paragraph (d)
import, you must consider the fol- of this section, you must promptly re-
lowing: evaluate the concerns associated with
(i) The hazard analysis of the food the factors in paragraph (a)(1) of this
conducted in accordance with § 1.504, section when you become aware of new
including the nature of the hazard re- information about these factors, and
quiring a control. the reevaluation must be documented.
(ii) The entity or entities that will be If you determine that the concerns as-
significantly minimizing or preventing sociated with importing a food from a
the hazards requiring a control or foreign supplier have changed, you
verifying that such hazards have been must promptly determine (and docu-
significantly minimized or prevented, ment) whether it is appropriate to con-
such as the foreign supplier, the for- tinue to import the food from the for-
eign supplier’s raw material or other eign supplier and whether the supplier
ingredient supplier, or another entity verification activities conducted under
in your supply chain. § 1.506 or § 1.511(c) need to be changed.
(iii) Foreign supplier performance, (2) If at the end of any 3-year period
including: you have not reevaluated the concerns
(A) The foreign supplier’s procedures, associated with the factors in para-
processes, and practices related to the graph (a)(1) of this section in accord-
safety of the food; ance with paragraph (c)(1) of this sec-
(B) Applicable FDA food safety regu- tion, you must reevaluate those con-
lations and information relevant to the cerns and take other appropriate ac-
foreign supplier’s compliance with tions, if necessary, in accordance with
those regulations, including whether paragraph (c)(1). You must document
the foreign supplier is the subject of an your reevaluation and any subsequent
FDA warning letter, import alert, or actions you take in accordance with
other FDA compliance action related paragraph (c)(1).
to food safety (or, when applicable, the (d) Review of another entity’s evalua-
relevant laws and regulations of a tion or reevaluation of a foreign supplier’s
country whose food safety system FDA performance and the risk posed by a food.
has officially recognized as comparable If an entity other than the foreign sup-
or determined to be equivalent to that plier has, using a qualified individual,
of the United States, and information performed the evaluation described in
relevant to the supplier’s compliance paragraph (a) of this section or the re-
with those laws and regulations); and evaluation described in paragraph (c)
(C) The foreign supplier’s food safety of this section, you may meet the re-
history, including available informa- quirements of the applicable paragraph
tion about results from testing foods by reviewing and assessing the evalua-
for hazards, audit results relating to tion or reevaluation conducted by that
the safety of the food, and responsive- entity. You must document your re-
ness of the foreign supplier in cor- view and assessment, including docu-
recting problems. menting that the evaluation or re-
(iv) Any other factors as appropriate evaluation was conducted by a quali-
and necessary, such as storage and fied individual.
transportation practices. (e) Inapplicability to certain cir-
(2) You must document the evalua- cumstances. You are not required to
tion you conduct under paragraph conduct an evaluation under this sec-
(a)(1) of this section. tion or to conduct foreign supplier
(b) Approval of foreign suppliers. You verification activities under § 1.506 if
must approve your foreign suppliers on one of the circumstances described in
the basis of the evaluation that you § 1.507 applies to your importation of a
conducted under paragraph (a) of this food and you are in compliance with
section or that you review and assess that section.
69
§ 1.506 21 CFR Ch. I (4–1–19 Edition)
§ 1.506 What foreign supplier packs the produce and significantly

verification and related activities minimizes or prevents the hazard or
must I conduct? verifies that the hazard has been sig-
(a) Use of approved foreign suppliers. nificantly minimized or prevented, or
(1) You must establish and follow writ- when the foreign supplier’s raw mate-
ten procedures to ensure that you im- rial supplier significantly minimizes or
port foods only from foreign suppliers prevents a hazard). The determination
you have approved based on the evalua- of appropriate supplier verification ac-
tion conducted under § 1.505 (or, when tivities must be based on the evalua-
necessary and appropriate, on a tem- tion of the food and foreign supplier
porary basis from unapproved foreign conducted under § 1.505.
suppliers whose foods you subject to (ii) Appropriate verification activities.
adequate verification activities before The following are appropriate supplier
importing the food). You must docu- verification activities:
ment your use of these procedures. (A) Onsite audits as specified in para-
(2) You may rely on an entity other graph (e)(1)(i) of this section;
than your foreign supplier to establish (B) Sampling and testing of a food as
the procedures and perform and docu- specified in paragraph (e)(1)(ii) of this
ment the activities required under section;
paragraph (a)(1) of this section pro- (C) Review of the foreign supplier’s
vided that you review and assess that relevant food safety records as speci-
entity’s documentation of the proce- fied in paragraph (e)(1)(iii) of this sec-
dures and activities, and you document tion; and
your review and assessment. (D) Other appropriate supplier
(b) Foreign supplier verification proce- verification activities as specified in
dures. You must establish and follow paragraph (e)(1)(iv) of this section.
adequate written procedures for ensur- (2) Verification activities for certain se-
ing that appropriate foreign supplier rious hazards. When a hazard in a food
verification activities are conducted will be controlled by the foreign sup-
with respect to the foods you import. plier and is one for which there is a
(c) Requirement of supplier verification. reasonable probability that exposure to
The foreign supplier verification ac- the hazard will result in serious ad-
tivities must provide assurance that verse health consequences or death to
the hazards requiring a control in the humans or animals, you must conduct
food you import have been signifi- or obtain documentation of an onsite
cantly minimized or prevented. audit of the foreign supplier before ini-
(d) Determination of appropriate foreign tially importing the food and at least
supplier verification activities—(1)(i) Gen- annually thereafter, unless you make
eral. Except as provided in paragraphs an adequate written determination
(d)(2) and (3) of this section, before im- that, instead of such initial and annual
porting a food from a foreign supplier, onsite auditing, other supplier
you must determine and document verification activities listed in para-
which verification activity or activi- graph (d)(1)(ii) of this section and/or
ties listed in paragraphs (d)(1)(ii)(A) less frequent onsite auditing are appro-
through (D) of this section, as well as priate to provide adequate assurances
the frequency with which the activity that the foreign supplier is producing
or activities must be conducted, are the food in accordance with paragraph
needed to provide adequate assurances (c) of this section, based on the deter-
that the food you obtain from the for- mination made under § 1.505.
eign supplier is produced in accordance (3) Reliance on a determination by an-
with paragraph (c) of this section. other entity. You may rely on a deter-
Verification activities must address mination of appropriate foreign sup-
the entity or entities that are signifi- plier verification activities in accord-
cantly minimizing or preventing the ance with paragraph (d)(1) or (2) of this
hazards or verifying that the hazards section made by an entity other than
have been significantly minimized or the foreign supplier if you review and
prevented (e.g., when an entity other assess whether the entity’s determina-
than the grower of produce subject to tion regarding appropriate activities

part 112 of this chapter harvests or (including the frequency with which
70
such activities must be conducted) is which the onsite audit would have been
appropriate. You must document your required to be conducted:
review and assessment, including docu- (1) The written results of an appro-
menting that the determination of ap- priate inspection of the foreign sup-
propriate verification activities was plier for compliance with applicable
made by a qualified individual. FDA food safety regulations conducted
(e) Performance of foreign supplier by FDA, representatives of other Fed-
verification activities—(1) Verification ac- eral Agencies (such as the USDA), or
tivities. Except as provided in paragraph representatives of State, local, tribal,
(e)(2) of this section, based on the de- or territorial agencies; or
termination made in accordance with (2) The written results of an inspec-
paragraph (d) of this section, you must tion of the foreign supplier by the food
conduct (and document) or obtain doc- safety authority of a country whose
umentation of one or more of the sup- food safety system FDA has officially
plier verification activities listed in recognized as comparable or deter-
paragraphs (e)(1)(i) through (iv) of this mined to be equivalent to that of the
section for each foreign supplier before United States, provided that the food
importing the food and periodically that is the subject of the onsite audit
thereafter. is within the scope of the official rec-
(i) Onsite audit of the foreign supplier. ognition or equivalence determination,
(A) An onsite audit of a foreign sup- and the foreign supplier is in, and
plier must be performed by a qualified under the regulatory oversight of, such
auditor. country.
(B) If the food is subject to one or (ii) Sampling and testing of the food.
more FDA food safety regulations, an You must retain documentation of
onsite audit of the foreign supplier each sampling and testing of a food, in-
must consider such regulations and including identification of the food test-
clude a review of the supplier’s written ed (including lot number, as appro-
food safety plan, if any, and its imple- priate), the number of samples tested,
mentation, for the hazard being con- the test(s) conducted (including the an-
trolled (or, when applicable, an onsite alytical method(s) used), the date(s) on
audit may consider relevant laws and which the test(s) were conducted and
regulations of a country whose food the date of the report of the testing,
safety system FDA has officially recog- the results of the testing, any correc-
nized as comparable or determined to tive actions taken in response to detec-
be equivalent to that of the United tion of hazards, information identi-
States). fying the laboratory conducting the
(C) If the onsite audit is conducted testing, and documentation that the
solely to meet the requirements of testing was conducted by a qualified
paragraph (e) of this section by an individual.
audit agent of a certification body that (iii) Review of the foreign supplier’s rel-
is accredited in accordance with sub- evant food safety records. You must re-
part M of this part, the audit is not tain documentation of each record re-
subject to the requirements in that view, including the date(s) of review,
subpart. the general nature of the records re-
(D) You must retain documentation viewed, the conclusions of the review,
of each onsite audit, including the any corrective actions taken in re-
audit procedures, the dates the audit sponse to significant deficiencies iden-
was conducted, the conclusions of the tified during the review, and docu-
audit, any corrective actions taken in mentation that the review was con-
response to significant deficiencies ducted by a qualified individual.
identified during the audit, and docu- (iv) Other appropriate activity. (A) You
mentation that the audit was con- may conduct (and document) or obtain
ducted by a qualified auditor. documentation of other supplier
(E) The following inspection results verification activities that are appro-
may be substituted for an onsite audit, priate based on foreign supplier per-
provided that the inspection was conformance and the risk associated with
ducted within 1 year of the date by the food.
71
§ 1.507 21 CFR Ch. I (4–1–19 Edition)
(B) You must retain documentation and payment must not be related to
of each activity conducted in accord- the results of the activity.
ance with paragraph (e)(1)(iv) of this
section, including a description of the § 1.507 What requirements apply when
activity, the date on which it was con- I import a food that cannot be con-
sumed without the hazards being
ducted, the findings or results of the controlled or for which the hazards
activity, any corrective actions taken are controlled after importation?
in response to significant deficiencies
identified, and documentation that the (a) Circumstances. You are not re-
activity was conducted by a qualified quired to conduct an evaluation of a
individual. food and foreign supplier under § 1.505
or supplier verification activities under
(2) Reliance upon performance of activi-
§ 1.506 when you identify a hazard re-
ties by other entities. (i) Except as speci-
quiring a control (identified hazard) in
fied in paragraph (e)(2)(ii) of this sec-
a food and any of the following cir-
tion, you may rely on supplier
cumstances apply:
verification activities conducted in ac-
(1) You determine and document that
cordance with paragraph (e)(1) of this
the type of food (e.g., raw agricultural
section by another entity provided that
commodities such as cocoa beans and
you review and assess the results of
coffee beans) could not be consumed
these activities in accordance with
without application of an appropriate
paragraph (e)(3) of this section.
control;
(ii) You may not rely on the foreign (2) You rely on your customer who is
supplier itself or employees of the for- subject to the requirements for hazard
eign supplier to perform supplier analysis and risk-based preventive con-
verification activities, except with re- trols in subpart C of part 117 or subpart
spect to sampling and testing of food in C of part 507 of this chapter to ensure
accordance with paragraph (e)(1)(ii) of that the identified hazard will be sig-
this section. nificantly minimized or prevented and
(3) Review of results of verification ac- you:
tivities. You must promptly review and (i) Disclose in documents accom-
assess the results of the verification panying the food, in accordance with
activities that you conduct or obtain the practice of the trade, that the food
documentation of under paragraph is ‘‘not processed to control [identified
(e)(1) of this section, or that are con- hazard]’’; and
ducted by other entities in accordance (ii) Annually obtain from your cus-
with paragraph (e)(2) of this section. tomer written assurance, subject to the
You must document your review and requirements of paragraph (c) of this
assessment of the results of section, that the customer has estab-
verification activities. If the results do lished and is following procedures
not provide adequate assurances that (identified in the written assurance)
the hazards requiring a control in the that will significantly minimize or pre-
food you obtain from the foreign sup- vent the identified hazard;
plier have been significantly minimized (3) You rely on your customer who is
or prevented, you must take appro- not subject to the requirements for
priate action in accordance with hazard analysis and risk-based preven-
§ 1.508(a). You are not required to re- tive controls in subpart C of part 117 or
tain documentation of supplier subpart C of part 507 of this chapter to
verification activities conducted by provide assurance it is manufacturing,
other entities, provided that you can processing, or preparing the food in ac-
obtain the documentation and make it cordance with the applicable food safe-
available to FDA in accordance with ty requirements and you:
§ 1.510(b). (i) Disclose in documents accom-
(4) Independence of qualified individ- panying the food, in accordance with
uals conducting verification activities. the practice of the trade, that the food
There must not be any financial con- is ‘‘not processed to control [identified
flicts of interests that influence the re- hazard]’’; and
sults of the verification activities set (ii) Annually obtain from your cus-
forth in paragraph (e)(1) of this section, tomer written assurance that it is
72
manufacturing, processing, or pre- (3) The assurance specified in the ap-

paring the food in accordance with applicable paragraph.
plicable food safety requirements; (c) Provision of assurances. The cus-
(4) You rely on your customer to pro- tomer or other subsequent entity in
vide assurance that the food will be the distribution chain for a food that
processed to control the identified haz- provides a written assurance under
ard by an entity in the distribution paragraph (a)(2), (3), or (4) of this sec-
chain subsequent to the customer and tion must act consistently with the as-
you: surance and document its actions
(i) Disclose in documents accom- taken to satisfy the written assurance.
panying the food, in accordance with
the practice of the trade, that the food § 1.508 What corrective actions must I
is ‘‘not processed to control [identified take under my FSVP?
hazard]’’; and (a) You must promptly take appro-
(ii) Annually obtain from your cus- priate corrective actions if you deter-
tomer written assurance, subject to the mine that a foreign supplier of food
requirements of paragraph (c) of this you import does not produce the food
section, that your customer: in compliance with processes and pro-
(A) Will disclose in documents ac- cedures that provide at least the same
companying the food, in accordance level of public health protection as
with the practice of the trade, that the those required under section 418 or 419
food is ‘‘not processed to control [iden- of the Federal Food, Drug, and Cos-
tified hazard]’’; and metic Act, if either is applicable, and
(B) Will only sell the food to another the implementing regulations, or pro-
entity that agrees, in writing, it will: duces food that is adulterated under
(1) Follow procedures (identified in a section 402 or misbranded under section
written assurance) that will signifi- 403(w) (if applicable) of the Federal
cantly minimize or prevent the identi- Food, Drug, and Cosmetic Act. This de-
fied hazard (if the entity is subject to termination could be based on a review
the requirements for hazard analysis of consumer, customer, or other com-
and risk-based preventive controls in plaints related to food safety, the
subpart C of part 117 or subpart C of verification activities conducted under
part 507 of this chapter) or manufac- § 1.506 or § 1.511(c), a reevaluation of the
ture, process, or prepare the food in ac- risks posed by the food and the foreign
cordance with applicable food safety supplier’s performance conducted
requirements (if the entity is not sub- under § 1.505(c) or (d), or any other rel-
ject to the requirements for hazard evant information you obtain. The ap-
analysis and risk-based preventive con- propriate corrective actions will de-
trols in subpart C of part 117 or subpart pend on the circumstances but could
C of part 507); or include discontinuing use of the foreign
(2) Obtain a similar written assur- supplier until the cause or causes of
ance from the entity’s customer, sub- noncompliance, adulteration, or mis-
ject to the requirements of paragraph branding have been adequately ad-
(c) of this section, as in paragraphs dressed. You must document any cor-
(a)(4)(ii)(A) and (B) of this section, as rective actions you take in accordance
appropriate; or with this paragraph.
(5) You have established, docu- (b) If you determine, by means other
mented, and implemented a system than the verification activities con-
that ensures control, at a subsequent ducted under § 1.506 or § 1.511(c) or a re-
distribution step, of the hazards in the evaluation conducted under § 1.505(c) or
food you distribute and you document (d), that a foreign supplier of food that
your implementation of that system. you import does not produce food in
(b) Written assurances. Any written compliance with processes and proce-
assurances required under this section dures that provide at least the same
must contain the following: level of public health protection as
(1) Effective date; those required under section 418 or 419
(2) Printed names and signatures of of the Federal Food, Drug, and Cos-
authorized officials; and metic Act, if either is applicable, and
73
§ 1.509 21 CFR Ch. I (4–1–19 Edition)
the implementing regulations, or pro- quest, for inspection and copying. Upon
duces food that is adulterated under FDA request, you must provide within
section 402 or misbranded under section a reasonable time an English trans-
403(w) (if applicable) of the Federal lation of records maintained in a lan-
Food, Drug, and Cosmetic Act, you guage other than English.
must promptly investigate to deter- (2) Offsite storage of records, includ-
mine whether your FSVP is adequate ing records maintained by other enti-
and, when appropriate, modify your ties in accordance with § 1.504, § 1.505, or
FSVP. You must document any inves- § 1.506, is permitted if such records can
tigations, corrective actions, and be retrieved and provided onsite within
changes to your FSVP that you under- 24 hours of request for official review.
take in accordance with this para- Electronic records are considered to be
graph. onsite if they are accessible from an
(c) This section does not limit your onsite location.
obligations with respect to other laws (3) If requested in writing by FDA,
enforced by FDA, such as those relat- you must send records to the Agency
ing to product recalls. electronically, or through another
means that delivers the records
§ 1.509 How must the importer be promptly, rather than making the
identified at entry? records available for review at your
(a) You must ensure that, for each place of business.
line entry of food product offered for (c) Record retention. (1) Except as
importation into the United States, specified in paragraph (c)(2) of this sec-
your name, electronic mail address, tion, you must retain records ref-
and unique facility identifier recog- erenced in this subpart until at least 2
nized as acceptable by FDA, identi- years after you created or obtained the
fying you as the importer of the food, records.
are provided electronically when filing (2) You must retain records that re-
entry with U.S. Customs and Border late to your processes and procedures,
Protection. including the results of evaluations
(b) Before an article of food is im- and determinations you conduct, for at
ported or offered for import into the least 2 years after their use is discon-
United States, the foreign owner or tinued (e.g., because you no longer im-
consignee of the food (if there is no port a particular food, you no longer
U.S. owner or consignee) must des- use a particular foreign supplier, you
ignate a U.S. agent or representative have reevaluated the risks associated
as the importer of the food for the pur- with a food and the foreign supplier, or
poses of the definition of ‘‘importer’’ in you have changed your supplier
§ 1.500. verification activities for a particular
food and foreign supplier).
§ 1.510 How must I maintain records of (d) Electronic records. Records that
my FSVP? are established or maintained to sat-
(a) General requirements for records. (1) isfy the requirements of this subpart
You must keep records as original and that meet the definition of elec-
records, true copies (such as photo- tronic records in § 11.3(b)(6) of this
copies, pictures, scanned copies, micro- chapter are exempt from the require-
film, microfiche, or other accurate re- ments of part 11 of this chapter.
productions of the original records), or Records that satisfy the requirements
electronic records. of this subpart, but that also are re-
(2) You must sign and date records quired under other applicable statutory
concerning your FSVP upon initial provisions or regulations, remain sub-
completion and upon any modification ject to part 11.
of the FSVP. (e) Use of existing records. (1) You do
(3) All records must be legible and not need to duplicate existing records
stored to prevent deterioration or loss. you have (e.g., records that you main-
(b) Record availability. (1) You must tain to comply with other Federal,
make all records required under this State, or local regulations) if they con-
subpart available promptly to an au- tain all of the information required by

thorized FDA representative, upon re- this subpart. You may supplement any
74
such existing records as necessary to lished are met for such food, and you
include all of the information required annually obtain from your customer
by this subpart. written assurance that it is in compli-
(2) You do not need to maintain the ance with those requirements, then for
information required by this subpart in that food you must comply with the re-
one set of records. If existing records quirements in §§ 1.503, 1.509, and 1.510,
you have contain some of the required but you are not required to comply
information, you may maintain any with the requirements in § 1.502 or
new information required by this sub- §§ 1.504 through 1.508.
part either separately or combined (c) Other importers of dietary supple-
with the existing records. ments—(1) General. If the food you im-
(f) Public disclosure. Records obtained port is a dietary supplement and nei-
by FDA in accordance with this sub- ther paragraph (a) or (b) of this section
part are subject to the disclosure re- is applicable, you must comply with
quirements under part 20 of this chap- paragraph (c) of this section and the re-
ter. quirements in §§ 1.503, 1.505(a)(1)(ii)
through (iv), (a)(2), and (b) through (d),
§ 1.511 What FSVP must I have if I am and 1.508 through 1.510, but you are not
importing a food subject to certain
requirements in the dietary supple- required to comply with the require-
ment current good manufacturing ments in §§ 1.504, 1.505(a)(1)(i), 1.506, and
practice regulation? 1.507. This requirement does not limit
(a) Importers subject to certain require- your obligations with respect to part
ments in the dietary supplement current 111 of this chapter or any other laws
good manufacturing practice regulation. enforced by FDA.
If you are required to establish speci- (2) Use of approved foreign suppliers. (i)
fications under § 111.70(b) or (d) of this You must establish and follow written
chapter with respect to a food that is a procedures to ensure that you import
dietary supplement or dietary supple- foods only from foreign suppliers that
ment component you import for fur- you have approved based on the evalua-
ther manufacturing, processing, or tion conducted under § 1.505 (or, when
packaging as a dietary supplement, and necessary and appropriate, on a tem-
you are in compliance with the require- porary basis from unapproved foreign
ments in §§ 111.73 and 111.75 of this suppliers whose foods you subject to
chapter applicable to determining adequate verification activities before
whether the specifications you estab- importing the food). You must docu-
lished are met for such food, then for ment your use of these procedures.
that food you must comply with the re- (ii) You may rely on an entity other
quirements in §§ 1.503 and 1.509, but you than the foreign supplier to establish
are not required to comply with the re- the procedures and perform and docu-
quirements in § 1.502, §§ 1.504 through ment the activities required under
1.508, or § 1.510. This requirement does paragraph (c)(2)(i) of this section pro-
not limit your obligations with respect vided that you review and assess that
to part 111 of this chapter or any other entity’s documentation of the proce-
laws enforced by FDA. dures and activities, and you document
(b) Importers whose customer is subject your review and assessment.
to certain requirements in the dietary sup- (3) Foreign supplier verification proce-
plement current good manufacturing dures. You must establish and follow
practice regulation. If your customer is adequate written procedures for ensur-
required to establish specifications ing that appropriate foreign supplier
under § 111.70(b) or (d) of this chapter verification activities are conducted
with respect to a food that is a dietary with respect to the foods you import.
supplement or dietary supplement (4) Determination of appropriate foreign
component you import for further supplier verification activities—(i) Gen-
manufacturing, processing, or pack- eral. Except as provided in paragraph
aging as a dietary supplement, your (c)(4)(iii) of this section, before import-
customer is in compliance with the re- ing a dietary supplement from a for-
quirements of §§ 111.73 and 111.75 of this eign supplier, you must determine and
chapter applicable to determining document which verification activity

whether the specifications it estab- or activities listed in paragraphs
75
§ 1.511 21 CFR Ch. I (4–1–19 Edition)
(c)(4)(ii)(A) through (D) of this section, a periodic onsite audit of your foreign
as well as the frequency with which the supplier.
activity or activities must be con- (1) An onsite audit of a foreign sup-
ducted, are needed to provide adequate plier must be performed by a qualified
assurances that the foreign supplier is auditor.
producing the dietary supplement in (2) The onsite audit must consider
accordance with processes and proce- the applicable requirements of part 111
dures that provide the same level of of this chapter and include a review of
public health protection as those re- the foreign supplier’s written food safe-
quired under part 111 of this chapter. ty plan, if any, and its implementation
This determination must be based on (or, when applicable, an onsite audit
the evaluation conducted under § 1.505. may consider relevant laws and regula-
(ii) Appropriate verification activities. tions of a country whose food safety
The following are appropriate supplier system FDA has officially recognized
verification activities: as comparable or determined to be
(A) Onsite audits as specified in para- equivalent to that of the United
graph (c)(5)(i)(A) of this section; States).
(B) Sampling and testing of a food as (3) If the onsite audit is conducted
specified in paragraph (c)(5)(i)(B) of solely to meet the requirements of
this section; paragraph (c)(5) of this section by an
(C) Review of the foreign supplier’s
audit agent of a certification body that
relevant food safety records as speci-
is accredited in accordance with sub-
fied in paragraph (c)(5)(i)(C) of this sec-
part M of this part, the audit is not
tion; and
subject to the requirements in that
(D) Other appropriate supplier
subpart.
verification activities as specified in
paragraph (c)(5)(i)(D) of this section. (4) You must retain documentation of
(iii) Reliance upon determination by each onsite audit, including the audit
other entity. You may rely on a deter- procedures, the dates the audit was
mination of appropriate foreign sup- conducted, the conclusions of the
plier verification activities in accord- audit, any corrective actions taken in
ance with paragraph (c)(4)(i) of this response to significant deficiencies
section made by an entity other than identified during the audit, and docu-
the foreign supplier if you review and mentation that the audit was con-
assess whether the entity’s determina- ducted by a qualified auditor.
tion regarding appropriate activities (5) The following inspection results
(including the frequency with which may be substituted for an onsite audit,
such activities must be conducted) is provided that the inspection was con-
appropriate based on the evaluation ducted within 1 year of the date by
conducted in accordance with § 1.505. which the onsite audit would have been
You must document your review and required to be conducted:
assessment, including documenting (i) The written results of appropriate
that the determination of appropriate inspection of the foreign supplier for
verification activities was made by a compliance with the applicable re-
qualified individual. quirements in part 111 of this chapter
(5) Performance of foreign supplier conducted by FDA, representatives of
verification activities. (i) Except as pro- other Federal Agencies (such as the
vided in paragraph (c)(5)(ii) of this sec- USDA), or representatives of State,
tion, for each dietary supplement you local, tribal, or territorial agencies; or
import under paragraph (c) of this sec- (ii) The written results of an inspec-
tion, you must conduct (and document) tion by the food safety authority of a
or obtain documentation of one or country whose food safety system FDA
more of the verification activities list- has officially recognized as comparable
ed in paragraphs (c)(5)(i)(A) through or determined to be equivalent to that
(D) of this section before importing the of the United States, provided that the
dietary supplement and periodically food that is the subject of the onsite
thereafter. audit is within the scope of the official
(A) Onsite auditing. You conduct (and recognition or equivalence determina-

document) or obtain documentation of tion, and the foreign supplier is in, and
76
under the regulatory oversight of, such (B) You may not rely on the foreign
country. supplier or employees of the foreign
(B) Sampling and testing of the food. supplier to perform supplier
You must retain documentation of verification activities, except with re-
each sampling and testing of a dietary spect to sampling and testing of food in
supplement, including identification of accordance with paragraph (c)(5)(i)(B)
the food tested (including lot number, of this section.
as appropriate), the number of samples (iii) Review of results of verification ac-
tested, the test(s) conducted (including tivities. You must promptly review and
the analytical method(s) used), the assess the results of the verification
date(s) on which the test(s) were con- activities that you conduct or obtain
ducted and the date of the report of the documentation of under paragraph
testing, the results of the testing, any (c)(5)(i) of this section, or that are con-
corrective actions taken in response to ducted by other entities in accordance
detection of hazards, information iden- with paragraph (c)(5)(ii) of this section.
tifying the laboratory conducting the You must document your review and
testing, and documentation that the assessment of the results of
testing was conducted by a qualified verification activities. If the results
individual. show that the foreign supplier is not
(C) Review of the foreign supplier’s food producing the dietary supplement in
safety records. You must retain docu- accordance with processes and proce-
mentation of each record review, in- dures that provide the same level of
cluding the date(s) of review, the gen- public health protection as those re-
eral nature of the records reviewed, the quired under part 111 of this chapter,
conclusions of the review, any correc- you must take appropriate action in
accordance with § 1.508(a). You are not
tive actions taken in response to sig-
required to retain documentation of
nificant deficiencies identified during
supplier verification activities con-
the review, and documentation that
ducted by other entities, provided that
the review was conducted by a quali-
you can obtain the documentation and
fied individual.
make it available to FDA in accord-
(D) Other appropriate activity. (1) You ance with § 1.510(b).
may conduct (and document) or obtain (iv) Independence of qualified individ-
documentation of other supplier uals conducting verification activities.
verification activities that are appro- There must not be any financial con-
priate based on foreign supplier per- flicts of interest that influence the re-
formance and the risk associated with sults of the verification activities set
the food. forth in paragraph (c)(5)(i) of this sec-
(2) You must retain documentation of tion, and payment must not be related
each activity conducted in accordance to the results of the activity.
with paragraph (c)(5)(i)(D)(1) of this
section, including a description of the [80 FR 74340, Nov. 27, 2015, as amended at 81
FR 25327, Apr. 28, 2016]
activity, the date on which it was con-
ducted, the findings or results of the § 1.512 What FSVP may I have if I am a
activity, any corrective actions taken very small importer or I am import-
in response to significant deficiencies ing certain food from certain small
identified, and documentation that the foreign suppliers?
activity was conducted by a qualified (a) Eligibility. This section applies
individual. only if:
(ii) Reliance upon performance of ac- (1) You are a very small importer; or
tivities by other entities. (A) Except as (2) You are importing certain food
specified in paragraph (c)(5)(ii)(B) of from certain small foreign suppliers as
this section, you may rely on supplier follows:
verification activities conducted in ac- (i) The foreign supplier is a qualified
cordance with paragraph (c)(5)(i) by an- facility as defined by § 117.3 or § 507.3 of
other entity provided that you review this chapter;
and assess the results of these activi- (ii) You are importing produce from a
ties in accordance with paragraph foreign supplier that is a farm that

(c)(5)(iii) of this section. grows produce and is not a covered
77
§ 1.512 21 CFR Ch. I (4–1–19 Edition)
farm under part 112 of this chapter in required to comply with the require-
accordance with § 112.4(a) of this chap- ments in §§ 1.504 through 1.508 or § 1.510.
ter, or in accordance with §§ 112.4(b) (3) Foreign supplier verification activi-
and 112.5 of this chapter; or ties. (i) If you are a very small im-
(iii) You are importing shell eggs porter, for each food you import, you
from a foreign supplier that is not sub- must obtain written assurance, before
ject to the requirements of part 118 of importing the food and at least every 2
this chapter because it has fewer than years thereafter, that your foreign sup-
3,000 laying hens. plier is producing the food in compli-
(b) Applicable requirements—(1) Docu- ance with processes and procedures
mentation of eligibility—(i) Very small im- that provide at least the same level of
porter status. (A) If you are a very small public health protection as those re-
importer and you choose to comply quired under section 418 or 419 of the
with the requirements in this section, Federal Food, Drug, and Cosmetic Act,
you must document that you meet the if either is applicable, and the imple-
definition of very small importer in menting regulations, and is producing
§ 1.500 with respect to human food and/ the food in compliance with sections
or animal food before initially import- 402 and 403(w) (if applicable) of the Fed-
ing food as a very small importer and eral Food, Drug, and Cosmetic Act.
thereafter on an annual basis by De- (ii) If your foreign supplier is a quali-
cember 31 of each calendar year. fied facility as defined by § 117.3 or
(B) For the purpose of determining § 507.3 of this chapter and you choose to
whether you satisfy the definition of comply with the requirements in this
very small importer with respect to section, you must obtain written assur-
human food and/or animal food for a ance, before importing the food and at
given calendar year, the relevant 3- least every 2 years thereafter, that the
year period of sales (and U.S. market foreign supplier is producing the food
value of human or animal food, as ap- in compliance with applicable FDA
propriate) is the period ending 1 year food safety regulations (or, when appli-
before the calendar year for which you cable, relevant laws and regulations of
intend to import food as a very small a country whose food safety system
importer. The baseline year for calcu- FDA has officially recognized as com-
lating the adjustment for inflation is parable or determined to be equivalent
2011. If you conduct any food sales in to that of the United States). The writ-
currency other than U.S. dollars, you ten assurance must include either:
must use the relevant currency ex- (A) A brief description of the preven-
change rate in effect on December 31 of tive controls that the supplier is imple-
the year in which sales occurred to cal- menting to control the applicable haz-
culate the value of these sales. ard in the food; or
(ii) Small foreign supplier status. If you (B) A statement that the supplier is
are a importing food from a small for- in compliance with State, local, coun-
eign supplier as specified in paragraph ty, tribal, or other applicable non-Fed-
(a)(2) of this section and you choose to eral food safety law, including relevant
comply with the requirements in this laws and regulations of foreign coun-
section, you must obtain written assur- tries.
ance that your foreign supplier meets (iii) If your foreign supplier is a farm
the criteria in paragraph (a)(2)(i), (ii), that grows produce and is not a cov-
or (iii) of this section before first ap- ered farm under part 112 of this chapter
proving the supplier for an applicable in accordance with § 112.4(a) of this
calendar year and thereafter on an an- chapter, or in accordance with
nual basis by December 31 of each cal- §§ 112.4(b) and 112.5 of this chapter, and
endar year, for the following calendar you choose to comply with the require-
year. ments in this section, you must obtain
(2) Additional requirements. If this sec- written assurance, before importing
tion applies and you choose to comply the produce and at least every 2 years
with the requirements in paragraph (b) thereafter, that the farm acknowledges
of this section, you also are required to that its food is subject to section 402 of
comply with the requirements in the Federal Food, Drug, and Cosmetic
§§ 1.502, 1.503, and 1.509, but you are not Act (or, when applicable, that its food
78
is subject to relevant laws and regula- (ii) Availability. (A) You must make
tions of a country whose food safety all records required under this subpart
system FDA has officially recognized available promptly to an authorized
as comparable or determined to be FDA representative, upon request, for
equivalent to that of the United inspection and copying. Upon FDA re-
States). quest, you must provide within a rea-
(iv) If your foreign supplier is a shell sonable time an English translation of
egg producer that is not subject to the records maintained in a language other
requirements of part 118 of this chapter than English.
because it has fewer than 3,000 laying (B) Offsite storage of records, includ-
hens and you choose to comply with ing records retained by other entities
the requirements in this section, you in accordance with paragraph (c) of
must obtain written assurance, before this section, is permitted if such
importing the shell eggs and at least records can be retrieved and provided
every 2 years thereafter, that the shell onsite within 24 hours of request for of-
egg producer acknowledges that its ficial review. Electronic records are
food is subject to section 402 of the considered to be onsite if they are ac-
Federal Food, Drug, and Cosmetic Act cessible from an onsite location.
(or, when applicable, that its food is (C) If requested in writing by FDA,
subject to relevant laws and regula-
you must send records to the Agency
tions of a country whose food safety
electronically or through another
system FDA has officially recognized
means that delivers the records
as comparable or determined to be
promptly, rather than making the
equivalent to that of the United
records available for review at your
States).
place of business.
(4) Corrective actions. You must
promptly take appropriate corrective (iii) Record retention. (A) Except as
actions if you determine that a foreign specified in paragraph (b)(5)(iii)(B) or
supplier of food you import does not (C) of this section, you must retain
produce the food consistent with the records required under this subpart for
assurance provided in accordance with a period of at least 2 years after you
§ 1.512(b)(3)(i) through (iv). The appro- created or obtained the records.
priate corrective actions will depend (B) If you are subject to paragraph (c)
on the circumstances but could include of this section, you must retain records
discontinuing use of the foreign sup- that relate to your processes and pro-
plier until the cause or causes of non- cedures, including the results of eval-
compliance, adulteration, or mis- uations of foreign suppliers and proce-
branding have been adequately ad- dures to ensure the use of approved
dressed. You must document any cor- suppliers, for at least 2 years after
rective actions you take in accordance their use is discontinued (e.g., because
with this paragraph (b)(4). This para- you have reevaluated a foreign sup-
graph (b)(4) does not limit your obliga- plier’s compliance history or changed
tions with respect to other laws en- your procedures to ensure the use of
forced by FDA, such as those relating approved suppliers).
to product recalls. (C) You must retain for at least 3
(5) Records—(i) General requirements years records that you rely on during
for records. (A) You must keep records the 3-year period preceding the applica-
as original records, true copies (such as ble calendar year to support your sta-
photocopies, pictures, scanned copies, tus as a very small importer.
microfilm, microfiche, or other accu- (iv) Electronic records. Records that
rate reproductions of the original are established or maintained to sat-
records), or electronic records. isfy the requirements of this subpart
(B) You must sign and date records and that meet the definition of elec-
concerning your FSVP upon initial tronic records in § 11.3(b)(6) of this
completion and upon any modification chapter are exempt from the require-
of the FSVP. ments of part 11 of this chapter.
(C) All records must be legible and Records that satisfy the requirements
stored to prevent deterioration or loss. of this part, but that also are required
79
§ 1.512 21 CFR Ch. I (4–1–19 Edition)
under other applicable statutory provi- ation must be documented. If you de-
sions or regulations, remain subject to termine that the concerns associated
part 11. with importing a food from a foreign
(v) Use of existing records. (A) You do supplier have changed, you must
not need to duplicate existing records promptly determine (and document)
you have (e.g., records that you main- whether it is appropriate to continue
tain to comply with other Federal, to import the food from the foreign
State, or local regulations) if they con- supplier.
tain all of the information required by (B) If at the end of any 3-year period
this subpart. You may supplement any you have not reevaluated the concerns
such existing records as necessary to associated with the foreign supplier’s
include all of the information required compliance history in accordance with
by this subpart. paragraph (c)(1)(ii)(A) of this section,
(B) You do not need to maintain the you must reevaluate those concerns
information required by this subpart in and take other appropriate actions, if
one set of records. If existing records necessary, in accordance with para-
you have contain some of the required graph (c)(1)(ii)(A). You must document
information, you may maintain any your reevaluation and any subsequent
new information required by this sub- actions you take in accordance with
part either separately or combined paragraph (c)(1)(ii)(A).
with the existing records. (iii) Review of another entity’s evalua-
(vi) Public disclosure. Records ob- tion or reevaluation of foreign supplier
tained by FDA in accordance with this compliance history. If an entity other
subpart are subject to the disclosure than the foreign supplier has, using a
requirements under part 20 of this qualified individual, performed the
chapter. evaluation described in paragraph
(c) Requirements for importers of food (c)(1)(i) of this section or the reevalua-
from certain small foreign suppliers. The
tion described in paragraph (c)(1)(ii),
following additional requirements
you may meet the requirements of the
apply if you are importing food from
applicable paragraph by reviewing and
certain small foreign suppliers as spec-
assessing the evaluation or reevalua-
ified in paragraph (a)(2) of this section
tion conducted by that entity. You
and you are not a very small importer:
must document your review and assess-
(1) Evaluation of foreign supplier com-
ment, including documenting that the
pliance history—(i) Initial evaluation.
evaluation or reevaluation was con-
Except as specified in paragraph
ducted by a qualified individual.
(c)(1)(iii) of this section, in approving
your foreign suppliers, you must evalu- (2) Approval of foreign supplier. You
ate the applicable FDA food safety reg- must approve your foreign suppliers on
ulations and information relevant to the basis of the evaluation you con-
the foreign supplier’s compliance with ducted under paragraph (c)(1)(i) of this
those regulations, including whether section or that you review and assess
the foreign supplier is the subject of an under paragraph (c)(1)(iii) of this sec-
FDA warning letter, import alert, or tion, and document your approval.
other FDA compliance action related (3) Use of approved foreign suppliers. (i)
to food safety, and document the eval- You must establish and follow written
uation. You may also consider other procedures to ensure that you import
factors relevant to a foreign supplier’s foods only from foreign suppliers you
performance, including those specified have approved based on the evaluation
in § 1.505(a)(1)(iii)(A) and (C). conducted under paragraph (c)(1)(i) of
(ii) Reevaluation of foreign supplier this section (or, when necessary and
compliance history. (A) Except as speci- appropriate, on a temporary basis from
fied in paragraph (c)(1)(iii) of this sec- unapproved foreign suppliers whose
tion, you must promptly reevaluate foods you subject to adequate
the concerns associated with the for- verification activities before importing
eign supplier’s compliance history the food). You must document your use
when you become aware of new infor- of these procedures.
mation about the matters in paragraph (ii) You may rely on an entity other
(c)(1)(i) of this section, and the reevalu- than the foreign supplier to establish
80
the procedures and perform and docu- depend on the circumstances but could
ment the activities required under include discontinuing use of the foreign
paragraph (c)(3)(i) of this section pro- supplier. You must document any cor-
vided that you review and assess that rective actions that you undertake in
entity’s documentation of the proce- accordance with this paragraph (b)(2).
dures and activities, and you document
your review and assessment. § 1.514 What are some consequences of
failing to comply with the require-
[80 FR 74340, Nov. 27, 2015, as amended at 81 ments of this subpart?
FR 25327, Apr. 28, 2016]
(a) Refusal of admission. An article of
§ 1.513 What FSVP may I have if I am food is subject to refusal of admission
importing certain food from a coun- under section 801(a)(3) of the Federal
try with an officially recognized or Food, Drug, and Cosmetic Act if it ap-
equivalent food safety system? pears that the importer of that food
(a) General. (1) If you meet the condi- fails to comply with this subpart with
tions and requirements of paragraph respect to that food. If there is no U.S.
(b) of this section for a food of the type owner or consignee of an article of food
specified in paragraph (a)(2) of this sec- at the time the food is offered for entry
tion that you are importing, then you into the United States, the article of
are not required to comply with the re- food may not be imported into the
quirements in §§ 1.504 through 1.508. United States unless the foreign owner
You would still be required to comply or consignee has appropriately des-
with the requirements in §§ 1.503, 1.509, ignated a U.S. agent or representative
and 1.510. as the importer in accordance with
(2) This section applies to food that is § 1.500.
not intended for further manufac- (b) Prohibited act. The importation or
offering for importation into the
turing/processing, including packaged
United States of an article of food
food products and raw agricultural
without the importer having an FSVP
commodities that will not be commer-
that meets the requirements of section
cially processed further before con-
805 of the Federal Food, Drug, and Cos-
sumption.
metic Act, including the requirements
(b) Conditions and requirements. (1) Be-
of this subpart, is prohibited under sec-
fore importing a food from the foreign
tion 301(zz) of the Federal Food, Drug,
supplier and annually thereafter, you
and Cosmetic Act.
must document that the foreign sup-
plier is in, and under the regulatory
oversight of, a country whose food safe- Subpart M—Accreditation of
ty system FDA has officially recog- Third-Party Certification Bod-
nized as comparable or determined to ies To Conduct Food Safety
be equivalent to that of the United Audits and To Issue Certifi-
States, and that the food is within the cations
scope of that official recognition or
equivalency determination. SOURCE: 80 FR 74650, Nov. 27, 2015, unless
(2) Before importing a food from the otherwise noted.
foreign supplier, you must determine
and document whether the foreign sup- § 1.600 What definitions apply to this
plier of the food is in good compliance subpart?
standing with the food safety authority (a) The FD&C Act means the Federal
of the country in which the foreign Food, Drug, and Cosmetic Act.
supplier is located. You must continue (b) Except as otherwise defined in
to monitor whether the foreign sup- paragraph (c) of this section, the defi-
plier is in good compliance standing nitions of terms in section 201 of the
and promptly review any information FD&C Act apply when the terms are
obtained. If the information indicates used in this subpart.
that food safety hazards associated (c) In addition, for the purposes of
with the food are not being signifi- this subpart:
cantly minimized or prevented, you Accreditation means a determination
must take prompt corrective action. by a recognized accreditation body (or,

The appropriate corrective action will in the case of direct accreditation, by
81
§ 1.600 21 CFR Ch. I (4–1–19 Edition)
FDA) that a third-party certification body or by FDA. An audit conducted

body meets the applicable require- under this subpart is not considered an
ments of this subpart. inspection under section 704 of the
Accreditation body means an author- FD&C Act.
ity that performs accreditation of Audit agent means an individual who
third-party certification bodies. is an employee or other agent of an ac-
Accredited third-party certification credited third-party certification body
body means a third-party certification who, although not individually accred-
body that a recognized accreditation ited, is qualified to conduct food safety
body (or, in the case of direct accredi- audits on behalf of an accredited third-
tation, FDA) has determined meets the party certification body. An audit
applicable requirements of this subpart agent includes a contractor of the ac-
and is accredited to conduct food safe- credited third-party certification body
ty audits and to issue food or facility but excludes subcontractors or other
certifications to eligible entities. An agents under outsourcing arrange-
accredited third-party certification ments for conducting food safety au-
body has the same meaning as accred- dits without direct control by the ac-
ited third-party auditor as defined in credited third-party certification body.
section 808(a)(4) of the FD&C Act. Consultative audit means an audit of
Assessment means: an eligible entity:
(i) With respect to an accreditation (i) To determine whether such entity
body, an evaluation by FDA of the is in compliance with the applicable
competency and capacity of the accred- food safety requirements of the FD&C
itation body under the applicable re- Act, FDA regulations, and industry
quirements of this subpart for the de- standards and practices;
fined scope of recognition. An assess- (ii) The results of which are for inter-
ment of the competency and capacity nal purposes only; and
of the accreditation body involves eval- (iii) That is conducted in preparation
uating the competency and capacity of for a regulatory audit; only the results
the operations of the accreditation of a regulatory audit may form the
body that are relevant to decisions on basis for issuance of a food or facility
recognition and, if recognized, an eval- certification under this subpart.
uation of its performance and the va- Direct accreditation means accredita-
lidity of its accreditation decisions tion of a third-party certification body
under the applicable requirements of by FDA.
this subpart. Eligible entity means a foreign entity
(ii) With respect to a third-party cer- in the import supply chain of food for
tification body, an evaluation by a rec- consumption in the United States that
ognized accreditation body (or, in the chooses to be subject to a food safety
case of direct accreditation, FDA) of audit under this subpart conducted by
the competency and capacity of a an accredited third-party certification
third-party certification body under body. Eligible entities include foreign
the applicable requirements of this facilities required to be registered
subpart for the defined scope of accred- under subpart H of this part.
itation. An assessment of the com- Facility means any structure, or
petency and capacity of the third-party structures of an eligible entity under
certification body involves evaluating one ownership at one general physical
the competency and capacity of the op- location, or, in the case of a mobile fa-
erations of the third-party certifi- cility, traveling to multiple locations,
cation body that are relevant to deci- that manufactures/processes, packs,
sions on accreditation and, if accred- holds, grows, harvests, or raises ani-
ited, an evaluation of its performance mals for food for consumption in the
and the validity of its audit results and United States. Transport vehicles are
certification decisions under the appli- not facilities if they hold food only in
cable requirements of this subpart. the usual course of business as carriers.
Audit means the systematic and func- A facility may consist of one or more
tionally independent examination of an contiguous structures, and a single
eligible entity under this subpart by an building may house more than one dis-
accredited third-party certification tinct facility if the facilities are under
82
separate ownership. The private resi- to accredit third-party certification

dence of an individual is not a facility. bodies under this subpart.
Non-bottled water drinking water col- Regulatory audit means an audit of an
lection and distribution establishments eligible entity:
and their structures are not facilities. (i) To determine whether such entity
Facilities for the purposes of this sub- is in compliance with the applicable
part are not limited to facilities re- food safety requirements of the FD&C
quired to be registered under subpart H Act and FDA regulations; and
of this part. (ii) The results of which are used in
Facility certification means an attesta- determining eligibility for certification
tion, issued for purposes of section under section 801(q) or under section
801(q) or 806 of the FD&C Act by an ac- 806 of the FD&C Act.
credited third-party certification body, Relinquishment means:
after conducting a regulatory audit (i) With respect to an accreditation
and any other activities necessary to body, a decision to cede voluntarily its
establish whether a facility complies authority to accredit third-party cer-
with the applicable food safety require- tification bodies as a recognized ac-
ments of the FD&C Act and FDA regu- creditation body prior to expiration of
lations. its recognition under this subpart; and
Food has the meaning given in sec- (ii) With respect to a third-party cer-
tion 201(f) of the FD&C Act, except tification body, a decision to cede vol-
that food does not include pesticides untarily its authority to conduct food
(as defined in 7 U.S.C. 136(u)). safety audits and to issue food and fa-
cility certifications to eligible entities
Food certification means an attesta-
as an accredited third-party certifi-
tion, issued for purposes of section
cation body prior to expiration of its
801(q) of the FD&C Act by an accred-
accreditation under this subpart.
ited third-party certification body,
Self-assessment means an evaluation
after conducting a regulatory audit
conducted by a recognized accredita-
and any other activities necessary to
tion body or by an accredited third-
establish whether a food of an eligible
party certification body of its com-
entity complies with the applicable petency and capacity under the appli-
food safety requirements of the FD&C cable requirements of this subpart for
Act and FDA regulations. the defined scope of recognition or ac-
Food safety audit means a regulatory creditation. For recognized accredita-
audit or a consultative audit that is tion bodies this involves evaluating the
conducted to determine compliance competency and capacity of the entire
with the applicable food safety require- operations of the accreditation body
ments of the FD&C Act, FDA regula- and the validity of its accreditation de-
tions, and for consultative audits, also cisions under the applicable require-
includes conformance with industry ments of this subpart. For accredited
standards and practices. An eligible en- third-party certification bodies this in-
tity must declare that an audit is to be volves evaluating the competency and
conducted as a regulatory audit or con- capacity of the entire operations of the
sultative audit at the time of audit third-party certification body and the
planning and the audit will be con- validity of its audit results under the
ducted on an unannounced basis under applicable requirements of this sub-
this subpart. part.
Foreign cooperative means an autono- Third-party certification body has the
mous association of persons, identified same meaning as third-party auditor as
as members, who are united through a that term is defined in section 808(a)(3)
jointly owned enterprise to aggregate of the FD&C Act and means a foreign
food from member growers or proc- government, agency of a foreign gov-
essors that is intended for export to ernment, foreign cooperative, or any
the United States. other third party that is eligible to be
Recognized accreditation body means considered for accreditation to conduct
an accreditation body that FDA has de- food safety audits and to certify that
termined meets the applicable require- eligible entities meet the applicable
ments of this subpart and is authorized food safety requirements of the FD&C
83
§ 1.601 21 CFR Ch. I (4–1–19 Edition)
Act and FDA regulations. A third- (ii) Any certification required under
party certification body may be a sin- section 801(q) of the FD&C Act does not
gle individual or an organization. Once apply with respect to food that is not
accredited, a third-party certification an alcoholic beverage that is received
body may use audit agents to conduct and distributed by a facility described
food safety audits. in paragraph (d)(1)(i) of this section,
provided such food:
§ 1.601 Who is subject to this subpart?
(A) Is received and distributed in pre-
(a) Accreditation bodies. Any accredi- packaged form that prevents any direct
tation body seeking recognition from human contact with such food; and
FDA to accredit third-party certifi- (B) Constitutes not more than 5 per-
cation bodies to conduct food safety cent of the overall sales of the facility,
audits and to issue food and facility
as determined by the Secretary of the
certifications under this subpart.
Treasury.
(b) Third-party certification bodies.
Any third-party certification body (iii) Any certification required under
seeking accreditation from a recog- section 801(q) of the FD&C Act does not
nized accreditation body or direct ac- apply with respect to raw materials or
creditation by FDA for: other ingredients that are imported for
(1) Conducting food safety audits; and use in alcoholic beverages provided
(2) Issuing certifications that may be that:
used in satisfying a condition of admis- (A) The imported raw materials or
sibility of an article of food under sec- other ingredients are used in the manu-
tion 801(q) of the FD&C Act; or issuing facturing/processing, packing, or hold-
a facility certification for meeting the ing of alcoholic beverages;
eligibility requirements for the Vol- (B) Such manufacturing/processing,
untary Qualified Importer Program packing, or holding is performed by the
under section 806 of the FD&C Act. importer;
(c) Eligible entities. Any eligible entity (C) The importer is required to reg-
seeking a food safety audit or a food or ister under section 415 of the Federal
facility certification from an accred- Food, Drug, and Cosmetic Act; and
ited third-party certification body (D) The importer is exempt from the
under this subpart.
regulations in part 117 of this chapter
(d) Limited exemptions from section
in accordance with § 117.5(i).
801(q) of the FD&C Act—(1) Alcoholic
beverages. (i) Any certification required (2) Certain meat, poultry, and egg prod-
under section 801(q) of the FD&C Act ucts. Any certification required under
does not apply with respect to alco- section 801(q) of the FD&C Act does not
holic beverages from an eligible entity apply with respect to:
that is a facility that meets the fol- (i) Meat food products that at the
lowing two conditions: time of importation are subject to the
(A) Under the Federal Alcohol Ad- requirements of the United States De-
ministration Act (27 U.S.C. 201 et seq.) partment of Agriculture (USDA) under
or chapter 51 of subtitle E of the Inter- the Federal Meat Inspection Act (21
nal Revenue Code of 1986 (26 U.S.C. 5001 U.S.C. 601 et seq.);
et seq.), the facility is a foreign facility (ii) Poultry products that at the time
of a type that, if it were a domestic fa- of importation are subject to the re-
cility, would require obtaining a per- quirements of the USDA under the
mit from, registering with, or obtain- Poultry Products Inspection Act (21
ing approval of a notice or application U.S.C. 451 et seq.); and
from the Secretary of the Treasury as (iii) Egg products that at the time of
a condition of doing business in the importation are subject to the require-
United States; and
ments of the USDA under the Egg
(B) Under section 415 of the FD&C
Products Inspection Act (21 U.S.C. 1031
Act, the facility is required to register
et seq.).
as a facility because it is engaged in
manufacturing/processing one or more

alcoholic beverages.
84
RECOGNITION OF ACCREDITATION BODIES § 1.612 What competency and capacity

UNDER THIS SUBPART must an accreditation body have to
qualify for recognition?
§ 1.610 Who is eligible to seek recogni- An accreditation body seeking rec-
tion?
ognition must demonstrate that it has:
An accreditation body is eligible to (a) The resources required to ade-
seek recognition by FDA if it can dem- quately implement its accreditation
onstrate that it meets the require- program, including:
ments of §§ 1.611 through 1.615. The ac- (1) Adequate numbers of employees
creditation body may use documenta- and other agents with relevant knowl-
tion of conformance with International edge, skills, and experience to effec-
Organization for Standardization/Inter- tively evaluate the qualifications of
national Electrotechnical Commission third-party certification bodies seeking
(ISO/IEC) 17011:2004, supplemented as accreditation and to effectively mon-
necessary, in meeting the applicable itor the performance of accredited
requirements of this subpart. third-party certification bodies; and
(2) Adequate financial resources for
§ 1.611 What legal authority must an its operations; and
accreditation body have to qualify (b) The capability to meet the appli-
for recognition? cable assessment and monitoring re-
(a) An accreditation body seeking quirements, the reporting and notifica-
recognition must demonstrate that it tion requirements, and the procedures
has the authority (as a governmental of this subpart, if recognized.
entity or as a legal entity with con-
§ 1.613 What protections against con-
tractual rights) to perform assessments flicts of interest must an accredita-
of a third-party certification body as tion body have to qualify for rec-
are necessary to determine its capa- ognition?
bility to conduct audits and certify An accreditation body must dem-
food facilities and food, including au- onstrate that it has:
thority to: (a) Implemented written measures to
(1) Review any relevant records; protect against conflicts of interest be-
(2) Conduct onsite assessments of the tween the accreditation body (and its
performance of third-party certifi- officers, employees, and other agents
cation bodies, such as by witnessing involved in accreditation activities)
the performance of a representative and any third-party certification body
sample of its agents (or, in the case of (and its officers, employees, and other
a third-party certification body that is agents involved in auditing and certifi-
an individual, such individual) con- cation activities) seeking accreditation
ducting a representative sample of au- from, or accredited by, such accredita-
dits; tion body; and
(3) Perform any reassessments or sur- (b) The capability to meet the appli-
veillance necessary to monitor compli- cable conflict of interest requirements
ance of accredited third-party certifi- of this subpart, if recognized.
cation bodies; and
§ 1.614 What quality assurance proce-
(4) Suspend, withdraw, or reduce the dures must an accreditation body
scope of accreditation for failure to have to qualify for recognition?
comply with the requirements of ac-
creditation. An accreditation body seeking rec-
ognition must demonstrate that it has:
(b) An accreditation body seeking
(a) Implemented a written program
recognition must demonstrate that it
for monitoring and evaluating the per-
is capable of exerting the authority (as
formance of its officers, employees, and
a governmental entity or as a legal en-
other agents and its accreditation pro-
tity with contractual rights) necessary gram, including procedures to:
to meet the applicable requirements of (1) Identify areas in its accreditation
this subpart, if recognized. program or performance where defi-

ciencies exist; and
85
§ 1.615 21 CFR Ch. I (4–1–19 Edition)
(2) Quickly execute corrective ac- (3) In conducting a review and audit
tions that effectively address defi- under paragraph (a)(1) or (2) of this sec-
ciencies when identified; and tion, an observation of a representative
(b) The capability to meet the appli- sample of onsite audits examining
cable quality assurance requirements compliance with the applicable food
of this subpart, if recognized. safety requirements of the FD&C Act
and FDA regulations as conducted by
§ 1.615 What records procedures must the third-party certification body or
an accreditation body have to qual- its agents (or, in the case of a third-
ify for recognition?
party certification body that is an indi-
An accreditation body seeking rec- vidual, such individual).
ognition must demonstrate that it has: (b) A recognized accreditation body
(a) Implemented written procedures must require a third-party certifi-
to establish, control, and retain cation body, as a condition of accredi-
records (including documents and data) tation under this subpart, to comply
for the period of time necessary to with the reports and notification re-
meet its contractual and legal obliga- quirements of §§ 1.652 and 1.656 and to
tions pertaining to this subpart and to agree to submit to FDA, electronically
provide an adequate basis for evalu- and in English, any food or facility cer-
ating its program and performance; tifications it issues for purposes of sec-
and tions 801(q) or 806 of the FD&C Act.
(b) The capability to meet the appli- (c) A recognized accreditation body
cable reporting and notification re- must maintain records on any denial of
quirements of this subpart, if recog- accreditation (in whole or in part) and
nized. on any withdrawal, suspension, or re-
REQUIREMENTS FOR ACCREDITATION BOD- duction in scope of accreditation of a
IES THAT HAVE BEEN RECOGNIZED third-party certification body under
UNDER THIS SUBPART this subpart. The records must include
the name and contact information for
§ 1.620 How must a recognized accredi- the third-party certification body; the
tation body evaluate third-party date of the action; the scope of accredi-
certification bodies seeking accreditation denied, withdrawn, suspended,
tation? or reduced; and the basis for such ac-
(a) Prior to accrediting a third-party tion.
certification body under this subpart, a (d) A recognized accreditation body
recognized accreditation body must must notify any third-party certifi-
perform, at a minimum, the following: cation body of an adverse decision as-
(1) In the case of a foreign govern- sociated with its accreditation under
ment or an agency of a foreign govern- this subpart, including denial of ac-
ment, such reviews and audits of the creditation or the withdrawal, suspen-
government’s or agency’s food safety sion, or reduction in the scope of its ac-
programs, systems, and standards as creditation. The recognized accredita-
are necessary to determine that it tion body must establish and imple-
meets the eligibility requirements of ment written procedures for receiving
§ 1.640(b). and addressing appeals from any third-
(2) In the case of a foreign coopera- party certification body challenging
tive or any other third-party seeking such an adverse decision and for inves-
accreditation as a third-party certifi- tigating and deciding on appeals in a
cation body, such reviews and audits of fair and meaningful manner. The ap-
the training and qualifications of peals procedures must provide similar
agents conducting audits for such coop- protections to those offered by FDA
erative or other third party (or in the under §§ 1.692 and 1.693, and include re-
case of a third-party certification body quirements to:
that is an individual, such individual) (1) Make the appeals procedures pub-
and such reviews of internal systems licly available;
and any other investigation of the co- (2) Use competent persons, who may
operative or other third party nec- or may not be external to the recog-
essary to determine that it meets the nized accreditation body, who are free
eligibility requirements of § 1.640(c). from bias or prejudice and have not
86
participated in the accreditation deci- the accredited third-party certification

sion or be subordinate to a person who body required by paragraph (a) of this
has participated in the accreditation section.
decision to investigate and decide ap-
peals; § 1.622 How must a recognized accredi-
(3) Advise third-party certification tation body monitor its own per-
formance?
bodies of the final decisions on their
appeals; and (a) A recognized accreditation body
(4) Maintain records under § 1.625 of must annually, and as required under
appeals, final decisions on appeals, and § 1.664(g), conduct a self-assessment
the bases for such decisions. that includes evaluation of compliance
with this subpart, including:
§ 1.621 How must a recognized accredi- (1) The performance of its officers,
tation body monitor the perform- employees, or other agents involved in
ance of third-party certification accreditation activities and the degree
bodies it accredited? of consistency in conducting accredita-
(a) A recognized accreditation body tion activities;
must annually conduct a comprehen- (2) The compliance of the recognized
sive assessment of the performance of accreditation body and its officers, em-
each third-party certification body it ployees, and other agents involved in
accredited under this subpart by reaccreditation activities, with the con-
viewing the accredited third-party cer- flict of interest requirements of § 1.624;
tification body’s self-assessments (in- and
cluding information on compliance (3) If requested by FDA, any other as-
with the conflict of interest require- pects of its performance relevant to a
ments of §§ 1.643 and 1.657); its regu- determination whether the recognized
latory audit reports and notifications accreditation body is in compliance
submitted to FDA under § 1.656; and with this subpart.
any other information reasonably (b) As a means to evaluate the recog-
available to the recognized accredita- nized accreditation body’s perform-
tion body regarding the compliance ance, the self-assessment must include
history of eligible entities the accred- onsite observation of regulatory audits
ited third-party certification body cer- of a representative sample of third-
tified under this subpart; or that is party certification bodies it accredited
otherwise relevant to a determination under this subpart. In meeting this re-
whether the accredited third-party cer- quirement, the recognized accredita-
tification body is in compliance with tion body may use the results of onsite
this subpart. observations performed under § 1.621(b).
(b) No later than 1 year after the ini- (c) Based on the evaluations con-
tial date of accreditation of the third- ducted under paragraphs (a) and (b) of
party certification body and every 2 this section, the recognized accredita-
years thereafter for duration of its action body must:
creditation under this subpart, a recog- (1) Identify any area(s) where defi-
nized accreditation body must conduct ciencies exist;
onsite observations of a representative (2) Quickly implement corrective ac-
sample of regulatory audits performed tion(s) that effectively address those
by the third-party certification body deficiencies; and
(or its audit agents) (or, in the case of (3) Establish and maintain records of
a third-party certification body that is any such corrective action(s) under
an individual, such individual) accred- § 1.625.
ited under this subpart and must visit (d) The recognized accreditation body
the accredited third-party certification must prepare, and as required by
body’s headquarters (or other location § 1.623(b) submit, a written report of the
that manages audit agents conducting results of its self-assessment that in-
food safety audits under this subpart, if cludes the following elements. Docu-
different than its headquarters). The mentation of conformance to ISO/IEC
recognized accreditation body will con- 17011:2004 may be used, supplemented
sider the results of such observations as necessary, in meeting the require-

and visits in the annual assessment of ments of this paragraph.
87
§ 1.623 21 CFR Ch. I (4–1–19 Edition)
(1) A description of any corrective ac- (ii) The name of one or more officers
tions taken under paragraph (c) of this of the accredited third-party certifi-
section; cation body;
(2) A statement disclosing the extent (iii) A list of the accredited third-
to which the recognized accreditation party certification body’s audit agents;
body, and its officers, employees, and and
other agents involved in accreditation (iv) The scope of accreditation, the
activities, complied with the conflict date on which it was granted, and its
of interest requirements in § 1.624; and expiration date.
(3) A statement attesting to the ex- (2) Withdrawing, suspending, or re-
tent to which the recognized accredita- ducing the scope of an accreditation
tion body complied with applicable re- under this subpart, and include:
quirements of this subpart. (i) The basis for such action; and
(ii) Any additional changes to accred-
§ 1.623 What reports and notifications itation information previously sub-
must a recognized accreditation mitted to FDA under paragraph (c)(1)
body submit to FDA?
of this section.
(a) Reporting results of assessments of (3) Determining that a third-party
accredited third-party certification body certification body it accredited failed
performance. A recognized accreditation to comply with § 1.653 in issuing a food
body must submit to FDA electroni- or facility certification under this sub-
cally, in English, a report of the results part, and include:
of any assessment conducted under (i) The basis for such determination;
§ 1.621, no later than 45 days after com- and
pleting such assessment. The report (ii) Any changes to accreditation in-
must include an up-to-date list of any formation previously submitted to
audit agents used by the accredited FDA under paragraph (c)(1) of this sec-
third-party certification body to con- tion.
duct food safety audits under this sub- (d) Other notification to FDA. A recog-
part. nized accreditation body must notify
(b) Reporting results of recognized ac- FDA electronically, in English, within
creditation body self-assessments. A rec- 30 days after:
ognized accreditation body must sub- (1) Denying accreditation (in whole
mit to FDA electronically, in English: or in part) under this subpart and in-
(1) A report of the results of an an- clude:
nual self-assessment required under (i) The name, address, telephone
§ 1.622, no later than 45 days after com- number, and email address of the third-
pleting such self-assessment; and party certification body;
(2) For a recognized accreditation (ii) The name of one or more officers
body subject to § 1.664(g)(1), a report of of the third-party certification body;
such self-assessment to FDA within 60 (iii) The scope of accreditation re-
days of the third-party certification quested; and
body’s withdrawal. A recognized ac- (iv) The scope and basis for such de-
creditation body may use a report pre- nial.
pared for conformance to ISO/IEC (2) Making any significant change
17011:2004, supplemented as necessary, that would affect the manner in which
in meeting the requirements this sec- it complies with the applicable require-
tion. ments of this subpart and include:
(c) Immediate notification to FDA. A (i) A description of the change; and
recognized accreditation body must no- (ii) An explanation for the purpose of
tify FDA electronically, in English, the change.
immediately upon:
(1) Granting (including expanding the § 1.624 How must a recognized accredi-
scope of) accreditation to a third-party tation body protect against con-
certification body under this subpart, flicts of interest?
and include: (a) A recognized accreditation body
(i) The name, address, telephone must implement a written program to
number, and email address of the ac- protect against conflicts of interest be-
credited third-party certification body; tween the recognized accreditation
88
body (and its officers, employees, and to-date list of the third-party certifi-
other agents involved in accreditation cation bodies it accredited under this
activities) and any third-party certifi- subpart and must identify the duration
cation body (and its officers, employ- and scope of each accreditation and the
ees, and other agents involved in audit- date(s) on which the accredited third-
ing and certification activities) seek- party certification body paid any fee or
ing accreditation from, or accredited reimbursement associated with such
by, such recognized accreditation body, accreditation. If the accreditation of a
including the following: certification body is suspended, with-
(1) Ensuring that the recognized ac- drawn, or reduced in scope, this list
creditation body (and its officers, em- must also include the date of suspen-
ployees, or other agents involved in ac- sion, withdrawal, or reduction in scope
creditation activities) does not own or and maintain that information for the
have a financial interest in, manage, or duration of accreditation or until the
otherwise control the third-party cer- suspension is lifted, the certification
tification body (or any affiliate, par- body is reaccredited, or the scope of ac-
ent, or subsidiary); and creditation is reinstated, whichever
(2) Prohibiting officers, employees, or comes first.
other agents involved in accreditation
activities of the recognized accredita- § 1.625 What records requirements
tion body from accepting any money, must an accreditation body that has
gift, gratuity, or item of value from been recognized meet?
the third-party certification body. (a) An accreditation body that has
(3) The items specified in paragraph been recognized must maintain elec-
(a)(2) of this section do not include: tronically for 5 years records created
(i) Money representing payment of while it is recognized (including docu-
fees for accreditation services and re- ments and data) demonstrating its
imbursement of direct costs associated compliance with this subpart, includ-
with an onsite assessment of the third- ing records relating to:
party certification body; or (1) Applications for accreditation and
(ii) Lunch of de minimis value pro- renewal of accreditation under § 1.660;
vided during the course of an assess- (2) Decisions to grant, deny, suspend,
ment and on the premises where the as- withdraw, or expand or reduce the
sessment is conducted, if necessary to scope of an accreditation;
facilitate the efficient conduct of the
(3) Challenges to adverse accredita-
assessment.
tion decisions under § 1.620(c);
(b) A recognized accreditation body
(4) Its monitoring of accredited third-
may accept the payment of fees for ac-
party certification bodies under § 1.621;
creditation services and the reimburse-
ment of direct costs associated with as- (5) Self-assessments and corrective
sessment of a certification body only actions under § 1.622;
after the date on which the report of (6) Regulatory audit reports, includ-
such assessment was completed or the ing any supporting information, that
date of which the accreditation was an accredited third-party certification
issued, whichever comes later. Such body may have submitted;
payment is not considered a conflict of (7) Any reports or notifications to
interest for purposes of paragraph (a) FDA under § 1.623, including any sup-
of this section. porting information; and
(c) The financial interests of the (8) Records of fee payments and reim-
spouses and children younger than 18 bursement of direct costs.
years of age of a recognized accredita- (b) An accreditation body that has
tion body’s officers, employees, and been recognized must make records re-
other agents involved in accreditation quired by paragraph (a) of this section
activities will be considered the finan- available for inspection and copying
cial interests of such officers, employ- promptly upon written request of an
ees, and other agents involved in ac- authorized FDA officer or employee at
creditation activities. the place of business of the accredita-
(d) A recognized accreditation body tion body or at a reasonably accessible

must maintain on its Web site an up- location. If the records required by
89
§ 1.630 21 CFR Ch. I (4–1–19 Edition)
paragraph (a) of this section are re- tify the applicant of any deficiencies.
quested by FDA electronically, the FDA will review an accreditation
records must be submitted to FDA body’s recognition or renewal applica-
electronically not later than 10 busi- tion on a first in, first out basis accord-
ness days after the date of the request. ing to the date on which the completed
Additionally, if the requested records application was submitted; however,
are maintained in a language other FDA may prioritize the review of spe-
than English, the accreditation body cific applications to meet the needs of
must electronically submit an English the program.
translation within a reasonable time.
(c) An accreditation body that has (b) Evaluation of recognition or re-
been recognized must not prevent or newal. FDA will evaluate any com-
interfere with FDA’s access to its ac- pleted recognition or renewal applica-
credited third-party certification bod- tion to determine whether the appli-
ies and the accredited third-party cer- cant meets the applicable requirements
tification body records required by of this subpart. Such evaluation may
§ 1.658. include an onsite assessment of the ac-
creditation body. FDA will notify the
PROCEDURES FOR RECOGNITION OF AC- applicant, in writing, regarding wheth-
CREDITATION BODIES UNDER THIS SUB- er the application has been approved or
PART denied. FDA may make such notifica-
§ 1.630 How do I apply to FDA for rection electronically. If FDA does not
ognition or renewal of recognition? reach a final decision on a renewal ap-
plication before an accreditation
(a) Applicant for recognition. An ac-
creditation body seeking recognition body’s recognition terminates by expi-
must submit an application dem- ration, FDA may extend such recogni-
onstrating that it meets the eligibility tion for a specified period of time or
requirements in § 1.610. until the Agency reaches a final deci-
(b) Applicant for renewal of recogni- sion on the renewal application.
tion. An accreditation body seeking re- (c) Issuance of recognition. FDA will
newal of its accreditation must submit notify an applicant that its recognition
a renewal application demonstrating or renewal application has been ap-
that it continues to meet the require- proved through issuance of recognition
ments of this subpart. that will list any limitations associ-
(c) Submission. Recognition and re- ated with the recognition.
newal applications and any documents (d) Issuance of denial of recognition or
provided as part of the application renewal application. FDA will notify an
process must be submitted electroni- applicant that its recognition or re-
cally, in English. An applicant must
newal application has been denied
provide any translation and interpreta-
through issuance of a denial of recogni-
tion services needed by FDA during the
processing of the application, including tion or denial of a renewal application
during onsite assessments of the appli- that will state the basis for such denial
cant by FDA. and provide the procedures for request-
(d) Signature. Recognition and re- ing reconsideration of the application
newal applications must be signed in under § 1.691.
the manner designated by FDA, by an (e) Notice of records custodian after de-
individual authorized to act on behalf nial of an application for renewal of rec-
of the applicant for purposes of seeking ognition. An applicant whose renewal
recognition or renewal of recognition. application was denied must notify
FDA electronically, in English, within
§ 1.631 How will FDA review my appli- 10 business days of the date of issuance
cation for recognition or renewal of
recognition and what happens once of a denial of a renewal application, of
FDA decides on my application? the name and contact information of
the custodian who will maintain the
(a) Review of recognition or renewal ap-
records required by § 1.625(a) and make
plication. FDA will examine an accredi-
tation body’s recognition or renewal them available to FDA as required by

application for completeness and no- § 1.625(b). The contact information for
90
the custodian must include, at a min- of the date of issuance of a denial of a

imum, an email address and the phys- renewal application and will describe
ical address where the records required the basis for the denial.
by § 1.625(a) will be located.
(f) Effect of denial of an application for § 1.632 What is the duration of recogni-
renewal of recognition of an accreditation tion?
body on accredited third-party certifi- FDA may grant recognition of an ac-
cation bodies. (1) FDA will issue a no- creditation body for a period not to ex-
tice of the denial of a recognition re- ceed 5 years from the date of recogni-
newal to any third-party certification tion.
bodies accredited by the accreditation
body whose renewal application was de- § 1.633 How will FDA monitor recog-
nied. The third-party certification nized accreditation bodies?
body’s accreditation will remain in ef- (a) FDA will evaluate the perform-
fect so long as the third-party certifi- ance of each recognized accreditation
cation body: body to determine its compliance with
(i) No later than 60 days after FDA’s the applicable requirements of this
issuance of the notice of the denial of subpart. Such assessment must occur
recognition renewal, conducts a self-as- by at least 4 years after the date of rec-
sessment under § 1.655 and reports the ognition for a 5-year recognition pe-
results of the self-assessment to FDA riod, or by no later than the mid-term
under § 1.656(b); and point for a recognition period of less
(ii) No later than 1 year after than 5 years. FDA may conduct addi-
issuance of the notice of denial of rec- tional assessments of a recognized ac-
ognition renewal or the original date of creditation body at any time.
the expiration of the accreditation, (b) An FDA assessment of a recog-
whichever comes first, becomes accred- nized accreditation body may include
ited by another recognized accredita- onsite assessments of a representative
tion body or by FDA through direct ac- sample of third-party certification bod-
creditation. ies the recognized accreditation body
(2) FDA may withdraw the accredita- accredited and onsite audits of a rep-
tion of a third-party certification body resentative sample of eligible entities
whenever FDA determines there is certified by such third-party certifi-
good cause for withdrawal of accredita- cation bodies under this subpart. These
tion under § 1.664(c). may be conducted at any time and, as
(g) Effect of denial of an application for FDA determines necessary or appro-
renewal of recognition of an accreditation priate, may occur without the recog-
body on food or facility certifications nized accreditation body or, in the case
issued to eligible entities. A food or facil- of an audit of an eligible entity, the ac-
ity certification issued by a third-party credited third-party certification body
certification body accredited by a rec- present.
ognized accreditation body prior to
issuance of a denial of the renewal ap- § 1.634 When will FDA revoke recogni-
plication will remain in effect until the tion?
certification expires. If FDA has reason (a) Grounds for revocation of recogni-
to believe that a certification issued tion. FDA will revoke the recognition
for purposes of section 801(q) or 806 of of an accreditation body found not to
the FD&C Act is not valid or reliable, be in compliance with the require-
FDA may refuse to consider the certifi- ments of this subpart, including for
cation in determining the admissibility any one or more of the following:
of the article of food for which the cer- (1) Refusal by the accreditation body
tification was offered or in determining to allow FDA to access records re-
the importer’s eligibility for participa- quired by § 1.625, or to conduct an as-
tion in the voluntary qualified im- sessment or investigation of the ac-
porter program (VQIP). creditation body or of a third-party
(h) Public notice of denial of an appli- certification body it accredited to en-
cation for renewal of recognition of an ac- sure the accreditation body’s continued
creditation body. FDA will provide no- compliance with the requirements of
tice on the Web site described in § 1.690 this subpart.
91
§ 1.634 21 CFR Ch. I (4–1–19 Edition)
(2) Failure to take timely and nec- (d) Effect of revocation of recognition of
essary corrective action when: an accreditation body on accredited third-
(i) The accreditation of a third-party party certification bodies. (1) FDA will
certification body it accredited is with- issue a notice of the revocation of rec-
drawn by FDA under § 1.664(a); ognition to any accredited third-party
(ii) A significant deficiency is identi- certification body accredited by the ac-
fied through self-assessment under creditation body whose recognition was
§ 1.622, monitoring under § 1.621, or self- revoked. The third-party certification
assessment by one or more of its ac- body’s accreditation will remain in ef-
credited third-party certification bod- fect if the third-party certification
ies under § 1.655; or body:
(iii) Directed to do so by FDA to en-
(i) No later than 60 days after FDA’s
sure compliance with this subpart.
(3) A determination by FDA that the issuance of the notice of revocation,
accreditation body has committed conducts a self-assessment under § 1.655
fraud or has submitted material false and reports the results of the self-as-
statements to the Agency. sessment to FDA under § 1.656(b); and
(4) A determination by FDA that (ii) No later than 1 year after
there is otherwise good cause for rev- issuance of the notice of the revoca-
ocation, including: tion, or the original date of expiration
(i) Demonstrated bias or lack of ob- of the accreditation, whichever comes
jectivity when conducting activities first, becomes accredited by another
under this subpart; or recognized accreditation body or by
(ii) Failure to adequately support one FDA through direct accreditation.
or more decisions to grant accredita- (2) FDA may withdraw the accredita-
tion under this subpart. tion of a third-party certification body
(iii) Failure to pay the annual user whenever FDA determines there is
fee within 90 days of the payment due good cause for withdrawal of accredita-
date, as specified in § 1.725(b)(3). tion under § 1.664(c).
(b) Records request associated with rev- (e) Effect of revocation of recognition of
ocation. To assist in determining
an accreditation body on food or facility
whether revocation is warranted under
certifications issued to eligible entities. A
paragraph (a) of this section, FDA may
request records of the accreditation food or facility certification issued by
body required by § 1.625 or the records, a third-party certification body accred-
required by § 1.658, of one or more of ited by a recognized accreditation body
the third-party certification bodies it prior to issuance of the revocation of
accredited under this subpart. recognition will remain in effect until
(c) Issuance of revocation of recogni- the certificate terminates by expira-
tion. (1) FDA will notify an accreditation. If FDA has reason to believe that
tion body that its recognition has been a certification issued for purposes of
revoked through issuance of a revoca- section 801(q) or 806 of the FD&C Act is
tion that will state the grounds for rev- not valid or reliable, FDA may refuse
ocation, the procedures for requesting to consider the certification in deter-
a regulatory hearing under § 1.693 on mining the admissibility of the article
the revocation, and the procedures for of food for which the certification was
requesting reinstatement of recogni- offered or in determining the import-
tion under § 1.636. er’s eligibility for participation in
(2) Within 10 business days of the VQIP.
date of issuance of the revocation, the (f) Public notice of revocation of rec-
accreditation body must notify FDA ognition. FDA will provide notice on
electronically, in English, of the name the Web site described in § 1.690 of the
of the custodian who will maintain the issuance of the revocation of recogni-
records and make them available to
tion of an accreditation body and will
FDA as required by § 1.625. The contact
describe the basis for revocation.
information for the custodian must
provide, at a minimum, an email ad- [80 FR 74650, Nov. 27, 2015, as amended at 81
dress and the physical address where FR 90193, Dec. 14, 2016]
the records will be located.
92
§ 1.635 What if I want to voluntarily nized accreditation body or by FDA

relinquish recognition or do not through direct accreditation.
want to renew recognition? (2) FDA may withdraw the accredita-
(a) Notice to FDA of intent to relinquish tion of a third-party certification body
or not to renew recognition. A recognized whenever FDA determines there is
accreditation body must notify FDA good cause for withdrawal of accredita-
electronically, in English, at least 60 tion under § 1.664(c).
days before voluntarily relinquishing (d) Effect of voluntary relinquishment
recognition or before allowing recogni- or expiration of recognition of an accredi-
tion to expire without seeking renewal. tation body on food or facility certifi-
The recognized accreditation body cations issued to eligible entities. A food
must provide the name and contact in- or facility certification issued by a
formation of the custodian who will third-party certification body accred-
maintain the records required under
ited by a recognized accreditation body
§ 1.625(a) after the date of relinquish-
prior to relinquishment or expiration
ment or the date recognition expires,
of its recognition will remain in effect
as applicable, and make them available
until the certification expires. If FDA
to FDA as required by § 1.625(b). The
contact information for the custodian has reason to believe that a certifi-
must include, at a minimum, an email cation issued for purposes of section
address and the physical address where 801(q) or 806 of the FD&C Act is not
the records required by § 1.625(a) will be valid or reliable, FDA may refuse to
located. consider the certification in deter-
(b) Notice to accredited third-party cer- mining the admissibility of the article
tification bodies of intent to relinquish or of food for which the certification was
not to renew recognition. No later than offered or in determining the import-
15 business days after notifying FDA er’s eligibility for participation in
under paragraph (a) of this section, the VQIP.
recognized accreditation body must no- (e) Public notice of voluntary relin-
tify any currently accredited third- quishment or expiration of recognition.
party certification body that it intends FDA will provide notice on the Web
to relinquish recognition or to allow site described in § 1.690 of the voluntary
its recognition to expire, specifying the relinquishment or expiration of rec-
date on which relinquishment or expi- ognition of an accreditation body
ration will occur. The recognized ac- under this subpart.
creditation body must establish and
maintain records of such notification § 1.636 How do I request reinstatement
under § 1.625. of recognition?
(c)(1) Effect of voluntary relinquish- (a) Application following revocation.
ment or expiration of recognition on third-
An accreditation body that has had its
party certification bodies. The accredita-
recognition revoked may seek rein-
tion of a third-party certification body
statement by submitting a new appli-
issued prior to the relinquishment or
expiration of its accreditation body’s cation for recognition under § 1.630. The
recognition will remain in effect, so accreditation body must submit evi-
long as the third-party certification dence that the grounds for revocation
body: have been resolved, including evidence
(i) No later than 60 days after the addressing the cause or conditions that
date of relinquishment or the date of were the basis for revocation and iden-
expiration of the recognition, conducts tifying measures that have been imple-
a self-assessment under § 1.655 and re- mented to help ensure that such
ports the results of the self-assessment cause(s) or condition(s) are unlikely to
to FDA under § 1.656(b); and recur.
(ii) No later than 1 year after the (b) Application following relinquish-
date of relinquishment or the date of ment. An accreditation body that pre-
expiration of recognition, or the origi- viously relinquished its recognition
nal date of the expiration of the ac- under § 1.635 may seek recognition by
creditation, whichever comes first, be- submitting a new application for rec-
comes accredited by another recog- ognition under § 1.630.
93
§ 1.640 21 CFR Ch. I (4–1–19 Edition)
ACCREDITATION OF THIRD-PARTY CER- (2) Conduct onsite audits of an eligi-

TIFICATION BODIES UNDER THIS SUB- ble entity; and
PART (3) Suspend or withdraw certification
for failure to comply with applicable
§ 1.640 Who is eligible to seek accredi- requirements.
tation?
(b) A third-party certification body
(a) A foreign government, agency of a seeking accreditation must dem-
foreign government, foreign coopera- onstrate that it is capable of exerting
tive, or any other third party may seek the authority (as a governmental enti-
accreditation from a recognized accred- ty or as legal entity with contractual
itation body (or, where direct accredi- rights) necessary to meet the applica-
tation is appropriate, FDA) to conduct ble requirements of accreditation
food safety audits and to issue food and
under this subpart if accredited.
facility certifications to eligible enti-
ties under this subpart. An accredited § 1.642 What competency and capacity
third-party certification body may use must a third-party certification
documentation of conformance with body have to qualify for accredita-
ISO/IEC 17021: 2011 or ISO/IEC 17065: tion?
2012, supplemented as necessary, in
A third-party certification body
meeting the applicable requirements of
this subpart. seeking accreditation must dem-
(b) A foreign government or an agen- onstrate that it has:
cy of a foreign government is eligible (a) The resources necessary to fully
for accreditation if it can demonstrate implement its certification program,
that its food safety programs, systems, including:
and standards meet the requirements (1) Adequate numbers of employees
of §§ 1.641 through 1.645. and other agents with relevant knowl-
(c) A foreign cooperative or other edge, skills, and experience to effec-
third party is eligible for accreditation tively examine for compliance with ap-
if it can demonstrate that the training plicable FDA food safety requirements
and qualifications of its agents used to of the FD&C Act and FDA regulations,
conduct audits (or, in the case of a conformance with applicable industry
third-party certification body that is standards and practices, and issuance
an individual, such individual) and its of valid and reliable certifications; and
internal systems and standards meet (2) Adequate financial resources for
the requirements of §§ 1.641 through its operations; and
1.645. (b) The competency and capacity to
meet the applicable requirements of
§ 1.641 What legal authority must a
third-party certification body have this subpart, if accredited.
to qualify for accreditation?
§ 1.643 What protections against con-
(a) A third-party certification body flicts of interest must a third-party
seeking accreditation from a recog- certification body have to qualify
nized accreditation body or from FDA for accreditation?
must demonstrate that it has the au-
A third-party certification body must
thority (as a governmental entity or as
demonstrate that it has:
a legal entity with contractual rights)
to perform such examinations of facili- (a) Implemented written measures to
ties, their process(es), and food(s) as protect against conflicts of interest be-
are necessary to determine compliance tween the third-party certification
with the applicable food safety require- body (and its officers, employees, and
ments of the FD&C Act and FDA regu- other agents involved in auditing and
lations, and conformance with applica- certification activities) and clients
ble industry standards and practices seeking examinations or certification
and to issue certifications where appro- from, or audited or certified by, such
priate based on a review of the findings third-party certification body; and
of such examinations. This includes au- (b) The capability to meet the con-
thority to: flict of interest requirements in § 1.657,

(1) Review any relevant records; if accredited.
94
§ 1.644 What quality assurance proce- (1) Has relevant knowledge and expe-
dures must a third-party certifi- rience that provides an adequate basis
cation body have to qualify for ac- for the audit agent to evaluate compli-
creditation? ance with applicable food safety re-
A third-party certification body quirements of the FD&C Act and FDA
seeking accreditation must dem- regulations and, for consultative au-
onstrate that it has: dits, also includes conformance with
(a) Implemented a written program applicable industry standards and prac-
for monitoring and evaluating the per- tices;
formance of its officers, employees, and (2) Has been determined by the ac-
other agents involved in auditing and credited third-party certification body,
certification activities, including pro-
through observations of a representa-
cedures to:
tive sample of audits, to be competent
(1) Identify deficiencies in its audit-
ing and certification program or per- to conduct food safety audits under
formance; and this subpart relevant to the audits
(2) Quickly execute corrective ac- they will be assigned to perform;
tions that effectively address any iden- (3) Has completed annual food safety
tified deficiencies; and training that is relevant to activities
(b) The capability to meet the qual- conducted under this subpart;
ity assurance requirements of § 1.655, if (4) Is in compliance with the conflict
accredited. of interest requirements of § 1.657 and
has no other conflicts of interest with
§ 1.645 What records procedures must the eligible entity to be audited that
a third-party certification body
have to qualify for accreditation? might impair the audit agent’s objec-
tivity; and
A third-party certification body (5) Agrees to notify its accredited
seeking accreditation must dem-
third-party certification body imme-
onstrate that it:
diately upon discovering, during a food
(a) Implemented written procedures
to establish, control, and retain safety audit, any condition that could
records (including documents and data) cause or contribute to a serious risk to
for a period of time necessary to meet the public health.
its contractual and legal obligations (b) In assigning an audit agent to
and to provide an adequate basis for conduct a food safety audit at a par-
evaluating its program and perform- ticular eligible entity, an accredited
ance; and third-party certification body must de-
(b) Is capable of meeting the report- termine that the audit agent is quali-
ing, notification, and records require- fied to conduct such audit under the
ments of this subpart, if accredited. criteria established in paragraph (a) of
this section and based on the scope and
REQUIREMENTS FOR THIRD-PARTY CER- purpose of the audit and the type of fa-
TIFICATION BODIES THAT HAVE BEEN cility, its process(es), and food.
ACCREDITED UNDER THIS SUBPART (c) An accredited third-party certifi-
§ 1.650 How must an accredited third- cation body cannot use an audit agent
party certification body ensure its to conduct a regulatory audit at an eli-
audit agents are competent and ob- gible entity if such audit agent con-
jective? ducted a consultative audit or regu-
(a) An accredited third-party certifi- latory audit for the same eligible enti-
cation body that uses audit agents to ty in the preceding 13 months, except
conduct food safety audits must ensure that such limitation may be waived if
that each such audit agent meets the the accredited third-party certification
following requirements with respect to body demonstrates to FDA, under
the scope of its accreditation under § 1.663, there is insufficient access to
this subpart. If the accredited third- audit agents in the country or region
party certification body is an indi- where the eligible entity is located. If
vidual, that individual is also subject the accredited third-party certification
to the following requirements, as appli- body is an individual, that individual is

cable: also subject to such limitations.
95
§ 1.651 21 CFR Ch. I (4–1–19 Edition)
§ 1.651 How must an accredited third- the accredited third-party certification

party certification body conduct a body (or its audit agent, where applica-
food safety audit of an eligible enti- ble) discovers a condition that could
ty? cause or contribute to a serious risk to
(a) Audit planning. Before beginning the public health and provide informa-
to conduct a food safety audit under tion required by § 1.656(c);
this subpart, an accredited third-party (5) Prepare reports of audits con-
certification body must: ducted under this subpart as follows:
(1) Require the eligible entity seek- (i) For consultative audits, prepare
ing a food safety audit to: reports that contain the elements spec-
(i) Identify the scope and purpose of ified in § 1.652(a) and maintain such
the food safety audit, including the fa- records, subject to FDA access in ac-
cility, process(es), or food to be au- cordance with section 414 of the FD&C
dited; whether the food safety audit is Act; and
to be conducted as a consultative or (ii) For regulatory audits, prepare re-
regulatory audit subject to the require- ports that contain the elements speci-
ments of this subpart, and if a regu- fied in § 1.652(b) and submit them to
latory audit, the type(s) of certifi- FDA and to its recognized accredita-
cation(s) sought; and tion body (where applicable) under
(ii) Provide a 30-day operating sched- § 1.656(a); and
ule for such facility that includes in- (6) Allow FDA and the recognized ac-
formation relevant to the scope and creditation body that accredited such
purpose of the audit; and third-party certification body, if any,
(2) Determine whether the requested to observe any food safety audit con-
audit is within its scope of accredita- ducted under this subpart for purposes
tion. of evaluating the accredited third-
(b) Authority to audit. In arranging a party certification body’s performance
food safety audit with an eligible enti- under §§ 1.621 and 1.662 or, where appro-
ty under this subpart, an accredited priate, the recognized accreditation
third-party certification body must en- body’s performance under §§ 1.622 and
sure it has authority, whether contrac- 1.633.
tual or otherwise, to: (c) Audit protocols. An accredited
(1) Conduct an unannounced audit to third-party certification body (or its
determine whether the facility, proc- audit agent, where applicable) must
ess(es), and food of the eligible entity conduct a food safety audit in a man-
(within the scope of the audit) comply ner consistent with the identified scope
with the applicable food safety require- and purpose of the audit and within the
ments of the FD&C Act and FDA regu- scope of its accreditation.
lations and, for consultative audits, (1) With the exception of records re-
also includes conformance with appli- view, which may be scheduled, the
cable industry standards and practices; audit must be conducted without an-
(2) Access any records and any area nouncement during the 30-day time-
of the facility, process(es), and food of frame identified under paragraph
the eligible entity relevant to the (a)(1)(ii) of this section and must be fo-
scope and purpose of such audit; cused on determining whether the fa-
(3) When, for a regulatory audit, sam- cility, its process(es), and food are in
pling and analysis is conducted, the ac- compliance with applicable food safety
credited third-party certification body requirements of the FD&C Act and
must use a laboratory that is accred- FDA regulations, and, for consultative
ited in accordance with: audits, also includes conformance with
(i) ISO/IEC 17025:2005; or applicable industry standards and prac-
(ii) Another laboratory accreditation tices that are within the scope of the
standard that provides at least a simi- audit.
lar level of assurance in the validity (2) The audit must include records re-
and reliability of sampling methodolo- view prior to the onsite examination;
gies, analytical methodologies, and an- an onsite examination of the facility,
alytical results. its process(es), and the food that re-
(4) Notify FDA immediately if, at sults from such process(es); and where
any time during a food safety audit, appropriate or when required by FDA,
96
environmental or product sampling and must maintain such report under

analysis. When, for a regulatory audit, § 1.658, subject to FDA access in accord-
sampling and analysis is conducted, ance with the requirements of section
the accredited third-party certification 414 of the FD&C Act. A consultative
body must use a laboratory that is ac- audit report must include:
credited in accordance with paragraph (1) The identity of the site or loca-
(b)(3) of this section. The audit may in- tion where the consultative audit was
clude any other activities necessary to conducted, including:
determine compliance with applicable (i) The name, address and the FDA
food safety requirements of the FD&C Establishment Identifier of the facility
Act and FDA regulations, and, for con- subject to the consultative audit and a
sultative audits, also includes conform-
unique facility identifier, if designated
ance with applicable industry stand-
by FDA; and
ards and practices.
(3) The audit must be sufficiently rig- (ii) Where applicable, the FDA reg-
orous to allow the accredited third- istration number assigned to the facil-
party certification body to determine ity under subpart H of this part;
whether the eligible entity is in com- (2) The identity of the eligible entity,
pliance with the applicable food safety if different from the facility, including
requirements of the FD&C Act and the name, address, the FDA Establish-
FDA regulations, and for consultative ment Identifier and unique facility
audits, also includes conformance with identifier, if designated by FDA, and,
applicable industry standards and prac- where applicable, registration number
tices, at the time of the audit; and for under subpart H of this part;
a regulatory audit, whether the eligible (3) The name(s) and telephone num-
entity, given its food safety system and ber(s) of the person(s) responsible for
practices would be likely to remain in compliance with the applicable food
compliance with the applicable food safety requirements of the FD&C Act
safety requirements of the FD&C Act and FDA regulations
and FDA regulations for the duration (4) The dates and scope of the con-
of any certification issued under this sultative audit;
subpart. An accredited third-party cer- (5) The process(es) and food(s) ob-
tification body (or its audit agent, served during such consultative audit;
where applicable) that identifies a defi- and
ciency requiring corrective action may (6) Any deficiencies observed that re-
verify the effectiveness of a corrective late to or may influence a determina-
action once implemented by the eligi- tion of compliance with the applicable
ble entity but must not recommend or
food safety requirements of the FD&C
provide input to the eligible entity in
Act and FDA regulations that require
identifying, selecting, or implementing
corrective action, the corrective action
the corrective action.
plan, and the date on which such cor-
(4) Audit observations and other data
rective actions were completed. Such
and information from the examination,
consultative audit report must be
including information on corrective ac-
maintained as a record under § 1.658 and
tions, must be documented and must be
used to support the findings contained must be made available to FDA in ac-
in the audit report required by § 1.652 cordance with section 414 of the FD&C
and maintained as a record under Act.
§ 1.658. (b) Regulatory audits. An accredited
third-party certification body must, no
§ 1.652 What must an accredited third- later than 45 days after completing a
party certification body include in regulatory audit, prepare and submit
food safety audit reports? electronically, in English, to FDA and
(a) Consultative audits. An accredited to its recognized accreditation body
third-party certification body must (or, in the case of direct accreditation,
prepare a report of a consultative audit only to FDA) and must provide to the
not later than 45 days after completing eligible entity a report of such regu-
such audit and must provide a copy of latory audit that includes the fol-
such report to the eligible entity and lowing information:
97
§ 1.653 21 CFR Ch. I (4–1–19 Edition)
(1) The identity of the site or loca- regulatory audit report as required by
tion where the regulatory audit was paragraph (b) of this section, regardless
conducted, including: of whether the certification body
(i) The name, address, and FDA Es- issued a food or facility certification to
tablishment Identifier of the facility the eligible entity.
subject to the regulatory audit and a (d) Notice and appeals of adverse regu-
unique facility identifier, if designated latory audit results. An accredited third-
by FDA; and party certification body must notify an
(ii) Where applicable, the FDA reg- eligible entity of a denial of certifi-
istration number assigned to the facil- cation and must establish and imple-
ity under subpart H of this part; ment written procedures for receiving
(2) The identity of the eligible entity, and addressing appeals from eligible
if different from the facility, including entities challenging such adverse regu-
the name, address, FDA Establishment latory audit results and for inves-
Identifier, and unique facility identi- tigating and deciding on appeals in a
fier, if designated by FDA, and, where fair and meaningful manner. The ap-
applicable, registration number under peals procedures must provide similar
subpart H of this part; protections to those offered by FDA
(3) The dates and scope of the regu- under §§ 1.692 and 1.693, including re-
latory audit; quirements to:
(4) The process(es) and food(s) ob- (1) Make the appeals procedures pub-
served during such regulatory audit; licly available;
(5) The name(s) and telephone num-
(2) Use competent persons, who may
ber(s) of the person(s) responsible for
or may not be external to the accred-
the facility’s compliance with the ap-
ited third-party certification body, who
plicable food safety requirements of
are free from bias or prejudice and have
the FD&C Act and FDA regulations;
not participated in the certification de-
(6) Any deficiencies observed during
cision or be subordinate to a person
the regulatory audit that present a
who has participated in the certifi-
reasonable probability that the use of
cation decision, to investigate and de-
or exposure to a violative product:
(i) Will cause serious adverse health cide appeals;
consequences or death to humans and (3) Advise the eligible entity of the
animals; or final decision on its appeal; and
(ii) May cause temporary or medi- (4) Maintain records under § 1.658 of
cally reversible adverse health con- the appeal, the final decision, and the
sequences or where the probability of basis for such decision.
serious adverse health consequences or
death to humans or animals is remote; § 1.653 What must an accredited third-
party certification body do when
(7) The corrective action plan for ad-
issuing food or facility certifi-
dressing each deficiency identified cations?
under paragraph (b)(6) of this section,
unless corrective action was imple- (a) Basis for issuance of a food or facil-
mented immediately and verified on- ity certification. (1) Prior to issuing a
site by the accredited third-party cer- food or facility certification to an eli-
tification body (or its audit agent, gible entity, an accredited third-party
where applicable); certification body (or, where applica-
(8) Whether any sampling and labora- ble, an audit agent on its behalf) must
tory analysis (e.g., under a micro- complete a regulatory audit that meets
biological sampling plan) is performed the requirements of § 1.651 and any
in or used by the facility; and other activities that may be necessary
(9) Whether the eligible entity has to determine compliance with the ap-
made significant changes to the facil- plicable food safety requirements of
ity, its process(es), or food products the FD&C Act and FDA regulations.
during the 2 years preceding the regu- (2) If, as a result of an observation
latory audit. during a regulatory audit, an eligible
(c) Submission of regulatory audit re- entity must implement a corrective ac-
port. An accredited third-party certifi- tion plan to address a deficiency, an ac-

cation body must submit a completed credited third-party certification body
98
may not issue a food or facility certifi- (ii) The name, address, FDA Estab-
cation to such entity until after the ac- lishment Identifier, and unique facility
credited third-party certification body identifier, if designated by FDA, of the
verifies that eligible entity has imple- eligible entity to which the food or fa-
mented the corrective action plan cility certification was issued;
through methods that reliably verify (iii) The name, address, FDA Estab-
the corrective action was taken and as lishment Identifier, and unique facility
a result the identified deficiency is un- identifier, if designated by FDA, of the
likely to recur, except onsite facility where the regulatory audit was
verification is required for corrective conducted, if different than the eligible
actions required to address deficiencies entity;
that are the subject of a notification (iv) The scope and date(s) of the regu-
under § 1.656(c). latory audit and the certification num-
(3) An accredited third-party certifi- ber;
cation body must consider each obser- (v) The name of the audit agent(s)
vation and the data and other informa- (where applicable) conducting the regu-
tion from a regulatory audit and other latory audit; and
activities conducted under § 1.651 to de- (vi) The scope of the food or facility
termine whether the entity was in certification, date of issuance, and date
compliance with the applicable food of expiration.
safety requirements of the FD&C Act (3) FDA may refuse to accept any
and FDA regulations at the time of the certification for purposes of section
audit and whether the eligible entity, 801(q) or 806 of the FD&C Act, if FDA
given its food safety system and prac- determines, that such food or facility
tices, would be likely to remain in certification is not valid or reliable be-
compliance for the duration of any cer- cause, for example:
tification issued under this subpart. (i) The certification is offered in sup-
(4) A single regulatory audit may report of the admissibility of a food that
sult in issuance of one or more food or was not within the scope of the certifi-
facility certifications under this sub- cation;
part, provided that the requirements of (ii) The certification was issued by an
issuance are met as to each such cer- accredited third-party certification
tification. body acting outside the scope of its ac-
(5) Where an accredited third-party creditation under this subpart; or
certification body uses an audit agent (iii) The certification was issued
to conduct a regulatory audit of an eli- without reliable demonstration that
gible entity under this subpart, the ac- the requirements of paragraph (a) of
credited third-party certification body this section were met.
(and not the audit agent) must make
the determination whether to issue a § 1.654 When must an accredited third-
food or facility certification based on party certification body monitor an
the results of such regulatory audit. eligible entity that it has issued a
(b) Issuance of a food or facility certifi- food or facility certification?
cation and submission to FDA. (1) Any If an accredited third-party certifi-
food or facility certification issued cation body has reason to believe that
under this subpart must be submitted an eligible entity to which it issued a
to FDA electronically and in English. food or facility certification may no
The accredited third-party certifi- longer be in compliance with the appli-
cation body may issue a food or facility cable food safety requirements of the
certification under this subpart for a FD&C Act and FDA regulations, the
term of up to 12 months. accredited third-party certification
(2) A food or facility certification body must conduct any monitoring (in-
must contain, at a minimum, the fol- cluding an onsite audit) of such eligible
lowing elements: entity necessary to determine whether
(i) The name and address of the ac- the entity is in compliance with such
credited third-party certification body requirements. The accredited third-
and the scope and date of its accredita- party certification body must imme-
tion under this subpart; diately notify FDA, under § 1.656(d), if
99
§ 1.655 21 CFR Ch. I (4–1–19 Edition)
it withdraws or suspends a food or fa- accredited third-party certification

cility certification because it deter- body must:
mines that the entity is no longer in (1) Identify any deficiencies in com-
compliance with the applicable food plying with the requirements of this
safety requirements of the FD&C Act subpart;
and FDA regulations. The accredited (2) Quickly implement corrective ac-
third-party certification body must tion(s) that effectively address the
maintain records of such monitoring identified deficiencies; and
under § 1.658. (3) Under § 1.658, establish and main-
tain records of such corrective ac-
§ 1.655 How must an accredited third- tion(s).
party certification body monitor its (d) The accredited third-party certifi-
own performance?
cation body must prepare a written re-
(a) An accredited third-party certifi- port of the results of its self-assess-
cation body must annually, upon FDA ment that includes:
request made for cause, or as required (1) A description of any corrective ac-
under § 1.631(f)(1)(i), § 1.634(d)(1)(i), or tion(s) taken under paragraph (c) of
§ 1.635(c)(1)(i), conduct a self-assess- this section;
ment that includes evaluation of com- (2) A statement disclosing the extent
pliance with this subpart, including: to which the accredited third-party
(1) The performance of its officers, certification body, and its officers, em-
employees, or other agents involved in ployees, and other agents involved in
auditing and certification activities, auditing and certification activities,
including the performance of audit complied with the conflict of interest
agents in examining facilities, proc- requirements in § 1.657; and
ess(es), and food using the applicable (3) A statement attesting to the ex-
food safety requirements of the FD&C tent to which the accredited third-
Act and FDA regulations; party certification body complied with
(2) The degree of consistency among the applicable requirements of this
its officers, employees, or other agents subpart.
involved in auditing and certification (e) An accredited third-party certifi-
activities, including evaluating wheth- cation body may use a report, supple-
er its audit agents interpreted audit mented as necessary, on its conform-
protocols in a consistent manner; ance to ISO/IEC 17021: 2011 or ISO/IEC
(3) The compliance of the accredited 17065: 2012 in meeting the requirements
third-party certification body and its of this section.
officers, employees, and other agents
involved in auditing and certification § 1.656 What reports and notifications
activities, with the conflict of interest must an accredited third-party cer-
requirements of § 1.657; tification body submit?
(4) Actions taken in response to the (a) Reporting results of regulatory au-
results of any assessments conducted dits. An accredited third-party certifi-
by FDA or, where applicable, the recog- cation body must submit a regulatory
nized accreditation body under § 1.621; audit report, as described in § 1.652(b),
and electronically, in English, to FDA and
(5) As requested by FDA, any other to the recognized accreditation body
aspects of its performance relevant to a that granted its accreditation (where
determination of whether the accred- applicable), no later than 45 days after
ited third-party certification body is in completing such audit.
compliance with this subpart. (b) Reporting results of accredited third-
(b) As a means to assess its perform- party certification body self-assessments.
ance, the accredited third-party certifi- An accredited third-party certification
cation body may evaluate the compli- body must submit the report of its an-
ance of one or more of eligible entities nual self-assessment required by § 1.655
to which a food or facility certification electronically to its recognized accred-
was issued under this subpart. itation body (or, in the case of direct
(c) Based on the assessments and accreditation, electronically and in
evaluations conducted under para- English, to FDA), within 45 days of the

graphs (a) and (b) of this section, the anniversary date of its accreditation
100
under this subpart. For an accredited creditation, except for third-party cer-
third-party certification body subject tification bodies directly accredited by
to an FDA request for cause, or FDA. Where feasible and reliable, the
§ 1.631(f)(1)(i), § 1.634(d)(1)(i), or accredited third-party certification
§ 1.635(c)(1)(i), the report of its self-as- body may contemporaneously notify
sessment must be submitted to FDA its recognized accreditation body and/
electronically, in English, within 60 or the eligible entity when notifying
days of the FDA request, denial of re- FDA.
newal, revocation, or relinquishment of (2) An accredited third-party certifi-
recognition of the accreditation body cation body must notify its recognized
that granted its accreditation. Such reaccreditation body (or, in the case of
port must include an up-to-date list of direct accreditation, FDA) electroni-
any audit agents it uses to conduct au-
cally, in English, within 30 days after
dits under this subpart.
making any significant change that
(c) Notification to FDA of a serious risk
would affect the manner in which it
to public health. An accredited third-
complies with the requirements of this
party certification body must imme-
diately notify FDA electronically, in subpart and must include with such no-
English, if during a regulatory or con- tification the following information:
sultative audit, any of its audit agents (i) A description of the change; and
or the accredited third-party certifi- (ii) An explanation for the purpose of
cation body itself discovers a condition the change.
that could cause or contribute to a se-
rious risk to the public health, pro- § 1.657 How must an accredited third-
viding the following information: party certification body protect
against conflicts of interest?
(1) The name, physical address, and
unique facility identifier, if designated (a) An accredited third-party certifi-
by FDA, of the eligible entity subject cation body must implement a written
to the audit, and, where applicable, the program to protect against conflicts of
registration number under subpart H of interest between the accredited third-
this part; party certification body (and its offi-
(2) The name, physical address, and cers, employees, and other agents in-
unique facility identifier, if designated volved in auditing and certification ac-
by FDA, of the facility where the con- tivities) and an eligible entity seeking
dition was discovered (if different from a food safety audit or food or facility
that of the eligible entity) and, where certification from, or audited or cer-
applicable, the registration number as- tified by, such accredited third-party
signed to the facility under subpart H certification body, including the fol-
of this part; and lowing:
(3) The condition for which notifica-
(1) Ensuring that the accredited
tion is submitted.
third-party certification body and its
(d) Immediate notification to FDA of
officers, employees, or other agents in-
withdrawal or suspension of a food or fa-
volved in auditing and certification ac-
cility certification. An accredited third-
party certification body must notify tivities do not own, operate, have a fi-
FDA electronically, in English, imme- nancial interest in, manage, or other-
diately upon withdrawing or sus- wise control an eligible entity to be
pending any food or facility certifi- certified, or any affiliate, parent, or
cation of an eligible entity and the subsidiary of the entity;
basis for such action. (2) Ensuring that the accredited
(e) Notification to its recognized accred- third-party certification body and, its
itation body or an eligible entity. (1) officers, employees, or other agents in-
After notifying FDA under paragraph volved in auditing and certification ac-
(c) of this section, an accredited third- tivities are not owned, managed, or
party certification body must imme- controlled by any person that owns or
diately notify the eligible entity of operates an eligible entity to be cer-
such condition and must immediately tified;
thereafter notify the recognized ac- (3) Ensuring that an audit agent of
creditation body that granted its ac- the accredited third-party certification
101
§ 1.658 21 CFR Ch. I (4–1–19 Edition)
body does not own, operate, have a fi- third-party certification body any fee
nancial interest in, manage, or other- or reimbursement associated with such
wise control an eligible entity or any audit or certification.
affiliate, parent, or subsidiary of the
entity that is subject to a consultative § 1.658 What records requirements
or regulatory audit by the audit agent; must a third-party certification
and body that has been accredited
(4) Prohibiting an accredited third- meet?
party certification body’s officer, em- (a) A third-party certification body
ployee, or other agent involved in au- that has been accredited must main-
diting and certification activities from tain electronically for 4 years records
accepting any money, gift, gratuity, or created during its period of accredita-
other item of value from the eligible tion (including documents and data)
entity to be audited or certified under that document compliance with this
this subpart. subpart, including:
(5) The items specified in paragraph (1) Any audit report and other docu-
(a)(4) of this section do not include: ments resulting from a consultative
(i) Money representing payment of audit conducted under this subpart, in-
fees for auditing and certification serv- cluding the audit agent’s observations,
ices and reimbursement of direct costs correspondence with the eligible enti-
associated with an onsite audit by the ty, verification of any corrective ac-
third-party certification body; or tion(s) taken to address deficiencies
(ii) Lunch of de minimis value pro- identified during the audit;
vided during the course of an audit and (2) Any request for a regulatory audit
on the premises where the audit is con- from an eligible entity;
ducted, if necessary to facilitate the ef- (3) Any audit report and other docu-
ficient conduct of the audit. ments resulting from a regulatory
(b) An accredited third-party certifi-
audit conducted under this subpart, in-
cation body may accept the payment of
cluding the audit agent’s observations,
fees for auditing and certification serv-
correspondence with the eligible enti-
ices and the reimbursement of direct
ty, verification of any corrective ac-
costs associated with an audit of an eli-
tion(s) taken to address deficiencies
gible entity only after the date on
identified during the audit, and, when
which the report of such audit was
sampling and analysis is conducted,
completed or the date a food or facility
laboratory testing records and results
certification was issued, whichever is
from a laboratory that is accredited in
later. Such payment is not considered
a conflict of interest for purposes of accordance with § 1.651(b)(3), and docu-
paragraph (a) of this section. mentation demonstrating such labora-
(c) The financial interests of the tory is accredited in accordance with
spouses and children younger than 18 § 1.651(b)(3);
years of age of accredited third-party (4) Any notification submitted by an
certification body’s officers, employ- audit agent to the accredited third-
ees, and other agents involved in audit- party certification body in accordance
ing and certification activities will be with § 1.650(a)(5);
considered the financial interests of (5) Any challenge to an adverse regu-
such officers, employees, and other latory audit decision and the disposi-
agents involved in auditing and certifi- tion of the challenge;
cation activities. (6) Any monitoring it conducted of an
(d) An accredited third-party certifi- eligible entity to which food or facility
cation body must maintain on its Web certification was issued;
site an up-to-date list of the eligible (7) Its self-assessments and corrective
entities to which it has issued food or actions taken to address any defi-
facility certifications under this sub- ciencies identified during a self-assess-
part. For each such eligible entity, the ment; and
Web site also must identify the dura- (8) Significant changes to its audit-
tion and scope of the food or facility ing or certification program that
certification and date(s) on which the might affect compliance with this sub-
eligible entity paid the accredited part.
102
(b) An accredited third-party certifi- physical address where the records re-
cation body must make the records of quired by § 1.658(a) will be located.
a consultative audit required by para- (c) Effect of denial of an application for
graph (a)(1) of this section available to renewal of accreditation on food or facil-
FDA in accordance with section 414 of ity certifications issued to eligible entities.
the FD&C Act. A food or facility certification issued
(c) An accredited third-party certifi- by an accredited third-party certifi-
cation body must make the records re- cation body prior to issuance of the de-
quired by paragraphs (a)(2) through (8) nial of its renewal application l will re-
of this section available for inspection main in effect until the certification
and copying promptly upon written re- expires. If FDA has reason to believe
quest of an authorized FDA officer or that a certification issued for purposes
employee at the place of business of
of section 801(q) or 806 of the FD&C Act
the accredited third-party certification
is not valid or reliable, FDA may
body or at a reasonably accessible loca-
refuse to consider the certification in
tion. If such records are requested by
FDA electronically, the records must determining the admissibility of the
be submitted electronically not later article of food for which the certifi-
than 10 business days after the date of cation was offered or in determining
the request. Additionally, if the the importer’s eligibility for participa-
records are maintained in a language tion in VQIP.
other than English, an accredited (d) Public notice of denial of an appli-
third-party certification body must cation for renewal of accreditation. FDA
electronically submit an English trans- will provide notice on the Web site de-
lation within a reasonable time. scribed in § 1.690 of the date of issuance
of a denial of renewal of accreditation
PROCEDURES FOR ACCREDITATION OF of a third-party certification body that
THIRD-PARTY CERTIFICATION BODIES had previous been accredited.
UNDER THIS SUBPART
§ 1.661 What is the duration of accredi-
§ 1.660 Where do I apply for accredita- tation by a recognized accreditation
tion or renewal of accreditation by body?
a recognized accreditation body
and what happens once the recog- A recognized accreditation body may
nized accreditation body decides on grant accreditation to a third-party
my application? certification body under this subpart
(a) Submission of accreditation or re- for a period not to exceed 4 years.
newal application to a recognized accredi-
§ 1.662 How will FDA monitor accred-
tation body. A third-party certification
ited third-party certification bod-
body seeking accreditation must sub- ies?
mit its request for accreditation or re-
newal of accreditation by a recognized (a) FDA will periodically evaluate
accreditation body identified on the the performance of each accredited
Web site described in § 1.690. third-party certification body to deter-
(b) Notice of records custodian after de- mine whether the accredited third-
nial of application for renewal of accredi- party certification body continues to
tation. An applicant whose renewal ap- comply with the applicable require-
plication was denied by a recognized ments of this subpart and whether
accreditation body must notify FDA there are deficiencies in the perform-
electronically, in English, within 10 ance of the accredited third-party cer-
business days of the date of issuance of tification body that, if not corrected,
a denial of accreditation or denial of would warrant withdrawal of its ac-
the renewal application, of the name creditation under § 1.664. FDA will
and contact information of the custo- evaluate each directly accredited
dian who will maintain the records re- third-party certification body annu-
quired by § 1.658(a) and make them ally. For a third-party certification
available to FDA as required by body accredited by a recognized accred-
§ 1.658(b) and (c). The contact informa- itation body, FDA will evaluate an ac-
tion for the custodian must include, at credited third-party certification body
a minimum, an email address and the not later than 3 years after the date of
103
§ 1.663 21 CFR Ch. I (4–1–19 Edition)
accreditation for a 4-year term of ac- ing the previous 13 months. The accred-
creditation, or by no later than the ited third-party certification body
mid-term point for accreditation seeking a waiver or waiver extension
granted for less than 4 years. FDA may must demonstrate there is insufficient
conduct additional performance assess- access to audit agents and any third-
ments of an accredited third-party cer- party certification bodies that are
tification body at any time. comprised of an individual in the coun-
(b) In evaluating the performance of try or region where the eligible entity
an accredited third-party certification is located.
body under paragraph (a) of this sec- (b) Requests for a waiver or waiver
tion, FDA may review any one or more extension and all documents provided
of the following: in support of the request must be sub-
(1) Regulatory audit reports and food mitted to FDA electronically, in
and facility certifications; English. The requestor must provide
(2) The accredited third-party certifi- such translation and interpretation
cation body’s self-assessments under services as are needed by FDA to proc-
§ 1.655; ess the request.
(3) Reports of assessments by a recog- (c) The request must be signed by the
nized accreditation body under § 1.621; requestor or by any individual author-
(4) Documents and other information ized to act on behalf of the requestor
relevant to a determination of the ac- for purposes of seeking such waiver or
credited third-party certification waiver extension.
body’s compliance with the applicable (d) FDA will review requests for
requirements of this subpart; and waivers and waiver extensions on a
(5) Information obtained by FDA, in- first in, first out basis according to the
cluding during inspections, audits, on- date on which the completed submis-
site observations, or investigations, of sion is received; however, FDA may
one or more eligible entities to which a prioritize the review of specific re-
food or facility certification was issued quests to meet the needs of the pro-
by such accredited third-party certifi- gram. FDA will evaluate any com-
cation body. pleted waiver request to determine
(c) FDA may conduct its evaluation whether the criteria for waiver have
of an accredited third-party certifi- been met.
cation body through a site visit to an (e) FDA will notify the requestor
accredited third-party certification whether the request for a waiver or
body’s headquarters (or other location waiver extension is approved or denied.
that manages audit agents conducting (f) If FDA approves the request,
food safety audits under this subpart, if issuance of the waiver will state the
different than its headquarters), duration of the waiver and list any lim-
through onsite observation of an ac- itations associated with it. If FDA de-
credited third party certification nies the request, the issuance of a de-
body’s performance during a food safe- nial of a waiver request will state the
ty audit of an eligible entity, or basis for denial and will provide the ad-
through document review. dress and procedures for requesting re-
consideration of the request under
§ 1.663 How do I request an FDA waiv- § 1.691.
er or waiver extension for the 13- (g) Unless FDA notifies a requestor
month limit for audit agents con- that its waiver request has been ap-
ducting regulatory audits? proved, an accredited third-party cer-
(a) An accredited third-party certifi- tification body must not use the audit
cation body may submit a request to agent to conduct a regulatory audit of
FDA to waive the requirements of such eligible entity until the 13-month
§ 1.650(c) preventing an audit agent limit in § 1.650(c) has elapsed.
from conducting a regulatory audit of
an eligible entity if the audit agent (or, § 1.664 When would FDA withdraw ac-
in the case that the third-party certifi- creditation?
cation body is an individual, the third- (a) Mandatory withdrawal. FDA will
party certification body) has conducted withdraw accreditation from a third-

a food safety audit of such entity dur- party certification body:
104
(1) Except as provided in paragraph when considering withdrawal under

(b) of this section, if the food or facil- paragraph (a)(1), (a)(2), or (c) of this
ity certified under this subpart is section.
linked to an outbreak of foodborne ill- (e) Notice to the third-party certifi-
ness or chemical or physical hazard cation body of withdrawal of accredita-
that has a reasonable probability of tion. (1) FDA will notify a third-party
causing serious adverse health con- certification body of the withdrawal of
sequences or death in humans or ani- its accreditation through issuance of a
mals; withdrawal that will state the grounds
(2) Following an evaluation and find- for withdrawal, the procedures for re-
ing by FDA that the third-party cer- questing a regulatory hearing under
tification body no longer complies with § 1.693 on the withdrawal, and the pro-
the applicable requirements of this cedures for requesting reaccreditation
subpart; or under § 1.666.
(3) Following its refusal to allow (2) Within 10 business days of the
FDA to access records under § 1.658 or date of issuance of the withdrawal, the
to conduct an audit, assessment, or in- third-party certification body must no-
vestigation necessary to ensure contin- tify FDA electronically, in English, of
ued compliance with this subpart. the name of the custodian who will
(4) If payment of the third-party cer- maintain the records required by
tification body’s annual fee is not re- § 1.658, and provide contact information
ceived within 90 days of the payment for the custodian, which will at least
due date, as specified in § 1.725(c)(3). include an email address, and the
(b) Exception. FDA may waive manda- street address where the records will be
tory withdrawal under paragraph (a)(1) located.
of this section, if FDA:
(f) Effect of withdrawal of accreditation
(1) Conducts an investigation of the
on eligible entities. A food or facility
material facts related to the outbreak
certification issued by a third-party
of human or animal illness;
certification body prior to withdrawal
(2) Reviews the relevant audit
will remain in effect until the certifi-
records and the actions taken by the
accredited third-party certification cation terminates by expiration. If
body in support of its decision to cer- FDA has reason to believe that a cer-
tify; and tification issued for purposes of section
(3) Determines that the accredited 801(q) or 806 of the FD&C Act is not
third-party certification body satisfied valid or reliable, FDA may refuse to
the requirements for issuance of cer- consider the certification in deter-
tification under this subpart. mining the admissibility of the article
(c) Discretionary withdrawal. FDA of food for which the certification was
may withdraw accreditation, in whole offered or in determining the import-
or in part, from a third-party certifi- er’s eligibility for participation in
cation body when such third-party cer- VQIP.
tification body is accredited by an ac- (g) Effect of withdrawal of accredita-
creditation body for which recognition tion on recognized accreditation bodies.
is revoked under § 1.634, if FDA deter- (1) FDA will notify a recognized accred-
mines there is good cause for with- itation body if the accreditation of a
drawal, including: third-party certification body it ac-
(1) Demonstrated bias or lack of ob- credited is withdrawn by FDA. Such
jectivity when conducting activities accreditation body’s recognition will
under this subpart; or remain in effect if, no later than 60
(2) Performance that calls into ques- days after withdrawal, the accredita-
tion the validity or reliability of its tion body conducts a self-assessment
food safety audits or certifications. under § 1.622 and reports the results of
(d) Records access. FDA may request the self-assessment to FDA as required
records of the accredited third-party by § 1.623(b).
certification body under § 1.658 and, (2) FDA may revoke the recognition
where applicable, may request records of an accreditation body whenever FDA
under § 1.625 of an accreditation body determines there is good cause for rev-
that has been recognized under § 1.625, ocation of recognition under § 1.634.
105
§ 1.665 21 CFR Ch. I (4–1–19 Edition)
(h) Public notice of withdrawal accredi- 801(q) or 806 of the FD&C Act is not
tation. FDA will provide notice on the valid or reliable, FDA may refuse to
Web site described in § 1.690 of its with- consider the certification in deter-
drawal of accreditation of a third-party mining the admissibility of the article
certification body and provide a de- of food for which the certification was
scription of the basis for withdrawal. offered or in determining the import-
[80 FR 74650, Nov. 27, 2015, as amended at 81 er’s eligibility for participation in
FR 90193, Dec. 14, 2016] VQIP.
(d) Public notice of voluntary relin-
§ 1.665 What if I want to voluntarily quishment or expiration of accreditation.
relinquish accreditation or do not
FDA will provide notice on the Web
want to renew accreditation?
site described in § 1.690 of the voluntary
(a) Notice to FDA of intent to relinquish relinquishment or expiration of accred-
or not to renew accreditation. A third- itation of a certification body under
party certification body must notify this subpart.
FDA electronically, in English, at least
60 days before voluntarily relin- § 1.666 How do I request reaccredita-
quishing accreditation or before allow- tion?
ing accreditation to expire without
seeking renewal. The certification (a) Application following withdrawal.
body must provide the name and con- FDA will reinstate the accreditation of
tact information of the custodian who a third-party certification body for
will maintain the records required which it has withdrawn accreditation:
under § 1.658(a) after the date of relin- (1) If, in the case of direct accredita-
quishment or the date accreditation tion, FDA determines, based on evi-
expires, as applicable, and make them dence presented by the third-party cer-
available to FDA as required by tification body, that the third-party
§ 1.658(b) and (c). The contact informa- certification body satisfies the applica-
tion for the custodian must include, at ble requirements of this subpart and
a minimum, an email address and the adequate grounds for withdrawal no
physical address where the records re- longer exist; or
quired by § 1.658(a) will be located. (2) In the case of a third-party certifi-
(b) Notice to recognized accreditation cation body accredited by an accredita-
body and eligible entities of intent to re- tion body for which recognition has
linquish or not to renew accreditation. No been revoked under § 1.634:
later than 15 business days after noti- (i) If the third-party certification
fying FDA under paragraph (a) of this
body becomes accredited by another
section, the certification body must
recognized accreditation body or by
notify its recognized accreditation
body and any eligible entity with cur- FDA through direct accreditation no
rent certifications that it intends to later than 1 year after withdrawal of
relinquish accreditation or to allow its accreditation, or the original date of
accreditation to expire, specifying the the expiration of accreditation, which-
date on which relinquishment or expi- ever comes first; or
ration will occur. The recognized ac- (ii) Under such conditions as FDA
creditation body must establish and may impose in withdrawing accredita-
maintain records of such notification tion.
under § 1.625(a). (b) Application following voluntary re-
(c) Effect of voluntary relinquishment linquishment. A third-party certifi-
or expiration of accreditation on food or cation body that previously relin-
facility certifications issued to eligible en- quished its accreditation under § 1.665
tities. A food or facility certification may seek accreditation by submitting
issued by a third-party certification a new application for accreditation
body prior to relinquishment or expira- under § 1.660 or, where applicable,
tion of its accreditation will remain in § 1.670.
effect until the certification expires. If
FDA has reason to believe that a cer-

tification issued for purposes of section
106
ADDITIONAL PROCEDURES FOR DIRECT to process the application, including

ACCREDITATION OF THIRD-PARTY CER- during an onsite audit of the applicant.
TIFICATION BODIES UNDER THIS SUB- (3) The application must be signed in
PART the manner designated by FDA by an
individual authorized to act on behalf
§ 1.670 How do I apply to FDA for di- of the applicant for purposes of seeking
rect accreditation or renewal of di- or renewing direct accreditation.
rect accreditation?
(a) Eligibility. (1) FDA will accept ap- § 1.671 How will FDA review my appli-
plications from third-party certification for direct accreditation or
renewal of direct accreditation and
cation bodies for direct accreditation what happens once FDA decides on
or renewal of direct accreditation only my application?
if FDA determines that it has not iden-
tified and recognized an accreditation (a) Review of a direct accreditation or
body to meet the requirements of sec- renewal application. FDA will examine a
third-party certification body’s direct
tion 808 of the FD&C Act within 2 years
accreditation or renewal application
after establishing the accredited third-
for completeness and notify the appli-
party audits and certification program.
cant of any deficiencies. FDA will re-
Such FDA determination may apply, as
view applications for direct accredita-
appropriate, to specific types of third-
tion and for renewal of direct accredi-
party certification bodies, types of ex-
tation on a first in, first out basis ac-
pertise, or geographic location; or
cording to the date the completed sub-
through identification by FDA of any
mission is received; however, FDA may
requirements of section 808 of the
prioritize the review of specific appli-
FD&C Act not otherwise met by pre- cations to meet the needs of the pro-
viously recognized accreditation bod- gram.
ies. FDA will only accept applications (b) Evaluation of a direct accreditation
for direct accreditation and renewal or renewal application. FDA will evalu-
applications that are within the scope ate any completed application to deter-
of the determination. mine whether the applicant meets the
(2) FDA may revoke or modify a de- requirements for direct accreditation
termination under paragraph (a)(1) of under this subpart. If FDA does not
this section if FDA subsequently iden- reach a final decision on a renewal ap-
tifies and recognizes an accreditation plication before the expiration of the
body that affects such determination. direct accreditation, FDA may extend
(3) FDA will provide notice on the the duration of such direct accredita-
Web site described in § 1.690 of a deter- tion for a specified period of time or
mination under paragraph (a)(1) of this until the Agency reaches a final deci-
section and of a revocation or modi- sion on the renewal application.
fication of the determination under (c) Notice of approval or denial. FDA
paragraph (a)(1) of this section, as de- will notify the applicant that its direct
scribed in paragraph (a)(2) of this sec- accreditation or renewal application
tion. has been approved through issuance of
(b) Application for direct accreditation or denied.
or renewal of direct accreditation. (1) A (d) Issuance of direct accreditation. If
third-party certification body seeking an application has been approved, the
direct accreditation or renewal of di- issuance of the direct accreditation
rect accreditation must submit an ap- that will list any limitations associ-
plication to FDA, demonstrating that ated with the accreditation.
it is within the scope of the determina- (e) Issuance of denial of direct accredi-
tion issued under paragraph (a)(1) of tation. If FDA issues a denial of direct
this section, and it meets the eligi- accreditation or denial of a renewal ap-
bility requirements of § 1.640. plication, the issuance of the denial of
(2) Applications and all documents direct accreditation will state the basis
provided as part of the application for such denial and provide the proce-
process must be submitted electroni- dures for requesting reconsideration of
cally, in English. An applicant must the application under § 1.691.
provide such translation and interpre- (f) Notice of records custodian after de-
tation services as are needed by FDA nial of application for renewal of direct
107
§ 1.672 21 CFR Ch. I (4–1–19 Edition)
accreditation. An applicant whose reaccredited third-party certification

newal application was denied must no- body or the recognized accreditation
tify FDA electronically, in English, body (where applicable) present. An
within 10 business days of the date of FDA audit conducted under this sec-
issuance of a denial of a renewal appli- tion will be conducted on an unan-
cation, of the name and contact infor- nounced basis and may be preceded by
mation of the custodian who will main- a request for a 30-day operating sched-
tain the records required by § 1.658(a) ule.
and make them available to FDA as re-
quired by § 1.658(b) and (c). The contact § 1.681 How frequently must eligible
information for the custodian must in- entities be recertified?
clude, at a minimum, an email address An eligible entity seeking recertifi-
and the physical address where the cation of a food or facility certification
records required by § 1.658(b) will be lo- under this subpart must apply for re-
cated. certification prior to the expiration of
(g) Effect of denial of renewal of direct its certification. For certifications
accreditation on food or facility certifi- used in meeting the requirements of
cations issued to eligible entities. A food section 801(q) or 806 of the FD&C Act,
or facility certification issued by an FDA may require an eligible entity to
accredited third-party certification apply for recertification at any time
body prior to issuance of the denial of FDA determines appropriate under
its renewal application will remain in such section.
effect until the certification expires. If
FDA has reason to believe that a cer- GENERAL REQUIREMENTS OF THIS
tification issued for purposes of section SUBPART
801(q) or 806 of the FD&C Act is not
valid or reliable, FDA may refuse to § 1.690 How will FDA make informa-
consider the certification in deter- tion about recognized accreditation
mining the admissibility of the article bodies and accredited third-party
of food for which the certification was certification bodies available to the
public?
offered or in determining the import-
er’s eligibility for participation in FDA will place on its Web site a reg-
VQIP. istry of recognized accreditation bodies
(h) Public notice of denial of renewal of and accredited third-party certifi-
direct accreditation. FDA will provide cation bodies, including the name, con-
notice on the Web site described in tact information, and scope and dura-
§ 1.690 of the issuance of a denial of re- tion of recognition or accreditation.
newal application for direct accredita- The registry may provide information
tion under this subpart. on third-party certification bodies ac-
credited by recognized accreditation
§ 1.672 What is the duration of direct bodies through links to the Web sites
accreditation? of such recognized accreditation bod-
FDA will grant direct accreditation ies. FDA will also place on its Web site
of a third-party certification body for a a list of accreditation bodies for which
period not to exceed 4 years. it has denied renewal of recognition,
for which FDA has revoked recogni-
REQUIREMENTS FOR ELIGIBLE ENTITIES tion, and that have relinquished their
UNDER THIS SUBPART recognition or have allowed their rec-
ognition to expire. FDA will also place
§ 1.680 How and when will FDA mon- in its Web site a list of certification
itor eligible entities? bodies whose renewal of accreditation
FDA may, at any time, conduct an has been denied, for which FDA has
onsite audit of an eligible entity that withdrawn accreditation, and that
has received food or facility certifi- have relinquished their accreditations
cation from an accredited third-party or have allowed their accreditations to
certification body under this subpart. expire. FDA will place on its Web site
Where FDA determines necessary or determinations under § 1.670(a)(1) and
appropriate, the unannounced audit modifications of such determinations

may be conducted with or without the under § 1.670(a)(2).
108
§ 1.691 How do I request reconsider- submitted electronically in English to

ation of a denial by FDA of an ap- the address specified in the denial upon
plication or a waiver request? reconsideration and must comply with
(a) An accreditation body may seek procedures it describes.
reconsideration of the denial of an ap- (c) Under § 10.75(d) of this chapter, in-
plication for recognition, renewal of ternal agency review of such denial
recognition, or reinstatement of rec- must be based on the information in
ognition no later than 10 business days the administrative file, which will in-
after the date of the issuance of such clude any supporting information sub-
denial. mitted under § 1.691(c).
(b) A third-party certification body (d) After completing the review and
may seek reconsideration of the denial evaluation of the administrative file,
of an application for direct accredita- FDA will notify the requestor of its de-
tion, renewal of direct accreditation, cision to overturn the denial and grant
reaccreditation of directly accredited the application or waiver request
third-party certification body, a re- through issuance of an application or
quest for a waiver of the conflict of in- waiver request upon reconsideration or
terest requirement in § 1.650(b), or a to affirm the denial of the application
waiver extension no later than 10 busi- or waiver request upon reconsideration
ness days after the date of the issuance through issuance of a denial of an ap-
of such denial. plication or waiver request upon recon-
(c) A request to reconsider an appli- sideration.
cation or waiver request under para- (e) Issuance by FDA of a denial of an
graph (a) or (b) of this section must be application or waiver request upon re-
signed by the requestor or by an indi- consideration constitutes final agency
vidual authorized to act on its behalf action under 5 U.S.C. 702.
in submitting the request for reconsid-
eration. The request must be submitted § 1.693 How do I request a regulatory
electronically in English and must hearing on a revocation of recogni-
tion or withdrawal of accredita-
comply with the procedures described tion?
in the notice.
(d) After completing its review and (a) Request for hearing on revocation.
evaluation of the request for reconsid- No later than 10 business days after the
eration, FDA will notify the requestor date of issuance of a revocation of rec-
through the issuance of the recogni- ognition of an accreditation body
tion, direct accreditation, or waiver under § 1.634, an individual authorized
upon reconsideration or through the to act on the accreditation body’s be-
issuance of a denial of the application half may submit a request for a regu-
or waiver request under paragraph (a) latory hearing on the revocation under
or (b) of this section upon reconsider- part 16 of this chapter. The issuance of
ation. revocation issued under § 1.634 will con-
tain all of the elements required by
§ 1.692 How do I request internal agen- § 16.22 of this chapter and will thereby
cy review of a denial of an applica- constitute the notice of an opportunity
tion or waiver request upon recon- for hearing under part 16 of this chap-
sideration? ter.
(a) No later than 10 business days (b) Request for hearing on withdrawal.
after the date of issuance of a denial of No later than 10 business days after the
an application or waiver request upon date of issuance of a withdrawal of ac-
reconsideration under § 1.691, the re- creditation of a third-party certifi-
questor may seek internal agency re- cation body under § 1.664, an individual
view of such denial under § 10.75(c)(1) of authorized to act on the third-party
this chapter. certification body’s behalf may submit
(b) The request for internal agency a request for a regulatory hearing on
review under paragraph (a) of this sec- the withdrawal under part 16 of this
tion must be signed by the requestor or chapter. The issuance of withdrawal
by an individual authorized to act on under § 1.664 will contain all of the ele-
its behalf in submitting the request for ments required by § 16.22 of this chapter
internal review. The request must be and will thereby constitute the notice
109
§ 1.694 21 CFR Ch. I (4–1–19 Edition)
of opportunity of hearing under part 16 cordingly, the following requirements

of this chapter. of part 16 are inapplicable to regu-
(c) Submission of request for regulatory latory hearings under this subpart:
hearing. The request for a regulatory § 16.22 (Initiation of a regulatory hear-
hearing under paragraph (a) or (b) of ing); § 16.24(e) (timing) and (f) (contents
this section must be submitted with a of notice); § 16.40 (Commissioner);
written appeal that responds to the § 16.60(a) (public process); § 16.95(b) (ad-
basis for the FDA decision, as described ministrative decision and record for de-
in the issuance of revocation or with- cision); and § 16.119 (Reconsideration
drawal, as appropriate, and includes and stay of action).
any supporting information upon (3) A decision by the presiding officer
which the requestor is relying. The re- to affirm the revocation of recognition
quest, appeal, and supporting informa- or the withdrawal of accreditation is
tion must be submitted in English to considered a final agency action under
the address specified in the notice and 5 U.S.C. 702.
must comply with the procedures it de-
scribes. § 1.694 Are electronic records created
(d) Effect of submission of request on under this subpart subject to the
FDA decision. The submission of a re- electronic records requirements of
quest for a regulatory hearing under part 11 of this chapter?
paragraph (a) or (b) of this section will Records that are established or main-
not operate to delay or stay the effect tained to satisfy the requirements of
of a decision by FDA to revoke recogni- this subpart and that meet the defini-
tion of an accreditation body or to tion of electronic records in § 11.3(b)(6)
withdraw accreditation of a third-party of this chapter are exempt from the re-
certification body unless FDA deter- quirements of part 11 of this chapter.
mines that a delay or a stay is in the Records that satisfy the requirements
public interest. of this subpart, but that also are re-
(e) Presiding officer. The presiding of- quired under other applicable statutory
ficer for a regulatory hearing for a rev- provisions or regulations, remain sub-
ocation or withdrawal under this subject to part 11 of this chapter.
part will be designated after a request
for a regulatory hearing is submitted § 1.695 Are the records obtained by
to FDA. FDA under this subpart subject to
(f) Denial of a request for regulatory public disclosure?
hearing. The presiding officer may deny Records obtained by FDA under this
a request for regulatory hearing for a subpart are subject to the disclosure
revocation or withdrawal under requirements under part 20 of this
§ 16.26(a) of this chapter when no gen- chapter.
uine or substantial issue of fact has
been raised. REQUIREMENTS FOR USER FEES UNDER
(g) Conduct of regulatory hearing. (1) If THIS SUBPART
the presiding officer grants a request
for a regulatory hearing for a revoca- SOURCE: Sections 1.700 through 1.725 appear
tion or withdrawal, the hearing will be at 81 FR 90193, Dec. 14, 2016, unless otherwise
held within 10 business days after the noted.
date the request was filed or, if applica-
ble, within a timeframe agreed upon in § 1.700 Who is subject to a user fee
under this subpart?
writing by requestor, the presiding offi-
cer, and FDA. (a) Accreditation bodies submitting
(2) The presiding officer must con- applications or renewal applications
duct the regulatory hearing for revoca- for recognition in the third-party cer-
tion or withdrawal under part 16 of this tification program;
chapter, except that, under § 16.5(b) of (b) Recognized accreditation bodies
this chapter, such procedures apply participating in the third-party certifi-
only to the extent that the procedures cation program;
are supplementary and do not conflict (c) Third-party certification bodies
with the procedures specified for regu- submitting applications or renewal ap-
latory hearings under this subpart. Ac- plications for direct accreditation; and
110
(d) Accredited third-party certifi- § 1.710 How will FDA notify the public
cation bodies (whether accredited by about the fee schedule?
recognized accreditation bodies or by FDA will notify the public of the fee
FDA through direct accreditation) par- schedule annually. The fee notice will
ticipating in the third-party certifi- be made publicly available prior to the
cation program. beginning of the fiscal year for which
the fees apply, except for the first fis-
§ 1.705 What user fees are established cal year in which this regulation is ef-
under this subpart? fective. Each new fee schedule will be
(a) The following application fees: adjusted for inflation and improve-
(1) Accreditation bodies applying for ments in the estimates of the cost to
recognition are subject to an applica- FDA of performing relevant work for
tion fee for the estimated average cost the upcoming year.
of the work FDA performs in reviewing
§ 1.715 When must a user fee required
and evaluating applications for rec- by this subpart be submitted?
ognition of accreditation bodies.
(a) Accreditation bodies applying for
(2) Recognized accreditation bodies
recognition and third-party certifi-
submitting renewal applications are
cation bodies applying for direct ac-
subject to a renewal application fee for
creditation must submit a fee concur-
the estimated average cost of the work
rently with submitting an application
FDA performs in reviewing and evalu-
or a renewal application.
ating renewal applications for recogni- (b) Accreditation bodies and third-
tion of accreditation bodies. party certification bodies subject to an
(3) Third-party certification bodies annual fee must submit payment with-
applying for direct accreditation are in 30 days of receiving billing for the
subject to an application fee for the es- fee.
timated average cost of the work FDA
performs in reviewing and evaluating § 1.720 Are user fees under this sub-
applications for direct accreditation. part refundable?
(4) Accredited third-party certifi- User fees accompanying completed
cation bodies applying for renewal of applications and annual fees under this
direct accreditation are subject to an subpart are not refundable.
application fee for the estimated aver-
age cost of the work FDA performs in § 1.725 What are the consequences of
reviewing and evaluating renewal ap- not paying a user fee under this
subpart on time?
plications for direct accreditation.
(b) The following annual fees: (a) An application for recognition or
(1) Recognized accreditation bodies renewal of recognition will not be con-
are subject to an annual fee for the es- sidered complete for the purposes of
§ 1.631(a) until the date that FDA re-
timated average cost of the work FDA
ceives the application fee. An applica-
performs to monitor performance of
tion for direct accreditation or for re-
recognized accreditation bodies under
newal of direct accreditation will not
§ 1.633.
be considered complete for the pur-
(2) Third-party certification bodies poses of § 1.671(a) until FDA receives
directly accredited by FDA are subject the application fee.
to an annual fee for the estimated av- (b) A recognized accreditation body
erage cost of the work FDA performs that fails to submit its annual user fee
to monitor directly accredited third- within 30 days of the due date will have
party certification bodies under § 1.662. its recognition suspended.
(3) Third-party certification bodies (1) FDA will notify the accreditation
accredited by recognized accreditation body electronically that its recognition
bodies are subject to an annual fee for is suspended. FDA will notify the pub-
the estimated average cost of the work lic of the suspension on the Web site
FDA performs to monitor third-party described in § 1.690.
certification bodies that are accredited (2) While an accreditation body’s rec-
by a recognized accreditation body ognition is suspended, the accredita-

under § 1.662. tion body will not be able to accredit
111
§ 1.900 21 CFR Ch. I (4–1–19 Edition)
additional third-party certification quirements of this subpart apply to

bodies. The accreditation of third- shippers, receivers, loaders, and car-
party certification bodies that oc- riers engaged in transportation oper-
curred prior to an accreditation body’s ations whether or not the food is being
suspension, as well as food or facility offered for or enters interstate com-
certifications issued by such third- merce. The requirements of this sub-
party certification bodies, would re- part apply in addition to any other re-
main in effect. quirements of this chapter that are ap-
(3) If payment is not received within plicable to the transportation of food,
90 days of the payment due date, FDA e.g., in 21 CFR parts 1, 117, 118, 225, 507,
will revoke the accreditation body’s and 589.
recognition under § 1.634(a)(4)(iii), and (b) The requirements of this subpart
provide notice of such revocation in ac- do not apply to shippers, receivers,
cordance with § 1.634. loaders, or carriers when they are en-
(c) An accredited third-party certifi-
gaged in transportation operations:
cation body that fails to submit its an-
nual fee within 30 days of the due date (1) Of food that is transshipped
will have its accreditation suspended. through the United States to another
(1) FDA will notify the third-party country; or
certification body that its accredita- (2) Of food that is imported for future
tion is suspended, electronically and in export, in accordance with section
English. FDA will notify a recognized 801(d)(3) of the Federal Food, Drug, and
accreditation body, electronically and Cosmetic Act, and that is neither con-
in English, if the accreditation of one if sumed nor distributed in the United
its third-party certification bodies is States; or
suspended. FDA will notify the public (3) Of food when it is located in food
of the suspension on the Web site de- facilities as defined in § 1.227 of this
scribed in § 1.690. chapter, that are regulated exclusively,
(2) While a third-party certification throughout the entire facility, by the
body’s accreditation is suspended, the U.S. Department of Agriculture under
third-party certification body will not the Federal Meat Inspection Act (21
be able to issue food or facility certifi- U.S.C. 601 et seq.), the Poultry Products
cations. A food or facility certification Inspection Act (21 U.S.C. 451 et seq.), or
issued by a third-party certification the Egg Products Inspection Act (21
body prior to the suspension of the U.S.C. 1031 et seq.).
auditor/certification body accredita-
tion will remain in effect. § 1.902 How do the criteria and defini-
(3) If payment is not received within tions in this subpart apply under
90 days of the payment due date, FDA the Federal Food, Drug, and Cos-
will withdraw the third-party certifi- metic Act?
cation body’s accreditation under (a) The criteria and definitions of
§ 1.664(a)(4), and provide notice of such this subpart apply in determining
withdrawal in accordance with § 1.664. whether food is adulterated within the
meaning of section 402(i) of the Federal
Subpart N [Reserved] Food, Drug, and Cosmetic Act in that
the food has been transported or of-
Subpart O—Sanitary Transpor- fered for transport by a shipper, carrier
tation of Human and Animal by motor vehicle or rail vehicle, load-
Food er, or receiver engaged in transpor-
tation operations under conditions
that are not in compliance with this
SOURCE: 81 FR 20166, Apr. 6, 2016, unless
otherwise noted. subpart.
(b) The failure by a shipper, carrier
GENERAL PROVISIONS by motor vehicle or rail vehicle, load-
er, or receiver engaged in transpor-
§ 1.900 Who is subject to this subpart? tation operations to comply with the
(a) Except for non-covered businesses requirements of this subpart is a pro-
as defined in § 1.904 and as provided for hibited act under section 301(hh) of the
in paragraph (b) of this section, the re- Federal Food, Drug, and Cosmetic Act.
112
§ 1.904 What definitions apply to this work in 1 year, 2,080 hours (i.e., 40
subpart? hours x 52 weeks). If the result is not a
The definitions and interpretations whole number, round down to the next
of terms in section 201 of the Federal lowest whole number.
Food, Drug, and Cosmetic Act are ap- Loader means a person that loads
plicable to such terms when used in food onto a motor or rail vehicle dur-
this part. The following definitions ing transportation operations.
also apply: Non-covered business means a shipper,
Adequate means that which is needed loader, receiver, or carrier engaged in
to accomplish the intended purpose in transportation operations that has less
keeping with good public health prac- than $500,000, as adjusted for inflation,
tice. in average annual revenues, calculated
Animal food means food for animals on a rolling basis, during the 3-year pe-
other than man, and includes pet food, riod preceding the applicable calendar
animal feed, and raw materials and in- year. For the purpose of determining
gredients. an entity’s 3-year average revenue
Bulk vehicle means a tank truck, hop- threshold as adjusted for inflation, the
per truck, rail tank car, hopper car, baseline year for calculating the ad-
cargo tank, portable tank, freight con- justment for inflation is 2011.
tainer, or hopper bin, or any other ve- Operating temperature means a tem-
hicle in which food is shipped in bulk, perature sufficient to ensure that
with the food coming into direct con- under foreseeable circumstances of
tact with the vehicle. temperature variation during trans-
Carrier means a person who phys- port, e.g., seasonal conditions, refrig-
ically moves food by rail or motor ve- eration unit defrosting, multiple vehi-
hicle in commerce within the United cle loading and unloading stops, the op-
States. The term carrier does not in- eration will meet the requirements of
clude any person who transports food § 1.908(a)(3).
while operating as a parcel delivery Pest means any objectionable ani-
service. mals or insects including birds, ro-
Cross-contact means the uninten- dents, flies, and larvae.
tional incorporation of a food allergen Receiver means any person who re-
as defined in section 201(qq) of the Fed- ceives food at a point in the United
eral Food, Drug, and Cosmetic Act into States after transportation, whether or
food, except animal food. not that person represents the final
Farm has the meaning given in § 1.227 point of receipt for the food.
of this chapter. Shipper means a person, e.g., the
Food not completely enclosed by a con- manufacturer or a freight broker, who
tainer means any food that is placed arranges for the transportation of food
into a container in such a manner that in the United States by a carrier or
it is partially open to the surrounding multiple carriers sequentially.
environment. Examples of such con- Small business means a business em-
tainers include an open wooden basket ploying fewer than 500 full-time equiv-
or crate, an open cardboard box, a alent employees except that for car-
vented cardboard box with a top, or a riers by motor vehicle that are not also
vented plastic bag. This term does not shippers and/or receivers, this term
include food transported in a bulk vehi- would mean a business subject to
cle as defined in this subpart. § 1.900(a) having less than $27,500,000 in
Full-time equivalent employee is a term annual receipts.
used to represent the number of em- Transportation means any movement
ployees of a business entity for the pur- of food in by motor vehicle or rail vehi-
pose of determining whether the busi- cle in commerce within the United
ness is a small business. The number of States.
full-time equivalent employees is de- Transportation equipment means
termined by dividing the total number equipment used in food transportation
of hours of salary or wages paid di- operations, e.g., bulk and non-bulk con-
rectly to employees of the business en- tainers, bins, totes, pallets, pumps, fit-
tity and of all of its affiliates and sub- tings, hoses, gaskets, loading systems,
sidiaries by the number of hours of and unloading systems. Transportation
113
§ 1.906 21 CFR Ch. I (4–1–19 Edition)
equipment also includes a railcar not to provide adequate temperature con-

attached to a locomotive or a trailer trol to prevent the food from becoming
not attached to a tractor. unsafe during transportation oper-
Transportation operations means all ations.
activities associated with food trans- (d) Vehicles and transportation
portation that may affect the sanitary equipment must be stored in a manner
condition of food including cleaning, that prevents it from harboring pests
inspection, maintenance, loading and or becoming contaminated in any other
unloading, and operation of vehicles manner that could result in food for
and transportation equipment. Trans- which it will be used becoming unsafe
portation operations do not include during transportation operations.
any activities associated with the
transportation of food that is com- TRANSPORTATION OPERATIONS
pletely enclosed by a container except
a food that requires temperature con- § 1.908 What requirements apply to
trol for safety, compressed food gases, transportation operations?
food contact substances as defined in (a) General requirements. (1) Unless
section 409(h)(6) of the Federal Food,
stated otherwise in this section, the re-
Drug, and Cosmetic Act, human food
quirements of this section apply to all
byproducts transported for use as ani-
shippers, carriers, loaders, and receiv-
mal food without further processing, or
ers engaged in transportation oper-
live food animals except molluscan
ations. A person may be subject to
shellfish. In addition, transportation
operations do not include any transpor- these requirements in multiple capac-
tation activities that are performed by ities, e.g., the shipper may also be the
a farm. loader and the carrier, if the person
Vehicle means a land conveyance that also performs the functions of those re-
is motorized, e.g., a motor vehicle, or spective persons as defined in this sub-
that moves on rails, e.g., a railcar, part. An entity subject to this subpart
which is used in transportation oper- (shipper, loader, carrier, or receiver)
ations. may reassign, in a written agreement,
its responsibilities under this subpart
VEHICLES AND TRANSPORTATION to another party subject to this sub-
EQUIPMENT part. The written agreement is subject
to the records requirements of
§ 1.906 What requirements apply to ve- § 1.912(d).
hicles and transportation equip-
ment? (2) Responsibility for ensuring that
transportation operations are carried
(a) Vehicles and transportation out in compliance with all require-
equipment used in transportation oper- ments in this subpart must be assigned
ations must be so designed and of such to competent supervisory personnel.
material and workmanship as to be
(3) All transportation operations
suitable and adequately cleanable for
must be conducted under such condi-
their intended use to prevent the food
tions and controls necessary to prevent
they transport from becoming unsafe,
i.e., adulterated within the meaning of the food from becoming unsafe during
section 402(a)(1), (2), and (4) of the Fed- transportation operations including:
eral Food, Drug, and Cosmetic Act dur- (i) Taking effective measures such as
ing transportation operations. segregation, isolation, or the use of
(b) Vehicles and transportation packaging to protect food from con-
equipment must be maintained in such tamination by raw foods and nonfood
a sanitary condition for their intended items in the same load.
use as to prevent the food they trans- (ii) Taking effective measures such
port from becoming unsafe during as segregation, isolation, or other pro-
transportation operations. tective measures, such as hand wash-
(c) Vehicles and transportation ing, to protect food transported in bulk
equipment used in transportation oper- vehicles or food not completely en-
ations for food requiring temperature closed by a container from contamina-
control for safety must be designed, tion and cross-contact during transpor-
maintained, and equipped as necessary tation operations.
114
(iii) Taking effective measures to en- quired for sanitary transport change
sure that food that requires tempera- based upon the type of food being
ture control for safety is transported transported, in which case the shipper
under adequate temperature control. shall so notify the carrier in writing
(4) The type of food, e.g., animal feed, before the shipment. The information
pet food, human food, and its produc- submitted by the shipper to the carrier
tion stage, e.g., raw material, ingre- is subject to the records requirements
dient or finished food, must be consid- in § 1.912(a).
ered in determining the necessary con- (2) Unless the shipper takes other
ditions and controls for the transpor- measures in accordance with paragraph
tation operation. (b)(5) of this section to ensure that ade-
(5) Shippers, receivers, loaders, and quate temperature control is provided
carriers, which are under the owner- during the transportation of food that
ship or operational control of a single requires temperature control for safety
legal entity, as an alternative to meet- under the conditions of shipment, a
ing the requirements of paragraphs (b), shipper of such food must specify in
(d), and (e) of this section may conduct writing to the carrier, except a carrier
transportation operations in conform- who transports the food in a thermally
ance with common, integrated written insulated tank, and, when necessary,
procedures that ensure the sanitary the loader, an operating temperature
transportation of food consistent with for the transportation operation in-
the requirements of this section. The cluding, if necessary, the pre-cooling
written procedures are subject to the
phase. One-time notification shall be
records requirements of § 1.912(e).
sufficient unless a factor, e.g., the con-
(6) If a shipper, loader, receiver, or
ditions of shipment, changes, necessi-
carrier becomes aware of an indication
tating a change in the operating tem-
of a possible material failure of tem-
perature, in which case the shipper
perature control or other conditions
shall so notify the carrier in writing
that may render the food unsafe during
before the shipment. The information
transportation, the food shall not be
submitted by the shipper to the carrier
sold or otherwise distributed, and these
is subject to the records requirements
persons must take appropriate action
in § 1.912(a).
including, as necessary, communica-
tion with other parties to ensure that (3) A shipper must develop and imple-
the food is not sold or otherwise dis- ment written procedures, subject to
tributed unless a determination is the records requirements of § 1.912(a),
made by a qualified individual that the adequate to ensure that vehicles and
temperature deviation or other condi- equipment used in its transportation
tion did not render the food unsafe. operations are in appropriate sanitary
(b) Requirements applicable to shippers condition for the transportation of the
engaged in transportation operations. (1) food, i.e., will prevent the food from be-
Unless the shipper takes other meas- coming unsafe during the transpor-
ures in accordance with paragraph tation operation. Measures to imple-
(b)(3) of this section to ensure that ve- ment these procedures may be accom-
hicles and equipment used in its trans- plished by the shipper or by the carrier
portation operations are in appropriate or another party covered by this sub-
sanitary condition for the transpor- part under a written agreement subject
tation of the food, i.e., that will pre- to the records requirements of
vent the food from becoming unsafe, § 1.912(a).
the shipper must specify to the carrier (4) A shipper of food transported in
and, when necessary, the loader, in bulk must develop and implement writ-
writing, all necessary sanitary speci- ten procedures, subject to the records
fications for the carrier’s vehicle and requirements of § 1.912(a), adequate to
transportation equipment to achieve ensure that a previous cargo does not
this purpose, including any specific de- make the food unsafe. Measures to en-
sign specifications and cleaning proce- sure the safety of the food may be ac-
dures. One-time notification shall be complished by the shipper or by the
sufficient unless the design require- carrier or another party covered by

ments and cleaning procedures re- this subpart under a written agreement
115
§ 1.908 21 CFR Ch. I (4–1–19 Edition)
subject to the records requirements of ambient temperature of the vehicle

§ 1.912(a). and its temperature setting, and con-
(5) The shipper of food that requires ducting a sensory inspection, e.g., for
temperature control for safety under off-odors.
the conditions of shipment must de- (e) Requirements applicable to carriers
velop and implement written proce- engaged in transportation operations.
dures, subject to the records require- When the carrier and shipper have a
ments of § 1.912(a), to ensure that the written agreement that the carrier is
food is transported under adequate responsible, in whole or in part, for
temperature control. Measures to en- sanitary conditions during the trans-
sure the safety of the food may be ac- portation operation, the carrier is re-
complished by the shipper or by the sponsible for the following functions as
carrier or another party covered by applicable per the agreement:
this subpart under a written agreement (1) A carrier must ensure that vehi-
subject to the records requirements of cles and transportation equipment
§ 1.912(a) and must include measures meet the shipper’s specifications and
equivalent to those specified for car- are otherwise appropriate to prevent
riers under paragraphs (e)(1) through the food from becoming unsafe during
(3) of this section. the transportation operation.
(c) Requirements applicable to loaders (2) A carrier must, once the transpor-
engaged in transportation operations. (1)
tation operation is complete and if re-
Before loading food not completely en-
quested by the receiver, provide the op-
closed by a container onto a vehicle or
erating temperature specified by the
into transportation equipment the
shipper in accordance with paragraph
loader must determine, considering, as
(b)(2) of this section and, if requested
appropriate, specifications provided by
by the shipper or receiver, demonstrate
the shipper in accordance with para-
that it has maintained temperature
graph (b)(1) of this section, that the ve-
conditions during the transportation
hicle or transportation equipment is in
operation consistent with the oper-
appropriate sanitary condition for the
ating temperature specified by the
transport of the food, e.g., it is in ade-
quate physical condition, and free of shipper in accordance with paragraph
visible evidence of pest infestation and (b)(2) of this section. Such demonstra-
previous cargo that could cause the tion may be accomplished by any ap-
food to become unsafe during transpor- propriate means agreeable to the car-
tation. This may be accomplished by rier and shipper, such as the carrier
any appropriate means. presenting measurements of the ambi-
(2) Before loading food that requires ent temperature upon loading and un-
temperature control for safety, the loading or time/temperature data
loader must verify, considering, as ap- taken during the shipment.
propriate, specifications provided by (3) Before offering a vehicle or trans-
the shipper in accordance with para- portation equipment with an auxiliary
graph (b)(2) of this section, that each refrigeration unit for use for the trans-
mechanically refrigerated cold storage portation of food that requires tem-
compartment or container is ade- perature control for safety under the
quately prepared for the transportation conditions of the shipment during
of such food, including that it has been transportation, a carrier must pre-cool
properly pre-cooled, if necessary, and each mechanically refrigerated cold
meets other sanitary conditions for storage compartment as specified by
food transportation. the shipper in accordance with para-
(d) Requirements applicable to receivers graph (b)(2) of this section.
engaged in transportation operations. (4) If requested by the shipper, a car-
Upon receipt of food that requires tem- rier that offers a bulk vehicle for food
perature control for safety under the transportation must provide informa-
conditions of shipment, the receiver tion to the shipper that identifies the
must take steps to adequately assess previous cargo transported in the vehi-
that the food was not subjected to sig- cle.
nificant temperature abuse, such as de- (5) If requested by the shipper, a car-
termining the food’s temperature, the rier that offers a bulk vehicle for food
116
transportation must provide informa- RECORDS

tion to the shipper that describes the
most recent cleaning of the bulk vehi- § 1.912 What record retention and
cle. other records requirements apply
to shippers, receivers, loaders, and
(6) A carrier must develop and imple- carriers engaged in transportation
ment written procedures subject to the operations?
records requirements of § 1.912(b) that:
(a) Shippers must retain records:
(i) Specify practices for cleaning,
(1) That demonstrate that they pro-
sanitizing if necessary, and inspecting
vide specifications and operating tem-
vehicles and transportation equipment
peratures to carriers as required by
that the carrier provides for use in the
§ 1.908(b)(1) and (2) as a regular part of
transportation of food to maintain the their transportation operations for a
vehicles and the transportation equip- period of 12 months beyond the termi-
ment in appropriate sanitary condition nation of the agreements with the car-
as required by § 1.906(b); riers.
(ii) Describe how it will comply with (2) Of written agreements and the
the provisions for temperature control written procedures required by
in paragraph (e)(2) of this section, and; § 1.908(b)(3), (4), and (5), for a period of
(iii) Describe how it will comply with 12 months beyond when the agreements
the provisions for the use of bulk vehi- and procedures are in use in their
cles in paragraphs (e)(4) and (5) of this transportation operations.
section. (b) Carriers must retain records of
the written procedures required by
TRAINING § 1.908(e)(6) for a period of 12 months be-
yond when the agreements and proce-
§ 1.910 What training requirements
apply to carriers engaged in trans- dures are in use in their transportation
portation operations? operations.
(c) Carriers must retain training
(a) When the carrier and shipper have records required by § 1.910(b) for a pe-
agreed in a written contract that the riod of 12 months beyond when the per-
carrier is responsible, in whole or in son identified in any such records stops
part, for the sanitary conditions during performing the duties for which the
transportation operations, the carrier training was provided.
must provide adequate training to per- (d) Any person subject to this subpart
sonnel engaged in transportation oper- must retain any other written agree-
ations that provides an awareness of ments assigning tasks in compliance
potential food safety problems that with this subpart for a period of 12
may occur during food transportation, months beyond the termination of the
basic sanitary transportation practices agreements.
to address those potential problems, (e) Shippers, receivers, loaders, and
and the responsibilities of the carrier carriers, which operate under the own-
under this part. The training must be ership or control of a single legal enti-
provided upon hiring and as needed ty in accordance with the provisions of
thereafter. § 1.908(a)(5), must retain records of the
(b) Carriers must establish and main- written procedures for a period of 12
tain records documenting the training months beyond when the procedures
described in paragraph (a) of this sec- are in use in their transportation oper-
tion. Such records must include the ations.
date of the training, the type of train- (f) Shippers, receivers, loaders, and
ing, and the person(s) trained. These carriers must make all records re-
records are subject to the records required by this subpart available to a
quirements of § 1.912(c). duly authorized individual promptly
upon oral or written request.
(g) All records required by this sub-
part must be kept as original records,
true copies (such as photocopies, pic-

tures, scanned copies, microfilm,
117
§ 1.914 21 CFR Ch. I (4–1–19 Edition)
microfiche, or other accurate reproduc- § 1.918 What must be included in the

tions of the original records), or elec- Statement of Grounds in a petition
tronic records. requesting a waiver?
(h) Records that are established or In addition to the requirements set
maintained to satisfy the requirements forth in § 10.30 of this chapter, the
of this subpart and that meet the defi- Statement of Grounds in a petition re-
nition of electronic records in questing a waiver must:
§ 11.3(b)(6) of this chapter are exempt
(a) Describe with particularity the
from the requirements of part 11 of this
chapter. Records that satisfy the re- waiver requested, including the per-
quirements of this subpart, but that sons, vehicles, food, or nonfood prod-
also are required under other applica- uct(s) to which the waiver would apply
ble statutory provisions or regulations, and the requirement(s) of this subpart
remain subject to part 11 of this chap- to which the waiver would apply; and
ter. (b) Present information dem-
(i) Except for the written procedures onstrating that the waiver will not re-
required by § 1.908(e)(6)(i), offsite stor- sult in the transportation of food under
age of records is permitted if such conditions that would be unsafe for
records can be retrieved and provided human or animal health and will not
onsite within 24 hours of request for of- be contrary to the public interest.
ficial review. The written procedures
required by § 1.908(e)(6)(i) must remain § 1.920 What information submitted in
onsite as long as the procedures are in a petition requesting a waiver or
use in transportation operations. Elec- submitted in comments on such a
petition is publicly available?
tronic records are considered to be on-
site if they are accessible from an on- We will presume that information
site location. submitted in a petition requesting a
(j) All records required by this sub- waiver and comments submitted on
part are subject to the disclosure re- such a petition does not contain infor-
quirements under part 20 of this chap- mation exempt from public disclosure
ter. under part 20 of this chapter and would
be made public as part of the docket
WAIVERS associated with this request.
§ 1.914 Under what circumstances will § 1.922 Who will respond to a petition
we waive a requirement of this sub- requesting a waiver?
part?
The Director or Deputy Directors of
We will waive any requirement of
the Center for Food Safety and Applied
this subpart with respect to any class
Nutrition (CFSAN) or the Center for
of persons, vehicles, food, or nonfood
Veterinary Medicine (CVM), or the Di-
products, when we determine that:
rector, Office of Compliance, CFSAN,
(a) The waiver will not result in the
or the Director, Office of Surveillance
transportation of food under conditions
and Compliance, CVM, will respond to
that would be unsafe for human or ani-
a petition requesting a waiver.
mal health; and
(b) The waiver will not be contrary to § 1.924 What process applies to a peti-
the public interest. tion requesting a waiver?
§ 1.916 When will we consider whether (a) In general, the procedures set
to waive a requirement of this sub- forth in § 10.30 of this chapter govern
part? our response to a petition requesting a
We will consider whether to waive a waiver.
requirement of this subpart on our own (b) Under § 10.30(h)(3) of this chapter,
initiative or on the petition submitted we will publish a notice in the FEDERAL
under § 10.30 of this chapter by any per- REGISTER, requesting information and
son who is subject to the requirements views on a filed petition, including in-
of this subpart with respect to any formation and views from persons who
class of persons, vehicles, food, or could be affected by the waiver if the

nonfood products. petition were to be granted.
118
(c) Under § 10.30(e)(3) of this chapter, § 1.934 What procedures apply if we

we will respond to the petitioner in determine that a waiver should be
writing. modified or revoked?
(1) If we grant the petition, either in (a) We will provide the following no-
whole or in part, we will publish a notifications:
tice in the FEDERAL REGISTER setting (1) We will notify the entity that ini-
forth any waiver and the reasons for tially requested the waiver, in writing
such waiver. at the address identified in its petition,
(2) If we deny the petition (including if we determine that a waiver granted
partial denials), our written response in response to its petition should be
to the petitioner will explain the rea- modified or revoked.
son(s) for the denial. (2) We will publish a notice of our de-
(d) We will make readily accessible termination that a waiver should be
to the public, and periodically update, modified or revoked in the FEDERAL
a list of filed petitions requesting waiv- REGISTER. This notice will establish a
ers, including the status of each peti- public docket so that interested parties
tion (for example, pending, granted, or may submit written submissions on
denied). our determination.
(b) We will consider timely written
§ 1.926 Under what circumstances may submissions submitted to the public
we deny a petition requesting a docket from interested parties.
waiver? (c) We will publish a notice of our de-
We may deny a petition requesting a cision in the FEDERAL REGISTER. The
waiver if the petition does not provide effective date of the decision will be
the information required under § 1.918 the date of publication of the notice.
(including the requirements of § 10.30 of
this chapter), or if we determine that Subpart P [Reserved]
the waiver could result in the transpor-
tation of food under conditions that Subpart Q—Administrative Deten-
would be unsafe for human or animal tion of Drugs Intended for
health, or that the waiver could be con- Human or Animal Use
trary to the public interest.
§ 1.980 Administrative detention of
§ 1.928 What process will we follow drugs.
when waiving a requirement of this
subpart on our own initiative? (a) General. This section sets forth
the procedures for detention of drugs
If we, on our own initiative, deter- believed to be adulterated or mis-
mine that a waiver is appropriate, we branded. Administrative detention is
will publish a notice in the FEDERAL intended to protect the public by pre-
REGISTER setting forth the waiver and venting distribution or use of drugs en-
the reasons for such waiver. countered during inspections that may
be adulterated or misbranded, until the
§ 1.930 When will a waiver that we
grant become effective? Food and Drug Administration (FDA)
has had time to consider what action it
Any waiver that we grant will be- should take concerning the drugs, and
come effective on the date that notice to initiate legal action, if appropriate.
of the waiver is published in the FED- Drugs that FDA orders detained may
ERAL REGISTER. not be used, moved, altered, or tam-
pered with in any manner by any per-
§ 1.932 Under what circumstances may son during the detention period, except
we modify or revoke a waiver? as authorized under paragraph (h) of
We may modify or revoke a waiver if this section, until FDA terminates the
we determine that the waiver could re- detention order under paragraph (j) of
sult in the transportation of food under this section, or the detention period ex-
conditions that would be unsafe for pires, whichever occurs first.
human or animal health or that the (b) Criteria for ordering detention. Ad-
waiver could be contrary to the public ministrative detention of drugs may be

interest. ordered in accordance with this section
119
§ 1.980 21 CFR Ch. I (4–1–19 Edition)
when an authorized FDA representa- (i) A statement that the drugs identi-
tive, during an inspection under sec- fied in the order are detained for the
tion 704 of the Federal Food, Drug, and period shown;
Cosmetic Act, has reason to believe (ii) A brief, general statement of the
that a drug, as defined in section 201(g) reasons for the detention;
of the Federal Food, Drug, and Cos- (iii) The location of the drugs;
metic Act, is adulterated or mis- (iv) A statement that these drugs are
branded. not to be used, moved, altered, or tam-
(c) Detention period. The detention is pered with in any manner during that
to be for a reasonable period that may period, except as permitted under para-
not exceed 20 calendar days after the graph (h) of this section, without the
detention order is issued, unless the written permission of an authorized
FDA District Director in whose district FDA representative;
the drugs are located determines that a (v) Identification of the detained
greater period is required to seize the
drugs;
drugs, to institute injunction pro-
(vi) The detention order number;
ceedings, or to evaluate the need for
legal action, in which case the District (vii) The date and hour of the deten-
Director may authorize detention for tion order;
10 additional calendar days. The addi- (viii) The period of the detention;
tional 10-calendar-day detention period (ix) The text of section 304(g) of the
may be ordered at the time the deten- Federal Food, Drug, and Cosmetic Act
tion order is issued or at any time and paragraphs (g)(1) and (g)(2) of this
thereafter. The entire detention period section;
may not exceed 30 calendar days, ex- (x) A statement that any informal
cept when the detention period is ex- hearing on an appeal of a detention
tended under paragraph (g)(6) of this order must be conducted as a regu-
section. An authorized FDA represent- latory hearing under part 16 of this
ative may, in accordance with para- chapter, with certain exceptions de-
graph (j) of this section, terminate a scribed in paragraph (g)(3) of this sec-
detention before the expiration of the tion; and
detention period. (xi) The location and telephone num-
(d) Issuance of detention order. (1) The ber of the FDA district office and the
detention order must be issued in writ- name of the FDA District Director.
ing, in the form of a detention notice, (e) Approval of detention order. A de-
signed by the authorized FDA rep- tention order, before issuance, must be
resentative who has reason to believe approved by the FDA District Director
that the drugs are adulterated or mis- in whose district the drugs are located.
branded, and issued to the owner, oper- If prior written approval is not fea-
ator, or agent in charge of the place sible, prior oral approval must be ob-
where the drugs are located. If the tained and confirmed by written
owner or the user of the drugs is dif- memorandum within FDA as soon as
ferent from the owner, operator, or possible.
agent in charge of the place where the
(f) Labeling or marking a detained
drugs are detained, a copy of the deten-
drug. An FDA representative issuing a
tion order must be provided to the
detention order under paragraph (d) of
owner or user of the drugs if the own-
this section must label or mark the
er’s or user’s identity can be readily
determined. drugs with official FDA tags that in-
clude the following information:
(2) If detention of drugs in a vehicle
or other carrier is ordered, a copy of (1) A statement that the drugs are
the detention order must be provided detained by the U.S. Government in ac-
to the shipper of record and the owner cordance with section 304(g) of the Fed-
of the vehicle or other carrier, if their eral Food, Drug, and Cosmetic Act (21
identities can be readily determined. U.S.C. 334(g)).
(3) The detention order must include

the following information:
120
(2) A statement that the drugs must (ii) A request for a hearing under this
not be used, moved, altered, or tam- section should be addressed to the FDA
pered with in any manner for the pe- District Director;
riod shown, without the written per- (iii) The last sentence of § 16.24(e) of
mission of an authorized FDA rep- this chapter, stating that a hearing
resentative, except as authorized in may not be required to be held at a
paragraph (h) of this section. time less than 2 working days after re-
(3) A statement that the violation of ceipt of the request for a hearing, does
a detention order or the removal or al- not apply to a hearing under this sec-
teration of the tag is punishable by tion;
fine or imprisonment or both (section (iv) Paragraph (g)(4) of this section,
303 of the Federal Food, Drug, and Cos- rather than § 16.42(a) of this chapter,
metic Act (21 U.S.C. 333)). describes the FDA employees, i.e., Of-
(4) The detention order number, the fice of Regulatory Affairs Program Di-
date and hour of the detention order, rectors or other FDA officials senior to
the detention period, and the name of an FDA District Director, who preside
the FDA representative who issued the at hearings under this section.
detention order. (4) The presiding officer of a regu-
(g) Appeal of a detention order. (1) A latory hearing on an appeal of a deten-
person who would be entitled to claim tion order, who also must decide the
the drugs, if seized, may appeal a de-
appeal, must be an Office of Regulatory
tention order. Any appeal must be sub-
Affairs Program Director or another
mitted in writing to the FDA District
FDA official senior to an FDA District
Director in whose district the drugs are
Director who is permitted by § 16.42(a)
located within 5 working days of re-
of this chapter to preside over the
ceipt of a detention order. If the appeal
hearing.
includes a request for an informal hear-
ing, as defined in section 201(x) of the (5) If the appellant requests a regu-
Federal Food, Drug, and Cosmetic Act latory hearing and requests that the
(21 U.S.C. 321(x)), the appellant must hearing be held within 5 working days
request either that a hearing be held after the appeal is filed, the presiding
within 5 working days after the appeal officer must, within 5 working days,
is filed or that the hearing be held at a hold the hearing and render a decision
later date, which must not be later affirming or revoking the detention.
than 20 calendar days after receipt of a (6) If the appellant requests a regu-
detention order. latory hearing and requests that the
(2) The appellant of a detention order hearing be held at a date later than
must state the ownership or propri- within 5 working days after the appeal
etary interest the appellant has in the is filed, but not later than 20 calendar
detained drugs. If the detained drugs days after receipt of a detention order,
are located at a place other than an es- the presiding officer must hold the
tablishment owned or operated by the hearing at a date agreed upon by FDA
appellant, the appellant must include and the appellant. The presiding officer
documents showing that the appellant must decide whether to affirm or re-
would have legitimate authority to voke the detention within 5 working
claim the drugs if seized. days after the conclusion of the hear-
(3) Any informal hearing on an ap- ing. The detention period extends to
peal of a detention order must be con- the date of the decision even if the 5-
ducted as a regulatory hearing under working-day period for making the de-
regulation in accordance with part 16 cision extends beyond the otherwise
of this chapter, except that: applicable 20-calendar-day or 30-cal-
(i) The detention order under para- endar-day detention period.
graph (d) of this section, rather than (7) If the appellant appeals the deten-
the notice under § 16.22(a) of this chap- tion order but does not request a regu-
ter, provides notice of opportunity for latory hearing, the presiding officer
a hearing under this section and is part must render a decision on the appeal,
of the administrative record of the reg- affirming or revoking the detention
ulatory hearing under § 16.80(a) of this within 5 working days after the filing
chapter; of the appeal.
121
§ 1.980 21 CFR Ch. I (4–1–19 Edition)
(8) If the presiding officer affirms a paragraph (h)(3) of this section, the de-
detention order, the drugs continue to tained drugs must remain segregated
be detained until FDA terminates the from other drugs and the person re-
detention under paragraph (j) of this sponsible for their movement must im-
section or the detention period expires, mediately orally notify the official
whichever occurs first. who approved the movement of the
(9) If the presiding officer revokes a drugs, or another responsible FDA dis-
detention order, FDA must terminate trict office official, of the new location
the detention under paragraph (j) of of the detained drugs.
this section. (5) Unless otherwise permitted by the
(h) Movement of detained drugs. (1) Ex- FDA representative who is notified of,
cept as provided in this paragraph, no or who approves, the movement of
person may move detained drugs with- drugs under this paragraph, the re-
in or from the place where they have quired tags must accompany the drugs
been ordered detained until FDA termi- during and after movement and must
nates the detention under paragraph (j) remain with the drugs until FDA ter-
of this section or the detention period minates the detention or the detention
expires, whichever occurs first. period expires, whichever occurs first.
(2) If detained drugs are not in final (i) Actions involving adulterated or mis-
form for shipment, the manufacturer branded drugs. If FDA determines that
may move them within the establish- the detained drugs, including any that
ment where they are detained to com- have been put in final form, are adul-
plete the work needed to put them in terated or misbranded, or both, it may
final form. As soon as the drugs are initiate legal action against the drugs
moved for this purpose, the individual or the responsible individuals, or both,
responsible for their movement must or request that the drugs be destroyed
orally notify the FDA representative or otherwise brought into compliance
who issued the detention order, or an- with the Federal Food, Drug, and Cos-
other responsible district office offi- metic Act under FDA’s supervision.
cial, of the movement of the drugs. As (j) Detention termination. If FDA de-
soon as the drugs are put in final form, cides to terminate a detention or when
they must be segregated from other the detention period expires, whichever
drugs, and the individual responsible occurs first, an FDA representative au-
for their movement must orally notify thorized to terminate a detention will
the FDA representative who issued the issue a detention termination notice
detention order, or another responsible releasing the drugs to any person who
district office official, of their new lo- received the original detention order or
cation. The drugs put in final form that person’s representative and will
must not be moved further without remove, or authorize in writing the re-
FDA approval. moval of, the required labels or tags.
(3) The FDA representative who (k) Recordkeeping requirements. (1)
issued the detention order, or another After issuance of a detention order
responsible district office official, may under paragraph (d) of this section, the
approve, in writing, the movement of owner, operator, or agent in charge of
detained drugs for any of the following any factory, warehouse, other estab-
purposes: lishment, or consulting laboratory
(i) To prevent interference with an where detained drugs are manufac-
establishment’s operations or harm to tured, processed, packed, or held, must
the drugs; have, or establish, and maintain ade-
(ii) To destroy the drugs; quate records relating to how the de-
(iii) To bring the drugs into compli- tained drugs may have become adulter-
ance; ated or misbranded, records on any dis-
(iv) For any other purpose that the tribution of the drugs before and after
FDA representative who issued the de- the detention period, records on the
tention order, or other responsible dis- correlation of any in-process detained
trict office official, believes is appro- drugs that are put in final form under
priate in the case. paragraph (h) of this section to the
(4) If an FDA representative approves completed drugs, records of any

the movement of detained drugs under changes in, or processing of, the drugs
122
permitted under the detention order, Subpart F—Caustic Poisons

and records of any other movement
under paragraph (h) of this section. 2.110 Definition of ammonia under Federal
Caustic Poison Act.
Records required under this paragraph
must be provided to FDA on request for Subpart G—Provisions Applicable to Spe-
review and copying. Any FDA request cific Products Subject to the Federal
for access to records required under Food, Drug, and Cosmetic Act
this paragraph must be made at a rea-
sonable time, must state the reason or 2.125 Use of ozone-depleting substances in
purpose for the request, and must iden- foods, drugs, devices, or cosmetics.
tify to the fullest extent practicable AUTHORITY: 15 U.S.C. 402, 409; 21 U.S.C. 321,
the information or type of information 331, 335, 342, 343, 346a, 348, 351, 352, 355, 360b,
sought in the records to which access is 361, 362, 371, 372, 374; 42 U.S.C. 7671 et seq.
requested.
SOURCE: 42 FR 15559, Mar. 22, 1977, unless
(2) Records required under this para- otherwise noted.
graph must be maintained for a max-
imum period of 2 years after the
issuance of the detention order or for Subpart A—General Provisions
such other shorter period as FDA di-
§ 2.5 Imminent hazard to the public
rects. When FDA terminates the deten- health.
tion or when the detention period ex-
pires, whichever occurs first, FDA will (a) Within the meaning of the Fed-
advise all persons required under this eral Food, Drug, and Cosmetic Act an
paragraph to keep records concerning imminent hazard to the public health
that detention whether further record- is considered to exist when the evi-
keeping is required for the remainder dence is sufficient to show that a prod-
of the 2-year, or shorter, period. FDA uct or practice, posing a significant
ordinarily will not require further rec- threat of danger to health, creates a
ordkeeping if the Agency determines public health situation (1) that should
that the drugs are not adulterated or be corrected immediately to prevent
misbranded or that recordkeeping is injury and (2) that should not be per-
not necessary to protect the public mitted to continue while a hearing or
health, unless the records are required other formal proceeding is being held.
under other regulations in this chapter The imminent hazard may be declared
(e.g., the good manufacturing practice at any point in the chain of events
regulation in part 211 of this chapter). which may ultimately result in harm
to the public health. The occurrence of
[79 FR 30719, May 29, 2014, as amended at 82 the final anticipated injury is not es-
FR 14144, Mar. 17, 2017] sential to establish that an imminent
hazard of such occurrence exists.
PART 2—GENERAL ADMINISTRATIVE (b) In exercising his judgment on
RULINGS AND DECISIONS whether an imminent hazard exists, the
Commissioner will consider the num-
Subpart A—General Provisions ber of injuries anticipated and the na-
ture, severity, and duration of the an-
Sec. ticipated injury.
2.5 Imminent hazard to the public health.
2.10 Examination and investigation sam- § 2.10 Examination and investigation
ples. samples.
2.19 Methods of analysis.
(a)(1) When any officer or employee
Subpart B—Human and Animal Foods of the Department collects a sample of
a food, drug, or cosmetic for analysis
2.25 Grain seed treated with poisonous sub- under the act, the sample shall be des-
stances; color identification to prevent
ignated as an official sample if records
adulteration of human and animal food.
2.35 Use of secondhand containers for the
or other evidence is obtained by him or
shipment or storage of food and animal any other officer or employee of the
Department indicating that the ship-
feed.
ment or other lot of the article from
Subparts C–E [Reserved] which such sample was collected was
123
§ 2.10 21 CFR Ch. I (4–1–19 Edition)
introduced or delivered for introduc- (c) After the Food and Drug Adminis-
tion into interstate commerce, or was tration has completed such analysis of
in or was received in interstate com- an official sample of a food, drug, or
merce, or was manufactured within a cosmetic as it determines, in the
Territory. Only samples so designated course of analysis and interpretation of
by an officer or employee of the De- analytical results, to be adequate to es-
partment shall be considered to be offi- tablish the respects, if any, in which
cial samples. the article is adulterated or mis-
(2) For the purpose of determining branded within the meaning of the act,
whether or not a sample is collected for or otherwise subject to the prohibi-
analysis, the term analysis includes ex- tions of the act, and has reserved an
aminations and tests. amount of the article it estimates to be
(3) The owner of a food, drug, or cos-
adequate for use as exhibits in the trial
metic of which an official sample is
of any case that may arise under the
collected is the person who owns the
act based on the sample, a part of the
shipment or other lot of the article
sample, if any remains available, shall
from which the sample is collected.
(b) When an officer or employee of be provided for analysis, upon written
the Department collects an official request, by any person named on the
sample of a food, drug, or cosmetic for label of the article, or the owner there-
analysis under the act, he shall collect of, or the attorney or agent of such
at least twice the quantity estimated person or owner, except when:
by him to be sufficient for analysis, un- (1) After collection, the sample or re-
less: maining part thereof has become de-
(1) The amount of the article avail- composed or otherwise unfit for anal-
able and reasonably accessible for sam- ysis, or
pling is less than twice the quantity so (2) The request is not made within a
estimated, in which case he shall col- reasonable time before the trial of any
lect as much as is available and reason- case under the act, based on the sample
ably accessible. to which such person or owner is a
(2) The cost of twice the quantity so party. The person, owner, attorney, or
estimated exceeds $150. agent who requests the part of sample
(3) The sample cannot by diligent use shall specify the amount desired. A re-
of practicable preservation techniques quest from an owner shall be accom-
available to the Food and Drug Admin- panied by a showing of ownership, and
istration be kept in a state in which it a request from an attorney or agent by
could be readily and meaningfully ana- a showing of authority from such per-
lyzed in the same manner and for the
son or owner to receive the part of
same purposes as the Food and Drug
sample. When two or more requests for
Administration’s analysis.
parts of the same sample are received
(4) The sample is collected from a
shipment or other lot which is being the requests shall be complied with in
imported or offered for import into the the order in which they were received
United States. so long as any part of the sample re-
(5) The sample is collected from a mains available therefor.
person named on the label of the arti- (d) When an official sample of food,
cle or his agent, and such person is also drug, or cosmetic is the basis of a no-
the owner of the article. tice given under section 305 of the act,
(6) The sample is collected from the or of a case under the act, and the per-
owner of the article, or his agent, and son to whom the notice was given, or
such article bears no label or, if it any person who is a party to the case,
bears a label, no person is named there- has no right under paragraph (c) of this
on. section to a part of the sample, such
In addition to the quantity of sample person or his attorney or agent may
set forth in this paragraph, the officer obtain a part of the sample upon re-
or employee shall, if practicable, col- quest accompanied by a written waiver
lect such further amount as he esti- of right under such paragraph (c) from
mates will be sufficient for use as trial each person named on the label of the
exhibits. article and owner thereof, who has not
124
exercised his right under such para- are available from the AOAC INTER-
graph (c). The operation of this para- NATIONAL, 481 North Frederick Ave.,
graph shall be subject to the excep- suite 500, Gaithersburg, MD 20877, or at
tions, terms, and conditions prescribed the National Archives and Records Ad-
in paragraph (c) of this section. ministration (NARA). For information
(e) The Food and Drug Administra- on the availability of this material at
tion is authorized to destroy: NARA, call 202–741–6030, or go to: http://
(1) Any official sample when it deter- www.archives.gov/federallregister/
mines that no analysis of such sample codeloflfederallregulations/
will be made; ibrllocations.html. In the absence of an
(2) Any official sample or part there- AOAC method, the Commissioner will
of when it determines that no notice furnish a copy of the particular meth-
under section 305 of the act, and no od, or a reference to the published
case under the act, is or will be based method, that the Food and Drug Ad-
on such sample; ministration will use in its enforce-
(3) Any official sample or part there- ment program. Other methods may be
of when the sample was the basis of a used for quality control, specifications,
notice under section 305 of the act, and contracts, surveys, and similar non-
when, after opportunity for presen- regulatory functions, but it is expected
tation of views following such notice, that they will be calibrated in terms of
it determines that no other such no- the method which the Food and Drug
tice, and no case under the act, is or Administration uses in its enforcement
will be based on such sample; program. Use of an AOAC method does
(4) Any official sample or part there- not relieve the practioner of the re-
of when the sample was the basis of a sponsibility to demonstrate that he
case under the act which has gone to can perform the method properly
final judgment, and when it determines through the use of positive and nega-
that no other such case is or will be tive controls and recovery and repro-
based on such sample; ducibility studies.
(5) Any official sample or part there-
of if the article is perishable; [42 FR 15559, Mar. 22, 1977, as amended at 47
FR 946, Jan. 8, 1982; 54 FR 9034, Mar. 3, 1989;
(6) Any official sample or part there- 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8,
of when, after collection, such sample 2005]
or part has become decomposed or oth-
erwise unfit for analysis;
(7) That part of any official sample
Subpart B—Human and Animal
which is in excess of three times the Foods
quantity it estimates to be sufficient § 2.25 Grain seed treated with poi-
for analysis. sonous substances; color identifica-
[42 FR 15559, Mar. 22, 1977, as amended at 63 tion to prevent adulteration of
FR 51299, Sept. 25, 1998] human and animal food.
(a) In recent years there has devel-
§ 2.19 Methods of analysis. oped increasing use of poisonous treat-
Where the method of analysis is not ments on seed for fungicidal and other
prescribed in a regulation, it is the pol- purposes. Such treated seed, if con-
icy of the Food and Drug Administra- sumed, presents a hazard to humans
tion in its enforcement programs to and livestock. It is not unusual for
utilize the methods of analysis of the stocks of such treated food seeds to re-
AOAC INTERNATIONAL (AOAC) as main on hand after the planting season
published in the latest edition (13th has passed. Despite the cautions re-
Ed., 1980) of their publication ‘‘Official quired by the Federal Seed Act (53
Methods of Analysis of the Association Stat. 1275, as amended 72 Stat. 476, 7
of Official Analytical Chemists,’’ and U.S.C. 1551 et seq.) in the labeling of the
the supplements thereto (‘‘Changes in treated seed, the Food and Drug Ad-
Methods’’ as published in the March ministration has encountered many
issues of the ‘‘Journal of the Associa- cases where such surplus stocks of
tion of Official Analytical Chemists’’), treated wheat, corn, oats, rye, barley,
which are incorporated by reference, and sorghum seed had been mixed with
when available and applicable. Copies untreated seed and sent to market for
125
§ 2.35 21 CFR Ch. I (4–1–19 Edition)
food or feed use. This has resulted in and animal feed stored or shipped in
livestock injury and in legal actions secondhand containers have been ren-
under the Federal Food, Drug, and Cos- dered dangerous to health. Such con-
metic Act against large quantities of tamination has been the result of the
food adulterated through such admix- original use of these containers for the
ture of poisonous treated seeds with storage and shipment of articles con-
good food. Criminal cases were brought taining or bearing disease organisms or
against some firms and individuals. poisonous or deleterious substances.
Where the treated seeds are promi- (b) The Commissioner concludes that
nently colored, buyers and users or such dangerous or potentially dan-
processors of agricultural food seed for
gerous practices include, but are not
food purposes are able to detect the ad-
limited to, the following:
mixture of the poisonous seed and thus
reject the lots; but most such buyers, (1) Some vegetable growers and pack-
users, and processors do not have the ers employ used poultry crates for
facilities or scientific equipment to de- shipment of fresh vegetables, including
termine the presence of the poisonous cabbage and celery. Salmonella orga-
chemical at the time crops are deliv- nisms are commonly present on dressed
ered, in cases where the treated seeds poultry and in excreta and fluid
have not been so colored. A suitable exudates from dressed birds. Thus
color for this use is one that is in suffi- wooden crates in which dressed poultry
cient contrast to the natural color of has been iced and packed are potential
the food seed as to make admixture of sources of Salmonella or other
treated, denatured seeds with good food enteropathogenic microorganisms that
easily apparent, and is so applied that may contaminate fresh vegetables
it is not readily removed. which are frequently consumed with-
(b) On and after December 31, 1964, out heat treatment.
the Food and Drug Administration will (2) Some potato growers and pro-
regard as adulterated any interstate ducers of animal feeds use secondhand
shipment of the food seeds wheat, corn, bags for shipment of these articles.
oats, rye, barley, and sorghum bearing Such bags may have originally been
a poisonous treatment in excess of a used for shipping or storing pesticide-
recognized tolerance or treatment for
treated seed or other articles bearing
which no tolerance or exemption from
or containing poisonous substances.
tolerance is recognized in regulations
promulgated pursuant to section 408 of Thus these secondhand bags are poten-
the Federal Food, Drug, and Cosmetic tial sources of contamination of the
Act, unless such seeds have been ade- food or animal feed stored or shipped
quately denatured by a suitable color therein.
to prevent their subsequent inad- (c) In a policy statement issued April
vertent use as food for man or feed for 11, 1968, the Food and Drug Administra-
animals. tion declared adulterated within the
(c) Attention is called to the labeling meaning of section 402(a) of the Fed-
requirements of the Federal Hazardous eral Food, Drug, and Cosmetic Act
Substances Act, where applicable to de- shipments of vegetables or other edible
natured seeds in packages suitable for food in used crates or containers that
household use. may render the contents injurious to
health. This policy statement is ex-
§ 2.35 Use of secondhand containers tended so that the Food and Drug Ad-
for the shipment or storage of food
and animal feed. ministration will regard as adulterated
within the meaning of section 402(a) of
(a) Investigations by the Food and the act shipments of vegetables, other
Drug Administration, the National edible food, or animal feed in used
Communicable Disease Center of the crates, bags, or other containers that
U.S. Public Health Service, the Con-
may render the contents injurious to
sumer and Marketing Service of the
health.
U.S. Department of Agriculture, and by
various State public health agencies

have revealed practices whereby food Subparts C–E [Reserved]
126
Subpart F—Caustic Poisons (3) [Reserved]

(4) Other essential uses. (i)–(ii) [Re-
§ 2.110 Definition of ammonia under served]
Federal Caustic Poison Act. (iii) Anesthetic drugs for topical use
For the purpose of determining on accessible mucous membranes of
whether an article containing ammo- humans where a cannula is used for ap-
nia is subject to the Federal Caustic plication.
Poison Act, the ammonia content is to (iv)–(ix) [Reserved]
be calculated as NH3. (f) Any person may file a petition
under part 10 of this chapter to request
Subpart G—Provisions Applicable that FDA initiate rulemaking to
to Specific Products Subject amend paragraph (e) of this section to
add an essential use. FDA may initiate
to the Federal Food, Drug, notice-and-comment rulemaking to
and Cosmetic Act add an essential use on its own initia-
§ 2.125 Use of ozone-depleting sub- tive or in response to a petition, if
stances in foods, drugs, devices, or granted.
cosmetics. (1) If the petition is to add use of a
(a) As used in this section, ozone-de- noninvestigational product, the peti-
pleting substance (ODS) means any class tioner must submit compelling evi-
I substance as defined in 40 CFR part dence that:
82, appendix A to subpart A, or class II (i) Substantial technical barriers
substance as defined in 40 CFR part 82, exist to formulating the product with-
appendix B to subpart A. out ODSs;
(b) Except as provided in paragraph (ii) The product will provide an un-
(c) of this section, any food, drug, de- available important public health ben-
vice, or cosmetic that is, consists in efit; and
part of, or is contained in an aerosol (iii) Use of the product does not re-
product or other pressurized dispenser lease cumulatively significant amounts
that releases an ODS is not an essen- of ODSs into the atmosphere or the re-
tial use of the ODS under the Clean Air lease is warranted in view of the un-
Act. available important public health ben-
(c) A food, drug, device, or cosmetic efit.
that is, consists in part of, or is con- (2) If the petition is to add use of an
tained in an aerosol product or other investigational product, the petitioner
pressurized dispenser that releases an must submit compelling evidence that:
ODS is an essential use of the ODS (i) Substantial technical barriers
under the Clean Air Act if paragraph exist to formulating the investiga-
(e) of this section specifies the use of tional product without ODSs;
that product as essential. For drugs, (ii) A high probability exists that the
including biologics and animal drugs, investigational product will provide an
and for devices, an investigational ap- unavailable important public health
plication or an approved marketing ap- benefit; and
plication must be in effect, as applica- (iii) Use of the investigational prod-
ble. uct does not release cumulatively sig-
(d) [Reserved] nificant amounts of ODSs into the at-
(e) The use of ODSs in the following mosphere or the release is warranted in
products is essential: view of the high probability of an un-
(1) Metered-dose corticosteroid human available important public health ben-
drugs for oral inhalation. Oral pressur- efit.
ized metered-dose inhalers containing (g) Any person may file a petition
the following active moieties: under part 10 of this chapter to request
(i)–(v) [Reserved] that FDA initiate rulemaking to
(2) Metered-dose short-acting adrenergic amend paragraph (e) of this section to
bronchodilator human drugs for oral in- remove an essential use. FDA may ini-
halation. Oral pressurized metered-dose tiate notice-and-comment rulemaking
inhalers containing the following ac- to remove an essential use on its own
tive moieties: initiative or in response to a petition,

(i)–(v) [Reserved] if granted. If the petition is to remove
127
an essential use from paragraph (e) of PART 3—PRODUCT JURISDICTION

this section, the petitioner must sub-
mit compelling evidence of any one of Subpart A—Assignment of Agency Com-
the following criteria: ponent for Review of Premarket Appli-
(1) The product using an ODS is no cations
longer being marketed; or
Sec.
(2) After January 1, 2005, FDA deter- 3.1 Purpose.
mines that the product using an ODS 3.2 Definitions.
no longer meets the criteria in para- 3.3 Scope.
graph (f) of this section after consulta- 3.4 Designated agency component.
tion with a relevant advisory com- 3.5 Procedures for identifying the des-
mittee(s) and after an open public ignated agency component.
3.6 Product jurisdiction officer.
meeting; or 3.7 Request for designation.
(3) For individual active moieties 3.8 Letter of designation.
marketed as ODS products and rep- 3.9 Effect of letter of designation.
resented by one new drug application 3.10 Stay of review time.
(NDA):
Subpart B [Reserved]
(i) At least one non-ODS product
with the same active moiety is mar-
AUTHORITY: 21 U.S.C. 321, 351, 353, 355, 360,
keted with the same route of adminis- 360c–360f, 360h–360j, 360gg–360ss, 360bbb–2,
tration, for the same indication, and 371(a), 379e, 381, 394; 42 U.S.C. 216, 262, 264.
with approximately the same level of
SOURCE: 56 FR 58756, Nov. 21, 1991, unless
convenience of use as the ODS product otherwise noted.
containing that active moiety;
(ii) Supplies and production capacity Subpart A—Assignment of Agen-
for the non-ODS product(s) exist or will cy Component for Review of
exist at levels sufficient to meet pa-
tient need;
Premarket Applications
(iii) Adequate U.S. postmarketing § 3.1 Purpose.
use data is available for the non-ODS This regulation relates to agency
product(s); and management and organization and has
(iv) Patients who medically required two purposes. The first is to implement
the ODS product are adequately served section 503(g) of the act, as added by
by the non-ODS product(s) containing section 16 of the Safe Medical Devices
that active moiety and other available Act of 1990 (Public Law 101–629) and
products; or amended by section 204 of the Medical
(4) For individual active moieties Device User Fee and Modernization Act
marketed as ODS products and rep- of 2002 (Public Law 107–250), by speci-
resented by two or more NDAs: fying how FDA will determine the or-
(i) At least two non-ODS products ganizational component within FDA
that contain the same active moiety designated to have primary jurisdic-
are being marketed with the same tion for the premarket review and reg-
route of delivery, for the same indica- ulation of products that are comprised
tion, and with approximately the same of any combination of a drug and a de-
level of convenience of use as the ODS vice; a device and a biological; a bio-
products; and logical and a drug; or a drug, a device
and a biological. This determination
(ii) The requirements of paragraphs
will eliminate, in most cases, the need
(g)(3)(ii), (g)(3)(iii), and (g)(3)(iv) of this
to receive approvals from more than
section are met. one FDA component for such combina-
[67 FR 48384, July 24, 2002, as amended at 71 tion products. The second purpose of
FR 70873, Dec. 7, 2006; 70 FR 17192, Apr. 4, this regulation is to enhance the effi-
2005; 75 FR 19241, Apr. 14, 2010; 73 FR 69552, ciency of agency management and op-
Nov. 19, 2008; 75 FR 19241, Apr. 14, 2010; 81 FR erations by providing procedures for
74302, Oct. 26, 2016] determining which agency component
will have primary jurisdiction for any

drug, device, or biological product
128
where such jurisdiction is unclear or in dosage form, strength, route of admin-

dispute. Nothing in this section pre- istration, or significant change in dose;
vents FDA from using any agency re- or
sources it deems necessary to ensure (4) Any investigational drug, device,
adequate review of the safety and effec- or biological product packaged sepa-
tiveness of any product, or the substan- rately that according to its proposed
tial equivalence of any device to a labeling is for use only with another
predicate device. individually specified investigational
[56 FR 58756, Nov. 21, 1991, as amended at 68 drug, device, or biological product
FR 37077, June 23, 2003] where both are required to achieve the
intended use, indication, or effect.
§ 3.2 Definitions. (f) Device has the meaning given the
For the purpose of this part: term in section 201(h) of the act.
(a) Act means the Federal Food, (g) Drug has the meaning given the
Drug, and Cosmetic Act. term in section 201(g)(1) of the act.
(b) Agency component means the Cen- (h) FDA means Food and Drug Ad-
ter for Biologics Evaluation and Re- ministration.
search, the Center for Devices and Ra- (i) Letter of designation means the
diological Health, the Center for Drug written notice issued by the product
Evaluation and Research, or alter- jurisdiction officer specifying the agen-
native organizational component of the cy component with primary jurisdic-
agency.
tion for a combination product.
(c) Applicant means any person who
submits or plans to submit an applica- (j) Letter of request means an appli-
tion to the Food and Drug Administra- cant’s written submission to the prod-
tion for premarket review. For pur- uct jurisdiction officer seeking the des-
poses of this section, the terms ‘‘spon- ignation of the agency component with
sor’’ and ‘‘applicant’’ have the same primary jurisdiction.
meaning. (k) Mode of action is the means by
(d) Biological product has the meaning which a product achieves an intended
given the term in section 351(a) of the therapeutic effect or action. For pur-
Public Health Service Act (42 U.S.C. poses of this definition, ‘‘therapeutic’’
262(a)). action or effect includes any effect or
(e) Combination product includes: action of the combination product in-
(1) A product comprised of two or tended to diagnose, cure, mitigate,
more regulated components, i.e., drug/ treat, or prevent disease, or affect the
device, biologic/device, drug/biologic, structure or any function of the body.
or drug/device/biologic, that are phys- When making assignments of combina-
ically, chemically, or otherwise com- tion products under this part, the agen-
bined or mixed and produced as a single cy will consider three types of mode of
entity; action: The actions provided by a bio-
(2) Two or more separate products logical product, a device, and a drug.
packaged together in a single package Because combination products are
or as a unit and comprised of drug and comprised of more than one type of
device products, device and biological regulated article (biological product,
products, or biological and drug prod- device, or drug), and each constituent
ucts; part contributes a biological product,
(3) A drug, device, or biological prod- device, or drug mode of action, com-
uct packaged separately that according bination products will typically have
to its investigational plan or proposed more than one identifiable mode of ac-
labeling is intended for use only with tion.
an approved individually specified (1) A constituent part has a biologi-
drug, device, or biological product cal product mode of action if it acts by
where both are required to achieve the means of a virus, therapeutic serum,
intended use, indication, or effect and toxin, antitoxin, vaccine, blood, blood
where upon approval of the proposed component or derivative, allergenic
product the labeling of the approved product, or analogous product applica-
product would need to be changed, e.g., ble to the prevention, treatment, or

to reflect a change in intended use, cure of a disease or condition of human
129
§ 3.3 21 CFR Ch. I (4–1–19 Edition)
beings, as described in section 351(i) of (p) Sponsor means ‘‘applicant’’ (see

the Public Health Service Act. § 3.2(c)).
(2) A constituent part has a device
mode of action if it meets the defini-
FR 398, Jan. 5, 1999; 64 FR 56447, Oct. 20, 1999;
tion of device contained in section 68 FR 37077, June 23, 2003; 70 FR 49861, Aug.
201(h)(1) to (h)(3) of the act, it does not 25, 2005]
have a biological product mode of ac-
tion, and it does not achieve its pri- § 3.3 Scope.
mary intended purposes through chem-
ical action within or on the body of This section applies to:
man or other animals and is not de- (a) Any combination product, or
pendent upon being metabolized for the (b) Any product where the agency
achievement of its primary intended component with primary jurisdiction is
purposes. unclear or in dispute.
(3) A constituent part has a drug
mode of action if it meets the defini- § 3.4 Designated agency component.
tion of drug contained in section (a) To designate the agency compo-
201(g)(1) of the act and it does not have nent with primary jurisdiction for the
a biological product or device mode of premarket review and regulation of a
action. combination product, the agency shall
(l) Premarket review includes the ex- determine the primary mode of action
amination of data and information in
of the product. Where the primary
an application for premarket review
mode of action is that of:
described in sections 505, 510(k), 513(f),
515, or 520(g) or 520(l) of the act or sec- (1) A drug (other than a biological
tion 351 of the Public Health Service product), the agency component
Act of data and information contained charged with premarket review of
in any investigational new drug (IND) drugs shall have primary jurisdiction;
application, investigational device ex- (2) A device, the agency component
emption (IDE), new drug application charged with premarket review of de-
(NDA), biologics license application, vices shall have primary jurisdiction;
device premarket notification, device (3) A biological product, the agency
reclassification petition, and pre- component charged with premarket re-
market approval application (PMA). view of biological products shall have
(m) Primary mode of action is the sin- primary jurisdiction.
gle mode of action of a combination (b) In some situations, it is not pos-
product that provides the most impor- sible to determine, with reasonable
tant therapeutic action of the com- certainty, which one mode of action
bination product. The most important will provide a greater contribution
therapeutic action is the mode of ac- than any other mode of action to the
tion expected to make the greatest overall therapeutic effects of the com-
contribution to the overall intended
bination product. In such a case, the
therapeutic effects of the combination
agency will assign the combination
product.
product to the agency component that
(n) Product means any article that
contains any drug as defined in section regulates other combination products
201(g)(1) of the act; any device as de- that present similar questions of safety
fined in section 201(h) of the act; or any and effectiveness with regard to the
biologic as defined in section 351(a) of combination product as a whole. When
the Public Health Service Act (42 there are no other combination prod-
U.S.C. 262(a)). ucts that present similar questions of
(o) Product jurisdiction officer is the safety and effectiveness with regard to
person or persons responsible for desig- the combination product as a whole,
nating the component of FDA with pri- the agency will assign the combination
mary jurisdiction for the premarket re- product to the agency component with
view and regulation of a combination the most expertise related to the most
product or any product requiring a ju- significant safety and effectiveness
risdictional designation under this questions presented by the combina-

part. tion product.
130
(c) The designation of one agency (b) For a combination product not
component as having primary jurisdic- covered by a guidance document or for
tion for the premarket review and reg- a product where the agency component
ulation of a combination product does with primary jurisdiction is unclear or
not preclude consultations by that in dispute, the sponsor of an applica-
component with other agency compo- tion for premarket review should fol-
nents or, in appropriate cases, the re- low the procedures set forth in § 3.7 to
quirement by FDA of separate applica- request a designation of the agency
tions. component with primary jurisdiction
before submitting the application.
FR 49861, Aug. 25, 2005] [56 FR 58756, Nov. 21, 1991, as amended at 68
FR 24879, May 9, 2003]
§ 3.5 Procedures for identifying the
designated agency component. § 3.6 Product jurisdiction officer.
(a)(1) The Center for Biologics Eval- The Office of Combination Products
uation and Research, the Center for (Food and Drug Administration, 10903
Devices and Radiological Health, and New Hampshire Ave., Bldg. 32, rm. 5129,
the Center for Drug Evaluation and Re- Silver Spring, MD 20993–0002, 301–796–
search have entered into agreements 8930,, e-mail: combination@fda.gov, is
clarifying product jurisdictional issues. the designated product jurisdiction of-
These guidance documents are on dis- ficer.
play in the Division of Dockets Man-
[68 FR 37077, June 23, 2003, as amended at 71
agement (HFA–305), Food and Drug Ad- FR 16033, Mar. 30, 2006; 75 FR 13678, Mar. 23,
ministration, 5630 Fishers Lane, rm. 2010]
1061, Rockville, MD 20852, and are enti-
tled ‘‘Intercenter Agreement Between § 3.7 Request for designation.
the Center for Drug Evaluation and Re-
search and the Center for Devices and (a) Who should file: the sponsor of:
Radiological Health;’’ ‘‘Intercenter (1) Any combination product the
Agreement Between the Center for De- sponsor believes is not covered by an
vices and Radiological Health and the intercenter agreement; or
Center for Biologics Evaluation and (2) Any product where the agency
Research;’’ ‘‘Intercenter Agreement component with primary jurisdiction is
Between the Center for Drug Evalua- unclear or in dispute.
tion and Research and the Center for (b) When to file: a sponsor should file
Biologics Evaluation and Research.’’ a request for designation before filing
The availability of any amendments to any application for premarket review,
these intercenter agreements will be whether an application for marketing
announced by FEDERAL REGISTER no- approval or a required investigational
tice. notice. Sponsors are encouraged to file
(2) These guidance documents de- a request for designation as soon as
scribe the allocation of responsibility there is sufficient information for the
for categories of products or specific agency to make a determination.
products. These intercenter agree- (c) What to file: an original and two
ments, and any amendments thereto, copies of the request for designation
are nonbinding determinations de- must be filed. The request for designa-
signed to provide useful guidance to tion must not exceed 15 pages, includ-
the public. ing attachments, and must set forth:
(3) The sponsor of a premarket appli- (1) The identity of the sponsor, in-
cation or required investigational fil- cluding company name and address, es-
ing for a combination or other product tablishment registration number, com-
covered by these guidance documents pany contact person and telephone
may contact the designated agency number.
component identified in the inter- (2) A description of the product, in-
center agreement before submitting an cluding:
application of premarket review or to (i) Classification, name of the prod-
confirm coverage and to discuss the ap- uct and all component products, if ap-
plication process. plicable;
131
§ 3.8 21 CFR Ch. I (4–1–19 Edition)
(ii) Common, generic, or usual name its mailing cover should be plainly
of the product and all component prod- marked ‘‘Request for Designation.’’
ucts; Concurrent submissions of electronic
(iii) Proprietary name of the product; copies of Requests for Designation may
(iv) Identification of any component be addressed to combination@fda.gov.
of the product that already has re- [56 FR 58756, Nov. 21, 1991, as amended at 68
ceived premarket approval, is mar- FR 37077, June 23, 2003; 70 FR 49861, Aug. 25,
keted as not being subject to pre- 2005]
market approval, or has received an in-
vestigational exemption, the identity § 3.8 Letter of designation.
of the sponsors, and the status of any (a) Each request for designation will
discussions or agreements between the be reviewed for completeness within 5
sponsors regarding the use of this prod- working days of receipt. Any request
uct as a component of a new combina- for designation determined to be in-
tion product. complete will be returned to the appli-
(v) Chemical, physical, or biological cant with a request for the missing in-
composition; formation. The sponsor of an accepted
(vi) Status and brief reports of the re- request for designation will be notified
sults of developmental work, including of the filing date.
animal testing; (b) Within 60 days of the filing date of
(vii) Description of the manufac- a request for designation, the product
turing processes, including the sources jurisdiction officer will issue a letter of
of all components; designation to the sponsor, with copies
(viii) Proposed use or indications; to the centers, specifying the agency
(ix) Description of all known modes component designated to have primary
of action, the sponsor’s identification jurisdiction for the premarket review
of the single mode of action that pro- and regulation of the product at issue,
vides the most important therapeutic and any consulting agency compo-
action of the product, and the basis for nents. The product jurisdiction officer
that determination. may request a meeting with the spon-
(x) Schedule and duration of use; sor during the review period to discuss
(xi) Dose and route of administration the request for designation. If the prod-
of drug or biologic; uct jurisdiction officer has not issued a
(xii) Description of related products, letter of designation within 60 days of
including the regulatory status of the filing date of a request for designa-
those related products; and tion, the sponsor’s recommendation of
(xiii) Any other relevant informa- the center with primary jurisdiction,
tion. in accordance with § 3.7(c)(3), shall be-
(3) The sponsor’s recommendation as come the designated agency compo-
to which agency component should nent.
have primary jurisdiction based on the (c) Request for reconsideration by
mode of action that provides the most sponsor: If the sponsor disagrees with
important therapeutic action of the the designation, it may request the
combination product. If the sponsor product jurisdiction officer to recon-
cannot determine with reasonable cer- sider the decision by filing, within 15
tainty which mode of action provides days of receipt of the letter of designa-
the most important therapeutic action tion, a written request for reconsider-
of the combination product, the spon- ation not exceeding 5 pages. No new in-
sor’s recommendation must be based formation may be included in a request
on the assignment algorithm set forth for reconsideration. The product juris-
in § 3.4(b) and an assessment of the as- diction officer shall review and act on
signment of other combination prod- the request in writing within 15 days of
ucts the sponsor wishes FDA to con- its receipt.
sider during the assignment of its com-
bination product. § 3.9 Effect of letter of designation.
(d) Where to file: all communications (a) The letter of designation con-
pursuant to this subpart shall be ad- stitutes an agency determination that
dressed to the attention of the product is subject to change only as provided in

jurisdiction officer. Such a request, in paragraph (b) of this section.
132
(b) The product jurisdiction officer Subpart B—Postmarketing Safety Reporting

may change the designated agency for Combination Products
component with the written consent of
4.100 What is the scope of this subpart?
the sponsor, or without its consent to 4.101 How does FDA define key terms and
protect the public health or for other phrases in this subpart?
compelling reasons. A sponsor shall be 4.102 What reports must you submit to FDA
given 30 days written notice of any pro- for your combination product or con-
posed nonconsensual change in des- stituent part?
ignated agency component. The spon- 4.103 What information must you share with
sor may request an additional 30 days other constituent part applicants for the
to submit written objections, not to ex- combination product?
4.104 How and where must you submit post-
ceed 15 pages, to the proposed change, marketing safety reports for your com-
and shall be granted, upon request, a bination product or constituent part?
timely meeting with the product juris- 4.105 What are the postmarketing safety re-
diction officer and appropriate center porting recordkeeping requirements for
officials. Within 30 days of receipt of your combination product or constituent
the sponsor’s written objections, the part?
product jurisdiction officer shall issue AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353,
to the sponsor, with copies to appro- 355, 360, 360b–360f, 360h–360j, 360l, 360hh–360ss,
priate center officials, a written deter- 360aaa–360bbb, 371(a), 372–374, 379e, 381, 383,
mination setting forth a statement of 394; 42 U.S.C. 216, 262, 263a, 264, 271.
reasons for the proposed change in des- SOURCE: 78 FR 4321, Jan. 22, 2013, unless
ignated agency component. A non- otherwise noted.
consensual change in the designated
agency component requires the concur- Subpart A—Current Good Manu-
rence of the Principal Associate Com- facturing Practice Require-
missioner. ments for Combination Prod-
[56 FR 58756, Nov. 21, 1991, as amended at 68 ucts
FR 37077, June 23, 2003]
§ 4.1 What is the scope of this subpart?
§ 3.10 Stay of review time.
This subpart applies to combination
Any filing with or review by the products. It establishes which current
product jurisdiction officer stays the good manufacturing practice require-
review clock or other established time ments apply to these products. This
periods for agency action for an appli- subpart clarifies the application of cur-
cation for marketing approval or re- rent good manufacturing practice regu-
quired investigational notice during lations to combination products, and
the pendency of the review by the prod- provides a regulatory framework for
uct jurisdiction officer. designing and implementing the cur-
rent good manufacturing practice oper-
Subpart B [Reserved] ating system at facilities that manu-
facture co-packaged or single-entity
PART 4—REGULATION OF combination products.
COMBINATION PRODUCTS § 4.2 How does FDA define key terms
and phrases in this subpart?
Subpart A—Current Good Manufacturing
The terms listed in this section have
Practice Requirements for Combina-
the following meanings for purposes of
tion Products
this subpart:
Sec. Biological product has the meaning set
4.1 What is the scope of this subpart? forth in § 3.2(d) of this chapter. A bio-
4.2 How does FDA define key terms and logical product also meets the defini-
phrases in this subpart? tions of either a drug or device as these
4.3 What current good manufacturing prac- terms are defined under this section.
tice requirements apply to my combina-
tion product?
Combination product has the meaning
4.4 How can I comply with these current set forth in § 3.2(e) of this chapter.
Constituent part is a drug, device, or
good manufacturing practice require-

ments for a co-packaged or single-entity biological product that is part of a
combination product? combination product.
133
§ 4.3 21 CFR Ch. I (4–1–19 Edition)
Co-packaged combination product has § 4.3 What current good manufac-

the meaning set forth in § 3.2(e)(2) of turing practice requirements apply
this chapter. to my combination product?
Current good manufacturing practice If you manufacture a combination
operating system means the operating product, the requirements listed in this
system within an establishment that is section apply as follows:
designed and implemented to address (a) The current good manufacturing
and meet the current good manufac- practice requirements in parts 210 and
turing practice requirements for a 211 of this chapter apply to a combina-
combination product. tion product that includes a drug con-
Current good manufacturing practice stituent part;
requirements means the requirements (b) The current good manufacturing
set forth under § 4.3(a) through (d). practice requirements in part 820 of
this chapter apply to a combination
Device has the meaning set forth in
product that includes a device con-
§ 3.2(f) of this chapter. A device that is
stituent part;
a constituent part of a combination (c) The current good manufacturing
product is considered a finished device practice requirements among the re-
within the meaning of the QS regula- quirements (including standards) for
tion. biological products in parts 600 through
Drug has the meaning set forth in 680 of this chapter apply to a combina-
§ 3.2(g) of this chapter. A drug that is a tion product that includes a biological
constituent part of a combination product constituent part to which
product is considered a drug product those requirements would apply if that
within the meaning of the drug constituent part were not part of a
CGMPs. combination product; and
Drug CGMPs refers to the current (d) The current good tissue practice
good manufacturing practice regula- requirements including donor eligi-
tions set forth in parts 210 and 211 of bility requirements for HCT/Ps in part
this chapter. 1271 of this chapter apply to a combina-
HCT/Ps refers to human cell, tissue, tion product that includes an HCT/P.
and cellular and tissue-based products, § 4.4 How can I comply with these cur-
as defined in § 1271.3(d) of this chapter. rent good manufacturing practice
An HCT/P that is not solely regulated requirements for a co-packaged or
under section 361 of the Public Health single-entity combination product?
Service Act may be a constituent part (a) Under this subpart, for single en-
of a combination product. Such an tity or co-packaged combination prod-
HCT/P is subject to part 1271 of this ucts, compliance with all applicable
chapter and is also regulated as a drug, current good manufacturing practice
device, and/or biological product. requirements for the combination prod-
Manufacture includes, but is not lim- uct shall be achieved through the de-
ited to, designing, fabricating, assem- sign and implementation of a current
bling, filling, processing, testing, label- good manufacturing practice operating
ing, packaging, repackaging, holding, system that is demonstrated to comply
and storage. with:
QS regulation refers to the quality (1) The specifics of each set of cur-
system regulation in part 820 of this rent good manufacturing practice regu-
chapter. lations listed under § 4.3 as they apply
to each constituent part included in
Single-entity combination product has
the combination product; or
the meaning set forth in § 3.2(e)(1) of
(2) Paragraph (b) of this section.
this chapter. (b) If you elect to establish a current
Type of constituent part refers to the good manufacturing practice operating
category of the constituent part, which system in accordance with paragraph
can be either a biological product, a de- (b) of this section, the following re-
vice, or a drug, as these terms are de- quirements apply:
fined under this section. (1) If the combination product in-

cludes a device constituent part and a
134
drug constituent part, and the current part, the current good manufacturing
good manufacturing practice operating practice operating system must also be
system has been shown to comply with shown to implement and comply with
the drug CGMPs, the following provi- all manufacturing requirements identi-
sions of the QS regulation must also be fied under § 4.3(c) that would apply to
shown to have been satisfied; upon that biological product if that con-
demonstration that these requirements stituent part were not part of a com-
have been satisfied, no additional bination product.
showing of compliance with respect to (4) In addition to being shown to
the QS regulation need be made: comply with the other applicable cur-
(i) Section 820.20 of this chapter. rent good manufacturing practice re-
Management responsibility. quirements listed under § 4.3, if the
(ii) Section 820.30 of this chapter. De- combination product includes an HCT/
sign controls. P, the current good manufacturing
(iii) Section 820.50 of this chapter. practice operating system must also be
Purchasing controls. shown to implement and comply with
(iv) Section 820.100 of this chapter. all current good tissue practice re-
Corrective and preventive action. quirements identified under § 4.3(d)
(v) Section 820.170 of this chapter. In- that would apply to that HCT/P if it
stallation. were not part of a combination prod-
(vi) Section 820.200 of this chapter. uct.
Servicing. (c) During any period in which the
(2) If the combination product in-
manufacture of a constituent part to
cludes a device constituent part and a
be included in a co-packaged or single
drug constituent part, and the current
entity combination product occurs at a
good manufacturing practice operating
separate facility from the other con-
system has been shown to comply with
stituent part(s) to be included in that
the QS regulation, the following provi-
single-entity or co-packaged combina-
sions of the drug CGMPs must also be
tion product, the current good manu-
shown to have been satisfied; upon
facturing practice operating system for
demonstration that these requirements
that constituent part at that facility
have been satisfied, no additional
must be demonstrated to comply with
showing of compliance with respect to
the drug CGMPs need be made: all current good manufacturing prac-
(i) Section 211.84 of this chapter. tice requirements applicable to that
Testing and approval or rejection of type of constituent part.
components, drug product containers, (d) When two or more types of con-
and closures. stituent parts to be included in a sin-
(ii) Section 211.103 of this chapter. gle-entity or co-packaged combination
Calculation of yield. product have arrived at the same facil-
(iii) Section 211.132 of this chapter. ity, or the manufacture of these con-
Tamper-evident packaging require- stituent parts is proceeding at the
ments for over-the-counter (OTC) same facility, application of a current
human drug products. good manufacturing process operating
(iv) Section 211.137 of this chapter. system that complies with paragraph
Expiration dating. (b) of this section may begin.
(v) Section 211.165 of this chapter. (e) The requirements set forth in this
Testing and release for distribution. subpart and in parts 210, 211, 820, 600
(vi) Section 211.166 of this chapter. through 680, and 1271 of this chapter
Stability testing. listed in § 4.3, supplement, and do not
(vii) Section 211.167 of this chapter. supersede, each other unless the regu-
Special testing requirements. lations explicitly provide otherwise. In
(viii) Section 211.170 of this chapter. the event of a conflict between regula-
Reserve samples. tions applicable under this subpart to
(3) In addition to being shown to combination products, including their
comply with the other applicable man- constituent parts, the regulations most
ufacturing requirements listed under specifically applicable to the con-
§ 4.3, if the combination product in- stituent part in question shall super-
cludes a biological product constituent sede the more general.
135
§ 4.100 21 CFR Ch. I (4–1–19 Edition)
Subpart B—Postmarketing Safety 351 of the Public Health Service Act (42
Reporting for Combination U.S.C. 262) and § 601.2 of this chapter.
Products Combination product has the meaning
given the term in § 3.2(e) of this chap-
ter.
SOURCE: 81 FR 92624, Dec. 20, 2016, unless
otherwise noted. Combination product applicant means
an applicant that holds the applica-
§ 4.100 What is the scope of this sub- tion(s) for a combination product.
part? Constituent part has the meaning
(a) This subpart identifies post- given the term in § 4.2.
marketing safety reporting require- Constituent part applicant means the
ments for combination product appli- applicant for a constituent part of a
cants and constituent part applicants. combination product the constituent
(b) This subpart does not apply to in- parts of which are marketed under ap-
vestigational combination products, plications held by different applicants.
combination products that have not re- Correction or removal report is a report
ceived marketing authorization, or to as described in § 806.10 of this chapter.
persons other than combination prod- De novo classification request is a sub-
uct applicants and constituent part ap- mission requesting de novo classifica-
plicants. tion under section 513(f)(2) of the Fed-
(c) This subpart supplements and eral Food, Drug, and Cosmetic Act.
does not supersede other provisions of Device has the meaning given the
this chapter, including the provisions term in section 201(h) of the Federal
in parts 314, 600, 606, 803, and 806 of this Food, Drug, and Cosmetic Act.
chapter, unless a regulation explicitly Device application means a PMA,
provides otherwise. PDP, premarket notification submis-
sion, de novo classification request, or
§ 4.101 How does the FDA define key
terms and phrases in this subpart? HDE.
Drug has the meaning given the term
Abbreviated new drug application in section 201(g)(1) of the Federal Food,
(ANDA) has the same meaning given Drug, and Cosmetic Act.
the term ‘‘abbreviated application’’ in
Field alert report is a report as de-
§ 314.3(b) of this chapter.
scribed in § 314.81 of this chapter.
Agency or we means Food and Drug
Fifteen-day report is a report required
Administration.
to be submitted within 15 days as de-
Applicant means, for the purposes of
scribed in § 314.80 of this chapter or
this subpart, a person holding an appli-
§ 600.80 of this chapter, as well as fol-
cation under which a combination
lowup reports to such a report.
product or constituent part of a com-
bination product has received mar- Five-day report is a report as de-
keting authorization (such as approval, scribed in §§ 803.3 and 803.53 of this
licensure, or clearance). For the pur- chapter, as well as supplemental or fol-
poses of this subpart, applicant is used lowup reports to such a report as de-
interchangeably with the term ‘‘you.’’ scribed in § 803.56 of this chapter.
Application means, for purposes of Humanitarian device exemption (HDE)
this subpart, a BLA, an NDA, an has the meaning given the term in
ANDA, or a device application, includ- § 814.3 of this chapter.
ing all amendments and supplements Malfunction report is a report as de-
to them. scribed in § 803.50 of this chapter as well
Biological product has the meaning as supplemental or followup reports to
given the term in section 351 of the such a report as described in § 803.56 of
Public Health Service Act (42 U.S.C. this chapter.
262). New drug application (NDA) has the
Biological product deviation report meaning given the term ‘‘application’’
(BPDR) is a report as described in in § 314.3(b) of this chapter.
§§ 600.14 and 606.171 of this chapter. Premarket approval application (PMA)
Biologics license application (BLA) has has the meaning given the term in
the meaning given the term in section § 814.3 of this chapter.
136
Premarket notification submission is a (3) If your combination product or bi-

submission as described in § 807.87 of ological product constituent part re-
this chapter. ceived marketing authorization under
Product Development Protocol (PDP) is a BLA, you must comply with the re-
a submission as set forth in section quirements for postmarketing safety
515(f) of the Federal Food, Drug, and reporting described in parts 600 and 606
Cosmetic Act. of this chapter with respect to your
product.
§ 4.102 What reports must you submit (c) Reporting requirements applicable
to FDA for your combination prod- only to combination product applicants. If
uct or constituent part? you are a combination product appli-
(a) In general. If you are a con- cant, in addition to compliance with
stituent part applicant, the reporting paragraph (a) of this section, you must
requirements applicable to you that also comply with the reporting require-
are identified in this section apply to ments identified under this paragraph
your constituent part, and if you are a as applicable to your product based on
combination product applicant, the re- its constituent parts. If you are a com-
porting requirements applicable to you bination product applicant, you are re-
that are identified in this section apply quired to submit a report as specified
to your combination product as a in this paragraph unless you have al-
whole. ready submitted a report in accordance
(b) Reporting requirements applicable to with paragraph (b) of this section for
both combination product applicants and the same event that: Includes the in-
constituent part applicants. If you are a formation required under the applica-
combination product applicant or con- ble regulations for the report identified
stituent part applicant, you must com- in this paragraph; is required to be sub-
ply with the reporting requirements mitted in the same manner under
identified in paragraphs (b)(1), (b)(2), or § 4.104 of this chapter; and, unless oth-
(b)(3) of this section for your product erwise specified in this paragraph,
based on its application type. If you meets the deadlines under the applica-
are a combination product applicant, ble regulations for the report identified
you are required to submit a report as in this paragraph.
specified in this paragraph unless you (1) If your combination product con-
have already submitted a report in ac- tains a device constituent part, you
cordance with paragraph (c) of this sec- must submit:
tion for the same event that: Includes (i) Five-day reports;
the information required under the ap- (ii) Malfunction reports; and
plicable regulations identified in this (iii) Correction or removal reports,
paragraph, is required to be submitted and maintain records as described in
in the same manner under § 4.104, and § 806.20 of this chapter for corrections
meets the deadlines under the applica- and removals not required to be re-
ble regulations identified in this para- ported.
graph. (2) If your combination product con-
(1) If your combination product or de- tains a drug constituent part, you must
vice constituent part received mar- submit:
keting authorization under a device ap- (i) Field alert reports; and
plication, you must comply with the (ii) Fifteen-day reports as described
requirements for postmarketing safety in § 314.80 of this chapter, which must
reporting described in parts 803 and 806 be submitted within 30 calendar days
of this chapter with respect to your instead of 15 calendar days if your com-
product. bination product received marketing
(2) If your combination product or authorization under a device applica-
drug constituent part received mar- tion.
keting authorization under an NDA or (3) If your combination product con-
ANDA, you must comply with the retains a biological product constituent
quirements for postmarketing safety part, you must submit:
reporting described in part 314 of this (i) Biological product deviation re-
chapter with respect to your product. ports; and
137
§ 4.103 21 CFR Ch. I (4–1–19 Edition)
(ii) Fifteen-day reports as described part applicant(s) for the combination

in § 600.80 of this chapter, which must product no later than 5 calendar days
be submitted within 30 calendar days of your receipt of the information.
instead of 15 calendar days if your com- (b) With regard to information you
bination product received marketing must provide to the other constituent
authorization under a device applica- part applicant(s) for the combination
tion. product, you must maintain records
(d) Other reporting requirements for that include:
combination product applicants. (1) If (1) A copy of the information you
you are the combination product appli- provided,
cant for a combination product that (2) The date the information was re-
contains a device constituent part and ceived by you,
that received marketing authorization (3) The date the information was pro-
under an NDA, ANDA, or BLA, in addi- vided to the other constituent part ap-
tion to the information otherwise re- plicant(s), and
quired in the periodic safety reports (4) The name and address of the other
you submit under § 314.80 or § 600.80 of constituent part applicant(s) to whom
this chapter, your periodic safety re- you provided the information.
ports must also include a summary and
analysis of the reports identified in § 4.104 How and where must you sub-
paragraphs (c)(1)(i) and (ii) of this sec- mit postmarketing safety reports
tion that were submitted during the re- for your combination product or
port interval. constituent part?
(2) If you are the combination prod- (a) If you are a constituent part ap-
uct applicant for a combination prod- plicant, you must submit post-
uct that received marketing authoriza- marketing safety reports in accordance
tion under a device application, in ad- with the regulations identified in
dition to the reports required under § 4.102(b) that are applicable to your
paragraphs (b) and (c) of this section, product based on its application type.
you must submit reports regarding (b) If you are a combination product
postmarketing safety events if notified applicant, you must submit post-
by the Agency in writing that the marketing safety reports required
Agency requires additional informa- under § 4.102 in the manner specified in
tion. We will specify what safety infor- the regulation applicable to the type of
mation is needed and will require such report, with the following exceptions:
information if we determine that pro- (1) You must submit the post-
tection of the public health requires marketing safety reports identified in
additional or clarifying safety informa- § 4.102(c)(1)(i) and (ii) in accordance
tion for the combination product. In with § 314.80(g) of this chapter if your
any request under this section, we will combination product received mar-
state the reason or purpose for the keting authorization under an NDA or
safety information request, specify the ANDA or in accordance with § 600.80(h)
due date for submitting the informa- of this chapter if your combination
tion, and clearly identify the reported product received marketing authoriza-
event(s) related to our request. tion under a BLA.
(2) You must submit the post-
§ 4.103 What information must you marketing safety reports identified in
share with other constituent part § 4.102(c)(2)(ii) and (c)(3)(ii) in accord-
applicants for the combination ance with § 803.12(a) of this chapter if
product?
your combination product received
(a) When you receive information re- marketing authorization under a de-
garding an event that involves a death vice application.
or serious injury as described in § 803.3
of this chapter, or an adverse experi- § 4.105 What are the postmarketing
ence as described in § 314.80(a) of this safety reporting recordkeeping re-
chapter or § 600.80(a) of this chapter, as- quirements for your combination
sociated with the use of the combina- product or constituent part?
tion product, you must provide the in- (a) If you are a constituent part ap-
formation to the other constituent plicant:
138
(1) You must maintain records in ac- Office of Minority Health.

cordance with the recordkeeping re- National Center for Toxicological Research.2
quirements in the applicable regula- Office of the Center Director.
Office of Management.
tion(s) described in § 4.102(b).
Office of Research.
(2) You must maintain records re- Division of Biochemical Toxicology.
quired under § 4.103(b) for the longest Division of Genetic and Molecular Toxi-
time period required for records under cology.
the postmarketing safety reporting Division of Microbiology.
regulations applicable to your product Division of Systems Biology.
under § 4.102(b). Division of Neurotoxicology.
(b) If you are a combination product Division of Bioinformatics and Biostatis-
tics.
applicant, you must maintain records
Office of Scientific Coordination.
in accordance with the longest time pe- Office of Foods and Veterinary Medicine.3
riod required for records under the reg- Communications and Public Engagement
ulations applicable to your product Staff.
under § 4.102. Executive Secretariat Staff.
Office of Resource Planning and Strategic Man-
agement.
PART 5—ORGANIZATION Strategic Planning and Budget Formula-
tion Staff.
Subparts A–L [Reserved] Risk Analytics Staff.
Office of Coordinated Outbreak Response and
Subpart M—Organization Evaluation Network.4
Prevention Staff.
Sec.
Response Staff.
5.1100 Headquarters.
Center for Food Safety and Applied Nutrition.5
5.1105 Chief Counsel, Food and Drug Admin-
Office of the Center Director.
istration.
International Affairs Staff.
5.1110 FDA Public Information Offices.
Executive Operations Staff.
AUTHORITY: 5 U.S.C. 552; 21 U.S.C. 301–397. Office of Management.
Safety Staff.
Division of Budget & Planning.
otherwise noted.
Division of Program Services.
Office of Analytics and Outreach.
Subparts A–L [Reserved] Food Defense and Emergency Coordination
Staff.
Biostatistics and Bioinformatics Staff.
Subpart M—Organization Division of Education, Outreach and Infor-
mation.
§ 5.1100 Headquarters.
Education and Outreach Branch.
Office of the Commissioner.1 Information Center Branch.
Office of the Chief Counsel. Web Branch.
Office of the Executive Secretariat. Division of Public Health Informatics and
Freedom of Information Staff. Analytics.
Dockets Management Staff. Epidemiology and Surveillance Branch.
Office of the Chief Scientist.1 Signals Management Branch.
Office of Counter-Terrorism and Emerging Consumers Studies Branch.
Threats. Division of Risk and Decision Analysis.
Office of Scientific Integrity. Risk Analysis Branch.
Office of Regulatory Science and Innovation. Contaminant Assessment Branch.
Division of Science Innovation and Critical Exposure Assessment Branch.
Path. Office of Food Safety.
Division of Scientific Computing and Med-
ical Information. 2 Mailing address: Food and Drug Adminis-
Office of Scientific Professional Development. tration, 3900 NCTR Rd., Jefferson, AR 72079.
Office of Health Informatics. 3 Mailing address: Food and Drug Adminis-
Office of Women’s Health. tration, 10903 New Hampshire Ave., Silver
Office of External Affairs. Spring, MD 20993.
Office of Media Affairs. 4 Mailing address: 4300 River Rd., Univer-
Office of Communications. sity Station (HFS–015), College Park, MD
Office of Health and Constituent Affairs. 20740.
5 Mailing address: Food and Drug Adminis-

1 Mailing address: 10903 New Hampshire tration, 5001 Campus Dr., College Park, MD
Ave., Silver Spring, MD 20993. 20740.
139
§ 5.1100 21 CFR Ch. I (4–1–19 Edition)
Retail Food Production Staff. Regulatory Implementation Staff.
Multi-Commodity Foods Staff. Center for Veterinary Medicine.6
Division of Seafood Science and Tech- Office of the Center Director.
nology. Office of Management.
Chemical Hazard Science Branch. Program and Resources Management Staff.
Microbiological Hazards Science Branch. Human Capital Management Staff.
Division of Food Processing Science & Talent Development Staff.
Technology. Management Logistics Staff.
Process Engineering Branch. Budget Planning and Evaluation Staff.
Food Technology Branch. Office of New Animal Drug Evaluation.
Division of Plant and Dairy Food Safety. Division of Therapeutic Drugs for Food
Plant Products Branch. Animals.
Dairy and Egg Branch. Division of Production Drugs.
Division of Seafood Safety. Division of Therapeutic Drugs for Non-
Shellfish and Aquaculture Policy Branch. Food Animals.
Seafood Processing and Technology Policy Division of Human Food Safety.
Branch. Division of Manufacturing Technologies.
Division of Produce Safety. Division of Scientific Support.
Fresh Produce Branch. Division of Generic Animal Drugs.
Processed Produce Branch. Division of Business Information Science
Division of Dairy, Egg, and Meat Products. and Management.
Milk and Milk Products Branch. Office of Surveillance and Compliance.
Egg and Meat Products Branch. Division of Surveillance.
Division of Plant Products and Beverages. Division of Animal Feeds.
Plant Products Branch. Division of Compliance.
Beverages Branch. Division of Veterinary Product Safety.
Office of Cosmetics and Colors. Office of Research.
Division of Color Certification and Tech- Division of Residue Chemistry.
nology. Division of Applied Veterinary Research.
Division of Cosmetics. Division of Animal and Food Microbiology.
Office of Regulatory Science. Office of Minor Use and Minor Species Animal
Division of Analytical Chemistry. Drug Development.
Methods Development Branch. OFFICE OF MEDICAL PRODUCTS AND TO-
Spectroscopy and Mass Spectrometry BACCO
Branch. Office of Medical Products and Tobacco—Imme-
Division of Microbiology. diate Office.7
Microbial Methods and Development Office of Special Medical Programs—Imme-
Branch. diate Office.8
Molecular Methods and Subtyping Branch. Advisory Committee Oversight and Man-
Division of Bioanalytical Chemistry. agement Staff.
Chemical Contaminants Branch. Good Clinical Practice Staff.
Bioanalytical Methods Branch. Office of Pediatric Therapeutics.
Office of Food Additive Safety.
Office of Orphan Products Development.
Division of Food Contract Notifications.
Office of Combination Products.
Division of Biotechnology and GRAS No-
Center for Biologics Evaluation and Research.9
tice Review.
Office of the Center Director.
Division of Petition Review.
Executive Operations Staff.
Office of Compliance.
Regulatory Information Management
Division of Enforcement.
Staff.
Division of Field Programs and Guidance.
Regulations and Policy Staff.
Office of Applied Research and Safety Assess-
Records Management Staff.
ment.
Bioinformatics Support Staff.
Division of Molecular Biology.
Business Operations Staff.
Division of Virulence Assessment.
Virulence Mechanisms Branch. Office of Management.
Immunobiology Branch. Planning and Performance Management
Division of Toxicology. Staff.
Office of Regulations, Policy and Social
Sciences. 6 Mailing address: Food and Drug Adminis-
Regulations and Special Government Em- tration, 7519 Standish Pl., Rockville MD
ployee Management Staff. 20855.
Division of Social Sciences. 7 Mailing address: 10903 New Hampshire
Office of Nutrition and Food Labeling. Ave., Bldg. 1, Silver Spring, MD 20993.
Food Labeling and Standards Staff. 8 Mailing address: 10903 New Hampshire
Nutrition Programs Staff. Ave., Bldg. 32, Silver Spring, MD 20993.

Office of Dietary Supplement Program. 9 Mailing address: 10903 New Hampshire
Evaluation and Research Staff. Ave., Bldg. 71, Silver Spring, MD 20993.
140
Division of Program Services. Laboratory of Respiratory and Special
Program Operations Branch. Pathogens.
Program Services Branch. Laboratory of Bacterial Polysaccharides.
Division of Budget and Resource Manage- Laboratory of Mucosal Pathogens and Cel-
ment. lular Immunology.
Budget Analysis and Formulation Branch. Division of Viral Products.
Resource Management Branch. Laboratory of Pediatric and Respiratory
Division of Program Services. Viral Diseases.
Building Operations Staff. Laboratory of Hepatitis Viruses.
Program Management Services Branch. Laboratory of Retroviruses.
Program Operations Branch. Laboratory of DNA Viruses.
Division of Scientific Advisors and Con- Laboratory of Vector-Borne Diseases.
sultants. Laboratory of Method Development.
Division of Veterinary Services. Laboratory of Immunoregulation.
Office of Compliance and Biologics Quality. Division of Vaccines and Related Products
Division of Case Management. Applications.
Blood and Tissue Compliance Branch. Clinical Review Branch 1.
Advertising and Promotional Labeling Clinical Review Branch 2.
Branch. CMC Review Branch 1.
Biological Drug and Device Compliance CMC Review Branch 2.
Branch. CMC Review Branch 3.
Division of Manufacturing and Product Review Management Support Branch.
Quality. Office of Communication, Outreach, and Devel-
Product Release Branch. opment.
Manufacturing Review Branch I. Division of Disclosure and Oversight Man-
Manufacturing Review Branch II. agement.
Applications Review Branch. Congressional and Oversight Branch.
Division of Inspections and Surveillance. Access Litigation and Freedom of Informa-
Program Surveillance Branch. tion Branch.
Bioresearch Monitoring Branch. Division of Manufacturers Assistance and
Division of Biological Standards and Qual- Training.
ity Control. Career Development and Directed Training
Laboratory of Analytical Chemistry and Branch.
Blood Related Products. Manufacturers Assistance and Technical
Quality Assurance Branch. Training Branch.
Laboratory of Microbiology, In-vivo Test- Division of Communication and Consumer
ing and Standards. Affairs.
Office of Blood Research and Review. Communication Technology Branch.
Administrative Staff. Consumer Affairs Branch.
Policy and Publication Staff. Office of Biostatistics and Epidemiology.
Regulatory Project Management Staff. Division of Biostatistics.
Division of Emerging and Transfusion Vaccine Evaluation Branch.
Transmitted Diseases. Therapeutics Evaluation Branch.
Laboratory of Molecular Virology. Division of Epidemiology.
Laboratory of Emerging Pathogens. Pharmacovigilance Branch.
Laboratory of Bacterial and Transmissible Analytic Epidemiology Branch.
Spongiform Encephalopathy Agents. Office of Cellular, Tissue and Gene Therapies.
Product Review Branch. Regulatory Management Staff.
Division of Hematology Clinical Review. Division of Cellular and Gene Therapies.
Hematology Product Review Branch. Cell Therapies Branch.
Clinical Review Branch. Gene Therapies Branch.
Division of Blood Components and Devices. Gene Transfer and Immunogencity Branch.
Blood and Plasma Branch. Tumor Vaccine and Biotechnology Branch.
Devices and Review Branch. Cellular and Tissue Therapy Branch.
Division of Hematology Research and Re- Division of Clinical Evaluation and Phar-
view. macological Toxicology Review.
Laboratory of Cellular Hematology. General Medicine Branch.
Laboratory of Hemostasis. Pharmacology/Toxicology Branch.
Laboratory of Plasma Derivatives. Oncology Branch.
Laboratory of Biochemistry and Vascular Division of Human Tissues.
Biology. Human Tissue and Reproduction Branch.
Office of Vaccine Research and Review. Center for Tobacco Products.10
Program Operations Staff. Office of the Center Director.
Division of Bacterial, Parasitic, and Aller-

genic Products. 10 Mailing address: 10903 New Hampshire
Laboratory of Immunobiochemistry. Ave., Bldg. 75, Silver Spring, MD 20993.
141
§ 5.1100 21 CFR Ch. I (4–1–19 Edition)
Office of Management. Human Capital Management Branch.
Acquisitions and Assistance Staff. Human Capital Programs Branch.
Information and Technology Staff. Facilities Operations Branch.
Management and Logistics Staff. Property and Travel Services Branch.
Division of Financial Management. Leave and Performance Management
Division of Human Capital. Branch.
Office of Regulations. Division of User Fee Management and
Office of Science. Budget Formulation.
Regulatory Science and Management Generics Branch.
Staff. Policy and Operations Branch.
Research Staff. Brands Branch.
Division of Regulatory Project Manage- Office of Communications.
ment. Division of Online Communications.
Regulatory Project Management Branch I. Division of Health Communications.
Regulatory Project Management Branch Division of Drug Information.
II. Office of Compliance.
Regulatory Project Management Branch Program Management and Analysis Staff.
III. Office of Manufacturing Quality.
Regulatory Project Management Branch Manufacturing Guidance and Policy Staff.
IV. Division of Drug Quality I.
Division of Regulatory Science Global Compliance Branch I.
Informatics. Global Compliance Branch II.
Division of Product Science. Division of Drug Quality II.
Division of Individual Health Science. Global Compliance Branch III.
Division of Population Health Science. Global Compliance Branch IV.
Division of Non-Clinical Science. Office of Unapproved Drugs and Labeling Com-
Office of Health Communication and Edu- pliance.
cation. Division of Prescription Drugs.
Division of Public Health Education. Prescription Drugs Branch.
Division of Health, Scientific, and Regu- Compounding and Pharmacy Practices
latory Communication. Branch.
Office of Compliance and Enforcement. Division of Non-Prescription Drugs and
Division of Enforcement and Manufac- Health Fraud.
turing. Over-the-Counter Drugs Branch.
Division of Promotion, Advertising and La- Health Fraud Branch.
beling. Office of Scientific Investigations.
Division of State Programs. Policy Staff.
Division of Business Operations. Division of Enforcement and Postmarket
Center for Drug Evaluation and Research.11 Safety.
Office of the Center Director. Compliance Enforcement Branch.
Controlled Substance Staff. Postmarketing Safety Branch.
Professional Affairs and Stakeholder En- Division of Clinical Compliance Evalua-
gagement Staff. tion.
Good Clinical Practice Compliance Over-
Counter-Terrorism and Emergency Coordi-
sight Branch.
nation Staff.
Good Clinical Practice Assessment Branch.
Drug Shortages Staff.
Office of Drug Security, Integrity and Response.
Office of Regulatory Policy.
Division of Import Exports and Recalls.
Division of Regulatory Policy I.
Recalls and Shortages Branch.
Division of Regulatory Policy II.
Import Export Compliance Branch.
Division of Regulatory Policy III.
Division of Supply Chain Integrity.
Division of Regulatory Policy IV.
Supply Chain Strategy and Policy Branch.
Division of Information Disclosure Policy.
Supply Chain Response and Enforcement
Proactive Disclosure Branch.
Branch.
Freedom of Information Branch.
Office of Program and Regulatory Operations.
Office of Management. Project Management and Coordination
Strategic Programs and Initiatives Staff. Staff I.
Ethics Liaison Staff. Project Management and Coordination
Division of Budget Execution and Resource Staff II.
Management. Drug Registration and Listing Staff.
Budget Execution Branch. Office of Medical Policy.
Acquisitions Support Branch. Office of Prescription Drug Promotion.
Financial Accountability Branch. Division of Consumer Drug Promotion.
Division of Management Services. Division of Professional Drug Promotion.
Office of Medical Policy Initiatives.

11 Mailing address: 10903 New Hampshire Division of Medical Policy Development.
Ave., Bldg. 51, Silver Spring, MD 20993. Division of Medical Policy Programs.
142
Division of Clinical Trial Quality. Division of Anesthesia, Analgesia, and Ad-
Office of Translational Science. diction Products.
Program Management and Analysis Staff. Office of Drug Evaluation III.
Office of Biostatistics. Division of Gastroenterology and Inborn
Division of Biometrics I. Effects Products.
Division of Biometrics II. Division of Bone, Reproductive and Uro-
Division of Biometrics III. logic Products.
Division of Biometrics IV. Division of Dermatology and Dental Prod-
Division of Biometrics V. ucts.
Division of Biometrics VI. Office of Antimicrobial Products.
Division of Biometrics VII. Division of Anti-Infective Products.
Division of Biometrics VIII. Division of Anti-Viral Products.
Office of Clinical Pharmacology. Division of Transplant and Ophthalmology
Division of Clinical Pharmacology I. Products.
Division of Clinical Pharmacology II. Office of Drug Evaluation IV.
Division of Clinical Pharmacology III. Division of Nonprescription Drug Products.
Division of Clinical Pharmacology IV. Division of Medical Imaging Products.
Division of Clinical Pharmacology V. Division of Pediatrics and Maternal
Division of Pharmacometrics. Health.
Division of Applied Regulatory Science. Office of Hematology and Oncology Drug Prod-
Office of Computational Science. ucts.
Office of Study Integrity and Surveillance. Division of Oncology Products I.
Division of Oncology Products II.
Division of New Drug Bioequivalence Eval-
Division of Hematology Products.
uation.
Division of Hematology Oncology Toxi-
Division of Generic Drug Bioequivalence
cology.
Evaluation.
Office of Strategic Programs.
Office of Executive Programs.
Office of Program and Strategic Analysis.
Division of Learning and Organizational
Program Evaluation and Implementation
Development.
Staff.
Scientific and Regulatory Education Economics Staff.
Branch. Performance Analysis and Data Services
Training Design and Delivery Branch. Staff.
Leadership and Organizational Develop- Lean Management Staff.
ment Branch. Office of Business Informatics.
Division of Executive Operations. Division of Regulatory Review and Drug
Division of Advisory Committee and Con- Safety Services and Solutions.
sultant Management. Division of Business Management Services
Office of Surveillance and Epidemiology. and Solutions.
Regulatory Science Staff. Division of Data Management Services and
Regulatory Affairs Staff. Solutions.
Program Management and Analysis Staff. Division of Drug Quality and Compliance
Project Management Staff. Services and Solutions.
Office of Medication Error Prevention and Risk Office of Generic Drugs.
Management. Clinical Safety Surveillance Staff.
Division of Medication Error Prevention Program Management and Analysis Staff.
and Analysis. Communications Staff.
Division of Risk Management. Office of Research and Standards.
Office of Pharmacovigilance and Epidemiology. Division of Therapeutic Performance.
Division of Epidemiology I. Division of Quantitative Methods and Mod-
Division of Epidemiology II. eling.
Division of Pharmacovigilance I. Office of Bioequivalence.
Division of Pharmacovigilance II. Division of Bioequivalence I.
Office of New Drugs. Division of Bioequivalence II.
Program Management and Analysis Staff. Division of Bioequivalence III.
Pharmacology/Toxicology Staff. Division of Clinical Review.
Regulatory Affairs Staff. Office of Generic Drug Policy.
Office of Drug Evaluation I. Division of Legal and Regulatory Support.
Division of Cardiovascular and Renal Prod- Division of Policy Development.
ucts. Office of Regulatory Operations.
Division of Neurology Products. Division of Labeling Review.
Division of Psychiatry Products. Division of Filing Review.
Office of Drug Evaluation II. Division of Project Management.
Division of Metabolism and Endocrinology Division of Quality Management Systems.
Products. Office of Pharmaceutical Quality.

Division of Pulmonary, Allergy, and Scientific Staff.
Rheumatology Products. Program Management and Analysis Staff.
143
§ 5.1100 21 CFR Ch. I (4–1–19 Edition)
Office of Biotechnology Products. Division of Quality Intelligence, Risk
Division of Biotechnology Review and Re- Analysis, and Modeling.
search I. Data Integrity Branch.
Division of Biotechnology Review and Re- Quality Intelligence Branch.
search II. Analysis and Modeling Branch.
Division of Biotechnology Review and Re- Division of Quality Surveillance Assess-
search III. ment.
Division of Biotechnology Review and Re- Quality Deviation and Assessment Branch.
search IV. Inspection Assessment Branch.
Office of New Drug Products. Office of Testing and Research.
Division of Life Cycle API. Division of Product Quality Research.
Life Cycle Branch I. Product Quality Branch I.
Life Cycle Branch II. Product Quality Branch II.
Life Cycle Branch III. Division of Pharmaceutical Analysis.
Division of New Drug API. Pharmaceutical Analysis Branch I.
Pharmaceutical Analysis Branch II.
New Drug Branch I.
Office of Program and Regulatory Operations.
New Drug Branch II.
Division of Regulatory and Business Proc-
Division of New Drug Products I.
ess Management I.
New Drug Products Branch I. Regulatory and Business Process Manage-
New Drug Products Branch II. ment Branch I.
New Drug Products Branch III. Regulatory and Business Process Manage-
Division of New Drug Products II. ment Branch II.
New Drug Products Branch IV. Division of Regulatory and Business Proc-
New Drug Products Branch V. ess Management II.
New Drug Products Branch VI. Regulatory and Business Process Manage-
Division of Biopharmaceutics. ment Branch III.
Biopharmaceutics Branch I. Regulatory and Business Process Manage-
Biopharmaceutics Branch II. ment Branch IV.
Biopharmaceutics Branch III. Division of Operational Excellence, Learn-
Office of Policy for Pharmaceutical Quality. ing, and Professional Development.
Division of Regulations, Guidance and Learning and Professional Development
Standards. Branch.
Policy Development and Evaluation Organizational Excellence Branch.
Branch I. Office of Lifecycle Drug Products.
Policy Development and Evaluation Division of Immediate Release Products I.
Branch II. Immediate Release Branch I.
Compendial Operations and Standards Immediate Release Branch II.
Branch. Immediate Release Branch III.
Division of Internal Policies and Programs. Division of Immediate Release Products II.
Policy Development and Evaluation Immediate Release Branch IV.
Branch I. Immediate Release Branch V.
Policy Development and Evaluation Immediate Release Branch VI.
Branch II. Division of Modified Release Products.
Office of Process and Facilities. Modified Release Branch I.
Division of Process Assessment I. Modified Release Branch II.
Process Assessment Branch I. Modified Release Branch III.
Process Assessment Branch II. Division of Liquid-Based Products.
Process Assessment Branch III. Liquid-Based Branch I.
Division of Process Assessment II. Liquid-Based Branch II.
Process Assessment Branch IV. Liquid-Based Branch III.
Process Assessment Branch V. Division of Post-Marketing Activities I.
Process Assessment Branch VI. Post-Marketing Branch I.
Division of Process Assessment III. Post-Marketing Branch II.
Process Assessment Branch VII. Division of Post-Marketing Activities II.
Process Assessment Branch VIII. Post-Marketing Branch III.
Process Assessment Branch IX. Post-Marketing Branch IV.
Division of Microbiology Assessment. Post-Marketing Branch V.
Microbiology Assessment Branch I. Center for Devices and Radiological Health. 12
Microbiology Assessment Branch II. Office of the Center Director.
Microbiology Assessment Branch III. Regulations Staff.
Microbiology Assessment Branch IV. Office of Management Operations.
Division of Ethics and Management Oper-
Division of Inspectional Assessment.
ations.
Inspectional Assessment Branch I.
Inspectional Assessment Branch II.

Inspectional Assessment Branch III. 12 Mailing address: 10903 New Hampshire
Office of Surveillance. Ave., Bldg. 66, Silver Spring, MD 20993.
144
Human Resources and Administrative Division of Ophthalmic and Ear, Nose, and
Management Branch. Throat Devices.
Integrity, Conference and Committee Man- Intraocular and Corneal Implant Devices
agement Branch. Branch.
Division of Planning, Analysis and Finance Diagnostic and Surgical Devices Branch.
and Property. Contact Lenses and Retinal Devices
Planning Branch. Branch.
Financial Management Branch. Ear, Nose and Throat Devices Branch.
Office of Compliance. Division of Anesthesiology, General Hos-
Program Management Staff. pital, Respiratory Infection Control, and
Division of Bioresearch Monitoring. Dental Devices.
Bioresearch Compliance Branch I. General Hospital Devices Branch.
Bioresearch Compliance Branch II. Infection Control Devices Branch.
Division of Analysis and Program Oper- Dental Devices Branch.
ations. Anesthesiology Devices Branch.
Quality Management System and Execu- Respiratory Devices Branch.
tive Secretary Staff. Division of Neurological and Physical Med-
Field Inspections Support Branch. icine Devices.
Recall Branch. Neurostimulation Devices Branch.
Registration and Risk Branch. Neurodiagnostic and Neurosurgical Devices
Allegations of Regulatory Misconduct Branch.
Branch. Physical Medicine Devices Branch.
Division of Manufacturing and Quality. Division of Surgical Devices.
Physical Medicine, Orthopedic, Neurology, General Surgery Devices Branch I.
and Dental Devices Branch. General Surgery Devices Branch II.
Cardiovascular Devices Branch. Plastic and Reconstructive Surgery De-
Abdominal and Surgical Devices Branch. vices Branch I.
Respiratory, Ear/Nose/Throat, General Plastic and Reconstructive Surgery De-
Hospital, and Ophthalmic Devices vices Branch II.
Branch. Office of Science and Engineering Laboratories.
Division of Premarket and Labeling Com- Division of Biology, Chemistry, and Mate-
pliance. rials Science.
Surveillance and Enforcement Branch I. Division of Biomedical Physics.
Surveillance and Enforcement Branch II Division of Imaging, Diagnostics, and Soft-
Division of International Compliance Oper- ware Reliability.
ations. Division of Applied Mechanics.
Foreign Enforcement Branch. Division of Administrative and Laboratory
Imports Branch. Support.
Exports Branch. Office of Communication and Education.
Office of Device Evaluation. Program Management Operations Staff.
Program Management Staff. Digital Communication Media Staff.
Program Operations Staff. Division of Health Communication.
Pre-Market Approval Staff. Web Communication Branch.
Investigational Device Exemption Staff. Strategic Communication Branch.
Pre-Market Notification Section. Division of Industry and Consumer Edu-
Division of Cardiovascular Devices. cation.
Circulatory Support Devices Branch. Postmarket and Consumer Branch.
Cardiac Diagnostics Devices Branch. Premarket Programs Branch.
Implantable Electrophysiology Devices Division of Information Disclosure.
Branch. Freedom of Information Branch A.
Vascular Surgery Devices Branch. Freedom of Information Branch B.
Structural Heart Devices Branch. Division of Employee Training and Devel-
Interventional Cardiology Devices Branch. opment.
Cardiac Electrophysiology Devices Branch. Employee Development Branch.
Peripheral Interventional Devices Branch. Technology and Learning Management
Division of Reproductive, Gastro-Renal, Branch.
and Urological Devices. Office of Surveillance and Biometrics.
Obstetrics/Gynecology Devices Branch. Program Management Staff.
Urology and Lithotripsy Devices Branch. Informatics Staff.
Renal Devices Branch. Signal Management Staff.
Gastroenterology Devices Branch. Division of Biostatistics.
Division of Orthopedic Devices. Therapeutic Statistics Branch I.
Restorative and Repair Devices Branch. Therapeutic Statistics Branch II.
Joint and Fixation Branch I. Therapeutic Statistics Branch III.
Joint and Fixation Branch II. Diagnostic Statistics Branch I.

Anterior Spine Devices Branch. Diagnostic Statistics Branch II.
Posterior Spine Devices Branch. Division of Postmarket Surveillance.
145
§ 5.1100 21 CFR Ch. I (4–1–19 Edition)
Product Evaluation Branch I. Information Technology Staff.
Product Evaluation Branch II. Office of Resource Management.16
Product Evaluation Branch III. Division of Planning Evaluation and Man-
Information Analysis Branch. agement.
MDR Policy Branch. Program Planning and Workforce Manage-
Division of Patient Safety Partnership. ment Branch.
Clinical Outreach Branch I. Program Evaluation Branch.
Clinical Outreach Branch II. Division of Budget Formulation and Exe-
Division of Epidemiology. cution.
Epidemiologic Evaluation and Research Division of Human Resources Develop-
Branch I. ment.
Epidemiologic Evaluation and Research Division of Management Operations.
Branch II. Office of Criminal Investigations.17
Epidemiologic Evaluation and Research Mid-Atlantic Area Office.
Branch III. Philadelphia Resident Unit.
Office of In Vitro Diagnostics and Radiological Midwest Area Office.
Health. Northeast Area Office.
Division of Chemistry and Toxicology De- Boston, MA Resident Unit.
vices. Pacific Area Office.
Chemistry Branch. San Francisco, CA Resident Unit.
Diabetes Branch. Southeast Area Office.
Toxicology Branch. San Juan, PR Resident Unit.
Cardio-Renal Diagnostics Branch. Atlanta, GA Resident Unit.
Division of Immunology and Hematology New Orleans, LA Resident Unit.
Devices. Southwest Area Office.
Hematology Branch. Dallas, TX Resident Unit.
Immunology and Flow Cytometry Branch. Office of Communications and Quality Program
Division of Microbiology Devices. Management.
Viral Respiratory and HPV Branch. Quality Management Systems Staff.
General Viral and Hepatitis Branch. Project Coordination Staff.
General Bacterial and Antimicrobial Sus- Division of Communications.
ceptibility Branch. Public Affairs and Editorial Services
Bacterial Respiratory and Medical Coun- Branch.
termeasures Branch. Web and Digital Media Strategies Branch.
Division of Radiological Health. Office of Partnerships.18
Magnetic Resonance and Electronic Prod- Standards Implementation Staff.
ucts Branch. Contracts and Grants Staff.
Diagnostic X-Ray Systems Branch. Office of Policy and Risk Management.19
Nuclear Medicine and Radiation Therapy Food and Feed Policy Staff.
Branch. Medical Products and Tobacco Policy
Mammography, Ultrasound and Imaging Staff.
Software Branch. Risk Management Staff.
Division of Mammography Quality Stand- Division of Planning Evaluation and Man-
ards. agement.
Program Management Branch. Program Evaluation Branch.
Information Management Branch. Work Planning Branch.
Division of Program Operations and Man- Office of Operations.20
agement. Audit Staff.
Division of Molecular Genetics and Pathol- Office of Enforcement and Import Operations.21
ogy. Division of Enforcement.
Molecular Pathology and Cytology Branch. Division of Compliance Systems.
Molecular Genetics Branch. Enforcement Systems Branch.
Office of Global Regulatory Operations and Pol- Import Compliance Systems Branch.
icy. 13
Office of International Programs.14 16 Mailing address: 12420 Parklawn Dr., Ele-
Office of Regulatory Affairs.15 ment Building, Rockville, MD 20857.
Office of the Associate Commissioner for Regu- 17 Mailing address: 7500 Standish Pl., MPN2
latory Affairs. Building, Rockville, MD 20855.
Executive Secretariat Staff. 18 Mailing address: 12420 Parklawn Dr., Ele-
ment Building, Rockville, MD 20857.

13 Mailing address: 10903 New Hampshire 19 Mailing address: 12420 Parklawn Dr., Ele-
Ave., Bldg. 1, Silver Spring, MD 20993. ment Building, Rockville, MD 20857.

14 Mailing address: 12420 Parklawn Dr., Ele- 20 Mailing address: 10903 New Hampshire
ment Building, Rockville, MD 20857. Ave., Bldg. 31, Silver Spring, MD 20993.
15 Mailing address: 10903 New Hampshire 21 Mailing address: 12420 Parklawn Dr., Ele-
Ave., Bldg. 31, Silver Spring, MD 20993. ment Building, Rockville, MD 20857.
146
Division of Import Operations. Microbiological Science Branch.
Import Operations and Maintenance Chemistry Branch 1.
Branch. Chemistry Branch 2.
Import Program Development and Imple- New England District Office.28
mentation Branch. Compliance Branch.
Office of Regulatory Science.22 Investigations Branch.
Food and Feed Scientific Staff. Resident Post Augusta, ME.
Medical Products and Tobacco Scientific Resident Post Bridgeport, CT.
Staff. Resident Post Concord, NH.
Laboratory Operations and Support Staff. Resident Post Hartford, CT.
Office of Food and Feed Operations.23 Resident Post Providence, RI.
Division of Food Defense Targeting. Resident Post Worcester, MA.
Division of Food and Feed Program Oper- Resident Post Calais, ME.
ations and Inspections. Resident Post Houlton, ME.
Food and Feed Program Operations Resident Post Highgate, VT.
Branch. Winchester Engineering and Analytical
Food and Feed Inspection Branch. Center.29
Food and Feed Trip Planning Branch. Analytical Branch.
Office of Medical Products and Tobacco Oper- Engineering Branch.
ations.24 Regional Field Office, Southwest Region, Dal-
Division of Products and Tobacco Program las, TX.30
Operations. State Cooperative Programs Staff.
Medical Device and Tobacco Program Op- Resident Post Pharr.
erations Branch. Dallas District Office.31
Team Biological Branch. Compliance Branch.
Division of Medical Products and Tobacco
Investigations Branch.
Inspections.
Resident Post Austin, TX.
Medical Products and Tobacco Inspection
Resident Post Fort Worth, TX.
Branch.
Resident Post Houston, TX.
Drug Inspection Branch.
Resident Post San Antonio, TX.
Medical Products and Tobacco Trip Plan-
Resident Post Oklahoma City, OK.
ning Branch.
Resident Post Little Rock, AR.
Regional Field Office, Northeast Region, Ja-
Kansas City District Office.32
maica, NY.25
Operations Staff. Investigations Branch.
Intergovernmental Affairs Staff. Resident Post Wichita, KS.
District Office New York.26 Resident Post Omaha, NE.
Domestic Compliance Branch. Resident Post Des Moines, IA.
Domestic Investigations Branch. Resident Post Springfield, MO.
Resident Post Long Island, NY. Resident Post St Louis, MO.
Resident Post White Plains, NY. Resident Post Davenport, IA.
Resident Post Albany, NY. Compliance Branch.
Resident Post Binghamton, NY. Denver District Office.33
Resident Post Rochester, NY. Compliance Branch.
Resident Post Newburgh, NY. Investigations Branch.
Resident Post Syracuse, NY. Resident Post Salt Lake City, UT.
Import Operations Branch (Downstate). Resident Post Albuquerque, NM.
Resident Post Port Elizabeth, NJ. Arkansas Regional Laboratory.34
Import Operations Branch (Upstate). General Chemistry Branch.
Resident Post Champlain, NY. Pesticide Chemistry Branch.
Resident Post Alexandra Bay, NY. Microbiology Branch.
Resident Post Massena, NY.
Resident Post Ogdensburg, NY. 28 Mailing address: 1 Montvale Ave., 4th
Northeast Regional Laboratory.27 Floor, Stoneham, MA 02180–3500.
29 Mailing address: 109 Holton St., Win-
22 Mailing address: 12420 Parklawn Dr., Ele- chester, MA 01890.
ment Building, Rockville, MD 20857. 30 Mailing address: 4040 North Central Ex-
23 Mailing address: 12420 Parklawn Dr., Ele- pressway, Dallas, TX 75204–3128.
ment Building, Rockville, MD 20857. 31 Mailing address: 4040 North Central Ex-
24 Mailing address: 12420 Parklawn Dr., Ele- pressway, Suite 300, Dallas, TX 75204–3128.
ment Building, Rockville, MD 20857. 32 Mailing address: 8050 Marshal Dr., Suite
25 Mailing address: 158–15 Liberty Ave., Ja- 250, Lenexa, KS 66214.
maica, NY 11433. 33 Mailing address: Sixth Avenue and Kip-
26 Mailing address: 158–15 Liberty Ave., Ja- ling Street, Building 20, P.O. Box 25087, Den-
maica, NY 11433. ver, CO 80255–0087—Denver Federal Center.

27 Mailing address: 158–15 Liberty Ave., Ja- 34 Mailing address: 3900 NCTR Rd., Bldg. 26,
maica, NY 11433. Jefferson, AR 72079.
147
§ 5.1100 21 CFR Ch. I (4–1–19 Edition)
Southwest Import District Office Dallas, District Office Parsippany, NJ.42
TX.35 Compliance Branch.
Compliance Branch. Investigations Branch.
Investigations Branch. Resident Post Voorhees, NJ.
Resident Post Calexico. Resident Post North Brunswick, NJ.
Resident Post Eagle Pass. District Office Philadelphia, PA.43
Resident Post El Paso Bota. Compliance Branch.
Resident Post El Paso Bota Westmoreland. Investigations Branch.
Resident Post El Paso Ysleta Bridge. Resident Post Harrisburg, PA.
Resident Post Houston (SWID). Resident Post Pittsburgh, PA.
Resident Post Laredo #2 Bridge. Resident Post Wilkes-Barre, PA.
Resident Post Laredo Columbia Bridge. Resident Post Wilmington, PA.
District Office Chicago, IL.44
Resident Post Laredo World Trade Bridge.
Compliance Branch.
Resident Post Los Tomates.
Resident Post Nogales #1.
Resident Post Peoria, IL.
Resident Post Nogales #2. Resident Post Hinsdale, IL.
Resident Post Otay Mesa #1. Resident Post Gurnee, IL.
Resident Post Otay Mesa #2. Resident Post Springfield, IL.
Resident Post Pharr. Resident Post O’Hare Airport.
Resident Post Rio Grande City. District Office Minneapolis, MN.45
Resident Post San Luis. Compliance Branch.
Kansas City Laboratory.36 Investigations Branch.
Denver Laboratory.37 Resident Post La Crosse, WI.
Central Regional Field Office Chicago IL.38 Resident Post Green Bay, WI.
State Cooperative Programs Staff I. Resident Post Milwaukee, WI.
State Cooperative Programs Staff II. Resident Post Madison, WI.
Regional Operations Staff. Resident Post Fargo, ND.
Baltimore District Office Baltimore, MD.39 Resident Post Stevens Point, WI.
Compliance Branch. Resident Post Sioux, SD.
Investigations Branch. District Office Detroit, MI.46
Resident Post Charleston, WV. Compliance Branch.
Resident Post Falls Church, VA. Investigations Branch.
Resident Post Seva. Resident Post Kalamazoo, MI.
Resident Post Richmond, VA. Resident Post South Bend, IN.
Resident Post Roanoke, VA. Resident Post Indianapolis, IN.
Resident Post Dundalk Marine Terminal, Resident Post Evansville, IN.
MD. Resident Post
Resident Post Morgantown, WV. Philadelphia Laboratory.47
District Office Cincinnati, OH.40 Detroit Laboratory.48
Southeast Regional Field Office Atlanta, GA.49
Compliance Branch.
State Cooperative Programs Staff
Atlanta District Office.50
Resident Post Brunswick, OH.
Compliance Branch.
Resident Post Columbus, OH.
Resident Post Toledo, OH.
42 Mailing address: 10 Waterview Blvd., 3rd
Resident Post Louisville, KY.
Forensic Chemistry Center.41 Floor, Parsippany, NJ 07054—Waterview Cor-
Inorganic Chemistry Branch. porate Center.
43 Mailing address: 200 Chestnut St., Room
Organic Chemistry Branch.
900, Philadelphia, PA 19106—U.S. Customs
House.
35 Mailing address: 4040 North Central Ex- 44 Mailing address: 550 West Jackson Blvd.,
pressway, Suite 300, Dallas, TX 75204–3128. Suite 1500, Chicago, IL 60661.

36 Mailing address: 11510 West 80th St., 45 Mailing address: 250 Marquette Ave.,
Lenexa, KS 66214. Suite 600, Minneapolis, MN 55401.
37 Mailing address: Sixth Avenue and Kip- 46 Mailing address: 300 River Pl., Suite 5900,
ling Street, Building 20, Denver, CO 80255– Detroit, MI 48207.

0087—Denver Federal Center. 47 Mailing address: 200 Chestnut St., Room
38 Mailing address: 20 N. Michigan Ave., 900, Philadelphia, PA 19106—U.S. Customs
Suite 510, Chicago, IL 60602. House.
39 Mailing address: 6000 Metro Dr., Suite 48 Mailing address: 300 River Pl., Suite 5900,
101, Baltimore, MD 21215. Detroit, MI 48207.

40 Mailing address: 6751 Steger Dr., Cin- 49 Mailing address: 60 Eighth St. NE., At-
cinnati, OH 45237. lanta, GA 30309.

41 Mailing address: 6751 Steger Dr., Cin- 50 Mailing address: 60 Eighth St. NE., At-
cinnati, OH 45237. lanta, GA 30309.
148
Investigations Branch. Investigations Branch.
Resident Post Savannah, GA. Resident Post Las Vegas, NV.
Resident Post Tifton, GA. Resident Post Fresno, CA.
Resident Post Charlotte, NC. Resident Post Sacramento, CA.
Resident Post Greensboro, NC. Resident Post Honolulu, HI.
Resident Post Greenville, NC. Resident Post San Jose, CA.
Resident Post Raleigh, NC. Resident Post Stockton, CA.
Resident Post Charleston, SC. Resident Post South San Francisco.
Resident Post Columbia, SC. District Office Los Angeles, CA.58
Resident Post Greenville, SC. Compliance Branch.
Resident Post Asheville, NC. Import Operations Branch.
Florida District Office.51 Resident Post Los Angeles Airport.
Compliance Branch. Resident Post Ontario, CA—Import.
Investigations Branch. Domestic Investigations Branch.
Resident Post Jacksonville, FL. Resident Post Woodland Hills, CA.
Resident Post Miami, FL. Resident Post San Diego, CA.
Resident Post Tallahassee, FL. Resident Post Tempe, AZ.
Resident Post Tampa, FL. Resident Post Ontario, CA—Domestic.
Resident Post Boca Raton, FL. District Office Seattle, WA.59
Resident Post Ft. Meyers, FL. Compliance Branch.
Resident Post Port Everglades, FL. Investigations Branch.
New Orleans, LA, District Office.52 Resident Post Anchorage, AK.
Compliance Branch. Resident Post Boise, ID.
Investigations Branch. Resident Post Portland, ID.
Resident Post Baton Rouge, LA. Resident Post Spokane, WA.
Resident Post Lafayette, LA. Resident Post Oroville, WA.
Resident Post Covington, LA. Resident Post Portland, OR—Airport.
Resident Post Jackson, MS. Resident Post Blaine, WA.
Resident Post Mobile, AL. Resident Post Helena, MT.
Nashville Branch. Resident Post Sweetgrass, MT.
Resident Post Knoxville, TN. Resident Post Tacoma, WA.
Resident Post Memphis, TN. Resident Post Puget Sound, WA.
Resident Post Birmingham, AL. Pacific Regional Laboratory Southwest.60
Resident Post Montgomery, AL. Food Chemistry Branch.
San Juan District Office.53 Drug Chemistry Branch.
Compliance Branch. Microbiology Branch.
Investigations Branch. Pacific Regional Laboratory Northwest.61
Resident Post Aquada, PR. Chemistry Branch.
Resident Post Ponce, PR. Microbiology Branch.
Southeast Regional Laboratory Atlanta, Seafood Products Research Center.
GA.54 Office of Operations.
Chemistry Branch I. Office of Business Services.
Microbiology Branch. Business Operations Staff.
Atlanta Center for Nutrient Analysis. Employee Resource and Information Cen-
Chemistry Branch II. ter.
San Juan Laboratory.55 Division of Ethics and Integrity.
Regional Field Office, Pacific Region, Oakland, Office of Equal Employment Opportunity.
CA.56 Compliance Staff.
State Cooperative Programs Staff. Office of Finance, Budget, and Acquisitions.
District Office San Francisco, CA.57 Office of Budget.
Compliance Branch. Division of Budget Formulation.
Division of Budget Execution and Control.
51 Mailing address: 555 Winderley Pl., Suite Office of Acquisition and Grant Services.
200, Maitland, FL 32751. Division of Acquisition Operations.
52 Mailing address: 404 BNA Dr., Building Division of Acquisition Programs.
200, Suite 500, Nashville, TN 37217. Division of Acquisition Support and
53 Mailing address: 466 Fernandez Juncos Grants.
Ave., San Juan, PR 00901.
54 Mailing address: 60 Eighth St., Atlanta, 58 Mailing address: 19701 Fairchild Rd.,
GA 30309. Irvine, CA 92612.
55 Mailing address: 466 Fernandez Juncos 59 Mailing address: 22215 26th Ave. SE.,
Ave., San Juan, PR 00901. Suite 210, Bothell, WA 98021.
56 Mailing address: 1301 Clay St., Room 60 Mailing address: 19701 Fairchild Rd.,
1180N, Oakland, CA 94612. Irvine, CA 92612.

57 Mailing address: 1431 Harbor Bay Pkwy., 61 Mailing address: 22201 23rd Dr. SE.,
Alameda, CA 94502. Bothell, WA 98021–4421.
149
§ 5.1105 21 CFR Ch. I (4–1–19 Edition)
Division of Information Technology. § 5.1105 Chief Counsel, Food and Drug
Office of Financial Operations. Administration.
Office of Financial Management.
Office of Financial Services. The Office of the Chief Counsel’s
Office of Human Resources. mailing address is White Oak Bldg. 1,
Commission Corps Affairs Staff. 10903 New Hampshire Ave., Silver
Management Analysis Services Staff. Spring, MD 20993.
Business Operations Staff.
Division of Workforce Relations.
§ 5.1110 FDA public information of-
Division of Policy, Programs, and Execu-
fices.
tive Resources.
Division of Human Resource Services for (a) Division of Dockets Management.
Office of the Commissioner/Office of Op- The Division of Dockets Management
erations. public room is located in rm. 1061, 5630
Division of Human Resource Services for
Office of Foods and Veterinary Medicine/
Fishers Lane, Rockville, MD 20852,
Office of Global Operations and Policy. Telephone: 301–827–6860.
Division of Human Resource Services for (b) Freedom of Information Staff. The
Office of Medical Products and Tobacco. Freedom of Information Staff’s Public
FDA University. Reading Room is located at the address
Office of Facilities, Engineering and Mission available on the agency’s web site at
Support Services.
http://www.fda.gov.
Jefferson Laboratories Complex Staff.
Division of Operations Management and (c) Press Relations Staff. Press offices
Community Relations. are located in White Oak Bldg. 1, 10903
Division of Planning, Engineering and New Hampshire Ave., Silver Spring,
Safety Management. MD 20993, Telephone: 301–827–6242; and
Office of Information Management and Tech- at5001 Campus Dr., College Park, MD
nology. 20740, Telephone: 301–436–2335.
Office of Information Management.
Office of Technology and Delivery. [77 FR 15962, Mar. 19, 2012, as amended at 79
Division of Infrastructure Operations. FR 68114, Nov. 14, 2014; 81 FR 49895, July 29,
Division of Application Services. 2016]
Division of Delivery Management and Sup-
port.
Office of Business and Customer Assurance. PART 7—ENFORCEMENT POLICY
Division of Business Partnership and Sup-
port. Subpart A—General Provisions
Division of Management Services.
Office of Enterprise and Portfolio Management. Sec.
Office of Safety, Security, and Crisis Manage- 7.1 Scope.
ment. 7.3 Definitions.
Office of Security Operations. 7.12 Guaranty.
Office of Crisis Management.
7.13 Suggested forms of guaranty.
Office of Emergency Operations.
Office of Policy, Planning, Legislation, and
Analysis.62 Subpart B [Reserved]
Management and Operations Staff.
Intergovernment Affairs Staff. Subpart C—Recalls (Including Product
Office of Policy. Corrections)—Guidance on Policy,
Regulations Policy and Management Staff. Procedures, and Industry Responsibil-
Policy Development and Coordination ities
Staff.
Office of Planning. 7.40 Recall policy.
Planning Staff. 7.41 Health hazard evaluation and recall
Program Evaluation and Process Improve- classification.
ment Staff. 7.42 Recall strategy.
Economics Staff. 7.45 Food and Drug Administration-re-
Risk Communication Staff. quested recall.
Office of Legislation. 7.46 Firm-initiated recall.
Office of Public Health Strategy and Analysis.
7.49 Recall communications.
[81 FR 78033, Nov. 7, 2016, as amended at 83 7.50 Public notification of recall.
FR 13106, Mar. 27, 2018] 7.53 Recall status reports.
7.55 Termination of a recall.

62 Mailing address: 10903 New Hampshire 7.59 General industry guidance.
Ave., Silver Spring, MD 20993.
Subpart D [Reserved]
150
Subpart E—Criminal Violations (e) [Reserved]

(f) Product means an article subject
7.84 Opportunity for presentation of views
before report of criminal violation. to the jurisdiction of the Food and
7.85 Conduct of a presentation of views be- Drug Administration, including any
fore report of criminal violation. food, drug, and device intended for
7.87 Records related to opportunities for human or animal use, any cosmetic
presentation of views conducted before and biologic intended for human use,
report of criminal violation. any tobacco product intended for
AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 241, human use, and any item subject to a
262, 263b–263n, 264. quarantine regulation under part 1240
SOURCE: 42 FR 15567, Mar. 22, 1977, unless of this chapter. Product does not in-
otherwise noted. clude an electronic product that emits
radiation and is subject to parts 1003
Subpart A—General Provisions and 1004 of this chapter.
(g) Recall means a firm’s removal or
§ 7.1 Scope. correction of a marketed product that
This part governs the practices and the Food and Drug Administration con-
procedures applicable to regulatory en- siders to be in violation of the laws it
forcement actions initiated by the administers and against which the
Food and Drug Administration pursu- agency would initiate legal action, e.g.,
ant to the Federal Food, Drug, and seizure. Recall does not include a mar-
Cosmetic Act (21 U.S.C. 301 et seq.) and ket withdrawal or a stock recovery.
other laws that it administers. This (h) Correction means repair, modifica-
part also provides guidance for manu- tion, adjustment, relabeling, destruc-
facturers and distributors to follow tion, or inspection (including patient
with respect to their voluntary re- monitoring) of a product without its
moval or correction of marketed viola- physical removal to some other loca-
tive products. This part is promulgated tion.
to clarify and explain the regulatory (i) Recalling firm means the firm that
practices and procedures of the Food initiates a recall or, in the case of a
and Drug Administration, enhance pub- Food and Drug Administration-re-
lic understanding, improve consumer quested recall, the firm that has pri-
protection, and assure uniform and mary responsibility for the manufac-
consistent application of practices and ture and marketing of the product to
procedures throughout the agency. be recalled.
[43 FR 26218, June 16, 1978, as amended at 65 (j) Market withdrawal means a firm’s
FR 56476, Sept. 19, 2000] removal or correction of a distributed
product which involves a minor viola-
§ 7.3 Definitions. tion that would not be subject to legal
(a) Agency means the Food and Drug action by the Food and Drug Adminis-
Administration. tration or which involves no violation,
(b) Citation or cite means a document e.g., normal stock rotation practices,
and any attachments thereto that pro- routine equipment adjustments and re-
vide notice to a person against whom pairs, etc.
criminal prosecution is contemplated (k) Stock recovery means a firm’s re-
of the opportunity to present views to moval or correction of a product that
the agency regarding an alleged viola- has not been marketed or that has not
tion. left the direct control of the firm, i.e.,
(c) Respondent means a person named the product is located on premises
in a notice who presents views con- owned by, or under the control of, the
cerning an alleged violation either in firm and no portion of the lot has been
person, by designated representative, released for sale or use.
or in writing. (l) Recall strategy means a planned
(d) Responsible individual includes specific course of action to be taken in
those in positions of power or author- conducting a specific recall, which ad-
ity to detect, prevent, or correct viola- dresses the depth of recall, need for
tions of the Federal Food, Drug, and public warnings, and extent of effec-
Cosmetic Act. tiveness checks for the recall.
151
§ 7.12 21 CFR Ch. I (4–1–19 Edition)
(m) Recall classification means the nu- listed herein is adulterated or misbranded
merical designation, i.e., I, II, or III, within the meaning of the Federal Food,
assigned by the Food and Drug Admin- Drug, and Cosmetic Act, or is an article
which may not, under the provisions of sec-
istration to a particular product recall
tion 404, 505, or 512 of the act, be introduced
to indicate the relative degree of into interstate commerce.
health hazard presented by the product (Signature and post-office address of per-
being recalled. son giving the guaranty or undertaking.)
(1) Class I is a situation in which
there is a reasonable probability that (2) General and continuing form.
the use of, or exposure to, a violative The article comprising each shipment or
product will cause serious adverse other delivery hereafter made by (name of
health consequences or death. person giving the guaranty or undertaking)
(2) Class II is a situation in which use to, or in the order of (name and post-office
of, or exposure to, a violative product address of person to whom the guaranty or
may cause temporary or medically re- undertaking is given) is hereby guaranteed,
versible adverse health consequences as of the date of such shipment or delivery,
to be, on such date, not adulterated or mis-
or where the probability of serious ad- branded within the meaning of the Federal
verse health consequences is remote. Food, Drug, and Cosmetic Act, and not an ar-
(3) Class III is a situation in which ticle which may not, under the provisions of
use of, or exposure to, a violative prod- section 404, 505, or 512 of the act, be intro-
uct is not likely to cause adverse duced into interstate commerce.
health consequences. (Signature and post-office address of per-
(n) Consignee means anyone who re- son giving the guaranty of undertaking.)
ceived, purchased, or used the product (c) The application of a guaranty or
being recalled. undertaking referred to in section
[42 FR 15567, Mar. 22, 1977, as amended at 43 303(c)(2) of the act to any shipment or
FR 26218, June 16, 1978; 44 FR 12167, Mar. 6, other delivery of an article shall expire
1979; 77 FR 5176, Feb. 2, 2012] when such article, after shipment or
delivery by the person who gave such
§ 7.12 Guaranty. guaranty or undertaking, becomes
In case of the giving of a guaranty or adulterated or misbranded within the
undertaking referred to in section meaning of the act, or becomes an arti-
303(c)(2) or (3) of the act, each person cle which may not, under the provi-
signing such guaranty or undertaking sions of section 404, 505, or 512 of the
shall be considered to have given it. act, be introduced into interstate com-
merce.
§ 7.13 Suggested forms of guaranty. (d) A guaranty or undertaking re-
(a) A guaranty or undertaking referred to in section 303(c)(3) of the act
ferred to in section 303(c)(2) of the act shall state that the shipment or other
may be: delivery of the color additive covered
(1) Limited to a specific shipment or thereby was manufactured by a signer
other delivery of an article, in which thereof. It may be a part of or attached
case it may be a part of or attached to to the invoice or bill of sale covering
the invoice or bill of sale covering such such color. If such shipment or delivery
shipment or delivery, or is from a foreign manufacturer, such
(2) General and continuing, in which guaranty or undertaking shall be
case, in its application to any shipment signed by such manufacturer and by an
or other delivery of an article, it shall agent of such manufacturer who re-
be considered to have been given at the sides in the United States.
date such article was shipped or deliv- (e) The following are suggested forms
ered by the person who gives the guar- of guaranty or undertaking under sec-
anty or undertaking. tion 303(c)(3) of the act:
(b) The following are suggested forms (1) For domestic manufacturers:
of guaranty or undertaking under sec-
tion 303(c)(2) of the act: (Name of manufacturer) hereby guarantees
(1) Limited form for use on invoice or that all color additives listed herein were
bill of sale. manufactured by him, and (where color addi-
tive regulations require certification) are

(Name of person giving the guaranty or un- from batches certified in accordance with
dertaking) hereby guarantees that no article the applicable regulations promulgated
152
under the Federal Food, Drug, and Cosmetic tration-initiated court action for re-
Act. moving or correcting violative, distrib-
(Signature and post-office address of man- uted products by setting forth specific
ufacturer.)
recall procedures for the Food and
(2) For foreign manufacturers: Drug Administration to monitor re-
(Name of manufacturer and agent) hereby
calls and assess the adequacy of a
severally guarantee that all color additives firm’s efforts in recall.
listed herein were manufactured by (name of (b) Recall may be undertaken volun-
manufacturer), and (where color additive tarily and at any time by manufactur-
regulations require certification) are from ers and distributors, or at the request
batches certified in accordance with the ap- of the Food and Drug Administration.
plicable regulations promulgated under the A request by the Food and Drug Ad-
Federal Food, Drug, and Cosmetic Act. ministration that a firm recall a prod-
(Signature and post-office address of man-
ufacturer.)
uct is reserved for urgent situations
(Signature and post-office address of and is to be directed to the firm that
agent.) has primary responsibility for the man-
ufacture and marketing of the product
(f) For the purpose of a guaranty or that is to be recalled.
undertaking under section 303(c)(3) of (c) Recall is generally more appro-
the act the manufacturer of a shipment priate and affords better protection for
or other delivery of a color additive is consumers than seizure, when many
the person who packaged such color. lots of product have been widely dis-
(g) A guaranty or undertaking, if
tributed. Seizure, multiple seizure, or
signed by two or more persons, shall
other court action is indicated when a
state that such persons severally guar-
firm refuses to undertake a recall re-
antee the article to which it applies.
quested by the Food and Drug Adminis-
(h) No representation or suggestion
tration, or where the agency has rea-
that an article is guaranteed under the
son to believe that a recall would not
act shall be made in labeling.
be effective, determines that a recall is
ineffective, or discovers that a viola-
Subpart B [Reserved] tion is continuing.
[43 FR 26218, June 16, 1978, as amended at 65
Subpart C—Recalls (Including FR 56476, Sept. 19, 2000]
Product Corrections)—Guid-
ance on Policy, Procedures, § 7.41 Health hazard evaluation and
and Industry Responsibilities recall classification.
(a) An evaluation of the health haz-
SOURCE: 43 FR 26218, June 16, 1978, unless ard presented by a product being re-
otherwise noted. called or considered for recall will be
conducted by an ad hoc committee of
§ 7.40 Recall policy. Food and Drug Administration sci-
(a) Recall is an effective method of entists and will take into account, but
removing or correcting consumer prod- need not be limited to, the following
ucts that are in violation of laws ad- factors:
ministered by the Food and Drug Ad- (1) Whether any disease or injuries
ministration. Recall is a voluntary ac- have already occurred from the use of
tion that takes place because manufac- the product.
turers and distributors carry out their (2) Whether any existing conditions
responsibility to protect the public could contribute to a clinical situation
health and well-being from products that could expose humans or animals
that present a risk of injury or gross to a health hazard. Any conclusion
deception or are otherwise defective. shall be supported as completely as
This section and §§ 7.41 through 7.59 rec- possible by scientific documentation
ognize the voluntary nature of recall and/or statements that the conclusion
by providing guidance so that respon- is the opinion of the individual(s) mak-
sible firms may effectively discharge ing the health hazard determination.
their recall responsibilities. These sec- (3) Assessment of hazard to various
tions also recognize that recall is an al- segments of the population, e.g., chil-
ternative to a Food and Drug Adminis- dren, surgical patients, pets, livestock,
153
§ 7.42 21 CFR Ch. I (4–1–19 Edition)
etc., who are expected to be exposed to chain to which the recall is to extend,
the product being considered, with par- as follows:
ticular attention paid to the hazard to (i) Consumer or user level, which
those individuals who may be at great- may vary with product, including any
est risk. intermediate wholesale or retail level;
(4) Assessment of the degree of seri- or
ousness of the health hazard to which (ii) Retail level, including any inter-
the populations at risk would be ex- mediate wholesale level; or
posed. (iii) Wholesale level.
(5) Assessment of the likelihood of (2) Public warning. The purpose of a
occurrence of the hazard. public warning is to alert the public
(6) Assessment of the consequences that a product being recalled presents
(immediate or long-range) of occur- a serious hazard to health. It is re-
rence of the hazard. served for urgent situations where
(b) On the basis of this determina- other means for preventing use of the
tion, the Food and Drug Administra- recalled product appear inadequate.
tion will assign the recall a classifica- The Food and Drug Administration in
tion, i.e., Class I, Class II, or Class III, consultation with the recalling firm
to indicate the relative degree of will ordinarily issue such publicity.
health hazard of the product being re- The recalling firm that decides to issue
called or considered for recall. its own public warning is requested to
submit its proposed public warning and
§ 7.42 Recall strategy. plan for distribution of the warning for
review and comment by the Food and
(a) General. (1) A recall strategy that
Drug Administration. The recall strat-
takes into account the following fac-
egy will specify whether a public warn-
tors will be developed by the agency for
ing is needed and whether it will issue
a Food and Drug Administration-re-
as:
quested recall and by the recalling firm
(i) General public warning through
for a firm-initiated recall to suit the
the general news media, either na-
individual circumstances of the par-
tional or local as appropriate, or
ticular recall:
(ii) Public warning through special-
(i) Results of health hazard evalua- ized news media, e.g., professional or
tion. trade press, or to specific segments of
(ii) Ease in identifying the product. the population such as physicians, hos-
(iii) Degree to which the product’s pitals, etc.
deficiency is obvious to the consumer (3) Effectiveness checks. The purpose of
or user. effectiveness checks is to verify that
(iv) Degree to which the product re- all consignees at the recall depth speci-
mains unused in the market-place. fied by the strategy have received noti-
(v) Continued availability of essen- fication about the recall and have
tial products. taken appropriate action. The method
(2) The Food and Drug Administra- for contacting consignees may be ac-
tion will review the adequacy of a pro- complished by personal visits, tele-
posed recall strategy developed by a re- phone calls, letters, or a combination
calling firm and recommend changes as thereof. A guide entitled ‘‘Methods for
appropriate. A recalling firm should Conducting Recall Effectiveness
conduct the recall in accordance with Checks’’ that describes the use of these
an approved recall strategy but need different methods is available upon re-
not delay initiation of a recall pending quest from the Division of Dockets
review of its recall strategy. Management (HFA–305), Food and Drug
(b) Elements of a recall strategy. A re- Administration, 5630 Fishers Lane, rm.
call strategy will address the following 1061, Rockville, MD 20852. The recalling
elements regarding the conduct of the firm will ordinarily be responsible for
recall: conducting effectiveness checks, but
(1) Depth of recall. Depending on the the Food and Drug Administration will
product’s degree of hazard and extent assist in this task where necessary and
of distribution, the recall strategy will appropriate. The recall strategy will
specify the level in the distribution specify the method(s) to be used for
154
and the level of effectiveness checks information relevant to the agency’s

that will be conducted, as follows: determination of the need for the re-
(i) Level A—100 percent of the total call or how the recall should be con-
number of consignees to be contacted; ducted.
(ii) Level B—Some percentage of the [43 FR 26218, June 16, 1978, as amended at 69
total number of consignees to be con- FR 17290, Apr. 2, 2004]
tacted, which percentage is to be deter-
mined on a case-by-case basis, but is § 7.46 Firm-initiated recall.
greater that 10 percent and less than (a) A firm may decide of its own voli-
100 percent of the total number of con- tion and under any circumstances to
signees; remove or correct a distributed prod-
(iii) Level C—10 percent of the total uct. A firm that does so because it be-
number of consignees to be contacted; lieves the product to be violative is re-
(iv) Level D—2 percent of the total quested to notify immediately the ap-
number of consignees to be contacted; propriate Food and Drug Administra-
or tion district office listed in § 5.115 of
(v) Level E—No effectiveness checks. this chapter. Such removal or correc-
[43 FR 26218, June 16, 1978, as amended at 46 tion will be considered a recall only if
FR 8455, Jan. 27, 1981; 59 FR 14363, Mar. 28, the Food and Drug Administration re-
1994; 68 FR 24879, May 9, 2003] gards the product as involving a viola-
tion that is subject to legal action,
§ 7.45 Food and Drug Administration- e.g., seizure. In such cases, the firm
requested recall.
will be asked to provide the Food and
(a) The Commissioner of Food and Drug Administration the following in-
Drugs or designee may request a firm formation:
to initiate a recall when the following (1) Identity of the product involved.
determinations have been made: (2) Reason for the removal or correc-
(1) That a product that has been dis- tion and the date and circumstances
tributed presents a risk of illness or in- under which the product deficiency or
jury or gross consumer deception. possible deficiency was discovered.
(2) That the firm has not initiated a (3) Evaluation of the risk associated
recall of the product. with the deficiency or possible defi-
(3) That an agency action is nec- ciency.
essary to protect the public health and (4) Total amount of such products
welfare. produced and/or the timespan of the
(b) The Commissioner or his designee production.
will notify the firm of this determina- (5) Total amount of such products es-
tion and of the need to begin imme- timated to be in distribution channels.
diately a recall of the product. Such (6) Distribution information, includ-
notification will be by letter or tele- ing the number of direct accounts and,
gram to a responsible official of the where necessary, the identity of the di-
firm, but may be preceded by oral com- rect accounts.
munication or by a visit from an au- (7) A copy of the firm’s recall com-
thorized representative of the local munication if any has issued, or a pro-
Food and Drug Administration district posed communication if none has
office, with formal, written confirma- issued.
tion from the Commissioner or his des- (8) Proposed strategy for conducting
ignee afterward. The notification will the recall.
specify the violation, the health hazard (9) Name and telephone number of
classification of the violative product, the firm official who should be con-
the recall strategy, and other appro- tacted concerning the recall.
priate instructions for conducting the (b) The Food and Drug Administra-
recall. tion will review the information sub-
(c) Upon receipt of a request to re- mitted, advise the firm of the assigned
call, the firm may be asked to provide recall classification, recommend any
the Food and Drug Administration any appropriate changes in the firm’s strat-
or all of the information listed in egy for the recall, and advise the firm
§ 7.46(a). The firm, upon agreeing to the that its recall will be placed in the
recall request, may also provide other weekly FDA Enforcement Report.
155
§ 7.49 21 CFR Ch. I (4–1–19 Edition)
Pending this review, the firm need not marked: ‘‘URGENT’’ for class I and class
delay initiation of its product removal II recalls and, when appropriate, for
or correction. class III recalls. Telephone calls or
(c) A firm may decide to recall a other personal contacts should ordi-
product when informed by the Food narily be confirmed by one of the above
and Drug Administration that the methods and/or documented in an ap-
agency has determined that the prod- propriate manner.
uct in question violates the law, but (c) Contents. (1) A recall communica-
the agency has not specifically re- tion should be written in accordance
quested a recall. The firm’s action also with the following guidelines:
is considered a firm-initiated recall (i) Be brief and to the point;
and is subject to paragraphs (a) and (b) (ii) Identify clearly the product, size,
of this section. lot number(s), code(s) or serial num-
(d) A firm that initiates a removal or ber(s) and any other pertinent descrip-
correction of its product which the tive information to enable accurate
firm believes is a market withdrawal and immediate identification of the
should consult with the appropriate product;
Food and Drug Administration district (iii) Explain concisely the reason for
office when the reason for the removal the recall and the hazard involved, if
or correction is not obvious or clearly any;
understood but where it is apparent, (iv) Provide specific instructions on
e.g., because of complaints or adverse what should be done with respect to
reactions regarding the product, that the recalled products; and
the product is deficient in some re- (v) Provide a ready means for the re-
spect. In such cases, the Food and Drug cipient of the communication to report
Administration will assist the firm in to the recalling firm whether it has
determining the exact nature of the any of the product, e.g., by sending a
problem. postage-paid, self-addressed postcard or
by allowing the recipient to place a
§ 7.49 Recall communications. collect call to the recalling firm.
(a) General. A recalling firm is re- (2) The recall communication should
sponsible for promptly notifying each not contain irrelevant qualifications,
of its affected direct accounts about promotional materials, or any other
the recall. The format, content, and ex- statement that may detract from the
tent of a recall communication should message. Where necessary, followup
be commensurate with the hazard of communications should be sent to
the product being recalled and the those who fail to respond to the initial
strategy developed for that recall. In recall communication.
general terms, the purpose of a recall (d) Responsibility of recipient. Con-
communication is to convey: signees that receive a recall commu-
(1) That the product in question is nication should immediately carry out
subject to a recall. the instructions set forth by the recall-
(2) That further distribution or use of ing firm and, where necessary, extend
any remaining product should cease the recall to its consignees in accord-
immediately. ance with paragraphs (b) and (c) of this
(3) Where appropriate, that the direct section.
account should in turn notify its cus-
tomers who received the product about § 7.50 Public notification of recall.
the recall. The Food and Drug Administration
(4) Instructions regarding what to do will promptly make available to the
with the product. public in the weekly FDA Enforcement
(b) Implementation. A recall commu- Report a descriptive listing of each new
nication can be accomplished by tele- recall according to its classification,
grams, mailgrams, or first class letters whether it was Food and Drug Admin-
conspicuously marked, preferably in istration-requested or firm-initiated,
bold red type, on the letter and the en- and the specific action being taken by
velope: ‘‘DRUG [or FOOD, BIOLOGIC, etc.] the recalling firm. The Food and Drug
RECALL [or CORRECTION]’’. The letter Administration will intentionally

and the envelope should be also delay public notification of recalls of
156
certain drugs and devices where the nated by the Food and Drug Adminis-
agency determines that public notifica- tration.
tion may cause unnecessary and harm-
ful anxiety in patients and that initial § 7.55 Termination of a recall.
consultation between patients and (a) A recall will be terminated when
their physicians is essential. The re- the Food and Drug Administration de-
port will not include a firm’s product termines that all reasonable efforts
removals or corrections which the have been made to remove or correct
agency determines to be market with- the product in accordance with the re-
drawals or stock recoveries. The recall strategy, and when it is reasonable
port, which also includes other Food to assume that the product subject to
and Drug Administration regulatory the recall has been removed and proper
actions, e.g., seizures that were ef- disposition or correction has been
fected and injunctions and prosecu- made commensurate with the degree of
tions that were filed, is available upon hazard of the recalled product. Written
request from the Office of Public Af- notification that a recall is terminated
fairs (HFI–1), Food and Drug Adminis- will be issued by the appropriate Food
tration, 5600 Fishers Lane, Rockville, and Drug Administration district office
MD 20857. to the recalling firm.
§ 7.53 Recall status reports. (b) A recalling firm may request ter-
mination of its recall by submitting a
(a) The recalling firm is requested to written request to the appropriate
submit periodic recall status reports to Food and Drug Adminstration district
the appropriate Food and Drug Admin- office stating that the recall is effec-
istration district office so that the tive in accordance with the criteria set
agency may assess the progress of the forth in paragraph (a) of this section,
recall. The frequency of such reports and by accompanying the request with
will be determined by the relative ur- the most current recall status report
gency of the recall and will be specified and a description of the disposition of
by the Food and Drug Administration the recalled product.
in each recall case; generally the re-
porting interval will be between 2 and § 7.59 General industry guidance.
4 weeks.
(b) Unless otherwise specified or in- A recall can be disruptive of a firm’s
appropriate in a given recall case, the operation and business, but there are
recall status report should contain the several steps a prudent firm can take
following information: in advance to minimize this disruptive
(1) Number of consignees notified of effect. Notwithstanding similar spe-
the recall, and date and method of no- cific requirements for certain products
tification. in other parts of this chapter, the fol-
(2) Number of consignees responding lowing is provided by the Food and
to the recall communication and Drug Administration as guidance for a
quatity of products on hand at the firm’s consideration:
time it was received. (a) Prepare and maintain a current
(3) Number of consignees that did not written contingency plan for use in ini-
respond (if needed, the identity of non- tiating and effecting a recall in accord-
responding consignees may be re- ance with §§ 7.40 through 7.49, 7.53, and
quested by the Food and Drug Adminis- 7.55.
tration). (b) Use sufficient coding of regulated
(4) Number of products returned or products to make possible positive lot
corrected by each consignee contacted identification and to facilitate effec-
and the quantity of products accounted tive recall of all violative lots.
for. (c) Maintain such product distribu-
(5) Number and results of effective- tion records as are necessary to facili-
ness checks that were made. tate location of products that are being
(6) Estimated time frames for com- recalled. Such records should be main-
pletion of the recall. tained for a period of time that exceeds
(c) Recall status reports are to be dis- the shelf life and expected use of the
continued when the recall is termi- product and is at least the length of
157
§ 7.84 21 CFR Ch. I (4–1–19 Edition)
time specified in other applicable regu- (3) Summarize the violations that
lations concerning records retention. constitute the basis of the con-
templated prosecution;
Subpart D [Reserved] (4) Describe the purpose and proce-
dure of the presentation; and
(5) Furnish a form on which the legal
Subpart E—Criminal Violations status of any person named in the no-
§ 7.84 Opportunity for presentation of tice may be designated.
views before report of criminal vio- (e) If more than one person is named
lation. in a notice, a separate opportunity for
(a)(1) Except as provided in para- presentation of views shall be sched-
graph (a) (2) and (3) of this section, a uled on request. Otherwise, the time
person against whom criminal prosecu- and place specified in a notice may be
tion under the Federal Food, Drug, and changed only upon a showing of reason-
Cosmetic Act is contemplated by the able grounds. A request for any change
Commissioner of Food and Drugs shall shall be addressed to the Food and
be given appropriate notice and an op- Drug Administration office that issued
portunity to present information and the notice and shall be received in that
views to show cause why criminal pros- office at least 3 working days before
ecution should not be recommended to the date set in the notice.
a United States attorney. (f) A person who has received a notice
(2) Notice and opportunity need not is under no legal obligation to appear
be provided if the Commissioner has or answer in any manner. A person
reason to believe that they may result choosing to respond may appear per-
in the alteration or destruction of evi- sonally, with or without a representa-
dence or in the prospective defendant’s tive, or may designate a representative
fleeing to avoid prosecution. to appear for him or her. Alternatively,
(3) Notice and opportunity need not a person may respond in writing. If a
be provided if the Commissioner con- person elects not to respond on or be-
templates recommending further inves- fore the time scheduled, the Commis-
tigation by the Department of Justice. sioner will, without further notice, de-
(b) If a statute enforced by the Com- cide whether to recommend criminal
missioner does not contain a provision prosecution to a United States attor-
for an opportunity to present views, ney on the basis of the information
the Commissioner need not, but may in available.
the Commissioner’s discretion, provide (g) If a respondent chooses to appear
notice and an opportunity to present solely by designated representative,
views. that representative shall present a
(c) If an apparent violation of the signed statement of authorization. If a
Federal Food, Drug, and Cosmetic Act representative appears for more than
also constitutes a violation of any one respondent, the representative
other Federal statute(s), and the Com- shall submit independent documenta-
missioner contemplates recommending tion of authority to act for each re-
prosecution under such other statute(s) spondent. If a representative appears
as well, the notice of opportunity to without written authorization, the op-
present views will include all viola- portunity to present views with respect
tions. to that respondent may be provided at
(d) Notice of an opportunity to that time only if the authenticity of
present views may be by letter, stand- the representative’s authority is first
ard form, or other document(s) identi- verified by telephone or other appro-
fying the products and/or conduct al- priate means.
leged to violate the law. The notice [44 FR 12167, Mar. 6, 1979]
shall—
(1) Be sent by registered or certified § 7.85 Conduct of a presentation of
mail, telegram, telex, personal deliv- views before report of criminal vio-
ery, or any other appropriate mode of lation.
written communication; (a) The presentation of views shall be
(2) Specify the time and place where heard by a designated Food and Drug
those named may present their views; Administration employee. Other Food
158
and Drug Administration employees the respondent’s views were presented.

may be present. If materials are submitted within 10
(b) A presentation of views shall not calendar days after receipt of the copy
be open to the public. The agency em- of the summary or transcription of the
ployee designated to receive views will presentation, as applicable, they will
permit participation of other persons be considered before a final decision as
only if they appear with the respondent to whether or not to recommend pros-
or the respondent’s designated rep- ecution. Any materials received after
resentative, and at the request of, and the supplemental response period gen-
on behalf of, the respondent. erally will be considered only if the
(c) A respondent may present any in- final agency decision has not yet been
formation of any kind bearing on the made.
Commissioner’s determination to rec- (h)(1) When consideration of a crimi-
ommend prosecution. Information may nal prosecution recommendation in-
include statements of persons appear- volving the same violations is closed
ing on the respondent’s behalf, letters, by the Commissioner with respect to
documents, laboratory analyses, if ap- all persons named in the notice, the
plicable, or other relevant information Commissioner will so notify each per-
or arguments. The opportunity to
son in writing.
present views shall be informal. The
(2) When it is determined that a per-
rules of evidence shall not apply. Any
information given by a respondent, in- son named in a notice will not be in-
cluding statements by the respondent, cluded in the Commissioner’s rec-
shall become part of the agency’s ommendation for criminal prosecution,
records concerning the matter and may the Commissioner will so notify that
be used for any official purpose. The person, if and when the Commissioner
Food and Drug Administration is under concludes that notification will not
no obligation to present evidence or prejudice the prosecution of any other
witnesses. person.
(d) If the respondent holds a ‘‘guar- (3) When a United States attorney in-
anty or undertaking’’ as described in forms the agency that no persons rec-
section 303(c) of the act (21 U.S.C. ommended will be prosecuted, the
333(c)) that is applicable to the notice, Commissioner will so notify each per-
that document, or a verified copy of it, son in writing, unless the United
may be presented by the respondent. States attorney has already done so.
(e) A respondent may have an oral (4) When a United States attorney in-
presentation recorded and transcribed forms the agency of intent to prosecute
at his or her expense, in which case a some, but not all, persons who had
copy of the transcription shall be fur- been provided an opportunity to
nished to the Food and Drug Adminis- present views and were subsequently
tration office from which the notice named in the Commissioner’s rec-
issued. The employee designated to re- ommendation for criminal prosecution,
ceive views may order a presentation of the Commissioner, after being advised
views recorded and transcribed at agen- by the United States attorney that the
cy expense, in which case a copy of notification will not prejudice the
such transcription shall be provided to prosecution of any other person, will so
each respondent. notify those persons eliminated from
(f) If an oral presentation is not re- further consideration, unless the
corded and transcribed, the agency em- United States attorney has already
ployee designated to receive views done so.
shall dictate a written summary of the
presentation. A copy of the summary [44 FR 12168, Mar. 6, 1979]
shall be provided to each respondent.
(g) A respondent may comment on § 7.87 Records related to opportunities
the summary or may supplement any for presentation of views conducted
before report of criminal violation.
response by additional written or docu-
mentary evidence. Any comment or ad- (a) Records related to a section 305
dition shall be furnished to the Food opportunity for presentation of views

and Drug Administration office where constitute investigatory records for
159
law enforcement purposes and may in- pelling public interest in the disclosure
clude inter- and intra-agency memo- of the names.
randums. (d) Names and other information that
(1) Notwithstanding the rule estab- would identify a Food and Drug Admin-
lished in § 20.21 of this chapter, no istration employee shall be deleted
record related to a section 305 presen- from records related to a section 305
tation is available for public disclosure presentation of views before public dis-
until consideration of criminal pros- closure only under § 20.32 of this chap-
ecution has been closed in accordance ter.
with paragraph (b) of this section, ex- [44 FR 12168, Mar. 6, 1979]
cept as provided in § 20.82 of this chap-
ter. Only very rarely and only under PART 10—ADMINISTRATIVE
circumstances that demonstrate a
compelling public interest will the
PRACTICES AND PROCEDURES
Commissioner exercise, in accordance
Subpart A—General Provisions
with § 20.82 of this chapter, the author-
ized discretion to disclose records re- Sec.
lated to a section 305 presentation be- 10.1 Scope.
fore the consideration of criminal pros- 10.3 Definitions.
ecution is closed. 10.10 Summaries of administrative prac-
tices and procedures.
(2) After consideration of criminal 10.19 Waiver, suspension, or modification of
prosecution is closed, the records are procedural requirements.
available for public disclosure in re-
sponse to a request under the Freedom Subpart B—General Administrative
of Information Act, except to the ex- Procedures
tent that the exemptions from disclo-
10.20 Submission of documents to Division
sure in subpart D of part 20 of this of Dockets Management; computation of
chapter are applicable. No statements time; availability for public disclosure.
obtained through promises of confiden- 10.25 Initiation of administrative pro-
tiality shall be available for public dis- ceedings.
closure. 10.30 Citizen petition.
(b) Consideration of criminal pros- 10.31 Citizen petitions and petitions for stay
of action related to abbreviated new drug
ecution based on a particular section
applications, certain new drug applica-
305 notice of opportunity for presen- tions, or certain biologics license appli-
tation of views shall be deemed to be cations.
closed within the meaning of this sec- 10.33 Administrative reconsideration of ac-
tion and § 7.85 when a final decision has tion.
been made not to recommend criminal 10.35 Administrative stay of action.
prosecution to a United States attor- 10.40 Promulgation of regulations for the ef-
ney based on charges set forth in the ficient enforcement of the law.
10.45 Court review of final administrative
notice and considered at the presen- action; exhaustion of administrative
tation, or when such a recommenda- remedies.
tion has been finally refused by the 10.50 Promulgation of regulations and or-
United States attorney, or when crimi- ders after an opportunity for a formal
nal prosecution has been instituted and evidentiary public hearing.
the matter and all related appeals have 10.55 Separation of functions; ex parte com-
been concluded, or when the statute of munications.
10.60 Referral by court.
limitations has run. 10.65 Meetings and correspondence.
(c) Before disclosure of any record 10.70 Documentation of significant deci-
specifically reflecting consideration of sions in administrative file.
a possible recommendation for crimi- 10.75 Internal agency review of decisions.
nal prosecution of any individual, all 10.80 Dissemination of draft Federal Reg-
names and other information that ister notices and regulations.
10.85 Advisory opinions.
would identify an individual whose
10.90 Food and Drug Administration regula-
prosecution was considered but not rections, recommendations, and agree-
ommended, or who was not prosecuted,
ments.
shall be deleted, unless the Commis- 10.95 Participation in outside standard-set-
sioner concludes that there is a com- ting activities.
160
10.100 Public calendar. § 10.3 Definitions.
10.105 Representation by an organization.
10.110 Settlement proposals.
(a) The following definitions apply in
10.115 Good guidance practices.
this part and parts 12, 13, 14, 15, 16, and
19:
Subpart C—Electronic Media Coverage of Act means the Federal Food, Drug,
Public Administrative Proceedings; and Cosmetic Act unless otherwise in-
Guideline on Policy and Procedures dicated.
Administrative action includes every
10.200 Scope. act, including the refusal or failure to
10.203 Definitions. act, involved in the administration of
10.204 General. any law by the Commissioner, except
10.205 Electronic media coverage of public that it does not include the referral of
administrative proceedings. apparent violations to U.S. attorneys
10.206 Procedures for electronic media cov- for the institution of civil or criminal
erage of agency public administrative proceedings or an act in preparation of
proceedings. a referral.
AUTHORITY: 5 U.S.C. 551–558, 701–706; 15 Administrative file means the file or
U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–397, files containing all documents per-
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, taining to a particular administrative
262, 263b, 264. action, including internal working
memoranda, and recommendations.
otherwise noted.
Administrative record means the docu-
ments in the administrative file of a
EDITORIAL NOTE: Nomenclature changes to particular administrative action on
part 10 appear at 68 FR 24879, May 9, 2003. which the Commissioner relies to sup-
port the action.
Subpart A—General Provisions Agency means the Food and Drug Ad-
ministration.
§ 10.1 Scope. Chief Counsel means the Chief Coun-
(a) Part 10 governs practices and pro- sel of the Food and Drug Administra-
tion.
cedures for petitions, hearings, and
Commissioner means the Commis-
other administrative proceedings and
sioner of Food and Drugs, Food and
activities conducted by the Food and Drug Administration, U.S. Department
Drug Administration under the Federal of Health and Human Services, or the
Food, Drug, and Cosmetic Act, the Commissioner’s designee.
Public Health Service Act, and other Department means the U.S. Depart-
laws which the Commissioner of Food ment of Health and Human Services.
and Drugs administers. Division of Dockets Management means
(b) If a requirement in another part the Division of Dockets Management,
of title 21 differs from a requirement in Office of Management and Operations
this part, the requirements of this part of the Food and Drug Administration,
apply to the extent that they do not U.S. Department of Health and Human
conflict with the other requirements. Services, 5630 Fishers Lane, rm. 1061,
(c) References in this part and parts Rockville, MD 20852.
12, 13, 14, 15, and 16 to regulatory sec- Ex parte communication means an oral
tions of the Code of Federal Regula- or written communication not on the
tions are to chapter I of title 21 unless public record for which reasonable
otherwise noted. prior notice to all parties is not given,
but does not include requests for status
(d) References in this part and parts
reports on a matter.
12, 13, 14, 15, and 16 to publication, or to FDA means the Food and Drug Ad-
the day or date of publication, or use of ministration.
the phrase to publish, refer to publica- Food and Drug Administration em-
tion in the FEDERAL REGISTER unless ployee or Food and Drug Administration
otherwise noted. representative includes members of the
Food and Drug Division of the office of
[44 FR 22323, Apr. 13, 1979, as amended at 54

FR 9034, Mar. 3, 1989; 69 FR 17290, Apr. 2, 2004] the General Counsel of the Department
of Health and Human Services.
161
§ 10.3 21 CFR Ch. I (4–1–19 Edition)
Formal evidentiary public hearing Public advisory committee or advisory

means a hearing conducted under part committee means any committee, board,
12. commission, council, conference, panel,
Interested person or any person who task force, or other similar group, or
will be adversely affected means a person any subcommittee or other subgroup of
who submits a petition or comment or an advisory committee, that is not
objection or otherwise asks to partici- composed wholly of full-time employ-
pate in an informal or formal adminis- ees of the Federal Government and is
trative proceeding or court action. established or utilized by the Food and
Meeting means any oral discussion, Drug Administration to obtain advice
whether by telephone or in person. or recommendations.
Office of the Commissioner includes the Public Board of Inquiry or Board
offices of the Associate Commissioners means an administrative law tribunal
but not the centers or the regional or constituted under part 13.
district offices. Public hearing before a public advisory
Order means the final agency disposi- committee means a hearing conducted
tion, other than the issuance of a regu- under part 14.
lation, in a proceeding concerning any Public hearing before a Public Board of
matter and includes action on a new
Inquiry means a hearing conducted
drug application, new animal drug ap-
under part 13.
plication, or biological license.
Public hearing before the Commissioner
Participant means any person partici-
pating in any proceeding, including means a hearing conducted under part
each party and any other interested 15.
person. Regulations means an agency rule of
Party means the center of the Food general or particular applicability and
and Drug Administration responsible future effect issued under a law admin-
for a matter involved and every person istered by the Commissioner or relat-
who either has exercised a right to re- ing to administrative practices and
quest or has been granted the right by procedures. In accordance with
the Commissioner to have a hearing § 10.90(a), each agency regulation will
under part 12 or part 16 or who has be published in the FEDERAL REGISTER
waived the right to a hearing to obtain and codified in the Code of Federal
the establishment of a Public Board of Regulations.
Inquiry under part 13 and as a result of Regulatory hearing before the Food and
whose action a hearing or a Public Drug Administration means a hearing
Board of Inquiry has been established. conducted under part 16.
Person includes an individual, part- Secretary means the Secretary of
nership, corporation, association, or Health and Human Services.
other legal entity. The laws administered by the Commis-
Petition means a petition, applica- sioner or the laws administered by the
tion, or other document requesting the Food and Drug Administration means all
Commissioner to establish, amend, or the laws that the Commissioner is au-
revoke a regulation or order, or to take thorized to administer.
or not to take any other form of ad-
(b) A term that is defined in section
ministrative action, under the laws ad-
201 of the Federal Food, Drug, and Cos-
ministered by the Food and Drug Ad-
ministration. metic Act or part 1 has the same defi-
nition in this part.
Presiding officer means the Commis-
sioner or the Commissioner’s designee (c) Words in the singular form in-
or an administrative law judge ap- clude the plural, words in the mas-
pointed as provided in 5 U.S.C. 3105. culine form include the feminine, and
Proceeding and administrative pro- vice versa.
ceeding means any undertaking to (d) Whenever a reference is made in
issue, amend, or revoke a regulation or this part to a person in FDA, e.g., the
order, or to take or refrain from taking director of a center, the reference in-
any other form of administrative ac- cludes all persons to whom that person
tion.
162
has delegated the specific function in- reference, unless previously submitted
volved. in the same proceeding.
(1) A copy of an article or other ref-
FR 8455, Jan. 27, 1981; 50 FR 8994, Mar. 6, 1985;
erence or source cited must be in-
54 FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, cluded, except where the reference or
1989; 59 FR 14363, Mar. 28, 1994; 69 FR 17290, source is:
Apr. 2, 2004] (i) A reported Federal court case;
(ii) A Federal law or regulation;
§ 10.10 Summaries of administrative (iii) An FDA document that is rou-
practices and procedures. tinely publicly available; or
To encourage public participation in (iv) A recognized medical or sci-
all agency activities, the Commis- entific textbook that is readily avail-
sioner will prepare for public distribu- able to the agency.
tion summaries of FDA administrative (2) If a part of the material submitted
practices and procedures in readily un- is in a foreign language, it must be ac-
derstandable terms. companied by an English translation
verified to be complete and accurate,
§ 10.19 Waiver, suspension, or modi- together with the name, address, and a
fication of procedural require- brief statement of the qualifications of
ments. the person making the translation. A
translation of literature or other mate-
The Commissioner or a presiding offi-
rial in a foreign language is to be ac-
cer may, either voluntarily or at the
companied by copies of the original
request of a participant, waive, sus-
publication.
pend, or modify any provision in parts
(3) Where relevant information is
12 through 16 applicable to the conduct
contained in a document also con-
of a public hearing by announcement
taining irrelevant information, the ir-
at the hearing or by notice in advance
relevant information is to be deleted
of the hearing if no participant will be
and only the relevant information is to
prejudiced, the ends of justice will
be submitted.
thereby be served, and the action is in
(4) Under § 20.63 (a) and (b), the names
accordance with law.
and other information that would iden-
tify patients or research subjects are to
Subpart B—General Administrative be deleted from any record before it is
Procedures submitted to the Division of Dockets
Management in order to preclude a
§ 10.20 Submission of documents to Di- clearly unwarranted invasion of per-
vision of Dockets Management; sonal privacy.
computation of time; availability for
public disclosure. (5) Defamatory, scurrilous, or intem-
perate matter is to be deleted from a
(a) A submission to the Division of record before it is submitted to the Di-
Dockets Management of a petition, vision of Dockets Management.
comment, objection, notice, compila- (6) The failure to comply with the re-
tion of information, or any other docu- quirements of this part or with § 12.80
ment is to be filed in four copies except or § 13.20 will result in rejection of the
as otherwise specifically provided in a submission for filing or, if it is filed, in
relevant FEDERAL REGISTER notice or exclusion from consideration of any
in another section of this chapter. The portion that fails to comply. If a sub-
Division of Dockets Management is the mission fails to meet any requirement
agency custodian of these documents. of this section and the deficiency be-
(b) A submission is to be signed by comes known to the Division of Dock-
the person making it, or by an attor- ets Management, the Division of Dock-
ney or other authorized representative ets Management shall not file the sub-
of that person. Submissions by trade mission but return it with a copy of
associations are also subject to the re- the applicable regulations indicating
quirements of § 10.105(b). those provisions not complied with. A
(c) Information referred to or relied deficient submission may be corrected
upon in a submission is to be included or supplemented and subsequently

in full and may not be incorporated by filed. The office of the Division of
163
§ 10.20 21 CFR Ch. I (4–1–19 Edition)
Dockets Management does not make subject to the False Reports to the
decisions regarding the confidentiality Government Act (18 U.S.C. 1001) under
of submitted documents. which a willfully false statement is a
(d) The filing of a submission means criminal offense.
only that the Division of Dockets Man- (j) The availability for public exam-
agement has identified no technical de- ination and copying of submissions to
ficiencies in the submission. The filing the Division of Dockets Management is
of a petition does not mean or imply governed by the following rules:
that it meets all applicable require- (1) Except to the extent provided in
ments or that it contains reasonable paragraphs (j)(2) and (3) of this section,
grounds for the action requested or the following submissions, including
that the action requested is in accord- all supporting material, will be on pub-
ance with law. lic display and will be available for
(e) Except as provided in § 10.31(b), all public examination between 9 a.m. and
submissions to the Division of Dockets 4 p.m., Monday through Friday. Re-
Management will be considered as sub- quests for copies of submissions will be
mitted on the date they are post- filed and handled in accordance with
marked or, if delivered in person dur- subpart C of part 20:
ing regular business hours, on the date (i) Petitions.
on which they are delivered, unless a (ii) Comments on petitions, on docu-
provision in this part, an applicable ments published in the FEDERAL REG-
FEDERAL REGISTER notice, or an order ISTER, and on similar public docu-
issued by an administrative law judge ments.
specifically states that the documents (iii) Objections and requests for hear-
must be received by a specified date, ings filed under part 12.
e.g., § 10.33(g) relating to a petition for (iv) Material submitted at a hearing
reconsideration, in which case they under § 12.32(a)(2) and parts 12, 13, and
will be submitted on the date received. 15.
(f) All submissions are to be mailed (v) Material placed on public display
or delivered in person to the Division under the regulations in this chapter,
of Dockets Management, Food and e.g., agency guidance documents devel-
Drug Administration, 5630 Fishers oped under § 10.115.
Lane, rm. 1061, Rockville, MD 20852. (2)(i) Material prohibited from public
(g) FDA ordinarily will not acknowl- disclosure under § 20.63 (clearly unwar-
edge or give receipt for documents, ex- ranted invasion of personal privacy)
cept: and, except as provided in paragraph
(1) Documents delivered in person or (j)(3) of this section, material sub-
by certified or registered mail with a mitted with objections and requests for
return receipt requested; and hearing filed under part 12, or at a
(2) Petitions for which acknowledg- hearing under part 12 or part 13, or an
ment of receipt of filing is provided by alternative form of public hearing be-
regulation or by customary practice, fore a public advisory committee or a
e.g., § 10.30(c) relating to a citizen peti- hearing under § 12.32(a) (2) or (3), of the
tion. following types will not be on public
(h) Saturdays, Sundays, and Federal display, will not be available for public
legal holidays are included in com- examination, and will not be available
puting the time allowed for the submis- for copying or any other form of ver-
sion of documents, except that when batim transcription unless it is other-
the time for submission expires on a wise available for public disclosure
Saturday, Sunday, or Federal legal hol- under part 20:
iday, the period will be extended to in- (a) Safety and effectiveness informa-
clude the next business day. tion, which includes all studies and
(i) All submissions to the Division of tests of an ingredient or product on
Dockets Management are representa- animals and humans and all studies
tions that, to the best of the knowl- and tests on the ingredient or product
edge, information, and belief of the for identity, stability, purity, potency,
person making the submission, the bioavailability, performance, and use-
statements made in the submission are fulness.

true and accurate. All submissions are (b) A protocol for a test or study.
164
(c) Manufacturing methods or proc- § 10.25 Initiation of administrative

esses, including quality control proce- proceedings.
dures. An administrative proceeding may be
(d) Production, sales distribution, initiated in the following three ways:
and similar information, except any (a) An interested person may petition
compilation of information aggregated the Commissioner to issue, amend, or
and prepared in a way that does not re- revoke a regulation or order, or to take
veal confidential information. or refrain from taking any other form
(e) Quantitative or semiquantitative of administrative action. A petition
formulas. must be either:
(f) Information on product design or (1) In the form specified in other ap-
construction. plicable FDA regulations, e.g., the
(ii) Material submitted under para- form for a color additive petition in
graph (j)(2) of this section is to be seg- § 71.1, for a food additive petition in
regated from all other submitted mate- § 171.1, for a new drug application in
rial and clearly so marked. A person § 314.50, for a new animal drug applica-
who does not agree that a submission tion in § 514.1, or
is properly subject to paragraph (j)(2) (2) in the form for a citizen petition
may request a ruling from the Asso- in § 10.30.
ciate Commissioner for Public Affairs (b) The Commissioner may initiate a
whose decision is final, subject to judi- proceeding to issue, amend, or revoke a
cial review under § 20.48. regulation or order or take or refrain
(3) Material listed in paragraph from taking any other form of adminis-
(j)(2)(i) (a) and (b) of this section may trative action. FDA has primary juris-
be disclosed under a protective order diction to make the initial determina-
issued by the administrative law judge tion on issues within its statutory
or other presiding officer at a hearing mandate, and will request a court to
referenced in paragraph (j)(2)(i). The dismiss, or to hold in abeyance its de-
administrative law judge or presiding termination of or refer to the agency
officer shall permit disclosure of the for administrative determination, any
data only in camera and only to the ex- issue which has not previously been de-
tent necessary for the proper conduct termined by the agency or which, if it
of the hearing. The administrative law has previously been determined, the
judge or presiding officer shall direct agency concluded should be reconsid-
to whom the information is to be made ered and subject to a new administra-
available (e.g., to parties or partici- tive determination. The Commissioner
may utilize any of the procedures es-
pants, or only to counsel for parties or
tablished in this part in reviewing and
participants), and persons not specifi-
making a determination on any matter
cally permitted access to the data will
initiated under this paragraph.
be excluded from the in camera part of
(c) The Commissioner will institute a
the proceeding. The administrative law
proceeding to determine whether to
judge or other presiding officer may
issue, amend, or revoke a regulation or
impose other conditions or safeguards.
order, or take or refrain from taking
The limited availability of material
any other form of administrative ac-
under this paragraph does not con-
tion whenever any court, on its own
stitute prior disclosure to the public as
initiative, holds in abeyance or refers
defined in § 20.81, and no information
any matter to the agency for an admin-
subject to a particular order is to be
istrative determination and the Com-
submitted to or received or considered missioner concludes that an adminis-
by FDA in support of a petition or trative determination is feasible with-
other request from any other person. in agency priorities and resources.
[44 FR 22323, Apr. 13, 1979, as amended at 46 [44 FR 22323, Apr. 13, 1979, as amended at 54
FR 8455, Jan. 27, 1981; 49 FR 7363, Feb. 29, FR 9034, Mar. 3, 1989]
1984; 54 FR 9034, Mar. 3, 1989; 59 FR 14363,
Mar. 28, 1994; 64 FR 69190, Dec. 10, 1999; 65 FR § 10.30 Citizen petition.
56477, Sept. 19, 2000; 66 FR 56035, Nov. 6, 2001;

66 FR 66742, Dec. 27, 2001; 68 FR 25285, May 12, (a) This section applies to any peti-
2003; 81 FR 78505, Nov. 8, 2016] tion submitted by a person (including a
165
§ 10.30 21 CFR Ch. I (4–1–19 Edition)
person who is not a citizen of the ((2) If the petition requests the Commis-
United States) except to the extent sioner to issue, amend, or revoke an order, a
that other sections of this chapter copy of the exact wording of the citation to
the existing order (if any) and the exact
apply different requirements to a par-
wording requested for the proposed order.)
ticular matter. ((3) If the petition requests the Commis-
(b) A petition (including any attach- sioner to take or refrain from taking any
ments) must be submitted in accord- other form of administrative action, the spe-
ance with § 10.20 and, if applicable, cific action or relief requested.)
§ 10.31. The certification requirement in
B. Statement of Grounds
this section does not apply to petitions
subject to the certification require- (A full statement, in a well-organized for-
ment of § 10.31. The petition must also mat, of the factual and legal grounds on
be submitted in accordance with the which the petitioner relies, including all rel-
evant information and views on which the
following paragraphs, as applicable: petitioner relies, as well as representative
(1) Electronic submission. Petitions (in- information known to the petitioner which
cluding any attachments) may be elec- is unfavorable to the petitioner’s position.)
tronically submitted in accordance
with paragraph (b)(3) of this section C. Environmental Impact
and § 10.20 through http:// (A) Claim for categorical exclusion under
www.regulations.gov at Docket No. FDA §§ 25.30, 25.31, 25.32, 25.33, or § 25.34 of this
2013–S–0610. It is only necessary to subchapter or an environmental assessment
mit one copy. under § 25.40 of this chapter.)
(2) Mail, delivery services, or other non- D. Economic Impact
electronic submissions. A petition (in-
(The following information is to be sub-
cluding any attachments), that is not
mitted only when requested by the Commis-
electronically submitted under para- sioner following review of the petition: A
graph (b)(1) of this section, must be statement of the effect of requested action
submitted in accordance with para- on: (1) Cost (and price) increases to industry,
graph (b)(3) and § 10.20 and delivered to government, and consumers; (2) productivity
this address: Division of Dockets Man- of wage earners, businesses, or government;
agement, Department of Health and (3) competition; (4) supplies of important
Human Services, Food and Drug Ad- materials, products, or services; (5) employ-
ment; and (6) energy supply or demand.)
ministration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. It is only E. Certification
necessary to submit two copies.
The undersigned certifies, that, to the best
(3) Petition format. A petition sub- knowledge and belief of the undersigned, this
mitted under paragraphs (b)(1) or (b)(2) petition includes all information and views
of this section must be in accordance on which the petition relies, and that it in-
with § 10.20 and in the following format: cludes representative data and information
known to the petitioner which are unfavor-
CITIZEN PETITION able to the petition.
Date: llllllllllllllllllll (Signature) lllllllllllllllll
The undersigned submits this petition (Name of petitioner) llllllllllll
under ll (relevant statutory sections, if (Mailing address) llllllllllllll
known) of the ll (Federal Food, Drug, and (Telephone number) lllllllllllll
Cosmetic Act or the Public Health Service
Act or any other statutory provision for (c) A petition that appears to meet
which authority has been delegated to the the requirements of paragraph (b)(3) of
Commissioner of Food and Drugs) to request this section, § 10.20, and, if applicable,
the Commissioner of Food and Drugs toll § 10.31, will be filed by the Division of
(issue, amend, or revoke a regulation or Dockets Management, stamped with
order or take or refrain from taking any
other form of administrative action).
the date of filing, and assigned a
unique docket number. The unique
A. Action Requested docket number identifies the docket
file established by the Division of
((1) If the petition requests the Commis-
sioner to issue, amend, or revoke a regula- Dockets Management for all submis-
sions relating to the petition, as pro-
tion, the exact wording of the existing regu-

lation (if any) and the proposed regulation or vided in this part. Subsequent submis-
amendment requested.) sions relating to the matter must refer
166
to the assigned docket number as- specify when a final response may be
signed in this paragraph and will be furnished.
filed in the established docket file. Re- (3) The Commissioner may grant or
lated petitions may be filed together deny such a petition, in whole or in
and given the same docket number. part, and may grant such other relief
The Division of Dockets Management or take other action as the petition
will promptly notify the petitioner of warrants. If, at any time, the Commis-
the filing and unique docket number of sioner determines that changes in law,
the petition. facts, or circumstances since the date
(d) An interested person may submit on which the petition was submitted
comments to the Division of Dockets have rendered the petition moot, the
Management on a filed petition, which Commissioner may dismiss the peti-
comments become part of the docket tion. The petitioner is to be notified of
file. The comments are to specify the the Commissioner’s decision. The deci-
docket number of the petition and in- sion will be placed in the public docket
clude, if applicable, the verification file and may also be in the form of a
under § 10.31, and may support or op- notice published in the FEDERAL REG-
pose the petition in whole or in part. A ISTER.
request for alternative or different ad- (4) The Commissioner shall furnish a
ministrative action must be submitted response to each petitioner within 90
as a separate petition. days of receipt of a petition filed under
(e)(1) The Commissioner shall, in ac- section 505(j)(2)(C) of the act. The re-
cordance with paragraph (e)(2), rule sponse will either approve or dis-
upon each petition filed under para- approve the petition. Agency action on
graph (c) of this section, taking into a petition shall be governed by § 314.93
consideration (i) available agency re- of this chapter.
sources for the category of subject
(5) The Commissioner intends to fur-
matter, (ii) the priority assigned to the
nish a response to each petitioner with-
petition considering both the category
in 150 days of receipt of a petition sub-
of subject matter involved and the
ject to section 505(q) of the Federal
overall work of the agency, and (iii)
Food, Drug, and Cosmetic Act.
time requirements established by stat-
(f) If a petition filed under paragraph
ute.
(c) of this section requests the Com-
(2) Except as provided in paragraphs
missioner to issue, amend, or revoke a
(e)(4) and (5) of this section, the Com-
regulation, § 10.40 or § 10.50 also apply.
missioner shall furnish a response to
each petitioner within 180 days of re- (g) A petitioner may supplement,
ceipt of the petition. The response will amend, or withdraw a petition without
either: Agency approval and without prejudice
(i) Approve the petition, in which to resubmission at any time until the
case the Commissioner shall concur- Commissioner rules on the petition,
rently take appropriate action (e.g., unless the petition has been referred
publication of a FEDERAL REGISTER no- for a hearing under parts 12, 13, 14, or 15
tice) implementing the approval; of this chapter. After a ruling or refer-
(ii) Deny the petition; ral, a petition may be supplemented,
(iii) Dismiss the petition if at any amended, or withdrawn only with the
time the Commissioner determines approval of the Commissioner. The
that changes in law, facts, or cir- Commissioner may approve with-
cumstances since the date on which the drawal, with or without prejudice
petition was submitted have rendered against resubmission of the petition.
the petition moot; or (h) In reviewing a petition the Com-
(iv) Provide a tentative response, in- missioner may use the following proce-
dicating why the agency has been un- dures:
able to reach a decision on the peti- (1) Conferences, meetings, discus-
tion, e.g., because of the existence of sions, and correspondence under § 10.65.
other agency priorities, or a need for (2) A hearing under parts 12, 13, 14, 15,
additional information. The tentative or 16.
response may also indicate the likely (3) A FEDERAL REGISTER notice re-
ultimate agency response, and may questing information and views.
167
§ 10.31 21 CFR Ch. I (4–1–19 Edition)
(4) A proposal to issue, amend, or re- forcement action and related cor-
voke a regulation, in accordance with respondence, or to requests, sugges-
§ 10.40 or § 12.20. tions, and recommendations made in-
(5) Any other specific public proce- formally in routine correspondence re-
dure established in this chapter and ex- ceived by FDA. Routine correspond-
pressly applicable to the matter. ence does not constitute a petition
(i) The record of the administrative within the meaning of this section un-
proceeding consists of the following: less it purports to meet the require-
(1) The petition, including all infor- ments of this section. Action on rou-
mation on which it relies, filed by the tine correspondence does not con-
Division of Dockets Management. stitute final administrative action sub-
(2) All comments received on the pe- ject to judicial review under § 10.45.
tition, including all information sub- (l) The Division of Dockets Manage-
mitted as a part of the comments. ment will maintain a chronological list
(3) If the petition resulted in a proof each petition filed under this section
posal to issue, amend, or revoke a regu- and § 10.85, but not of petitions sub-
lation, all of the documents specified mitted elsewhere in the agency under
in § 10.40(g). § 10.25(a)(1), showing:
(4) The record, consisting of any (1) The docket number;
transcripts, minutes of meetings, re- (2) The date the petition was filed by
ports, FEDERAL REGISTER notices, and the Division of Dockets Management;
other documents resulting from the op- (3) The name of the petitioner;
tional procedures specified in para- (4) The subject matter involved; and
graph (h) of this section, except a tran- (5) The disposition of the petition.
script of a closed portion of a public ad- [44 FR 22323, Apr. 13, 1979, as amended at 46
visory committee meeting. FR 8455, Jan. 27, 1981; 50 FR 16656, Apr. 26,
(5) The Commissioner’s decision on 1985; 54 FR 9034, Mar. 3, 1989; 57 FR 17980, Apr.
the petition, including all information 28, 1992; 59 FR 14364, Mar. 28, 1994; 62 FR 40592,
identified or filed by the Commissioner July 29, 1997; 66 FR 6467, Jan. 22, 2001; 66 FR
12848, Mar. 1, 2001; 78 FR 76749, Dec. 19, 2013;
with the Division of Dockets Manage-
81 FR 78505, Nov. 8, 2016]
ment as part of the record supporting
the decision. § 10.31 Citizen petitions and petitions
(6) All documents filed with the Divi- for stay of action related to abbre-
sion of Dockets Management under viated new drug applications, cer-
§ 10.65(h). tain new drug applications, or cer-
(7) If a petition for reconsideration or tain biologics license applications.
for a stay of action is filed under para- (a) Applicability. This section applies
graph (j) of this section, the adminis- to a citizen petition or petition for
trative record specified in § 10.33(k) or stay of action that meets all of the fol-
§ 10.35(h). lowing criteria:
(j) The administrative record speci- (1) The petition requests that the
fied in paragraph (i) of this section is Commissioner take any form of action
the exclusive record for the Commis- that could, if taken, delay approval of
sioner’s decision. The record of the ad- an abbreviated new drug application
ministrative proceeding closes on the submitted under section 505(j) of the
date of the Commissioner’s decision Federal Food, Drug, and Cosmetic Act,
unless some other date is specified. a new drug application submitted
Thereafter any interested person may through the pathway described by sec-
submit a petition for reconsideration tion 505(b)(2) of the Federal, Food,
under § 10.33 or a petition for stay of ac- Drug and Cosmetic Act, or a biologics
tion under § 10.35. A person who wishes license application submitted under
to rely upon information or views not section 351(k) of the Public Health
included in the administrative record Service Act.
shall submit them to the Commissioner (2) The petition is submitted on or
with a new petition to modify the deci- after September 27, 2007.
sion in accordance with this section. (3) The petition is submitted in writ-
(k) This section does not apply to the ing and under § 10.30 (for citizen peti-
referral of a matter to a United States tions) or § 10.35 (for petitions for stay of
attorney for the initiation of court en- action).
168
(b) Date of submission. A petition sub- (c) Certification. (1) FDA will not con-
ject to this section and submitted in sider for review a petition that is sub-
accordance with § 10.20, § 10.30, § 10.31, or ject to this section unless the petition
§ 10.35 is regarded as submitted on the is in writing and contains the following
date on which the petition is received certification:
by the Division of Dockets Manage-
ment.
(2) The certification in paragraph associated with a particular date must

(c)(1) of this section must contain one be identified.
or more specific dates (month, day, and (d) Verification. (1) FDA will not ac-
year) in the first blank space provided. cept for review any supplemental infor-
If different categories of information mation or comments on a petition that
become known at different times, the is subject to this section unless the
certification must contain each esti- supplemental information or com-
mated relevant date. The information ments are in writing and contain the
following verification:
(2) The verification in paragraph mated relevant date. The information

(d)(1) of this section must contain one associated with a particular date must
or more specific dates (month, day, and be identified.
year) in the first blank space provided.
[81 FR 78506, Nov. 8, 2016]
If different categories of information
ER08NO16.001</GPH>
become known at different times, the

verification must contain each esti-
169
ER08NO16.000</GPH>
§ 10.33 21 CFR Ch. I (4–1–19 Edition)
§ 10.33 Administrative reconsideration ments of § 10.30 (c) and (d), except that
of action. it is filed in the same docket file as the
(a) The Commissioner may at any petition to which it relates.
time reconsider a matter, on the Com- (d) The Commissioner shall promptly
missioner’s own initiative or on the pe- review a petition for reconsideration.
tition of an interested person. The Commissioner may grant the peti-
(b) An interested person may request tion when the Commissioner deter-
reconsideration of part or all of a deci- mines it is in the public interest and in
sion of the Commissioner on a petition the interest of justice. The Commis-
submitted under § 10.25. Each request sioner shall grant a petition for recon-
for reconsideration must be submitted sideration in any proceeding if the
in accordance with § 10.20 and in the Commissioner determines all of the fol-
following form no later than 30 days lowing apply:
after the date of the decision involved. (1) The petition demonstrates that
The Commissioner may, for good cause, relevant information or views con-
permit a petition to be filed after 30 tained in the administrative record
days. In the case of a decision pub- were not previously or not adequately
lished in the FEDERAL REGISTER, the considered.
day of publication is the day of deci- (2) The petitioner’s position is not
sion. frivolous and is being pursued in good
faith.
(Date) llllllllllllllllllll
(3) The petitioner has demonstrated
Division of Dockets Management, Food sound public policy grounds supporting
and Drug Administration, Department of reconsideration.
Health and Human Services, rm. 1–23, 5630
(4) Reconsideration is not outweighed
Fishers Lane, rm. 1061, Rockville, MD 20852.
by public health or other public inter-
PETITION FOR RECONSIDERATION ests.
(e) A petition for reconsideration
[Docket No.]
may not be based on information and
The undersigned submits this petition for views not contained in the administra-
reconsideration of the decision of the Com- tive record on which the decision was
missioner of Food and Drugs in Docket No.
made. An interested person who wishes
ll.
to rely on information or views not in-
A. Decision involved cluded in the administrative record
(A concise statement of the decision of the shall submit them with a new petition
Commissioner which the petitioner wishes to to modify the decision under § 10.25(a).
have reconsidered.) (f) The decision on a petition for re-
consideration is to be in writing and
B. Action requested placed on public display as part of the
(The decision which the petitioner requests docket file on the matter in the office
the Commissioner to make upon reconsider- of the Division of Dockets Manage-
ation of the matter.) ment. A determination to grant recon-
C. Statement of grounds sideration will be published in the FED-
ERAL REGISTER if the Commissioner’s
(A full statement, in a well-organized for-
original decision was so published. Any
mat, of the factual and legal grounds upon
which the petitioner relies. The grounds other determination to grant or deny
must demonstrate that relevant information reconsideration may also be published
and views contained in the administrative in the FEDERAL REGISTER.
record were not previously or not adequately (g) The Commissioner may consider a
considered by the Commissioner. petition for reconsideration only before
(No new information or views may be in- the petitioner brings legal action in
cluded in a petition for reconsideration.) the courts to review the action, except
(Signature) lllllllllllllllll that a petition may also be considered
(Name of petitioner) llllllllllll if the Commissioner has denied a peti-
(Mailing address) llllllllllllll tion for stay of action and the peti-
(Telephone number) lllllllllllll
tioner has petitioned for judicial re-
(c) A petition for reconsideration review of the Commissioner’s action and
lating to a petition submitted under requested the reviewing court to grant

§ 10.25(a)(2) is subject to the require- a stay pending consideration of review.
170
A petition for reconsideration sub- (7) If the Commissioner reconsiders

mitted later than 30 days after the date the matter, the administrative record
of the decision involved will be denied relating to reconsideration specified in
as untimely unless the Commissioner § 10.30(i).
permits the petition to be filed after 30 [44 FR 22323, Apr. 13, 1979, as amended at 46
days. A petition for reconsideration FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28,
will be considered as submitted on the 1994; 66 FR 6467, Jan. 22, 2001; 66 FR 12848,
day it is received by the Division of Mar. 1, 2001]
Dockets Management.
(h) The Commissioner may initiate § 10.35 Administrative stay of action.
the reconsideration of all or part of a (a) The Commissioner may at any
matter at any time after it has been time stay or extend the effective date
decided or action has been taken. If re- of an action pending or following a de-
view of the matter is pending in the cision on any matter.
courts, the Commissioner may request (b) An interested person may request
that the court refer the matter back to the Commissioner to stay the effective
the agency or hold its review in abey- date of any administrative action. A
ance pending administrative reconsid- stay may be requested for a specific
eration. The administrative record of time period or for an indefinite time
the proceeding is to include all addi- period. A request for stay must be sub-
tional documents relating to such re- mitted in accordance with § 10.20 and in
consideration. the following form (except that a re-
(i) After determining to reconsider a quest for stay subject to § 10.31 must
matter, the Commissioner shall review also include the certification provided
and rule on the merits of the matter in § 10.31(c)) no later than 30 days after
under § 10.30(e). The Commissioner may the date of the decision involved. The
reaffirm, modify, or overrule the prior Commissioner may, for good cause,
decision, in whole or in part, and may permit a petition to be filed after 30
grant such other relief or take such days. In the case of a decision pub-
other action as is warranted. lished in the FEDERAL REGISTER, the
(j) The Commissioner’s reconsider- day of publication is the date of deci-
ation of a matter relating to a petition sion.
submitted under § 10.25(a)(2) is subject (Date) llllllllllllllllllll
to § 10.30 (f) through (h), (j), and (k). Division of Dockets Management, Food
(k) The record of the administrative and Drug Administration, Department of
proceeding consists of the following: Health and Human Services, 5630 Fishers
(1) The record of the original petition Lane, rm. 1061, Rockville, MD 20852.
specified in § 10.30(i). PETITION FOR STAY OF ACTION
(2) The petition for reconsideration,
including all information on which it The undersigned submits this petition re-
questing that the Commissioner of Food and
relies, filed by the Division of Dockets Drugs stay the effective date of the following
Management. matter.
(3) All comments received on the pe-
tition, including all information sub- A. Decision involved
mitted as a part of the comments. (The specific administrative action being
(4) The Commissioner’s decision on taken by the Commissioner for which a stay
the petition under paragraph (f) of this is requested, including the docket number or
section, including all information iden- other citation to the action involved.)
tified or filed by the Commissioner B. Action requested
with the Division of Dockets Manage-
(The length of time for which the stay is
ment as part of the record supporting requested, which may be for a specific or in-
the decision. definite time period.)
(5) Any FEDERAL REGISTER notices or
other documents resulting from the pe- C. Statement of grounds
tition. (A full statement, in a well-organized for-
(6) All documents filed with the Divi- mat, of the factual and legal grounds upon
sion of Dockets Management under which the petitioner relies for the stay.)
§ 10.65(h). (Signature) lllllllllllllllll
171
§ 10.35 21 CFR Ch. I (4–1–19 Edition)
(Name of petitioner) llllllllllll (f) The Commissioner’s decision on a
(Mailing address) llllllllllllll petition for stay of action is to be in
(Telephone number) lllllllllllll writing and placed on public display as
(c) A petition for stay of action relat- part of the file on the matter in the of-
ing to a petition submitted under fice of the Division of Dockets Manage-
§ 10.25(a)(2) is subject to the requirement. A determination to grant a stay
ments of § 10.30 (c) and (d), except that will be published in the FEDERAL REG-
it will be filed in the same docket file ISTER if the Commissioner’s original
as the petition to which it relates. decision was so published. Any other
(d) Neither the filing of a petition for determination to grant or to deny a
a stay of action nor action taken by an stay may also be published in the FED-
interested person in accordance with ERAL REGISTER.
any other administrative procedure in (g) A petition for a stay of action
this part or in any other section of this submitted later than 30 days after the
chapter, e.g., the filing of a citizen pe- date of the decision involved will be de-
tition under § 10.30 or a petition for re- nied as untimely unless the Commis-
consideration under § 10.33 or a request sioner permits the petition to be filed
for an advisory opinion under § 10.85, after 30 days. A petition for a stay of
will stay or otherwise delay any ad- action is considered submitted on the
ministrative action by the Commis-
day it is received by the Division of
sioner, including enforcement action of
Dockets Management.
any kind, unless one of the following
applies: (h) The record of the administrative
(1) The Commissioner determines proceeding consists of the following:
that a stay or delay is in the public in- (1) The record of the proceeding to
terest and stays the action. which the petition for stay of action is
(2) A statute requires that the matter directed.
be stayed. (2) The petition for stay of action, in-
(3) A court orders that the matter be cluding all information on which it re-
stayed. lies, filed by the Division of Dockets
(e) The Commissioner shall promptly Management.
review a petition for stay of action. (3) All comments received on the pe-
The Commissioner may grant or deny a tition, including all information sub-
petition, in whole or in part; and may mitted as a part of the comments.
grant such other relief or take such (4) The Commissioner’s decision on
other action as is warranted by the pe- the petition under paragraph (e) of this
tition. If, at any time, the Commis- section, including all information iden-
sioner determines that changes in law, tified or filed by the Commissioner
facts, or circumstances since the date with the Division of Dockets Manage-
on which the petition was submitted ment as part of the record supporting
have rendered the petition moot, the the decision.
Commissioner may dismiss the peti- (5) Any FEDERAL REGISTER notices or
tion. The Commissioner may grant a other documents resulting from the pe-
stay in any proceeding if it is in the tition.
public interest and in the interest of
(6) All documents filed with the Divi-
justice. The Commissioner shall grant
a stay in any proceeding if all of the sion of Dockets Management under
following apply: § 10.65(h).
(1) The petitioner will otherwise suf- (i) A petitioner may supplement,
fer irreparable injury. amend, or withdraw a petition for stay
(2) The petitioner’s case is not frivo- of action in writing without Agency
lous and is being pursued in good faith. approval and without prejudice to re-
(3) The petitioner has demonstrated submission at any time until the Com-
sound public policy grounds supporting missioner rules on the petition, pro-
the stay. vided the resubmission is made in ac-
(4) The delay resulting from the stay cordance with paragraph (b) of this sec-
is not outweighted by public health or tion, unless the petition for stay of ac-
other public interests. tion has been referred for a hearing
172
under parts 12, 13, 14, or 15 of this chap- (ii) The nature of the action, e.g.,
ter. After a ruling or referral, a peti- proposed rule, or notice;
tion for stay of action may be supple- (iii) A summary in the first para-
mented, amended, or withdrawn only graph describing the substance of the
with the approval of the Commissioner. document in easily understandable
The Commissioner may approve with- terms;
drawal with or without prejudice (iv) Relevant dates, e.g., comment
against resubmission of the petition for closing date, and proposed effective
stay of action. date(s);
(v) The name, business address, and
FR 8455, Jan. 27, 1981; 54 FR 9034, Mar. 3, 1989; phone number of an agency contact
59 FR 14364, Mar. 28, 1994; 66 FR 6468, Jan. 22, person who can provide further infor-
2001; 66 FR 12848, Mar. 1, 2001; 81 FR 78506, mation to the public about the notice;
Nov. 8, 2016] (vi) An address for submitting writ-
ten comments;
§ 10.40 Promulgation of regulations for (vii) Supplementary information
the efficient enforcement of the about the notice in the form of a pre-
law. amble that summarizes the proposal
(a) The Commissioner may propose and the facts and policy underlying it,
and promulgate regulations for the ef- includes references to all information
ficient enforcement of the laws admin- on which the Commissioner relies for
istered by FDA whenever it is nec- the proposal (copies or a full list of
essary or appropriate to do so. The which are a part of the docket file on
issuance, amendment, or revocation of the matter in the office of the Division
a regulation may be initiated in any of of Dockets Management), and cites the
the ways specified in § 10.25. authority under which the regulation
(1) This section applies to any regula- is proposed;
tion: (i) Not subject to § 10.50 and part (viii) Either the terms or substance
12, or (ii) if it is subject to § 10.50 and of the proposed regulation or a descrip-
part 12, to the extent that those provi- tion of the subjects and issues in-
sions make this section applicable. volved;
(2) A regulation proposed by an inter- (ix) A reference to the existence or
ested person in a petition submitted lack of need for an environmental im-
under § 10.25(a) will be published in the pact statement under § 25.52 of this
FEDERAL REGISTER as a proposal if: chapter; and
(i) The petition contains facts dem- (x) The docket number of the matter,
onstrating reasonable grounds for the which identifies the docket file estab-
proposal; and lished by the Division of Dockets Man-
(ii) The petition substantially shows agement for all relevant submissions.
that the proposal is in the public inter- (2) The proposal will provide 60 days
est and will promote the objectives of for comment, although the Commis-
the act and the agency. sioner may shorten or lengthen this
(3) Two or more alternative proposed time period for good cause. In no event
regulations may be published on the is the time for comment to be less than
same subject to obtain comment on the 10 days.
different alternatives. (3) After publication of the proposed
(4) A regulation proposed by an inter- rule, any interested person may re-
ested person in a petition submitted quest the Commissioner to extend the
under § 10.25(a) may be published to- comment period for an additional spec-
gether with the Commissioner’s pre- ified period by submitting a written re-
liminary views on the proposal and any quest to the Division of Dockets Man-
alternative proposal. agement stating the grounds for the re-
(b) Except as provided in paragraph quest. The request is submitted under
(e) of this section, each regulation § 10.35 but should be headed ‘‘REQUEST
must be the subject of a notice of pro- FOR EXTENSION OF COMMENT PE-
posed rulemaking published in the RIOD.’’
FEDERAL REGISTER. (1) The notice will (i) A request must discuss the reason
contain: comments could not feasibly be sub-

(i) The name of the agency; mitted within the time permitted, or
173
§ 10.40 21 CFR Ch. I (4–1–19 Edition)
that important new information will first paragraph describing the sub-
shortly be available, or that sound pub- stance of the document in easily under-
lic policy otherwise supports an exten- standable terms, (iv) relevant dates,
sion of the time for comment. The e.g., the rule’s effective date and com-
Commissioner may grant or deny the ment closing date, if an opportunity
request or may grant an extension for for comment is provided, (v) the name,
a time period different from that re- business address, and phone number of
quested. An extension may be limited an agency contact person who can pro-
to specific persons who have made and vide further information to the public
justified the request, but will ordi- about the notice, (vi) an address for the
narily apply to all interested persons. submission of written comments when
(ii) A comment time extension of 30 they are permitted, (vii) supple-
days or longer will be published in the mentary information about the regula-
FEDERAL REGISTER and will be application in the body of the preamble that
ble to all interested persons. A com- contains references to prior notices re-
ment time extension of less than 30 lating to the same matter and a sum-
days will be the subject either of a let- mary of each type of comment sub-
ter or memorandum filed with the Di- mitted on the proposal and the Com-
vision of Dockets Management or of a missioner’s conclusions with respect to
notice published in the FEDERAL REG- each. The preamble is to contain a
ISTER. thorough and comprehensible expla-
(4) A notice of proposed rulemaking nation of the reasons for the Commis-
will request that four copies of all com- sioner’s decision on each issue.
ments be submitted to the Division of (4) The effective date of a final regu-
Dockets Management, except that indi- lation may not be less than 30 days
viduals may submit single copies. Com- after the date of publication in the
ments will be stamped with the date of FEDERAL REGISTER, except for:
receipt and will be numbered chrono-
(i) A regulation that grants an ex-
logically.
emption or relieves a restriction; or
(5) Persons submitting comments
(ii) A regulation for which the Com-
critical of a proposed regulation are
encouraged to include their preferred missioner finds, and states in the no-
alternative wording. tice good cause for an earlier effective
(c) After the time for comment on a date.
proposed regulation has expired, the (d) The provisions for notice and
Commissioner will review the entire comment in paragraphs (b) and (c) of
administrative record on the matter, this section apply only to the extent
including all comments and, in a no- required by the Administrative Proce-
tice published in the FEDERAL REG- dure Act (5 U.S.C. 551, 552, and 553). As
ISTER, will terminate the proceeding, a matter of discretion, however, the
issue a new proposal, or promulgate a Commissioner may voluntarily follow
final regulation. those provisions in circumstances in
(1) The quality and persuasiveness of which they are not required by the Ad-
the comments will be the basis for the ministrative Procedure Act.
Commissioner’s decision. The number (e) The requirements of notice and
or length of comments will not ordi- public procedure in paragraph (b) of
narily be a significant factor in the de- this section do not apply in the fol-
cision unless the number of comments lowing situations:
is material where the degree of public (1) When the Commissioner deter-
interest is a legitimate factor for con- mines for good cause that they are im-
sideration. practicable, unnecessary, or contrary
(2) The decision of the Commissioner to the public interest. In these cases,
on the matter will be based solely upon the notice promulgating the regulation
the administrative record. will state the reasons for the deter-
(3) A final regulation published in the mination, and provide an opportunity
FEDERAL REGISTER will have a pre- for comment to determine whether the
amble stating: (i) The name of the regulation should subsequently be
agency, (ii) the nature of the action modified or revoked. A subsequent no-
e.g., final rule, notice, (iii) a summary tice based on those comments may, but
174
need not, provide additional oppor- (7) A final regulation published in the
tunity for public comment. FEDERAL REGISTER that provides an op-
(2) Food additive and color additive portunity for the submission of further
petitions, which are subject to the pro- comments, in accordance with para-
visions of § 12.20(b)(2). graph (e)(1) of this section.
(3) New animal drug regulations, (8) Any other public procedure estab-
which are promulgated under section lished in this chapter and expressly ap-
512(i) of the act. plicable to the matter.
(f) In addition to the notice and pub- (g) The record of the administrative
lic procedure required under paragraph proceeding consists of all of the fol-
(b) of this section, the Commissioner lowing:
may also subject a proposed or final (1) If the regulation was initiated by
regulation, before or after publication a petition, the administrative record
in the FEDERAL REGISTER, to the fol- specified in § 10.30(i).
lowing additional procedures: (2) If a petition for reconsideration or
for a stay of action is filed, the admin-
(1) Conferences, meetings, discus-
istrative record specified in §§ 10.33(k)
sions, and correspondence under § 10.65.
and 10.35(h).
(2) A hearing under parts 12, 13, 14, or (3) The proposed rule published in the
15. FEDERAL REGISTER, including all infor-
(3) A notice published in the FEDERAL mation identified or filed by the Com-
REGISTER requesting information and missioner with the Division of Dockets
views before the Commissioner deter- Management on the proposal.
mines whether to propose a regulation. (4) All comments received on the pro-
(4) A draft of a proposed regulation posal, including all information sub-
placed on public display in the office of mitted as a part of the comments.
the Division of Dockets Management. (5) The notice promulgating the final
If this procedure is used, the Commis- regulation, including all information
sioner shall publish an appropriate no- identified or filed by the Commissioner
tice in the FEDERAL REGISTER stating with the Division of Dockets Manage-
that the document is available and ment as part of the administrative
specifying the time within which com- record of the final regulation.
ments on the draft proposal may be (6) The transcripts, minutes of meet-
submitted orally or in writing. ings, reports, FEDERAL REGISTER no-
(5) A revised proposal published in tices, and other documents resulting
the FEDERAL REGISTER, which proposal from the procedures specified in para-
is subject to all the provisions in this graph (f) of this section, but not the
section relating to proposed regula- transcript of a closed portion of a pub-
tions. lic advisory committee meeting.
(6) A tentative final regulation or (7) All documents submitted to the
tentative revised final regulation Division of Dockets Management under
placed on public display in the office of § 10.65(h).
the Division of Dockets Management (h) The record of the administrative
and, if deemed desirable by the Com- proceeding closes on the date of publi-
missioner, published in the FEDERAL cation of the final regulation in the
REGISTER. If the tentative regulation is FEDERAL REGISTER unless some other
placed on display only, the Commis- date is specified. Thereafter, any inter-
sioner shall publish an appropriate no- ested person may submit a petition for
tice in the FEDERAL REGISTER stating reconsideration under § 10.33 or a peti-
that the document is available and tion for stay of action under § 10.35. A
specifying the time within which com- person who wishes to rely upon infor-
ments may be submitted orally or in mation or views not included in the ad-
writing on the tentative final regula- ministrative record shall submit it to
tion. The Commissioner shall mail a the Commissioner with a new petition
copy of the tentative final regulation to modify the final regulation.
and the FEDERAL REGISTER notice to (i) The Division of Dockets Manage-
each person who submitted comments ment shall maintain a chronological
on the proposed regulation if one has list of all regulations proposed and pro-
been published. mulgated under this section and § 10.50
175
§ 10.45 21 CFR Ch. I (4–1–19 Edition)
(which list will not include regulations Commissioner’s decision on a petition

resulting from petitions filed and as- submitted in a timely manner pursuant
signed a docket number under § 10.30) to § 10.35, the Commissioner shall re-
showing— quest dismissal of the court action or
(1) The docket number (for a petition referral to the agency for an initial de-
submitted directly to a center, the list termination on the grounds of a failure
also includes the number or other des- to exhaust administrative remedies,
ignation assigned by the center, e.g., the lack of final agency action as re-
the number assigned to a food additive quired by 5 U.S.C. 701 et seq., and the
petition); lack of an actual controversy as re-
(2) The name of the petitioner, if any; quired by 28 U.S.C. 2201. If a court ac-
(3) The subject matter involved; and tion is filed requesting a stay of admin-
(4) The disposition of the petition. istrative action after a petition for a
stay of action is denied because it was
FR 36401, Sept. 29, 1987; 54 FR 9034, Mar. 3,
submitted after expiration of the time
1989; 56 FR 13758, Apr. 4, 1991; 62 FR 40592, period provided under § 10.35, or after
July 29, 1997; 66 FR 6468, Jan. 22, 2001; 66 FR the time for submitting such a petition
12848, Mar. 1, 2001] has expired, the Commissioner will re-
quest dismissal of the court action on
§ 10.45 Court review of final adminis- the ground of a failure to exhaust ad-
trative action; exhaustion of admin- ministrative remedies.
istrative remedies. (d) Unless otherwise provided, the
(a) This section applies to court re- Commissioner’s final decision con-
view of final administrative action stitutes final agency action (review-
taken by the Commissioner, including able in the courts under 5 U.S.C. 701 et
action taken under §§ 10.25 through seq. and, where appropriate, 28 U.S.C.
10.40 and § 16.1(b), except action subject 2201) on a petition submitted under
to § 10.50 and part 12. § 10.25(a), on a petition for reconsider-
(b) A request that the Commissioner ation submitted under § 10.33, on a peti-
take or refrain from taking any form of tion for stay of action submitted under
administrative action must first be the § 10.35, on an advisory opinion issued
subject of a final administrative deci- under § 10.85, on a matter involving ad-
sion based on a petition submitted ministrative action which is the sub-
under § 10.25(a) or, where applicable, a ject of an opportunity for a hearing
hearing under § 16.1(b) before any legal under § 16.1(b) of this chapter, or on the
action is filed in a court complaining issuance of a final regulation published
of the action or failure to act. If a in accordance with § 10.40, except that
court action is filed complaining of the the agency’s response to a petition
action or failure to act before the sub- filed under section 505(j)(2)(C) of the
mission of the decision on a petition act (21 U.S.C. 355(j)(2)(C)) and § 314.93 of
under § 10.25(a) or, where applicable, a this chapter will not constitute final
hearing under § 16.1(b), the Commis- agency action until any petition for re-
sioner shall request dismissal of the consideration submitted by the peti-
court action or referral to the agency tioner is acted on by the Commis-
for an initial administrative deter- sioner.
mination on the grounds of a failure to (1) It is the position of FDA except as
exhaust administrative remedies, the otherwise provided in paragraph (d)(2)
lack of final agency action as required of this section, that:
by 5 U.S.C. 701 et seq., and the lack of (i) Final agency action exhausts all
an actual controversy as required by 28 administrative remedies and is ripe for
U.S.C. 2201. preenforcement judicial review as of
(c) A request that administrative ac- the date of the final decision, unless
tion be stayed must first be the subject applicable law explicitly requires that
of an administrative decision based the petitioner take further action be-
upon a petition for stay of action sub- fore judicial review is available;
mitted under § 10.35 before a request is (ii) An interested person is affected
made that a court stay the action. If a by, and thus has standing to obtain ju-
court action is filed requesting a stay dicial review of final agency action;
of administrative action before the and
176
(iii) It is not appropriate to move to (1) A request for transfer of one or

dismiss a suit for preenforcement judi- more suits to consolidate separate ac-
cial review of final agency action on tions, under 28 U.S.C. 1404(a) or 28
the ground that indispenable parties U.S.C. 2112(a);
are not joined or that it is an (2) A request that actions in all but
unconsented suit against the United one jurisdiction be stayed pending the
States if the defect could be cured by conclusion of one proceeding;
amending the complaint. (3) A request that all but one action
(2) The Commissioner shall object to be dismissed pending the conclusion of
judicial review of a matter if: one proceeding, with the suggestion
(i) The matter is committed by law that the other plaintiffs intervene in
to the discretion of the Commissioner, that one suit; or
e.g., a decision to recommend or not to (4) A request that one of the suits be
recommend civil or criminal enforce- maintained as a class action in behalf
ment action under sections 302, 303, and of all affected persons.
304 of the act; or (h)(1) For the purpose of 28 U.S.C.
(ii) Review is not sought in a proper 2112(a), a copy of any petition filed in
court. any U.S. Court of Appeals challenging
a final action of the Commissioner
(e) An interested person may request
shall be sent by certified mail, return
judicial review of a final decision of the
receipt requested, or by personal deliv-
Commissioner in the courts without
ery to the Chief Counsel of FDA. The
first petitioning the Commissioner for
petition copy shall be time-stamped by
reconsideration or for a stay of action,
the clerk of the court when the origi-
except that in accordance with para- nal is filed with the court. The petition
graph (c) of this section, the person copy should be addressed to: Office of
shall request a stay by the Commis- the Chief Counsel (GCF–1), Food and
sioner under § 10.35 before requesting a Drug Administration, 5600 Fishers
stay by the court. Lane, Rockville, MD 20857. The Chief
(f) The Commissioner shall take the Counsel requests that the purpose of
position in an action for judicial re- all petitions mailed or delivered to the
view under 5 U.S.C. 701 et seq., whether Office of Chief Counsel to satisfy 28
or not it includes a request for a de- U.S.C. 2112(a) be clearly identified in a
claratory judgment under 28 U.S.C. cover letter.
2201, or in any other case in which the (2) If the Chief Counsel receives two
validity of administrative action is or more petitions filed in two or more
properly challenged, that the validity U.S. Courts of Appeals for review of
of the action must be determined sole- any agency action within 10 days of the
ly on the basis of the administrative effective date of that action for the
record specified in §§ 10.30(i), 10.33(k), purpose of judicial review, the Chief
10.35(h), 10.40(g), and 16.80(a) or the ad- Counsel will notify the U.S. Judicial
ministrative record applicable to any Panel on Multidistrict Litigation of
decision or action under the regula- any petitions that were received within
tions referenced in § 16.1(b), and that the 10-day period, in accordance with
additional information or views may the applicable rule of the panel.
not be considered. An interested person (3) For the purpose of determining
who wishes to rely upon information or whether a petition for review has been
views not included in the administra- received within the 10-day period under
tive record shall submit them to the paragraph (h)(2) of this section, the pe-
Commissioner with a new petition to tition shall be considered to be re-
modify the action under § 10.25(a). ceived on the date of delivery, if per-
(g) The Commissioner requests that sonally delivered. If the delivery is ac-
all petitions for judicial review of a complished by mail, the date of receipt
particular matter be filed in a single shall be the date noted on the return
U.S. District court. If petitions are receipt card.
filed in more than one jurisdiction, the (i) Upon judicial review of adminis-
Commissioner will take appropriate ac- trative action under this section:
tion to prevent a multiplicity of suits (1) If a court determines that the ad-
in various jurisdictions, such as: ministrative record is inadequate to
177
§ 10.50 21 CFR Ch. I (4–1–19 Edition)
support the action, the Commissioner opportunity for a formal evidentiary

shall determine whether to proceed public hearing.
with such action. (i) If the Commis- (2) The person requesting the hearing
sioner decides to proceed with the ac- has a right to an opportunity for a
tion, the court will be requested to re- hearing and submits adequate justifica-
mand the matter to the agency to re- tion for the hearing as required by
open the administrative proceeding §§ 12.20 through 12.22 and other applica-
and record, or on the Commissioner’s ble provisions in this chapter, e.g.,
own initiative the administrative pro- §§ 314.200, 514.200, and 601.7(a).
ceeding and record may be reopened (b) The Commissioner may order a
upon receipt of the court determina- formal evidentiary public hearing on
tion. A reopened administrative pro- any matter whenever it would be in the
ceeding will be conducted under the public interest to do so.
provisions of this part and in accord- (c) The provisions of the act, and
ance with any directions of the court. other laws, that afford a person who
(ii) If the Commissioner concludes would be adversely affected by admin-
that the public interest requires that istrative action an opportunity for a
the action remain in effect pending fur- formal evidentiary public hearing as
ther administrative proceedings, the listed below. The list imparts no right
court will be requested not to stay the to a hearing where the statutory sec-
matter in the interim and the Commis- tion provides no opportunity for a
sioner shall expedite the further ad- hearing.
ministrative proceedings. (1) Section 401 on any action for the
(2) If a court determines that the ad- amendment or repeal of any definition
ministrative record is adequate, but and standard of identity for any dairy
the rationale for the action must be product (including products regulated
further explained: under parts 131, 133, and 135 of this
(i) The Commissioner shall request chapter) or maple sirup (regulated
either that further explanation be pro- under § 168.140 of this chapter).
vided in writing directly to the court (2) Section 403(j) on regulations for
without further administrative pro- labeling of foods for special dietary
ceedings, or that the administrative uses.
proceeding be reopened in accordance (3) Section 404(a) on regulations for
with paragraph (i)(1)(i) of this section; emergency permit control.
and (4) Section 406 on tolerances for poi-
(ii) If the Commissioner concludes sonous substances in food.
that the public interest requires that (5) Section 409 (c), (d), and (h) on food
the action remain in effect pending fur- additive regulations.
ther court or administrative pro- (6) Section 501(b) on tests or methods
ceedings, the court will be requested of assay for drugs described in official
not to stay the matter in the interim compendia.
and the Commissioner shall expedite (7) [Reserved]
the further proceedings. (8) Section 502(h) on regulations des-
ignating requirements for drugs liable
FR 6886, Feb. 15, 1989; 54 FR 9034, Mar. 3, 1989;
to deterioration.
57 FR 17980, Apr. 28, 1992; 65 FR 56477, Sept. (9) Section 502(n) on prescription
19, 2000; 69 FR 31705, June 4, 2004] drug advertising regulations.
(10)–(11) [Reserved]
§ 10.50 Promulgation of regulations (12) Section 512(n)(5) on regulations
and orders after an opportunity for for animal antibiotic drugs and certifi-
a formal evidentiary public hear- cation requirements.
ing. (13) Section 721 (b) and (c) on regula-
(a) The Commissioner shall promul- tions for color additive listing and cer-
gate regulations and orders after an op- tification.
portunity for a formal evidentiary pub- (14) Section 4(a) of the Fair Pack-
lic hearing under part 12 whenever all aging and Labeling Act on food, drug,
of the following apply: device, and cosmetic labeling.
(1) The subject matter of the regula- (15) Section 5(c) of the Fair Pack-
tion or order is subject by statute to an aging and Labeling Act on additional
178
economic regulations for food, drugs, tween representatives of the center and
devices, and cosmetics. representatives of the office of the
(16) Section 505 (d) and (e) on new Commissioner concerning the matter
drug applications. before the decision of the Commis-
(17) Section 512 (d), (e) and (m) (3) and sioner. The Commissioner may, how-
(4) on new animal drug applications. ever, designate representatives of a
(18) Section 515(g) on device pre- center to advise the office of the Com-
market approval applications and prod- missioner, or designate members of
uct development protocols. that office to advise a center. The des-
(19) Section 351(a) of the Public ignation will be in writing and filed
Health Service Act on a biologics li- with the Division of Dockets Manage-
cense for a biological product. ment no later than the time specified
(20) Section 306 on debarment, debar- in paragraph (b)(2) of this section for
ment period and considerations, termi- the application of separation of func-
nation of debarment under section tions. All members of FDA other than
306(d)(3), suspension, and termination representatives of the involved center
of suspension. (except those specifically designated
otherwise) shall be available to advise
FR 9034, Mar. 3, 1989; 58 FR 49190, Sept. 22, and participate with the office of the
1993; 60 FR 38626, July 27, 1995; 63 FR 26697, Commissioner in its functions relating
May 13, 1998; 64 FR 398, Jan. 5, 1999; 64 FR to the hearing and the final decision.
56448, Oct. 20, 1999; 67 FR 4906, Feb. 1, 2002] (ii) The Chief Counsel for FDA shall
designate members of the office of Gen-
§ 10.55 Separation of functions; ex eral Counsel to advise and participate
parte communications. with the center in its functions in the
(a) This section applies to any matter hearing and members who are to advise
subject by statute to an opportunity the office of the Commissioner in its
for a formal evidentiary public hear- functions related to the hearing and
ing, as listed in § 10.50(c), and any mat- the final decision. The members of the
ter subject to a hearing before a Public office of General Counsel designated to
Board of Inquiry under part 13. advise the center may not participate
(b) In the case of a matter listed in or advise in any decision of the Com-
§ 10.50(c) (1) through (10) and (12) missioner except as counsel in public
through (15): proceedings. The designation is to be in
(1) An interested person may meet or the form of a memorandum filed with
correspond with any FDA representa- the Division of Dockets Management
tive concerning a matter prior to publi- and made a part of the administrative
cation of a notice announcing a formal record in the proceeding. There may be
evidentiary public hearing or a hearing no other communication between those
before a Public Board of Inquiry on the members of the office of General Coun-
matter; the provisions of § 10.65 apply sel designated to advise the office of
to the meetings and correspondence; the Commissioner and any other per-
and sons in the office of General Counsel or
(2) Upon publication of a notice an- in the involved center with respect to
nouncing a formal evidentiary public the matter prior to the decision of the
hearing or a hearing before a Public Commissioner. The Chief Counsel may
Board of Inquiry, the following separa- assign new attorneys to advise either
tion of functions apply: the center or the office of the Commis-
(i) The center responsible for the sioner at any stage of the proceedings.
matter is, as a party to the hearing, re- The Chief Counsel will ordinarily ad-
sponsible for all investigative func- vise and participate with the office of
tions and for presentation of the posi- the Commissioner in its functions re-
tion of the center at the hearing and in lating to the hearing and the final deci-
any pleading or oral argument before sion.
the Commissioner. Representatives of (iii) The office of the Commissioner
the center may not participate or ad- is responsible for the agency review
vise in any decision except as witness and final decision of the matter, with
or counsel in public proceedings. There the advice and participation of anyone

is to be no other communication be- in FDA other than representatives of
179
§ 10.60 21 CFR Ch. I (4–1–19 Edition)
the involved center and those members Division of Dockets Management. A

of the office of General Counsel des- person, including a representative of a
ignated to assist in the center’s func- participant in the hearing, who is in-
tions in the hearing. volved in an oral communication con-
(c) In a matter listed in § 10.50(c) (11) trary to this section, must, if possible,
and (16) through (19), the provisions re- be made available for cross-examina-
lating to separation of functions set tion during the hearing with respect to
forth in §§ 314.200(f), 514.200, and 601.7(a) the substance of that conversation. Re-
are applicable before publication of a buttal testimony pertinent to a writ-
notice announcing a formal evidentiary ten or oral communication contrary to
public hearing or a hearing before a this section will be permitted. Cross-
Public Board of Inquiry. Following examination and rebuttal testimony
publication of the notice of hearing, will be transcribed and filed with the
the rules in paragraph (b)(2) of this sec- Division of Dockets Management.
tion apply. (e) The prohibitions specified in para-
(d) Except as provided in paragraph graph (d) of this section apply to a per-
(e) of this section, between the date son who knows of a notice of hearing in
that separation of functions applies advance of its publication from the
under paragraph (b) or (c) of this sec- time the knowledge is acquired.
tion and the date of the Commis- (f) The making of a communication
sioner’s decision on the matter, com- contrary to this section may, con-
munication concerning the matter in- sistent with the interests of justice and
volved in the hearing will be restricted the policy of the underlying statute,
as follows: result in a decision adverse to the per-
(1) No person outside the agency may son knowingly making or causing the
have an ex parte communication with making of such a communication.
the presiding officer or any person rep-
resenting the office of the Commis- [44 FR 22323, Apr. 13, 1979, as amended at 50
FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989;
sioner concerning the matter in the 64 FR 398, Jan. 5, 1999]
hearing. Neither the presiding officer
nor any person representing the office § 10.60 Referral by court.
of the Commissioner may have any ex
parte communication with a person (a) This section applies when a Fed-
outside the agency concerning the mat- eral, State, or local court holds in
ter in the hearing. All communications abeyance, or refers to the Commis-
are to be public communications, as sioner, any matter for an initial ad-
witness or counsel, under the applica- ministrative determination under
ble provisions of this part. § 10.25(c) or § 10.45(b).
(2) A participant in the hearing may (b) The Commissioner shall promptly
submit a written communication to agree or decline to accept a court refer-
the office of the Commissioner with re- ral. Whenever feasible in light of agen-
spect to a proposal for settlement. cy priorities and resources, the Com-
These communications are to be in the missioner shall agree to accept a refer-
form of pleadings, served on all other ral and shall proceed to determine the
participants, and filed with the Divi- matter referred.
sion of Dockets Management like any (c) In reviewing the matter, the Com-
other pleading. missioner may use the following proce-
(3) A written communication con- dures:
trary to this section must be imme- (1) Conferences, meetings, discus-
diately served on all other participants sions, and correspondence under § 10.65.
and filed with the Division of Dockets (2) A hearing under parts 12, 13, 14, 15,
Management by the presiding officer at or 16.
the hearing, or by the Commissioner, (3) A notice published in the FEDERAL
depending on who received the commu- REGISTER requesting information and
nication. An oral communication con- views.
trary to this section must be imme- (4) Any other public procedure estab-
diately recorded in a written memo- lished in other sections of this chapter
randum and similarly served on all and expressly applicable to the matter
other participants and filed with the under those provisions.
180
(d) If the Commissioner’s review of or preclude, the attendance of a spe-

the matter results in a proposed rule, cific FDA employee.
the provisions of § 10.40 or § 10.50 also (3) A person who wishes to attend a
apply. private meeting, but who is not invited
to attend either by the person request-
§ 10.65 Meetings and correspondence. ing the meeting or by FDA, or who oth-
(a) In addition to public hearings and erwise cannot attend the meeting, may
proceedings established under this part request a separate meeting with FDA
and other sections of this chapter, to discuss the same matter or an addi-
meetings may be held and correspond- tional matter.
ence may be exchanged between rep- (d) FDA employees have a responsi-
resentatives of FDA and an interested bility to meet with all segments of the
person outside FDA on a matter within public to promote the objectives of the
the jurisdiction of the laws adminis- laws administered by the agency. In
tered by the Commissioner. Action on pursuing this responsibility, the fol-
meetings and correspondence does not lowing general policy applies where
constitute final administrative action agency employees are invited by per-
subject to judicial review under § 10.45. sons outside the Federal Government
(b) The Commissioner may conclude to attend or participate in meetings
that it would be in the public interest outside agency offices as representa-
to hold an open public meeting to dis- tives of the agency.
cuss a matter (or class of matters) (1) A person outside the executive
pending before FDA, in which any in- branch may invite an agency rep-
terested person may participate. resentative to attend or participate in
(1) The Commissioner shall inform a meeting outside agency offices. The
the public of the time and place of the agency representative is not obligated
meeting and of the matters to be dis- to attend or participate, but may do so
cussed. where it is in the public interest and
(2) The meeting will be informal, i.e., will promote the objectives of the act.
any interested person may attend and (2) The agency representative may
participate in the discussion without request that the meeting be open if
prior notice to the agency unless the that would be in the public interest.
notice of the meeting specifies other- The agency representative may decline
wise. to participate in a meeting held as a
(c) Every person outside the Federal private meeting if that will best serve
Government may request a private the public interest.
meeting with a representative of FDA (3) An agency representative may not
in agency offices to discuss a matter. knowingly participate in a meeting
FDA will make reasonable efforts to that is closed on the basis of gender,
accommodate such requests. race, or religion.
(1) The person requesting a meeting (e) An official transcript, recording,
may be accompanied by a reasonable or memorandum summarizing the sub-
number of employees, consultants, or stance of any meeting described in this
other persons with whom there is a section will be prepared by a represent-
commercial arrangement within the ative of FDA when the agency deter-
meaning of § 20.81(a) of this chapter. mines that such documentation will be
Neither FDA nor any other person may useful.
require the attendance of a person who (f) FDA promptly will file in the ap-
is not an employee of the executive propriate administrative file memo-
branch of the Federal Government randa of meetings prepared by FDA
without the agreement of the person representatives and all correspondence,
requesting the meeting. Any person including any written summary of a
may attend by mutual consent of the meeting from a participant, that relate
person requesting the meeting and to a matter pending before the agency.
FDA. (g) Representatives of FDA may ini-
(2) FDA will determine which rep- tiate a meeting or correspondence on
resentatives of the agency will attend any matter concerning the laws admin-
the meeting. The person requesting the istered by the Commissioner. Unless
meeting may request, but not require otherwise required by law, meetings
181
§ 10.70 21 CFR Ch. I (4–1–19 Edition)
may be public or private at FDA’s dis- (5) If it records the views, analyses,
cretion. recommendations, or decisions of an
(h) A meeting of an advisory com- agency employee in addition to the au-
mittee is subject to the requirements thor, be given to the other employees;
of part 14 of this chapter. and
(6) Once completed (i.e., typed in
[66 FR 6468, Jan. 22, 2001]
final form, dated, and signed) not be al-
§ 10.70 Documentation of significant tered or removed. Later additions to or
decisions in administrative file. revisions of the document must be
made in a new document.
(a) This section applies to every sig- (d) Memoranda or other documents
nificant FDA decision on any matter that are prepared by agency employees
under the laws administered by the and are not in the administrative file
Commissioner, whether it is raised for- have no status or effect.
mally, for example, by a petition or in- (e) FDA employees working on a
formally, for example, by correspond- matter have access to the administra-
ence. tive file on that matter, as appropriate
(b) FDA employees responsible for for the conduct of their work. FDA em-
handling a matter are responsible for ployees who have worked on a matter
insuring the completeness of the ad- have access to the administrative file
ministrative file relating to it. The file on that matter so long as attention to
must contain: their assignments is not impeded. Rea-
(1) Appropriate documentation of the sonable restrictions may be placed
basis for the decision, including rel- upon access to assure proper cataloging
evant evaluations, reviews, memo- and storage of documents, the avail-
randa, letters, opinions of consultants, ability of the file to others, and the
minutes of meetings, and other perti- completeness of the file for review.
nent written documents; and
(2) The recommendations and deci- § 10.75 Internal agency review of deci-
sions of individual employees, includ- sions.
ing supervisory personnel, responsible (a) A decision of an FDA employee,
for handling the matter. other than the Commissioner, on a
(i) The recommendations and deci- matter, is subject to review by the em-
sions are to reveal significant con- ployee’s supervisor under the following
troversies or differences of opinion and circumstances:
their resolution. (1) At the request of the employee.
(ii) An agency employee working on a (2) On the initiative of the super-
matter and, consistent with the visor.
prompt completion of other assign- (3) At the request of an interested
ments, an agency employee who has person outside the agency.
worked on a matter may record indi- (4) As required by delegations of au-
vidual views on that matter in a writ- thority.
ten memorandum, which is to be placed (b)(1) The review will be made by
in the file. consultation between the employee and
(c) A written document placed in an the supervisor or by review of the ad-
administrative file must: ministrative file on the matter, or
(1) Relate to the factual, scientific, both. The review will ordinarily follow
legal or related issues under consider- the established agency channels of su-
ation; pervision or review for that matter.
(2) Be dated and signed by the au- (2) A sponsor, applicant, or manufac-
thor; turer of a drug or device regulated
(3) Be directed to the file, to appro- under the act or the Public Health
priate supervisory personnel, and to Service Act (42 U.S.C. 262), may request
other appropriate employees, and show review of a scientific controversy by an
all persons to whom copies were sent; appropriate scientific advisory panel as
(4) Avoid defamatory language, in- described in section 505(n) of the act, or
temperate remarks, undocumented an advisory committee as described in
charges, or irrelevant matters (e.g., section 515(g)(2)(B) of the act. The rea-
personnel complaints); son(s) for any denial of a request for
182
such review shall be briefly set forth in notice or proposed regulation may be
writing to the requester. Persons who discussed with a person outside the ex-
receive a Center denial of their request ecutive branch only with the specific
under this section may submit a re- permission of the Commissioner. The
quest for review of the denial. The re- permission must be in writing and filed
quest should be sent to the Chief Medi- with the Division of Dockets Manage-
ator and Ombudsman. ment.
(c) An interested person outside the (2) A draft of a notice or proposed
agency may request internal agency re- regulation or its preamble, or a portion
view of a decision through the estab- of either, may be furnished to an inter-
lished agency channels of supervision ested person outside the executive
or review. Personal review of these branch only if it is made available to
matters by center directors or the of- all interested persons by a notice pub-
fice of the Commissioner will occur for lished in the FEDERAL REGISTER. A
any of the following purposes: draft of a notice or proposed regulation
(1) To resolve an issue that cannot be made available in this manner may,
resolved at lower levels within the without the prior permission of the
agency (e.g., between two parts of a Commissioner, be discussed with an in-
center or other component of the agen- terested person to clarify and resolve
cy, between two centers or other com- questions raised and concerns ex-
ponents of the agency, or between the pressed about the draft.
agency and an interested person out- (c) After publication of a notice or
side the agency). proposed regulation in the FEDERAL
(2) To review policy matters requir-
REGISTER, and before preparation of a
ing the attention of center or agency
draft of the final notice or regulation,
management.
a representative of FDA may discuss
(3) In unusual situations requiring an
the proposal with an interested person
immediate review in the public inter-
as provided in paragraph (b)(2) of this
est.
(4) As required by delegations of au- section.
thority. (d) Final notices and regulations. (1)
(d) Internal agency review of a deci- Details of a draft of a final notice or
sion must be based on the information regulation may be discussed with an
in the administrative file. If an inter- interested person outside the executive
ested person presents new information branch only with the specific permis-
not in the file, the matter will be re- sion of the Commissioner. The permis-
turned to the appropriate lower level in sion must be in writing and filed with
the agency for reevaluation based on the Division of Dockets Management.
the new information. (2) A draft of a final notice or regula-
tion or its preamble, or any portion of
FR 8994, Mar. 6, 1985; 63 FR 63982, Nov. 18,
either, may be furnished to an inter-
1998] ested person outside the executive
branch only if it is made available to
§ 10.80 Dissemination of draft Federal all interested persons by a notice pub-
Register notices and regulations. lished in the FEDERAL REGISTER, except
(a) A representative of FDA may dis- as otherwise provided in paragraphs (g)
cuss orally or in writing with an inter- and (j) of this section. A draft of a final
ested person ideas and recommenda- notice or regulation made available to
tions for notices or regulations. FDA an interested person in this manner
welcomes assistance in developing may, without the prior permission of
ideas for, and in gathering the informa- the Commissioner, be discussed as pro-
tion to support, notices and regula- vided in paragraph (b)(2) of this sec-
tions. tion.
(b) Notices and proposed regulations. (1) (i) The final notice or regulation and
Once it is determined that a notice or its preamble will be prepared solely on
proposed regulation will be prepared, the basis of the administrative record.
the general concepts may be discussed (ii) If additional technical informa-
by a representative of FDA with an in- tion from a person outside the execu-
terested person. Details of a draft of a tive branch is necessary to draft the
183
§ 10.85 21 CFR Ch. I (4–1–19 Edition)
final notice or regulation or its pre- considered for an electronic product,

amble, it will be requested by FDA in and any draft of any proposed or final
general terms and furnished directly to standard will be furnished to an inter-
the Division of Dockets Management ested person upon request and may be
to be included as part of the adminis- discussed in detail.
trative record. (i) The provisions of § 10.65 apply to
(iii) If direct discussion by FDA of a meetings and correspondence relating
draft of a final notice or regulation or to draft notices and regulations.
its preamble is required with a person (j) The provisions of this section re-
outside the executive branch, appro- stricting discussion and disclosure of
priate protective procedures will be un- draft notices and regulations do not
dertaken to make certain that a full apply to situations covered by §§ 20.83
and impartial administrative record is through 20.89.
established. Such procedures may in- [44 FR 22323, Apr. 13, 1979, as amended at 54
clude either: FR 9035, Mar. 3, 1989; 64 FR 398, Jan. 5, 1999]
(a) The scheduling of an open public
meeting under § 10.65(b) at which inter- § 10.85 Advisory opinions.
ested persons may participate in re- (a) An interested person may request
view of and comment on the draft doc- an advisory opinion from the Commis-
ument; or sioner on a matter of general applica-
(b) The preparation of a tentative bility.
final regulation or tentative revised (1) The request will be granted when-
final regulation under § 10.40(f)(6), on ever feasible.
which interested persons will be given (2) The request may be denied if:
an additional period of time for oral (i) The request contains incomplete
and written comment. information on which to base an in-
(e) After a final regulation is pub- formed advisory opinion;
lished, an FDA representative may dis- (ii) The Commissioner concludes that
cuss any aspect of it with an interested an advisory opinion cannot reasonably
person. be given on the matter involved;
(f) In addition to the requirements of (iii) The matter is adequately cov-
this section, the provisions of § 10.55 ered by a prior advisory opinion or a
apply to the promulgation of a regula- regulation;
tion subject to § 10.50 and part 12. (iv) The request covers a particular
(g) A draft of a final food additive product or ingredient or label and does
color additive, or new animal drug reg- not raise a policy issue of broad appli-
ulation may be furnished to the peti- cability; or
tioner for comment on the technical (v) The Commissioner otherwise con-
accuracy of the regulation. Every cludes that an advisory opinion would
meeting with a petitioner relating to not be in the public interest.
the draft will be recorded in a written (b) A request for an advisory opinion
memorandum, and all memoranda and is to be submitted in accordance with
correspondence will be filed with the § 10.20, is subject to the provisions of
Division of Dockets Management as § 10.30 (c) through (l), and must be in
part of the administrative record of the the following form:
regulation under the provisions of
§ 10.65. (Date) llllllllllllllllllll
(h) In accordance with 42 U.S.C 263f, Division of Dockets Management, Food
the Commissioner shall consult with and Drug Administration, Department of
interested persons and with the Tech- Health and Human Services, 5630 Fishers
nical Electronic Product Radiation Lane, rm. 1061, Rockville, MD 20852.
Safety Standards Committee REQUEST FOR ADVISORY OPINION
(TEPRSSC) before prescribing any per-
formance standard for an electronic The undersigned submits this request for
an advisory opinion of the Commissioner of
product. Accordingly, the Commis-
Food and Drugs with respect to lll (the
sioner shall publish in the FEDERAL general nature of the matter involved).
REGISTER an announcement when a
A. Issues involved.
proposed or final performance stand- (A concise statement of the issues and
ard, including any amendment, is being questions on which an opinion is requested.)
184
B. Statement of facts and law. (f) In unusual situations involving an
(A full statement of all facts and legal immediate and significant danger to
points relevant to the request.) health, the Commissioner may take ap-
The undersigned certifies that, to the best propriate civil enforcement action con-
of his/her knowledge and belief, this request
includes all data, information, and views rel-
trary to an advisory opinion before
evant to the matter, whether favorable or amending or revoking the opinion. This
unfavorable to the position of the under- action may be taken only with the ap-
signed, which is the subject of the request. proval of the Commissioner, who may
not delegate this function. Appropriate
(Signature) lllllllllllllllll
(Person making request) llllllllll
amendment or revocation of the advi-
(Mailing address) llllllllllllll sory opinion involved will be expedited.
(Telephone number) lllllllllllll (g) An advisory opinion may be
amended or revoked at any time after
(c) The Commissioner may respond to it has been issued. Notice of amend-
an oral or written request to the agen- ment or revocation will be given in the
cy as a request for an advisory opinion, same manner as notice of the advisory
in which case the request will be filed opinion was originally given or in the
with the Division of Dockets Manage- FEDERAL REGISTER, and will be placed
ment and be subject to this section. on public display as part of the file on
(d) A statement of policy or interpre- the matter in the office of the Division
tation made in the following docu- of Dockets Management. The Division
ments, unless subsequently repudiated of Dockets Management shall maintain
by the agency or overruled by a court, a separate chronological index of all
will constitute an advisory opinion: advisory opinions filed. The index will
(1) Any portion of a FEDERAL REG- specify the date of the request for the
ISTER notice other than the text of a advisory opinion, the date of the opin-
proposed or final regulation, e.g., a no- ion, and identification of the appro-
tice to manufacturers or a preamble to priate file.
a proposed or final regulation. (h) Action undertaken or completed
(2) Trade Correspondence (T.C. Nos. in conformity with an advisory opinion
1–431 and 1A–8A) issued by FDA be- which has subsequently been amended
tween 1938 and 1946. or revoked is acceptable to FDA unless
(3) Compliance policy guides issued the Commissioner determines that sub-
by FDA beginning in 1968 and codified stantial public interest considerations
in the Compliance Policy Guides man- preclude continued acceptance. When-
ual. ever possible, an amended or revoked
(4) Other documents specifically advisory opinion will state when action
identified as advisory opinions, e.g., ad- previously undertaken or completed
visory opinions on the performance does not remain acceptable, and any
standard for diagnostic X-ray systems, transition period that may be applica-
issued before July 1, 1975, and filed in a ble.
permanent public file for prior advi- (i) An interested person may submit
sory opinions maintained by the Divi- written comments on an advisory opin-
sion of Freedom of Information ion or modified advisory opinion. Four
(ELEM–1029)’’ and adding in its place copies of any comments are to be sent
‘‘(the Freedom of Information Staff’s to the Division of Dockets Manage-
address is available on the agency’s ment for inclusion in the public file on
web site at http://www.fda.gov.) the advisory opinion. Individuals may
(e) An advisory opinion represents submit only one copy. Comments will
the formal position of FDA on a matter be considered in determining whether
and except as provided in paragraph (f) further modification of an advisory
of this section, obligates the agency to opinion is warranted.
follow it until it is amended or re- (j) An advisory opinion may be used
voked. The Commissioner may not rec- in administrative or court proceedings
ommend legal action against a person to illustrate acceptable and unaccept-
or product with respect to an action able procedures or standards, but not
taken in conformity with an advisory as a legal requirement.
opinion which has not been amended or (k) A statement made or advice pro-
revoked. vided by an FDA employee constitutes
185
§ 10.90 21 CFR Ch. I (4–1–19 Edition)
an advisory opinion only if it is issued similar written documents executed by

in writing under this section. A state- FDA and another person will be in-
ment or advice given by an FDA em- cluded in the public file on agreements
ployee orally, or given in writing but established by the Division of Freedom
not under this section or § 10.90, is an of Information (ELEM–1029)’’ and add-
informal communication that rep- ing in its place ‘‘(the Freedom of Infor-
resents the best judgment of that em- mation Staff’s address is available on
ployee at that time but does not con- the agency’s web site at http://
stitute an advisory opinion, does not www.fda.gov) under § 20.108. A docu-
necessarily represent the formal posi- ment not included in the public file is
tion of FDA, and does not bind or oth- deemed to be rescinded and has no
erwise obligate or commit the agency force or effect whatever.
to the views expressed.
[44 FR 22323, Apr. 13, 1979, as amended at 46 FR 9035, Mar. 3, 1989; 65 FR 56477, Sept. 19,
FR 8455, Jan. 27, 1981; 59 FR 14364, Mar. 28,
2000; 75 FR 16346, Apr. 1, 2010; 79 FR 68114,
1994; 65 FR 56477, Sept. 19, 2000; 76 FR 31469,
Nov. 14, 2014]
June 1, 2011; 79 FR 68114, Nov. 14, 2014]
§ 10.90 Food and Drug Administration § 10.95 Participation in outside stand-

regulations, recommendations, and ard-setting activities.
agreements. (a) General. This section applies to
(a) Regulations. FDA regulations are participation by FDA employees in
issued in the FEDERAL REGISTER under standard-setting activities outside the
§ 10.40 or § 10.50 and codified in the Code agency. Standard-setting activities in-
of Federal Regulations. Regulations clude matters such as the development
may contain provisions that will be en- of performance characteristics, testing
forced as legal requirements, or which methodology, manufacturing practices,
are intended only as guidance docu- product standards, scientific protocols,
ments and recommendations, or both. compliance criteria, ingredient speci-
The dissemination of draft notices and fications, labeling, or other technical
regulations is subject to § 10.80. or policy criteria. FDA encourages em-
(b) [Reserved] ployee participation in outside stand-
(c) Recommendations. In addition to ard-setting activities that are in the
the guidance documents subject to public interest.
§ 10.115, FDA often formulates and dis- (b) Standard-setting activities by other
seminates recommendations about Federal Government agencies. (1) An FDA
matters which are authorized by, but employee may participate in these ac-
do not involve direct regulatory action tivities after approval of the activity
under, the laws administered by the under procedures specified in the cur-
Commissioner, e.g., model State and
rent agency Staff Manual Guide.
local ordinances, or personnel practices
(2) Approval forms and all pertinent
for reducing radiation exposure, issued
under 42 U.S.C. 243 and 21 U.S.C. 360ii. background information describing the
These recommendations may, in the activity will be included in the public
discretion of the Commissioner, be file on standard-setting activities es-
handled under the procedures estab- tablished by the Division of Freedom of
lished in § 10.115, except that the rec- Information (ELEM–1029)’’ and adding
ommendations will be included in a in its place ‘‘(the Freedom of Informa-
separate public file of recommendation Staff’s address is available on the
tions established by the Division of agency’s web site at http://
Dockets Management and will be sepa- www.fda.gov).
rated from the guidance documents in (3) If a member of the public is in-
the notice of availability published in vited by FDA to present views to, or to
the FEDERAL REGISTER, or be published accompany, the FDA employee at a
in the FEDERAL REGISTER as regula- meeting, the invitations will be ex-
tions under paragraph (a) of this sec- tended to a representative sampling of
tion. the public, including consumer groups,
(d) Agreements. Formal agreements, industry associations, professional so-

memoranda of understanding, or other cieties, and academic institutions.
186
(4) An FDA employee appointed as the Commissioner or the center direc-

the liaison representative to an activ- tor to the organization stating—
ity shall refer all requests for informa- (i) Whether participation by the indi-
tion about or participation in the ac- vidual will be as a voting or nonvoting
tivity to the group or organization re- liaison representative;
sponsible for the activity. (ii) That participation by the indi-
(c) Standard-setting activities by State vidual does not connote FDA agree-
and local government agencies and by ment with, or endorsement of, any de-
United Nations organizations and other cisions reached; and
international organizations and foreign (iii) That participation by the indi-
governments pursuant to treaty. (1) An vidual precludes service as the deciding
FDA employee may participate in official on the standard involved if it
these activities after approval of the should later come before FDA. The de-
activity under procedures specified in ciding official is the person who signs a
the current agency Staff Manual document ruling upon the standard.
Guide.
(2) The letter requesting official FDA
(2) Approval forms and all pertinent participation, the approval form, and
background information describing the
the Commissioner’s or center director’s
activity will be included in the public
letter, together with all pertinent
file on standard-setting activities es-
background information describing the
tablished by the Division of Freedom of
activities involved, will be included in
Information (ELEM–1029)’’ and adding
the public file on standard-setting ac-
in its place ‘‘(the Freedom of Informa-
tivities established by the Division of
tion Staff’s address is available on the
Freedom of Information (ELEM–1029)’’
agency’s web site at http://
and adding in its place ‘‘(the Freedom
www.fda.gov).
of Information Staff’s address is avail-
(3) The availability for public disclo-
able on the agency’s web site at http://
sure of records relating to the activity
www.fda.gov).
will be governed by part 20.
(3) The availability for public disclo-
(4) If a member of the public is in-
sure of records relating to the activi-
vited by FDA to present views to, or to
ties will be governed by part 20.
accompany, the FDA employee at a
meeting, the invitation will be ex- (4) An FDA employee appointed as
tended to a representative sampling of the liaison representative to an activ-
the public, including consumer groups, ity shall refer all requests for informa-
industry associations, professional so- tion about or participation in the ac-
cieties, and academic institutions. tivity to the group or organization re-
(5) An FDA employee appointed as sponsible for the activity.
the liaison representative to an activ- (5) The following minimum standards
ity shall refer all requests for informa- apply to an outside private standard-
tion about or participation in the ac- setting activity in which FDA employ-
tivity to the group or organization re- ees participate:
sponsible for the activity. (i) The activity will be based upon
(d) Standard-setting activities by pri- consideration of sound scientific and
vate groups and organizations. (1) An technological information, will permit
FDA employee may engage in these ac- revision on the basis of new informa-
tivities after approval of the activity tion, and will be designed to protect
under procedures specified in the cur- the public against unsafe, ineffective,
rent agency Staff Manual Guide. A re- or deceptive products or practices.
quest for official participation must be (ii) The activity and resulting stand-
made by the group or organization in ards will not be designed for the eco-
writing, must describe the scope of the nomic benefit of any company, group,
activity, and must demonstrate that or organization, will not be used for
the minimum standards set out in such antitrust violations as fixing
paragraph (d)(5) of this section are met. prices or hindering competition, and
Except as provided in paragraph (d)(7) will not involve establishment of cer-
of this section, a request that is grant- tification or specific approval of indi-

ed will be the subject of a letter from vidual products or services.
187
§ 10.100 21 CFR Ch. I (4–1–19 Edition)
(iii) The group or organization re- tivities established by the Division of

sponsible for the standard-setting ac- Freedom of Information (ELEM–1029)’’
tivity must have a procedure by which and adding in its place ‘‘(the Freedom
an interested person will have an op- of Information Staff’s address is avail-
portunity to provide information and able on the agency’s web site at http://
views on the activity and standards in- www.fda.gov).
volved, without the payment of fees, (i) American Association of Food Hy-
and the information and views will be giene Veterinarians (AAFHV).
considered. How this is accomplished, (ii) American Public Health Associa-
including whether the presentation tion (APHA).
will be in person or in writing, will be (iii) Association of American Feed
decided by the group or organization Control Officials, Inc. (AAFCO).
responsible for the activity. (iv) Association of Food and Drug Of-
(6) Membership of an FDA employee ficials (AFDO).
in an organization that also conducts a (v) AOAC INTERNATIONAL (AOAC).
standard-setting activity does not in- (vi) Association of State and Terri-
voke the provisions of this section un- torial Health Officials (ASTHO).
less the employee participates in the (vii) Conference for Food Protection
standard-setting activity. Participa- (CFP).
tion in a standard-setting activity is (viii) Conference of State Health and
subject to this section. Environmental Managers (COSHEM).
(7) The Commissioner may determine (ix) Conference of Radiation Control
in writing that, because direct involve- Program Directors (CRCPD).
ment by FDA in a particular standard- (x) International Association of Milk,
setting activity is in the public inter- Food, and Environmental Sanitation,
est and will promote the objectives of Inc. (IAMFES).
the act and the agency, the participa- (xi) Interstate Shellfish Sanitation
tion is exempt from the requirements Conference (ISSC).
of paragraph (d)(1) (ii) and/or (iii) of (xii) National Association of Boards
this section. This determination will be of Pharmacy (NABP).
included in the public file on standard- (xiii) National Association of Depart-
setting activities established by the Di- ments of Agriculture (NADA).
vision of Freedom of Information (xiv) National Conference on Inter-
(ELEM–1029)’’ and adding in its place state Milk Shipments (NCIMS).
‘‘(the Freedom of Information Staff’s (xv) National Conference of Local En-
address is available on the agency’s vironmental Health Administrators
web site at http://www.fda.gov) and in (NCLEHA).
any relevant administrative file. The (xvi) National Conference on Weights
activity may include the establishment and Measures (NCWW).
and validation of analytical methods (xvii) National Environmental Health
for regulatory use, drafting uniform Association (NEHA).
laws and regulations, and the develop- (xviii) National Society of Profes-
ment of recommendations concerning sional Sanitarians (NSPS).
public health and preventive medicine [44 FR 22323, Apr. 13, 1979, as amended at 46
practices by national and international FR 8455, Jan. 27, 1981; 52 FR 35064, Sept. 17,
organizations. 1987; 54 FR 9035, Mar. 3, 1989; 70 FR 40880,
(8) Because of the close daily co- July 15, 2005; 70 FR 67651, Nov. 8, 2005; 76 FR
operation between FDA and the asso- 31469, June 1, 2011; 79 FR 68114, Nov. 14, 2014]
ciations of State and local government
officials listed below in this paragraph, § 10.100 Public calendar.
and the large number of agency em- (a) Public calendar. A public calendar
ployees who are members of or work will be prepared and made publicly
with these associations, participation available by FDA each week showing,
in the activities of these associations is to the extent feasible, significant
exempt from paragraphs (d)(1) through events of the previous week, including
(7) of this section, except that a list of significant meetings with persons out-
the committees and other groups of side the executive branch, that involve
these associations will be included in the representatives of FDA designated

the public file on standard-setting ac- under paragraph (c) of this section.
188
(1) Public calendar entries will in- participating in an administrative pro-

clude: ceeding subject to this part.
(i) Significant meetings with mem- (b) A petition, comment, objection,
bers of the judiciary, representatives of or other representation by an organiza-
Congress, or staffs of congressional tion will not abridge the right of a
committees when the meeting relates member to take individual action of a
to a pending court case, administrative similar type, in the member’s own
hearing, or other regulatory action or name.
decision; (c) It is requested that each organiza-
(ii) Significant meetings, con- tion participating in FDA administra-
ferences, seminars, and speeches; and tive proceedings file annually with the
(iii) Social events sponsored by the Division of Dockets Management a cur-
regulated industry. rent list of all of the members of the
(2) The public calendar will not in- organization.
clude reports of meetings that would (d) The filing by an organization of
prejudice law enforcement activities an objection or request for hearing
(e.g., a meeting with an informant) or under §§ 12.20 through 12.22 does not
invade privacy (e.g., a meeting with a provide a member a legal right with re-
candidate for possible employment at spect to the objection or request for
FDA), meetings with members of the hearing that the member may individ-
press, or meetings with onsite contrac- ually exercise. A member of an organi-
tors. zation wishing to file an objection or
(b) Calendar entries. The calendar will request for hearing must do so individ-
specify for each entry the date, per- ually.
son(s), and subject matter involved. If (e) In a court proceeding in which an
a large number of persons are in at- organization participates, the Commis-
tendance, the name of each individual sioner will take appropriate legal
need not be specified. When more than
measures to have the case brought or
one FDA representative is in attend-
considered as a class action or other-
ance, the most senior agency official
wise as binding upon all members of
will report the meeting on the public
the organization except those specifi-
calendar.
cally excluded by name. Regardless of
(c) Affected persons. The following
whether the case is brought or consid-
FDA representatives are subject to the
ered as a class action or as otherwise
requirements of this section:
binding upon all members of the orga-
(1) Commissioner of Food and Drugs.
nization except those specifically ex-
(2) Senior Associate Commissioners.
cluded by name, the Commissioner will
(3) Deputy Commissioners. take the position in any subsequent
(4) Associate Commissioner for Regu- suit involving the same issues and a
latory Affairs. member of the organization that the
(5) Center Directors. issues are precluded from further liti-
(6) Chief Counsel for the Food and gation by the member under the doc-
Drug Administration. trines of collateral estoppel or res judi-
(d) Public display. The public calendar cata.
will be placed on public display at the
following locations: § 10.110 Settlement proposals.
(1) Division of Dockets Management.
At any time in the course of a pro-
(2) Office of the Associate Commis-
ceeding subject to this part, a person
sioner for Public Affairs.
may propose settlement of the issues
(3) The FDA home page, to the extent
involved. A participant in a proceeding
feasible.
will have an opportunity to consider a
[66 FR 6468, Jan. 22, 2001] proposed settlement. Unaccepted pro-
posals of settlement and related mat-
§ 10.105 Representation by an organi- ters, e.g., proposed stipulations not
zation. agreed to, will not be admissible in evi-
(a) An organization may represent its dence in an FDA administrative pro-
members by filing petitions, com- ceeding. FDA will oppose the admission
ments, and objections, and otherwise in evidence of settlement information
189
§ 10.115 21 CFR Ch. I (4–1–19 Edition)
in a court proceeding or in another ad- forceable rights or responsibilities.

ministrative proceeding. They do not legally bind the public or
FDA.
§ 10.115 Good guidance practices. (2) You may choose to use an ap-
(a) What are good guidance practices? proach other than the one set forth in
Good guidance practices (GGP’s) are a guidance document. However, your
FDA’s policies and procedures for de- alternative approach must comply with
veloping, issuing, and using guidance the relevant statutes and regulations.
documents. FDA is willing to discuss an alter-
(b) What is a guidance document? (1) native approach with you to ensure
Guidance documents are documents that it complies with the relevant stat-
prepared for FDA staff, applicants/ utes and regulations.
sponsors, and the public that describe (3) Although guidance documents do
the agency’s interpretation of or policy not legally bind FDA, they represent
on a regulatory issue. the agency’s current thinking. There-
(2) Guidance documents include, but fore, FDA employees may depart from
are not limited to, documents that re- guidance documents only with appro-
late to: The design, production, label- priate justification and supervisory
ing, promotion, manufacturing, and concurrence.
testing of regulated products; the proc- (e) Can FDA use means other than a
essing, content, and evaluation or ap- guidance document to communicate new
proval of submissions; and inspection agency policy or a new regulatory ap-
and enforcement policies. proach to a broad public audience? The
(3) Guidance documents do not in- agency may not use documents or
clude: Documents relating to internal other means of communication that
FDA procedures, agency reports, gen-
are excluded from the definition of
eral information documents provided
guidance document to informally com-
to consumers or health professionals,
municate new or different regulatory
speeches, journal articles and edi-
expectations to a broad public audience
torials, media interviews, press mate-
for the first time. These GGP’s must be
rials, warning letters, memoranda of
followed whenever regulatory expecta-
understanding, or other communica-
tions that are not readily apparent
tions directed to individual persons or
from the statute or regulations are
firms.
first communicated to a broad public
(c) What other terms have a special
meaning? (1) ‘‘Level 1 guidance docu- audience.
ments’’ include guidance documents (f) How can you participate in the de-
that: velopment and issuance of guidance docu-
(i) Set forth initial interpretations of ments? (1) You can provide input on
statutory or regulatory requirements; guidance documents that FDA is devel-
(ii) Set forth changes in interpreta- oping under the procedures described in
tion or policy that are of more than a paragraph (g) of this section.
minor nature; (2) You can suggest areas for guid-
(iii) Include complex scientific issues; ance document development. Your sug-
or gestions should address why a guidance
(iv) Cover highly controversial document is necessary.
issues. (3) You can submit drafts of proposed
(2) ‘‘Level 2 guidance documents’’ are guidance documents for FDA to con-
guidance documents that set forth ex- sider. When you do so, you should
isting practices or minor changes in in- mark the document ‘‘Guidance Docu-
terpretation or policy. Level 2 guidance ment Submission’’ and submit it to Di-
documents include all guidance docu- vision of Dockets Management (HFA–
ments that are not classified as Level 305), 5630 Fishers Lane, rm. 1061, Rock-
1. ville, MD 20852. If you wish to submit
(3) ‘‘You’’ refers to all affected par- the draft of a proposed guidance docu-
ties outside of FDA. ment electronically, submit it through
(d) Are you or FDA required to follow a https://www.regulations.gov at Docket
guidance document? (1) No. Guidance No. FDA–2013–S–0610. It is only nec-

documents do not establish legally en- essary to submit one copy.
190
(4) You can, at any time, suggest that (A) Hold public meetings or work-
FDA revise or withdraw an already ex- shops; or
isting guidance document. Your sug- (B) Present the draft guidance docu-
gestion should address why the guid- ment to an advisory committee for re-
ance document should be revised or view.
withdrawn and, if applicable, how it (iv) After providing an opportunity
should be revised. for public comment on a Level 1 guid-
(5) Once a year, FDA will publish, ance document, FDA will:
both in the FEDERAL REGISTER and on (A) Review any comments received
the Internet, a list of possible topics and prepare the final version of the
for future guidance document develop- guidance document that incorporates
ment or revision during the next year. suggested changes, when appropriate;
You can comment on this list (e.g., by (B) Publish a notice in the FEDERAL
suggesting alternatives or making rec- REGISTER announcing that the guid-
ommendations on the topics that FDA ance document is available;
is considering). (C) Post the guidance document on
(6) To participate in the development the Internet and make it available in
and issuance of guidance documents hard copy; and
through one of the mechanisms de- (D) Implement the guidance docu-
scribed in paragraphs (f)(1), (f)(2), or ment.
(f)(4) of this section, you should con-
(v) After providing an opportunity
tact the center or office that is respon-
for comment, FDA may decide that it
sible for the regulatory activity cov-
should issue another draft of the guid-
ered by the guidance document.
ance document. In this case, FDA will
(7) If FDA agrees to draft or revise a
follow the steps in paragraphs (g)(1)(ii),
guidance document, under a suggestion
(g)(1)(iii), and (g)(1)(iv) of this section.
made under paragraphs (f)(1), (f)(2),
(2) FDA will not seek your comment
(f)(3) or (f)(4) of this section, you can
before it implements a Level 1 guid-
participate in the development of that
ance document if the agency deter-
guidance document under the proce-
mines that prior public participation is
dures described in paragraph (g) of this
not feasible or appropriate.
section.
(g) What are FDA’s procedures for de- (3) FDA will use the following proce-
veloping and issuing guidance documents? dures for developing and issuing Level
(1) FDA’s procedures for the develop- 1 guidance documents under the cir-
ment and issuance of Level 1 guidance cumstances described in paragraph
documents are as follows: (g)(2) of this section:
(i) Before FDA prepares a draft of a (i) After FDA prepares a guidance
Level 1 guidance document, FDA can document, FDA will:
seek or accept early input from indi- (A) Publish a notice in the FEDERAL
viduals or groups outside the agency. REGISTER announcing that the guid-
For example, FDA can do this by par- ance document is available;
ticipating in or holding public meet- (B) Post the guidance document on
ings and workshops. the Internet and make it available in
(ii) After FDA prepares a draft of a hard copy;
Level 1 guidance document, FDA will: (C) Immediately implement the guid-
(A) Publish a notice in the FEDERAL ance document; and
REGISTER announcing that the draft (D) Invite your comment when it
guidance document is available; issues or publishes the guidance docu-
(B) Post the draft guidance document ment. Paragraph (h) of this section
on the Internet and make it available tells you how to submit your com-
in hard copy; and ments.
(C) Invite your comment on the draft (ii) If FDA receives comments on the
guidance document. Paragraph (h) of guidance document, FDA will review
this section tells you how to submit those comments and revise the guid-
your comments. ance document when appropriate.
(iii) After FDA prepares a draft of a (4) FDA will use the following proce-
Level 1 guidance document, FDA also dures for developing and issuing Level
can: 2 guidance documents:
191
§ 10.115 21 CFR Ch. I (4–1–19 Edition)
(i) After it prepares a guidance docu- (vii) Contain the word ‘‘draft’’ if the
ment, FDA will: document is a draft guidance.
(A) Post the guidance document on (2) Guidance documents must not in-
the Internet and make it available in clude mandatory language such as
hard copy; ‘‘shall,’’ ‘‘must,’’ ‘‘required,’’ or ‘‘re-
(B) Immediately implement the guid- quirement,’’ unless FDA is using these
ance document, unless FDA indicates words to describe a statutory or regu-
otherwise when the document is made latory requirement.
available; and (3) When issuing draft guidance docu-
(C) Invite your comment on the Level ments that are the product of inter-
2 guidance document. Paragraph (h) of national negotiations (e.g., guidances
this section tells you how to submit resulting from the International Con-
your comments. ference on Harmonisation), FDA need
(ii) If FDA receives comments on the not apply paragraphs (i)(1) and (i)(2) of
guidance document, FDA will review this section. However, any final guid-
those comments and revise the docu- ance document issued according to this
ment when appropriate. If a version is provision must contain the elements in
revised, the new version will be placed paragraphs (i)(1) and (i)(2) of this sec-
on the Internet. tion.
(5) You can comment on any guid- (j) Who, within FDA, can approve
ance document at any time. Paragraph issuance of guidance documents? Each
(h) of this section tells you how to sub- center and office must have written
mit your comments. FDA will revise procedures for the approval of guidance
guidance documents in response to documents. Those procedures must en-
your comments when appropriate. sure that issuance of all documents is
(h) How should you submit comments approved by appropriate senior FDA of-
on a guidance document? (1) If you ficials.
choose to submit comments on any (k) How will FDA review and revise ex-
guidance document under paragraph (g) isting guidance documents? (1) The agen-
of this section, you must send them to cy will periodically review existing
the Division of Dockets Management guidance documents to determine
(HFA–305), 5630 Fishers Lane, rm. 1061, whether they need to be changed or
Rockville, MD 20852. withdrawn.
(2) Comments should identify the (2) When significant changes are
docket number on the guidance docu- made to the statute or regulations, the
ment, if such a docket number exists. agency will review and, if appropriate,
For documents without a docket num- revise guidance documents relating to
ber, the title of the guidance document that changed statute or regulation.
should be included. (3) As discussed in paragraph (f)(3) of
(3) Comments will be available to the this section, you may at any time sug-
public in accordance with FDA’s regu- gest that FDA revise a guidance docu-
lations on submission of documents to ment.
the Division of Dockets Management (l) How will FDA ensure that FDA staff
specified in § 10.20(j). are following GGP’s? (1) All current and
(i) What standard elements must FDA new FDA employees involved in the de-
include in a guidance document? (1) A velopment, issuance, or application of
guidance document must: guidance documents will be trained re-
(i) Include the term ‘‘guidance,’’ garding the agency’s GGP’s.
(ii) Identify the center(s) or office(s) (2) FDA centers and offices will mon-
issuing the document, itor the development and issuance of
(iii) Identify the activity to which guidance documents to ensure that
and the people to whom the document GGP’s are being followed.
applies, (m) How can you get copies of FDA’s
(iv) Prominently display a statement guidance documents? FDA will make
of the document’s nonbinding effect, copies available in hard copy and, as
(v) Include the date of issuance, feasible, through the Internet.
(vi) Note if it is a revision to a pre- (n) How will FDA keep you informed of
viously issued guidance and identify the guidance documents that are avail-
the document that it replaces, and able? (1) FDA will maintain on the
192
Internet a current list of all guidance practices and procedures throughout

documents. New documents will be the agency.
added to this list within 30 days of
issuance. § 10.203 Definitions.
(2) Once a year, FDA will publish in (a) Public administrative proceeding as
the FEDERAL REGISTER its comprehen- used in this guideline means any FDA
sive list of guidance documents. The proceeding which the public has a right
comprehensive list will identify docu- to attend. This includes a formal evi-
ments that have been added to the list dentiary public hearing as set forth in
or withdrawn from the list since the part 12, a public hearing before a Pub-
previous comprehensive list. lic Board of Inquiry as set forth in part
(3) FDA’s guidance document lists 13, a public hearing before a Public Ad-
will include the name of the guidance visory Committee as set forth in part
document, issuance and revision dates, 14, a public hearing before the Commis-
and information on how to obtain cop- sioner as set forth in part 15, a regu-
ies of the document. latory hearing before FDA as set forth
in part 16, consumer exchange meet-
(o) What can you do if you believe that
ings, and Commissioner’s public meet-
someone at FDA is not following these
ings with health professionals.
GGP’s? If you believe that someone at (b) Advance notice as used in this
FDA did not follow the procedures in guideline means written or telephone
this section or that someone at FDA notification to FDA’s Office of Public
treated a guidance document as a bind- Affairs (Press Relations Staff) of intent
ing requirement, you should contact to electronically record an agency pub-
that person’s supervisor in the center lic administrative proceeding.
or office that issued the guidance docu- (c) Electronic recording as used in this
ment. If the issue cannot be resolved, guideline means any visual or audio re-
you should contact the next highest su- cording made by videotape recording
pervisor. You can also contact the cen- equipment or moving film camera, and/
ter or office ombudsman for assistance or other electronic recording equip-
in resolving the issue. If you are unable ment.
to resolve the issue at the center or of-
fice level or if you feel that you are not [49 FR 14726, Apr. 13, 1984, as amended at 54
FR 9035, Mar. 3, 1989]
making progress by going through the
chain of command, you may ask the § 10.204 General.
Office of the Chief Mediator and Om-
budsman to become involved. (a) FDA has for many years willingly
committed itself to a policy of open-
[65 FR 56477, Sept. 19, 2000, as amended at 83 ness. In many instances FDA has
FR 13416, Mar. 29, 2018] sought to make the open portions of
agency public administrative pro-
Subpart C—Electronic Media Cov- ceedings more accessible to public par-
erage of Public Administrative ticipation. Similarly, FDA has sought,
Proceedings; Guideline on wherever possible, to allow full written
media access to its proceedings, so that
Policy and Procedures members of the press would have the
opportunity to provide first-hand re-
SOURCE: 49 FR 14726, Apr. 13, 1984, unless ports. However, because electronic
otherwise noted. media coverage presents certain dif-
ficulties that are easier to resolve with
§ 10.200 Scope. advance notice to the agency and all
This guideline describes FDA’s policy participants, FDA believes that codi-
and procedures applicable to electronic fication of its policy will facilitate and
media coverage of agency public ad- further increase media access to its
ministrative proceedings. It is a guide- public administrative proceedings. The
line intended to clarify and explain agency intends to refer to this guide-
FDA’s policy on the presence and oper- line when notices of hearing, or indi-
ation of electronic recording equip- vidual advisory committee meetings,
ment at such proceedings and to assure are published in the FEDERAL REG-
uniform and consistent application of ISTER. Thus, all parties to a proceeding
193
§ 10.204 21 CFR Ch. I (4–1–19 Edition)
will be on notice that the proceeding (e) The agency requests advance no-
may be recorded electronically and any tice of intent to record a proceeding
person interested in videotaping or electronically to facilitate the orderly
otherwise recording the proceeding will conduct of the proceeding. Knowledge
be notified that there are established of anticipated media coverage will
procedures to be followed. allow the presiding officer to make any
(b) The designated presiding officer special arrangements required by the
of a public administrative proceeding circumstances of the proceeding. The
retains the existing discretionary au- agency believes that this guideline es-
thority set forth in specific regulations tablishes sufficiently specific criteria
pertaining to each type of administra- to promote uniformity.
tive proceeding to regulate the conduct (f) The agency would like to allow all
of the proceeding over which he or she interested media representatives to
presides. The responsibilities of the videotape a proceeding in which they
presiding officer, established elsewhere have an interest. However, should
in parts 10 through 16, include an obli- space limitations preclude a multitude
gation to be concerned with the timely of cameras, the presiding officer may
conduct of a hearing, the limited avail- require pool sharing. In such a case,
ability of certain witnesses, and reduc- pool sharing arrangements of the re-
ing disruptions to the proceeding which sulting videotape should be made be-
may occur. Each proceeding varies, and tween those allowed to film and those
the presiding officer cannot anticipate who were excluded. Arrangements for
all that might occur. Discretionary au- who is designated to present the pool
thority to regulate conduct at a pro- and a method of distributing the re-
ceeding has traditionally been granted sulting film or tape may be determined
to presiding officers to enable them to by the established networks’ pooling
fulfill their responsibility to maintain system. However, the agency has a
a fair and orderly hearing conducted in strong commitment to ensuring that
an expeditious manner. media representatives other than the
(c) This guideline provides the pre- major networks also be able to obtain
siding officer with a degree of flexi- a copy of the tape at cost. FDA is con-
bility in that it sets forth the agency’s cerned that if the network pool rep-
policy as well as the procedures that resentative wishes to record only a
presiding officers should ordinarily fol- short portion of a proceeding, but an
low, but from which they may depart excluded party wishes to record the en-
in particular situations if necessary, tire proceeding, confusion will result.
subject to the presumption of openness The agency expects the interested
of public proceedings to electronic media representatives to negotiate a
media coverage. The presiding officer’s suitable agreement among themselves
discretion to establish additional pro- before commencement of the pro-
cedures or to limit electronic coverage ceeding. For example, the network pool
is to be exercised only in the unusual representatives might agree to record a
circumstances defined in this guide- portion of the proceeding up to a break
line. Even though a presiding officer in the proceeding, at which time, while
may establish additional procedures or the network representative is dis-
limits as may be required in a par- assembling equipment, another media
ticular situation, he or she will be representative might set up to con-
guided by the policy expressed in this tinue recording. If an agreement can-
guideline in establishing these condi- not be reached before the proceeding,
tions. The presiding officer may also be the agency will use the time of receipt
less restrictive, taking into account of any advance notice to determine the
such factors as the duration of a hear- representation for each category of
ing and the design of the room. media, e.g., one network reporter, one
(d) If a portion or all of a proceeding independent reporter. The agency rec-
is closed to the public because material ommends that parties intending to vid-
is to be discussed that is not eotape provide as much advance notice
disclosable to the public under applica- as possible, so that the agency may
ble laws, the proceeding also will be best respond to the needs of the elec-
closed to electronic media coverage. tronic media.
194
(g) To ensure the timely conduct of § 10.206 Procedures for electronic

agency hearings and to prevent disrup- media coverage of agency public
tions, equipment is to be stationary administrative proceedings.
during a proceeding and should be set (a) To facilitate the agency’s re-
up and taken down when the pro- sponse to media needs, a person intend-
ceeding is not in progress. As noted ing to videotape an FDA public admin-
previously, the presiding officer may, istrative proceeding should, whenever
at his or her discretion, be less restric- possible, provide advance notice to the
tive if appropriate. Press Relations Staff (HFI–20), Office of
(h) The agency recognizes that elec- Public Affairs, Food and Drug Adminis-
tronic media representatives may de- tration, 5600 Fishers Lane, Rockville,
sire only short footage of a proceeding, MD 20857, in writing or by telephone
a facsimile of the proceeding, and/or (telephone 301–443–4177), at least 48
interview opportunities and may be un- hours in advance of the proceeding.
necessarily restricted by requirements The Press Relations Staff will inform
for setting up before a proceeding and the presiding officer that the pro-
then waiting until a break in the proceeding will be attended by representa-
ceeding before being permitted to take tives of the electronic media, and as-
down their equipment. To accommo- certain whether any special provisions
date this possibility, FDA’s Press Rela- in addition to those set forth in this
tions Staff will attempt to make ar- subpart are required by the presiding
rangements to respond to such needs officer. If so, the Press Relations Staff
by, for example, requesting that the will function as a liaison between the
presiding officer provide a break short- presiding officer and the person intend-
ly after commencement of the pro- ing to record the proceeding in facili-
ceeding to permit take down of equip- tating any procedures in addition to
ment. those outlined in this subpart. The pre-
(i) The agency is making a full com- siding officer will not deny access for
mitment to allowing, whenever pos- failure to provide a 48-hour advance no-
sible, electronic coverage of its public tice. Any advance notice may describe
administrative proceedings subject to the intended length of recording if
the limited restrictions established in known, the amount and type of equip-
this guideline. ment to be used, and any special needs
such as interviews.
§ 10.205 Electronic media coverage of (b) Cameras should be completely set
public administrative proceedings.
up before a proceeding is scheduled to
(a) A person may record electroni- begin or during a break in the pro-
cally any open public administrative ceeding and should remain standing in
proceeding, subject to the procedures the area designated for electronic
specified in this guideline. The proce- media equipment. Cameras may be
dures include a presumption that agen- taken down only during breaks or after
cy public proceedings are open to the the hearing is over. Roving cameras
electronic media. Whenever possible, will not be permitted during the pro-
FDA will permit all interested persons ceeding. Any artificial lighting should
access to record agency public adminis- be unobtrusive. Microphones, like cam-
trative proceedings. Restrictions other eras, should be in place before the start
than those listed in § 10.206 will be im- of a proceeding and may be taken down
posed only under exceptional cir- as indicated in this paragraph.
cumstances. (c) When space in the hearing room is
(b) A videotape recording of an FDA limited, the presiding officer may re-
public administrative proceeding is not strict the number of cameras or the
an official record of the proceeding. equipment present. Should such a re-
The only official record is the written striction become necessary, the pool
transcript of the proceeding, which is arrangements are the responsibility of
taken by the official reporter. the participating media. The agency

encourages the network pool to make
195
§ 10.206 21 CFR Ch. I (4–1–19 Edition)
copies of the tape, film, or other prod- conditions imposed by the presiding of-
uct available at cost to nonpool par- ficer (as described in paragraph (e) of
ticipants. However, if this is not pos- this section) to requesting members of
sible, the agency may need to use the the media. Any appeals should be made
time of receipt of any advance notice in accordance with paragraph (h) of
to determine the representation for this section.
each category, e.g., one network re- (g) The presiding officer retains au-
porter, one independent reporter, etc. thority to restrict or discontinue
(d) Off the record portions of a pro- videotaping or other recording of a pro-
ceeding may not be videotaped. ceeding, or parts of a proceeding,
(e) Before or during the proceeding, should such a decision become nec-
the presiding officer may establish essary. The presiding officer’s responsi-
other conditions specific to the pro- bility to conduct the hearing includes
ceeding for which the request is being the right and duty to remove a source
made. These conditions may be more or of substantial disruption. In exercising
less restrictive than those stated in his or her authority, the presiding offi-
this guideline, except that the pre- cer shall observe the presumption that
siding officer shall observe the agen- agency public proceedings are open to
cy’s presumption of openness of its the electronic media. The presiding of-
public proceedings to the electronic ficer shall exercise his or her discretion
media. Only a substantial and clear to restrict or discontinue electronic
threat to the agency’s interests in coverage of a public proceeding, or por-
order, fairness, and timeliness author- tions of a public proceeding, only if he
izes the presiding officer to impose ad- or she determines that the agency’s in-
ditional restrictions. This threat must terest in the fair and orderly adminis-
outweigh the public interest in elec- trative process is substantially threat-
tronic media coverage of agency pro- ened. A clear and substantial threat to
ceedings. Additional restrictions shall the integrity of agency proceedings
be narrowly drawn to the particular must clearly outweigh the public inter-
circumstances. The following factors est in electronic media coverage of the
are listed to assist presiding officers in proceedings before additional restric-
determining whether the agency’s in- tions are imposed on the electronic
terest is sufficiently compelling to call media during the course of the pro-
for the unusual step of imposing addi- ceedings. The factors noted in para-
tional restrictions. Generally this step graph (e) of this section indicate the
is justified when one of the following kind of substantial threat to the agen-
factors is met: cy interests that may require imposing
(1) Electronic recording would result additional restrictions during the
in a substantial likelihood of disrup- course of the proceedings. If additional
tion that clearly cannot be contained requirements are established during
by the procedures established in para- the hearing, the presiding officer shall
graphs (a) through (d) of this section. notify immediately the Deputy Com-
(2) Electronic recording would result missioner of Food and Drugs of that
in a substantial likelihood of preju- fact by telephone and submit a written
dicial impact on the fairness of the pro- explanation of the circumstances that
ceeding or the substantive discussion necessitated such an action within 24
in a proceeding. hours or sooner if requested by the
(3) There is a substantial likelihood Deputy Commissioner. In the absence
that a witness’ ability to testify may or unavailability of the Deputy Com-
be impaired due to unique personal cir- missioner, the presiding officer shall
cumstances such as the age or psycho- notify the Associate Commissioner for
logical state of the witness or the par- Regulatory Affairs.
ticularly personal or private nature of (h) A decision by a presiding officer,
the witness’ testimony, if the witness’ made either before the proceeding or
testimony were electronically re- during the course of a proceeding, to
corded. establish requirements in addition to
(f) Before the proceeding, the Press the minimum standards set forth in
Relations Staff will, upon request, pro- this guideline may be appealed by any
vide written copies of any additional adversely affected person who intends
196
to record the proceeding electronically. fied, maintained, archived, retrieved,

Appeals may be made in writing or by or transmitted, under any records re-
phone to the Deputy Commissioner or, quirements set forth in agency regula-
in his or her absence, to the Associate tions. This part also applies to elec-
Commissioner for Regulatory Affairs. tronic records submitted to the agency
The filing of an appeal, whether before under requirements of the Federal
or during a proceeding, does not re- Food, Drug, and Cosmetic Act and the
quire the presiding officer to interrupt Public Health Service Act, even if such
the proceeding. However, the Deputy records are not specifically identified
Commissioner or, in his or her absence, in agency regulations. However, this
the Associate Commissioner for Regu- part does not apply to paper records
latory Affairs will resolve an appeal as that are, or have been, transmitted by
expeditiously as possible so as to pre- electronic means.
serve, to the extent possible, the re- (c) Where electronic signatures and
porters’ opportunity to record the pro- their associated electronic records
ceedings. meet the requirements of this part, the
[49 FR 14726, Apr. 13, 1984, as amended at 54 agency will consider the electronic sig-
FR 9035, Mar. 3, 1989] natures to be equivalent to full hand-
written signatures, initials, and other
PART 11—ELECTRONIC RECORDS; general signings as required by agency
regulations, unless specifically ex-
ELECTRONIC SIGNATURES cepted by regulation(s) effective on or
Subpart A—General Provisions after August 20, 1997.
(d) Electronic records that meet the
Sec. requirements of this part may be used
11.1 Scope. in lieu of paper records, in accordance
11.2 Implementation. with § 11.2, unless paper records are spe-
11.3 Definitions.
cifically required.
Subpart B—Electronic Records (e) Computer systems (including
hardware and software), controls, and
11.10 Controls for closed systems. attendant documentation maintained
11.30 Controls for open systems. under this part shall be readily avail-
11.50 Signature manifestations.
able for, and subject to, FDA inspec-
11.70 Signature/record linking.
tion.
Subpart C—Electronic Signatures (f) This part does not apply to
records required to be established or
11.100 General requirements. maintained by §§ 1.326 through 1.368 of
11.200 Electronic signature components and
this chapter. Records that satisfy the
controls.
11.300 Controls for identification codes/pass- requirements of part 1, subpart J of
words. this chapter, but that also are required
under other applicable statutory provi-
AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 262.
sions or regulations, remain subject to
SOURCE: 62 FR 13464, Mar. 20, 1997, unless this part.
otherwise noted. (g) This part does not apply to elec-
tronic signatures obtained under
Subpart A—General Provisions § 101.11(d) of this chapter.
(h) This part does not apply to elec-
§ 11.1 Scope. tronic signatures obtained under
(a) The regulations in this part set § 101.8(d) of this chapter.
forth the criteria under which the (i) This part does not apply to
agency considers electronic records, records required to be established or
electronic signatures, and handwritten maintained by part 117 of this chapter.
signatures executed to electronic Records that satisfy the requirements
records to be trustworthy, reliable, and of part 117 of this chapter, but that also
generally equivalent to paper records are required under other applicable
and handwritten signatures executed statutory provisions or regulations, re-
on paper. main subject to this part.
(b) This part applies to records in (j) This part does not apply to
electronic form that are created, modi- records required to be established or
197
§ 11.2 21 CFR Ch. I (4–1–19 Edition)
maintained by part 507 of this chapter. cy, persons may use electronic records
Records that satisfy the requirements in lieu of paper records or electronic
of part 507 of this chapter, but that also signatures in lieu of traditional signa-
are required under other applicable tures, in whole or in part, provided
statutory provisions or regulations, re- that the requirements of this part are
main subject to this part. met.
(k) This part does not apply to (b) For records submitted to the
records required to be established or agency, persons may use electronic
maintained by part 112 of this chapter. records in lieu of paper records or elec-
Records that satisfy the requirements tronic signatures in lieu of traditional
of part 112 of this chapter, but that also signatures, in whole or in part, pro-
are required under other applicable vided that:
statutory provisions or regulations, re- (1) The requirements of this part are
main subject to this part. met; and
(l) This part does not apply to (2) The document or parts of a docu-
records required to be established or ment to be submitted have been identi-
maintained by subpart L of part 1 of fied in public docket No. 92S–0251 as
this chapter. Records that satisfy the being the type of submission the agen-
requirements of subpart L of part 1 of cy accepts in electronic form. This
this chapter, but that also are required docket will identify specifically what
under other applicable statutory provi- types of documents or parts of docu-
sions or regulations, remain subject to ments are acceptable for submission in
this part. electronic form without paper records
(m) This part does not apply to and the agency receiving unit(s) (e.g.,
records required to be established or specific center, office, division, branch)
maintained by subpart M of part 1 of to which such submissions may be
this chapter. Records that satisfy the made. Documents to agency receiving
requirements of subpart M of part 1 of unit(s) not specified in the public dock-
this chapter, but that also are required et will not be considered as official if
under other applicable statutory provi- they are submitted in electronic form;
sions or regulations, remain subject to paper forms of such documents will be
this part. considered as official and must accom-
(n) This part does not apply to pany any electronic records. Persons
records required to be established or are expected to consult with the in-
maintained by subpart O of part 1 of tended agency receiving unit for de-
this chapter. Records that satisfy the tails on how (e.g., method of trans-
requirements of subpart O of part 1 of mission, media, file formats, and tech-
this chapter, but that also are required nical protocols) and whether to proceed
under other applicable statutory provi- with the electronic submission.
sions or regulations, remain subject to
this part. § 11.3 Definitions.
(o) This part does not apply to (a) The definitions and interpreta-
records required to be established or tions of terms contained in section 201
maintained by part 121 of this chapter. of the act apply to those terms when
Records that satisfy the requirements used in this part.
of part 121 of this chapter, but that also (b) The following definitions of terms
are required under other applicable also apply to this part:
statutory provisions or regulations, re- (1) Act means the Federal Food, Drug,
main subject to this part. and Cosmetic Act (secs. 201–903 (21
U.S.C. 321–393)).
FR 71655, Dec. 9, 2004; 79 FR 71253, 71291, Dec. (2) Agency means the Food and Drug
1, 2014; 80 FR 71253, June 19, 2015; 80 FR 56144, Administration.
56336, Sept. 17, 2015; 80 FR 74352, 74547, 74667, (3) Biometrics means a method of
Nov. 27, 2015; 81 FR 20170, Apr. 6, 2016; 81 FR verifying an individual’s identity based
34218, May 27, 2016] on measurement of the individual’s
physical feature(s) or repeatable ac-
§ 11.2 Implementation. tion(s) where those features and/or ac-
(a) For records required to be main- tions are both unique to that indi-
tained but not submitted to the agen- vidual and measurable.
198
(4) Closed system means an environ- tended performance, and the ability to
ment in which system access is con- discern invalid or altered records.
trolled by persons who are responsible (b) The ability to generate accurate
for the content of electronic records and complete copies of records in both
that are on the system. human readable and electronic form
(5) Digital signature means an elec- suitable for inspection, review, and
tronic signature based upon cryp- copying by the agency. Persons should
tographic methods of originator au- contact the agency if there are any
thentication, computed by using a set
questions regarding the ability of the
of rules and a set of parameters such
that the identity of the signer and the agency to perform such review and
integrity of the data can be verified. copying of the electronic records.
(6) Electronic record means any com- (c) Protection of records to enable
bination of text, graphics, data, audio, their accurate and ready retrieval
pictorial, or other information rep- throughout the records retention pe-
resentation in digital form that is cre- riod.
ated, modified, maintained, archived, (d) Limiting system access to author-
retrieved, or distributed by a computer ized individuals.
system. (e) Use of secure, computer-gen-
(7) Electronic signature means a com- erated, time-stamped audit trails to
puter data compilation of any symbol independently record the date and time
or series of symbols executed, adopted, of operator entries and actions that
or authorized by an individual to be create, modify, or delete electronic
the legally binding equivalent of the records. Record changes shall not ob-
individual’s handwritten signature. scure previously recorded information.
(8) Handwritten signature means the
Such audit trail documentation shall
scripted name or legal mark of an indi-
be retained for a period at least as long
vidual handwritten by that individual
as that required for the subject elec-
and executed or adopted with the
present intention to authenticate a tronic records and shall be available
writing in a permanent form. The act for agency review and copying.
of signing with a writing or marking (f) Use of operational system checks
instrument such as a pen or stylus is to enforce permitted sequencing of
preserved. The scripted name or legal steps and events, as appropriate.
mark, while conventionally applied to (g) Use of authority checks to ensure
paper, may also be applied to other de- that only authorized individuals can
vices that capture the name or mark. use the system, electronically sign a
(9) Open system means an environ- record, access the operation or com-
ment in which system access is not puter system input or output device,
controlled by persons who are respon- alter a record, or perform the operation
sible for the content of electronic at hand.
records that are on the system. (h) Use of device (e.g., terminal)
checks to determine, as appropriate,
Subpart B—Electronic Records the validity of the source of data input
or operational instruction.
§ 11.10 Controls for closed systems.
(i) Determination that persons who
Persons who use closed systems to develop, maintain, or use electronic
create, modify, maintain, or transmit record/electronic signature systems
electronic records shall employ proce- have the education, training, and expe-
dures and controls designed to ensure rience to perform their assigned tasks.
the authenticity, integrity, and, when
(j) The establishment of, and adher-
appropriate, the confidentiality of elec-
ence to, written policies that hold indi-
tronic records, and to ensure that the
signer cannot readily repudiate the viduals accountable and responsible for
signed record as not genuine. Such pro- actions initiated under their electronic
cedures and controls shall include the signatures, in order to deter record and
following: signature falsification.
(a) Validation of systems to ensure (k) Use of appropriate controls over

accuracy, reliability, consistent in- systems documentation including:
199
§ 11.30 21 CFR Ch. I (4–1–19 Edition)
(1) Adequate controls over the dis- Subpart C—Electronic Signatures

tribution of, access to, and use of docu-
mentation for system operation and § 11.100 General requirements.
maintenance. (a) Each electronic signature shall be
(2) Revision and change control pro- unique to one individual and shall not
cedures to maintain an audit trail that be reused by, or reassigned to, anyone
documents time-sequenced develop- else.
ment and modification of systems doc- (b) Before an organization estab-
umentation. lishes, assigns, certifies, or otherwise
sanctions an individual’s electronic
§ 11.30 Controls for open systems. signature, or any element of such elec-
tronic signature, the organization shall
Persons who use open systems to cre-
verify the identity of the individual.
ate, modify, maintain, or transmit (c) Persons using electronic signa-
electronic records shall employ proce- tures shall, prior to or at the time of
dures and controls designed to ensure such use, certify to the agency that the
the authenticity, integrity, and, as ap- electronic signatures in their system,
propriate, the confidentiality of elec- used on or after August 20, 1997, are in-
tronic records from the point of their tended to be the legally binding equiv-
creation to the point of their receipt. alent of traditional handwritten signa-
Such procedures and controls shall in- tures.
clude those identified in § 11.10, as ap- (1) The certification shall be sub-
propriate, and additional measures mitted in paper form and signed with a
such as document encryption and use traditional handwritten signature, to
of appropriate digital signature stand- the Office of Regional Operations
ards to ensure, as necessary under the (HFC–100), 5600 Fishers Lane, Rock-
circumstances, record authenticity, in- ville, MD 20857.
tegrity, and confidentiality. (2) Persons using electronic signa-
tures shall, upon agency request, pro-
§ 11.50 Signature manifestations. vide additional certification or testi-
mony that a specific electronic signa-
(a) Signed electronic records shall
ture is the legally binding equivalent
contain information associated with of the signer’s handwritten signature.
the signing that clearly indicates all of
the following: § 11.200 Electronic signature compo-
(1) The printed name of the signer; nents and controls.
(2) The date and time when the signa- (a) Electronic signatures that are not
ture was executed; and based upon biometrics shall:
(3) The meaning (such as review, ap- (1) Employ at least two distinct iden-
proval, responsibility, or authorship) tification components such as an iden-
associated with the signature. tification code and password.
(b) The items identified in para- (i) When an individual executes a se-
graphs (a)(1), (a)(2), and (a)(3) of this ries of signings during a single, contin-
section shall be subject to the same uous period of controlled system ac-
controls as for electronic records and cess, the first signing shall be executed
shall be included as part of any human using all electronic signature compo-
readable form of the electronic record nents; subsequent signings shall be exe-
(such as electronic display or printout). cuted using at least one electronic sig-
nature component that is only execut-
§ 11.70 Signature/record linking. able by, and designed to be used only
by, the individual.
Electronic signatures and hand- (ii) When an individual executes one
written signatures executed to elec- or more signings not performed during
tronic records shall be linked to their a single, continuous period of con-
respective electronic records to ensure trolled system access, each signing
that the signatures cannot be excised, shall be executed using all of the elec-
copied, or otherwise transferred to fal- tronic signature components.
sify an electronic record by ordinary (2) Be used only by their genuine

means. owners; and
200
(3) Be administered and executed to PART 12—FORMAL EVIDENTIARY

ensure that attempted use of an indi- PUBLIC HEARING
vidual’s electronic signature by anyone
other than its genuine owner requires Subpart A—General Provisions
collaboration of two or more individ-
uals. Sec.
12.1 Scope.
(b) Electronic signatures based upon
biometrics shall be designed to ensure Subpart B—Initiation of Proceedings
that they cannot be used by anyone
12.20 Initiation of a hearing involving the
other than their genuine owners.
issuance, amendment, or revocation of a
regulation.
§ 11.300 Controls for identification 12.21 Initiation of a hearing involving the
codes/passwords. issuance, amendment, or revocation of
Persons who use electronic signa- an order.
tures based upon use of identification 12.22 Filing objections and requests for a
hearing on a regulation or order.
codes in combination with passwords 12.23 Notice of filing of objections.
shall employ controls to ensure their 12.24 Ruling on objections and requests for
security and integrity. Such controls hearing.
shall include: 12.26 Modification or revocation of regula-
(a) Maintaining the uniqueness of tion or order.
12.28 Denial of hearing in whole or in part.
each combined identification code and 12.30 Judicial review after waiver of hearing
password, such that no two individuals on a regulation.
have the same combination of identi- 12.32 Request for alternative form of hear-
fication code and password. ing.
(b) Ensuring that identification code 12.35 Notice of hearing; stay of action.
12.37 Effective date of a regulation.
and password issuances are periodically 12.38 Effective date of an order.
checked, recalled, or revised (e.g., to
cover such events as password aging). Subpart C—Appearance and Participation
(c) Following loss management pro-
12.40 Appearance.
cedures to electronically deauthorize 12.45 Notice of participation.
lost, stolen, missing, or otherwise po- 12.50 Advice on public participation in hear-
tentially compromised tokens, cards, ings.
and other devices that bear or generate
identification code or password infor- Subpart D—Presiding Officer
mation, and to issue temporary or per- 12.60 Presiding officer.
manent replacements using suitable, 12.62 Commencement of functions.
rigorous controls. 12.70 Authority of presiding officer.
(d) Use of transaction safeguards to 12.75 Disqualification of presiding officer.
12.78 Unavailability of presiding officer.
prevent unauthorized use of passwords
and/or identification codes, and to de- Subpart E—Hearing Procedures
tect and report in an immediate and
urgent manner any attempts at their 12.80 Filing and service of submissions.
unauthorized use to the system secu- 12.82 Petition to participate in forma
pauperis.
rity unit, and, as appropriate, to orga- 12.83 Advisory opinions.
nizational management. 12.85 Disclosure of data and information by
(e) Initial and periodic testing of de- the participants.
vices, such as tokens or cards, that 12.87 Purpose; oral and written testimony;
bear or generate identification code or burden of proof.
12.89 Participation of nonparties.
password information to ensure that
12.90 Conduct at oral hearings or con-
they function properly and have not ferences.
been altered in an unauthorized man- 12.91 Time and place of prehearing con-
ner. ference.
12.92 Prehearing conference procedure.
12.93 Summary decisions.
12.94 Receipt of evidence.

12.95 Official notice.
12.96 Briefs and argument.
201
§ 12.1 21 CFR Ch. I (4–1–19 Edition)
12.97 Interlocutory appeal from ruling of (ii) If no form is specified, by a peti-
presiding officer. tion under § 10.30.
12.98 Official transcript.
12.99 Motions.
(b) If the Commissioner receives a pe-
tition under paragraph (a)(2) of this
Subpart F—Administrative Record section, the Commissioner will—
(1) If it involves any matter subject
12.100 Administrative record of a hearing. to section 701(e) of the act or section 4
12.105 Examination of record.
or 5 of the Fair Packaging and Label-
Subpart G—Initial and Final Decisions ing Act, and meets the requirements
for filing, follow the provisions of
12.120 Initial decision. § 10.40 (b) through (f);
12.125 Appeal from or review of initial deci-
(2) If it involves a color additive or
sion.
12.130 Decision by Commissioner on appeal food additive, and meets the require-
or review of initial decision. ments for filing in §§ 71.1 and 71.2, or in
12.139 Reconsideration and stay of action. §§ 171.1, 171.6, 171.7, and 171.100, publish
a notice of filing of the petition within
Subpart H—Judicial Review 30 days after the petition is filed in-
12.140 Review by the courts. stead of a notice of proposed rule-
12.159 Copies of petitions for judicial re- making.
view. (c) [Reserved]
AUTHORITY: 21 U.S.C. 141–149, 321–393, 467f, (d) The notice promulgating the reg-
679, 821, 1034; 42 U.S.C. 201, 262, 263b–263n, 264; ulation will describe how to submit ob-
15 U.S.C. 1451–1461; 5 U.S.C. 551–558, 701–721; 28 jections and requests for hearing.
U.S.C. 2112. (e) On or before the 30th day after the
SOURCE: 44 FR 22339, Apr. 13, 1979, unless date of publication of a final regula-
otherwise noted. tion, or of a notice withdrawing a pro-
posal initiated by a petition under
Subpart A—General Provisions § 10.25(a), a person may submit to the
Commissioner written objections and a
§ 12.1 Scope. request for a hearing. The 30-day period
The procedures in this part apply may not be extended except that addi-
when— tional information supporting an objec-
(a) A person has a right to an oppor- tion may be received after 30 days upon
tunity for a hearing under the laws a showing of inadvertent omission and
specified in § 10.50; or hardship, and if review of the objection
(b) The Commissioner concludes that and request for hearing will not there-
it is in the public interest to hold a for- by be impeded. If, after a final color ad-
mal evidentiary public hearing on any ditive regulation is published, a peti-
matter before FDA. tion or proposal relating to the regula-
tion is referred to an advisory com-
mittee in accordance with section
Subpart B—Initiation of 721(b)(5)(C) of the act, objections and
Proceedings requests for a hearing may be sub-
§ 12.20 Initiation of a hearing involv- mitted on or before the 30th day after
ing the issuance, amendment, or the date on which the order confirming
revocation of a regulation. or modifying the Commissioner’s pre-
vious order is published.
(a) A proceeding under section 409(f),
502(n), 512(n)(5), 701(e), or 721(d) of the [44 FR 22339, Apr. 13, 1979, as amended at 64
act or section 4 or 5 of the Fair Pack- FR 399, Jan. 5, 1999]
aging and Labeling Act may be initi-
ated— § 12.21 Initiation of a hearing involv-
(1) By the Commissioner on the Com- ing the issuance, amendment, or
missioner’s own initiative, e.g., as pro- revocation of an order.
vided in § 170.15 for food additives; or (a) A proceeding under section 505 (d)
(2) By a petition— or (e), 512 (d), (e), (m) (3) or (4), of sec-
(i) In the form specified elsewhere in tion 515(g)(1) of the act, or section
this chapter, e.g., the form for a color 351(a) of the Public Health Service Act,
additive petition in § 71.1; or may be initiated—
202
(1) By the Commissioner on the Com- scription and analysis of the factual in-
missioner’s own initiative; formation to be presented in support of
(2) By a petition in the form specified the objection. Failure to include a de-
elsewhere in this chapter, e.g., § 314.50 scription and analysis for an objection
for new drug applications, § 514.1 for constitutes a waiver of the right to a
new animal drug applications, § 514.2 hearing on that objection. The descrip-
for applications for animal feeds, or tion and analysis may be used only for
§ 601.3 for licenses for biologic products; the purpose of determining whether a
or hearing has been justified under § 12.24,
(3) By a petition under § 10.30. and do not limit the evidence that may
(b) A notice of opportunity for hear-
be presented if a hearing is granted.
ing on a proposal to deny or revoke ap-
proval of all or part of an order will be (i) A copy of any report, article, sur-
published together with an explanation vey, or other written document relied
of the grounds for the proposed action. upon must be submitted, except if the
The notice will describe how to submit document is—
requests for hearing. A person subject (a) An FDA document that is rou-
to the notice has 30 days after its tinely publicly available; or
issuance to request a hearing. The 30- (b) A recognized medical or scientific
day period may not be extended. textbook that is readily available to
(c) The Commissioner may use an op- the agency.
tional procedure specified in § 10.30(h) (ii) A summary of the nondocumen-
to consider issuing, amending, or re- tary testimony to be presented by any
voking an order. witnesses relied upon must be sub-
(d) In a proceeding under sections mitted.
505(e), 512(e) or (m), or 515(e) of the act (b) Requests for hearing submitted
in which a party wishes to apply for re- under § 12.21 will be submitted to the
imbursement of certain expenses under Division of Dockets Management and
the Equal Access to Justice Act (5
will be accepted for filing if they meet
U.S.C. 504 and 504 note), FDA will fol-
the following conditions:
low the Department of Health and
Human Services’ regulations in 45 CFR (1) They are submitted on or before
part 13. the 30th day after the date of publica-
tion of the notice of opportunity for
[44 FR 22339, Apr. 13, 1979, as amended at 47 hearing.
FR 25734, June 15, 1982; 54 FR 9035, Mar. 3,
1989] (2) They comply with §§ 314.200,
514.200, or 601.7(a).
§ 12.22 Filing objections and requests (c) If an objection or request for a
for a hearing on a regulation or public hearing fails to meet the re-
order. quirements of this section and the defi-
(a) Objections and requests for a ciency becomes known to the Division
hearing under § 12.20(d) must be sub- of Dockets Management, the Division
mitted to the Division of Dockets Man- of Dockets Management shall return it
agement and will be accepted for filing with a copy of the applicable regula-
if they meet the following conditions: tions, indicating those provisions not
(1) They are submitted within the complied with. A deficient objection or
time specified in § 12.20(e). request for a hearing may be supple-
(2) Each objection is separately num- mented and subsequently filed if sub-
bered. mitted within the 30-day time period
(3) Each objection specifies with par- specified in § 12.20(e) or § 12.21(b).
ticularity the provision of the regula-
(d) If another person objects to a reg-
tion or proposed order objected to.
ulation issued in response to a petition
(4) Each objection on which a hearing
submitted under § 12.20(a)(2), the peti-
is requested specifically so states. Fail-
ure to request a hearing on an objec- tioner may submit a written reply to
tion constitutes a waiver of the right the Division of Dockets Management.
to a hearing on that objection.

(5) Each objection for which a hear- FR 9035, Mar. 3, 1989; 64 FR 69190, Dec. 10,
ing is requested includes a detailed de- 1999]
203
§ 12.23 21 CFR Ch. I (4–1–19 Edition)
§ 12.23 Notice of filing of objections. sufficient to justify the factual deter-

As soon as practicable after the expi- mination urged, even if accurate.
(4) Resolution of the factual issue in
ration of the time for filing objections
the way sought by the person is ade-
to and requests for hearing on agency
action involving the issuance, amend- quate to justify the action requested. A
ment, or revocation of a regulation hearing will not be granted on factual
under sections 502(n), 701(e), or 721(d) of issues that are not determinative with
respect to the action requested, e.g., if
the act or sections 4 or 5 of the Fair
the Commissioner concludes that the
Packaging and Labeling Act, the Com-
missioner shall publish a notice in the action would be the same even if the
FEDERAL REGISTER specifying those factual issue were resolved in the way
parts of the regulation that have been sought, or if a request is made that a
stayed by the filing of proper objec- final regulation include a provision not
tions and, if no objections have been reasonably encompassed by the pro-
filed, stating that fact. The notice does posal. A hearing will be granted upon
not constitute a determination that a proper objection and request when a
hearing is justified on any objections food standard or other regulation is
or requests for hearing that have been shown to have the effect of excluding
filed. When to do so will cause no or otherwise affecting a product or in-
undue delay, the notice required by gredient.
this section may be combined with the (5) The action requested is not incon-
notices described in §§ 12.28 and 12.35. sistent with any provision in the act or
any regulation in this chapter particu-
§ 12.24 Ruling on objections and re- larizing statutory standards. The prop-
quests for hearing. er procedure in those circumstances is
(a) As soon as possible the Commis- for the person requesting the hearing
sioner will review all objections and re- to petition for an amendment or waiver
quests for hearing filed under § 12.22 of the regulation involved.
and determine— (6) The requirements in other appli-
(1) Whether the regulation should be cable regulations, e.g., §§ 10.20, 12.21,
modified or revoked under § 12.26; 12.22, 314.200, 514.200, and 601.7(a), and in
(2) Whether a hearing has been justi- the notice promulgating the final regu-
fied; and lation or the notice of opportunity for
(3) Whether, if requested, a hearing hearing are met.
before a Public Board of Inquiry under (c) In making the determination in
part 13 or before a public advisory com- paragraph (a) of this section, the Com-
mittee under part 14 or before the Com- missioner may use any of the optional
missioner under part 15 has been justi- procedures specified in § 10.30(h) or in
fied. other applicable regulations, e.g.,
(b) A request for a hearing will be §§ 314.200, 514.200, and 601.7(a).
granted if the material submitted (d) If it is uncertain whether a hear-
shows the following: ing has been justified under the prin-
(1) There is a genuine and substantial ciples in paragraph (b) of this section,
issue of fact for resolution at a hear- and the Commissioner concludes that
ing. A hearing will not be granted on summary decision against the person
issues of policy or law. requesting a hearing should be consid-
(2) The factual issue can be resolved ered, the Commissioner may serve
by available and specifically identified upon the person by registered mail a
reliable evidence. A hearing will not be proposed order denying a hearing. The
granted on the basis of mere allega- person has 30 days after receipt of the
tions or denials or general descriptions proposed order to demonstrate that the
of positions and contentions. submission justifies a hearing.
(3) The data and information sub- [44 FR 22339, Apr. 13, 1979, as amended at 54
mitted, if established at a hearing, FR 9035, Mar. 3, 1989; 64 FR 399, Jan. 5, 1999]
would be adequate to justify resolution
of the factual issue in the way sought § 12.26 Modification or revocation of
by the person. A hearing will be denied regulation or order.
if the Commissioner concludes that the If the Commissioner determines upon

data and information submitted are in- review of an objection or request for
204
hearing that the regulation or order (2) If the proceeding involves an

should be modified or revoked, the order—
Commissioner will promptly take such (i) The notice of opportunity for
action by notice in the FEDERAL REG- hearing;
ISTER. Further objections to or re- (ii) The requests for hearing filed by
quests for hearing on the modification the Division of Dockets Management;
or revocation may be submitted under (iii) The transcripts, minutes of
§§ 12.20 through 12.22 but no further meetings, reports, FEDERAL REGISTER
issue may be taken with other provi- notices, and other documents consti-
sions in the regulation or order. Objec- tuting the record of any of the optional
tions and requests for hearing that are procedures specified in § 12.24(c) used by
not affected by the modification or rev- the Commissioner, but not the tran-
ocation will remain on file and be script of a closed portion of a public ad-
acted upon in due course. visory committee meeting; and
(iv) The notice denying the hearing.
§ 12.28 Denial of hearing in whole or (c) The record specified in paragraph
in part. (b) of this section is the exclusive
If the Commissioner determines upon record for the Commissioner’s decision
review of the objections or requests for on the complete or partial denial of a
hearing that a hearing is not justified, hearing. The record of the proceeding
in whole or in part, a notice of the de- will be closed as of the date of the
termination will be published. Commissioner’s decision unless an-
(a) The notice will state whether the other date is specified. A person who
hearing is denied in whole or in part. If requested and was denied a hearing
the hearing is denied in part, the no- may submit a petition for reconsider-
tice will be combined with the notice ation under § 10.33 or a petition for stay
of hearing required by § 12.35, and will of action under § 10.35. A person who
specify the objections and requests for wishes to rely upon information or
hearing that have been granted and de- views not included in the administra-
nied. tive record shall submit them to the
(1) Any denial will be explained. A de- Commissioner with a petition under
nial based on an analysis of the infor- § 10.25(a) to modify the final regulation
mation submitted to justify a hearing or order.
will explain the inadequacy of the in- (d) Denial of a request for a hearing
formation. in whole or in part is final agency ac-
tion reviewable in the courts, under
(2) The notice will confirm or modify
the statutory provisions governing the
or stay the effective date of the regula-
matter involved, as of the date of pub-
tion or order involved.
lication of the denial in the FEDERAL
(b) The record of the administrative REGISTER.
proceeding relating to denial of a pub- (1) Before requesting a court for a
lic hearing in whole or in part on an stay of action pending review, a person
objection or request for hearing con- shall first submit a petition for a stay
sists of the following: of action under § 10.35.
(1) If the proceeding involves a regu- (2) Under 28 U.S.C. 2112(a), FDA will
lation— request consolidation of all petitions
(i) The documents specified in on a particular matter.
§ 10.40(g); (3) The time for filing a petition for
(ii) The objections and requests for judicial review of a denial of a hearing
hearing filed by the Division of Dock- on an objection or issue begins on the
ets Management; date the denial is published in the FED-
(iii) If the proceeding involves a color ERAL REGISTER, (i) When an objection
additive regulation referred to an advi- or issues relates to a regulation, if a
sory committee in accordance with hearing is denied on all objections and
section 721(b)(5)(C) of the act, the com- issues concerning a part of the proposal
mittee’s report and the record of the the effectiveness of which has not been
committee’s proceeding; and deferred pending a hearing on other
(iv) The notice denying a formal evi- parts of the proposal; or (ii) when an
dentiary public hearing. issue relates to an order, if a hearing is
205
§ 12.30 21 CFR Ch. I (4–1–19 Edition)
denied on all issues relating to a par- publication of a notice of hearing under

ticular new drug application, new ani- § 12.35 or a denial of hearing under
mal drug application, device premarket § 12.28; and
approval application or product devel- (3) Must be—
opment protocol, or biologics license. (i) In lieu of a request for a hearing
The failure to file a petition for judi- under this part; or
cial review within the period estab- (ii) If submitted after or with a re-
lished in the statutory provision gov- quest for hearing, in the form of a
erning the matter involved constitutes waiver of the right to request a hearing
a waiver of the right to judicial review conditioned on an alternative form of
of the objection or issue, regardless hearing. Upon acceptance by the Com-
whether a hearing has been granted on missioner, the waiver becomes binding
other objections and issues.
and may be withdrawn only by waiving
§ 12.30 Judicial review after waiver of any right to any form of hearing unless
hearing on a regulation. the Commissioner determines other-
wise.
(a) A person with a right to submit
objections and a request for hearing (c) When more than one person re-
under § 12.20(d) may submit objections quests and justifies a hearing under
and waive the right to a hearing. The this part, an alternative form of hear-
waiver may be either an explicit state- ing may by used only if all the persons
ment, or a failure to request a hearing, concur and waive their right to request
as provided in 12.22(a)(4). a hearing under this part.
(b) If a person waives the right to a (d) The Commissioner will determine
hearing, the Commissioner will rule whether an alternative form of hearing
upon the person’s objections under should be used, and if so, which alter-
§§ 12.24 through 12.28. As a matter of native is acceptable, after considering
discretion, the Commissioner may also the requests submitted and the appro-
order a hearing on the matter under priateness of the alternatives for the
any of the provisions of this part. issues raised in the objections. The
(c) If the Commissioner rules ad- Commissioner’s acceptance is binding
versely on a person’s objection, the unless, for good cause, the Commis-
person may petition for judicial review sioner determines otherwise.
in a U.S. Court of Appeals under the (e) The Commissioner will publish a
act. notice of an alternative form of hear-
(1) The record for judicial review is ing setting forth the following informa-
the record designated in § 12.28(b)(1). tion:
(2) The time for filing a petition for (1) The regulation or order that is the
judicial review begins as of the date of subject of the hearing.
publication of the Commissioner’s rul- (2) A statement specifying any part
ing on the objections. of the regulation or order that has been
§ 12.32 Request for alternative form of stayed by operation of law or in the
hearing. Commissioner’s discretion.
(3) The time, date, and place of the
(a) A person with a right to request a
hearing, or a statment that such infor-
hearing may waive that right and re-
mation will be contained in a later no-
quest one of the following alternatives:
tice.
(1) A hearing before a Public Board of
Inquiry under part 13. (4) The parties to the hearing.
(2) A hearing before a public advisory (5) The issues at the hearing. The
committee under part 14. statement of issues determines the
(3) A hearing before the Commis- scope of the hearing.
sioner under part 15. (6) If the hearing will be conducted
(b) The request— by a Public Board of Inquiry, the time
(1) May be on the person’s own initia- within which—
tive or at the suggestion of the Com- (i) The parties should submit nomi-
missioner. nees for the Board under § 13.10(b);
(2) Must be submitted in the form of (ii) A notice of participation under

a citizen petition under § 10.30 before § 12.45 should be filed; and
206
(iii) Participants should submit writ- (4) The issues of fact on which a hear-
ten information under § 13.25. The no- ing has been justified.
tice will list the contents of the por- (5) A statement of any objections or
tions of the administrative record rel- requests for hearing for which a hear-
evant to the issues at the hearing being has not been justified, which are
fore the Board. The portions listed will subject to § 12.28.
be placed on public display in the office (6) The presiding officer, or a state-
of the Division of Dockets Management ment that the presiding officer will be
before the notice is published. Addi- designated in a later notice.
tional copies of material already sub- (7) The time within which notices of
mitted under § 13.25 need not be in- participation should be filed under
cluded with any later submissions. § 12.45.
(f)(1) The decision of a hearing before (8) The date, time, and place of the
a Public Board of Inquiry or a public prehearing conference, or a statement
advisory committee under this section that the date, time, and place will be
has legal status of and will be handled announced in a later notice. The pre-
as an initial decision under § 12.120. hearing conference may not commence
(2) The decision of a public hearing until after the time expires for filing
before the Commissioner under this the notice of participation required by
section will be issued as a final order. § 12.45(a).
The final order will have the same con- (9) The time within which partici-
tent as an initial decision, as specified pants should submit written informa-
in § 12.120 (b) and (c). tion and views under § 12.85. The notice
(3) Thereafter, the participants in the will list the contents of the portions of
proceeding may pursue the administra- the administrative record relevant to
tive and court remedies specified in the issues at the hearing. The portions
§§ 12.120 through 12.159. listed will be placed on public display
(g) If a hearing before a public advi- in the office of the Division of Dockets
sory committee or a hearing before the Management before the notice is pub-
Commissioner is used as an alternative lished. Additional copies of material
form of hearing, all submissions will be already submitted under § 12.85 need
made to the Division of Dockets Man- not be included with any later submis-
agement, and § 10.20(j) governs their sions.
availability for public examination and (b) The statement of the issues deter-
copying. mines the scope of the hearing and the
(h) This section does not affect the matters on which evidence may be in-
right to an opportunity for a hearing troduced. The issues may be revised by
before a public advisory committee the presiding officer. A participant
under section 515(g)(2) of the act re- may obtain interlocutory review by the
garding device premarket approval ap- Commissioner of a decision by the pre-
plications and product development siding officer to revise the issues to in-
protocols. Advisory committee hearing clude an issue on which the Commis-
procedures are found in part 14. sioner has not granted a hearing or to
eliminate an issue on which a hearing
§ 12.35 Notice of hearing; stay of ac- has been granted.
tion. (c) A hearing is deemed to begin on
(a) If the Commissioner determines the date of publication of the notice of
upon review of the objections and re- hearing.
quests for hearing that a hearing is jus- [44 FR 22339, Apr. 13, 1979, as amended at 47
tified on any issue, the Commissioner FR 26375, June 18, 1982]
will publish a notice setting forth the
following: § 12.37 Effective date of a regulation.
(1) The regulation or order that is the (a) If no objections are filed and no
subject of the hearing. hearing is requested on a regulation
(2) A statement specifying any part under § 12.20(e), the regulation is effec-
of the regulation or order that has been tive on the date specified in the regula-
stayed by operation of law or in the tion as promulgated.
Commissioner’s discretion. (b) The Commissioner shall publish a

(3) The parties to the hearing. confirmation of the effective date of
207
§ 12.38 21 CFR Ch. I (4–1–19 Edition)
the regulation. The FEDERAL REGISTER Division of Dockets Management, Food

document confirming the effective date and Drug Administration, Department of
of the regulation may extend the time Health and Human Services, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
for compliance with the regulation.
NOTICE OF PARTICIPATION
§ 12.38 Effective date of an order.
Docket No. ll
(a) If a person who is subject to a no-
tice of opportunity for hearing under Under 21 CFR part 12, please enter the par-
§ 12.21(b) does not request a hearing, ticipation of:
the Commissioner will— (Name) llllllllllllllll
(1) Publish a final order denying or (Street address) llllllllllll
withdrawing approval of an NDA, (City and State) llllllllllll
NADA, device premarket approval ap- (Telephone number) llllllllll
plication, or biologics license, in whole Service on the above will be accepted by:
or in part, or revoking a device product (Name) llllllllllllllll
development protocol or notice of com- (Street address) llllllllllll
pletion, or declaring that such a pro- (City and State) llllllllllll
tocol has not been completed, and stat- (Telephone number) llllllllll
ing the effective date of the order; and The following statements are made as part
(2) If the order involves withdrawal of of this notice of participation:
approval of an NADA, forthwith re- A. Specific interests. (A statement of the
voke, in whole or in part, the applica- specific interest of the person in the pro-
ble regulation, under section 512(i) of ceeding, including the specific issues of fact
the act. concerning which the person desires to be
heard. This part need not be completed by a
(b) If a person who is subject to a no- party to the proceeding.)
tice of opportunity for hearing under B. Commitment to participate. (A statement
§ 12.21(b) requests a hearing and others that the person will present documentary
do not, the Commissioner may issue a evidence or testimony at the hearing and
final order covering all the drug or de- will comply with the requirements of 21 CFR
vice products at once or may issue 12.85, or, in the case of a hearing before a
more than one final order covering dif- Public Board of Inquiry, with the require-
ments of 21 CFR 13.25.)
ferent drug or device products at dif-
ferent times. (Signed) llllllllllllllll
(b) An amendment to a notice of par-
Subpart C—Appearance and ticipation should be filed with the Di-
Participation vision of Dockets Management and
served on all participants.
§ 12.40 Appearance. (c) No person may participate in a
(a) A person who has filed a notice of hearing who has not filed a written no-
participation under § 12.45 may appear tice of participation or whose partici-
in person or by counsel or other rep- pation has been stricken under para-
resentative in any hearing and, subject graph (e) of this section.
to § 12.89, may be heard concerning all (d) The presiding officer may permit
relevant issues. the late filing of a notice of participa-
tion upon a showing of good cause.
(b) The presiding officer may strike a
(e) The presiding officer may strike
person’s appearance for violation of the
the participation of a person for non-
rules of conduct in § 12.90.
participation in the hearing or failure
§ 12.45 Notice of participation. to comply with any requirement of this
subpart, e.g., disclosure of information
(a) Within 30 days after publication as required by § 12.85 or the prehearing
of the notice of hearing under § 12.35, a order issued under § 12.92. Any person
person desiring to participate in a whose participation is stricken may pe-
hearing is to file with the Division of tition the Commissioner for interlocu-
Dockets Management under § 10.20 a tory review.
notice of participation in the following
form: [44 FR 22339, Apr. 13, 1979, as amended at 46

FR 8456, Jan. 27, 1981; 59 FR 14364, Mar. 28,
(Date) 1994; 68 FR 24879, May 9, 2003]
208
§ 12.50 Advice on public participation ticipants may be urging views contrary

in hearings. to those of the center involved or to
(a) Designated agency contact. All in- what may ultimately be the final con-
quiries from the public about sched- clusions of the Commissioner. Accord-
uling, location, and general procedures ingly, members of the office of the
should be addressed to the Deputy Chief Counsel, other than the attor-
Commissioner for Policy (HF–22), Food neys responsible for representing the
and Drug Administration, 5600 Fishers center whose action is the subject of
Lane, Rockville, MD 20857, or telephone the hearing, will not answer questions
301–443–3480. The staff of the Associate about the hearing from any participant
Commissioner for Regulatory Affairs or potential participant.
will attempt to respond promptly to all (e) Communication between participants
inquiries from members of the public, and attorneys. Participants in a hearing
as well as to simple requests for infor- may communicate with the attorneys
mation from participants in hearings. responsible for representing the center
(b) Hearing schedule changes. Requests whose action is the subject of the hear-
by hearing participants for changes in
ing, in the same way that they may
the schedule of a hearing or for filing
communicate with counsel for any
documents, briefs, or other pleadings
should be made in writing directly to other party in interest about the pres-
the Administrative Law Judge (HF–3), entation of matters at the hearing. It
Food and Drug Administration, 5600 would be inappropriate to bar discus-
Fishers Lane, Rockville, MD 20857. sion of such matters as stipulations of
(c) Legal advice to individuals. FDA fact, joint presentation of witnesses, or
does not have the resources to provide possible settlement of hearing issues.
legal advice to members of the public Members of the public, including par-
concerning participation in hearings. ticipants at hearings, are advised, how-
Furthermore, to do so would com- ever, that all such communications, in-
promise the independence of the Com- cluding those by telephone, will be re-
missioner’s office and invite charges of corded in memoranda that can be filed
improper interference in the hearing with the Division of Dockets Manage-
process. Accordingly, the Deputy Com- ment.
missioner for Policy (HF–22) will not
answer questions about the strengths
FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989;
or weaknesses of a party’s position at a 58 FR 17096, Apr. 1, 1993]
hearing, litigation strategy, or similar
matters.
(d) Role of the office of the Chief Coun- Subpart D—Presiding Officer
sel. Under no circumstances will the of-
fice of the Chief Counsel of FDA di- § 12.60 Presiding officer.
rectly provide advice about a hearing The presiding officer in a hearing
to any person who is participating or will be the Commissioner, a member of
may participate in the hearing. In the Commissioner’s office to whom the
every hearing, certain attorneys in the responsibility for the matter involved
office are designated to represent the has been delegated, or an administra-
center or centers whose action is the tive law judge qualified under 5 U.S.C.
subject of the hearing. Other members 3105.
of the office, including ordinarily the
Chief Counsel, are designated to advise § 12.62 Commencement of functions.
the Commissioner on a final decision in
The functions of the presiding officer
the matter. It is not compatible with
these functions, nor would it be profes- begin upon designation and end upon
sionally responsible, for the attorneys the filing of the initial decision.
in the office of the Chief Counsel also
§ 12.70 Authority of presiding officer.
to advise other participants in a hear-
ing, or for any attorney who may be The presiding officer has all powers
called on to advise the Commissioner necessary to conduct a fair, expedi-
to respond to inquiries from other par- tious, and orderly hearing, including
ticipants in the hearing, for such par- the power to—
209
§ 12.75 21 CFR Ch. I (4–1–19 Edition)
(a) Specify and change the date, § 12.78 Unavailability of presiding offi-
time, and place of oral hearings and cer.
conferences; (a) If the presiding officer is unable
(b) Establish the procedures for use to act for any reason, the Commis-
in developing evidentiary facts, includ- sioner will assign the powers and du-
ing the procedures in § 12.92(b) and to ties to another presiding officer. The
rule on the need for oral testimony and substitution will not affect the hear-
cross-examination under § 12.87(b); ing, except as the new presiding officer
(c) Prepare statements of the areas of may order.
factual disagreement among the par-
(b) Any motion based on the substi-
ticipants;
tution must be made within 10 days.
(d) Hold conferences to settle, sim-
plify, or determine the issues in a hear-
ing or to consider other matters that Subpart E—Hearing Procedures
may expedite the hearing;
§ 12.80 Filing and service of submis-
(e) Administer oaths and affirma- sions.
tions;
(f) Control the course of the hearing (a) Submissions, including pleadings
and the conduct of the participants; in a hearing, are to be filed with the
(g) Examine witnesses and strike Division of Dockets Management under
their testimony if they fail to respond § 10.20 except that only two copies need
fully to proper questions; be filed. To determine compliance with
(h) Rule on, admit, exclude, or limit filing deadlines in a hearing, a submis-
evidence; sion is considered submitted on the
(i) Set the time for filing pleadings; date it is actually received by the Divi-
(j) Rule on motions and other proce- sion of Dockets Management. When
dural matters; this part allows a response to a submis-
(k) Rule on motions for summary de- sion and prescribes a period of time for
cision under § 12.93; the filing of the response, an additional
(l) Conduct the hearing in stages if 3 days are allowed for the filing of the
the number of parties is large or the response if the submission is served by
issues are numerous and complex; mail.
(m) Waive, suspend, or modify any (b) The person making a submission
rule in this subpart under § 10.19 if the shall serve copies of it on the other
presiding officer determines that no participants. Submissions of documen-
party will be prejudiced, the ends of tary data and information are not re-
justice will be served, and the action is quired to be served on each participant,
in accordance with law; but any accompanying transmittal let-
(n) Strike the participation of any ter, pleading, summary, statement of
person under § 12.45(e) or exclude any position, certification under paragraph
person from the hearing under § 12.90, (d) of this section, or similar document
or take other reasonable disciplinary must be served on each participant.
action; and (c) Service is accomplished by mail-
(o) Take any action for the fair, expe- ing a submission to the address shown
ditious, and orderly conduct of the in the notice of participation or by per-
hearing. sonal delivery.
(d) All submissions are to be accom-
§ 12.75 Disqualification of presiding of- panied by a certificate of service, or a
ficer. statement that service is not required.
(a) A participant may request the (e) No written submission or other
presiding officer to disqualify himself/ portion of the administrative record
herself and withdraw from the pro- may be held in confidence, except as
ceeding. The ruling on any such re- provided in § 12.105.
quest may be appealed in accordance
with § 12.97(b). § 12.82 Petition to participate in forma
(b) A presiding officer who is aware of pauperis.
grounds for disqualification shall with- (a) A participant who believes that
draw from the proceeding. compliance with the filing and service
210
requirements of this section con- kept, e.g., the food additive master file
stitutes an unreasonable financial bur- and the food additive petition in the
den may submit to the Commissioner a case of issues concerning a food addi-
petition to participate in forma tive, or the new drug application in the
pauperis. case of issues concerning a new drug.
(b) The petition will be in the form Internal memoranda reflecting the de-
specified in § 10.30 except that the head- liberative process, and attorney work
ing will be ‘‘Request to Participate in product and material prepared specifi-
Forma Pauperis, Docket No. ll.’’ Fil- cally for use in connection with the
ing and service requirements for the hearing, are not required to be sub-
petition are described in paragraph (c)
mitted.
of this section, whether or not the peti-
(3) All other documentary data and
tion is granted. The petition must dem-
onstrate that either: (1) The person is information relied upon.
indigent and a strong public interest (4) A narrative position statement on
justifies participation, or (2) the per- the factual issues in the notice of hear-
son’s participation is in the public in- ing and the type of supporting evidence
terest because it can be considered of the director intends to introduce.
primary benefit to the general public. (5) A signed statement that, to the
(c) The Commissioner may grant or director’s best knowledge and belief,
deny the petition. If the petition is the submission complies with this sec-
granted, the participant need file only tion.
one copy of each submission with the (b) Within 60 days of the publication
Division of Dockets Management. The of the notice of hearing or, if no partic-
Division of Dockets Management will ipant will be prejudiced, within an-
make sufficient additional copies for other period of time set by the pre-
the administrative record, and serve a siding officer, each participant shall
copy on each other participant. submit to the Division of Dockets Man-
§ 12.83 Advisory opinions. agement all data and information spec-
ified in paragraph (a)(2) through (5) of
Before or during a hearing, a person this section, and any objections that
may, under § 10.85, request the Commis-
the administrative record filed under
sioner for an advisory opinion on
paragraph (a)(1) of this section is in-
whether any regulation or order under
complete. With respect to the data and
consideration in the proceeding applies
to a specific situation. information specified in paragraph
(a)(2) of this section, participants shall
§ 12.85 Disclosure of data and informa- exercise reasonable diligence in identi-
tion by the participants. fying documents in files comparable to
(a) Before the notice of hearing is those described in that paragraph.
published under § 12.35, the director of (c) Submissions required by para-
the center responsible for the matters graphs (a) and (b) of this section may
involved in the hearing shall submit be supplemented later in the pro-
the following to the Division of Dock- ceeding, with the approval of the pre-
ets Management: siding officer, upon a showing that the
(1) The relevant portions of the ad- material contained in the supplement
ministrative record of the proceeding. was not reasonably known or available
Portions of the administrative record when the submission was made or that
not relevant to the issues in the hear- the relevance of the material contained
ing are not part of the administrative in the supplement could not reasonably
record. have been forseen.
(2) All documents in the director’s (d) A participant’s failure to comply
files containing factual information,
substantially and in good faith with
whether favorable or unfavorable to
this section constitutes a waiver of the
the director’s position, which relate to
the issues involved in the hearing. Files right to participate further in the hear-
means the principal files in the center ing; failure of a party to comply con-
in which documents relating to the stitutes a waiver of the right to a hear-

issues in the hearing are ordinarily ing.
211
§ 12.87 21 CFR Ch. I (4–1–19 Edition)
(e) Participants may reference each to which, each wishes to present direct
other’s submissions. To reduce duplica- testimony orally or in writing.
tive submissions, participants are en- (ii) Oral cross-examination of wit-
couraged to exchange and consolidate nesses will be permitted if it appears
lists of documentary evidence. If a par- that alternative means of developing
ticular document is bulky or in limited the evidence are insufficient for a full
supply and cannot reasonably be repro- and true disclosure of the facts and
duced, and it constitutes relevant evi- that the party requesting oral cross-ex-
dence, the presiding officer may au- amination will be prejudiced by denial
thorize submission of a reduced number of the request or that oral cross-exam-
of copies. ination is the most effective and effi-
(f) The presiding officer will rule on cient means to clarify the matters at
questions relating to this section. issue.
(2) Witnesses shall give testimony
FR 9035, Mar. 3, 1989] under oath.
(c) Except as provided in paragraph
§ 12.87 Purpose; oral and written testi- (d) of this section, in a hearing involv-
mony; burden of proof. ing issuing, amending, or revoking a
(a) The objective of a formal evi- regulation or order, the originator of
dentiary hearing is the fair determina- the proposal or petition or of any sig-
tion of relevant facts consistent with nificant modification will be, within
the right of all interested persons to the meaning of 5 U.S.C. 556(d), the pro-
participate and the public interest in ponent of the regulation or order, and
promptly settling controversial mat- will have the burden of proof. A partic-
ters affecting the public health and ipant who proposes to substitute a new
welfare. provision for a provision objected to
(b) Accordingly, the evidence at a has the burden of proof in relation to
hearing is to be developed to the max- the new provision.
imum extent through written submis- (d) At a hearing involving issuing,
sions, including written direct testi- amending, or revoking a regulation or
mony, which may be in narrative or in order relating to the safety or effec-
question-and-answer form. tiveness of a drug, device, food addi-
(1) In a hearing, the issues may have tive, or color additive, the participant
general applicability and depend on who is contending that the product is
general facts that do not concern par- safe or effective or both and who is re-
ticular action of a specific party, e.g., questing approval or contesting with-
the safety or effectiveness of a class of drawal of approval has the burden of
drug products, the safety of a food or proof in establishing safety or effec-
color additive, or a definition and tiveness or both and thus the right to
standard of identity for a food; or the approval. The burden of proof remains
issues may have specific applicability on that participant in an amendment
to past action and depend upon par- or revocation proceeding.
ticular facts concerning only that [44 FR 22339, Apr. 13, 1979, as amended at 64
party, e.g., the applicability of a grand- FR 399, Jan. 5, 1999]
father clause to a particular brand of a
drug or the failure of a particular man- § 12.89 Participation of nonparties.
ufacturer to meet required manufac- (a) A nonparty participant may—
turing and processing specifications or (1) Attend all conferences (including
other general standards. the prehearing conference), oral pro-
(i) If the proceeding involves general ceedings, and arguments;
issues, direct testimony will be sub- (2) Submit written testimony and
mitted in writing, except on a showing documentary evidence for inclusion in
that written direct testimony is insuf- the record;
ficient for a full and true disclosure of (3) File written objections, briefs, and
relevant facts and that the participant other pleadings; and
will be prejudiced if unable to present (4) Present oral argument.
oral direct testimony. If the proceeding (b) A nonparty participant may not—
involves particular issues, each party (1) Submit written interrogatories;

may determine whether, and the extent and
212
(2) Conduct cross-examination. § 12.92 Prehearing conference proce-

(c) A person whose petition is the dure.
subject of the hearing has the same (a) Participants in a hearing are to
right as a party. appear at the prehearing conference
(d) A nonparty participant will be prepared to discuss and resolve all mat-
permitted additional rights if the pre- ters specified in paragraph (b) of this
siding officer concludes that the par- section.
ticipant’s interests would not be ade- (1) To expedite the hearing, partici-
quately protected otherwise or that pants are encouraged to prepare in ad-
broader participation is required for a vance for the prehearing conference.
full and true disclosure of the facts, Participants should cooperate with
but the rights of a nonparty partici- each other, and request information
pant may not exceed the rights of a and begin preparation of testimony at
party. the earliest possible time. Failure of a
participant to appear at the prehearing
[44 FR 22339, Apr. 13, 1979, as amended at 48 conference or to raise matters that
FR 51770, Nov. 14, 1983] could reasonably be anticipated and re-
solved at that time will not delay the
§ 12.90 Conduct at oral hearings or
conferences. progress of the hearing, and con-
stitutes a waiver of the rights of the
All participants in a hearing will participant regarding such matters as
conduct themselves with dignity and objections to the agreements reached,
observe judicial standards of practice actions taken, or rulings issued by the
and ethics. They may not indulge in presiding officer and may be grounds
personal attacks, unseemly wrangling, for striking the participation under
or intemperate accusations or charac- § 12.45.
terizations. Representatives of parties (2) Participants shall bring to the
shall, to the extent possible, restrain prehearing conference the following
clients from improprieties in connec- specific information, which will be
tion with any proceeding. Disrespect- filed with the Division of Dockets Man-
ful, disorderly, or contumacious lan- agement under § 12.80:
guage or conduct, refusal to comply (i) Any additional information to
with directions, use of dilatory tactics, supplement the submission filed under
or refusal to adhere to reasonable § 12.85, which may be filed if approved
standards of orderly and ethical con- under § 12.85(c).
duct during any hearing, constitute (ii) A list of all witnesses whose testi-
grounds for immediate exclusion from mony will be offered, orally or in writ-
the proceeding by the presiding officer. ing, at the hearing, with a full cur-
riculum vitae for each. Additional wit-
§ 12.91 Time and place of prehearing nesses may later be identified, with the
conference. approval of the presiding officer, on a
showing that the witness was not rea-
A prehearing conference will com- sonably available at the time of the
mence at the date, time, and place an- prehearing conference or the relevance
nounced in the notice of hearing, or in of the witness’ views could not reason-
a later notice, or as specified by the ably have been foreseen at that time.
presiding officer in a notice modifying (iii) All prior written statements in-
a prior notice. At that conference the cluding articles and any written state-
presiding officer will establish the ment signed or adopted, or a recording
methods and procedures to be used in or transcription of an oral statement
developing the evidence, determine made, by persons identified as wit-
reasonable time periods for the conduct nesses if—
of the hearing, and designate the times (a) The statement is available with-
and places for the production of wit- out making request of the witness or
nesses for direct and cross-examination any other person;
if leave to conduct oral examination is (b) The statement relates to the sub-
granted on any issue, as far as prac- ject matter of the witness’ testimony;
ticable at that time. and
213
§ 12.93 21 CFR Ch. I (4–1–19 Edition)
(c) The statement either was made hearing conference and setting forth
before the time the person agreed to the schedule for the hearing. The order
become a witness or has been made will control the subsequent course of
publicly available by the person. the hearing unless modified by the pre-
(b) The presiding officer will conduct siding officer for good cause.
a prehearing conference for the fol-
lowing purposes: § 12.93 Summary decisions.
(1) To determine the areas of factual (a) After the hearing commences, a
disagreement to be considered at the participant may move, with or without
hearing. The presiding officer may hold supporting affidavits, for a summary
conferences off the record in an effort decision on any issue in the hearing.
to reach agreement on disputed factual Any other participant may, within 10
questions. days after service of the motion, which
(2) To identify the most appropriate time may be extended for an additional
techniques for developing evidence on 10 days for good cause, serve opposing
issues in controversy and the manner affidavits or countermove for summary
and sequence in which they will be decision. The presiding officer may set
used, including, where oral examina- the matter for argument and call for
tion is to be conducted, the sequence in
the submission of briefs.
which witnesses will be produced for,
(b) The presiding officer will grant
and the time and place of, oral exam-
the motion if the objections, requests
ination. The presiding officer may con-
sider— for hearing, other pleadings, affidavits,
(i) Submission of narrative state- and other material filed in connection
ments of position on factual issues in with the hearing, or matters officially
controversy; noticed, show that there is no genuine
(ii) Submission of evidence or identi- issue as to any material fact and that
fication of previously submitted evi- a participant is entitled to summary
dence to support such statements, such decision.
as affidavits, verified statements of (c) Affidavits should set forth facts
fact, data, studies, and reports; that would be admissible in evidence
(iii) Exchange of written interrog- and show affirmatively that the affiant
atories directed to particular wit- is competent to testify to the matters
nesses; stated. When a properly supported mo-
(iv) Written requests for the production for summary decision is made, a
tion of additional documentation, data, participant opposing the motion may
or other relevant information; not rest upon mere allegations or deni-
(v) Submission of written questions als or general descriptions of positions
to be asked by the presiding officer of and contentions; affidavits or other re-
a specific witness; and sponses must set forth specific facts
(vi) Identification of facts for which showing that there is a genuine issue of
oral examination and/or cross-exam- fact for the hearing.
ination is appropriate. (d) Should it appear from the affida-
(3) To group participants with sub- vits of a participant opposing the mo-
stantially like interests for presenting tion that for sound reasons stated,
evidence, making motions and objec- facts essential to justify the opposition
tions, including motions for summary cannot be presented by affidavit, the
decision, filing briefs, and presenting presiding officer may deny the motion
oral argument. for summary decision, order a continu-
(4) To hear and rule on objections to ance to permit affidavits or additional
admitting into evidence information evidence to be obtained, or issue other
submitted under § 12.85. just order.
(5) To obtain stipulations and admis- (e) If on motion under this section a
sions of facts. summary decision is not rendered upon
(6) To take other action that may ex- the whole case or for all the relief
pedite the hearing. asked. and evidentiary facts need to be
(c) The presiding officer shall issue, developed, the presiding officer will
orally or in writing, a prehearing order issue an order specifying the facts that
reciting the actions taken at the pre- appear without substantial controversy
214
and directing further evidentiary pro- (ii) Exclusion of part or all of the evi-
ceedings. The facts so specified will be dence is necessary to enforce the re-
deemed established. quirements of this part.
(f) A participant may obtain inter- (2) If oral evidence is excluded as in-
locutory review by the Commissioner admissible, the participant may take
of a summary decision of the presiding written exception to the ruling in a
officer. brief to the Commissioner, without
§ 12.94 Receipt of evidence. taking oral exception at the hearing.
Upon review, the Commissioner may
(a) A hearing consists of the develop- reopen the hearing to permit the evi-
ment of evidence and the resolution of dence to be admitted if the Commis-
factual issues as set forth in this sub-
sioner determines that its exclusion
part and in the prehearing order.
was erroneous and prejudicial.
(b) All orders, transcripts, written
statements of position, written direct (e) The presiding officer may sched-
testimony, written interrogatories and ule conferences as needed to monitor
responses, and any other written mate- the program of the hearing, narrow and
rial submitted in the proceeding is a simplify the issues, and consider and
part of the administrative record of the rule on motions, requests, and other
hearing, and will be promptly placed on matters concerning the development of
public display in the office of the Divi- the evidence.
sion of Dockets Management, except as (f) The presiding officer will conduct
provided in § 12.105. such proceedings as are necessary for
(c) Written evidence, identified as the taking of oral testimony, for the
such, is admissible unless a participant oral examination of witnesses by the
objects and the presiding officer ex- presiding officer on the basis of written
cludes it on objection of a participant questions previously submitted by the
or on the presiding officer’s own initia- parties, and for the conduct of cross-ex-
tive. amination of witnesses by the parties.
(1) The presiding officer may exclude The presiding officer shall exclude ir-
written evidence as inadmissible only relevant or repetitious written ques-
if— tions and limit oral cross-examination
(i) The evidence is irrelevant, imma-
to prevent irrelevant or repetitious ex-
terial, unreliable, or repetitive;
amination.
(ii) Exclusion of part or all of the
written evidence of a participant is (g) The presiding officer shall order
necessary to enforce the requirements the proceedings closed for the taking of
of this subpart; or oral testimony relating to matters
(iii) The evidence was not submitted specified in § 10.20(j)(2)(i) (a) and (b).
as required by § 12.85. Such closed proceedings will be con-
(2) Items of written evidence are to ducted in accordance with § 10.20(j)(3).
be submitted as separate documents, Participation in closed proceedings
sequentially numbered, except that a will be limited to the witness, the wit-
voluminous document may be sub- ness’ counsel, and Federal Government
mitted in the form of a cross-reference executive branch employees and spe-
to the documents filed under § 12.85. cial government employees. Closed pro-
(3) Written evidence excluded by the ceedings will be permitted only for, and
presiding officer as inadmissible re- will be limited to, oral testimony di-
mains a part of the administrative rectly relating to matters specified in
record, as an offer of proof, for judicial § 10.20(j)(3).
review.
(d) Testimony, whether on direct or § 12.95 Official notice.
on cross-examination, is admissible as
(a) Official notice may be taken of
evidence unless a participant objects
and the presiding officer excludes it. such matters as might be judicially no-
(1) The presiding officer may exclude ticed by the courts of the United
oral evidence as inadmissible only if— States or of any other matter pecu-
(i) The evidence is irrelevant, imma- liarly within the general knowledge of
terial, unreliable, or repetitive; or FDA as an expert agency.
215
§ 12.96 21 CFR Ch. I (4–1–19 Edition)
(b) If official notice is taken of a ma- rects. If no briefs are authorized, the
terial fact not appearing in the evi- appeal will be presented as an oral ar-
dence of record, a participant, on time- gument to the Commissioner. The oral
ly request, will be afforded an oppor- argument will be transcribed. If briefs
tunity to show the contrary. are authorized, oral argument will be
heard only at the discretion of the
§ 12.96 Briefs and arguments. Commissioner.
(a) Promptly after the taking of evi-
dence is completed, the presiding offi- § 12.98 Official transcript.
cer will announce a schedule for the fil- (a) The presiding officer will arrange
ing of briefs. Briefs are to be filed ordi- for a verbatim stenographic transcript
narily within 45 days of the close of the of oral testimony and for necessary
hearing. Briefs must include a state- copies of the transcript.
ment of position on each issue, with (b) One copy of the transcript will be
specific and complete citations to the placed on public display in the office of
evidence and points of law relied on. the Division of Dockets Management
Briefs must contain proposed findings upon receipt.
of fact and conclusions of law. (c) Except as provided in § 12.105, cop-
(b) The presiding officer may, as a ies of the transcript may be obtained
matter of discretion, permit oral argu- by application to the official reporter
ment after the briefs are filed. and payment of costs thereof or under
(c) Briefs and oral argument are to part 20.
refrain from disclosing specific details (d) Witnesses, participants, and coun-
of written and oral testimony and doc- sel have 30 days from the time the
uments relating to matters specified in transcript becomes available to pro-
§ 10.20(j)(2)(i)(a) and (b), except as spe- pose corrections in the transcript of
cifically authorized in a protective oral testimony. Corrections are per-
order issued under § 10.20(j)(3). mitted only for transcription errors.
The presiding officer shall promptly
§ 12.97 Interlocutory appeal from rul- order justified corrections.
ing of presiding officer.
(a) Except as provided in paragraph § 12.99 Motions.
(b) of this section and in §§ 12.35(b), (a) A motion on any matter relating
12.45(e), 12.93(f), and 12.99(d), when an to the proceeding is to be filed under
interlocutory appeal is specifically au- § 12.80, and must include a draft order,
thorized by this subpart, rulings of the except one made in the course of an
presiding officer may not be appealed oral hearing before the presiding offi-
to the Commissioner before the Com- cer.
missioner’s consideration of the entire (b) A response may be filed within 10
record of the hearing. days of service of a motion. The time
(b) A ruling of the presiding officer is may be shortened or extended by the
subject to interlocutory appeal to the presiding officer for good cause shown.
Commissioner if the presiding officer (c) The moving party has no right to
certifies on the record or in writing reply, except as permitted by the pre-
that immediate review is necessary to siding officer.
prevent exceptional delay, expense, or (d) The presiding officer shall rule
prejudice to any participant, or sub- upon the motion and may certify that
stantial harm to the public interest. ruling to the Commissioner for inter-
(c) When an interlocutory appeal is locutory review.
made to the Commissioner, a partici-
pant may file a brief with the Commis- Subpart F—Administrative Record
sioner only if specifically authorized
by the presiding officer or the Commis- § 12.100 Administrative record of a
sioner, and if such authorization is hearing.
granted, within the period the Commis- (a) The record of a hearing consists
sioner directs. If a participant is au- of—
thorized to file a brief, any other par- (1) The order or regulation or notice
ticipant may file a brief in opposition, of opportunity for hearing that gave
within the period the Commissioner di- rise to the hearing;
216
(2) All objections and requests for Subpart G—Initial and Final
hearing filed by the Division of Dock- Decisions
ets Management under §§ 12.20 through
12.22; § 12.120 Initial decision.
(3) The notice of hearing published (a) The presiding officer shall prepare
under § 12.35; and file an initial decision as soon as
(4) All notices of participation filed possible after the filing of briefs and
under § 12.45; oral argument.
(5) All FEDERAL REGISTER notices (b) The initial decision must con-
pertinent to the proceeding; tain—
(6) All submissions filed under § 12.82, (1) Findings of fact based issued upon
e.g., the submissions required by § 12.85, relevant, material, and reliable evi-
all other documentary evidence and dence of record;
written testimony, pleadings, state- (2) Conclusions of law;
ments of position, briefs, and other (3) A discussion of the reasons for the
similar documents; findings and conclusions, including a
(7) The transcript, written order, and discussion of the significant conten-
all other documents relating to the tions made by any participant;
prehearing conference, prepared under (4) Citations to the record supporting
§ 12.92; the findings and conclusions;
(8) All documents relating to any mo- (5) An appropriate regulation or
tion for summary decision under § 12.93; order supported by substantial evi-
(9) All documents of which official dence of record and based upon the
notice is taken under § 12.95; findings of fact and conclusions of law;
(10) All pleadings filed under § 12.96; and
(11) All documents relating to any in- (6) An effective date for the regula-
terlocutory appeal under § 12.97; tion or order.
(12) All transcripts prepared under (c) The initial decision must refrain
§ 12.98; and from disclosing specific details of mat-
(13) Any other document relating to ters specified in § 10.20(j)(2)(i) (a) and
the hearing and filed with the Division (b), except as specifically authorized in
of Dockets Management by the pre- a protective order issued pursuant to
siding officer or any participant; § 10.20(j)(3).
(b) The record of the administrative (d) The initial decision is to be filed
proceeding is closed— with the Division of Dockets Manage-
ment and served upon all participants.
(1) With respect to the taking of evi-
Once the initial decision is filed with
dence, when specified by the presiding
the Division of Dockets Management,
officer; and
the presiding officer has no further ju-
(2) With respect to pleadings, at the risdiction over the matter, and any
time specified in § 12.96(a) for the filing motions or requests filed with the Divi-
of briefs. sion of Dockets Management will be
(c) The presiding officer may reopen decided by the Commissioner.
the record to receive further evidence (e) The initial decision becomes the
at any time before the filing of the ini- final decision of the Commissioner by
tial decision. operation of law unless a participant
files exceptions with the Division of
§ 12.105 Examination of record. Dockets Management under § 12.125(a)
Documents in the record will be pub- or the Commissioner files a notice of
licly available in accordance with review under § 12.125(f).
§ 10.20(j). Documents available for ex- (f) Notice that an initial decision has
amination or copying will be placed on become the decision of the Commis-
public display in the office of the Divi- sioner without appeal to or review by
sion of Dockets Management promptly the Commissioner will be published in
the FEDERAL REGISTER, or the Commis-
upon receipt in that office.

sioner may publish the decision when
it is of widespread interest.
217
§ 12.125 21 CFR Ch. I (4–1–19 Edition)
§ 12.125 Appeal from or review of ini- § 12.130 Decision by Commissioner on

tial decision. appeal or review of initial decision.
(a) A participant may appeal an ini- (a) On appeal from or review of the
tial decision to the Commissioner by initial decision, the Commissioner has
filing exceptions with the Division of all the powers given to make the ini-
Dockets Management, and serving tial decision. On the Commissioner’s
them on the other participants, within own initiative or on motion, the Com-
60 days of the date of the initial deci- missioner may remand the matter to
sion. the presiding officer for any further ac-
(b) Exceptions must specifically iden- tion necessary for a proper decision.
tify alleged errors in the findings of (b) The scope of the issues on appeal
fact or conclusions of law in the initial is the same as the scope of the issues at
decision, and provide supporting cita- the public hearing unless the Commis-
tions to the record. Oral argument be- sioner specifies otherwise.
fore the Commissioner may be re- (c) As soon as possible after the filing
quested in the exceptions. of briefs and any oral argument, the
(c) Any reply to the exceptions is to Commissioner will issue a final deci-
be filed and served within 60 days of sion in the proceeding, which meets the
the end of the period for filing excep- requirements established in § 12.120 (b)
tions. and (c).
(d) The Commissioner may extend (d) The Commissioner may adopt the
the time for filing exceptions under initial decision as the final decision.
paragraph (a) of this section or replies (e) Notice of the Commissioner’s de-
to exceptions under paragraph (c) of cision will be published in the FEDERAL
this section only upon a showing by a REGISTER, or the Commissioner may
participant of extraordinary cir- publish the decision when it is of wide-
cumstances. Such an extension shall be spread interest.
requested by filing a written request
with the Commissioner’s Executive § 12.139 Reconsideration and stay of
Secretariat (HF–40) and serving copies action.
of the request on the Division of Dock- Following notice or publication of
ets Management (HFA–305), the Chief the final decisions, a participant may
Counsel (GCF–1), and all hearing par- petition the Commissioner for recon-
ticipants.
sideration of any part or all of the deci-
(e) If the Commissioner decides to sion under § 10.33 or may petition for a
hear oral argument, the participants stay of the decision under § 10.35.
will be informed of the date, time, and
place, the amount of time allotted to
each participant, and the issues to be Subpart H—Judicial Review
addressed.
§ 12.140 Review by the courts.
(f) Within 10 days following the expi-
ration of the time for filing exceptions (a) The Commissioner’s final decision
(including any extensions), the Com- constitutes final agency action from
missioner may file with the Division of which a participant may petition for
Dockets Management, and serve on the judicial review under the statutes gov-
participants, a notice of the Commis- erning the matter involved. Before re-
sioner’s determination to review the questing an order from a court for a
initial decision. The Commissioner stay of action pending review, a partic-
may invite the participants to file ipant shall first submit a petition for a
briefs or present oral argument on the stay of action under § 10.35.
matter. The time for filing briefs or (b) Under 28 U.S.C. 2112(a), FDA will
presenting oral argument will be speci- request consolidation of all petitions
fied in that or a later notice. related to a particular matter.

FR 29453, Aug. 5, 1988]
218
§ 12.159 Copies of petitions for judicial act as an administrative law tribunal

review. concerning the matters involved, and
The Chief Counsel for FDA has been the Commissioner decides to accept
designated by the Secretary as the offi- this request.
cer on whom copies of petitions of judi- § 13.5 Notice of a hearing before a
cial review are to be served. This offi- Board.
cer is responsible for filing the record
on which the final decision is based. If the Commissioner determines that
The record of the proceeding is cer- a Board should be established to con-
tified by the Commissioner. duct a hearing on any matter, a notice
of hearing will be published in the FED-
ERAL REGISTER setting forth the fol-
PART 13—PUBLIC HEARING BEFORE lowing information:
A PUBLIC BOARD OF INQUIRY (a) If the hearing is under § 13.1 (a) or
(b), all applicable information de-
Subpart A—General Provisions scribed in § 12.32(e).
Sec. (1) Any written document that is to
13.1 Scope. be the subject matter of the hearing
13.5 Notice of a hearing before a Board. will be published as a part of the no-
13.10 Members of a Board. tice, or the notice will refer to it if the
13.15 Separation of functions; ex parte com- document has already been published
munications; administrative support. in the FEDERAL REGISTER or state that
the document is available from the Di-
Subpart B—Hearing Procedures vision of Dockets Management or an
13.20 Submissions to a Board. agency employee designated in the no-
13.25 Disclosure of data and information by tice.
the participants. (2) For purposes of a hearing under
13.30 Proceedings of a Board. § 13.1 (a) or (b), all participants who file
a notice of participation under
Subpart C—Records of a Hearing Before a § 12.32(e)(6)(ii) are deemed to be parties
Board and entitled to participate in selection
13.40 Administrative record of a Board. of the Board under § 13.15(b).
13.45 Examination of administrative record. (b) If the hearing is in lieu of a for-
13.50 Record for administrative decision. mal evidentiary hearing, as provided in
AUTHORITY: 5 U.S.C. 551–558, 701–721; 15 § 13.1(c), all of the information de-
U.S.C. 1451–1461; 21 U.S.C. 141–149, 321–393, scribed in § 12.32(e).
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201,
262, 263b–263n, 264.
FR 26375, June 18, 1982]
otherwise noted. § 13.10 Members of a Board.
(a) All members of a Board are to
Subpart A—General Provisions have medical, technical, scientific, or
other qualifications relevant to the
§ 13.1 Scope. issues to be considered, are subject to
The procedures in this part apply the conflict of interest rules applicable
when— to special Government employees, and
(a) The Commissioner concludes, as a are to be free from bias or prejudice
matter of discretion, that it is in the concerning the issues involved. A mem-
public interest to hold a public hearing ber of a Board may be a full-time or
before a Public Board of Inquiry part-time Federal Government em-
(Board) with respect to any matter be- ployee or may serve on an FDA advi-
fore FDA; sory committee but, except with the
(b) Under specific sections of this agreement of all parties, may not cur-
chapter a matter before FDA is subject rently be a full-time or part-time em-
to a hearing before a Board; or ployee of FDA or otherwise act as a
(c) Under § 12.32, a person who has a special Government employee of FDA.
right to an opportunity for a formal (b) Within 30 days of publication of
evidentiary public hearing waives that the notice of hearing, the director of
opportunity and requests that a Board the center of FDA responsible for a
219
§ 13.15 21 CFR Ch. I (4–1–19 Edition)
matter before a Board, the other par- needed, the Commissioner will request
ties to the proceeding, and any person the submission of the required addi-
whose petition was granted and is the tional nominees or information.
subject of the hearing, shall each sub- (2) If a person fails to submit a list of
mit to the Division of Dockets Manage- nominees as required by paragraph (b)
ment the names and full curricula of this section, the Commissioner may
vitae of five nominees for members of choose a qualified member without fur-
the Board. Nominations are to state ther consultation with that person.
that the nominee is aware of the nomi- (3) The Commissioner will announce
nation, is interested in becoming a the members of a Board by filing a
member of the Board, and appears to memorandum in the record of the pro-
have no conflict of interest. ceeding and sending a copy to all par-
(1) Any two or more persons entitled ticipants.
to nominate members may agree upon (d) Instead of using the selection
a joint list of five qualified nominees. method in paragraphs (b) and (c) of this
(2) The lists of nominees must be sub- section, the director of the center, the
mitted to the persons entitled to sub- other parties to the proceeding, and
mit a list of nominees under this para- any person whose petition was granted
graph but not to all participants. With- and is the subject of the hearing, may,
in 10 days of receipt of the lists of with the approval of the Commissioner,
nominees, such persons may submit agree that a standing advisory com-
comments to the Division of Dockets mittee listed in § 14.80 constitutes the
Management on whether the nominees Board for a particular proceeding, or
of the other persons meet the criteria that another procedure is to be used for
established in paragraph (a) of this sec- selection of the members of the Board,
tion. A person submitting comments to or that the Board consists of a larger
the Division of Dockets Management number of members.
shall submit them to all persons enti- (e) The members of a Board serve as
tled to submit a list of nominees. consultants to the Commissioner and
(3) The lists of nominees and com- are special Government employees or
ments on them are to be held in con- Government employees. A Board func-
fidence by the Division of Dockets tions as an administrative law tribunal
Management as part of the administra- in the proceeding and is not an advi-
tive record of the proceeding and are sory committee subject to the require-
not to be made available for public dis- ments of the Federal Advisory Com-
closure, and all persons who submit or mittee Act or part 14.
receive them shall similarly hold them
(f) The Chairman of the Board has
in confidence. This portion of the ad-
the authority of a presiding officer set
ministrative record remains confiden-
out in § 12.70.
tial but is available for judicial review
in the event that it becomes relevant [44 FR 22348, Apr. 13, 1979, as amended at 50
to any issue before a court. FR 8994, Mar. 6, 1985]
(c) After reviewing the lists of nomi-
nees and any comments, the Commis- § 13.15 Separation of functions; ex
sioner will choose three qualified per- parte communications; administra-
sons as members of a Board. One mem- tive support.
ber will be from the lists of nominees (a) The proceeding of a Board are
submitted by the director of the center subject to the provisions of § 10.55 relat-
and by any person whose petition was ing to separation of functions and ex
granted and is the subject of the hear- parte communications. Representa-
ing. The second will be from the lists of tives of the participants in any pro-
nominees submitted by the other par- ceeding before a Board, including any
ties. The Commissioner may choose the members of the office of the Chief
third member from any source. That Counsel of FDA assigned to advise the
member is the Chairman of the Board. center responsible for the matter, may
(1) If the Commissioner is unable to have no contact with the members of
find a qualified person with no conflict the Board, except as participants in the
of interest from among a list of nomi- proceeding, and may not participate in
nees or if additional information is the deliberations of the Board.
220
(b) Administrative support for a (3) All documents in the director’s

Board is to be provided only by the of- files containing factual information,
fice of the Commissioner and the office whether favorable or unfavorable to
of the Chief Counsel for FDA. the director’s position, which relate to
the issues involved in the hearing. Files
FR 9035, Mar. 3, 1989] means the principal files in the center
in which documents relating to the
issues in the hearing are ordinarily
Subpart B—Hearing Procedures kept, e.g., the food additive master file
§ 13.20 Submissions to a Board. and the food additive petition in the
case of issues concerning a food addi-
(a) Submissions are to be filed with tive, or the new drug application in the
the Division of Dockets Management case of issues concerning a new drug.
under § 10.20. Internal memoranda reflecting the de-
(b) The person making a submission liberative process, and attorney work
shall serve copies of it on each partici- product and material prepared specifi-
pant in the proceeding, except as pro- cally for use in connection with the
vided in §§ 13.10(b)(2) and 13.45. Submis- hearing, are not required to be sub-
sions of documentary data and infor- mitted;
mation need not be sent to each partic-
(4) All other documentary informa-
ipant, but any accompanying trans-
tion relied on; and
mittal letter, summary, statement of
position, certification under paragraph (5) A signed statement that, to the
(d) of this section, or similar document best of the director’s knowledge and
must be. belief, the submission complies with
(c) A submission must be mailed to this section.
the address shown in the notice of ap- (b) Within the time prescribed in the
pearance or personally delivered. notice of hearing published under § 13.5,
(d) All submissions are to be accom- each participant shall submit to the
panied by a certificate of service, or a Division of Dockets Management all
statement that service is not required. information specified in paragraph
(e) No written submission or other (a)(2) through (5) of this section and
portion of the administrative record any objections that the administrative
may be held in confidence, except as record filed under paragraph (a)(1) of
provided in §§ 13.10(b)(2) and 13.45. this section is incomplete. With re-
(f) A participant who believes that spect to the information specified in
compliance with the requirements of paragraph (a)(3) of this section, partici-
this section constitutes an unreason- pants are to exercise reasonable dili-
able financial burden may submit to gence in identifying documents in files
the Commissioner a petition to partici- comparable to those described in that
pate in forma pauperis in the form and paragraph.
manner specified in § 12.82. (c) The submissions required by para-
graphs (a) and (b) of this section may
§ 13.25 Disclosure of data and informa- be supplemented later in the pro-
tion by the participants. ceeding, with the approval of the
(a) Before the notice of hearing is Board, on a showing that the views of
published under § 13.5, the director of the persons or the material contained
the center responsible for the matters in the supplement was not known or
involved in the hearing must submit to reasonably available when the initial
the Division of Dockets Management— submission was made or that the rel-
(1) The relevant portions of the exist- evance of the views of the persons or
ing administrative record of the pro- the material contained in the supple-
ceeding. Portions of the administrative ment could not reasonably have been
record not relevant to the issues in the foreseen.
hearing are not part of the administra- (d) The failure to comply substan-
tive record; tially and in good faith with this sec-
(2) A list of all persons whose views tion in the case of a participant con-
will be presented orally or in writing at stitutes a waiver of the right to par-

the hearing; ticipate further in the hearing and in
221
§ 13.30 21 CFR Ch. I (4–1–19 Edition)
the case of a party constitutes a waiver (e) Within the time specified by the
of the right to a hearing. Board after its first hearing, partici-
(e) The Chairman rules on questions pants may submit written rebuttal in-
relating to this section. Any partici- formation and views in accordance
pant dissatisfied with a ruling may pe- with § 13.20. The Chariman will then
tition the Commissioner for interlocu- schedule a second hearing, if requested
tory review. and justified by a participant. A second
hearing, and any subsequent hearing,
FR 8994, Mar. 6, 1985; 54 FR 9035, Mar. 3, 1989] will be called only if the Chairman con-
cludes that it is needed to fully and
§ 13.30 Proceedings of a Board. fairly present information that cannot
otherwise adequately be considered and
(a) The purpose of a Board is to re- to properly resolve the issues. Notice of
view medical, scientific, and technical the time and location of any hearing is
issues fairly and expeditiously. The
to be published at least 15 days in ad-
proceedings of a Board are conducted
vance. The hearing is open to the pub-
as a scientific inquiry rather than a
lic.
legal trial.
(f) A Board may consult with any
(b) A Board may not hold its first
person who it concludes may have in-
hearing until after all participants
formation or views relevant to the
have submitted the information re-
issues.
quired by § 13.25.
(1) The consultation may occur only
(c) The Chairman calls the first hear-
at an announced hearing of a Board.
ing of the Board. Notice of the time
Participants have the right to suggest
and location of the first hearing is to
or, with the permission of the Chair-
be published at least 15 days in advance
and the hearing will be open to the man, ask questions of the consultant
public. All participants will have an and present rebuttal information and
opportunity at the first hearing to views, as provided in paragraphs (c)
make an oral presentation of the infor- and (d) of this section except that writ-
mation and views which in their opin- ten statements may be submitted to
ion are pertinent to the resolution of the Board with the consent of all par-
the issues being considered by a Board. ticipants.
A participant’s presentation may be (2) A participant may submit a re-
made by more than one person. The quest that the Board consult with a
Chairman determines the order of the specific person who may have informa-
presentation. Participants may not in- tion or views relevant to the issues.
terrupt a presentation, but members of The request will state why the person
the Board may ask questions. At the should be consulted and why the per-
conclusion of a presentation, each of son’s views cannot be furnished to the
the other participants may briefly Board by means other than having
comment on the presentation and may FDA arrange for the person’s appear-
request that the Board conduct further ance. The Board may, in its discretion,
questioning on specified matters. Mem- grant or deny the request.
bers of the Board may then ask further (g) All hearings are to be transcribed.
questions. Any other participant may All hearings are open to the public, ex-
be permitted to ask questions if the cept that a hearing under § 10.20(j)(3) is
Chairman determines that it will help closed to all persons except those per-
resolve the issues. sons making and participating in the
(d) The hearing is informal and the presentation and Federal Government
rules of evidence do not apply. No mo- executive branch employees and spe-
tions or objections relating to the ad- cial Government employees. At least a
missibility of information and views majority of Board members are to be
may be made or considered, but other present at every hearing. The executive
participants may comment upon or sessions of a Board, during which a
rebut all such information and views. Board deliberates on the issues, are to
No participant may interrupt the pres- be closed and are not transcribed. All
entation of another participant for any members of the Board shall vote on the
reason. report of the Board.
222
(h) All legal questions are to be re- § 13.45 Examination of administrative

ferred to the Chief counsel for FDA for record.
resolution. The Chief Counsel’s advice (a) The availability for public exam-
on any matter of procedure or legal au- ination and copying of each document
thority is to be transmitted in writing which is a part of the administrative
and made a part of the record or pre- record of the hearing is governed by
sented in open session and transcribed. § 10.20(j). Each document available for
(i) At the conclusion of all public public examination or copying is
hearings the Board will announce that placed on public display in the office of
the record is closed to receiving infor- the Division of Dockets Management
mation. The Board will provide an op- promptly upon receipt in that office.
portunity for participants to submit (b) Lists of nominees and comments
written statements of their positions, submitted on them under § 13.10(b)(3)
with proposed findings and conclusions, are not subject to disclosure unless
and may in its discretion, provide an they become an issue in a court pro-
opportunity for participants to summa- ceeding.
rize their positions orally.
(j) The Board will prepare a decision § 13.50 Record for administrative deci-
on all issues. The decision is to include sion.
specific findings and references sup- The administrative record of the
porting and explaining the Board’s con- hearing specified in § 13.40(a) con-
clusions, and a detailed statement of stitutes the exclusive record for deci-
the reasoning on which the conclusions sion.
are based. Any member of the Board
may file a separate report stating addi-
tional or dissenting views.
PART 14—PUBLIC HEARING BEFORE
A PUBLIC ADVISORY COMMITTEE
Subpart C—Records of a Hearing Subpart A—General Provisions.
Before a Board
Sec.
§ 13.40 Administrative record of a 14.1 Scope.
Board. 14.5 Purpose of proceedings before an advi-
(a) The administrative record of a sory committee.
14.7 Administrative remedies.
hearing before a Board consists of the
14.10 Applicability to Congress.
following:
14.15 Committees working under a contract
(1) All relevant FEDERAL REGISTER with FDA.
notices.
(2) All written submissions under Subpart B—Meeting Procedures
§ 13.20.
14.20 Notice of hearing before an advisory
(3) The transcripts of all hearings of
committee.
the Board. 14.22 Meetings of an advisory committee.
(4) The initial decision of the Board. 14.25 Portions of advisory committee meet-
(b) The record of the administrative ings.
proceeding is closed— 14.27 Determination to close portions of ad-
(1) Relevant to receiving information visory committee meetings.
and data, at the time specified in 14.29 Conduct of a hearing before an advi-
§ 13.30(i); and sory committee.
(2) Relevant to pleadings, at the time 14.30 Chairperson of an advisory committee.
14.31 Consultation by an advisory com-
specified in § 13.30(i) for filing a written
mittee with other persons.
statement of position with proposed
14.33 Compilation of materials for members
findings and conclusions. of an advisory committee.
(c) The Board may, in its discretion, 14.35 Written submissions to an advisory
reopen the record to receive further committee.
evidence at any time before filing an 14.39 Additional rules for a particular advi-
initial decision. sory committee.
223
§ 14.1 21 CFR Ch. I (4–1–19 Edition)
Subpart C—Establishment of Advisory Subpart I—Advisory Committees for

Committees Human Prescription Drugs
14.40 Establishment and renewal of advisory 14.160 Establishment of standing technical
committees. advisory committees for human prescrip-
14.55 Termination of advisory committees. tion drugs.
14.171 Utilization of an advisory committee
Subpart D—Records of Meetings and on the initiative of FDA.
Hearings Before Advisory Committees 14.172 Utilization of an advisory committee
at the request of an interested person.
14.60 Minutes and reports of advisory com- 14.174 Advice and recommendations in writ-
mittee meetings. ing.
14.61 Transcripts of advisory committee
meetings. AUTHORITY: 5 U.S.C. App. 2; 15 U.S.C. 1451–
14.65 Public inquiries and requests for advi- 1461, 21 U.S.C. 41–50, 141–149, 321–394, 467f, 679,
sory committee records. 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262,
14.70 Administrative record of a public 263b, 264; Pub. L. 107–109; Pub. L. 108–155; Pub.
hearing before an advisory committee. L. 113–54.
14.75 Examination of administrative record SOURCE: 44 FR 22351, Apr. 13, 1979, unless
and other advisory committee records. otherwise noted.
Subpart E—Members of Advisory
Committees Subpart A—General Provisions
14.80 Qualifications for members of standing § 14.1 Scope.
policy and technical advisory commit-
tees. (a) This part governs the procedures
14.82 Nominations of voting members of when any of the following applies:
standing advisory committees. (1) The Commissioner concludes, as a
14.84 Nominations and selection of non- matter of discretion, that it is in the
voting members of standing technical ad- public interest for a standing or ad hoc
visory committees. policy or technical public advisory
14.86 Rights and responsibilities of non-
committee (advisory committee or com-
voting members of advisory committees.
14.90 Ad hoc advisory committee members. mittee) to hold a public hearing and to
14.95 Compensation of advisory committee review and make recommendations on
members. any matter before FDA and for inter-
ested persons to present information
Subpart F—Standing Advisory Committees and views at an oral public hearing be-
fore the advisory committee.
14.100 List of standing advisory committees.
(2) Under specific provisions in the
Subpart G—Technical Electronic Products FD&C Act or other sections of this
Radiation Safety Standards Committee chapter, a matter is subject to a hear-
ing before an advisory committee. The
14.120 Establishment of the Technical Elec- specific provisions are—
tronic Product Radiation Safety Stand-
(i) Section 14.120 on review of a per-
ards Committee (TEPRSSC).
14.122 Functions of TEPRSSC. formance standard for an electronic
14.125 Procedures of TEPRSSC. product by the Technical Electronic
14.127 Membership of TEPRSSC. Product Radiation Safety Standards
14.130 Conduct of TEPRSSC meetings; Committee (TEPRSSC);
availability of TEPRSSC records. (ii) Section 14.140 on review of the
safety of color additives;
Subpart H—Color Additive Advisory (iii) Section 14.160 on review of the
Committees safety and effectiveness of human pre-
14.140 Establishment of a color additive ad- scription drugs;
visory committee. (iv) Section 330.10 on review of the
14.142 Functions of a color additive advisory safety and effectiveness of over-the-
committee. counter drugs;
14.145 Procedures of a color additive advi- (v) [Reserved]
sory committee.
14.147 Membership of a color additive advi- (vi) Part 860, on classification of de-
vices;
sory committee.
14.155 Fees and compensation pertaining to (vii) Section 514(b)(5) of the FD&C
a color additive advisory committee. Act on establishment, amendment, or
224
revocation of a device performance (i) A group of persons convened on an

standard; ad hoc basis to discuss a matter of cur-
(viii) Section 515 of the FD&C Act on rent interest to FDA, but which has no
review of device premarket approval continuing function or organization
applications and product development and does not involve substantial spe-
protocols; and cial preparation.
(ix) Section 520(f) of the FD&C Act on (ii) A group of two or more FDA con-
review of device good manufacturing sultants meeting with the agency on
practice regulations. an ad hoc basis.
(3) A person who has a right to an op- (iii) A group of experts who are em-
portunity for a formal evidentiary pub- ployed by a private company or a trade
lic hearing under part 12 waives that association which has been requested
opportunity and instead under § 12.32 by FDA to provide its views on a regu-
requests a hearing before an advisory latory matter pending before FDA.
committee, and the Commissioner, as a (iv) A consulting firm hired by FDA
matter of discretion, accepts the re- to provide advice regarding a matter.
quest. (6) An advisory committee that is
(b) In determining whether a group is utilized by FDA is subject to this sub-
a public advisory committee as defined in part even though it was not established
§ 10.3(a) and thus subject to this part by FDA. In general, a committee is uti-
and to the Federal advisory Committee lized when FDA requests advice or rec-
Act, the following guidelines will be ommendations from the committee on
used: a specific matter in order to obtain an
(1) An advisory committee may be a independent review and consideration
standing advisory committee or an ad of the matter, and not when FDA is
hoc advisory committee. All standing merely seeking the comments of all in-
advisory committees are listed in terested persons or of persons who have
§ 14.100. a specific interest in the matter.
(2) An advisory committee may be a (i) A committee formed by an inde-
policy advisory committee or a tech- pendent scientific or technical organi-
nical advisory committee. A policy ad- zation is utilized if FDA requests ad-
visory committee advises on broad and vice of that committee rather than of
general matters. A technical advisory the parent organization, or if the cir-
committee advises on specific tech- cumstances show that the advice given
nical or scientific issues, which may re- is that of the committee and not of the
late to regulatory decisions before parent organization. A committee
FDA. formed by an independent scientific or
(3) An advisory committee includes technical organization is not utilized if
any of its subgroups when the subgroup FDA requests advice of the organiza-
is working on behalf of the committee. tion rather than of a committee and if
Section 14.40(d) describes when a sub- the recommendations of any com-
group will be established as an advi- mittee formed in response to the re-
sory committee separate from the par- quest are subject to substantial inde-
ent committee. pendent policy and factual review by
(4) A committee composed entirely of the governing body of the parent orga-
full-time Federal Government employ- nization.
ees is not an advisory committee. (ii) A committee is not utilized by
(5) An advisory committee ordinarily FDA if it provides only information, as
has a fixed membership, a defined pur- contrasted with advice or opinions or
pose of providing advice to the agency recommendations.
on a particular subject, regular or peri- (iii) FDA is charged with seeking out
odic meetings, and an organizational the views of all segments of the public
structure, for example, a Chairperson on enforcement of the laws adminis-
and staff, and serves as a source of tered by the Commissioner. The fact
independent expertise and advice rath- that a group of individuals or a com-
er than as a representative of or advo- mittee meets regularly with FDA, for
cate for any particular interest. The example, a monthly meeting with con-
following groups are not advisory com- sumer representatives, does not make
mittees: that group or committee an advisory
225
§ 14.5 21 CFR Ch. I (4–1–19 Edition)
committee. Thus, this subpart does not tees established under the Medical De-
apply to routine meetings, discussions, vice Amendments of 1976.
and other dealings, including ex-
changes of views, between FDA and FR 9035, Mar. 3, 1989; 78 FR 17087, Mar. 20,
any committee representing or advo- 2013; 81 FR 45409, July 14, 2016]
cating the particular interests of con-
sumers, industry, professional organi- § 14.5 Purpose of proceedings before
zations, or others. an advisory committee.
(7) The inclusion of one or two FDA (a) An advisory committee is utilized
consultants who are special Govern- to conduct public hearings on matters
ment employees on an internal FDA of importance that come before FDA,
committee does not make that com- to review the issues involved, and to
mittee an advisory committee. provide advice and recommendations
(8) A Public Board of Inquiry estab- to the Commissioner.
lished under part 13, or other similar
(b) The Commissioner has sole discre-
group convened by agreement between
tion concerning action to be taken and
the parties to a regulatory proceeding
policy to be expressed on any matter
pending before FDA to review and pre-
considered by an advisory committee.
pare an initial decision on the issues in
lieu of a formal evidentiary public § 14.7 Administrative remedies.
hearing, is acting as an administrative
law tribunal and is not an advisory A person who alleges noncompliance
committee. by the Commissioner or an advisory
(9) An open public conference or committee with any provision of this
meeting conducted under § 10.65(b) is part or the Federal Advisory Com-
not an advisory committee meeting. mittee Act may pursue the following
(10) An FDA committee that pri- administrative remedies:
marily has operational responsibility (a) If the person objects to any ac-
rather than that of providing advice tion, including a failure to act, other
and recommendations is not an advi- than denial of access to an advisory
sory committee, for example, the Re- committee document, the person shall
search Involving Human Subjects Com- submit a petition in the form and in
mittee (RIHSC). accordance with the requirements of
(c) This part applies only when a § 10.30. The provisions of § 10.45 relating
committee convenes to conduct com- to exhaustion of administrative rem-
mittee business. Site visits, social edies are applicable.
gatherings, informal discussions by (1) If the person objects to past ac-
telephone or during meals or while tion, the person shall submit the peti-
traveling or at other professional function within 30 days after the action ob-
tions, or other similar activities do not jected to. If the Commissioner deter-
constitute a meeting. mines that there was noncompliance
(d) An advisory committee that is with any provision of this subpart or of
utilized but not established by FDA is the Federal Advisory Committee Act,
subject to this part only to the extent the Commissioner will grant any ap-
of such utilization, and not concerning propriate relief and take appropriate
any other activities of such committee. steps to prevent its future recurrence.
(e) Any conference or meeting be- (2) If the person objects to proposed
tween an employee of FDA and a com- future action, the Commissioner will
mittee or group which is not an advi- expedite the review of the petition and
sory committee shall be subject to make a reasonable effort to render a
§ 10.65 or other provisions specifically decision before the action concerned in
applicable to the committee or group, the petition.
for example, part 13 for a Public Board (3) If the person objects to action
of Inquiry. that is imminent or occurring and
(f) This part applies to all FDA advi- which could not reasonably have been
sory committees, except to the extent anticipated, e.g., the closing of a por-
that specific statutes require otherwise tion of a meeting which is made known
for a particular committee, for exam- for the first time on the day of the
ple, TEPRSSC and advisory commit- meeting, the matter may be handled by
226
an oral petition in lieu of a written pe- (2) Minutes of open sessions are to be
tition. maintained, with all written submis-
(b) If the person objects to a denial of sions attached which were made to the
access to an advisory committee docu- committee in open session. After ap-
ment, administrative review is in ac- proval, the minutes are to be forwarded
cordance with the procedures estab- to the Division of Dockets Manage-
lished by the Department of Health and ment and placed on public display. The
Human Services under 45 CFR 5.34. extent to which the committee main-
[44 FR 22351, Apr. 13, 1979, as amended at 55 tains minutes of closed sessions is in
FR 1404, Jan. 16, 1990] the discretion of the committee.
(3) In selecting the members of the
§ 14.10 Applicability to Congress. committee, the organization involved
This part applies to Congress, indi- is to apply the principles relating to
vidual Members of Congress, and other conflicts of interest that FDA uses in
employees or representatives of Con- establishing a public advisory com-
gress in the same way that they apply mittee. Those principles are set out or
to any other member of the public, ex- cross-referenced in this part and in
cept that disclosure of advisory com- part 19. Upon request, FDA will assist
mittee records to Congress is governed or provide guidance to any organiza-
by § 20.87. tion in meeting this requirement.
§ 14.15 Committees working under a Subpart B—Meeting Procedures

contract with FDA.
(a) FDA may enter into contracts § 14.20 Notice of hearing before an ad-
with independent scientific or tech- visory committee.
nical organizations to obtain advice (a) Before the first of each month,
and recommendations on particular and at least 15 days in advance of a
matters, and these organizations may meeting, the Commissioner will pub-
in turn undertake such work through lish a notice in the FEDERAL REGISTER
existing or new committees. Whether a of all advisory committee meetings to
particular committee working under be held during the month. Any advi-
such a contract is an advisory com- sory committee meetings for that
mittee subject to the Federal Advisory month called after the publication of
Committee Act and this subpart de- the general monthly notice are to be
pends upon application of the criteria announced in the FEDERAL REGISTER on
and principles in § 14.1(b). an individual basis at least 15 days in
(b) The following minimum standards advance. The Commissioner may au-
apply to any committee of an inde- thorize an exception to these notice re-
pendent scientific or technical organi- quirements in an emergency or for
zation which is working under a con- other reasons requiring an immediate
tract initially executed with FDA after meeting of an advisory committee, in
July 1, 1975, but which is determined which case public notice will be given
not to be an advisory committee: at the earliest time and in the most ac-
(1) The committee shall give public cessible form feasible including, when-
notice of its meetings and agenda, and ever possible, publication in the FED-
provide interested persons an oppor- ERAL REGISTER.
tunity to submit relevant information (b) The FEDERAL REGISTER notice
and views in writing at any time, and will include—
orally at specified times. The notice (1) The name of the committee;
may be published in the FEDERAL REG- (2) The date, time, and place of the
ISTER or disseminated by other reason- meeting;
able means. It is in any event to be (3) The general function of the com-
filed with the Division of Dockets Man- mittee;
agement not less than 15 days before (4) A list of all agenda items, showing
the meeting. The time for oral presen- whether each will be discussed in an
tations and the extent to which the open or closed portion of the meeting;
committee meets in open session other (5) If any portion of the meeting is
than for such oral presentations is in closed, a statement of the time of the
the discretion of the committee. open and closed portions;
227
§ 14.22 21 CFR Ch. I (4–1–19 Edition)
(6) The nature of the subjects to be the beginning of the open portion of
discussed during, and the reasons for the meeting.
closing, any closed portion of the meet- (2) The advisory committee meeting
ing; is to be conducted in accordance with
(7) The time set aside for oral state- the approved final agenda insofar as
ments and other public participation; practical.
(8) The name, address, and telephone (b) Advisory committee meetings
number of the advisory committee Des- will be held at places that are reason-
ignated Federal Officer and any other ably accessible to the public. All advi-
agency employee designated as respon- sory committee meetings will be held
sible for the administrative support for in Washington, DC, or Rockville, MD,
the advisory committee; or the immediate vicinity, unless the
(9) A statement that written submis- Commissioner receives and approves a
sions may be made to the advisory written request from the advisory com-
committee through the Designated mittee for a different location. A dif-
Federal Officer at any time, unless a ferent location may be approved when
cutoff date has been established under one or more of the following applies:
§ 14.35(d)(2); (1) The total cost of the meeting to
(10) When a notice is published in the the Government will be reduced.
FEDERAL REGISTER less than 15 days be- (2) A substantial number of the com-
fore a meeting, an explanation for the mittee members will be at the location
lateness of the notice; and at no expense to FDA for other reasons,
(c) If a public hearing before an advi- e.g., for a meeting of a professional as-
sory committee is used in lieu of a for- sociation.
mal evidentiary public hearing under (3) It is a central location more read-
§ 14.1(a)(3), an initial notice of hearing ily accessible to committee members.
is to be published separately in the (4) There is a need for increased par-
FEDERAL REGISTER containing all the ticipation available at that location.
information described in § 12.32(e). This (5) The committee wishes to review
procedure may be used for any other work or facilities in a specific location.
hearing before an advisory committee (6) The committee is concerned with
when the Commissioner concludes, as a matters that functionally or histori-
matter of discretion, that it would be cally occur in some other location, e.g.,
informative to the public. the Science Advisory Board of the Na-
(d) A list of advisory committee tional Center for Toxicological Re-
meetings will be distributed to the search will generally hold meetings in
press by the Associate Commissioner the Little Rock, AR, vicinity.
for Public Affairs. (c) Advisory committee members
[44 FR 22351, Apr. 13, 1979, as amended at 47 may, with the approval of FDA, con-
FR 26375, June 1, 1982; 54 FR 9035, Mar. 3, duct onsite visits relevant to their
1989; 66 FR 6469, Jan. 22, 2001; 66 FR 12850, work.
Mar. 1, 2001] (d) Unless the committee charter pro-
vides otherwise, a quorum for an advi-
§ 14.22 Meetings of an advisory com- sory committee is a majority of the
mittee. current voting members of the com-
(a) No advisory committee may con- mittee, except as provided in § 14.125(c)
duct a meeting except at the call or for TEPRSSC. Any matter before the
with the advance approval of, and with advisory committee is to be decided by
an agenda approved by, the designated a majority vote of the voting members
Federal employee or alternate. No present at the time, except that the
meeting may be held in the absence of designated Federal official may require
the designated Federal employee. that any final report be voted upon by
(1) If any matter is added to the all current voting members of the com-
agenda after its publication in the FED- mittee. Any current voting member of
ERAL REGISTER under § 14.20(b)(4), an at- the committee may file a separate re-
tempt is to be made to inform persons port with additional or minority views.
known to be interested in the matter, (e) If space is available, any inter-

and the change is to be announced at ested person may attend any portion of
228
any advisory committee meeting which (3) There may be no reporting or dis-
is not closed. cussion of information prohibited from
(f) Whenever feasible, meetings are to public disclosure under § 14.75.
be held in government facilities or (4) Notes or minutes kept or reports
other facilities involving the least ex- prepared by a committee member have
pense to the public. The size of the no status or effect unless adopted into
meeting room is to be reasonable, con- the official minutes or report by the
sidering such factors as the size of the committee.
committee, the number of persons ex- [44 FR 22351, Apr. 13, 1979; 48 FR 40887, Sept.
pected to attend a meeting, and the re- 12, 1983, as amended at 54 FR 9035, Mar. 3,
sources and facilities available. 1989; 78 FR 17087, Mar. 20, 2013]
(g) The Commissioner may authorize
§ 14.25 Portions of advisory committee
a meeting to be held by conference meetings.
telephone call. For these meetings, a
An advisory committee meeting has
speaker phone will be provided in a
the following portions:
conference room located in Wash-
(a) The open public hearing. Every
ington, DC, or Rockville, MD, or the
committee meeting includes an open
immediate vicinity, to permit public portion, which constitutes a public
participation in open portions of the hearing during which interested per-
meetings, as provided in §§ 14.25 and sons may present relevant information
14.29. These meetings generally will be or views orally or in writing. The hear-
brief, and authorized— ing is conducted in accordance with
(1) For the purpose of taking final § 14.29.
votes or otherwise confirming actions (b) The open committee discussion. A
taken by the committee at other meet- committee discusses any matter pend-
ings; or ing before it in an open portion of its
(2) Where time does not permit a meeting unless the meeting has been
meeting to be held at a central loca- closed for that matter under § 14.27. To
tion. the maximum extent feasible, con-
(h) Any portion of a meeting will be sistent with the policy expressed in
closed by the committee Chairperson § 14.27, a committee conducts its discus-
only when matters are to be discussed sion of pending matters in an open por-
which the Commissioner has deter- tion. No public participation is permis-
mined may be considered in closed ses- sible during this portion of the meeting
sion under § 14.27(b). If a portion of the except with the consent of the com-
meeting is closed, the closed portion mittee Chairperson.
will be held after the conclusion of the (c) The closed presentation of data. In-
open portion whenever practicable. formation prohibited from public dis-
(i) Any committee member may take closure under part 20 and the regula-
notes during meetings and report and tions referenced therein is presented to
the committee in a closed portion of its
discuss committee deliberations after a
meeting. However, if information is in
meeting is completed and before offi-
the form of a summary that is not pro-
cial minutes or a report are available,
hibited from public disclosure, the
within the rules and regulations adopt-
presentation is to be made in an open
ed by FDA and by the advisory com-
portion of a meeting.
mittee with the concurrence of FDA, (d) The closed committee deliberations.
including all of the following: Deliberations about matters before an
(1) There may be no attribution of in- advisory committee may be held in a
dividual views expressed in a closed closed portion of a meeting only upon
session or revealing of numerical votes. an appropriate determination by the
(2) There may be no reporting or dis- Commissioner under § 14.27.
cussion of any particular matter if the
committee or FDA specifically so di- § 14.27 Determination to close portions
rects, e.g., where deliberations are in- of advisory committee meetings.
complete or involve a sensitive regu- (a) No committee meeting may be en-
latory decision that requires prepara- tirely closed. A portion of a meeting

tion or implementation. may be closed only in accordance with
229
§ 14.27 21 CFR Ch. I (4–1–19 Edition)
a written determination by the Com- that do not independently justify clos-

missioner under this section. ing.
(b) The Designated Federal Officer or (5) No portion of a meeting devoted
other designated agency employee to matters other than those designated
shall prepare the initial request for a in paragraph (b) (1) through (3) of this
determination to close a portion of a section may be closed.
meeting, specifying the matter(s) to be (6) A matter which is properly con-
discussed during the closed portion and sidered in an open portion of a meeting
the reasons why the portion should be may instead be considered in a closed
closed. The Commissioner, based upon portion only if it is so inextricably
this request and with the concurrence intertwined with matters to be dis-
of the Chief Counsel, will determine cussed in a closed portion that it is not
whether to close a portion of a meet- feasible to separate them or discussion
ing. The reasons for closing a portion of the matter in an open portion would
of a meeting will be announced in the compromise the matters to be dis-
FEDERAL REGISTER notice of the meet- cussed in the closed portion.
ing under § 14.20 in accordance with the (c) Attendance at a closed portion of
following rules: a meeting is governed by the following
(1) Any determination to close a por- rules:
tion of a meeting restricts the closing (1) A portion of a meeting closed for
to the shortest possible time consistent the presentation or discussion of infor-
with the policy in this section. mation that constitutes a trade secret
or confidential commercial or financial
(2) A portion of a meeting may be
information as defined in § 20.61 may be
closed only if the Commissioner deter-
attended only by voting advisory com-
mines that the closing is permitted
mittee members, nonvoting members
under 5 U.S.C. 552b(c), and that the
representing consumer interests who
closing is necessary.
are also special government employees
(3) Portions of meetings may ordi- as provided in § 14.80(b), the Designated
narily be closed if they concern the re- Federal Officer of the advisory com-
view, discussion, and evaluation of mittee, a transcriber, consultants, and
drafts or regulations, guidance docu- such other regular employees of FDA
ments or similar preexisting internal (including members of the Office of the
agency documents, but only if their Chief Counsel) as the Chairperson of
premature disclosure would signifi- the advisory committee may invite,
cantly impede proposed agency action; and by those persons authorized to be
review of trade secrets and confidential present under § 14.25(c), for presen-
commercial or financial information; tation of information prohibited from
consideration of matters involving in- public disclosure. A person making a
vestigatory files compiled for law en- presentation described in § 14.25(c) may
forcement purposes; and review of mat- be accompanied by a reasonable num-
ters, the disclosure of which would con- ber of employees, consultants, or other
stitute a clearly unwarranted invasion persons in a commercial arrangement
of personal privacy. within the meaning of § 20.81(a).
(4) Portions of meetings ordinarily (2) A portion of a meeting that has
may not be closed if they concern re- been closed for consideration of exist-
view, discussion, and evaluation of gen- ing internal agency documents falling
eral preclinical and clinical test proto- within § 20.62 where premature disclo-
cols and procedures for a class of drugs sure is likely to significantly impede
or devices; consideration of labeling re- proposed agency action; personnel,
quirements for a class of marketed medical, and similar files, disclosure of
drugs and devices; review of informa- which would be a clearly unwarranted
tion on specific investigational or mar- invasion of personal privacy within the
keted drugs and devices that have pre- meaning of § 20.63; or investigatory
viously been made public; presentation records compiled for law enforcement
of any other information not exempt purposes as defined in § 20.64 may be at-
from public disclosure under 5 U.S.C. tended only by committee members
552b(c); the formulation of advice and (voting and nonvoting), the Designated
recommendations to FDA on matters Federal Officer of the committee, a
230
transcriber, and other regular employ- form the Designated Federal Officer or
ees of FDA (including members of the other designated agency employee,
Office of the Chief Counsel) whom the orally or in writing, before the meet-
Chairperson of the committee may in- ing.
vite. Consultants, individuals per- (1) The person shall state the general
forming personal service contracts, nature of the presentation and the ap-
employees of other Federal agencies, proximate time desired. Whenever pos-
and the general public may not attend sible, all written information to be dis-
such portions. cussed by that person at the meeting
(3) If a person other than a person should be furnished in advance to the
permitted to attend in accordance with Designated Federal Officer or other
paragraph (c) (1) and (2) of this section designated agency employee. This ma-
attempts to attend a closed portion of terial may be distributed or mailed by
a meeting without the approval of the FDA to the committee members in ad-
Designated Federal Officer and the vance of the meeting if time permits,
Chairperson, and the matter is brought and otherwise will be distributed to the
to their attention, the person will be members when they arrive for the
required to leave the meeting imme- meeting. The mailing or distribution
diately. This inadvertent and unau- may be undertaken only by FDA unless
thorized attendance does not enable FDA grants permission to a person to
other unauthorized persons to attend, mail or distribute the material
nor does it, of itself, constitute (2) Before the meeting, the Des-
grounds for release of transcripts of ignated Federal Officer or other des-
closed portions or any other documents ignated agency employee shall deter-
otherwise exempt from disclosure mine the amount of time allocated to
under § 14.75 and part 20. each person for oral presentation and
(4) If a person other than a person the time that the presentation is to
permitted to attend in accordance with begin. Each person will be so informed
paragraphs (c) (1) and (2) of this section in writing, if time permits, or by tele-
is allowed by the Designated Federal phone. FDA may require persons with
Officer and the Chairperson to attend a common interests to make joint pres-
closed portion of a meeting, that por- entations.
tion is open to attendance by any in- (c) The Chairperson of the committee
terested person. shall preside at the meeting in accord-
[44 FR 22351, Apr. 13, 1979, as amended at 65 ance with § 14.30 and be accompanied by
FR 56479, Sept. 19, 2000] other committee members, who serve
as a panel in conducting the hearing
§ 14.29 Conduct of a hearing before an portion of the meeting.
advisory committee. (d) Each person may use the allotted
(a) For each meeting, the open por- time as desired, consistent with an or-
tion for public participation, which derly hearing. A person may be accom-
constitutes a public hearing under panied by additional persons, and may
§ 14.25(a), will be at least 1 hour, unless present any written information or
public participation does not last that views for inclusion in the record of the
long, and may last for whatever longer hearing, subject to the requirements of
time the committee Chairperson deter- § 14.35(c).
mines will facilitate the work of the (e) If a person is absent at the time
committee. The FEDERAL REGISTER no- specified for that person’s presen-
tice published under § 14.20 will des- tation, the persons following will ap-
ignate the time specifically reserved pear in order. An attempt will be made
for the hearing, which is ordinarily the to hear the person at the conclusion of
first portion of the meeting. Further the hearing. Interested persons attend-
public participation in any open por- ing the hearing who did not request an
tion of the meeting under § 14.25(b) is opportunity to make an oral presen-
solely at the discretion of the Chair- tation may be given an opportunity to
person. do so at the discretion of the Chair-
(b) An interested person who wishes person.
to be assured of the right to make an (f) The Chairperson and other mem-
oral presentation at a meeting shall in- bers may question a person concerning
231
§ 14.30 21 CFR Ch. I (4–1–19 Edition)
that person’s presentation. No other (c) A committee may confer with a

person, however, may question the per- person who is not a Federal Govern-
son. The Chairperson may allot addi- ment executive branch employee only
tional time when it is in the public in- during the open portions of a meeting.
terest, but may not reduce the time al- The person may, however, submit
lotted without consent of the person. views in writing to the committee as
(g) Participants may question a com- part of the administrative record under
mittee member only with that mem- § 14.70. The person may participate at
ber’s permission and only about mat- the closed portions of a meeting only if
ters before the committee. appointed as a special Government em-
(h) The hearing is informal, and the ployee by the Commissioner as pro-
rules of evidence do not apply. No mo- vided in paragraph (e) of this section.
tions or objections relating to the ad- This paragraph (c) is not intended to
missibility of information and views bar the testimony of a person during a
may be made or considered, but other closed portion of a meeting about mat-
participants may comment upon or ters prohibited from public disclosure
rebut matters presented. No partici- under §§ 14.25(c) and 14.27(c).
pant may interrupt the presentation of (d) To prevent inadvertent violation
another participant. of Federal conflict of interest laws and
laws prohibiting disclosure of trade se-
§ 14.30 Chairperson of an advisory crets (18 U.S.C. 208, 21 U.S.C. 331(j), 18
committee. U.S.C. 1905), Federal executive branch
(a) The advisory committee Chair- employees who are not employees of
person has the authority to conduct the Department may not confer, tes-
hearings and meetings, including the tify, or otherwise participate (other
authority to adjourn a hearing or than as observers) at any portion of an
meeting if the Chairperson determines advisory committee meeting unless
that adjournment is in the public in- they are appointed as special Govern-
terest, to discontinue discussion of a ment employees by the Commissioner
matter, to conclude the open portion of under paragraph (e) of this section. this
a meeting, or to take any other action paragraph does not apply to Federal
to further a fair and expeditious hear- executive branch employees who are
ing or meeting. appointed as members of TEPRSSC, as
(b) If the Chairperson is not a full- provided in § 14.127.
time employee of FDA, the Designated (e) The Commissioner may appoint
Federal Officer or other designated persons as special Government employ-
agency employee, or alternate, is to be ees to be consultants to an advisory
the designated Federal employee who is committee. Consultants may be ap-
assigned to the advisory committee. pointed to provide expertise, generally
The designated Federal employee is concerning a highly technical matter,
also authorized to adjourn a hearing or not readily available from the mem-
meeting if the employee determines ad- bers of the committee. Consultants
journment to be in the public interest. may be either from outside the Govern-
ment or from agencies other than the
§ 14.31 Consultation by an advisory Food and Drug Administration. Re-
committee with other persons. ports, data, information, and other
written submissions made to a public
(a) A committee may confer with any
advisory committee by a consultant
person who may have information or
are part of the administrative record
views relevant to any matter pending
itemized in § 14.70.
before the committee.
(b) An interested person may submit [44 FR 22351, Apr. 13, 1979, as amended at 55
to the committee a written request FR 42703, Oct. 23, 1990]
that it confer with specific persons
about any matter pending before the § 14.33 Compilation of materials for
committee. The request is to contain members of an advisory committee.
adequate justification. The committee The Commissioner shall prepare and
may, in its discretion, grant the re- provide to all committee members a
quest. compilation of materials bearing upon
232
members’ duties and responsibilities, quest the applicant or sponsor of an ap-

including— plication or petition about a specific
(a) All applicable conflict of interest product on which action is pending be-
laws and regulations and a summary of fore FDA, and is being reviewed by an
their principal provisions; advisory committee, to present or dis-
(b) All applicable laws and regula- cuss safety, effectiveness, or other data
tions relating to trade secrets and con- concerning the product during a regu-
fidential commercial or financial infor- larly scheduled meeting of the com-
mation that may not be disclosed pub- mittee. The request may be for an oral
licly and a summary of their principal presentation or for a concise, well-or-
provisions; ganized written summary of pertinent
(c) All applicable laws, regulations, information for review by the com-
and guidance documents relating to mittee members before the meeting, or
the subject matter covered by the advi- both. Unless specified otherwise, one
sory committee and a summary of copy of the written summary along
their principal provisions; with a proposed agenda outlining the
(d) All applicable laws, regulations, topics to be covered and identifying the
including the regulations in part 20 of participating industry staff members
this chapter, advisory committee char- or consultants that will present each
ters, FEDERAL REGISTER notices, cur- topic is to be submitted to the Des-
ricula vitae, rules adopted by the advi- ignated Federal Officer or other des-
sory committee, and other material re- ignated agency employee at least 3
lating to the formation, composition, weeks before the meeting.
and operation of the advisory com-
(d) An interested person may submit
mittee, and a summary of their prin-
to a committee written information or
cipal provisions;
(e) Instructions on whom to contact views on any matter being reviewed.
when questions arise; and Voluminous data is to be accompanied
(f) Other material relating to FDA by a summary. A submission is to be
and the subject matter covered by the made to the Designated Federal Officer
committee which may facilitate the and not directly to a committee mem-
work of the committee. ber.
(1) FDA will distribute submissions
[44 FR 22351, Apr. 13, 1979, as amended at 65 to each member, either by mail or at
FR 56479, Sept. 19, 2000]
the next meeting. Submissions will be
§ 14.35 Written submissions to an advi- considered by the committee in its re-
sory committee. view of the matter.
(a) Ten copies of written submissions (2) A committee may establish, and
to a committee are to be sent to the give public notice of, a cutoff date
Designated Federal Officer unless an after which submissions about a mat-
applicable FEDERAL REGISTER notice or ter will no longer be received or consid-
other regulations in this chapter speci- ered.
fy otherwise. Submissions are subject (e) The Commissioner will provide
to the provisions of § 10.20, except that the committee all information the
it is not necessary to send copies to the Commissioner deems relevant. A mem-
Division of Dockets Management. ber will, upon request, also be provided
(b) At the request of a committee, or any material available to FDA which
on the Commissioner’s own initiative, the member believes appropriate for an
the Commissioner may issue in the independent judgment on the matter,
FEDERAL REGISTER a notice requesting e.g., raw data underlying a summary or
the submission to the committee of report, or a briefing on the legal as-
written information and views perti- pects of the matter.
nent to a matter being reviewed by the
committee. The notice may specify the § 14.39 Additional rules for a par-
manner in which the submission should ticular advisory committee.
be made. (a) In addition to these rules, an ad-
(c) At the request of a committee, or visory committee may, with the con-
on the Commissioner’s own initiative, currence of the designated Federal em-

the Commissioner may at any time re- ployee, adopt additional rules which
233
§ 14.40 21 CFR Ch. I (4–1–19 Edition)
are not inconsistent with this subpart lished as a separate committee when
or with other legal requirements. the charter of the parent committee
(b) Any additional rules will be in- does not incorporate the activities of
cluded in the minutes of the meeting the subgroup, or when the subgroup in-
when adopted and in the materials cludes members who are not all drawn
compiled under § 14.33 and will be avail- from the parent committee.
able for public disclosure under (e) An advisory committee not re-
§ 14.65(c). quired to be established by law will be
established or utilized only if it is in
Subpart C—Establishment of the public interest and only if its func-
Advisory Committees tions cannot reasonably be performed
by other existing advisory committees
§ 14.40 Establishment and renewal of or by FDA.
advisory committees. (f) An advisory committee must meet
(a) An advisory committee may be the following standards:
established or renewed whenever it is (1) Its purpose is clearly defined.
necessary or appropriate for the com- (2) Its membership is balanced fairly
mittee to hold a public hearing and to in terms of the points of view rep-
review and make recommendations on resented in light of the functions to be
any matter pending before FDA. Ex- performed. Although proportional rep-
cept for committees established by resentation is not required, advisory
statute, before a committee is estab- committee members are selected with-
lished or renewed it must first be ap- out regard to race, color, national ori-
proved by the Department pursuant to gin, religion, age, or sex.
45 CFR part 11 and by the General (3) It is constituted and utilizes pro-
Services Administration. cedures designed to assure that its ad-
(b) When an advisory committee is vice and recommendations are the re-
established or renewed, the Commis- sult of the advisory committee’s inde-
sioner will issue a FEDERAL REGISTER pendent judgment.
notice certifying that the establish- (4) Its staff is adequate. The Commis-
ment or renewal is in the public inter- sioner designates an Designated Fed-
est and stating the structure, function, eral Officer and alternate for every ad-
and purposes of the committee and, if visory committee, who are employees
it is a standing advisory committee, of FDA. The Designated Federal Officer
shall amend § 14.100 to add it to the list is responsible for all staff support un-
of standing advisory committees. A no- less other agency employees are des-
tice of establishment will be published ignated for this function.
at least 15 days before the filing of the (5) Whenever feasible, or required by
advisory committee charter under statute, it includes representatives of
paragraph (c) of this section. A notice the public interest.
of renewal does not require the 15-day [44 FR 22351, Apr. 13, 1979, as amended at 55
notice. FR 42703, Oct. 23, 1990]
(c) No committee may meet or take
action until its charter is prepared and § 14.55 Termination of advisory com-
filed as required by section 9(c) of the mittees.
Federal Advisory Committee Act. This (a) Except as provided in paragraph
requirement is to be met by an advi- (c) of this section, a standing advisory
sory committee utilized by FDA, even committee is terminated when it is no
though it is not established by the longer needed, or not later than 2 years
agency, prior to utilization. after its date of establishment unless it
(d) The regulations of the Depart- is renewed for an additional 2-year pe-
ment cited in paragraph (a) of this sec- riod. A committee may be renewed for
tion provide that the charter of a par- as many 2-year periods as the public in-
ent committee may incorporate infor- terest requires. The requirements for
mation concerning activities of a sub- establishment of a committee under
group. In such instances, a subgroup § 14.40 also apply to its renewal.
will not be established as a committee (b) FDA will issue a FEDERAL REG-
distinct from the parent committee. ISTER notice announcing the reasons
However, a subgroup will be estab- for terminating a committee and, if it
234
is a standing committee, amending § 14.61, must be transcribed or recorded

§ 14.100 to delete it from the list. by the agency. Their accuracy is ap-
(c) TEPRSSC is a permanent statu- proved by the committee and certified
tory advisory committee established by the Chairperson. The approval and
by section 358(f)(1)(A) of the Public certification may be accomplished by
Health Service Act, as added by the mail or by telephone.
Radiation Control for Health and Safe- (b) The minutes include the fol-
ty Act of 1968, transferred to the FD&C lowing:
Act (21 U.S.C. 360kk(f)(1)(A)), and is not (1) The time and place of the meet-
subject to termination and renewal ing.
under paragraph (a) of this section, ex- (2) The members, committee staff,
cept that a new charter is prepared and and agency employees present, and the
filed at the end of each 2-year period as names and affiliations or interests of
provided in § 14.40(c). Also, the statu- public participants.
tory medical device classification pan- (3) A copy of or reference to all writ-
els established under section 513(b)(1) ten information made available for
of the FD&C Act (21 U.S.C. 360c(b)(1)) consideration by the committee at the
and part 860, and the statutory medical proceedings.
device good manufacturing practice ad- (4) A complete and accurate descrip-
visory committees established under tion of matters discussed and conclu-
section 520(f)(3) of the FD&C Act (21 sions reached. A description is to be
U.S.C. 360j(f)(3)), are specifically ex- kept separately for the following por-
empted from the normal 2-year dura- tions of the meeting to facilitate their
tion period. public disclosure: The open portions
(d) Color additive advisory commit- specified in § 14.25 (a) and (b), any
tees are required to be established closed portion during which a presen-
under the circumstances specified in tation is made under § 14.25(c), and any
sections 721(b)(5)(C) and (D) of the closed deliberative portion under
FD&C Act (21 U.S.C. 379e(b)(5)(C) and § 14.25(d). The minutes of a closed delib-
(D)). A color additive advisory com- erative portion of a meeting may not
mittee is subject to the termination refer to members by name, except upon
and renewal requirements of the Fed- their request, or to data or information
eral Advisory Committee Act and of described in § 14.75(b). Any inadvertent
this part. references that occur are to be deleted
(e) The Tobacco Products Scientific before public disclosure.
Advisory Committee is a permanent (5) A copy of or reference to all re-
statutory advisory committee estab- ports received, issued, or approved by
lished by section 917 of the Family the committee.
Smoking Prevention and Tobacco Con-
(6) The extent to which the meeting
trol Act (21 U.S.C. 387q) (Pub. L. 111–31)
was open to the public.
and is not subject to termination and
(7) The extent of public participation,
renewal under paragraph (a) of this sec-
including a list of members of the pub-
tion.
lic who presented oral or written state-
[44 FR 22351, Apr. 13, 1979, as amended at 75 ments.
FR 73953, Nov. 30, 2010; 78 FR 17087, Mar. 20, (c) For a meeting that has a closed
2013] portion, either (1) the minutes of the
closed portion are available for public
Subpart D—Records of Meetings disclosure under § 14.75(a)(6)(i), or (2) if
and Hearings Before Advisory under § 14.75(a)(6)(ii) they are not
Committees promptly available, the Designated
Federal Officer or other designated
§ 14.60 Minutes and reports of advi- agency employee shall prepare a brief
sory committee meetings. summary of the matters considered in
(a) The Designated Federal Officer or an informative manner to the public,
other designated agency employee pre- consistent with 5 U.S.C. 552(b).
pares detailed minutes of all advisory (d) Where a significant portion of the
committee meetings, except that less meeting of a committee is closed, the
detailed minutes may be prepared for committee will issue a report at least
open portions of meetings which under annually setting forth a summary of
235
§ 14.61 21 CFR Ch. I (4–1–19 Edition)
its activities and related matters in- Bldg. 32, Rm. 5103, Silver Spring, MD
formative to the public consistent with 20993.
5 U.S.C. 552(b). This report is to be a (b) Public inquiries on matters relat-
compilation of or be prepared from the ing to a specific committee, except re-
individual reports on closed portions of quests for records, are to be directed to
meeting prepared under paragraph (c) the Designated Federal Officer or the
of this section. designated agency employee listed in
[44 FR 22351, Apr. 13, 1979, as amended at 45 the FEDERAL REGISTER notices pub-
FR 85725, Dec. 30, 1980] lished under § 14.20.
(c) Requests for public advisory com-
§ 14.61 Transcripts of advisory committee records, including minutes, are
mittee meetings.
to be made, to FDA’s Division of Free-
(a) The agency will arrange for a dom of Information (the Freedom of In-
transcript or recording to be made for formation Staff’s address is available
each portion of a meeting. on the agency’s web site at http://
(b) A transcript or recording of an www.fda.gov) under § 20.40 and the re-
open portion of a meeting made by lated provisions of part 20.
FDA is to be included in the record of
the committee proceedings. [44 FR 22351, Apr. 13, 1979, as amended at 46
(c) A transcript or recording of any FR 8456, Jan. 27, 1981; 76 FR 31469, June 1,
closed portion of a meeting made by 2011; 78 FR 17087, Mar. 20, 2013; 79 FR 68114,
FDA will not be included in the admin- Nov. 14, 2014]
istrative record of the committee pro-
ceedings. The transcript or recording § 14.70 Administrative record of a pub-
lic hearing before an advisory com-
will be retained as confidential by
mittee.
FDA, and will not be discarded or
erased. (a) Advice or recommendations of an
(d) Any transcript or recording of a advisory committee may be given only
meeting or portion thereof which is on matters covered in the administra-
publicly available under this section tive record of the committee’s pro-
will be available at actual cost of du- ceedings. Except as specified in other
plication, which will be, where applica- FDA regulations, the administrative
ble, the fees established in § 20.45. FDA record consists of all the following
may furnish the requested transcript items relating to the matter:
or recording for copying to a private (1) Any transcript or recording of an
contractor who shall charge directly open portion of a meeting.
for the cost of copying under § 20.53. (2) The minutes of all portions of all
(e) A person attending any open por- meetings, after any deletions under
tion of a meeting may, consistent with
§ 14.60(b)(4).
the orderly conduct of the meeting,
record or otherwise take a transcript of (3) All written submissions to and in-
the meeting. This transcription will formation considered by the com-
not be part of the administrative mittee.
record. (4) All reports made by the com-
(f) Only FDA may make a transcript mittee.
or recording of a closed portion of a (5) Any reports prepared by a con-
meeting. sultant under § 14.31(e).
(b) The record of the proceeding is
FR 25285, May 12, 2003] closed at the time the advisory com-
mittee renders its advice or rec-
§ 14.65 Public inquiries and requests ommendations or at any earlier time
for advisory committee records. specified by the committee or in other
(a) Public inquiries on general com- sections in this chapter.
mittee matters, except requests for
records, are to be directed to the Com- § 14.75 Examination of administrative
mittee Management Officer in the Ad- record and other advisory com-
visory Committee Oversight and Man- mittee records.
agement Staff, Food and Drug Admin- (a) The administrative record and
istration, 10903 New Hampshire Ave., other committee records are available
236
for public disclosure under part 20, ex- made available for public disclosure
cept as provided in paragraph (b) of without undue interference with agen-
this section, at the following times: cy or committee operations.
(1) The written information for con- (b) The following information con-
sideration by the committee at any tained in the administrative record is
meeting: at the same time it is made not available for public examination or
available to the committee. copying except as provided in § 12.32(g):
(2) The transcript or recording of any (1) Material provided to the com-
open portion of a meeting: as soon as it mittee by FDA that is exempt from
is available. public disclosure under part 20 and the
(3) The minutes of any open portion regulations referenced there.
of a meeting: after they have been ap- (2) Material provided to the advisory
proved by the committee and certified committee by a person making a pres-
by the Chairperson. entation described in § 14.25(c) and
(4) The brief summary of any closed which is prohibited from public disclo-
portion of a meeting prepared under sure under part 20 and the regulations
§ 14.60(c): as soon as it is available. referenced there.
(5) All written information or views (c) The Division of Dockets Manage-
submitted to the committee at an open ment (HFA–305) will maintain a file for
portion of a meeting: as soon as they each committee containing the fol-
are submitted. lowing principal records for ready ac-
(6) The minutes or portions thereof of cess by the public:
a closed portion of a meeting— (1) The committee charter.
(i) For a matter not directed to be (2) A list of committee members and
maintained as confidential under their curricula vitae.
§ 14.22(i)(2): After they have been ap- (3) The minutes of committee meet-
proved by the committee and certified ings.
by the Chairperson; and (4) Any formal advice or report of the
(ii) For a matter directed to be main- committee.
tained as confidential under § 14.22(i)(2): [44 FR 22351, Apr. 13, 1979, as amended at 54
After the advice or report of the com- FR 9035, Mar. 3, 1989]
mittee relevant to those minutes or
portions thereof is acted upon by the Subpart E—Members of Advisory
Commissioner, or upon a determina- Committees
tion by the Commissioner that such
minutes or portions thereof may be § 14.80 Qualifications for members of
made available for public disclosure standing policy and technical advi-
without undue interference with agen- sory committees.
cy or advisory committee operations. (a) Members of a policy advisory
(7) Formal advice or a report of the committee—
committee: After it has been acted (1) Shall have diverse interests, edu-
upon, i.e., approved, disapproved, or re- cation, training, and experience; spe-
jected as inadequate, by the Commis- cific technical expertise is not a re-
sioner, or upon a determination by the quirement;
Commissioner that such formal advice (2) Are subject to the conflict of in-
or report may be made available for terest laws and regulations either as
public disclosure without undue inter- special Government employees or as
ference with agency or committee op- members of the uniformed services, in-
erations. Such formal advice or report cluding the Commissioned Corps of the
may be retained as confidential while Public Health Service (the Commis-
it is under active advisement. sioner has determined that, because
(8) Any other committee records re- members representing particular inter-
lating to the matter, except transcripts ests, e.g., a representative of labor, in-
and recordings of closed portions of dustry, consumers, or agriculture, are
meetings: After the advice or report of included on advisory committees spe-
the committee relevant to those cifically for the purpose of rep-
records is acted upon by the Commis- resenting these interests, any financial
sioner, or upon a determination by the interest covered by 18 U.S.C. 208(a) in

Commissioner that the records may be the class which the member represents
237
§ 14.82 21 CFR Ch. I (4–1–19 Edition)
is irrelevant to the services which the (e) Members appointed to an advisory

Government expects from them and committee serve for the duration of the
thus is hereby exempted under 18 committee, or until their terms of ap-
U.S.C. 208(b) as too remote and incon- pointment expire, they resign, or they
sequential to affect the integrity of are removed from membership by the
their services); and Commissioner.
(3) Shall be voting members. (f) A committee member may be re-
(b) Technical advisory committee. (1) moved from membership for good
Voting members of technical advisory cause. Good cause includes excessive
committees— absenteeism from committee meetings,
(i) Shall have expertise in the subject a demonstrated bias that interferes
matter with which the committee is with the ability to render objective ad-
concerned and have diverse profes- vice, failure to abide by the procedures
sional education, training, and experi- established in this subpart, or violation
ence so that the committee will reflect of other applicable rules and regula-
a balanced composition of sufficient tions, e.g., for nonvoting members, the
scientific expertise to handle the prob- provisions of § 14.86(c).
lems that come before it; and (g) Consultants appointed under
(ii) Except for members of the Tech- § 14.31(e) are not members of advisory
nical Electronic Product Radiation committees.
Safety Standards Committee
(TEPRSSC), are subject to the conflict [44 FR 22351, Apr. 13, 1979, as amended at 53
of interest laws and regulations either FR 50949, Dec. 19, 1988; 54 FR 9035, Mar. 3,
as special Government employees or as 1989]
members of the uniformed services, in-
cluding the Commissioned Corps of the § 14.82 Nominations of voting members
Public Health Service. of standing advisory committees.
(2) The Commissioner shall, when re- (a) The Commissioner will publish
quired by statute, and may when not one or more notices in the FEDERAL
required by statute, provide for non- REGISTER each year requesting nomi-
voting members of a technical advisory nations for voting members of all exist-
committee to serve as representatives ing standing advisory committees. The
of and liaison with interested organiza- notice will invite the submission of
tions. Nonvoting members— nominations for voting members from
(i) Shall be selected by the interested both individuals and organizations.
organizations, as provided in § 14.84; (b) The notice announcing the estab-
technical expertise in the subject mat- lishment of a new committee under
ter with which the committee is in- § 14.40(b) will invite the submission of
volved is not a requirement; and nominations for voting members.
(ii) May be special Government em- (c) A person may nominate one or
ployees subject to the conflict of inter- more qualified persons to an advisory
est laws and regulations, except as pro-
committee. Nominations will specify
vided in § 14.84(e).
the advisory committee for which the
(c) A person may serve as a voting or nominee is recommended and will in-
nonvoting member on only one FDA
clude a complete curriculum vitae of
advisory committee unless the Com-
the nominee. Nominations are to state
missioner determines in writing that
dual membership will aid the work of that the nominee is aware of the nomi-
the committees involved and is in the nation, is willing to serve as a member
public interest. of the advisory committee, and appears
(d) Members of FDA advisory com- to have no conflict of interest that
mittees, and the Chairperson, are ap- would preclude membership.
pointed from among those nominated (d) Voting members serve as individ-
under §§ 14.82 and 14.84 and from any uals and not as representatives of any
other sources by the Secretary, or, by group or organization which nominated
delegation of authority, by the Assist- them or with which they may be affili-
ant Secretary for Health, or the Com- ated.

missioner.
238
§ 14.84 Nominations and selection of any advisory committee or sub-

nonvoting members of standing committee. Nominations that do not
technical advisory committees. comply with the requirements of this
(a) This section applies when the paragraph will not be considered.
Commissioner concludes that a tech- (3) The Advisory Committee Over-
nical advisory committee should in- sight and Management Staff will com-
clude nonvoting members to represent pile a list of organizations whose objec-
and serve as a liaison with interested tives are to promote, encourage, and
individuals and organizations. contribute to the advancement of con-
(b) Except when the Commissioner sumer education and to the resolution
concludes otherwise, nonvoting mem- of consumer problems. All organiza-
bers of a technical advisory committee tions listed are entitled to vote upon
are selected in accordance with para- the nominees. The list will include or-
graphs (c) and (d) of this section and ganizations representing the public in-
are normally limited to one person se- terest, consumer advocacy groups, and
lected by consumer groups and organi- consumer/health branches of Federal,
zations and one person selected by in- State, and local governments. Any or-
dustry groups and organizations. ganization that meets the criteria may
(c) To select a nonvoting member to be included on such list on request.
represent consumer interests, except as (4) The executive secretary, or other
provided in paragraph (c)(5) of this sec- designated agency employee, will re-
tion, the Commissioner publishes a no- view the list of nominees and select
tice in the FEDERAL REGISTER request- three to five qualified nominees to be
ing nominations for each specific com- placed on a ballot. Names not selected
mittee, or subcommittee, for which will remain on a list of eligible nomi-
nonvoting members are to be ap- nees and be reviewed periodically by
pointed. the Advisory Committee Oversight and
(1) A period of 30 days will be per- Management Staff to determine con-
mitted for submission of nominations tinued interest. Upon selection of the
for that committee or subcommittee. nominees to be placed on the ballot,
Interested persons may nominate one the curriculum vitae for each of the
or more qualified persons to represent nominees will be sent to each of the or-
consumer interests. Although nomina- ganizations on the list complied under
tions from individuals will be accepted, paragraph (c)(3) of this section, to-
individuals are encouraged to submit gether with a ballot to be filled out and
their nominations through consumer returned within 30 days. After the time
organizations as defined in paragraph for return of the ballots has expired,
(c)(3) of this section. Nominations of the ballots will be counted and the
qualified persons for general consider- nominee who has received the highest
ation as nonvoting members of unspec- number of votes will be selected as the
ified advisory committees or sub- nonvoting member representing con-
committees may be made at any time. sumer interests for that particular ad-
All nominations are to be submitted in visory committee or subcommittee. In
writing to Advisory Committee Over- the event of a tie, the Commissioner
sight and Management Staff, Food and will select the winner by lot from
Drug Administration, 10903 New Hamp- among those tied for the highest num-
shire Ave., Bldg. 32, rm. 1503, Silver ber of votes
Spring, MD 20993. (5) If a member representing con-
(2) A complete curriculum vitae of sumer interests resigns or is removed
any nominee is to be included. Nomina- before termination of the committee
tions must state that the nominee is on which the member is serving, the
aware of the nomination, is willing to following procedures will be used to ap-
serve as a member of an advisory com- point a replacement to serve out the
mittee, and appears to have no conflict term of the former member:
of interest. The nomination must state (i) The Commissioner will appoint
whether a nominee is interested only the runner-up, in order of number of
in a particular advisory committee or ballots received, on the original ballot
subcommittee, or whether the nominee submitted under paragraph (c)(4) of

is interested in becoming a member of this section to fill the vacancy. If the
239
§ 14.86 21 CFR Ch. I (4–1–19 Edition)
runner-up is no longer willing to serve resenting consumer and industry inter-

as a member, then the next runner-up ests are included on advisory commit-
will be appointed. tees specifically for the purpose of rep-
(ii) If none of the nominees on the resenting such interests and have no
original ballot is willing to serve, or if vote, any financial interest covered by
there was only one nominee on the 18 U.S.C. 208(a) in the class which the
original ballot, the Advisory Com- member represents is irrelevant to the
mittee Oversight and Management services the Government expects from
Staff will contact by telephone eligible them and thus is hereby exempted
individuals whose names have been under 18 U.S.C. 208(b) as too remote
submitted in the past as candidates for and inconsequential to affect the integ-
membership as representatives of con- rity of their services.
sumer interests. A list of persons who [44 FR 22351, Apr. 13, 1979, as amended at 54
are interested in serving on an advi- FR 9035, Mar. 3, 1989; 75 FR 15342, Mar. 29,
sory committee will then be prepared. 2010]
The curricula vitae of these persons,
together with a ballot, will be sent to § 14.86 Rights and responsibilities of
a representative number of consumer nonvoting members of advisory
organizations that have been deter- committees.
mined to be eligible to vote for con- (a) A nonvoting member of an advi-
sumer representatives in accordance sory committee selected to represent
with paragraph (c)(3) of this section. and serve as a liaison with interested
After 4 days have elapsed, the Advisory individuals, associations, and organiza-
Committee Oversight and Management tions has the same rights as any other
Staff will contact the consumer organi- committee member except that—
zations by telephone and elicit their (1) A nonvoting member may vote
votes. The candidate who has received only on procedural matters such as ad-
the highest number of votes will be se- ditional rules adopted under § 14.39(a),
lected. In the event of a tie, the Com- approval of minutes under § 14.60(a), de-
missioner will select the winner by lot cisions on transcripts under § 14.61(b),
from among those tied for the highest and future meeting dates;
number of votes. (2) A nonvoting member who is a rep-
(d) To select a nonvoting member to resentative of industry interest may
represent industry interests, the Com- have access to data and information
missioner will publish, for each com- that constitute a trade secret or con-
mittee for which the Commissioner has fidential commercial or financial infor-
determined to appoint a nonvoting mation as defined in § 20.61 only if the
member, a notice requesting that, person has been appointed as a special
within 30 days, any industry organiza- Government employee under § 14.80(b).
tion interested in participating in the (b) A nonvoting member of an advi-
selection of an appropriate nonvoting sory committee is subject to, and shall
member to represent industry interests abide by, all rules and regulations
send a letter stating that interest to adopted by FDA and the committee.
the FDA employee designated in the (c) It is the responsibility of the non-
notice. After 30 days, a letter will be voting consumer and industry members
sent to each organization that has ex- of an advisory committee to represent
pressed an interest, attaching a com- the consumer and industry interests in
plete list of all such organizations, and all deliberations.
stating that it is their responsibility to (1) A nonvoting member does not rep-
consult with each other in selecting, resent any particular organization or
within 60 days after receipt of the let- group, but rather represents all inter-
ter, a single nonvoting member to rep- ested persons within the class which
resent industry interests for that com- the member is selected to represent.
mittee. If no individual is selected Accordingly, an interested person with-
within 60 days, the Commissioner will in the class represented by that non-
select the nonvoting member rep- voting member may, upon request,
resenting industry interests. have access to all written statements
(e) The Commissioner has determined or oral briefings concerning the com-
that, because nonvoting members rep- mittee prepared by the nonvoting
240
member for distribution to any person § 14.90 Ad hoc advisory committee

outside the committee. When docu- members.
ments are prepared with non-Govern- In selecting members of an ad hoc ad-
ment funds, persons desiring copies visory committee, the Commissioner
may be required to pay a reasonable fee may use the procedures in §§ 14.82 and
to cover printing and similar costs. 14.84 or any other procedure deemed ap-
(2) The nonvoting member reviews all propriate.
official committee minutes to assure
their completeness and accuracy. § 14.95 Compensation of advisory com-
mittee members.
(3) The nonvoting member acts as a
liaison between the committee and the (a)(1) Except as provided in para-
interested persons whom that member graphs (a) (2) and (3) of this section, all
represents, and transmits requests for voting advisory committee members
information from the committee and shall, and nonvoting members may, be
relevant information and views to the appointed as special Government em-
ployees and receive a consultant fee
committee. The nonvoting member
and be reimbursed for travel expenses,
takes the initiative in contacting in-
including per diem in lieu of subsist-
terested persons whom the member ence, unless such compensation and re-
represents to seek out relevant infor- imbursement are waived.
mation and views and to relate the (2) Members of the Technical Elec-
progress of the advisory committee. tronic Product Radiation Safety
(4) A nonvoting industry member rep- Standards Committee (TEPRSSC) are
resents all members of the industry, not appointed as special Government
and not any particular association, employees. Any member of TEPRSSC
company, product, or ingredient. If a who is not a Federal employee or mem-
matter comes before the committee ber of the uniformed services, includ-
that directly or indirectly affects the ing the Commissioned Corps of the
company employing the nonvoting in- Public Health Service, shall receive a
dustry member, the member shall so consultant fee and be reimbursed for
inform the committee but need not be travel expenses, including per diem in
absent during the discussion or decline lieu of subsistence, unless such com-
to participate in the discussion. a non- pensation and reimbursement are
voting industry member may not dis- waived.
cuss the company’s position as such, (3) Voting and nonvoting advisory
but may discuss any matter in general committee members who are members
terms. All presentations and discus- of the uniformed services, including
sions of scientific data and their inter- the Commissioned Corps of the Public
pretation on behalf of a company will Health Service, provide service on
occur in open session, except as pro- Food and Drug Administration advi-
vided in § 14.25(c). sory committees as part of their as-
signed functions, are not appointed as
(5) A nonvoting member of an advi-
special government employees, but are
sory committee may not make any
reimbursed by the Food and Drug Ad-
presentation to that advisory com-
ministration for travel expenses.
mittee during a hearing conducted by
(b) Notwithstanding the member’s
that committee. primary residence, an advisory com-
(6) Although a nonvoting member mittee member, while attending meet-
serves in a representative capacity, the ings of the full committee or a sub-
nonvoting member shall exercise re- committee, will be paid whether the
straint in performing such functions meetings are held in the Washington,
and may not engage in unseemly advo- DC, area or elsewhere.
cacy or attempt to exert undue influ- (c) A committee member who partici-
ence over the other members of the pates in any agency-directed assign-
committee. ment will be paid at an hourly rate
(d) A nonvoting member of an advi- when doing assigned work at home, a
sory committee may be removed by the place of business, or in an FDA facility
Commissioner for failure to comply located within the member’s com-

with this section as well as § 14.80(f). muting area, and at a daily rate when
241
§ 14.100 21 CFR Ch. I (4–1–19 Edition)
required to travel outside of that com- Subpart F—Standing Advisory

muting area to perform the assign- Committees
ment. A committee member will not be
paid for time spent on normal prepara- § 14.100 List of standing advisory com-
tion for a committee meeting. mittees.
(1) An agency-directed assignment is
an assignment that meets the fol- Standing advisory committees and
lowing criteria: the dates of their establishment are as
(i) An activity that requires under- follows:
taking a definitive study. The activity (a) Office of the Commissioner—
must produce a tangible end product, (1) Board of Tea Experts.
usually a written report. Examples are: (i) Date established: March 2, 1897.
(a) An analysis of the risks and bene- (ii) Function: Advises on establish-
fits of the use of a class of drugs or a ment of uniform standards of purity,
report on a specific problem generated quality, and fitness for consumption of
by an IND or NDA; all tea imported into the United States
(b) The performance of similar inves- under 21 U.S.C. 42.
tigations or analysis of complex indus- (2) Science Board to the Food and Drug
try submissions to support advisory Administration.
committee deliberations other than (i) Date established: June 26, 1992.
normal meeting preparation; (ii) Function: The board shall provide
(c) The preparation of a statistical
advice primarily to the agency’s Senior
analysis leading to an estimate of
Science Advisor and, as needed, to the
toxicologically safe dose levels; and
Commissioner and other appropriate
(d) The design or analysis of animal
officials on specific complex and tech-
studies of toxicity, mutagenicity,
nical issues as well as emerging issues
teratogenicity, or carcinogenicity.
(ii) The performance of an IND or within the scientific community in in-
NDA review or similar review. dustry and academia. Additionally, the
(2) A committee member who under- board will provide advice to the agency
takes a special assignment, the end on keeping pace with technical and sci-
product of which does not represent the entific evolutions in the fields of regu-
end product of the advisory committee, latory science; on formulating an ap-
but rather of the committee member’s propriate research agenda; and on up-
own assignment, can be compensated. grading its scientific and research fa-
Should this preparatory work by mem- cilities to keep pace with these
bers collectively result in an end prod- changes. It will also provide the means
uct of the committee, this is to be con- for critical review of agency sponsored
sidered normal meeting preparation intramural and extramural scientific
and committee members are not to be research programs.
compensated for this work. (3) Pediatric Advisory Committee.
(d) Salary while in travel status is (i) Date established: June 18, 2004.
authorized when a committee mem- (ii) Function: Advises on pediatric
ber’s ordinary pursuits are interrupted therapeutics, pediatric research, and
for the substantial portion of an addi- other matters involving pediatrics for
tional day beyond the day or days which the Food and Drug Administra-
spent in performing those services, and tion has regulatory responsibility.
as a consequence the committee mem- (4) Risk Communication Advisory Com-
ber loses some regular compensation. mittee.
This applies on weekends and holidays (i) Date rechartered: July 9, 2009.
if the special Government employee (ii) Function: The committee reviews
loses income that would otherwise be and evaluates strategies and programs
earned on that day. For travel pur- designed to communicate with the pub-
poses, a substantial portion of a day is lic about the risks and benefits of FDA-
defined as 50 percent of the working regulated products so as to facilitate
day, and the traveler will be paid at a optimal use of these products. The
daily rate. committee also reviews and evaluates
[44 FR 22351, Apr. 13, 1979, as amended at 53 research relevant to such communica-
FR 50949, Dec. 19, 1988] tion to the public by both FDA and
242
other entities. It also facilitates inter- (2) Cellular, Tissue and Gene Therapies
actively sharing risk and benefit infor- Advisory Committee.
mation with the public to enable peo- (i) Date established: October 28, 1988.
ple to make informed independent (ii) Function: Reviews and evaluates
judgments about use of FDA-regulated available data relating to the safety,
products. effectiveness, and appropriate use of
(5) Tobacco Products Scientific Advisory human cells, human tissues, gene
Committee. transfer therapies and
(i) Date Established: August 12, 2009. xenotransplantation products which
(ii) Function: The committee reviews are intended for transplantation, im-
and evaluates safety, dependence, and plantation, infusion, and transfer in
health issues relating to tobacco prod- the prevention and treatment of a
ucts and provides appropriate advice, broad spectrum of human diseases and
information, and recommendations to in the reconstruction, repair or re-
the Commissioner of Food and Drugs. placement of tissues for various condi-
Specifically, the committee will sub- tions. The Committee also considers
mit reports and recommendations on the quality and relevance of FDA’s re-
tobacco-related topics, including: The search program which provides sci-
impact of the use of menthol in ciga- entific support for the regulation of
rettes on the public health, including these products, and makes appropriate
recommendations to the Commissioner
such use among children, African
of Food and Drugs.
Americans, Hispanics and other racial
(3) Blood Products Advisory Committee.
and ethnic minorities; the nature and
(i) Date established: May 13, 1980.
impact of the use of dissolvable to-
(ii) Function: Reviews and evaluates
bacco products on the public health, in-
data on the safety and effectiveness,
cluding such use on children; the ef-
and appropriate use of blood products
fects of the alteration of nicotine
intended for use in the diagnosis, pre-
yields from tobacco products and
vention, or treatment of human dis-
whether there is a threshold level
eases.
below which nicotine yields do not
(4) Vaccines and Related Biological
produce dependence on the tobacco Products Advisory Committee—
product involved; and any application (i) Date established: December 31,
submitted by a manufacturer for a 1979.
modified risk tobacco product. The (ii) Function: Reviews and evaluates
committee may provide recommenda- data on the safety and effectiveness of
tions to the Secretary of Health and vaccines intended for use in the diag-
Human Services regarding any regula- nosis, prevention, or treatment of
tions to be issued under the Federal human diseases.
Food, Drug, and Cosmetic Act and may (c) Center for Drug Evaluation and Re-
review any applications for new to- search—
bacco products or petitions for exemp- (1) Anesthetic and Analgesic Drug
tion under section 906(e) of the Family Products Advisory Committee.
Smoking Prevention and Tobacco Con- (i) Date established: May 1, 1978.
trol Act. The committee may consider (ii) Function: Reviews and evaluates
and provide recommendations on any data concerning the safety and effec-
other matter as provided in the Family tiveness of marketed and investiga-
Smoking Prevention and Tobacco Con- tional human drug products including
trol Act. analgesics, e.g., abuse-deterrent
(b) Center for Biologics Evaluation and opioids, novel analgesics, and issues re-
Research— lated to opioid abuse, and those for use
(1) Allergenic Products Advisory Com- in anesthesiology.
mittee. (2) Antimicrobial Drugs Advisory Com-
(i) Date established: July 9, 1984. mittee.
(ii) Function: Reviews and evaluates (i) Date established: October 7, 1980.
data on the safety and effectiveness of (ii) Function: Reviews and evaluates
allergenic biological products intended available data concerning the safety
for use in the diagnosis, prevention, or and effectiveness of marketed and in-
treatment of human disease. vestigational human drug products for
243
§ 14.100 21 CFR Ch. I (4–1–19 Edition)
use in the treatment of infectious dis- drugs for use in gastrointestinal dis-
eases and disorders. eases.
(3) Arthritis Advisory Committee. (10) Oncologic Drugs Advisory Com-
(i) Date established: April 5, 1974. mittee.
(ii) Function: Reviews and evaluates (i) Date established: September 1,
data on the safety and effectiveness of 1978.
marketed and investigational human (ii) Function: Reviews and evaluates
drugs for use in arthritic conditions. data on the safety and effectiveness of
(4) Cardiovascular and Renal Drugs Ad- marketed and investigational human
visory Committee. drugs for use in treatment of cancer.
(i) Date established: August 27, 1970. (11) Peripheral and Central Nervous
(ii) Function: Reviews and evaluates System Drugs Advisory Committee.
data on the safety and effectiveness of (i) Date established: June 4, 1974.
marketed and investigational human (ii) Function: Reviews and evaluates
drugs for use in cardiovascular and data on the safety and effectiveness of
renal disorders. marketed and investigational human
(5) Dermatologic and Ophthalmic Drugs drugs for use in neurological disease.
Advisory Committee. (12) Psychopharmacologic Drugs Advi-
(i) Date established: October 7, 1980. sory Committee.
(ii) Function: Reviews and evaluates (i) Date established: June 4, 1974.
available data concerning the safety (ii) Function: Reviews and evaluates
and effectiveness of marketed and in- data on the safety and effectiveness of
vestigational human drug products for marketed and investigational human
use in the treatment of dermatologic drugs for use in the practice of psychi-
and ophthalmic disorders. atry and related fields.
(6) Drug Safety and Risk Management (13) Pulmonary-Allergy Drugs Advisory
Advisory Committee. Committee.
(i) Date established: May 31, 1978. (i) Date established: February 17,
(ii) Function: Reviews and evaluates 1972.
data on risk management plans, pro- (ii) Function: Reviews and evaluates
vides active surveillance methodolo- data on the safety and effectiveness of
gies, trademark studies, methodologies marketed and investigational human
for risk management communication, drugs for use in the treatment of pul-
and related issues. monary disease and diseases with aller-
(7) Endocrinologic and Metabolic Drugs gic and/or immunologic mechanisms.
Advisory Committee. (14) Medical Imaging Drugs Advisory
(i) Date established: August 27, 1970. Committee.
(ii) Function: Reviews and evaluates (i) Date established: May 18, 2011.
data on the safety and effectiveness of (ii) Function: Reviews and evaluates
marketed and investigational human data concerning the safety and effec-
drugs for use in endocrine and meta- tiveness of marketed and investiga-
bolic disorders. tional human drug products for use in
(8) Bone, Reproductive and Urologic diagnostic and therapeutic procedures
Drugs Advisory Committee. using radioactive pharmaceuticals and
(i) Date established: March 23, 1978. contrast media used in diagnostic radi-
(ii) Function: Advises the Commis- ology.
sioner or designee in discharging re- (15) Pharmaceutical Science and Clin-
sponsibilities as they relate to helping ical Pharmacology Advisory Committee.
to ensure safe and effective drugs for (i) Date established: January 22, 1990.
human use and, as required, any other (ii) Function: The committee shall
product for which the Food and Drug provide advice on scientific, clinical
Administration has regulatory respon- and technical issues related to safety
sibility. and effectiveness of drug products for
(9) Gastrointestinal Drugs Advisory use in the treatment of a broad spec-
Committee. trum of human diseases, the quality
(i) Date established: March 3, 1978. characteristics which such drugs pur-
(ii) Function: Reviews and evaluates port or are represented to have and as
data on the safety and effectiveness of required, any other product for which
marketed and investigational human the Food and Drug Administration has
244
regulatory responsibility, and make (ii) Function: Advises on technical

appropriate recommendations to the feasibility, reasonableness, and prac-
Commissioner of Food and Drugs. The ticability of performance standards for
Committee may also review agency electronic products to control the
sponsored intramural and extramural emission of radiation under 42 U.S.C.
biomedical research programs in sup- 263f(f)(1)(A).
port of FDA’s drug regulatory respon- (4) National Mammography Quality As-
sibilities and its critical path initia- surance Advisory Committee.
tives related to improving the efficacy
(i) Date established: July 6, 1993.
and safety of drugs and improving the
(ii) Function: Advises on developing
efficiency of drug development.
appropriate quality standards and reg-
(16) Nonprescription Drugs Advisory
Committee. ulations for the use of mammography
facilities.
(i) Date established: August 27, 1991.
(ii) Functions: The committee re- (5) Patient Engagement Advisory Com-
views and evaluates available data con- mittee.
cerning the safety and effectiveness of (i) Date Established: October 6, 2015.
over-the-counter (nonprescription) (ii) Function: Provides advice to the
human drug products for use in the Commissioner on complex issues relat-
treatment of a broad spectrum of ing to medical devices, the regulation
human symptoms and diseases. of devices, and their use by patients.
(17) Pharmacy Compounding Advisory Agency guidance and policies, clinical
Committee. trial or registry design, patient pref-
(i) Date re-established: April 25, 2012. erence study design, benefit-risk deter-
(ii) Function: Provides advice on sci- minations, device labeling, unmet clin-
entific, technical, and medical issues ical needs, available alternatives, pa-
concerning drug compounding under tient reported outcomes, and device-re-
sections 503A and 503B of the Federal lated quality of life or health status
Food, Drug, and Cosmetic Act and, as issues are among the topics that may
required, any other product for which be considered by the Committee. The
the Food and Drug Administration has Committee provides relevant skills and
regulatory responsibility, and makes perspectives in order to improve com-
appropriate recommendations to the munication of benefits, risks, and clin-
Commissioner of Food and Drugs. ical outcomes, and increase integration
(d) Center for Devices and Radiological of patient perspectives into the regu-
Health— latory process for medical devices. It
(1) Medical Devices Advisory Committee. performs its duties by identifying new
(i) Date established: October 27, 1990. approaches, promoting innovation, rec-
(ii) Function: Reviews and evaluates ognizing unforeseen risks or barriers,
data on the safety and effectiveness of and identifying unintended con-
marketed and investigational devices sequences that could result from FDA
and makes recommendations for their policy.
regulation.
(e) National Center for Toxicological
(2) Device Good Manufacturing Practice Research—Science Advisory Board.
Advisory Committee.
(1) Date established: June 2, 1973.
(i) Date established: May 17, 1987.
(2) Function: Advises on establish-
(ii) Function: Reviews proposed regu-
ment and implementation of a research
lations for good manufacturing prac-
tices governing the methods used in, program that will assist the Commis-
and the facilities and controls used for, sioner of Food and Drugs to fulfill reg-
the manufacture, packing, storage, and ulatory responsibilities.
installation of devices, and makes rec- [54 FR 9036, Mar. 3, 1989]
ommendations on the feasibility and
reasonableness of the proposed regula- EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 14.100, see the List of CFR
tions.
Sections Affected, which appears in the
(3) Technical Electronic Product Radi-
Finding Aids section of the printed volume

ation Safety Standards Committee. and at www.govinfo.gov.
(i) Date established: October 18, 1968.
245
§ 14.120 21 CFR Ch. I (4–1–19 Edition)
Subpart G—Technical Electronic (c) Ten members constitute a

Products Radiation Safety quorum, provided at least three mem-
bers are present from each group speci-
Standards Committee fied in 21 U.S.C. 360kk(f)(1)(A) and in
§ 14.120 Establishment of the Tech- § 14.127(a), i.e., Government, industry,
nical Electronic Product Radiation and the public.
Safety Standards Committee (d) The Chairperson of TEPRSSC will
(TEPRSSC). ordinarily submit a report to the Com-
missioner of the committee’s consider-
The Technical Electronic Product
ation of any proposed performance
Radiation Safety Standards Committee
standard for an electronic product
(TEPRSSC), consisting of 15 members,
within 60 days after consideration. If
is established in accordance with the
the Chairperson believes that more
Federal Food, Drug, and Cosmetic Act
time is needed, the Chairperson will in-
(21 U.S.C. 360kk(f)(1)(A)) to provide
form the Director of the Center for De-
consultation before the Commissioner
vices and Radiological Health in writ-
prescribes any performance standard
ing, in which case an additional 30 days
for an electronic product.
will be allowed to make the report.
[44 FR 22351, Apr. 13, 1979, as amended at 78 (e) Sections 14.1 through 14.7 apply to
FR 17087, Mar. 20, 2013] TEPRSSC, except where other provi-
sions are specifically included in
§ 14.122 Functions of TEPRSSC. §§ 14.120 through 14.130.
(a) In performing its function of ad- [44 FR 22351, Apr. 13, 1979, as amended at 54
vising the Commissioner, TEPRSSC— FR 9037, Mar. 3, 1989; 78 FR 17087, Mar. 20,
(1) May propose electronic product 2013]
radiation safety standards to the Com-
missioner for consideration; § 14.127 Membership of TEPRSSC.
(2) Provides consultation to the Com- (a) The Commissioner will appoint
missioner on all performance standards the members after consultation with
proposed for consideration under 21 public and private organizations con-
U.S.C. 360kk; and cerned with the technical aspect of
(3) May make recommendations to electronic product radiation safety.
the Commissioner on any other mat- TEPRSSC consists of 15 members, each
ters it deems necessary or appropriate of whom is technically qualified by
in fulfilling the purposes of the act. training and experienced in one or
(b) Responsibility for action on per- more fields of science or engineering
formance standards under 21 U.S.C. applicable to electronic product radi-
360kk rests with the Commissioner, ation safety, as follows:
after receiving the advice of TEPRSSC. (1) Five members selected from gov-
ernment agencies, including State and
[44 FR 22351, Apr. 13, 1979, as amended at 78 Federal Governments.
FR 17087, Mar. 20, 2013]
(2) Five members selected from the
affected industries after consultation
§ 14.125 Procedures of TEPRSSC.
with industry representatives.
(a) When the Commissioner is consid- (3) Five members selected from the
ering promulgation of a performance general public, of whom at least one
standard for an electronic product, or shall be a representative of organized
an amendment of an existing standard, labor.
before issuing a proposed regulation in (b) The Commissioner will appoint a
the FEDERAL REGISTER the Commis- committee member as Chairperson of
sioner will submit to TEPRSSC the TEPRSSC.
proposed standard or amendment under (c) Appointments of members are for
consideration, together with other rel- a term of 3 years or as specified by the
evant information to aid TEPRSSC in Commissioner.
its deliberations. (1) The Chairperson is appointed for a
(b) The agenda and other material to term concurrent with the Chair-
be considered at any meeting will be person’s term as a member of
sent to members whenever possible at TEPRSSC. If the Chairpersonship be-

least 2 weeks before the meeting. comes vacant without adequate notice,
246
the Designated Federal Officer may ap- Subpart H—Color Additive

point a committee member as tem- Advisory Committees
porary Chairperson pending appoint-
ment of a new Chairperson by the Com- § 14.140 Establishment of a color addi-
missioner. tive advisory committee.
(2) Members may not be reappointed The Commissioner will establish a
for a second consecutive full term. color additive advisory committee
(d) A person otherwise qualified for under the following circumstances:
membership is not eligible for selection (a) The Commissioner concludes, as a
as a member of TEPRSSC from Gov- matter of discretion, that it would be
ernment agencies or the general public in the public interest for a color addi-
if the Commissioner determines that tive advisory committee to review and
the person does not meet the require- make recommendations about the safe-
ments of the conflict of interest laws ty of a color additive on which impor-
and regulations. tant issues are pending before FDA and
(e) Retention of membership is condi- for interested persons to present infor-
tioned upon the following: mation and views at an oral public
(1) Continued status as a member of hearing before a color additive advi-
the group from which the member was sory committee.
selected as specified in paragraph (a) of (b) There is an issue arising under
section 721(b)(5)(B) of the FD&C Act
this section.
concerning the safety of a color addi-
(2) Absence of any conflict of interest tive, including its potential or actual
during the term of membership as spec- carcinogenicity, that requires the exer-
ified in paragraph (d) of this section. cise of scientific judgment and a person
(3) Active participation in TEPRSSC who would be adversely affected by the
activities. issuance, amendment, or repeal of a
(f) Appointment as a member of regulation listing a color additive re-
TEPRSSC is conditioned on certifi- quests that the matter, or the Commis-
cation that the prospective member: sioner as a matter of discretion deter-
(1) Agrees to the procedures and cri- mines that the matter should, be re-
teria specified in this subpart. ferred to a color additive advisory com-
(2) Has no conflict of interest as spec- mittee.
ified in paragraph (d) of this section. (1) Paragraph (b) does not apply to
(3) Will notify the Designated Fed- any issue arising under the transi-
eral Officer of TEPRSSC before any tional provisions in section 203 of the
change in representative status on Color Additive Amendments of 1960 re-
TEPRSSC which may be contrary to lating to provisional listing of com-
the conditions of the appointment. mercially established colors. A color
(g) Members of TEPRSSC who are additive advisory committee to con-
not full-time officers or employees of sider any such matter will be estab-
the United States receive compensa- lished under paragraph (a) of this sec-
tion under § 14.95, in accordance with 42 tion.
U.S.C. 210(c). (2) A request for establishment of a
color additive advisory committee is to
§ 14.130 Conduct of TEPRSSC meeting; be made in accordance with § 10.30. The
availability of TEPRSSC records. Commissioner may deny any petition if
inadequate grounds are stated for es-
(a) In accordance with 21 U.S.C.
tablishing a color additive advisory
360kk(f)(1)(B), all proceedings of
committee. A request for establish-
TEPRSSC are recorded, and the record
ment of a color additive advisory com-
of each proceeding is available for pub-
mittee may not rest on mere allega-
lic inspection.
tions or denials, but must set forth spe-
(b) All proceedings of TEPRSSC are cific facts showing that there is a gen-
open except when the Commissioner uine and substantial issue of fact that
has determined, under § 14.27, that a requires scientific judgment and justi-
portion of a meeting may be closed. fies a hearing before a color additive
[44 FR 22351, Apr. 13, 1979, as amended at 78 advisory committee. When it conclu-
FR 17087, Mar. 20, 2013] sively appears from the request for a
247
§ 14.142 21 CFR Ch. I (4–1–19 Edition)
color additive advisory committee that tion to the administrative record fur-
the matter is premature or that it does nished to it.
not involve an issue arising under sec- (d) If the Chairperson concludes that
tion 721(b)(5)(B) of the FD&C Act or the color additive advisory committee
that there is no genuine and substan- needs additional time, the Chairperson
tial issue of fact requiring scientific shall so inform the Commissioner in
judgment, or for any other reason a writing and may certify the report of
color additive advisory committee is the committee to the Commissioner
not justified, the Commissioner may within 90 days instead of 60 days.
deny the establishment of a color addi- (e) More than one matter may be
tive advisory committee. handled concurrently by a color addi-
(3) Establishment of a color additive tive advisory committee.
advisory committee on the request of
an interested person is conditioned § 14.145 Procedures of a color additive
advisory committee.
upon receipt of the application fee
specified in § 14.155. (a) A color additive advisory com-
(4) Any person adversely affected mittee is subject to all the require-
may request referral of the matter to a ments of the Federal Advisory Com-
color additive advisory committee at mittee Act and this part.
any time before, or within 30 days (b) All interested persons have a
after, publication of an order of the right to consult with the color additive
Commissioner acting upon a color ad- advisory committee reviewing a mat-
ditive petition or proposal. ter and to submit information and
views to a color additive advisory com-
§ 14.142 Functions of a color additive mittee, in accordance with the proce-
advisory committee. dures in this part.
(a) A color additive advisory com- § 14.147 Membership of a color addi-
mittee reviews all available informative advisory committee.
tion relating to the matter referred to (a) The members of a color additive
it, including all information contained advisory committee are selected in the
in any pertinent color additive petition following manner:
and in FDA files. All information re- (1) If a color additive advisory com-
viewed is placed on public display and mittee is established for purposes that
is available for review at the office of do not include review of an issue aris-
the Division of Dockets Management. ing under section 721(b)(5)(B) of the act,
(b) The Commissioner specifies to the or is established on the initiative of
color additive advisory committee, in the Commissioner, the Commissioner
writing, the issues on which review and may use the procedure in paragraph
recommendations are requested. (a)(2) of this section to select the mem-
(c) The date of the first meeting of a bers or may use an existing standing
color additive advisory committee, fol- advisory committee listed in § 14.100, or
lowing receipt of the administrative may establish a new advisory com-
record by each of the committee mem- mittee under this subpart. Once the
bers, is designated as the beginning of Commissioner has established a color
the period allowed for consideration of additive advisory committee under this
the matter by the committee. Within paragraph and has referred to it a mat-
60 days after the first meeting, unless ter relating to a color additive, no in-
the time is extended as provided in terested person may subsequently re-
paragraph (d) of this section, the Chair- quest that an additional or different
person of the committee shall certify color additive advisory committee be
to the Commissioner the report con- established to review and make rec-
taining the recommendations of the ommendations about that color addi-
committee, including any minority re- tive.
port. The report states the rec- (2) If the Commissioner established a
ommendations of the committee and color additive advisory committee to
the reasons or basis for them. The re- review an issue arising under section
port includes copies of all material 721(b)(5)(B) of the FD&C Act on the re-
considered by the committee in addi- quest of an interested person, it shall
248
be established under the following re- cludes personal compensation of com-

quirements: mittee members at a rate not to exceed
(i) Except as provided in paragraph $128.80 per member per day.
(a)(2) (ii) and (iii) of this section, the (b) In the case of a request for refer-
Commissioner will request the Na- ral to a color additive advisory com-
tional Academy of Sciences to select mittee, a special advance deposit is to
the members of a color additive advi- be made in the amount of $2,500. Where
sory committee from among experts required, further advances in incre-
qualified in the subject matter to be re- ments of $2,500 each are to be made
viewed by the committee, and of ade- upon request of the Commissioner. All
quately diversified professional back-
deposits for referrals to a color addi-
grounds. The Commissioner will ap-
tive advisory committee in excess of
point one of the members as the Chair-
person. actual expenses will be refunded to the
(ii) If the National Academy of depositor.
Sciences is unable or refuses to select (c) All deposits and fees required by
the members of a color additive advi- this section are to be paid by money
sory committee, the Commissioner will order, bank draft, or certified check
select the members. drawn to the order of the Food and
(iii) If the Commissioner and the re- Drug Administration, collectible at par
questing party agree, section in Washington, DC. All deposits and
721(b)(5)(D) of the FD&C Act may be fees are to be forwarded to the Asso-
waived and the matter may be referred ciate Commissioner for Management
to any standing advisory committee and Operations, Food and Drug Admin-
listed in § 14.100 or to any advisory istration, 5600 Fishers Lane, Rockville,
committee established under any other MD 20857, and after appropriate record
procedure that is mutually agreeable. of them is made, they will be trans-
Once the Commissioner has established mitted to the Treasurer of the United
a color additive advisory committee States for deposit in the special ac-
and has referred to it a matter relating count ‘‘Salaries and Expenses, Certifi-
to a color additive, no interested per- cation, Inspection, and Other Services,
son may subsequently request that an Food and Drug Administration.’’
additional or different color additive
(d) The Commissioner may waive or
advisory committee be established to
refund such fees in whole or in part
review and make recommendations
when, in the Commissioner’s judgment,
about that color additive.
such action will promote the public in-
(b) Members of a color additive advi-
sory committee are subject to the re- terest. Any person who believes that
quirements of the Federal Advisory payment of these fees will be a hard-
Committee Act and this subpart, ex- ship may petition the Commissioner
cept that no member of a color additive under § 10.30 to waive or refund the
advisory committee may by reason of fees.
such membership alone be a special
government employee or be subject to Subpart I—Advisory Committees
the conflict of interest laws and regula- for Human Prescription Drugs
tions.
§ 14.160 Establishment of standing
§ 14.155 Fees and compensation per- technical advisory committees for
taining to a color additive advisory human prescription drugs.
committee.
The standing technical advisory com-
(a) When a matter is referred to a
mittees for human prescription drugs
color additive advisory committee, all
related costs, including personal com- are established to advise the Commis-
pensation of committee members, trav- sioner:
el, materials, and other costs, are (a) Generally on the safety and effec-
borne by the person requesting the re- tiveness, including the labeling and ad-
ferral, such costs to be assessed on the vertising, and regulatory control of the
basis of actual cost to the government. human prescription drugs falling with-
The compensation of such costs in- in the pharmacologic class covered by
249
§ 14.171 21 CFR Ch. I (4–1–19 Edition)
the advisory committee and on the sci- tributional controls, or boxed warn-
entific standards appropriate for a de- ings.
termination of safety and effectiveness (2) Marketed drugs for which an im-
in that class of drugs. portant new use has been discovered or
(b) Specifically on any particular which pose newly discovered safety
matter involving a human prescription hazards, or which are the subject of
drug pending before FDA, including major scientific or public controversy,
whether the available information is or which may be subject to important
adequate to support a determination regulatory actions such as withdrawal
that— of approval for marketing, boxed warn-
(1) A particular IND study may prop- ings, distributional controls, or newly
erly be conducted; required scientific studies.
(2) A particular drug meets the statu- (c) The committee may request the
tory standard for proof of safety and ef- Commissioner for an opportunity to
fectiveness necessary for approval or hold a public hearing and to review any
continued approval for marketing; or matter involving a human prescription
drug which falls within the pharmaco-
(3) A particular drug is properly clas-
logic class covered by the committee.
sified as a new drug, an old drug, or a
The Commissioner may, after con-
banned drug.
sulting with the committee on such re-
§ 14.171 Utilization of an advisory com- quest, grant or deny the request in
mittee on the initiative of FDA. light of the priorities of the other mat-
ters pending before the committee.
(a) Any matter involving a human Whenever feasible, consistent with the
prescription drug under review within other work of the committee, the re-
the agency may, in the discretion of quest will be granted.
the Commissioner, be the subject of a (d) For a drug that meets any of the
public hearing and continuing or peri- criteria established in paragraph (b) of
odic review by the appropriate stand- this section, one or more members of
ing technical advisory committee for or consultants to the appropriate advi-
human prescription drugs. The Com- sory committee may be selected for
missioner’s determinations on the more detailed monitoring of the mat-
agenda of the committee are based ter and consultation with FDA on be-
upon the priorities of the various mat- half of the committee. The member or
ters pending before the agency which consultant may be invited to attend
fall within the pharmacologic class appropriate meetings and shall assist
covered by that committee. the center in any briefing of the com-
(b) High priority for such hearing and mittee on that matter.
review by the appropriate standing (e) An advisory committee may ob-
technical advisory committee for tain advice and recommendations from
human prescription drugs are given to other agency advisory committees,
the following types of human prescrip- consultants, and experts which the ad-
tion drugs: visory committee and the center con-
(1) Investigational drugs which are clude would facilitate the work of the
potential therapeutic advances over advisory committee.
currently marketed products from the (f) Presentation of all relevant infor-
standpoint of safety or effectiveness, or mation about the matter will be made
which pose significant safety hazards, in open session unless it relates to an
or which present narrow benefit-risk IND the existence of which has not pre-
considerations requiring a close viously been disclosed to the public as
judgmental decision on approval for defined in § 20.81 or is otherwise prohib-
marketing, or which have a novel de- ited from public disclosure under part
livery system or formulation, or which 20 and the regulations referenced there-
are the subject of major scientific or in. Sections 314.430 and 601.51 deter-
public controversy, or which may be mine whether, and the extent to which,
subject to special regulatory require- relevant information may be made
ments such as a limitation on clinical available for public disclosure, summa-
trials, a patient followup requirement, rized and discussed in open session but
postmarketing Phase IV studies, dis- not otherwise made available for public
250
disclosure, or not in any way discussed AUTHORITY: 5 U.S.C. 553; 15 U.S.C. 1451–1461;
or disclosed in open session or other- 21 U.S.C. 141–149, 321–393, 467f, 679, 821, 1034; 28
wise disclosed to the public. U.S.C. 2112; 42 U.S.C. 201, 262, 263b–263n, 264.
[44 FR 22351, Apr. 13, 1979, as amended at 54 otherwise noted.
FR 9037, Mar. 3, 1989]
§ 14.172 Utilization of an advisory com- Subpart A—General Provisions

mittee at the request of an inter-
ested person. § 15.1 Scope.
Any interested person may request, The procedures in this part apply
under § 10.30, that a specific matter re- when:
lating to a particular human prescrip- (a) The Commissioner concludes, as a
tion drug be submitted to an appro- matter of discretion, that it is in the
priate advisory committee for a hear- public interest to permit persons to
ing and review and recommendations. present information and views at a
The request must demonstrate the im- public hearing on any matter pending
portance of the matter and the reasons before the Food and Drug
why it should be submitted for a hear- Administation.
(b) The act or regulation specifically
ing at that time. The Commissioner
provides for a public hearing before the
may grant or deny the request.
Commissioner on a matter, e.g.,
§ 14.174 Advice and recommendations § 330.10(a)(8) relating to over-the-
in writing. counter drugs and sections 520 (b) and
(f)(1)(B), and 521 of the act relating to
Advice and recommendations given proposals to allow persons to order cus-
by a committee on a specific drug or a tom devices, to proposed device good
class of drugs are ordinarily in the manufacturing practice regulations,
form of a written report. The report and to proposed exemptions from pre-
may consist of the approved minutes of emption of State and local device re-
the meeting or a separate written requirements under § 808.25(e).
port. The report responds to the spe- (c) A person who has right to an op-
cific issues or questions which the portunity for a formal evidentiary pub-
Commissioner has addressed to the ad- lic hearing under part 12 waives that
visory committee, and states the basis opportunity and instead requests under
of the advice and recommendations of § 12.32 a public hearing before the Com-
the committee. missioner, and the Commissioner, as a
matter of discretion, accepts the re-
PART 15—PUBLIC HEARING BEFORE quest.
THE COMMISSIONER
Subpart B—Procedures for Public
Subpart A—General Provisions Hearing Before the Commissioner
Sec. § 15.20 Notice of a public hearing be-
15.1 Scope. fore the Commissioner.
Subpart B—Procedures for Public Hearing (a) If the Commissioner determines
Before the Commissioner that a public hearing should be held on
a matter, the Commissioner will pub-
15.20 Notice of a public hearing before the lish a notice of hearing in the FEDERAL
Commissioner. REGISTER setting forth the following
15.21 Notice of participation; schedule for information:
hearing. (1) If the hearing is under § 15.1 (a) or
15.25 Written submissions. (b), the notice will state the following:
15.30 Conduct of a public hearing before the (i) The purpose of the hearing and the
Commissioner.
subject matter to be considered. If a
written document is to be the subject
Subpart C—Records of a Public Hearing
matter of the hearing, it will be pub-
Before the Commissioner
lished as part of the notice, or ref-
15.40 Administrative record. erence made to it if it has already been

15.45 Examination of administrative record. published in the FEDERAL REGISTER, or
251
§ 15.21 21 CFR Ch. I (4–1–19 Edition)
the notice will state that the document designated person by the close of busi-
is available from an agency office iden- ness of the day specified in the notice.
tified in the notice. (b) Promptly after expiration of the
(ii) The time, date, and place of the time for filing a notice, the Commis-
hearing, or a statement that the infor- sioner will determine the amount of
mation will be contained in a subse- time allotted to each person and the
quent notice. approximate time that oral presen-
(2) If the hearing is in lieu of a formal tation is scheduled to begin. If more
evidentiary public hearing under than one hearing is held on the same
§ 15.1(c), all of the information de-
subject, a person will ordinarily be al-
scribed in § 12.32(e).
lotted time for a presentation at only
(b) The scope of the hearing is deter-
mined by the notice of hearing and any one hearing.
regulation under which the hearing is (c) Individuals and organizations
held. If a regulation, e.g., § 330.10(a)(10), with common interests are urged to
limits a hearing to review of an exist- consolidate or coordinate their presen-
ing administrative record, information tations and to request time for a joint
not already in the record may not be presentation. The Commissioner may
considered at the hearing. require joint presentations by persons
(c) The notice of hearing may require with common interests.
participants to submit the text of their (d) The Commissioner will prepare a
presentations in advance of the hearing hearing schedule showing the persons
if the Commissioner determines that making oral presentations and the
advance submissions are necessary for time alloted to each person, which will
the panel to formulate useful questions be filed with the Division of Dockets
to be posed at the hearing under Management and mailed or telephoned
§ 15.30(e). The notice may provide for before the hearing to each participant.
the submission of a comprehensive out- (e) The hearing schedule will state
line as an alternative to the submis- whether participants must be present
sion of the text if the Commissioner de- by a specified time to be sure to be
termines that submission of an outline heard in case the absence of partici-
will be sufficient. pants advances the schedule.
FR 26375, June 18, 1982] § 15.25 Written submissions.
A person may submit information or
§ 15.21 Notice of participation; sched-
ule for hearing. views on the subject of the hearing in
writing to the Division of Dockets
(a) The notice of hearing will provide Management, under § 10.20. The record
persons an opportunity to file a writ- of the hearing will remain open for 15
ten notice of participation with the Di- days after the hearing is held for any
vision of Dockets Management within additional written submissions, unless
a specified period of time containing
the notice of the hearing specifies oth-
the information specified in the notice,
erwise or the presiding officer rules
e.g., name of participant, address,
otherwise.
phone number, affiliation, if any, topic
of presentation and approximate § 15.30 Conduct of a public hearing be-
amount of time requested for the pres- fore the Commissioner.
entation. If the public interest re-
quires, e.g., a hearing is to be con- (a) The Commissioner or a designee
ducted within a short period of time or may preside at the hearing, except
is to be primarily attended by individ- where a regulation provides that the
uals without an organizational affili- Commissioner will preside personally.
ation, the notice may name a specific The presiding officer may be accom-
FDA employee and telephone number panied by other FDA employees or
to whom an oral notice of participation other Federal Government employees
may be given or provide for submitting designated by the Commissioner, who
notices of participation at the time of may serve as a panel in conducting the
the hearing. A written or oral notice of hearing.

participation must be received by the (b) The hearing will be transcribed.
252
(c) Persons may use their alloted pend, modify, or waive any provision of
time in whatever way they wish, con- this part.
sistent with a reasonable and orderly
hearing. A person may be accompanied Subpart C—Records of a Public
by any number of additional persons, Hearing Before the Commissioner
and may present any written informa-
tion or views for inclusion in the § 15.40 Administrative record.
record of the hearing, subject to the re-
quirements of § 15.25. The presiding offi- (a) The administrative record of a
cer may allot additional time to any public hearing before the Commis-
person when the officer concludes that sioner consists of the following:
it is in the public interest, but may not (1) All relevant FEDERAL REGISTER
reduce the time allotted for any person notices, including any documents to
without the consent of the person. which they refer.
(d) If a person is not present at the (2) All written submissions under
time specified for the presentation, the § 15.25.
persons following will appear in order, (3) The transcript of the oral hearing.
with adjustments for those appearing (b) The record of the administrative
at their scheduled time. An attempt proceeding will be closed at the time
will be made to hear any person who is specified in § 15.25.
late at the conclusion of the hearing.
Other interested persons attending the § 15.45 Examination of administrative
hearing who did not request an oppor- record.
tunity to make an oral presentation Section 10.20(j) governs the avail-
will be given an opportunity to make ability for public examination and
an oral presentation at the conclusion copying of each document in the ad-
of the hearing, in the discretion of the ministrative record of the hearing
presiding officer, to the extent that
time permits.
(e) The presiding officer and any
PART 16—REGULATORY HEARING
other persons serving on a panel may BEFORE THE FOOD AND DRUG
question any person during or at the ADMINISTRATION
conclusion of the presentation. No
other person attending the hearing Subpart A—General Provisions
may question a person making a pres- Sec.
entation. The presiding officer may, as 16.1 Scope.
a matter of discretion, permit ques- 16.5 Inapplicability and limited applica-
tions to be submitted to the presiding bility.
officer or panel for response by them or
by persons attending the hearing. Subpart B—Initiation of Proceedings
(f) The hearing is informal in nature,
and the rules of evidence do not apply. 16.22 Initiation of regulatory hearing.
No motions or objections relating to 16.24 Regulatory hearing required by the
act or a regulation.
the admissibility of information and
16.26 Denial of hearing and summary deci-
views may be made or considered, but sion.
other participants may comment upon
or rebut all such information and Subpart C—Commissioner and Presiding
views. No participant may interrupt Officer
the presentation of another participant
at any hearing for any reason. 16.40 Commissioner.
(g) The hearing may end early only if 16.42 Presiding officer.
all persons scheduled for a later presen- 16.44 Communication to presiding officer
tation have already appeared or it is and Commissioner.
past the time specified in the hearing
Subpart D—Procedures for Regulatory
schedule, under § 15.21(e), by which par-
Hearing
ticipants must be present.
(h) The Commissioner or the pre- 16.60 Hearing procedure.

siding officer may, under § 10.19, sus- 16.62 Right to counsel.
253
§ 16.1 21 CFR Ch. I (4–1–19 Edition)
Subpart E—Administrative Record and Section 515(e)(1) of the act relating to the
Decision proposed withdrawal of approval of a de-
vice premarket approval application.
16.80 Administrative record of a regulatory Section 515(e)(3) of the act relating to the
hearing. temporary suspension of approval of a pre-
16.85 Examination of administrative record. market approval application.
16.95 Administrative decision and record for Section 515(f)(6) of the act relating to a pro-
decision. posed order revoking a device product de-
velopment protocol or declaring a protocol
Subpart F—Reconsideration and Stay not completed.
Section 515(f)(7) of the act relating to revoca-
16.119 Reconsideration and stay of action. tion of a notice of completion of a product
development protocol.
Subpart G—Judicial Review Section 516(b) of the act regarding a proposed
regulation to ban a medical device with a
16.120 Judicial review. special effective date.
Section 518(b) of the act relating to a deter-
AUTHORITY: 15 U.S.C. 1451–1461; 21 U.S.C.
mination that a device is subject to a re-
141–149, 321–394, 467f, 679, 821, 1034; 28 U.S.C.
pair, replacement, or refund order or that
2112; 42 U.S.C. 201–262, 263b, 364.
a correction plan, or revised correction
SOURCE: 44 FR 22367, Apr. 13, 1979, unless plan, submitted by a manufacturer, im-
otherwise noted. porter, or distributor is inadequate.
Section 518(e) of the act relating to a cease
distribution and notification order or man-
Subpart A—General Provisions datory recall order concerning a medical
device for human use.
§ 16.1 Scope. Section 520(f)(2)(D) of the act relating to ex-
The procedures in this part apply emptions or variances from device current
when: good manufacturing practice requirements
(see § 820.1(d)).
(a) The Commissioner is considering Section 520(g)(4) and (g)(5) of the act relating
any regulatory action, including a re- to disapproval and withdrawal of approval
fusal to act, and concludes, as a matter of an application from an investigational
of discretion, on the Commissioner’s device exemption (see §§ 812.19(c), 812.30(c),
initiative or at the suggestion of any 813.30(d), and 813.35(c) of this chapter).
person, to offer an opportunity for a Section 903(a)(8)(B)(ii) of the Federal Food,
regulatory hearing to obtain additional Drug, and Cosmetic Act relating to the
misbranding of tobacco products.
information before making a decision Section 906(e)(1)(B) of the Federal Food,
or taking action. Drug, and Cosmetic Act relating to the es-
(b) The act or a regulation provides a tablishment of good manufacturing prac-
person with an opportunity for a hear- tice requirements for tobacco products.
ing on a regulatory action, including Section 910(d)(1) of the Federal Food, Drug,
proposed action, and the act or a regu- and Cosmetic Act relating to the with-
lation either specifically provides an drawal of an order allowing a new tobacco
product to be introduced or delivered for
opportunity for a regulatory hearing introduction into interstate commerce.
under this part or provides an oppor- Section 911(j) of the Federal Food, Drug, and
tunity for a hearing for which no pro- Cosmetic Act relating to the withdrawal of
cedures are specified by regulation. an order allowing a modified risk tobacco
Listed below are the statutory and reg- product to be introduced or delivered for
ulatory provisions under which regu- introduction into interstate commerce.
latory hearings are available: (2) Regulatory provisions:
(1) Statutory provisions:
§§ 1.634 and 1.664, relating to revocation of
Section 304(g) of the act relating to the ad- recognition of an accreditation body and
ministrative detention of devices and drugs withdrawal of accreditation of third-party
(see §§ 800.55(g) and 1.980(g) of this chapter). certification bodies that conduct food safe-
Section 304(h) of the act relating to the ad- ty audits of eligible entities in the food im-
ministrative detention of food for human port supply chain and issue food and facil-
or animal consumption (see part 1, subpart ity certifications.
k of this chapter). § 56.121(a), relating to disqualifying an insti-
Section 419(c)(2)(D) of the Federal Food, tutional review board or an institution.
Drug, and Cosmetic Act relating to the § 58.204(b), relating to disqualifying a testing
modification or revocation of a variance facility.

from the requirements of section 419 (see § 71.37(a), relating to use of food containing a
part 112, subpart P of this chapter). color additive.
254
§ 80.31(b), relating to refusal to certify a supplements, that bear a nutrient content
batch of a color additive. claim or a health claim, infant formulas,
§ 80.34(b), relating to suspension of certifi- food and color additives, and tobacco prod-
cation service for a color additive. ucts.
§ 99.401(c), relating to a due diligence deter- § 814.46(c) relating to withdrawal of approval
mination concerning the conduct of studies of a device premarket approval applica-
necessary for a supplemental application tion.
for a new use of a drug or device. § 822.7(a)(3), relating to an order to conduct
§§ 112.201 through 112.213, (see part 112, sub- postmarket surveillance of a medical de-
part R of this chapter), relating to with- vice under section 522 of the act.
drawal of a qualified exemption. § 830.130, relating to suspension or revocation
§§ 117.251 through 117.287 (part 117, subpart E of the accreditation of an issuing agency.
of this chapter), relating to withdrawal of § 895.30(c), regarding a proposed regulation to
a qualified facility exemption. ban a medical device with a special effec-
§ 130.17(1), relating to a temporary permit to tive date.
vary from a food standard. § 900.7, relating to approval, reapproval, or
§ 170.17(b), relating to use of food containing withdrawal of approval of mammography
an investigational food additive. accreditation bodies or rejection of a pro-
§ 202.1(j)(5), relating to approval of prescrip- posed fee for accreditation.
tion drug advertisements. § 900.14, relating to suspension or revocation
§ 312.70, relating to whether an investigator of a mammography certificate.
is eligible to receive test articles under § 900.25, relating to approval or withdrawal of
part 312 of this chapter and eligible to con- approval of certification agencies.
duct any clinical investigation that sup- § 1003.11(a)(3), relating to the failure of an
ports an application for a research or mar- electronic product to comply with an ap-
keting permit for products regulated by plicable standard or to a defect in an elec-
FDA, including drugs, biologics, devices, tronic product.
new animal drugs, foods, including dietary § 1003.31(d), relating to denial of an exemp-
supplements, that bear a nutrient content tion from notification requirements for an
claim or a health claim, infant formulas, electronic product which fails to comply
food and color additives, and tobacco prod- with an applicable standard or has a de-
ucts. fect.
§ 312.70(d) and 312.44, relating to termination § 1004.6, relating to plan for repurchase, re-
of an IND for a sponsor. pair, or replacement of an electronic prod-
§ 312.160(b), relating to termination of an IND uct.
for tests in vitro and in laboratory re- § 1107.1(d), relating to rescission of an exemp-
search animals for a sponsor. tion from the requirement of dem-
§§ 507.60 through 507.85 (part 507, subpart D of onstrating substantial equivalence for a
this chapter) relating to withdrawal of a tobacco product.
qualified facility exemption. § 1210.30, relating to denial, suspension, or
§ 511.1(b)(5), relating to use of food containing revocation of a permit under the Federal
an investigational new animal drug. Import Milk Act.
§ 511.1 (c)(1), relating to whether an investi- § 1270.43(e), relating to the retention, recall,
gator is eligible to receive test articles and destruction of human tissue.
under part 511 of this chapter and eligible § 1271.440(e) relating to the retention, recall,
to conduct any clinical investigation that and destruction of human cells, tissues,
supports an application for a research or and cellular and tissue-based products
marketing permit for products regulated (HCT/Ps), and/or the cessation of manufac-
by FDA including drugs, biologics, devices, turing HCT/Ps.
new animal drugs, foods, including dietary [44 FR 22367, Apr. 13, 1979]
supplements, that bear a nutrient content
claim or a health claim, infant formulas, EDITORIAL NOTE: For FEDERAL REGISTER ci-
food and color additives, and tobacco prod- tations affecting § 16.1, see the List of CFR
ucts; and any nonclinical laboratory study Sections Affected, which appears in the
intended to support an application for a re- Finding Aids section of the printed volume
search or marketing permit for a new ani- and at www.govinfo.gov.
mal drug.
§ 511.1(c) (4) and (d), relating to termination § 16.5 Inapplicability and limited ap-
of an INAD for a sponsor. plicability.
§ 812.119, relating to whether an investigator (a) This part does not apply to the
is eligible to receive test articles under following:
part 812 of this chapter and eligible to con-
(1) Informal presentation of views be-
duct any clinical investigation that sup-
ports an application for a research or mar- fore reporting a criminal violation
under section 305 of the act and section
keting permit for products regulated by

FDA including drugs, biologics, devices, 5 of the Federal Import Milk Act and
new animal drugs, foods, including dietary § 1210.31.
255
§ 16.22 21 CFR Ch. I (4–1–19 Edition)
(2) A hearing on a refusal of admis- (4) State the time within which a
sion of a food, drug, device, or cosmetic hearing may be requested, and state
under section 801(a) of the act and the name, address, and telephone num-
§ 1.94, or of an electronic product under ber of the FDA employee to whom any
section 360(a) of the Public Health request for hearing is to be addressed.
Service Act and § 1005.20. (5) Refer to FDA’s guideline on elec-
(3) Factory inspections, recalls (ex- tronic media coverage of its adminis-
cept mandatory recalls of medical de- trative proceedings (21 CFR part 10,
vices intended for human use), regu- subpart C).
latory letters, and similar compliance (b) A person offered an opportunity
activities related to law enforcement. for a hearing has the amount of time
(4) A hearing on an order for re- specified in the notice, which may not
labeling, diversion, or destruction of be less than 3 working days after re-
shell eggs under section 361 of the Pub- ceipt of the notice, within which to re-
lic Health Service Act (42 U.S.C. 264) quest a hearing. The request may be
and §§ 101.17(h) and 115.50 of this chap- filed by mail, telegram, telex, personal
ter. delivery, or any other mode of written
(5) A hearing on an order for diver- communication, addressed to the des-
sion or destruction of shell eggs under ignated FDA employee. If no response
section 361 of the Public Health Service is filed within that time, the offer is
Act (42 U.S.C. 264), and § 118.12 of this deemed to have been refused and no
chapter. hearing will be held.
(b) If a regulation provides a person (c) If a hearing is requested, the Com-
with an opportunity for hearing and missioner will designate a presiding of-
specifies some procedures for the hear- ficer, and the hearing will take place at
ing but not a comprehensive set of pro- a time and location agreed upon by the
cedures, the procedures in this part party requesting the hearing, the FDA,
apply to the extent that they are sup- and the presiding officer or, if agree-
plementary and not in conflict with ment cannot be reached, at a reason-
the other procedures specified for the able time and location designated by
hearing. Thus, the procedures in sub- the presiding officer.
part A of part 108 relating to emer- (d) A notice of opportunity for hear-
gency permit control are supplemented ing under this section will not operate
by the nonconflicting procedures in to delay or stay any administrative ac-
this part, e.g., the right to counsel, tion, including enforcement action by
public notice of the hearing, reconsid- the agency unless the Commissioner,
eration and stay, and judicial review. as a matter of discretion, determines
that delay or a stay is in the public in-
[44 FR 22367, Apr. 13, 1979, as amended at 57 terest.
FR 58403, Dec. 10, 1992; 65 FR 76110, Dec. 5,
2000; 74 FR 33095, July 9, 2009] [44 FR 22367, Apr. 13, 1979, as amended at 49
FR 32173, Aug. 13, 1984]
Subpart B—Initiation of § 16.24 Regulatory hearing required by

Proceedings the act or a regulation.
(a) A regulatory hearing required by
§ 16.22 Initiation of regulatory hear- the act or a regulation under § 16.1(b)
ing.
will be initiated in the same manner as
(a) A regulatory hearing is initiated other regulatory hearings subject to
by a notice of opportunity for hearing the additional procedures in this sec-
from FDA. The notice will— tion.
(1) Be sent by mail, telegram, telex, (b) [Reserved]
personal delivery, or any other mode of (c) The notice will state whether any
written communication; action concerning the matter that is
(2) Specify the facts and the action the subject of the opportunity for hear-
that are the subject of the opportunity ing is or is not being taken pending the
for a hearing; hearing under paragraph (d) of this sec-
(3) State that the notice of oppor- tion.
tunity for hearing and the hearing are (d) The Commissioner may take such
governed by this part; and action pending a hearing under this
256
section as the Commissioner concludes to the parties explaining the reason for
is necessary to protect the public denial.
health, except where expressly prohib- (b) After a hearing commences, the
ited by statute or regulation. A hear- presiding officer may issue a summary
ing to consider action already taken, decision on any issue in the hearing if
and not stayed by the Commissioner, the presiding officer determines from
will be conducted on an expedited the material submitted in connection
basis. with the hearing, or from matters offi-
(e) The hearing may not be required cially noticed, that there is no genuine
to be held at a time less than 2 working and substantial issue of fact respecting
days after receipt of the request for that issue. For the purpose of this
hearing. paragraph, a hearing commences upon
(f) Before the hearing, FDA will give the receipt by FDA of a request for
to the party requesting the hearing hearing submitted under § 16.22(b).
(c) The Commissioner or his or her
reasonable notice of the matters to be
delegate may review any summary de-
considered at the hearing, including a
cision of the presiding officer issued
comprehensive statement of the basis
under paragraph (b) of this section at
for the decision or action taken or pro-
the request of a party or on the Com-
posed that is the subject of the hearing
missioner’s or his or her delegate’s own
and a general summary of the informa-
initiative.
tion that will be presented by FDA at
the hearing in support of the decision [53 FR 4615, Feb. 17, 1988, as amended at 69
or action. This information may be FR 17290, Apr. 2, 2004]
given orally or in writing, in the dis-
cretion of FDA. Subpart C—Commissioner and
(g) FDA and the party requesting the Presiding Officer
hearing will, if feasible, at least 1 day
before the hearing provide to each § 16.40 Commissioner.
other written notice of any published Whenever the Commissioner has del-
articles or written information to be egated authority on a matter for which
presented at or relied on at the hear- a regulatory hearing is available under
ing. A copy will also be provided in ad- this part, the functions of the Commis-
vance if the other participant could not sioner under this part may be per-
reasonably be expected to have or be formed by any of the officials to whom
able to obtain a copy. If written notice the authority has been delegated, e.g.,
or a copy is not provided, the presiding a center director.
officer may, if time permits, allow the [69 FR 17290, Apr. 2, 2004]
party who did not receive the notice or
copy additional time after the close of § 16.42 Presiding officer.
the hearing to make a submission con-
(a) An FDA employee to whom the
cerning the article or information.
Commissioner delegates such author-
[44 FR 22367, Apr. 13, 1979, as amended at 47 ity, or any other agency employee des-
FR 26375, June 18, 1982; 54 FR 9037, Mar. 3, ignated by an employee to whom such
1989] authority is delegated, or, consistent
with 5 CFR 930.209(b) or (c), an adminis-
§ 16.26 Denial of hearing and summary trative law judge to whom such author-
decision.
ity is delegated, may serve as the pre-
(a) A request for a hearing may be de- siding officer and conduct a regulatory
nied, in whole or in part, if the Com- hearing under this part.
missioner or the FDA official to whom (b) In a regulatory hearing required
authority is delegated to make the by the act or a regulation, the pre-
final decision on the matter deter- siding officer is to be free from bias or
mines that no genuine and substantial prejudice and may not have partici-
issue of fact has been raised by the ma- pated in the investigation or action
terial submitted. If the Commissioner that is the subject of the hearing or be
or his or her delegate determines that subordinate to a person, other than the
a hearing is not justified, written no- Commissioner, who has participated in

tice of the determination will be given such investigation or action.
257
§ 16.44 21 CFR Ch. I (4–1–19 Edition)
(c)(1) The Commissioner or the dele- and made part of the record, and the
gate under § 16.40 is not precluded by other party provided an opportunity to
this section from prior participation in respond.
the investigation or action that is the (c) A copy of any letter or memo-
subject of the hearing. If there has randum of meeting between a partici-
been prior participation, the Commis- pant in the hearing and the presiding
sioner or the delegate should, if fea- officer or the Commissioner, e.g., a re-
sible, designate a presiding officer for sponse by the presiding officer to a re-
the hearing who is not a subordinate. quest for a change in the time of the
Thus, if the Commissioner’s authority hearing, is to be sent to all partici-
to make a final decision has been dele- pants by the person writing the letter
gated to a center director, the pre- or the memorandum.
siding officer may be an official in an-
other center or the office of the Com- Subpart D—Procedures for
missioner. The exercise of general su- Regulatory Hearing
pervisory responsibility, or the des-
ignation of the presiding officer, does § 16.60 Hearing procedure.
not constitute prior participation in (a) A regulatory hearing is public, ex-
the investigation or action that is the cept when the Commissioner deter-
subject of the hearing so as to preclude mines that all or part of a hearing
the Commissioner or delegate from should be closed to prevent a clearly
designating a subordinate as the pre- unwarranted invasion of personal pri-
siding officer. vacy; to prevent the disclosure of a
(2) The party requesting a hearing trade secret or confidential commer-
may make a written request to have cial or financial information that is
the Commissioner or the delegate not available for public disclosure
under § 16.40 be the presiding officer, under § 20.61; or to protect investiga-
notwithstanding paragraph (c)(1) of tory records complied for law enforce-
this section. If accepted, as a matter of ment purposes that are not available
discretion, by the Commissioner or the for public disclosure under § 20.64.
delegate, the request is binding upon (1) The Commissioner may determine
the party making the request. that a regulatory hearing is closed ei-
(3) A different presiding officer may ther on the Commissioner’s initiative
be substituted for the one originally or on a request by the party asking for
designated under § 16.22 without notice a regulatory hearing, in the request for
to the parties. the hearing.
[44 FR 22367, Apr. 13, 1979, as amended at 54 (2) If the hearing is a private hearing,
FR 9037, Mar. 3, 1989; 67 FR 53306, Aug. 15, no persons other than the party re-
2002] questing the hearing, counsel and wit-
nesses, and an employee or consultant
§ 16.44 Communication to presiding of- or other person subject to a commer-
ficer and Commissioner. cial arrangement as defined in § 20.81(a)
(a) Regulatory hearings are not sub- and FDA representatives with a direct
ject to the separation of functions professional interest in the subject
rules in § 10.55. matter of the proceeding are entitled
(b) Those persons who are directly in- to attend.
volved in the investigation or presen- (b) A regulatory hearing will be con-
tation of the position of FDA or any ducted by a presiding officer. Employ-
party at a regulatory hearing that is ees of FDA will first give a full and
required by the act or a regulation complete statement of the action
should avoid any off-the-record com- which is the subject of the hearing, to-
munication on the matter to the pre- gether with the information and rea-
siding officer or the Commissioner or sons supporting it, and may present
their advisors if the communication is any oral or written information rel-
inconsistent with the requirement of evant to the hearing. The party re-
§ 16.95(b)(1) that the administrative questing the hearing may then present
record be the exclusive record for deci- any oral or written information rel-
sion. If any communication of this type evant to the hearing. All parties may
occurs, it is to be reduced to writing confront and conduct reasonable cross-
258
examination of any person (except for § 16.62 Right to counsel.

the presiding officer and counsel for
Any party to a hearing under this
the parties) who makes any statement part has the right at all times to be ad-
on the matter at the hearing. vised and accompanied by counsel.
(c) The hearing is informal in nature,
and the rules of evidence do not apply.
No motions or objections relating to
Subpart E—Administrative Record
the admissibility of information and and Decision
views will be made or considered, but § 16.80 Administrative record of a reg-
any other party may comment upon or ulatory hearing.
rebut all such data, information, and
views. (a) The administrative record of the
regulatory hearing consists of the fol-
(d) The presiding officer may order
lowing:
the hearing to be transcribed. The
(1) The notice of opportunity for
party requesting the hearing may have
hearing and the response.
the hearing transcribed, at the party’s
(2) All written information and views
expense, in which case a copy of the
submitted to the presiding officer at
transcript is to be furnished to FDA.
the hearing or after if specifically per-
Any transcript of the hearing will be mitted by the presiding officer.
included with the presiding officer’s re- (3) Any transcript of the hearing.
port of the hearing.
(4) The presiding officer’s report of
(e) The presiding officer shall prepare the hearing and comments on the re-
a written report of the hearing. All port under § 16.60(e).
written material presented at the hear- (5) All letters and memoranda of
ing will be attached to the report. meetings or communications between
Whenever time permits, the parties to participants and the presiding officer
the hearing will be given the oppor- or the Commissioner referred to in
tunity to review and comment on the § 16.44(c).
presiding officer’s report of the hear- (b) The record of the regulatory hear-
ing. ing is closed to the submission of infor-
(f) The presiding officer shall include mation and views, at the close of the
as part of the report of the hearing a hearing, unless the presiding officer
finding on the credibility of witnesses specifically permits additional time for
(other than expert witnesses) whenever a further submission.
credibility is a material issue, and
shall include a recommended decision, § 16.85 Examination of administrative
with a statement of reasons, unless the record.
Commissioner directs otherwise. Part 20 governs the availability for
(g) The presiding officer has the public disclosure of each document
power to take such actions and make that is a part of the administrative
such rulings as are necessary or appro- record of a regulatory hearing.
priate to maintain order and to con-
§ 16.95 Administrative decision and
duct a fair, expeditious, and impartial record for decision.
hearing, and to enforce the require-
ments of this part concerning the con- (a) With respect to a regulatory hear-
duct of hearings. The presiding officer ing at the Commissioner’s initiative
may direct that the hearing be con- under § 16.1(a), the Commissioner shall
ducted in any suitable manner per- consider the administrative record of
mitted by law and these regulations. the hearing specified in § 16.80(a) to-
gether with all other relevant informa-
(h) The Commissioner or the pre-
tion and views available to FDA in de-
siding officer has the power under termining whether regulatory action
§ 10.19 to suspend, modify, or waive any should be taken and, if so, in what
provision of this part. form.
(b) With respect to a regulatory hear-

FR 6469, Jan. 22, 2001; 66 FR 12850, Mar. 1, ing required by the act or a regulation
2001] under § 16.1(b)—
259
§ 16.119 21 CFR Ch. I (4–1–19 Edition)
(1) The administrative record of the 17.25 Exchange of witness lists, witness
hearing specified in § 16.80(a) con- statements, and exhibits.
stitutes the exclusive record for deci- 17.27 Hearing subpoenas.
sion; 17.28 Protective order.
(2) On the basis of the administrative 17.29 Fees.
record of the hearing, the Commis- 17.30 Computation of time.
17.31 Form, filing, and service of papers.
sioner shall issue a written decision
17.32 Motions.
stating the reasons for the Commis-
17.33 The hearing and burden of proof.
sioner’s administrative action and the 17.34 Determining the amount of penalties
basis in the record; and and assessments.
(3) For purposes of judicial review 17.35 Sanctions.
under § 10.45, the record of the adminis- 17.37 Witnesses.
trative proceeding consists of the 17.39 Evidence.
record of the hearing and the Commis- 17.41 The administrative record.
sioner’s decision. 17.43 Posthearing briefs.
17.45 Initial decision.
Subpart F—Reconsideration and 17.47 Appeals.
17.48 Harmless error.
Stay
17.51 Judicial review.
§ 16.119 Reconsideration and stay of 17.54 Deposit in the Treasury of the United
action. States.
After any final administrative action AUTHORITY: 21 U.S.C. 331, 333, 337, 351, 352,
that is the subject of a hearing under 355, 360, 360c, 360f, 360i, 360j, 371; 42 U.S.C. 262,
263b, 300aa–28; 5 U.S.C. 554, 555, 556, 557.
this part, any party may petition the
Commissioner for reconsideration of SOURCE: 60 FR 38626, July 27, 1995, unless
any part or all of the decision or action otherwise noted.
under § 10.33 or may petition for a stay EDITORIAL NOTE: Nomenclature changes to
of the decision or action under § 10.35. part 17 appear at 68 FR 24879, May 9, 2003.
FR 9037, Mar. 3, 1989]
§ 17.1 Scope.
This part sets forth practices and
Subpart G—Judicial Review procedures for hearings concerning the
administrative imposition of civil
§ 16.120 Judicial review. money penalties by FDA. Listed below
Section 10.45 governs the availability are the statutory provisions that au-
of judicial review concerning any regu- thorize civil money penalties that are
latory action which is the subject of a governed by these procedures.
hearing under this part (a) Section 303(b)(2) and (b)(3) of the
(the act) authorizing civil money pen-
PART 17—CIVIL MONEY PENALTIES alties for certain violations of the act
HEARINGS that relate to prescription drug mar-
keting practices.
Sec. (b) Section 303(f)(1) of the act author-
17.1 Scope.
izing civil money penalties for certain
17.2 Maximum penalty amounts.
17.3 Definitions. violations of the act that relate to
17.5 Complaint. medical devices and section 303(f)(2) of
17.7 Service of complaint. the act authorizing civil money pen-
17.9 Answer. alties for certain violations of the act
17.11 Default upon failure to file an answer. that relate to pesticide residues.
17.13 Notice of hearing. (c) Section 303(f)(3) of the act author-
17.15 Parties to the hearing. izing civil money penalties for certain
17.17 Summary decisions.
violations relating to the submission of
17.18 Interlocutory appeal from ruling of
presiding officer.
certifications and/or clinical trial in-
17.19 Authority of the presiding officer. formation to the clinical trial data
bank and section 303(f)(4) of the act au-
17.20 Ex parte contacts.

17.21 Prehearing conferences. thorizing civil money penalties for cer-
17.23 Discovery. tain violations of the act relating to
260
postmarket studies, clinical trial re- money penalties can be found at 45

quirements, and risk evaluation and CFR 102.3.
mitigation strategies for drugs. [81 FR 62358, Sept. 9, 2016]
(d) Section 303(g)(1) of the act author-
izing civil money penalties for certain § 17.3 Definitions.
violations of the act that relate to dis- The following definitions are applica-
semination of direct-to-consumer ad- ble in this part:
vertisements for approved drugs or bio- (a) For specific acts giving rise to
logical products. civil money penalty actions brought
(e) Section 307 of the act authorizing under 21 U.S.C. 333(f)(1):
civil money penalties for certain ac- (1) Significant departure, for the pur-
tions in connection with an abbre- pose of interpreting 21 U.S.C.
viated new drug application or certain 333(f)(1)(B)(i), means a departure from
actions in connection with a person or requirements that is either a single
individual debarred under section 306 of major incident or a series of incidents
the act. that collectively are consequential.
(f) Section 539(b)(1) of the act author- (2) Knowing departure, for the pur-
izing civil money penalties for certain poses of interpreting 21 U.S.C.
violations of the act that relate to 333(f)(1)(B)(i), means a departure from a
electronic products. requirement taken:
(g) Section 351(d)(2) of the Public (i) With actual knowledge that the
Health Service Act (the PHS Act) au- action is such a departure; or
thorizing civil money penalties for vio- (ii) In deliberate ignorance of a re-
lations of biologic recall orders. quirement; or
(h) Section 354(h)(3) of the PHS Act, (ii) In reckless disregard of a require-
as amended by the Mammography ment.
Quality Standards Act of 1992 and the (3) Minor violations, for the purposes
Mammography Quality Standards Act of interpreting 21 U.S.C. 333(f)(1)(B)(ii),
of 1998, authorizing civil money pen- means departures from requirements
alties for failure to obtain a certificate that do not rise to a level of a single
and failure to comply with established major incident or a series of incidents
standards, among other things. that are collectively consequential.
(i) Section 2128(b)(1) of the PHS Act (4) Defective, for the purposes of inter-
authorizing civil money penalties for preting 21 U.S.C. 333(f)(1)(B)(iii), in-
intentionally destroying, altering, fal- cludes any defect in performance, man-
sifying, or concealing any record or re- ufacture, construction, components,
port required to be prepared, main- materials, specifications, design, in-
tained, or submitted by vaccine manu- stallation, maintenance, or service of a
facturers under section 2128 of the PHS device, or any defect in mechanical,
Act. physical, or chemical properties of a
(j) Section 303(f) of the act author- device.
izing civil money penalties for any per- (b) Person or respondent includes an
son who violates a requirement of the individual, partnership, corporation,
Family Smoking Prevention and To- association, scientific or academic es-
bacco Control Act which relates to to- tablishment, government agency or or-
bacco products. ganizational unit thereof, or other
legal entity, or as may be defined in
[60 FR 38626, July 27, 1995, as amended at 69 the act or regulation pertinent to the
FR 43301, July 20, 2004; 73 FR 66752, Nov. 12, civil penalty action being brought.
2008; 75 FR 73953, Nov. 30, 2010] (c) Presiding officer means an admin-
istrative law judge qualified under 5
§ 17.2 Maximum penalty amounts.
U.S.C. 3105.
The maximum civil money penalties (d) Any term that is defined in the
associated with the statutory provi- act has the same definition for civil
sions authorizing civil money penalties money penalty actions that may be
under the Federal Food, Drug, and Cos- brought under that act.
metic Act or the Public Health Service (e) Any term that is defined in Title
Act can be found at 45 CFR part 102. 21 of the Code of Federal Regulations
The table of these maximum civil has the same definition for civil money
261
§ 17.5 21 CFR Ch. I (4–1–19 Edition)
penalty actions that may arise from (d) The presiding officer will be as-
the application of the regulation(s). signed to the case upon the filing of the
(f) Any term that is defined in the complaint under this part.
PHS Act has the same definition for [60 FR 38626, July 27, 1995, as amended at 79
civil money penalty actions that may FR 6091, Feb. 3, 2014]
be brought under that act.
(g) Departmental Appeals Board (DAB) § 17.7 Service of complaint.
means the Departmental Appeals (a) Service of a complaint may be
Board of the Department of Health and made by:
Human Services. (1) Certified or registered mail or
similar mail delivery service with a re-
[60 FR 38626, July 27, 1995, as amended at 82 turn receipt record reflecting receipt;
FR 34402, July 25, 2017] or
(2) Delivery in person to:
§ 17.5 Complaint. (i) An individual respondent; or
(a) The Center with principal juris- (ii) An officer or managing or general
diction over the matter involved shall agent in the case of a corporation or
begin all administrative civil money unincorporated business.
penalty actions by serving on the re- (b) Proof of service, stating the name
spondent(s) a complaint signed by the and address of the person on whom the
Office of the Chief Counsel attorney for complaint was served, and the manner
the Center and by filing a copy of the and date of service, may be made by:
(1) Affidavit or declaration under
complaint with the Division of Dockets
penalty of perjury of the individual
Management (HFA–305), Food and Drug
serving the complaint by personal de-
Administration, 5630 Fishers Lane, Rm. livery;
1061, Rockville, MD 20852. For a civil (2) A United States Postal Service or
money penalty action against retailers similar mail delivery service return re-
of tobacco products, the complaint ceipt record reflecting receipt; or
may be signed by any Agency employee (3) Written acknowledgment of re-
designated by the Chief Counsel. ceipt by the respondent or by the re-
(b) The complaint shall state: spondent’s counsel or authorized rep-
(1) The allegations of liability resentative or agent.
against the respondent, including the
statutory basis for liability, the identi- § 17.9 Answer.
fication of violations that are the basis (a) The respondent may request a
for the alleged liability, and the rea- hearing by filing an answer with the
sons that the respondent is responsible Division of Dockets Management
for the violations; (HFA–305), Food and Drug Administra-
(2) The amount of penalties and as- tion, 5630 Fishers Lane, rm. 1061, Rock-
sessments that the Center is seeking; ville, MD 20852, within 30 days of serv-
(3) Instructions for filing an answer ice of the complaint. Unless stated oth-
erwise, an answer shall be deemed to be
to request a hearing, including a spe-
a request for hearing.
cific statement of the respondent’s
(b) In the answer, the respondent:
right to request a hearing by filing an (1) Shall admit or deny each of the
answer and to retain counsel to rep- allegations of liability made in the
resent the respondent; and complaint; allegations not specifically
(4) That failure to file an answer denied in an answer are deemed admit-
within 30 days of service of the com- ted;
plaint will result in the imposition of (2) Shall state all defenses on which
the proposed amount of penalties and the respondent intends to rely;
assessments, as provided in § 17.11. (3) Shall state all reasons why the re-
(c) The Center may, on motion, sub- spondent contends that the penalties
sequently amend its complaint to con- and assessments should be less than
form with the evidence adduced during the requested amount; and
(4) Shall state the name, address, and
the administrative process, as justice

may require. telephone number of the respondent’s
counsel, if any.
262
(c) If the respondent is unable to file tion, if such a decision has been issued,
an answer meeting the requirements of and shall grant the respondent an op-
paragraph (b) of this section within the portunity to answer the complaint as
time provided, the respondent shall, be- provided in § 17.9(a).
fore the expiration of 30 days from (e) If the presiding officer decides
service of the complaint, file a request that the respondent’s failure to file an
for an extension of time within which answer in a timely manner is not ex-
to file an answer that meets the re- cused, he or she shall affirm the deci-
quirements of paragraph (b) of this sec- sion under paragraph (a) of this sec-
tion. The presiding officer may, for tion, and the decision shall become
good cause shown, grant the respond- final and binding upon the parties 30
ent up to 30 additional days within days after the presiding officer issues
which to file an answer that meets the the decision on the respondent’s mo-
requirements of paragraph (b) of this tion filed under paragraph (c) of this
section. section.
(d) The respondent may, on motion,
amend its answer to conform with the § 17.13 Notice of hearing.
evidence as justice may require. After an answer has been filed, the
Center shall serve a notice of hearing
§ 17.11 Default upon failure to file an on the respondent. Such notice shall
answer. include:
(a) If the respondent does not file an (a) The date, time, and place of a pre-
answer within the time prescribed in hearing conference, if any, or the date,
§ 17.9 and if service has been effected as time, and place of the hearing if there
provided in § 17.7, the presiding officer is not to be a prehearing conference;
shall assume the facts alleged in the (b) The nature of the hearing and the
complaint to be true, and, if such facts legal authority and jurisdiction under
establish liability under the relevant which the hearing is to be held;
statute, the presiding officer shall (c) A description of the procedures
issue an initial decision within 30 days for the conduct of the hearing;
of the time the answer was due, impos- (d) The names, addresses, and tele-
ing: phone numbers of the representatives
(1) The maximum amount of pen- of the government and of the respond-
alties provided for by law for the viola- ent, if any; and
tions alleged; or (e) Such other matters as the Center
(2) The amount asked for in the com- or the presiding officer deems appro-
plaint, whichever amount is smaller. priate.
(b) Except as otherwise provided in
this section, by failing to file a timely § 17.15 Parties to the hearing.
answer, the respondent waives any (a) The parties to the hearing shall
right to a hearing and to contest the be the respondent and the Center(s)
amount of the penalties and assess- with jurisdiction over the matter at
ments imposed under paragraph (a) of issue. No other person may participate.
this section, and the initial decision (b) The parties may at any time prior
shall become final and binding upon to a final decision by the entity decid-
the parties 30 days after it is issued. ing any appeal agree to a settlement of
(c) If, before such a decision becomes all or a part of the matter. The settle-
final, the respondent files a motion ment agreement shall be filed in the
seeking to reopen on the grounds that docket and shall constitute complete
extraordinary circumstances prevented or partial resolution of the administra-
the respondent from filing an answer, tive case as so designated by the settle-
the initial decision shall be stayed ment agreement. The settlement docu-
pending a decision on the motion. ment shall be effective upon filing in
(d) If, on such motion, the respondent the docket and need not be ratified by
can demonstrate extraordinary cir- the presiding officer or the Commis-
cumstances excusing the failure to file sioner of Food and Drugs.
an answer in a timely manner, the pre- (c) The parties may be represented by
siding officer may withdraw the deci- counsel, who may be present at the
sion under paragraph (a) of this sec- hearing.
263
§ 17.17 21 CFR Ch. I (4–1–19 Edition)
§ 17.17 Summary decisions. § 17.18 Interlocutory appeal from rul-

ing of presiding officer.
(a) At any time after the filing of a
complaint, a party may move, with or (a) Except as provided in paragraph
without supporting affidavits (which, (b) of this section, rulings of the pre-
for purposes of this part, shall include siding officer may not be appealed be-
declarations under penalty of perjury), fore consideration on appeal of the en-
for a summary decision on any issue in tire record of the hearing.
the hearing. The other party may, (b) A ruling of the presiding officer is
within 30 days after service of the mo- subject to interlocutory appeal to the
tion, which may be extended for an ad- entity deciding the appeal (currently
ditional 10 days for good cause, serve the DAB) if the presiding officer cer-
opposing affidavits or countermove for tifies on the record or in writing that
summary decision. immediate review is necessary to pre-
The presiding officer may set the vent exceptional delay, expense, or
matter for argument and call for the prejudice to any participant, or sub-
stantial harm to the public interest.
submission of briefs.
(c) When an interlocutory appeal is
(b) The presiding officer shall grant
made, a participant may file a brief on
the motion if the pleadings, affidavits,
the appeal only if specifically author-
and other material filed in the record,
ized by the presiding officer or the en-
or matters officially noticed, show that
tity deciding the appeal (currently the
there is no genuine issue as to any ma- DAB), and if such authorization is
terial fact and that the party is enti- granted, only within the period allowed
tled to summary decision as a matter by the presiding officer or the entity
of law. deciding the appeal. If a participant is
(c) Affidavits shall set forth only authorized to file a brief, any other
such facts as would be admissible in participant may file a brief in opposi-
evidence and shall show affirmatively tion, within the period allowed by the
that the affiant is competent to testify entity deciding the appeal (currently
to the matters stated. When a motion the DAB). The deadline for filing an in-
for summary decision is made and sup- terlocutory appeal is subject to the dis-
ported as provided in this regulation, a cretion of the presiding officer.
party opposing the motion may not
rest on mere allegations or denials or § 17.19 Authority of the presiding offi-
general descriptions of positions and cer.
contentions; affidavits or other re- (a) The presiding officer shall con-
sponses must set forth specific facts duct a fair and impartial hearing, avoid
showing that there is a genuine issue of delay, maintain order, and assure that
material fact for the hearing. a record of the proceeding is made.
(d) If, on motion under this section, a (b) The presiding officer has the au-
summary decision is not rendered on thority to:
all issues or for all the relief asked, and (1) Set and change the date, time,
if additional facts need to be developed, and place of the hearing on reasonable
the presiding officer will issue an order notice to the parties;
specifying the facts that appear with- (2) Continue or recess the hearing in
out substantial controversy and direct- whole or in part for a reasonable time;
ing further evidentiary proceedings on (3) Require parties to attend con-
facts still at issue. The facts specified ferences for settlement, to identify or
not to be at issue shall be deemed es- simplify the issues, or to consider
tablished. other matters that may aid in the ex-
(e) Except as provided in § 17.18, a peditious disposition of the proceeding;
party may not obtain interlocutory re- (4) Administer oaths and affirma-
view by the entity deciding the appeal tions;
(currently the DAB) of a partial sum- (5) Issue subpoenas requiring the at-
mary decision of the presiding officer. tendance and testimony of witnesses
A review of final summary decisions on and the production of evidence that re-
all issues may be had through the pro- lates to the matter under investiga-
cedure set forth in § 17.47. tion;
264
(6) Rule on motions and other proce- (b) Upon the motion of any party, the
dural matters; presiding officer shall schedule at least
(7) Regulate the scope and timing of one prehearing conference at a reason-
discovery consistent with § 17.23; able time in advance of the hearing.
(8) Regulate the course of the hearing (c) The presiding officer may use a
and the conduct of the parties; prehearing conference to discuss the
(9) Examine witnesses; following:
(10) Upon motion of a party for good (1) Simplification of the issues;
cause shown, the presiding officer may (2) The necessity or desirability of
allow a witness to be recalled for addi- amendments to the pleadings, includ-
tional testimony; ing the need for a more definite state-
(11) Receive, rule on, exclude, or ment;
limit evidence; (3) Stipulations and admissions of
(12) Upon motion of a party or on the fact as to the contents and authen-
presiding officer’s own motion, take of- ticity of documents;
ficial notice of facts; (4) Whether the parties can agree to
(13) Upon motion of a party, decide submission of the case on a stipulated
cases, in whole or in part, by summary record;
decision when there is no genuine issue (5) Whether a party chooses to waive
of material fact; appearance at an oral hearing and to
(14) Conduct any conference, argu- submit only documentary evidence
ment, or hearing on motions in person (subject to the objection of the other
or by telephone; party) and written argument;
(15) Consolidate related or similar (6) Limitation of the number of wit-
proceedings or sever unrelated matters; nesses;
(16) Limit the length of pleadings; (7) Scheduling dates for the exchange
(17) Waive, suspend, or modify any of witness lists and of proposed exhib-
rule in this part if the presiding officer its;
determines that no party will be preju- (8) Discovery and scheduling dates
diced, the ends of justice will be served, for completion of discovery;
and the action is in accordance with (9) The date, time, and place for the
law; hearing; and
(18) Issue protective orders pursuant (10) Such other matters as may tend
to § 17.28; and to expedite the fair and just disposition
(19) Exercise such other authority as of the proceedings.
is necessary to carry out the respon- (d) The presiding officer shall issue
sibilities of the presiding officer under an order containing all matters agreed
this part. upon by the parties or ordered by the
(c) The presiding officer does not presiding officer at a prehearing con-
have the authority to find Federal ference.
statutes or regulations invalid.
§ 17.23 Discovery.
§ 17.20 Ex parte contacts. (a) No later than 60 days prior to the
No party or person (except employees hearing, unless otherwise ordered by
of the presiding officer’s office) shall the presiding officer, a party may
communicate in any way with the pre- make a request to another party for
siding officer on any matter at issue in production, inspection, and copying of
a case, unless on notice and oppor- documents that are relevant to the
tunity for all parties to participate. issues before the presiding officer. Doc-
This provision does not prohibit a per- uments must be provided no later than
son or party from inquiring about the 30 days after the request has been
status of a case or asking routine ques- made.
tions concerning administrative func- (b) For the purpose of this part, the
tions or procedures. term documents includes information,
reports, answers, records, accounts, pa-
§ 17.21 Prehearing conferences. pers and other data and documentary
(a) The presiding officer may sched- evidence. Nothing contained in this
ule prehearing conferences as appro- section may be interpreted to require

priate. the creation of a document, except that
265
§ 17.25 21 CFR Ch. I (4–1–19 Edition)
requested data stored in an electronic tified the failure to make a timely ex-
data storage system must be produced change of witness lists under paragraph
in a form readily accessible to the re- (a) of this section, he or she must ex-
questing party. clude from the party’s hearing evidence
(c) Requests for documents, requests the testimony of any witness whose
for admissions, written interrogatories, name does not appear on the witness
depositions, and any forms of dis- list.
covery, other than those permitted (3) If the presiding officer finds that
under paragraphs (a) and (e) of this sec- extraordinary circumstances existed,
tion, are not authorized. the presiding officer must then deter-
(d)(1) Within 10 days of service of a mine whether the admission of the tes-
request for production of documents, a timony of any witness whose name
party may file a motion for a protec- does not appear on the witness lists ex-
tive order. changed under paragraph (a) of this
(2) The presiding officer may grant a section would cause substantial preju-
motion for a protective order, in whole dice to the objecting party. If the pre-
or in part, if he or she finds that the siding officer finds that there is not
discovery sought: substantial prejudice, the evidence
(i) Is unduly costly or burdensome, may be admitted. If the presiding offi-
(ii) Will unduly delay the proceeding, cer finds that there is substantial prej-
or udice, the presiding officer may ex-
(iii) Seeks privileged information. clude the evidence, or at his or her dis-
(3) The burden of showing that a pro- cretion, may postpone the hearing for
tective order is necessary shall be on such time as is necessary for the ob-
the party seeking the order. jecting party to prepare and respond to
(4) The burden of showing that docu- the evidence.
ments should be produced is on the (c) Unless a party objects within 5
party seeking their production. days prior to the hearing, documents
(e) The presiding officer shall order exchanged in accordance with para-
depositions upon oral questions only graph (a) of this section will be deemed
upon a showing that: to be authentic for the purpose of ad-
(1) The information sought cannot be missibility at the hearing.
obtained by alternative methods, and
(2) There is a substantial reason to § 17.27 Hearing subpoenas.
believe that relevant and probative evi- (a) A party wishing to procure the
dence may otherwise not be preserved appearance and testimony of any indi-
for presentation by a witness at the vidual at the hearing may, when au-
hearing. thorized by law, request that the pre-
siding officer issue a subpoena.
§ 17.25 Exchange of witness lists, wit- (b) A subpoena requiring the attend-
ness statements, and exhibits. ance and testimony of an individual
(a) At least 30 days before the hear- may also require the individual to
ing, or by such other time as is speci- produce documents at the hearing.
fied by the presiding officer, the par- (c) A party seeking a subpoena shall
ties shall exchange witness lists, copies file a written request therefor not less
of prior written statements of proposed than 20 days before the date fixed for
witnesses, and copies of proposed hear- the hearing unless otherwise allowed
ing exhibits, including written testi- by the presiding officer, upon a show-
mony. ing by the party of good cause. Such
(b)(1) If a party objects to the pro- request shall specify any documents to
posed admission of evidence not ex- be produced and shall designate the
changed in accordance with paragraph witnesses and describe the address and
(a) of this section, the presiding officer location thereof with sufficient par-
will exclude such evidence if he or she ticularity to permit such witnesses to
determines that the failure to comply be found.
with paragraph (a) of this section (d) The subpoena shall specify the
should result in its exclusion. time and place at which the witness is
(2) Unless the presiding officer finds to appear and any documents the wit-
that extraordinary circumstances jus- ness is to produce.
266
(e) The party seeking the subpoena (7) That the parties simultaneously
shall serve it in the manner prescribed file specified documents or information
for service of a complaint in § 17.7. enclosed in sealed envelopes to be
(f) If a party or the individual to opened as directed by the presiding of-
whom the subpoena is directed believes ficer.
a subpoena to be unreasonable, oppres-
sive, excessive in scope, or unduly bur- § 17.29 Fees.
densome, or if it wishes to raise any The party requesting a subpoena
other objection or privilege recognized shall pay the cost of the fees and mile-
by law, the party or individual may file age of any witness subpoenaed in the
a motion to quash the subpoena within amounts that would be payable to a
10 days after service or on or before the witness in a proceeding in a United
time specified in the subpoena for com- States District Court. A check for wit-
pliance if it is less than 10 days after ness fees and mileage shall accompany
service. Such a filing will state the the subpoena when served.
basis for the motion to quash. The pre-
siding officer may quash or modify the § 17.30 Computation of time.
subpoena or order it implemented, as (a) In computing any period of time
justice may require. under this part or in an order issued
thereunder, the time begins with the
§ 17.28 Protective order. day following the act or event, and in-
(a) A party or a prospective witness cludes the last day of the period, unless
may file a motion for a protective either such day is a Saturday, Sunday,
order with respect to discovery sought or Federal holiday, in which event the
by a party or with respect to the hear- time includes the next business day.
ing, seeking to limit the availability or (b) When the period of time allowed
disclosure of evidence. is less than 7 days, intermediate Satur-
(b) When issuing a protective order, days, Sundays, and Federal holidays
the presiding officer may make any shall be excluded from the computa-
order which justice requires to protect tion.
a party or person from oppression or (c) When a document has been served
undue burden or expense, or to protect or issued by placing it in the mail, an
trade secrets or confidential commer- additional 5 days will be added to the
cial information, as defined in § 20.61 of time permitted for any response.
this chapter, information the disclo-
sure of which would constitute a clear- § 17.31 Form, filing, and service of pa-
ly unwarranted invasion of personal pers.
privacy, or other information that (a) Form. (1) Documents filed with the
would be withheld from public disclo- Division of Dockets Management
sure under 21 CFR part 20. Such orders (HFA–305), Food and Drug Administra-
may include, but are not limited to, tion, 5630 Fishers Lane, rm. 1061, Rock-
one or more of the following: ville, MD 20852, shall include an origi-
(1) That the discovery not be had; nal and two copies.
(2) That the discovery may be had (2) The first page of every pleading
only on specified terms and conditions, and paper filed in the proceeding shall
including a designation of the time or contain a caption setting forth the
place; title of the action, the case number as-
(3) That the discovery may be had signed by the Office of the Chief Coun-
only through a method of discovery sel, and designation of the pleading or
provided for by this part other than paper (e.g., ‘‘motion to quash sub-
that requested; poena’’).
(4) That certain matters not be in- (3) Every pleading shall be signed by,
quired into, or that the scope of dis- and shall contain the address and tele-
covery be limited to certain matters; phone number of, the party or the per-
(5) That the contents of discovery or son on whose behalf the pleading was
evidence be sealed; filed, or his or her counsel.
(6) That the information not be dis- (4) Pleadings or papers are considered
closed to the public or be disclosed filed when they are received by the Di-
only in a designated way; or vision of Dockets Management.
267
§ 17.32 21 CFR Ch. I (4–1–19 Edition)
(b) Service. A party filing a document money penalty considering any aggra-
with the Division of Dockets Manage- vating or mitigating factors.
ment under this part shall, no later (b) In order to prevail, the Center
than the time of filing, serve a copy of must prove respondent’s liability and
such document on every other party. the appropriateness of the penalty
Service upon any party of any docu- under the applicable statute by a pre-
ment, other than service of a com- ponderance of the evidence.
plaint, shall be made by delivering a (c) The respondent must prove any
copy personally or by placing a copy of affirmative defenses and any miti-
the document in the United States gating factors by a preponderance of
mail or express delivery service, post- the evidence.
age prepaid and addressed, to the par- (d) The hearing shall be open to the
ty’s last known address. When a party public unless otherwise ordered by the
is represented by counsel, service shall presiding officer, who may order clo-
be made on such counsel in lieu of the sure only to protect trade secrets or
actual party. confidential commercial information,
(c) Proof of service. A certificate of as defined in § 20.61 of this chapter, in-
the individual serving the document by formation the disclosure of which
personal delivery or by mail, setting would constitute a clearly unwarranted
forth the time and manner of service, invasion of personal privacy, or other
shall be proof of service. information that would be withheld
from public disclosure under part 20 of
§ 17.32 Motions.
this chapter.
(a) Any application to the presiding
officer for an order or ruling shall be § 17.34 Determining the amount of
by motion. Motions shall state the re- penalties and assessments.
lief sought, the authority relied upon, (a) When determining an appropriate
and the facts alleged, and shall be filed amount of civil money penalties and
with the Division of Dockets Manage- assessments, the presiding officer and
ment (HFA–305), Food and Drug Ad- the Commissioner of Food and Drugs or
ministration, 5630 Fishers Lane, rm. entity designated by the Commissioner
1061, Rockville, MD 20852, delivered to to decide the appeal (currently the
the presiding officer, and served on all DAB) shall evaluate any circumstances
other parties. that mitigate or aggravate the viola-
(b) Except for motions made during a tion and shall articulate in their opin-
prehearing conference or at the hear- ions the reasons that support the pen-
ing, all motions shall be in writing. alties and assessments imposed.
The presiding officer may require that
(b) The presiding officer and the enti-
oral motions be reduced to writing.
ty deciding the appeal shall refer to the
(c) Within 15 days after a written mo-
factors identified in the statute under
tion is served, or such other time as
which the penalty is assessed for pur-
may be fixed by the presiding officer,
poses of determining the amount of
any party may file a response to such
penalty.
motion.
(d) The presiding officer may not (c) Nothing in this section shall be
grant a written motion before the time construed to limit the presiding officer
for filing responses thereto has expired, or the entity deciding the appeal from
except upon consent of the parties or considering any other factors that in
following a hearing on the motion, but any given case may mitigate or aggra-
may overrule or deny such motion vate the offense for which penalties
without awaiting a response. and assessments are imposed.
§ 17.33 The hearing and burden of § 17.35 Sanctions.

proof. (a) The presiding officer may sanc-
(a) The presiding officer shall con- tion a person, including any party or
duct a hearing on the record to deter- counsel for:
mine whether the respondent is liable (1) Failing to comply with an order,
for a civil money penalty and, if so, the subpoena, rule, or procedure governing
appropriate amount of any such civil the proceeding;
268
(2) Failing to prosecute or defend an provided to all other parties along with
action; or the last known address of the witness.
(3) Engaging in other misconduct Any prior written statements of wit-
that interferes with the speedy, or- nesses proposed to testify at the hear-
derly, or fair conduct of the hearing. ing shall be exchanged as provided in
(b) Any such sanction, including, but § 17.25(a).
not limited to, those listed in para- (c) The presiding officer shall exer-
graphs (c), (d), and (e) of this section, cise reasonable control over the man-
shall reasonably relate to the severity ner and order of questioning witnesses
and nature of the failure or mis- and presenting evidence so as to:
conduct. (1) Make the examination and presen-
(c) When a party fails to comply with tation effective for the ascertainment
a discovery order, including discovery of the truth;
and subpoena provisions of this part, (2) Avoid undue consumption of time;
the presiding officer may: and
(1) Draw an inference in favor of the (3) Protect witnesses from harass-
requesting party with regard to the in- ment or undue embarrassment.
formation sought; (d) The presiding officer shall permit
(2) Prohibit the party failing to com- the parties to conduct such cross-ex-
ply with such order from introducing amination as may be required for a full
evidence concerning, or otherwise rely- disclosure of the facts.
ing upon, testimony relating to the in- (e) At the discretion of the presiding
formation sought; and officer, a witness may be cross-exam-
(3) Strike any part of the pleadings ined on relevant matters without re-
or other submissions of the party fail- gard to the scope of his or her direct
ing to comply with such request. examination. To the extent permitted
(d) The presiding officer may exclude by the presiding officer, a witness may
from participation in the hearing any be cross-examined on relevant matters
legal counsel, party, or witness who re- with regard to the scope of his or her
fuses to obey an order of the presiding direct examination. To the extent per-
officer. In the case of repeated refusal, mitted by the presiding officer, cross-
the presiding officer may grant judg- examination on matters outside the
ment to the opposing party. scope of direct examination shall be
(e) If a party fails to prosecute or de- conducted in the manner of direct ex-
fend an action under this part after amination and may proceed by leading
service of a notice of hearing, the pre- questions only if the witness is a hos-
siding officer may dismiss the action or tile witness, an adverse party, or a wit-
may issue an initial decision imposing ness identified with an adverse party.
penalties and assessments. (f) Upon motion of any party, the
(f) The presiding officer may refuse presiding officer may order witnesses
to consider any motion, request, re- excluded so that they cannot hear the
sponse, brief, or other document that is testimony of the other witnesses. This
not filed in a timely fashion or in com- rule does not authorize exclusion of:
pliance with the rules of this part. (1) A party who is an individual;
(g) Sanctions imposed under this sec- (2) In the case of a party that is not
tion may be the subject of an inter- an individual, an officer or employee of
locutory appeal as allowed in § 17.18(b), the party designated to be the party’s
provided that no such appeal will stay sole representative for purposes of the
or delay a proceeding. hearing; or
(3) An individual whose presence is
§ 17.37 Witnesses. shown by a party to be essential to the
(a) Except as provided in paragraph presentation of its case, including an
(b) of this section, testimony at the individual employed by a party en-
hearing shall be given orally by wit- gaged in assisting counsel for the
nesses under oath or affirmation. party.
(b) Direct testimony shall be admit- (g) If a witness’ testimony is sub-
ted in the form of a written declaration mitted in writing prior to cross-exam-
submitted under penalty of perjury. ination, the cross-examining party

Any such written declaration must be need not subpoena the witness or pay
269
§ 17.39 21 CFR Ch. I (4–1–19 Edition)
for his or her travel to the hearing. The § 17.41 The administrative record.
sponsoring party is responsible for pro-
(a) The hearing will be recorded and
ducing the witness at its own expense,
transcribed. Witnesses, participants,
and failure to do so shall result in the
and counsel have 30 days from the time
striking of the witness’ testimony.
the transcript becomes available to
§ 17.39 Evidence. propose corrections in the transcript of
oral testimony. Corrections are per-
(a) The presiding officer shall deter-
mitted only for transcription errors.
mine the admissibility of evidence.
The presiding officer shall promptly
(b) Except as provided in this part,
order justified corrections. Transcripts
the presiding officer shall not be bound
may be obtained following the hearing
by the ‘‘Federal Rules of Evidence.’’
from the Division of Dockets Manage-
However, the presiding officer may
ment at a cost not to exceed the actual
apply the ‘‘Federal Rules of Evidence’’
cost of duplication.
when appropriate, e.g., to exclude unre-
liable evidence. (b) The transcript of testimony, ex-
(c) The presiding officer shall exclude hibits, and other evidence admitted at
evidence that is not relevant or mate- the hearing and all papers and requests
rial. filed in the proceeding constitute the
(d) Relevant evidence may be ex- administrative record for the decision
cluded if its probative value is substan- by the presiding officer and the entity
tially outweighed by the danger of un- designated by the Commissioner of
fair prejudice, confusion of the issues, Food and Drugs to decide the appeal,
or by considerations of undue delay or currently the DAB.
needless presentation of cumulative (c) The administrative record may be
evidence. inspected and copied (upon payment of
(e) Relevant evidence may be ex- a reasonable fee) by anyone unless oth-
cluded if it is privileged under Federal erwise ordered by the presiding officer,
law. who shall upon motion of any party
(f) Evidence of furnishing or offering order otherwise when necessary to pro-
or promising to furnish, or accepting or tect trade secrets or confidential com-
offering or promising to accept, a valu- mercial information, as defined in
able consideration in settling or at- § 20.61 of this chapter, information the
tempting to settle a civil money pen- disclosure of which would constitute a
alty assessment which was disputed as clearly unwarranted invasion of per-
to either validity or amount, is not ad- sonal privacy, or other information
missible to prove liability for or inva- that would be withheld from public dis-
lidity of the civil money penalty or its closure under part 20.
amount. Evidence of conduct or state-
§ 17.43 Posthearing briefs.
ments made in settlement negotiations
is likewise not admissible. This rule Any party may file a posthearing
does not require the exclusion of any brief. The presiding officer shall fix the
evidence otherwise discoverable merely time for filing such briefs (which shall
because it is presented in the course of be filed simultaneously), which shall
settlement negotiations. This rule also not exceed 60 days from the date the
does not require exclusion when the parties received the transcript of the
evidence is offered for another purpose, hearing or, if applicable, the stipulated
such as proving bias or prejudice of a record. Such briefs may be accom-
witness or opposing a contention of panied by proposed findings of fact and
undue delay. conclusions of law. The presiding offi-
(g) The presiding officer may in his cer may permit the parties to file re-
or her discretion permit the parties to sponsive briefs. No brief may exceed 30
introduce rebuttal witnesses and evi- pages (exclusive of proposed findings
dence. and conclusions) unless the presiding
(h) All documents and other evidence officer has previously found that the
offered or taken for the record shall be issues in the proceeding are so com-
open to examination by all parties, un- plex, or the administrative record is so
less otherwise ordered by the presiding voluminous, as to justify longer briefs,

officer pursuant to § 17.28. in which case the presiding officer may
270
set a longer page limit. Proposed find- § 17.47 Appeals.

ings of fact and conclusions of law
(a) Either the Center or any respond-
shall not exceed 30 pages unless the
ent may appeal an initial decision, in-
presiding officer has previously found
cluding a decision not to withdraw a
that the issues in the proceeding are so
default judgment, or a decision grant-
complex, or the administrative record
ing summary decision to the Commis-
is so voluminous, as to justify longer
sioner of Food and Drugs or other enti-
proposed findings and conclusions, in
ty the Commissioner designates to de-
which case the presiding officer may
cide the appeal. The Commissioner has
set a longer page limit.
currently designated the Departmental
§ 17.45 Initial decision. Appeals Board (DAB) to decide appeals
under this part. Parties may appeal to
(a) The presiding officer shall issue the DAB by filing a notice of appeal
an initial decision based only on the with the DAB, Appellate Division
administrative record. The decision
MS6127, Departmental Appeals Board,
shall contain findings of fact, conclu-
United States Department of Health
sions of law, and the amount of any
and Human Services, 330 Independence
penalties and assessments imposed.
Ave. SW., Cohen Bldg., rm. G–644,
(b) The findings of fact shall include
Washington, DC 20201, and the Division
a finding on each of the following
of Dockets Management (HFA–305),
issues:
Food and Drug Administration, 5630
(1) Whether the allegations in the
Fishers Lane, rm. 1061, Rockville, MD
complaint are true, and, if so, whether
20852, in accordance with this section.
respondent’s actions identified in the
(b)(1) A notice of appeal may be filed
complaint violated the law;
at any time within 30 days after the
(2) Whether any affirmative defenses
presiding officer issues an initial deci-
are meritorious; and
sion or decision granting summary de-
(3) If the respondent is liable for pen-
cision.
alties or assessments, the appropriate
amount of any such penalties or assess- (2) The Commissioner or the entity
ments, considering any mitigating or designated by the Commissioner to
aggravating factors that he or she finds hear appeals may, within his or her dis-
in the case. cretion, extend the initial 30-day period
(c) The presiding officer shall serve for an additional period of time if the
the initial decision or the decision Center or any respondent files a re-
granting summary decision on all par- quest for an extension within the ini-
ties within 90 days after the time for tial 30-day period and shows good
submission of posthearing briefs and cause.
responsive briefs (if permitted) has ex- (c) A notice of appeal shall be accom-
pired. If the presiding officer believes panied by a written brief of no greater
that he or she cannot meet the 90-day length than that allowed for the
deadline, he or she shall notify the posthearing brief. The notice must
Commissioner of Food and Drugs or identify specific exceptions to the ini-
other entity designated by the Com- tial decision, must support each excep-
missioner to decide the appeal of the tion with citations to the record, and
reason(s) therefor, and the Commis- must explain the basis for each excep-
sioner or that entity may then set a tion.
new deadline. (d) The opposing party may file a
(d) Unless the initial decision or the brief of no greater length than that al-
decision granting summary decision of lowed for the posthearing brief in oppo-
the presiding officer is timely ap- sition to exceptions within 30 days of
pealed, the initial decision or the deci- receiving the notice of appeal and ac-
sion granting summary decision shall companying brief, unless such time pe-
constitute the final decision of FDA riod is extended by the Commissioner
and shall be final and binding on the or the entity designated by the Com-
parties 30 days after it is issued by the missioner to hear appeals on request of

presiding officer. the opposing party for good cause
271
§ 17.48 21 CFR Ch. I (4–1–19 Edition)
shown. Any brief in opposition to ex- (k) The standard of review on a dis-
ceptions shall be filed with the Divi- puted issue of fact is whether the ini-
sion of Dockets Management and the tial decision is supported by substan-
DAB (addresses above). tial evidence on the whole record. The
(e) The appellant may file a reply standard of review on a disputed issue
brief not more than 10 pages in length of law is whether the initial decision is
within 10 days of being served with ap- erroneous.
pellee’s brief.
[60 FR 38626, July 27, 1995, as amended at 71
(f) There is no right to appear person- FR 5979, Feb. 6, 2006]
ally before the Commissioner of Food
and Drugs or other entity deciding the § 17.48 Harmless error.
appeal (currently the DAB).
(g) The entity deciding the appeal No error in either the admission or
will consider only those issues raised the exclusion of evidence, and no error
before the presiding officer, except that or defect in any ruling or order or in
the appellee may make any argument any act done or omitted by the pre-
based on the record in support of the siding officer or by any of the parties is
initial decision or decision granting grounds for vacating, modifying, or
summary decision. otherwise disturbing an otherwise ap-
(h) If on appeal the entity deciding propriate ruling or order or act, unless
the appeal considers issues not ade- refusal to take such action appears to
quately briefed by the parties, the enti- the presiding officer or the Commis-
ty may ask for additional briefing. sioner of Food and Drugs or other enti-
However, no such additional briefs will ty deciding the appeal (currently the
be considered unless so requested. DAB) to be inconsistent with substan-
(i) If any party demonstrates to the tial justice. The presiding officer and
satisfaction of the entity deciding the the entity deciding the appeal at every
appeal (currently the DAB) that addi- stage of the proceeding will disregard
tional evidence not presented at the any error or defect in the proceeding
hearing is relevant and material and that does not affect the substantial
that there were reasonable grounds for rights of the parties.
the failure to adduce such evidence at
§ 17.51 Judicial review.
the hearing, the entity deciding the ap-
peal may remand the matter to the (a) The final decision of the Commis-
presiding officer for consideration of sioner of Food and Drugs or other enti-
the additional evidence. ty deciding the appeal (currently the
(j) The Commissioner of Food and DAB) constitutes final agency action
Drugs or other entity deciding the ap- from which a respondent may petition
peal (currently the DAB) will issue a for judicial review under the statutes
decision on the appeal within 60 days, governing the matter involved. Al-
if practicable, of the due date for sub- though the filing of a petition for judi-
mission of the appellee’s brief. In the cial review does not stay a decision
decision, the entity deciding the appeal under this part, a respondent may file
may decline to review the case, affirm a petition for stay of such decision
the initial decision or decision grant- under § 10.35 of this chapter.
ing summary decision (with or without (b) The Chief Counsel of FDA has
an opinion), or reverse the initial deci- been designated by the Secretary of
sion or decision granting summary de- Health and Human Services as the offi-
cision, or increase, reduce, reverse, or cer on whom copies of petitions for ju-
remand any civil money penalty deter- dicial review are to be served. This offi-
mined by the presiding officer in the cer is responsible for filing the record
initial decision. If the entity deciding on which the final decision is based.
the appeal declines to review the case, The record of the proceeding is cer-
the initial decision or the decision tified by the entity deciding the appeal
granting summary decision shall con- (currently the DAB).
stitute the final decision of FDA and (c) Exhaustion of an appeal to the en-
shall be final and binding on the par- tity deciding the appeal (currently the
ties 30 days after the declination by the DAB) is a jurisdictional prerequisite to

entity deciding the appeal. judicial review.
272
§ 17.54 Deposit in the Treasury of the (b) The provisions of 45 CFR part 73a
United States. supplement the Department standards
All amounts assessed pursuant to of conduct and apply only to Food and
this part shall be delivered to the Di- Drug Administration employees except
rector, Division of Financial Manage- special government employees.
ment (HFA–100), Food and Drug Ad-
§ 19.6 Code of ethics for government
ministration, rm. 11–61, 5600 Fishers service.
Lane, Rockville, MD 20857, and shall be
deposited as miscellaneous receipts in The following code of ethics, adopted
the Treasury of the United States. by Congress on July 11, 1958, shall
apply to all Food and Drug Administra-
PART 19—STANDARDS OF CON- tion employees:
DUCT AND CONFLICTS OF INTER- CODE OF ETHICS FOR GOVERNMENT SERVICE
EST
Any person in Government service should:
1. Put loyalty to the highest moral prin-
ciples and to country above loyalty to per-
Sec. sons, party, or Government department.
19.1 Scope. 2. Uphold the Constitution, laws, and legal
19.5 Reference to Department regulations. regulations of the United States and of all
19.6 Code of ethics for government service. governments therein and never be a party to
19.10 Food and Drug Administration Con- their evasion.
flict of Interest Review Board. 3. Give a full day’s labor for a full day’s
pay; giving to the performance of his duties
Subpart B—Reporting of Violations his earnest effort and best thought.
4. Seek to find and employ more efficient
19.21 Duty to report violations. and economical ways of getting tasks accom-
plished.
Subpart C—Disqualification Conditions 5. Never discriminate unfairly by the dis-
pensing of special favors or privileges to any-
19.45 Temporary disqualification of former one, whether for remuneration or not; and
employees. never accept, for himself or his family, fa-
19.55 Permanent disqualification of former vors or benefits under circumstances which
employees. might be construed by reasonable persons as
AUTHORITY: 21 U.S.C. 371. influencing the performance of his govern-
mental duties.
SOURCE: 42 FR 15615, Mar. 22, 1977, unless 6. Make no private promises of any kind
otherwise noted. binding upon the duties of office, since a
Government employee has no private word
Subpart A—General Provisions which can be binding on public duty.
7. Engage in no business with the Govern-
§ 19.1 Scope. ment, either directly or indirectly, which is
inconsistent with the conscientious perform-
This part governs the standards of ance of his governmental duties.
conduct for, and establishes regula- 8. Never use any information coming to
tions to prevent conflicts of interest him confidentially in the performance of
by, all Food and Drug Administration governmental duties as a means for making
employees. private profit.
9. Expose corruption wherever discovered.
§ 19.5 Reference to Department regula- 10. Uphold these principles, ever conscious
tions. that public office is a public trust.
(a) The provisions of 45 CFR part 73,
establishing standards of conduct for § 19.10 Food and Drug Administration
Conflict of Interest Review Board.
all Department employees, are fully
applicable to all Food and Drug Admin- (a) The Commissioner shall establish
istration employees, except that such a permanent five-member Conflict of
regulations shall be applicable to spe- Interest Review Board, which shall re-
cial government employees, i.e., con- view and make recommendations to
sultants to the Food and Drug Admin- the Commissioner on all specific or
istration, only to the extent stated in policy matters relating to conflicts of

subpart L of 45 CFR part 73. interest arising within the Food and
273
§ 19.21 21 CFR Ch. I (4–1–19 Edition)
Drug Administration that are for- sonal privacy in violation of § 20.63 of

warded to it by: (1) The Associate Com- this chapter.
missioner for Management and Oper- [42 FR 15615, Mar. 22, 1977, as amended at 46
ations or (2) anyone who is the subject FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23,
of an adverse determination by the As- 1985; 55 FR 1404, Jan. 16, 1990; 65 FR 56479,
sociate Commissioner for Management Sept. 19, 2000; 76 FR 31469, June 1, 2011]
and Operations on any matter arising
under the conflict of interest laws, ex- Subpart B—Reporting of Violations
cept a determination of an apparent
violation of law. The Director, Division § 19.21 Duty to report violations.
of Ethics and Program Integrity, Office (a) The Office of Internal Affairs, Of-
of Management and Operations, shall fice of the Commissioner, is responsible
serve as executive secretary of the Re- for obtaining factual information for
view Board. the Food and Drug Administration on
(b) It shall be the responsibility of any matter relating to allegations of
every Food and Drug Administration misconduct, impropriety, conflict of
employee with whom any specific or interest, or other violations of Federal
policy issue relating to conflicts of in- statutes by agency personnel.
terest is raised, or who otherwise wish- (b) Any Food and Drug Administra-
tion employee who has factual infor-
es to have any such matter resolved, to
mation showing or who otherwise be-
forward the matter to the Associate
lieves that any present or former Food
Commissioner for Management and Op-
and Drug Administration employee has
erations for resolution, except that re- violated or is violating any provision of
porting of apparent violations of law this subpart or of 45 CFR parts 73 or 73a
are governed by § 19.21. or of any statute listed in appendix A
(c) All general policy relating to con- to 45 CFR part 73 should report such in-
flicts of interest shall be established in formation directly to the Office of In-
guidance documents pursuant to the ternal Affairs. Any such reports shall
provisions of § 10.90(b) of this chapter be in writing or shall with the assist-
and whenever feasible shall be incor- ance of the Office of Internal Affairs,
porated in regulations in this subpart. be reduced to writing, and shall be
(d) All decisions relating to specific promptly investigated.
individuals shall be placed in a public (c) Any report pursuant to paragraph
file established for this purpose by the (b) of this section and any records re-
Division of Freedom of Information, lating to an investigation of such re-
e.g., a determination that a consultant ports shall be maintained in strict con-
may serve on an advisory committee fidence in the files of the Office of In-
with specific limitations or with public ternal Affairs, shall be exempt from
disclosure of stock holdings, except public disclosure, and may be reviewed
that such determination shall be writ- only by authorized Food and Drug Ad-
ministration employees who are re-
ten in a way that does not identify the
quired to do so in the performance of
individual in the following situations:
their duties.
(1) A determination that an employee
must dispose of prohibited financial in- [42 FR 15615, Mar. 22, 1977, as amended at 46
terests or refrain from incompatible FR 8456, Jan. 27, 1981; 50 FR 52278, Dec. 23,
1985; 60 FR 47478, Sept. 13, 1995]
outside activities in accordance with
established Department or agency reg-
ulations. Subpart C—Disqualification
(2) A determination that a proposed Conditions
consultant is not eligible for employ- § 19.45 Temporary disqualification of
ment by the agency. former employees.
(3) A determination that public dis-
Within 1 year after termination of
closure of any information would con- employment with the Food and Drug
stitute an unwarranted invasion of per- Administration, no former Food and
Drug Administration employee, includ-

ing a special government employee,
274
shall appear personally before the Food 20.24 Preparation of new records.
and Drug Administration or other fed- 20.25 Retroactive application of regulations.
eral agency or court as agent or attor- 20.26 Indexes of certain records.
20.27 Submission of records marked as con-
ney for any person other than the fidential.
United States in connection with any 20.28 Food and Drug Administration deter-
proceeding or matter in which the minations of confidentiality.
United States is a party or has a direct 20.29 Prohibition on withdrawal of records
and substantial interest and which was from Food and Drug Administration
under his official responsibility at any files.
time within one year preceding termi- 20.30 Food and Drug Administration Free-
dom of Information Staff.
nation of such responsibility. The term 20.31 Retention schedule of requests for
official responsibility means the direct Food and Drug Administration records.
administrative or operating authority, 20.32 Disclosure of Food and Drug Adminis-
whether intermediate or final, and ei- tration employee names.
ther exercisable alone or with others, 20.33 Form or format of response.
and either personally or through subor- 20.34 Search for records.
dinates, to approve, disapprove, or oth-
Subpart C—Procedures and Fees
erwise direct government action.
20.40 Filing a request for records.
§ 19.55 Permanent disqualification of 20.41 Time limitations.
former employees. 20.42 Aggregation of certain requests.
No former Food and Drug Adminis- 20.43 Multitrack processing.
20.44 Expedited processing.
tration employee, including a special 20.45 Fees to be charged.
government employee, shall knowingly 20.46 Waiver or reduction of fees.
act as agent or attorney for anyone 20.47 Situations in which confidentiality is
other than United States in connection uncertain.
with any judicial or other proceeding, 20.48 Judicial review of proposed disclosure.
application, request for a ruling or 20.49 Denial of a request for records.
other determination, contract, claim, 20.50 Nonspecific and overly burdensome re-
quests.
controversy, charge, accusation, or 20.51 Referral to primary source of records.
other particular matter involving a 20.52 Availability of records at National
specific party or parties in which the Technical Information Service.
United States is a party or has a direct 20.53 Use of private contractor for copying.
and substantial interest and in which 20.54 Request for review without copying.
he participated personally and substan- 20.55 Indexing trade secrets and confidential
tially through decision, approval, dis- commercial or financial information.
approval, recommendation, rendering Subpart D—Exemptions
of advice, investigation, or otherwise
as a Food and Drug Administration 20.60 Applicability of exemptions.
employee. 20.61 Trade secrets and commercial or fi-
nancial information which is privileged
or confidential.
PART 20—PUBLIC INFORMATION 20.62 Inter- or intra-agency memoranda or
letters.
Subpart A—Official Testimony and 20.63 Personnel, medical, and similar files,
Information disclosure of which constitutes a clearly
unwarranted invasion of personal pri-
Sec. vacy.
20.1 Testimony by Food and Drug Adminis- 20.64 Records or information compiled for
tration employees. law enforcement purposes.
20.2 Production of records by Food and Drug 20.65 National defense and foreign policy.
Administration employees. 20.66 Internal personnel rules and practices.
20.3 Certification and authentication of 20.67 Records exempted by other statutes.
Food and Drug Administration records.
Subpart E—Limitations on Exemptions
Subpart B—General Policy
20.80 Applicability of limitations on exemp-
20.20 Policy on disclosure of Food and Drug tions.
Administration records. 20.81 Data and information previously dis-
20.21 Uniform access to records. closed to the public.

20.22 Partial disclosure of records. 20.82 Discretionary disclosure by the Com-
20.23 Request for existing records. missioner.
275
§ 20.1 21 CFR Ch. I (4–1–19 Edition)
20.83 Disclosure required by court order. SOURCE: 42 FR 15616, Mar. 22, 1977, unless
20.84 Disclosure to consultants, advisory otherwise noted.
committees, State and local government
officials commissioned pursuant to 21 Subpart A—Official Testimony and
U.S.C. 372(a), and other special govern-
ment employees. Information
20.85 Disclosure to other Federal govern-
ment departments and agencies. § 20.1 Testimony by Food and Drug
20.86 Disclosure in administrative or court Administration employees.
proceedings. (a) No officer or employee of the
20.87 Disclosure to Congress. Food and Drug Administration or of
20.88 Communications with State and local any other office or establishment in
government officials. the Department of Health and Human
20.89 Communications with foreign govern-
Services, except as authorized by the
ment officials.
20.90 Disclosure to contractors.
Commissioner of Food and Drugs pur-
20.91 Use of data or information for admin- suant to this section or in the dis-
istrative or court enforcement action. charge of his official duties under the
laws administered by the Food and
Subpart F—Availability of Specific Drug Administration, shall give any
Categories of Records testimony before any tribunal per-
taining to any function of the Food and
20.100 Applicability; cross-reference to Drug Administration or with respect to
other regulations.
20.101 Administrative enforcement records.
any information acquired in the dis-
20.102 Court enforcement records. charge of his official duties.
20.103 Correspondence. (b) Whenever a subpoena, in appro-
20.104 Summaries of oral discussions. priate form, has been lawfully served
20.105 Testing and research conducted by or upon an officer or employee of the
with funds provided by the Food and Food and Drug Administration com-
Drug Administration. manding the giving of any testimony,
20.106 Studies and reports prepared by or such officer or employee shall, unless
with funds provided by the Food and otherwise authorized by the Commis-
Drug Administration. sioner, appear in response thereto and
20.107 Food and Drug Administration manu-
als.
respectfully decline to testify on the
20.108 Agreements between the Food and grounds that it is prohibited by this
Drug Administration and other depart- section.
ments, agencies, and organizations. (c) A person who desires testimony
20.109 Data and information obtained by from any employee may make written
contract. request therefor, verified by oath, di-
20.110 Data and information about Food and rected to the Commissioner setting
Drug Administration employees. forth his interest in the matter sought
20.111 Data and information submitted vol- to be disclosed and designating the use
untarily to the Food and Drug Adminis-
to which such testimony will be put in
tration.
20.112 Voluntary drug experience reports the event of compliance with such re-
submitted by physicians and hospitals. quest: Provided, That a written request
20.113 Voluntary product defect reports. therefor made by a health, food, or
20.114 Data and information submitted pur- drug officer, prosecuting attorney, or
suant to cooperative quality assurance member of the judiciary of any State,
agreements. Territory, or political subdivision
20.115 Product codes for manufacturing or thereof, acting in his official capacity,
sales dates. need not be verified by oath. If it is de-
20.116 Drug and device registration and list-
termined by the Commissioner, or any
ing information.
20.117 New drug information. other officer or employee of the Food
20.118 Advisory committee records. and Drug Administration whom he
20.119 Lists of names and addresses. may designate to act on his behalf for
20.120 Records available in Food and Drug the purpose, that such testimony will
Administration Public Reading Rooms. be in the public interest and will pro-
AUTHORITY: 5 U.S.C. 552; 18 U.S.C. 1905; 19 mote the objectives of the act and the
agency, the request may be granted.
U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401–1403;

42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, Where a request for testimony is grant-
263b–263n, 264, 265, 300u–300u–5, 300aa–1. ed, one or more employees of the Food
276
and Drug Administration may be des- privacy, the property rights of persons
ignated to appear, in response to a sub- in trade secrets and confidential com-
poena, and testify with respect thereto. mercial or financial information, and
the need for the agency to promote
§ 20.2 Production of records by Food frank internal policy deliberations and
and Drug Administration employ- to pursue its regulatory activities
ees. without disruption.
(a) Any request for records of the (b) Except where specifically exempt
Food and Drug Administration, wheth- pursuant to the provisions of this part,
er it be by letter or by a subpena duces all Food and Drug Administration
tecum or by any other writing, shall be records shall be made available for
handled pursuant to the procedures es- public disclosure.
tablished in subpart B of this part, and (c) Except as provided in paragraph
shall comply with the rules governing (d) of this section, all nonexempt
public disclosure established in sub- records shall be made available for
parts C, D, E, and F of this part and in public disclosure upon request regard-
other regulations cross-referenced in less whether any justification or need
§ 20.100(c). for such records have been shown.
(b) Whenever a subpoena duces (d) Under § 21.71 of this chapter, a
tecum, in appropriate form, has been statement of the purposes to which the
lawfully served upon an officer or em- record requested is to be put, and a cer-
ployee of the Food and Drug Adminis- tification that the record will be so
tration commanding the production of used, may be requested when:
any record, such officer or employee (1) The requested record is contained
shall appear in response thereto, rein a Privacy Act Record System as de-
spectfully decline to produce the fined in § 21.3(c) of this chapter;
record on the ground that it is prohib- (2) The requester is a person other
ited by this section, and state that the than the individual who is the subject
production of the record(s) involved of the record that is so retrieved or a
will be handled by the procedures es- person acting on his behalf; and
tablished in this part. (3) The disclosure is one that is dis-
cretionary, i.e., not required under this
§ 20.3 Certification and authentication part.
of Food and Drug Administration (e) ‘‘Record’’ and any other term used
records. in this section in reference to informa-
(a) Upon request, the Food and Drug tion includes any information that
administration will certify the authen- would be an agency record subject to
ticity of copies of records that are re- the requirements of this part when
quested to be disclosed pursuant to this maintained by the agency in any for-
part or will authenticate copies of mat, including an electronic format.
records previously disclosed. [42 FR 15616, Mar. 22, 1977, as amended at 68
(b) A request for certified copies of FR 25285, May 12, 2003]
records or for authentication of records
shall be sent in writing to the Division § 20.21 Uniform access to records.
of Freedom of Information at the ad- Any record of the Food and Drug Ad-
dress located on the agency’s web site ministration that is disclosed in an au-
at http://www.fda.gov. thorized manner to any member of the
[42 FR 15616, Mar. 22, 1977, as amended at 46 public is available for disclosure to all
FR 8456, Jan. 27, 1981; 76 FR 31469, June 1, members of the public, except that:
2011; 79 FR 68114, Nov. 14, 2014] (a) Data and information subject to
the exemptions established in § 20.61 for
Subpart B—General Policy trade secrets and confidential commer-
cial or financial information, and in
§ 20.20 Policy on disclosure of Food § 20.63 for personal privacy, shall be dis-
and Drug Administration records. closed only to the persons for the pro-
(a) The Food and Drug Administra- tection of whom these exemptions
tion will make the fullest possible dis- exist.
closure of records to the public, con- (b) The limited disclosure of records
sistent with the rights of individuals to permitted in § 7.87(c) of this chapter for
277
§ 20.22 21 CFR Ch. I (4–1–19 Edition)
section 305 hearing records, in § 20.80(b) the Freedom of Information Act,

regarding certain limitations on ex- whether or not the Freedom of Infor-
emptions, in § 20.103(b) for certain cor- mation Act is mentioned in the re-
respondence, and in § 20.104(b) for cer- quest, and shall be governed by the
tain summaries of oral discussions, provisions of this part.
shall be subject to the special rules (b) Records or documents prepared by
stated therein. the Food and Drug Administration for
(c) Disclosure of a record about an in- routine public distribution, e.g., pam-
dividual, as defined in § 21.3(a) of this phlets, speeches, and educational mate-
chapter, that is retrieved by the indi- rials, shall be furnished free of charge
vidual’s name or other personal identi- upon request as long as the supply
fier and is contained in a Privacy Act lasts. The provisions of this part shall
Record System, as defined in § 21.3(c) of not be applicable to such requests ex-
this chapter, shall be subject to the cept when the supply of such material
special requirements of part 21 of this is exhausted and it is necessary to re-
chapter. Disclosure of such a record to produce individual copies upon specific
an individual who is the subject of the request.
record does not invoke the rule estab- (c) All existing Food and Drug Ad-
lished in this section that such records ministration records are subject to
shall be made available for disclosure routine destruction according to stand-
to all members of the public. ard record retention schedules.
[42 FR 15616, Mar. 22, 1977, as amended at 54 § 20.24 Preparation of new records.
FR 9037, Mar. 3, 1989]
(a) The Freedom of Information Act
§ 20.22 Partial disclosure of records. and the provisions of this part apply
only to existing records that are rea-
(a) If a record contains both
sonably described in a request filed
disclosable and nondisclosable informa-
with the Food and Drug Administra-
tion, the nondisclosable information
tion pursuant to the procedures estab-
will be deleted and the remaining
lished in subpart C of this part.
record will be disclosed unless the two
(b) The Commissioner may, in his
are so inextricably intertwined that it
discretion, prepare new records in
is not feasible to separate them or re-
order to respond adequately to a re-
lease of the disclosable information
quest for information when he con-
would compromise or impinge upon the
cludes that it is in the public interest
nondisclosable portion of the record.
and promotes the objectives of the act
(b)(1) Whenever information is de-
and the agency.
leted from a record that contains both
disclosable and nondisclosable informa- § 20.25 Retroactive application of regu-
tion, the amount of information de- lations.
leted shall be indicated on the portion
The provisions of this part apply to
of the record that is made available,
all records in Food and Drug Adminis-
unless including that indication would
tration files.
harm an interest protected by an ex-
emption under the Freedom of Infor- § 20.26 Indexes of certain records.
mation Act.
(a) Indexes shall be maintained, and
(2) When technically feasible, the
revised at least quarterly, for the fol-
amount of information deleted shall be
lowing Food and Drug Administration
indicated at the place in the record
records:
where the deletion is made.
(1) Final orders published in the
[42 FR 15616, Mar. 22, 1977, as amended at 68 FEDERAL REGISTER with respect to
FR 25285, May 12, 2003] every denial or withdrawal of approval
of a new drug application or a new ani-
§ 20.23 Request for existing records. mal drug application for which a public
(a) Any written request to the Food hearing has been requested.
and Drug Administration for existing (2) Statements of policy and interpre-
records not prepared for routine dis- tation adopted by the agency and still
tribution to the public shall be deemed in force and not published in the FED-
to be a request for records pursuant to ERAL REGISTER.
278
(3) Administrative staff manuals and agency until disposed of pursuant to

instructions to staff that affect a mem- routine record disposal procedures.
ber of the public. [42 FR 15616, Mar. 22, 1977, as amended at 68
(4) Records that have been released FR 25285, May 12, 2003]
to any person in response to a Freedom
of Information request and that the § 20.30 Food and Drug Administration
agency has determined have become, or Division of Freedom of Information.
are likely to become, the subject of (a) The office responsible for Agency
subsequent requests for substantially compliance with the Freedom of Infor-
the same records. mation Act and this part is the Divi-
(b) Each such index will be made sion of Freedom of Informationat the
available by accessing the agency’s web address located on the agency’s web
site at http://www.fda.gov. A printed site at http://www.fda.gov.
copy of each index is available by writ- (b) All requests for Agency records
ing or visiting the Freedom of Informa- shall be sent in writing to this office.
tion Staff’s address on the agency’s
web site at http://www.fda.gov. [76 FR 31469, June 1, 2011, as amended at 79
FR 68114, Nov. 14, 2014]
FR 8456, Jan. 27, 1981; 68 FR 25285, May 12, § 20.31 Retention schedule of requests
2003; 76 FR 31469, June 1, 2011; 79 FR 68114, for Food and Drug Administration
Nov. 14, 2014] records.
(a) Unless unusual circumstances dic-
§ 20.27 Submission of records marked
as confidential. tate otherwise, the Food and Drug Ad-
ministration shall maintain and dis-
Marking records submitted to the pose of files of requests and reponses
Food and Drug Administration as con- furnished thereto within the time lim-
fidential, or with any other similar its authorized by GSA General Records
term, raises no obligation by the Food Schedule 14, FPMR 101–11–4, January
and Drug Administration to regard 10, 1977, as follows:
such records as confidential, to return (1) Files created by the receipt of and
them to the person who has submitted response to freedom of information re-
them, to withhold them from disclo- quests, except denials and/or appeals,
sure to the public, or to advise the per- may be destroyed 2 years from date of
son submitting them when a request final response.
for their public disclosure is received (2) Files created by a freedom of in-
or when they are in fact disclosed. formation request which was wholly or
[42 FR 15616, Mar. 22, 1977, as amended at 68 partially denied may be destroyed 5
FR 25285, May 12, 2003] years after the denial letter was issued.
(3) Files created by a freedom of in-
§ 20.28 Food and Drug Administration formation request which was wholly or
determinations of confidentiality. partially denied and which denial was
A determination that data or infor- subsequently appealed to the Depart-
mation submitted to the Food and ment of Health and Human Services
Drug Administration will be held in may be destroyed 4 years after final de-
confidence and will not be available for termination by FDA or 3 years after
public disclosure shall be made only in final adjudication by courts, whichever
the form of a regulation published or is later.
cross-referenced in this part. (b) This destruction schedule will
automatically be revised whenever the
[42 FR 15616, Mar. 22, 1977, as amended at 68 time limits pertaining to these records
FR 25285, May 12, 2003]
are revised by the GSA General
§ 20.29 Prohibition on withdrawal of Records Schedule.
records from Food and Drug Ad- [47 FR 24277, June 4, 1982]
ministration files.
No person may withdraw records sub- § 20.32 Disclosure of Food and Drug
mitted to the Food and Drug Adminis- Administration employee names.
tration. All Food and Drug Administra- The names of Food and Drug Admin-
tion records shall be retained by the istration employees will not be deleted
279
§ 20.33 21 CFR Ch. I (4–1–19 Edition)
from disclosable records except where (b) A request for Food and Drug Ad-
such deletion is necessary to prevent ministration records shall reasonably
disclosure of an informant or danger to describe the records being sought, in a
the life or physical safety of the em- way that they can be identified and lo-
ployee or under other extraordinary cated. A request should include all per-
circumstances. tinent details that will help identify
the records sought.
§ 20.33 Form or format of response. (1) If the description is insufficient to
(a) The Food and Drug Administra- locate the records requested, the Food
tion shall make reasonable efforts to and Drug Administration will so notify
provide a record in any requested form the person making the request and in-
or format if the record is readily repro- dicate the additional information need-
ducible by the agency in that form or ed to identify the records requested.
format. (2) Every reasonable effort shall be
(b) If the agency determines that a made by the Food and Drug Adminis-
record is not readily reproducible in tration to assist in the identification
the requested form or format, the agen- and location of the records sought.
cy may notify the requester of alter- (c) Upon receipt of a request for
native forms and formats that are records, the Division of Freedom of In-
available. If the requester does not ex- formation shall enter it in a public log.
press a preference for an alternative in The log shall state the date received,
response to such notification, the agen- the name of the person making the re-
cy may provide its response in the form quest, the nature of the record re-
and format of the agency’s choice. quested, the action taken on the re-
[68 FR 25285, May 12, 2003] quest, the date of determination letter
sent pursuant to § 20.41(b), and the
§ 20.34 Search for records. date(s) any records are subsequently
(a) In responding to a request for furnished.
records, the Food and Drug Adminis- (d) A request by an individual, as de-
tration shall make reasonable efforts fined in § 21.3(a) of this chapter, for a
to search for records kept in electronic record about himself shall be subject
form or format, except when such ef- to:
(1) The special requirements of part
forts would significantly interfere with
21 of this chapter (the privacy regula-
the operation of the agency’s auto-
tions), and not to the provisions of this
mated information systems.
(b) The term ‘‘search’’ means to re- subpart, if the record requested is re-
view, manually or by automated trieved by the individual’s name or
means, agency records for the purpose other personal identifier and is con-
of locating those records that are retained in a Privacy Act Record Sys-
sponsive to the request. tem, as defined in § 21.3(c) of this chap-
ter.
[68 FR 25285, May 12, 2003] (2) The provisions of this subpart if
the record requested is not retrieved by
Subpart C—Procedures and Fees the individual’s name or other personal
identifier, whether or not the record is
§ 20.40 Filing a request for records. contained in a Privacy Act Record Sys-
(a) All requests for Food and Drug tem.
Administration records shall be made [42 FR 15616, Mar. 22, 1977, as amended at 46
in writing by mailing or delivering the FR 8456, Jan. 27, 1981; 68 FR 25285, May 12,
request to the Freedom of Information 2003; 76 FR 31469, June 1, 2011; 79 FR 68114,
Staff at the address on the agency’s Nov. 14, 2014]
web site at http://www.fda.gov or by
faxing it to the fax number listed on § 20.41 Time limitations.
the agency’s web site at http:// (a) All time limitations prescribed
www.fda.gov. All requests must contain pursuant to this section shall begin as
the postal address and telephone num- of the time at which a request for
ber of the requester and the name of records is logged in by the Division of
the person responsible for payment of Freedom of Information pursuant to

any fees that may be charged. § 20.40(c). An oral request for records
280
shall not begin any time requirement. separate from the agency component
A written request for records sent else- responsible for processing the request;
where within the agency shall not (B) There is a need to search for, col-
begin any time requirement until it is lect, and appropriately examine a volu-
redirected to the Division of Freedom minous amount of separate and dis-
of Information and is logged in there in tinct records that are demanded in a
accordance with § 20.40(c). single request; or
(b) Within 20 working days (excluding (C) There is need for consultation,
Saturdays, Sundays, and legal public which shall be conducted with all prac-
holidays) after a request for records is ticable speed, with another agency hav-
logged in at the Division of Freedom of ing a substantial interest in the deter-
Information, the agency shall send a mination of the request, or among two
letter to the requester providing the or more components of the Food and
agency’s determination as to whether, Drug Administration having substan-
or the extent to which, the agency will tial subject-matter interest in the de-
comply with the request, and, if any termination.
(4) If any record is denied, the letter
records are denied, the reasons for the
shall state the right of the person re-
denial.
questing such records to appeal any ad-
(1) If all of the records requested have verse determination to the Assistant
been located and a final determination Secretary for Health, Department of
has been made with respect to disclo- Health and Human Services, in accord-
sure of all of the records requested, the ance with the provisions of 45 CFR 5.34.
letter shall so state. (c) The Food and Drug Administra-
(2) If all of the records have not been tion shall provide a determination of
located or a final determination has whether to provide expedited proc-
not yet been made with respect to dis- essing within 10 calendar days of re-
closure of all of the records requested, ceipt by the Division of Freedom of In-
e.g., because it is necessary to consult formation of the request and the re-
the person affected pursuant to § 20.47, quired documentation of compelling
the letter shall state the extent to need in accordance with § 20.44(b).
which the records involved shall be dis-
closed pursuant to the rules estab- FR 8456, Jan. 27, 1981; 55 FR 1405, Jan. 16,
lished in this part. 1990; 59 FR 533, Jan. 5, 1994; 68 FR 25285, May
(3)(i) In unusual circumstances, the 12, 2003; 76 FR 31469, June 1, 2011]
agency may extend the time for send-
ing the letter for an additional period. § 20.42 Aggregation of certain re-
(A) The agency may provide for an quests.
extension of up to 10 working days by The Food and Drug Administration
providing written notice to the re- may aggregate certain requests by the
quester setting out the reasons for the same requester, or by a group of re-
extension and the date by which a de- questers acting in concert, if the re-
termination is expected to be sent. quests involve clearly related matters
(B) The agency may provide for an and the agency reasonably believes
extension of more than 10 working days that such requests actually constitute
by providing written notice to the re- a single request which would otherwise
quester setting out the reasons for the satisfy the unusual circumstances
extension. The notice also will give the specified in § 20.41(b)(3)(ii)(B). FDA may
requester an opportunity to limit the extend the time for processing aggre-
scope of the request so that it may be gated requests in accordance with the
processed in a shorter time and/or an unusual circumstances provisions of
opportunity to agree on a timeframe § 20.41.
longer than the 10 extra working days [68 FR 25286, May 12, 2003]
for processing the request.
(ii) Unusual circumstances may exist § 20.43 Multitrack processing.
under any of the following conditions: (a) Each Food and Drug Administra-
(A) There is a need to search for and tion component is responsible for de-
collect the requested records from field termining whether to use a multitrack
facilities or other components that are system to process requests for records
281
§ 20.44 21 CFR Ch. I (4–1–19 Edition)
maintained by that component. A mul- authorized representative of the indi-

titrack system provides two or more vidual, and must demonstrate a reason-
tracks for processing requests, based able basis for concluding that failure to
on the amount of work and/or time re- obtain the requested records on an ex-
quired for a request to be processed. pedited basis could reasonably be ex-
The availability of multitrack proc- pected to pose a specific and identifi-
essing does not affect expedited proc- able imminent threat to the life or
essing in accordance with § 20.44. safety of the individual.
(b) If multitrack processing is not (c) A request for expedited processing
adopted by a particular agency compo- made under paragraph (a)(2) of this sec-
nent, that component will process all tion must demonstrate that:
requests in a single track, ordinarily (1) The requester is primarily en-
on a first-in, first-out basis. gaged in disseminating information to
(c) If a multitrack processing system the general public and not merely to a
is established by a particular agency narrow interest group;
component, that component may deter- (2) There is an urgent need for the re-
mine how many tracks to establish and quested information and that it has a
the specific criteria for assigning re- particular value that will be lost if not
quests to each track. Multiple tracks obtained and disseminated quickly;
may be established for requests based however, a news media publication or
on the amount of work and/or time re- broadcast deadline alone does not qual-
quired for a request to be processed. ify as an urgent need, nor does a re-
(d) Requests assigned to a given quest for historical information; and
track will ordinarily be processed on a (3) The request for records specifi-
first-in, first-out basis within that cally concerns identifiable operations
track. or activities of the Federal Govern-
(e) If a request does not qualify for ment.
the fastest processing track, the re- (d) All requests for expedited proc-
quester may be provided an oppor- essing shall be filed in writing as pro-
tunity to limit the scope of the request vided by § 20.40. Each such request shall
in order to qualify for faster proc- include information that demonstrates
essing. a reasonable basis for concluding that
[68 FR 25286, May 12, 2003] a compelling need exists within the
meaning of paragraph (a) of this sec-
§ 20.44 Expedited processing. tion and a certification that the infor-
(a) The Food and Drug Administra- mation provided in the request is true
tion will provide expedited processing and correct to the best of the request-
of a request for records when the re- er’s knowledge and belief. Any state-
quester demonstrates a compelling ments made in support of a request for
need, or in other cases as determined expedited processing are subject to the
by the agency. A compelling need ex- False Reports to the Government Act
ists when: (18 U.S.C. 1001).
(1) A failure to obtain requested (e) The Assistant Commissioner for
records on an expedited basis could rea- Public Affairs (or delegatee) will deter-
sonably be expected to pose an immi- mine whether to grant a request for ex-
nent threat to the life or physical safe- pedited processing within 10 days of re-
ty of an individual; or ceipt by the Division of Freedom of In-
(2) With respect to a request made by formation of all information required
a person primarily engaged in dissemi- to make a decision.
nating information, there is a dem- (f) If the agency grants a request for
onstrated urgency to inform the public expedited processing, the agency shall
concerning actual or alleged Federal process the request as soon as prac-
Government activity. ticable.
(b) A request for expedited processing (g) If the agency denies a request for
made under paragraph (a)(1) of this sec- expedited processing, the agency shall
tion must be made by the specific indi- process the request with other non-
vidual who is subject to an imminent expedited requests.
threat, or by a family member, medical (h) If the agency denies a request for
or health care professional, or other expedited processing, the requester
282
may appeal the agency’s decision by for the operator’s time, multiplied by
writing to the official identified in the 2.
denial letter. (3) If, under paragraph (a)(2) or (a)(3)
[68 FR 25286, May 12, 2003, as amended at 76 of this section, there is no charge for
FR 31469, June 1, 2011] the first 100 pages of duplication, then
those 100 pages are the first 100 pages
§ 20.45 Fees to be charged. of photocopies of standard size pages,
(a) Categories of requests. Paragraphs or the first 100 pages of computer print-
(a) (1) through (3) of this section state, out. If this method to calculate the fee
for each category of request, the type reduction cannot be used, then the
of fees that the Food and Drug Admin- total duplication fee will be reduced by
istration will generally charge. How- the normal charge for photocopying a
ever, for each of these categories, the standard size page, multiplied by 100.
fees may be limited, waived, or reduced (4) No charge will be made if the
for the reasons given in paragraphs (b) costs of routine collection and proc-
and (c) of this section and in § 20.46 or essing of the fee are likely to equal or
for other reasons. exceed the amount of the fee.
(1) Commercial use request. If the re-
(5) If it is determined that a re-
quest is for a commercial use, the Food
and Drug Administration will charge quester (acting either alone or together
for the costs of search, review, and du- with others) is breaking down a single
plication. request into a series of requests in
(2) Educational and scientific institu- order to avoid (or reduce) the fees
tions and news media. If the request is charged, all these requests may be ag-
from an educational institution or a gregated for purposes of calculating
noncommercial scientific institution, the fees charged.
operated primarily for scholarly or sci- (6) Interest will be charged on unpaid
entific research, or a representative of bills beginning on the 31st day fol-
the news media, and the request is not lowing the day the bill was sent. Provi-
for a commercial use, the Food and sions in 45 CFR part 30, the Depart-
Drug Administration will charge only ment of Health and Human Services
for the duplication of documents. Also, regulations governing claims collec-
the Food and Drug Administration will tion, will be used in assessing interest,
not charge the copying costs for the administrative costs, and penalties,
first 100 pages of duplication. and in taking actions to encourage
(3) Other requests. If the request is not payment.
the kind described in paragraph (a)(1) (c) Fee schedule. The Food and Drug
or (a)(2) of this section, then the Food Administration charges the following
and Drug Administration will charge
fees in accordance with the regulations
only for the search and the duplication.
of the Department of Health and
Also, the Food and Drug Administra-
Human Services at 45 CFR part 5.
tion will not charge for the first 2
hours of search time or for the copying (1) Manual searching for or reviewing
costs of the first 100 pages of duplica- of records. When the search or review is
tion. performed by employees at grade GS–1
(b) General provisions. (1) The Food through GS–8, an hourly rate based on
and Drug Administration may charge the salary of a GS–5, step 7, employee;
search fees even if the records found when done by a GS–9 through GS–14, an
are exempt from disclosure or if no hourly rate based on the salary of a
records are found. GS–12, step 4, employee; and when done
(2) If, under paragraph (a)(3) of this by a GS–15 or above, an hourly rate
section, there is no charge for the first based on the salary of a GS–15, step 7,
2 hours of search time, and those 2 employee. In each case, the hourly rate
hours are spent on a computer search, will be computed by taking the current
then the 2 free hours are the first 2 hourly rate for the specified grade and
hours of the operator’s own operation. step, adding 16 percent of that rate to
If the operator spends less than 2 hours cover benefits, and rounding to the
on the search, the total search fees will nearest whole dollar. When a search in-
be reduced by the average hourly rate volves employees at more than one of
283
§ 20.46 21 CFR Ch. I (4–1–19 Edition)
these levels, the Food and Drug Admin- employees, at the rates given in para-
istration will charge the rate appro- graph (c)(1) of this section.
priate for each. (d) Procedures for assessing and col-
(2) Computer searching and printing. lecting fees—(1) Agreement to pay. The
The actual cost of operating the com- Food and Drug Administration gen-
puter plus charges for the time spent erally assumes that a requester is will-
by the operator, at the rates given in ing to pay the fees charged for services
paragraph (c)(1) of this section. associated with the request. The re-
(3) Photocopying standard size pages. quester may specify a limit on the
$0.10 per page. Freedom of Information amount to be spent. If it appears that
Officers may charge lower fees for par- the fees will exceed the limit, the Food
ticular documents where: and Drug Administration will consult
the requester to determine whether to
(i) The document has already been
proceed with the search.
printed in large numbers;
(2) Advance payment. If a requester
(ii) The program office determines has failed to pay previous bills in a
that using existing stock to answer timely fashion, or if the Food and Drug
this request, and any other anticipated Administration’s initial review of the
Freedom of Information requests, will request indicates that the charges will
not interfere with program require- exceed $250, the requester will be re-
ments; and quired to pay past due fees and/or the
(iii) The Freedom of Information Of- estimated fees, or a deposit, before the
ficer determines that the lower fee is search for the requested records begins.
adequate to recover the prorated share In such cases, the requester will be no-
of the original printing costs. tified promptly upon receipt of the re-
(4) Photocopying odd-size documents quest, and the administrative time
(such as punchcards or blueprints), or re- limits prescribed in § 20.41 will begin
producing other records (such as tapes). only after there is an agreement with
The actual costs of operating the ma- the requester over payment of fees, or
chine, plus the actual cost of the mate- a decision that fee waiver or reduction
rials used, plus charges for the time is appropriate.
spent by the operator, at the rates (3) Billing and payment. Ordinarily,
given in paragraph (c)(1) of this sec- the requester will be required to pay
tion. all fees before the Food and Drug Ad-
(5) Certifying that records are true cop- ministration will furnish the records.
ies. This service is not required by the At its discretion, the Food and Drug
Freedom of Information Act. If the Administration may send the requester
Food and Drug Administration agrees a bill along with or following the
to provide certification, there is a $10 records. For example, the Food and
charge per certification. Drug Administration may do this if the
(6) Sending records by express mail or requester has a history of prompt pay-
other special methods. This service is not ment. The Food and Drug Administra-
required by the Freedom of Informa- tion may also, at its discretion, aggre-
tion Act. If the Food and Drug Admin- gate the charges for certain time peri-
istration agrees to provide this service, ods in order to avoid sending numerous
the requester will be required to di- small bills to frequent requesters, or to
rectly pay, or be directly charged by, businesses or agents representing re-
the courier. The agency will not agree questers. For example, the Food and
to any special delivery method that Drug Administration might send a bill
does not permit the requester to di- to such a requester once a month. Fees
rectly pay or be directly charged for should be paid in accordance with the
the service. instructions furnished by the person
(7) Performing any other special service who responds to the request.
in connection with a request to which the [59 FR 533, Jan. 5, 1994. Redesignated and
Food and Drug Administration has amended at 68 FR 25286, May 12, 2003]
agreed. Actual costs of operating any
machinery, plus actual cost of any ma- § 20.46 Waiver or reduction of fees.
terials used, plus charges for the time (a) Standard. The Assistant Commis-
of the Food and Drug Administration’s sioner for Public Affairs (or delegatee)
284
will waive or reduce the fees that test of furthering the specific public in-
would otherwise be charged if disclo- terest described in paragraph (b) of this
sure of the information meets both of section, the Food and Drug Adminis-
the following tests: tration will determine whether disclo-
(1) Is in the public interest because it sure also furthers the requester’s com-
is likely to contribute significantly to mercial interest and, if so, whether
public understanding of the operations this effect outweighs the advancement
or activities of the Government; and of that public interest. In applying this
(2) It is not primarily in the commer- second test, the Food and Drug Admin-
cial interest of the requester. These istration will consider the following
two tests are explained in paragraphs factors:
(b) and (c) of this section. (1) Whether disclosure would further
(b) Public interest. Disclosure of infor- a commercial interest of the requester,
mation satisfies the first test only if it or of someone on whose behalf the re-
furthers the specific public interest of quester is acting. Commercial interests
being likely to contribute significantly include interests relating to business,
to public understanding of Government trade, and profit. Both profit and non-
operations or activities, regardless of profit-making corporations have com-
any other public interest it may fur- mercial interests, as well as individ-
ther. In analyzing this question, the uals, unions, and other associations.
Food and Drug Administration will The interest of a representative of the
consider the following factors: news media in using the information
(1) Whether the records to be dis- for news dissemination purposes will
closed pertain to the operations or ac- not be considered a commercial inter-
tivities of the Federal Government; est.
(2) Whether disclosure of the records (2) If disclosure would further a com-
would reveal any meaningful informa- mercial interest of the requester,
tion about Government operations or whether that effect outweighs the ad-
activities that is not already public vancement of the public interest as de-
knowledge; fined in paragraph (b) of this section.
(3) Whether disclosure will advance (d) Deciding between waiver and reduc-
the understanding of the general public tion. If the disclosure of the informa-
as distinguished from a narrow seg- tion requested passes both tests de-
ment of interested persons. Under this scribed in paragraphs (b) and (c) of this
factor, the Food and Drug Administra- section, the Food and Drug Adminis-
tion may consider whether the re- tration will normally waive fees. How-
quester is in a position to contribute to ever, in some cases the Food and Drug
public understanding. For example, the Administration may decide only to re-
Food and Drug Administration may duce the fees. For example, the Food
consider whether the requester has and Drug Administration may do this
such knowledge or expertise as may be when disclosure of some but not all of
necessary to understand the informa- the requested records passes the tests.
tion, and whether the requester’s in- (e) Procedure for requesting a waiver or
tended use of the information would be reduction. A requester must request a
likely to disseminate the information waiver or reduction of fees at the same
to the public. An unsupported claim to time as the request for records. The re-
be doing research for a book or article quester should explain why a waiver or
does not demonstrate that likelihood, reduction is proper under the factors
while such a claim by a representative set forth in paragraphs (a) through (d)
of the news media is better evidence; of this section. Only the Associate
and Commissioner for Public Affairs may
(4) Whether the contribution to pub- make the decision whether to waive or
lic understanding will be a significant reduce the fees. If the Food and Drug
one, i.e., will the public’s under- Administration does not completely
standing of the Government’s oper- grant the request for a waiver or reduc-
ations be substantially greater as a re- tion, the denial letter will designate a
sult of the disclosure. review official. The requester may ap-
(c) Not primarily in the requester’s com- peal the denial to that official. The ap-
mercial interest. If disclosure passes the peal letter should address reasons for
285
§ 20.47 21 CFR Ch. I (4–1–19 Edition)
the Associate Commissioner’s decision (c) A letter denying a request for

that are set forth in the denial letter. records, in whole or in part, shall state
the reasons for the denial and shall
[59 FR 534, Jan. 5, 1994. Redesignated and
amended at 68 FR 25286, 25287, May 12, 2003] state that an appeal may be made to
the Deputy Assistant Secretary for
§ 20.47 Situations in which confiden- Public Affairs (Media), Department of
tiality is uncertain. Health and Human Services. The agen-
In situations where the confiden- cy will also make a reasonable effort to
tiality of data or information is uncer- include in the letter an estimate of the
tain and there is a request for public volume of the records denied, unless
disclosure, the Food and Drug Adminis- providing such an estimate would harm
tration will consult with the person an interest protected by an exemption
who has submitted or divulged the data under the Freedom of Information Act.
or information or who would be af- This estimate will ordinarily be pro-
fected by disclosure before determining vided in terms of the approximate
whether or not such data or informa- number of pages or some other reason-
tion is available for public disclosure. able measure. This estimate will not be
provided if the volume of records de-
[42 FR 15616, Mar. 22, 1977. Redesignated at 68 nied is otherwise indicated through de-
FR 25286, May 12, 2003] letions on records disclosed in part.
§ 20.48 Judicial review of proposed (d) Minor deletions of nondisclosable
disclosure. data and information from disclosable
records shall not be deemed to be a de-
Where the Food and Drug Adminis- nial of a request for records.
tration consults with a person who will
be affected by a proposed disclosure of [42 FR 15616, Mar. 22, 1977, as amended at 46
data or information contained in Food FR 8457, Jan. 27, 1981; 55 FR 1405, Jan. 16,
1990. Redesignated and amended at 68 FR
and Drug Administration records pur-
25286, 25287, May 12, 2003]
suant to § 20.47, and rejects the person’s
request that part or all of the records § 20.50 Nonspecific and overly burden-
not be made available for public disclo- some requests.
sure, the decision constitutes final The Food and Drug Administration
agency action that is subject to judi- will make every reasonable effort to
cial review pursuant to 5 U.S.C. chap- comply fully with all requests for dis-
ter 7. The person affected will be per- closure of nonexempt records. Nonspe-
mitted 5 days after receipt of notifica- cific requests or requests for a large
tion of such decision within which to number of documents that require the
institute suit in a United States Dis- deployment of a substantial amount of
trict Court to enjoin release of the agency man-hours to search for and
records involved. If suit is brought, the compile will be processed taking into
Food and Drug Administration will not account the staff-hours required, the
disclose the records involved until the tasks from which these resources must
matter and all related appeals have be diverted, the impact that this diver-
been concluded. sion will have upon the agency’s con-
[42 FR 15616, Mar. 22, 1977. Redesignated and sumer protection activities, and the
amended at 68 FR 25286, 25287, May 12, 2003] public policy reasons justifying the re-
quests. A decision on the processing of
§ 20.49 Denial of a request for records. such a request for information shall be
(a) A denial of a request for records, made after balancing the public benefit
in whole or in part, shall be signed by to be gained by the disclosure against
the Assistant Commissioner for Public the public loss that will result from di-
Affairs (or delegatee). verting agency personnel from their
(b) The name and title or position of other responsibilities. In any situation
each person who participated in the de- in which it is determined that a re-
nial of a request for records shall be set quest for voluminous records would un-
forth in the letter denying the request. duly burden and interfere with the op-
This requirement may be met by at- erations of the Food and Drug Admin-
taching a list of such individuals to the istration, the person making the re-
letter. quest will be asked to be more specific
286
and to narrow the request, and to agree § 20.54 Request for review without
on an orderly procedure for the produc- copying.
tion of the requested records, in order (a) A person requesting disclosure of
to satisfy the request without dis- records shall be permitted an oppor-
proportionate adverse effects on agen- tunity to review them without the ne-
cy operations. cessity for copying them where the
[42 FR 15616, Mar. 22, 1977. Redesignated at 68 records involved contain only
FR 25286, May 12, 2003] disclosable data and information.
Under these circumstances, the Food
§ 20.51 Referral to primary source of and Drug Administration will charge
records. only for the costs of searching for the
records.
Upon receipt of a request for a record
(b) Where a request is made for re-
or document which is contained in
view of records without copying, and
Food and Drug Administration files
the records involved contain both
but which is available elsewhere at a
disclosable and nondisclosable informa-
lower cost, the person requesting the tion, the records containing
record or document shall be referred to nondisclosable information shall first
the primary source of the record or be copied with the nondisclosable in-
document. formation blocked out and the Food
[42 FR 15616, Mar. 22, 1977. Redesignated at 68 and Drug Administration will charge
FR 25286, May 12, 2003] for the costs of searching and copying.
[42 FR 15616, Mar. 22, 1977. Redesignated at 68
§ 20.52 Availability of records at Na- FR 25286, May 12, 2003]
tional Technical Information Serv-
ice. § 20.55 Indexing trade secrets and con-
The Food and Drug Administration is fidential commercial or financial in-
furnishing a number of records to the formation.
National Technical Information Serv- Whenever the Food and Drug Admin-
ice (NTIS), 5285 Port Royal Rd., Spring- istration denies a request for a record
field, VA 22162, which reproduces and or portion thereof on the grounds that
distributes such information to the the record or portion thereof is exempt
public at cost. A single copy of each from public disclosure as trade secret
such record shall be available for pub- or confidential commercial or financial
lic review at the Food and Drug Ad- data and information under § 20.61, and
ministration. All persons requesting the person requesting the record subse-
copies of such records shall be an- quently contests the denial in the
swered by referring the person request- courts, the Food and Drug Administra-
ing the records to NTIS. tion will so inform the person affected,
i.e., the person who submitted the
[42 FR 15616, Mar. 22, 1977, as amended at 54 record, and will require that such per-
FR 9038, Mar. 3, 1989. Redesignated at 68 FR son intervene to defend the exempt sta-
25286, May 12, 2003] tus of the record. If a court requires
the Food and Drug Administration to
§ 20.53 Use of private contractor for itemize and index such records, the
copying. Food and Drug Administration will so
The Food and Drug Administration inform the person affected and will re-
may furnish requested records to a pri- quire that such person undertake the
vate contractor for copying after dele- itemization and indexing of the
tion of all nondisclosable data and in- records. If the affected person fails to
formation. Under these circumstances, intervene to defend the exempt status
the Food and Drug Administration will of the records and to itemize and index
charge the person requesting the the disputed records, the Food and
records for all of the fees involved pur- Drug Administration will take this
suant to § 20.45. failure into consideration in deciding
whether that person has waived such
[42 FR 15616, Mar. 22, 1977. Redesignated and exemption so as to require the Food
amended at 68 FR 25286, 25287, May 12, 2003] and Drug Administration to promptly
287
§ 20.60 21 CFR Ch. I (4–1–19 Edition)
make the records available for public ministration which fall within the defi-
disclosure. nitions of a trade secret or confidential
[42 FR 15616, Mar. 22, 1977, as amended at 59 commercial or financial information
FR 535, Jan. 5, 1994. Redesignated at 68 FR are not available for public disclosure.
25286, May 12, 2003] (d) A person who submits records to
the Government may designate part or
Subpart D—Exemptions all of the information in such records
as exempt from disclosure under ex-
§ 20.60 Applicability of exemptions. emption 4 of the Freedom of Informa-
(a) The exemptions established in tion Act. The person may make this
this subpart shall apply to all Food and designation either at the time the
Drug Administration records, except as records are submitted to the Govern-
provided in subpart E of this part. Ac- ment or within a reasonable time
cordingly, a record that is ordinarily thereafter. The designation must be in
available for public disclosure in ac- writing. Where a legend is required by
cordance with the provisions in subpart a request for proposals or request for
F of this part or of another regulation quotations, pursuant to 48 CFR 352.215–
cross-referenced in § 20.100(c) is not 12, then that legend is necessary for
available for such disclosure to the ex- this purpose. Any such designation will
tent that it falls within an exemption expire 10 years after the records were
contained in this subpart, except as submitted to the Government.
provided by the limitations on exemp- (e) The procedures in this paragraph
tions specified in subpart E of this apply to records on which the sub-
part. For example, correspondence that mitter has designated information as
is ordinarily disclosable under § 20.103 provided in paragraph (d) of this sec-
is not disclosable to the extent that it tion. These procedures also apply to
contains trade secrets exempt from dis- records that were submitted to the
closure under § 20.61 and is not subject Food and Drug Administration when
to discretionary release under § 20.82. the agency has substantial reason to
(b) Where application of one or more believe that information in the records
exemptions results in a record being could reasonably be considered exempt
disclosable in part and nondisclosable under exemption 4 of the Freedom of
in part, the rule established in § 20.22 Information Act. Certain exceptions to
shall apply. these procedures are set forth in para-
§ 20.61 Trade secrets and commercial graph (f) of this section.
or financial information which is (1) When the Food and Drug Adminis-
privileged or confidential. tration receives a request for such
(a) A trade secret may consist of any records and determines that disclosure
commercially valuable plan, formula, may be required, the Food and Drug
process, or device that is used for the Administration will make reasonable
making, preparing, compounding, or efforts to notify the submitter about
processing of trade commodities and these facts. The notice will include a
that can be said to be the end product copy of the request, and it will inform
of either innovation or substantial ef- the submitter about the procedures and
fort. There must be a direct relation- time limits for submission and consid-
ship between the trade secret and the eration of objections to disclosure. If
productive process. the Food and Drug Administration
(b) Commercial or financial informa- must notify a large number of submit-
tion that is privileged or confidential ters, notification may be done by post-
means valuable data or information ing or publishing a notice in a place
which is used in one’s business and is of where the submitters are reasonably
a type customarily held in strict con- likely to become aware of it.
fidence or regarded as privileged and (2) The submitter has 5 working days
not disclosed to any member of the from receipt of the notice to object to
public by the person to whom it be- disclosure of any part of the records
longs. and to state all bases for its objections.
(c) Data and information submitted (3) The Food and Drug Administra-
or divulged to the Food and Drug Ad- tion will give consideration to all bases
288
that have been stated in a timely man- empt from disclosure when the sub-
ner by the submitter. If the Food and mitter had an opportunity to do so at
Drug Administration decides to dis- the time of submission of the informa-
close the records, the Food and Drug tion or within a reasonable time there-
Administration will notify the sub- after, unless the Food and Drug Admin-
mitter in writing. This notice will istration has substantial reason to be-
briefly explain why the agency did not lieve that disclosure of the information
sustain the submitter’s objections. The would result in competitive harm; or
Food and Drug Administration will in- (5) The designation appears to be ob-
clude with the notice a copy of the viously frivolous, but in this case the
records about which the submitter ob- Food and Drug Administration will
jected, as the agency proposes to dis- still give the submitter the written no-
close them. The notice will state that tice required by paragraph (e)(3) of this
the Food and Drug Administration in- section (although this notice need not
tends to disclose the records 5 working explain our decision or include a copy
days after the submitter receives the of the records), and the Food and Drug
notice unless a U.S. District Court or- Administration will notify the re-
ders the agency not to release them. quester as described in paragraph (e)(5)
(4) If a requester files suit under the of this section.
Freedom of Information Act to obtain [42 FR 15616, Mar. 22, 1977, as amended at 59
records covered by this paragraph, the FR 535, Jan. 5, 1994]
Food and Drug Administration will
promptly notify the submitter. § 20.62 Inter- or intra-agency memo-
(5) Whenever the Food and Drug Ad- randa or letters.
ministration sends a notice to a sub- All communications within the Exec-
mitter under paragraph (e)(1) of this utive Branch of the Federal govern-
section, the Food and Drug Adminis- ment which are in written form or
tration will notify the requester that which are subsequently reduced to
the Food and Drug Administration is writing may be withheld from public
giving the submitter a notice and an disclosure except that factual informa-
opportunity to object. Whenever the tion which is reasonably segregable in
Food and Drug Administration sends a accordance with the rule established in
notice to a submitter under paragraph § 20.22 is available for public disclosure.
(e)(3) of this section, the Food and
Drug Administration will notify the re- § 20.63 Personnel, medical, and similar
quester of this fact. files, disclosure of which con-
(f) The notice requirements in para- stitutes a clearly unwarranted inva-
graph (e) of this section do not apply in sion of personal privacy.
the following situations: (a) The names or other information
(1) The Food and Drug Administra- which would identify patients or re-
tion decided not to disclose the search subjects in any medical or simi-
records; lar report, test, study, or other re-
(2) The information has previously search project shall be deleted before
been published or made generally the record is made available for public
available; disclosure.
(3) Disclosure is required by a regula- (b) The names and other information
tion issued after notice and oppor- which would identify patients or re-
tunity for public comment, that speci- search subjects should be deleted from
fies narrow categories of records that any record before it is submitted to the
are to be disclosed under the Freedom Food and Drug Administration. If the
of Information Act, but in this case a Food and Drug Administration subse-
submitter may still designate records quently needs the names of such indi-
as described in paragraph (d) of this viduals, a separate request will be
section, and in exceptional cases, the made.
Food and Drug Administration may, at (c) Requests for deletion of business
its discretion, follow the notice proce- or product names prior to disclosure of
dures in paragraph (e) of this section; any record to the public shall not be
(4) The information requested has not granted on the ground of privacy, but
been designated by the submitter as ex- such deletion may be justified under
289
§ 20.64 21 CFR Ch. I (4–1–19 Edition)
another exemption established in this the person who is the subject of the re-
subpart, e.g., the exemption for trade port upon request.
secrets and confidential commercial or (2) Preemption. No State or local gov-
financial information under § 20.61. erning entity shall establish or con-
(d) Names of individuals conducting tinue in effect any law, rule, regula-
investigations, studies, or tests on tion, or other requirement that per-
products or ingredients shall not be de- mits or requires disclosure of the iden-
leted prior to disclosure of any record tities of the voluntary reporter or
to the public unless extraordinary cir- other person identified in an adverse
cumstances are shown. event report except as provided in this
(e) A request for all records relating section.
to a specific individual will be denied [42 FR 15616, Mar. 22, 1977, as amended at 60
as a clearly unwarranted invasion of FR 16968, Apr. 3, 1995]
personal privacy unless accompanied
by the written consent of the indi- § 20.64 Records or information com-
vidual named. piled for law enforcement purposes.
(f) The names and any information (a) Records or information compiled
that would identify the voluntary re- for law enforcement purposes may be
porter or any other person associated withheld from public disclosure pursu-
with an adverse event involving a ant to the provisions of this section to
human drug, biologic, or medical de- the extent that disclosure of such
vice product shall not be disclosed by records or information:
the Food and Drug Administration or (1) Could reasonably be expected to
by a manufacturer in possession of interfere with enforcement pro-
such reports in response to a request, ceedings;
demand, or order. Information that (2) Would deprive a person to a right
would identify the voluntary reporter to a fair trial or an impartial adjudica-
or persons identified in the report in- tion;
cludes, but is not limited to, the name, (3) Could reasonably be expected to
address, institution, or any other infor- constitute an unwarranted invasion of
mation that would lead to the identi- personal privacy;
ties of the reporter or persons identi- (4) Could reasonably be expected to
fied in a report. This provision does not disclose the identity of a confidential
affect disclosure of the identities of resource, including a State, local, or for-
porters required by a Federal statute eign agency or authority or any pri-
or regulation to make adverse event re- vate institution which furnished infor-
ports. Disclosure of the identities of mation on a confidential basis; and in-
such reporters is governed by the appli- formation furnished by a confidential
cable Federal statutes and regulations. source in the case of a record compiled
(1) Exceptions. (i) Identities may be by the Food and Drug Administration
disclosed if both the voluntary reporter or any other criminal law enforcement
and the person identified in an adverse authority in the course of a criminal
event report or that person’s legal rep- investigation or by an agency con-
resentative consent in writing to dis- ducting a lawful national security in-
closure, but neither FDA nor any man- telligence investigation;
ufacturer in possession of such reports (5) Would disclose techniques and
shall be required to seek consent for procedures for law enforcement inves-
disclosure from the voluntary reporter tigations or prosecutions or would dis-
or the person identified in the adverse close guidelines for law enforcement
event report or that person’s legal rep- investigations or prosecutions, if such
resentative; or disclosure could reasonably be ex-
(ii) Identities of the voluntary re- pected to risk circumvention of the
porter and the person who experienced law; or
the reported adverse event may be dis- (6) Could reasonably be expected to
closed pursuant to a court order in the endanger the life or physical safety of
course of medical malpractice litiga- any individual.
tion involving both parties; or (iii) The (b) Records include all records relat-
report, excluding the identities of any ing to regulatory enforcement action,

other individuals, shall be disclosed to including both administrative and
290
court action, which have not been dis- (ii) If it relates to court action, when
closed to any member of the public, in- a final decision has been made not to
cluding any person who is the subject recommend such action to a United
of the investigation. States attorney based upon that
(c) Any record which is disclosed to record, or a recommendation has been
any person, including any person who finally refused by a United States at-
is the subject of a Food and Drug Ad- torney, or court action has been insti-
ministration investigation, and any tuted and the matter and all related
data or information received from any appeals have been concluded, or the
person who is the subject of a Food and statute of limitations runs.
Drug Administration investigation re- (iii) If it relates to both administra-
lating to such investigation, is avail- tive and court action, when the events
able for public disclosure at that time described in both paragraph (d)(3) (i)
in accordance with the rule established and (ii) of this section have occurred.
in § 20.21, except that: (4) Prior to disclosure of any record
(1) Disclosure of such records shall be specifically reflecting consideration of
subject to the other exemptions estab- possible criminal prosecution of any
lished in this subpart and to the limi- individual, all names and other infor-
tations on exemptions established in mation that would identify an indi-
subpart E of this part. vidual who was considered for criminal
(2) The record of a section 305 hearing prosecution but who was not pros-
shall be available for public disclosure ecuted shall be deleted unless the Com-
only in accordance with the provisions missioner concludes that there is a
of § 7.87 of this chapter. compelling public interest in the dis-
(d) Records for law enforcement pur- closure of such names.
poses shall be subject to the following (e) Names and other information that
rules: would identify a Food and Drug Admin-
(1) No such record is available for istration employee shall be deleted
public disclosure prior to the consider- from records prior to public disclosure
ation of regulatory enforcement action only pursuant to § 20.32.
based upon that record’s being closed,
except as provided in § 20.82. The Com- FR 536, Jan. 5, 1994]
missioner will exercise his discretion
to disclose records relating to possible § 20.65 National defense and foreign
criminal prosecution pursuant to § 20.82 policy.
prior to consideration of criminal pros-
(a) Records or information may be
ecution being closed only very rarely
withheld from public disclosure if they
and only under circumstances that
are:
demonstrate a compelling public inter-
(1) Specifically authorized under cri-
est.
teria established by an Executive order
(2) After the consideration of regu-
to be kept secret in the interest of na-
latory enforcement action is closed,
tional defense or foreign policy; and
such records shall be made available
(2) In fact properly classified under
for public disclosure except to the ex-
such Executive order.
tent that other exemptions from dis-
(b) [Reserved]
closure in this subpart are applicable.
No statements of witnesses obtained [70 FR 41958, July 21, 2005]
through promises of confidentiality are
available for public disclosure. § 20.66 Internal personnel rules and
(3) The consideration of regulatory practices.
enforcement action based upon a par- Records or information may be with-
ticular record shall be deemed to be held from public disclosure if they are
closed within the meaning of this sec- related solely to the internal personnel
tion: rules and practices of the Food and
(i) If it relates to administrative ac- Drug Administration (FDA). Under this
tion, when a final decision has been exemption, FDA may withhold records
made not to take such action or such or information about routine internal
action has been taken and the matter agency practices and procedures. Under
has been concluded. this exemption, the agency may also
291
§ 20.67 21 CFR Ch. I (4–1–19 Edition)
withhold internal records whose re- trative or court proceedings, in

lease would help some persons cir- § 20.87(b), Congress, in § 20.88, State and
cumvent the law. local government officials, in § 20.89,
[70 FR 41958, July 21, 2005]
foreign government officials, and in
§ 20.90, contractors, which does not re-
§ 20.67 Records exempted by other sult in disclosure of the record to any
statutes. member of the public in an authorized
Records or information may be with- manner, shall not invoke the rule es-
held from public disclosure if a statute tablished in § 20.21.
specifically allows the Food and Drug (c) Disclosure to government employ-
Administration (FDA) to withhold ees and special government employees
them. FDA may use another statute to of records exempt from public disclo-
justify withholding records and infor- sure shall subject those persons to the
mation only if it absolutely prohibits same restrictions with respect to the
disclosure, sets forth criteria to guide disclosure of such records as any Food
our decision on releasing material, or and Drug Administration employee.
identifies particular types of matters (d) In the case of a record in a Pri-
to be withheld. vacy Act Record System, as defined in
§ 21.3(c) of this chapter:
[70 FR 41958, July 21, 2005] (1) The availability to an individual,
as defined in § 21.3(a), of a record about
Subpart E—Limitations on himself that is retrieved by the indi-
Exemptions vidual’s name or other personal identi-
fier and is contained in a Privacy Act
§ 20.80 Applicability of limitations on Record System shall be subject to the
exemptions. special requirements of part 21 of this
(a) The limitations on exemptions es- chapter (the privacy regulations) and
tablished in this subpart shall apply to shall not be subject to the exemptions
all Food and Drug Administration in subpart D of this part except that
records, except as specifically provided where the system is exempt and the re-
herein. Accordingly, a record that is quested record is not available under
ordinarily exempt from public disclo- § 21.61 of this chapter, the provisions of
sure in accordance with the provisions this part shall apply.
in subpart D of this part is available (2) The availability of a record about
for such disclosure to the extent that it an individual to persons other than the
falls within a limitation on the exemp- individual who is the subject of the
tion contained in this subpart. For ex- record shall be subject to the special
ample, an investigatory record that is requirements of part 21, subpart G, of
ordinarily exempt from disclosure this chapter (restrictions on disclosure
under § 20.64 is disclosable to Congress in the privacy regulations), and shall
in accordance with the provisions of not be subject to the limitations on ex-
§ 20.87. emptions in this subpart except as pro-
(b) Disclosure of a record to any vided in part 21, subpart G, of this
member of the public pursuant to the chapter.
provisions in § 20.81, data and informa-
tion previously disclosed to the public, § 20.81 Data and information pre-
in § 20.82, discretionary disclosure by viously disclosed to the public.
the Commissioner, and in § 20.83, disclo- (a) Any Food and Drug Administra-
sure pursuant to a court order, shall in- tion record that is otherwise exempt
volve the rule established in § 20.21 that from public disclosure pursuant to sub-
the record shall be made available for part D of this part is available for pub-
disclosure to all members of the public lic disclosure to the extent that it con-
who request it. Disclosure of a record tains data or information that have
only to the limited categories of per- previously been disclosed in a lawful
sons and under the conditions specified manner to any member of the public,
in § 20.84, special government employ- other than an employee or consultant
ees, in § 20.85, other Federal govern- or pursuant to other commerical ar-
ment departments and agencies, in rangements with appropriate safe-

§ 20.86, in camera disclosure in adminis- guards for secrecy.
292
(1) For purposes of this section, an (b) The Commissioner shall not make
individual shall be deemed to be a con- available for public disclosure any
sultant only if disclosure of the infor- record that is:
mation was necessary in order to per- (1) Exempt from public disclosure
form that specific consulting service pursuant to § 20.61.
and the purpose of the disclosure was (2) Exempt from public disclosure
solely to obtain that service. The num- pursuant to § 20.63.
ber of consultants who have received (3) Prohibited from public disclosure
such information shall have been lim- under statute.
ited to the number reasonably needed (4) Contained in a Privacy Act
to perform that particular consulting Record System where disclosure would
service. constitute a clearly unwarranted inva-
(2) For purposes of this section, other sion of personal privacy or is otherwise
commercial arrangements shall include in violation of 5 U.S.C. 552a(b), as ap-
licenses, contracts, and similar legal plied in part 21, subpart G, of this chap-
relationships between business associ- ter (restrictions on disclosure in the
ates. privacy regulations).
(3) For purposes of this section, data (c) Discretionary disclosure of a
and information disclosed to clinical record pursuant to this section shall
investigators or members of institu- invoke the requirement that the record
tional review committees, whether re- shall be disclosed to any person who re-
quired by regulations of the Food and quests it pursuant to § 20.21, but shall
Drug Administration, or made volun- not set a precedent for discretionary
tarily, if accompanied by appropriate disclosure of any similar or related
safeguards to assure secrecy and other- record and shall not obligate the Com-
wise in accordance with this section, missioner to exercise his discretion to
are not deemed to have been previously disclose any other record that is ex-
disclosed to any member of the public empt from disclosure.
within the meaning of paragraph (a) of [42 FR 15616, Mar. 22, 1977, as amended at 70
this section. FR 41958, July 21, 2005]
(b) Any statement relating to prior
public disclosure is subject to the False § 20.83 Disclosure required by court
Reports to the Government Act, 18 order.
U.S.C. 1001. (a) Records of the Food and Drug Ad-
ministration which the Commissioner
FR 9038, Mar. 3, 1989; 59 FR 536, Jan. 5, 1994; has determined are not available for
68 FR 25287, May 12, 2003] public disclosure, in the form of a regu-
lation published or cross-referenced in
§ 20.82 Discretionary disclosure by the this part, shall nevertheless be made
Commissioner. available for public disclosure in com-
(a) Except as provided in paragraph pliance with a final court order requir-
(b) of this section, the Commissioner ing such disclosure.
may, in his discretion, disclose part or (b) Where the Food and Drug Admin-
all of any Food and Drug Administra- istration record ordered disclosed
tion record that is otherwise exempt under paragraph (a) of this section is a
from disclosure pursuant to subpart D record about an individual that is not
of this part. The Commissioner shall available for public disclosure under
exercise his discretion to disclose such § 20.63, the Food and Drug Administra-
records whenever he determines that tion shall attempt to notify the indi-
such disclosure is in the public inter- vidual who is the subject of the record
est, will promote the objectives of the of the disclosure, by sending a notice
act and the agency, and is consistent to the individual’s last known address.
with the rights of individuals to pri- (c) Paragraph (b) of this section shall
vacy, the property rights of persons in not apply where the name or other per-
trade secrets, and the need for the sonal identifying information is de-
agency to promote frank internal pol- leted prior to disclosure.
icy deliberations and to pursue its reg- [42 FR 15616, Mar. 22, 1977, as amended at 68
ulatory activities without disruption. FR 25287, May 12, 2003]
293
§ 20.84 21 CFR Ch. I (4–1–19 Edition)
§ 20.84 Disclosure to consultants, advi- imum necessary under the cir-

sory committees, State and local cumstances.
government officials commissioned
pursuant to 21 U.S.C. 372(a), and
FR 38633, July 27, 1995]
other special government employ-
ees. § 20.87 Disclosure to Congress.
Data and information otherwise ex- (a) All records of the Food and Drug
empt from public disclosure may be Administration shall be disclosed to
disclosed to Food and Drug Adminis- Congress upon an authorized request.
tration consultants, advisory commit- (b) An authorized request for Food
tees, State and local government offi- and Drug Administration records by
cials commissioned pursuant to 21 Congress shall be made by the chair-
U.S.C. 372(a), and other special govern- man of a committee or subcommittee
ment employees for use only in their of Congress acting pursuant to com-
work with the Food and Drug Adminis- mittee business.
tration. Such persons are thereafter (c) An individual member of Congress
subject to the same restrictions with who requests a record for his own use
respect to the disclosure of such data or on behalf of any constituent shall be
and information as any other Food and subject to the same rules in this part
Drug Administration employee. that apply to any other member of the
public.
§ 20.85 Disclosure to other Federal
government departments and agen- [42 FR 15616, Mar. 22, 1977, as amended at 59
cies. FR 536, Jan. 5, 1994]
Any Food and Drug Administration § 20.88 Communications with State

record otherwise exempt from public and local government officials.
disclosure may be disclosed to other (a) A State or local government offi-
Federal government departments and cial commissioned by the Food and
agencies, except that trade secrets and Drug Administration pursuant to 21
confidential commercial or financial U.S.C. 372(a) shall have the same status
information prohibited from disclosure with respect to disclosure of Food and
by 21 U.S.C. 331(j), 21 U.S.C. 360(j)(c), 42 Drug Administration records as any
U.S.C. 263g(d) and 42 U.S.C. 263i(e) may special government employee.
be released only as provided by those (b) Communications with State and
sections. Any disclosure under this sec- local government officials with respect
tion shall be pursuant to a written to law enforcement activities under-
agreement that the record shall not be taken pursuant to a contract between
further disclosed by the other depart- the Food and Drug Administration and
ment or agency except with the writ- such officials shall be subject to the
ten permission of the Food and Drug rules for public disclosure established
Administration. in § 20.64.
(c) Communications with State and
[47 FR 10804, Mar. 12, 1982, as amended at 59 local government officials who are not
FR 536, Jan. 5, 1994]
commissioned pursuant to 21 U.S.C.
372(a) or under a contract to perform
§ 20.86 Disclosure in administrative or
court proceedings. law enforcement activities shall have
the same status as communications
Data and information otherwise ex- with any member of the public, except
empt from public disclosure may be re- that:
vealed in Food and Drug Administra- (1) Investigatory records compiled for
tion administrative proceedings pursu- law enforcement purposes by State and
ant to parts 10, 12, 13, 14, 15, 17, and 19 local government officials who perform
of this chapter or court proceedings, counterpart functions to the Food and
where data or information are rel- Drug Administration at the State and
evant. The Food and Drug Administra- local level, and trade secrets and con-
tion will take appropriate measures, or fidential commercial or financial infor-
request that appropriate measures be mation obtained by such officials,

taken, to reduce disclosure to the min- which are voluntarily disclosed to the
294
Food and Drug Administration as part (B) Disclosure would be in the inter-
of cooperative law enforcement and est of public health by reason of the
regulatory efforts, shall be exempt State government’s possessing infor-
from public disclosure to the same ex- mation concerning the safety, effec-
tent to which the records would be so tiveness, or quality of a product or in-
exempt pursuant to §§ 20.61 and 20.64, as formation concerning an investigation,
if they had been prepared by or sub- or by reason of the State government
mitted directly to Food and Drug Ad- being able to exercise its regulatory
ministration employees, except that authority more expeditiously than the
investigatory records shall be exempt Food and Drug Administration; or
from disclosure for a longer period of (C) The disclosure is to a State gov-
time if the State or local government ernment scientist visiting the Food
officials so require as a condition of and Drug Administration on the agen-
their furnishing the information to the cy’s premises as part of a joint review
Food and Drug Administration. or long-term cooperative training ef-
(2) Disclosure of investigatory fort authorized under section 708 of the
records compiled for law enforcement Federal Food, Drug, and Cosmetic Act
purposes by the Food and Drug Admin- (the act), the review is in the interest
istration to State and local govern- of public health, the Food and Drug
ment officials who perform counterpart Administration retains physical con-
functions to the Food and Drug trol over the information, the Food and
Administratrion at the State and local Drug Administration requires the vis-
level as part of cooperative law en- iting State government scientist to
forcement efforts does not invoke the sign a written commitment to protect
rule established in § 20.21 that such the confidentiality of the information,
records shall be made available for dis- and the visiting State government sci-
closure to all members of the public. entist provides a written assurance
(d)(1) The Commissioner of Food and that he or she has no financial interest
Drugs, or any other officer or employee in the regulated industry of the type
of the Food and Drug Administration that would preclude participation in
whom the Commissioner may designate the review of the matter if the indi-
to act on his or her behalf for the pur- vidual were subject to the conflict of
pose, may authorize the disclosure of interest rules applicable to the Food
confidential commercial information and Drug Administration advisory
submitted to the Food and Drug Ad- committee members under § 14.80(b)(1)
ministration, or incorporated into of this chapter. Subject to all the fore-
agency-prepared records, to State gov- going conditions, a visiting State gov-
ernment officials as part of cooperative ernment scientist may have access to
law enforcement or regulatory efforts, trade secret information, entitled to
provided that: protection under section 301(j) of the
(i) The State government agency has act, in those cases where such disclo-
provided both a written statement es- sures would be a necessary part of the
tablishing its authority to protect con- joint review or training.
fidential commercial information from (2) Except as provided under para-
public disclosure and a written com- graph (d)(1)(ii)(C) of this section, this
mitment not to disclose any such infor- provision does not authorize the disclo-
mation provided without the written sure to State government officials of
permission of the sponsor or written trade secret information concerning
confirmation by the Food and Drug Ad- manufacturing methods and processes
ministration that the information no prohibited from disclosure by section
longer has confidential status; and 301(j) of the act, unless pursuant to an
(ii) The Commissioner of Food and express written authorization provided
Drugs or the Commissioner’s designee by the submitter of the information.
makes one or more of the following de- (3) Any disclosure under this section
terminations: of information submitted to the Food
(A) The sponsor of the product appli- and Drug Administration or incor-
cation has provided written authoriza- porated into agency-prepared records

tion for the disclosure; does not invoke the rule established in
295
§ 20.89 21 CFR Ch. I (4–1–19 Edition)
§ 20.21 that such records shall be made For such officials, the statement and
available to all members of the public. commitment required by paragraph
(e)(1) The Senior Associate Commis- (e)(1)(i) of this section shall be provided
sioner for Policy, Planning, and Legis- by both the organization and the indi-
lation, or the Deputy Commissioner for vidual.
International and Constituent Rela-
tions, or any other officer or employee
FR 63381, Dec. 8, 1995; 65 FR 11887, Mar. 7,
of the Food and Drug Administration 2000]
whom the Senior Associate Commis-
sioner for Policy, Planning, and Legis- § 20.89 Communications with foreign
lation or the Deputy Commissioner for government officials.
International and Constituent Rela-
tions may designate to act on their be- Communications with foreign gov-
half for the purpose, may authorize the ernment officials shall have the same
disclosure to, or receipt from, an offi- status as communications with any
cial of a State government agency of member of the public, except that:
nonpublic, predecisional documents (a) Investigatory records compiled
concerning the Food and Drug Admin- for law enforcement purposes by for-
istration’s or the other government eign government officials who perform
agency’s regulations or other regu- counterpart functions to the Food and
latory requirements, or other non- Drug Administration in a foreign coun-
public information relevant to either try, and trade secrets and confidential
agency’s activities, as part of efforts to commercial or financial information
improve Federal-State uniformity, co- obtained by such officials, which are
operative regulatory activities, or im- voluntarily disclosed to the Food and
plementation of Federal-State agree- Drug Administration as part of cooper-
ments, provided that: ative law enforcement and regulatory
(i) The State government agency has efforts, shall be exempt from public
the authority to protect such non- disclosure to the same extent to which
public documents from public disclo- the records would be so exempt pursu-
sure and will not disclose any such doc- ant to §§ 20.61 and 20.64, as if they had
uments provided without the written been prepared by or submitted directly
confirmation by the Food and Drug Ad- to Food and Drug Administration em-
ministration that the documents no ployees, except that investigatory
longer have nonpublic status; and records shall be exempt from disclosure
(ii) The Senior Associate Commis- for a longer period of time if the for-
sioner for Policy, Planning, and Legis- eign government officials so require as
lation or the Deputy Commissioner for a condition of their furnishing the in-
International and Constituent Rela- formation to the Food and Drug Ad-
tions or their designee makes the de- ministration.
termination that the exchange is rea- (b) Disclosure of investigatory
sonably necessary to improve Federal- records compiled for law enforcement
State uniformity, cooperative regu- purposes by the Food and Drug Admin-
latory activities, or implementation of istration to foreign government offi-
Federal-State agreements. cials who perform counterpart func-
(2) Any exchange under this section tions to the Food and Drug Adminis-
of nonpublic documents does not in- tration in a foreign country as part of
voke the rule established at § 20.21 that cooperative law enforcement efforts
such records shall be made available to does not invoke the rule established in
all members of the public. § 20.21 that such records shall be made
(3) For purposes of this paragraph, available for disclosure to all members
the term official of a State government of the public.
agency includes, but is not limited to, (c)(1) The Commissioner of Food and
an agent contracted by the State gov- Drugs, or any other officer or employee
ernment, and an employee of an orga- of the Food and Drug Administration
nization of State officials having re- whom the Commissioner may designate
sponsibility to facilitate harmoni- to act on his or her behalf for the pur-
zation of State standards and require- pose, may authorize the disclosure of
ments in FDA’s areas of responsibility. confidential commercial information
296
submitted to the Food and Drug Ad- Food, Drug, and Cosmetic Act (the
ministration, or incorporated into act), in those cases where such disclo-
agency-prepared records, to foreign sures would be a necessary part of the
government officials who perform joint review or training.
counterpart functions to the Food and (2) Except as provided under para-
Drug Administration as part of cooper- graph (c)(1)(ii)(C) of this section, this
ative law enforcement or regulatory ef- provision does not authorize the disclo-
forts, provided that: sure to foreign government officials of
(i) The foreign government agency other countries of trade secret infor-
has provided both a written statement mation concerning manufacturing
establishing its authority to protect methods and processes prohibited from
confidential commercial information disclosure by section 301(j) of the act,
from public disclosure and a written unless pursuant to an express written
commitment not to disclose any such authorization provided by the sub-
information provided without the writ- mitter of the information.
ten permission of the sponsor or writ- (3) Any disclosure under this section
ten confirmation by the Food and Drug of information submitted to the Food
Administration that the information and Drug Administration or incor-
no longer has confidential status; and porated into agency-prepared records
(ii) The Commissioner of Food and does not invoke the rule established in
Drugs or the Commissioner’s designee § 20.21 that such records shall be made
makes one or more of the following de- available to all members of the public.
terminations: (d)(1) The Senior Associate Commis-
(A) The sponsor of the product appli- sioner for Policy, Planning, and Legis-
cation has provided written authoriza- lation, or the Deputy Commissioner for
tion for the disclosure; International and Constituent Rela-
(B) Disclosure would be in the inter- tions, or any other officer or employee
est of public health by reason of the of the Food and Drug Administration
foreign government’s possessing infor- whom the Senior Associate Commis-
mation concerning the safety, efficacy, sioner for Policy, Planning, and Legis-
or quality of a product or information lation or the Deputy Commissioner for
concerning an investigation; or International and Constituent Rela-
(C) The disclosure is to a foreign sci- tions may designate to act on their be-
entist visiting the Food and Drug Ad- half for the purpose, may authorize the
ministration on the agency’s premises disclosure to, or receipt from, an offi-
as part of a joint review or long-term cial of a foreign government agency of
cooperative training effort authorized nonpublic, predecisional documents
under section 708 of the act, the review concerning the Food and Drug Admin-
is in the interest of public health, the istration’s or the other government
Food and Drug Administration retains agency’s regulations or other regu-
physical control over the information, latory requirements, or other non-
the Food and Drug Administration re- public information relevant to either
quires the visiting foreign scientist to agency’s activities, as part of coopera-
sign a written commitment to protect tive efforts to facilitate global harmo-
the confidentiality of the information, nization of regulatory requirements,
and the scientist provides a written as- cooperative regulatory activities, or
surance that he or she has no financial implementation of international agree-
interest in the regulated industry of ments, provided that:
the type that would preclude participa- (i) The foreign government agency
tion in the review of the matter if the has the authority to protect such non-
individual were subject to the conflict public documents from public disclo-
of interest rules applicable to the Food sure and will not disclose any such doc-
and Drug Administration advisory uments provided without the written
committee members under § 14.80(b)(1) confirmation by the Food and Drug Ad-
of this chapter. Subject to all of the ministration that the documents no
foregoing conditions, visiting foreign longer have nonpublic status; and
scientists may have access to trade se- (ii) The Senior Associate Commis-
cret information, entitled to protec- sioner for Policy, Planning, and Legis-
tion under section 301(j) of the Federal lation or the Deputy Commissioner for
297
§ 20.90 21 CFR Ch. I (4–1–19 Edition)
International and Constituent Rela- written agreement shall include, where

tions or their designee makes the de- appropriate, provisions establishing:
termination that the exchange is rea- (1) Restrictions on access to the data
sonably necessary to facilitate global and information by the contractor, its
harmonization of regulatory require- employees, or other persons;
ments, cooperative regulatory activi- (2) Physical storage requirements;
ties, or implementation of inter- (3) Requirements for the handling
national agreements. and accountability of the data and in-
(2) Any exchange under this section formation by the contractor and its
of nonpublic documents does not in- employees;
voke the rule established in § 20.21 that (4) Limitations on reproduction,
such records shall be made available to transmission, and disclosure of the
all members of the public. data and information;
(e) For purposes of this section, the
(5) A requirement of advance ap-
term ‘‘official of a foreign government
proval by the Food and Drug Adminis-
agency’’ includes, but is not limited to,
tration of the use by the contractor of
employees (whether temporary or per-
subcontractors, vendors, or suppliers;
manent) of and agents contracted by
the foreign government, or by an inter- (6) Procedures to be followed when
national organization established by the contractor employs time-shared
law, treaty, or other governmental ac- computer operations;
tion and having responsibility to facili- (7) Methods of destroying source doc-
tate global or regional harmonization uments or related waste material; and
of standards and requirements in (8) The period during which the con-
FDA’s areas of responsibility or to pro- tractor may retain such data and infor-
mote and coordinate public health ef- mation.
forts. For such officials, the statement
and commitment required by para- § 20.91 Use of data or information for
administrative or court enforce-
graph (c)(1)(i) of this section shall be ment action.
provided on behalf of both the organi-
zation and the individual. Nothing in this part or this chapter
shall prevent the Food and Drug Ad-
[42 FR 15616, Mar. 22, 1977, as amended at 58 ministration from using any data or in-
FR 61603, Nov. 19, 1993; 60 FR 63382, Dec. 8,
formation, whether obtained volun-
1995; 65 FR 11888, Mar. 7, 2000]
tarily or involuntarily and whether or
§ 20.90 Disclosure to contractors. not it is available for public disclosure,
as the basis for taking any administra-
(a) Data and information otherwise
tive or court enforcement action with-
exempt from public disclosure may be
in its jurisdiction. Data and informa-
disclosed to contractors with the Food
tion otherwise exempt from public dis-
and Drug Administration and their em-
closure are nevertheless available for
ployees for use only in their work for
public disclosure to the extent nec-
the Food and Drug Administration.
essary to effectuate such action, e.g.,
Contractors and their employees are
the brand name, code designation, and
thereafter subject to the same legal re-
distribution information are released
strictions and penalties with respect to
when a product is recalled.
the disclosure of such data and infor-
mation as Food and Drug Administra-
tion employees. Subpart F—Availability of Specific
(b) A written agreement between the Categories of Records
Food and Drug Administration and any
contractor shall be entered into before § 20.100 Applicability; cross-reference
data and information otherwise exempt to other regulations.
from public disclosure may be disclosed (a) The provisions set forth in this
to the contractor. The contractor shall subpart or cross-referenced in para-
agree to establish and follow security graph (c) of this section state the way
precautions considered by the Food and in which specific categories of Food
Drug Administration to be necessary and Drug Administration records are
to ensure proper and confidential han- handled upon a request for public dis-
dling of the data and information. The closure. The exemptions established in
298
subpart D of this part and the limita- (12) Investigational new animal drug
tions on exemptions established in sub- notice and a new animal drug applica-
part E of this part shall be applicable tion file for an antibiotic drug, in
to all Food and Drug Administration § 514.10 of this chapter.
records, as provided in §§ 20.60 and 20.80. (13) Methadone patient records, in
Accordingly, a record that is ordinarily § 291.505(g) of this chapter.
available for public disclosure in ac- (14) Investigational new drug notice,
cordance with this part or under other in § 312.130 of this chapter.
regulations is not available for such (15) Labeling for and lists of approved
disclosure to the extent that it falls new drug applications, in § 314.430 of
within an exemption contained in sub- this chapter.
part D of this part except as provided (16) Master file for a new drug appli-
by the limitations on exemptions spec- cation, in § 312.420 of this chapter.
ified in subpart E of this part. (17) New drug application file, in
(b) The Commissioner, on his own § 314.430 of this chapter.
initiative or on the petition of any in- (18) Data and information submitted
terested person, may amend this sub- for in vitro diagnostic products, in
part or promulgate and cross-reference § 809.4 of this chapter.
additional regulations to state the sta- (19) Data and information submitted
tus of additional categories of docu- for OTC drug review, in § 330.10(a)(2) of
ments to settle pending questions or to this chapter.
reflect court decisions. (20) Investigational new drug notice
(c) In addition to the provisions of for an antibiotic drug, in § 431.70 of this
this part, rules on the availability of chapter.
the following specific categories of (21) Antibiotic drug file, in § 314.430 of
Food and Drug Administration records this chapter.
are established by regulations in this (22) [Reserved]
chapter: (23) Investigational new drug notice
(1) Section 305 hearing records, in for a biological product, in § 601.50 of
§ 7.87(c) of this chapter. this chapter.
(2) Flavor ingredient records and (24) Applications for biologics li-
notes, in § 101.22(i)(4)(iv) of this chap- censes for biological products, in
ter. § 601.51 of this chapter.
(3) Environmental assessments; find- (25) Cosmetic establishment registra-
ing of no significant impact, in § 25.51 tions, in § 710.7 of this chapter.
of this chapter, or draft and final envi- (26) Cosmetic product ingredient and
ronmental impact statements, in § 25.52 cosmetic raw material composition
of this chapter. statements, § 720.8 of this chapter.
(4) Color additive petitions, in § 71.15 (27) Cosmetic product experience re-
of this chapter. ports, in § 730.7 of this chapter.
(5) Food standard temporary permits, (28) Device premarket notification
in § 130.17(k) of this chapter. submissions, in § 807.95 of this chapter.
(6) Information on thermal proc- (29) Electronic product information,
essing of low-acid foods packaged in in §§ 1002.4 and 1002.42 of this chapter.
hermetically sealed containers, in (30) Data and information submitted
§ 108.35(l) of this chapter. to the Commissioner or to classifica-
(7) Food additive petitions, in tion panels in connection with the clas-
§§ 171.1(h) and 571.1(h) of this chapter. sification or reclassification of devices
(8) Action levels for natural and unintended for human use, in § 860.5 of
avoidable defects in food for human this chapter.
use, in § 110.110(e) of this chapter. (31) Data and information submitted
(9) Drug establishment registrations in offers to develop a proposed perform-
and drug listings, in § 207.81 of this ance standard for medical devices, in
chapter. § 861.26 of this chapter.
(10) Investigational new animal drug (32) Investigational device exemp-
notices, in § 514.12 of this chapter. tions in § 812.38 of this chapter.
(11) New animal drug application (33) Health claims petitions, in

files, in § 514.11 of this chapter. § 101.70 of this chapter.
299
§ 20.101 21 CFR Ch. I (4–1–19 Edition)
(34) Premarket approval application, tion, are available for public disclosure
in § 814.9 of this chapter. at the time such disclosure is first
(35) Report of certain adverse experi- made. Such records include correspond-
ences with a medical device, in § 803.9 of ence with companies following factory
this chapter. inspection, recall or detention re-
(36) Disqualification determination of quests, notice of refusal of admission of
an institutional review board, in an imported product, regulatory let-
§ 56.122 of this chapter. ters, information letters, Forms FD–483
(37) Disqualification determination of and FD–2275 furnished to companies
a nonclinical laboratory, in § 58.213 of after factory inspection, and similar
this chapter. records.
(38) Minutes or records regarding a (b) To the extent that any of such
public advisory committee, in § 14.65(c) records fall within the exemption for
of this chapter. investigatory records established in
(39) Data submitted regarding per- § 20.64, the Commissioner determines
sons receiving an implanted pacemaker that they are subject to discretionary
device or lead, in § 805.25 of this chap- release pursuant to § 20.82.
ter. (c) Records relating to administra-
(40) Humanitarian device exemption tive enforcement action that are not
application, in § 814.122 of this chapter. disclosed to any member of the public
(41) Premarket notifications for food constitute investigatory records that
contact substances, in § 170.102 of this are subject to the rules for disclosure
chapter. established in § 20.64. For example, an
(42) Registration of food facilities, in establishment inspection report is an
§ 1.243 of this chapter. investigatory record and thus subject
(43) Minor-use or minor-species to § 20.64 except insofar as the Commis-
(MUMS) drug designations, in § 516.52 of sioner exercises his discretion to re-
this chapter. lease it pursuant to § 20.82.
(44) Minor-species drug index listings,
in § 516.171 of this chapter. § 20.102 Court enforcement records.
(45) Postmarket notifications of a (a) All records and documents filed in
permanent discontinuance or an inter- the courts are available for public dis-
ruption in manufacturing of certain closure unless the court orders other-
drugs or biological products, in wise. The Food and Drug Administra-
§§ 310.306, 314.81(b)(3)(iii), and 600.82 of tion will make available for public dis-
this chapter. closure such records or documents if
(46) Generally recognized as safe the agency can determine that it has
(GRAS) notices, in part 170, subpart E an accurate copy of the actual record
and part 570, subpart E of this chapter. or document filed in the court. If the
[42 FR 15616, Mar. 22, 1977, as amended at 42 Food and Drug Administration cannot
FR 19989, Apr. 15, 1977; 42 FR 42526, Aug. 28, determine whether it has an accurate
1977; 42 FR 58889, Nov. 11, 1977; 43 FR 32993, copy of such a record or document, the
July 28, 1978; 51 FR 22475, June 19, 1986; 54 FR person requesting a copy shall be re-
9038, Mar. 3, 1989; 58 FR 2533, Jan. 6, 1993; 59 ferred to the court involved.
FR 536, Jan. 5, 1994; 61 FR 33244, June 26, 1996; (b) After a recommendation for court
62 FR 40592, July 29, 1997; 64 FR 56448, Oct. 20, action has been finally refused by a
1999; 67 FR 13717, Mar. 26, 2002; 67 FR 35729,
United States attorney, the cor-
May 21, 2002; 68 FR 58965, Oct. 10, 2003; 72 FR
41017, July 26, 2007; 72 FR 69118, Dec. 6, 2007; respondence with the United States at-
80 FR 38938, July 8, 2015; 81 FR 45409, July 14, torney and the Department of Justice
2016; 81 FR 55046, Aug. 17, 2016; 81 FR 60212, with respect to that recommendation,
Aug. 31, 2016] including the pleadings recommended
for filing with the court, is available
§ 20.101 Administrative enforcement for public disclosure. Prior to disclo-
records. sure of any record specifically reflect-
(a) All Food and Drug Administra- ing consideration of possible criminal
tion records relating to administrative prosecution of any individual, all
enforcement action disclosed to any names and other information that
member of the public, including the would identify an individual who was
person who is the subject of such ac- considered for criminal prosecution but
300
who was not prosecuted shall be de- by or with funds provided by the Food
leted unless the Commissioner con- and Drug Administration is available
cludes that there is a compelling public for public disclosure.
interest in the disclosure of such (b) Any contract relating to agency
names. testing and research, and any progress
report relating thereto, is available for
§ 20.103 Correspondence. public disclosure.
(a) All correspondence to and from (c) The results of all testing or re-
members of the public, members of search conducted by or with funds pro-
Congress, organization or company of- vided by the Food and Drug Adminis-
ficials, or other persons, except mem- tration, such as toxicological testing,
bers of the Executive Branch of the compliance assays, methodology stud-
Federal Government and special gov- ies, and product testing, are available
ernment employees, is available for for public disclosure when the final re-
public disclosure. port is complete and accepted by the
(b) Any such correspondence is avail- responsible Food and Drug Administra-
able for public disclosure at the time tion official, after deletion of any in-
that it is sent or received by the Food formation that would reveal confiden-
and Drug Administration unless a dif- tial investigative techniques and pro-
ferent time for such disclosure is speci- cedures, e.g., the use of ‘‘markers’’ to
fied in other rules established or cross- document adulteration of a product. If
referenced in this part, e.g., cor- such results are disclosed in an author-
respondence relating to an IND notice ized manner to any member of the pub-
or an NDA in § 314.430 of this chapter. lic before the final report is available,
[42 FR 15616, Mar. 22, 1977, as amended at 54 they are immediately available for
FR 9038, Mar. 3, 1989] public disclosure to any member of the
public who requests them.
§ 20.104 Summaries of oral discussions. (d) Access to all raw data, slides,
(a) All written summaries of oral dis- worksheets, and other similar working
cussions, whether in person or by tele- materials shall be provided at the same
phone, with members of the public, time that the final report is disclosed.
members of Congress, organization or
company officials, or other persons, ex- § 20.106 Studies and reports prepared
cept members of the Executive Branch by or with funds provided by the
of the Federal government or special Food and Drug Administration.
government employees, are available (a) The following types of reports and
for public disclosure. studies prepared by or with funds pro-
(b) Any such summary is available vided by the Food and Drug Adminis-
for public disclosure at the time that it tration are available for public disclo-
is prepared by the Food and Drug Ad- sure upon their acceptance by the re-
ministration unless a different time for sponsible agency official:
such disclosure is specified in other (1) Quarterly and annual reports of
rules established or cross-referenced in the agency.
this part, e.g., summaries of oral dis- (2) External investigations or review
cussions relating to a food additive pe- of agency needs and performance.
tition in § 171.1(h)(3) of this chapter. (3) Surveys, compilations, and sum-
(c) If more than one summary of an maries of data and information.
oral discussion exists in a Food and
(4) Consumer surveys.
Drug Administration file, all such sum-
maries shall be disclosed in response to (5) Compliance surveys.
any request for such summary. (6) Compliance programs, except that
names of specific firms, the location of
§ 20.105 Testing and research con- specific activities, and details about
ducted by or with funds provided sampling numbers or sizes shall be de-
by the Food and Drug Administra- leted until implementation of the pro-
tion. gram is completed.
(a) Any list that may be prepared by (7) Work plans prepared by Food and
the Food and Drug Administration of Drug Administration centers, field of-
testing and research being conducted fices, and other components, except
301
§ 20.107 21 CFR Ch. I (4–1–19 Edition)
that names of specific firms, the loca- General Counsel, are available for pub-
tion of specific activities, and details lic disclosure.
about sampling numbers or sizes shall
be deleted until implementation of the FR 8457, Jan. 27, 1981; 46 FR 14340, Feb. 27,
plan is completed. 1981; 68 FR 25287, May 12, 2003; 76 FR 31469,
(b) The following types of reports and June 1, 2011; 79 FR 68115, Nov. 14, 2014]
studies prepared by or with funds pro-
vided by the Food and Drug Adminis- § 20.108 Agreements between the Food
tration are not available for public dis- and Drug Administration and other
departments, agencies, and organi-
closure: zations.
(1) Internal audits of agency needs
and performance. (a) All written agreements and un-
(2) Records relating to the internal derstandings signed by the Food and
Drug Administration and other depart-
planning and budget process.
ments, agencies, and organizations are
(3) Legislative proposals or com-
available for public disclosure.
ments prior to submission to Congress.
(b) All written agreements and
[42 FR 15616, Mar. 22, 1977, as amended at 50 memoranda of understanding between
FR 8995, Mar. 6, 1985] FDA and any entity, including, but not
limited to other departments, Agen-
§ 20.107 Food and Drug Administration cies, and organizations will be made
manuals. available through the Food and Drug
(a) Food and Drug Administration Administration Web site at http://
administrative staff manuals and in- www.fda.gov once finalized.
structions that affect a member of the (c) Agreements and understandings
public are available for public disclo- signed by officials of FDA with respect
sure. An index of all such manuals is to activities of the Office of Criminal
available by writing to the Division of Investigations are exempt from the re-
Freedom of Informationat the address quirements set forth in paragraph (b)
located on the agency’s web site at of this section. Although such agree-
http://www.fda.gov.; or by visiting the ments and understandings will not be
Division of Freedom of Information made available through the FDA Web
Public Reading Room, located in rm. site, these agreements will be available
1050, at the same address. The index for disclosure in response to a request
from the public after deletion of infor-
and all manuals created by the agency
mation that would disclose confiden-
on or after November 1, 1996, will be
tial investigative techniques or proce-
made available through the Internet at
dures, or information that would dis-
http://www.fda.gov. close guidelines for law enforcement
(b) Manuals relating solely to inter- investigations if such disclosure could
nal personnel rules and practices are reasonably be expected to risk cir-
not available for public disclosure ex- cumvention of the law.
cept to the extent that the Commis-
sioner determines that they should be [42 FR 15616, Mar. 22, 1977, as amended at 46
FR 8457, Jan. 27, 1981; 58 FR 48794, 48796, Sept.
disclosed pursuant to § 20.82. 20, 1993; 76 FR 31470, June 1, 2011; 77 FR 50591,
(c) All Food and Drug Administration Aug. 22, 2012]
action levels which are used to deter-
mine when the agency will take regu- § 20.109 Data and information ob-
latory action against a violative prod- tained by contract.
uct, limits of sensitivity and varia- (a) All data and information obtained
bility of analytical methods which are by the Food and Drug Administration
used in determining whether a product by contract, including all progress re-
violates the law, and direct reference ports pursuant to a contract, are avail-
levels above which Food and Drug Ad- able for public disclosure when accept-
ministration field offices may request ed by the responsible agency official
legal action directly to the office of the except to the extent that they remain
subject to an exemption established in

subpart D of this part, e.g., they relate
302
to law enforcement matters as pro- for public disclosure unless extraor-

vided in § 20.88(b). dinary circumstances are shown:
(b) Upon the awarding of a contract (1) All safety, effectiveness, and
by the Food and Drug Administration, functionality data and information for
the technical proposal submitted by a marketed ingredient or product, ex-
the successful offeror will be available cept as provided in § 330.10(a)(2) of this
for public disclosure. All cost proposals chapter for OTC drugs.
and the technical proposals of unsuc- (2) A protocol for a test or study, un-
cessful offerors submitted in response less it is shown to fall within the ex-
to a request for proposals are exempt emption established in § 20.61 for trade
from disclosure as confidential com- secrets and confidential commercial or
mercial or financial information pursu- financial information.
ant to § 20.61. (3) Adverse reaction reports, product
experience reports, consumer com-
§ 20.110 Data and information about plaints, and other similar data and in-
Food and Drug Administration em- formation shall be disclosed as follows:
ployees. (i) If submitted by a consumer or
(a) The name, title, grade, position user of the product, the record is avail-
description, salary, work address, and able for public disclosure after deletion
work telephone number for every Food of names and other information that
and Drug Administration employee are would identify the person submitting
available for public disclosure. The the information.
home address and home telephone (ii) If submitted by the manufacturer
number of any such employee are not of the product, the record is available
available for public disclosure. for public disclosure after deletion of:
(b) Statistics on the prior employ- (a) Names and any information that
ment experience of present agency em- would identify the person using the
ployees, and subsequent employment of product.
past agency employees, are available (b) Names and any information that
for public disclosure. would identify any third party involved
with the report, such as a physician or
§ 20.111 Data and information sub- hospital or other institution.
mitted voluntarily to the Food and (c) Names and any other information
Drug Administration. that would identify the manufacturer
(a) The provisions of this section or the brand designation of the prod-
shall apply only to data and informa- uct, but not the type of product or its
tion submitted voluntarily to the Food ingredients.
and Drug Administration, whether in (iii) If submitted by a third party,
the course of a factory inspection or at such as a physician or hospital or other
any other time, and not as a part of institution, the record is available for
any petition, application, master file, public disclosure after deletion of:
or other required submission or request (a) Names and any information that
for action. Data and information that would identify the person using the
may be required to be submitted to the product.
Food and Drug Administration but (b) Names and any information that
that are submitted voluntarily instead would identify any third party involved
are not subject to the provisions of this with the report, such as a physician or
section and will be handled as if they hospital or other institution.
had been required to be submitted. (iv) If obtained through a Food and
(b) A determination that data or in- Drug Administration investigation, the
formation submitted voluntarily will record shall have the same status as
be held in confidence and will not be the initial report which led to the in-
available for public disclosure shall be vestigation, i.e., it shall be disclosed in
made only in the form of a regulation accordance with paragraph (c)(3)(i)
published or cross-referenced in this through (iii) of this section.
part. (v) Any compilation of data, informa-
(c) The following data and information, and reports prepared in a way
tion submitted voluntarily to the Food that does not reveal data or informa-
and Drug Administration are available tion which is not available for public
303
§ 20.112 21 CFR Ch. I (4–1–19 Edition)
disclosure under this section is avail- (e) For purposes of this regulation,
able for public disclosure. safety, effectiveness, and functionality
(vi) If a person requests a copy of any data include all studies and tests of an
such record relating to a specific indi- ingredient or a product on animals and
vidual or a specific incident, such re- humans and all studies and tests on the
quest will be denied unless accom- ingredient or product for identity, sta-
panied by the written consent to such bility, purity, potency, bioavailability,
disclosure of the person who submitted performance, and usefulness.
the report to the Food and Drug Ad-
ministration and the individual who is [42 FR 15616, Mar. 22, 1977, as amended at 68
the subject of the report. The record FR 25287, May 12, 2003]
will be disclosed to the individual who
is the subject of the report upon re- § 20.112 Voluntary drug experience re-
quest. ports submitted by physicians and
(4) A list of all ingredients contained hospitals.
in a food or cosmetic, whether or not it (a) A voluntary drug experience re-
is in descending order of predominance, port to the Food and Drug Administra-
or a list of all active ingredients and tion on FDA Form 3500 shall be han-
any inactive ingredients previously dled in accordance with the rules es-
disclosed to the public as defined in tablished in § 20.111(c)(3)(iii).
§ 20.81 contained in a drug, or a list of
(b) If a person requests a copy of any
all ingredients or components in a de-
such record relating to a specific indi-
vice.
vidual or a specific incident, such re-
(5) An assay method or other analyt-
ical method, unless it serves no regu- quest will be denied unless accom-
latory or compliance purpose and is panied by the written consent to such
shown to fall within the exemption es- disclosure of the person who submitted
tablished in § 20.61. the report to the Food and Drug Ad-
(d) The following data and informa- ministration and the individual who is
tion submitted voluntarily to the Food the subject of the report.
and Drug Administration are not avail- [42 FR 15616, Mar. 22, 1977, as amended at 54
able for public disclosure unless they FR 9038, Mar. 3, 1989; 62 FR 52249, Oct. 7, 1997]
have been previously disclosed to the
public as defined in § 20.81 or they re- § 20.113 Voluntary product defect re-
late to a product or ingredient that has ports.
been abandoned and they no longer rep-
resent a trade secret or confidential Voluntary reports of defects in prod-
commercial or financial information as ucts subject to the jurisdiction of the
defined in § 20.61: Food and Drug Administration are
(1) All safety, effectiveness, and available for public disclosure:
functionality data and information for (a) If the report is submitted by the
a developmental ingredient or product manufacturer, after deletion of data
that has not previously been disclosed and information falling within the ex-
to the public as defined in § 20.81. emptions established in § 20.61 for trade
(2) Manufacturing methods or proc- secrets and confidential commercial or
esses, including quality control proce- financial information and in § 20.63 for
dures. personal privacy.
(3) Production, sales, distribution, (b) If the report is submitted by any
and similar data and information, ex- person other than the manufacturer,
cept that any compilation of such data after deletion of names and other infor-
and information aggregated and pre- mation that would identify the person
pared in a way that does not reveal submitting the report and any data or
data or information which is not avail- information falling within the exemp-
able for public disclosure under this
tion established in § 20.63 for personal
provision is available for public disclo-
privacy.
sure.
(4) Quantitative or semiquantitative

formulas.
304
§ 20.114 Data and information sub- (3) A listing of new drug applications,
mitted pursuant to cooperative abbreviated new drug applications,
quality assurance agreements. which were approved since 1938 and
Data and information submitted to which are still approved, covering mar-
the Food and Drug Administration pur- keted prescription drug products ex-
suant to a cooperative quality assur- cept prescription drug products covered
ance agreement shall be handled in ac- by applications deemed approved under
cordance with the rules established in the Drug Amendments of 1962 and not
§ 20.111. yet determined to be effective in the
Drug Efficacy Study Implementation
§ 20.115 Product codes for manufac- program. The listing includes the name
turing or sales dates. of the active ingredient, the type of
dosage form, the route of administra-
Data or information in Food and
tion, the trade name of the product,
Drug Administration files which pro-
the name of the application holder, and
vide a means for deciphering or decod-
the strength or potency of the product.
ing a manufacturing date or sales date
The listing also includes, for each ac-
or use date contained on the label or in tive ingredient in a particular dosage
labeling or otherwise used in connec- form for which there is more than one
tion with a product subject to the ju- approved application, an evaluation of
risdiction of the Food and Drug Admin- the therapeutic equivalence of the drug
istration are available for public dis- products covered by such applications.
closure.
(b) Other computer printouts con-
§ 20.116 Drug and device registration taining IND and NDA information are
and listing information. available to the extent that they do
not reveal data or information prohib-
Information submitted to the Food ited from disclosure under §§ 20.61,
and Drug Administration pursuant to 312.130, and 314.430 of this chapter.
section 510(a) through (j) of the Federal
Food, Drug, and Cosmetic Act shall be [42 FR 15616, Mar. 22, 1977, as amended at 45
subject only to the special disclosure FR 72608, Oct. 31, 1980; 46 FR 8457, Jan. 27,
1981; 54 FR 9038, Mar. 3, 1989; 64 FR 399, Jan.
provisions established in §§ 207.81 and 5, 1999]
807.37 of this chapter.
[81 FR 60212, Aug. 31, 2016] § 20.118 Advisory committee records.
All advisory committee records shall
§ 20.117 New drug information. be handled in accordance with the rules
(a) The following computer printouts established in parts 10, 12, 13, 14, 15, 16,
are available for public inspection in and 19 of this chapter.
the Food and Drug Administration’s
Freedom of Information Public Room: § 20.119 Lists of names and addresses.
(1) A numerical listing of all new Names and addresses of individuals in
drug applications and abbreviated new Food and Drug Administration records
drug applications approved since 1938, shall not be sold or rented. Names and
showing the NDA number, the trade addresses shall not be disclosed if dis-
name, the applicant, the approval date, closure is prohibited as a clearly un-
and, where applicable, the date the ap- warranted invasion of personal privacy,
proval was withdrawn and the date the e.g., lists of names and home addresses
Food and Drug Administration was no- of Food and Drug Administration em-
tified that marketing of the product ployees, which shall not be disclosed
was discontinued. under § 20.110.
(2) A numerical listing of all new
drug applications and abbreviated new § 20.120 Records available in Food and
drug applications approved since 1938 Drug Administration Public Read-
which are still approved, showing the ing Rooms.
same information as is specified in (a) The Freedom of Information Staff
paragraph (a)(1) of this section except and the Division of Dockets Manage-
that it does not show a withdrawal ment Public Reading Room are located
date. at the same address. Both are located
305
in rm. 1061, 5630 Fishers Lane, Rock- found at http://www.fda.gov. At the

ville, MD 20852. The telephone number agency’s discretion, the Food and Drug
for the Division of Docket Management Administration may also make avail-
is 301–827–6860; the telephone number able through the Internet such addi-
for the Freedom of Information Staff’s tional records and information it be-
Public Reading Room is located at the lieves will be useful to the public.
address on the agency’s web site at
[68 FR 25287, May 12, 2003; 68 FR 65392, Nov.
http://www.fda.gov. Both public reading 20, 2003, as amended at 76 FR 31470, June 1,
rooms are open from 9 a.m. to 4 p.m., 2011; 79 FR 68115, Nov. 14, 2014]
Monday through Friday, excluding
legal public holidays.
(b) The following records are avail- PART 21—PROTECTION OF
able at the Division of Freedom of In- PRIVACY
formation Public Reading Room:
(1) A guide for making requests for Subpart A—General Provisions
records or information from the Food Sec.
and Drug Administration; 21.1 Scope.
(2) Administrative staff manuals and 21.3 Definitions.
instructions to staff that affect a mem- 21.10 Policy concerning records about indi-
ber of the public; viduals.
(3) Food and Drug Administration
records which have been released to Subpart B—Food and Drug Administration
any person in response to a Freedom of Privacy Act Record Systems
Information request and which the
21.20 Procedures for notice of Food and
agency has determined have become or Drug Administration Privacy Act Record
are likely to become the subject of sub- Systems.
sequent requests for substantially the 21.21 Changes in systems and new systems.
same records;
(4) Indexes of records maintained in Subpart C—Requirements for Specific
the Division of Freedom of Information Categories of Records
Public Reading Room; and
(5) Such other records and informa- 21.30 Records of contractors.
tion as the agency determines are ap- 21.31 Records stored by the National Ar-
chives and Records Administration.
propriate for inclusion in the public
21.32 Personnel records.
reading room. 21.33 Medical records.
(c) The following records are avail-
able in the Division of Dockets Man- Subpart D—Procedures for Notification of
agement’s Public Reading Room: and Access to Records in Privacy Act
(1) Final opinions, including concur- Record Systems
ring and dissenting opinions, as well as
orders, made in the adjudication of 21.40 Procedures for submitting requests for
cases; notification and access.
(2) Statements of policy and interpre- 21.41 Processing of requests.
21.42 Responses to requests.
tation adopted by the agency that are
21.43 Access to requested records.
still in force and not published in the
21.44 Verification of identity.
FEDERAL REGISTER; 21.45 Fees.
(3) Indexes of records maintained in
the Division of Dockets Management’s Subpart E—Procedures for Requests for
Public Reading Room; and Amendment of Records
(4) Such other records and informa-
tion as the agency determines are ap- 21.50 Procedures for submitting requests for
propriate for inclusion in the public amendment of records.
reading room. 21.51 Responses to requests for amendment
of records.
(d) The agency will make reading
21.52 Administrative appeals of refusals to
room records created by the Food and amend records.
Drug Administration on or after No- 21.53 Notation and disclosure of disputed
vember 1, 1996, available electronically
records.
through the Internet at the agency’s 21.54 Amended or disputed records received
World Wide Web site which can be from other agencies.
306
Subpart F—Exemptions tions) and other regulations referred to

therein determine when Food and Drug
21.60 Policy.
21.61 Exempt systems. Administration records are disclosable
21.65 Access to records in exempt systems. to members of the public generally.
Subpart G of this part limits the provi-
Subpart G—Disclosure of Records in Pri- sions of part 20 of this chapter with re-
vacy Act Record Systems to Persons spect to disclosures of records about in-
Other Than the Subject Individual dividuals from Privacy Act Record Sys-
tems to persons other than individuals
21.70 Disclosure and intra-agency use of
records in Privacy Act Record Systems; who are the subjects of the records.
no accounting required. (3) Make available information com-
21.71 Disclosure of records in Privacy Act piled by the Food and Drug Adminis-
Record Systems; accounting required. tration in reasonable anticipation of
21.72 Individual consent to disclosure of court litigation or formal administra-
records to other persons. tive proceedings. The availability of
21.73 Accuracy, completeness, timeliness,
such information to any member of the
and relevance of records disclosed from
Privacy Act Record Systems. public, including any subject indi-
21.74 Providing notice that a record is dis- vidual or party to such litigation or
puted. proceeding shall be governed by appli-
21.75 Rights of legal guardians. cable constitutional principles, rules of
AUTHORITY: 21 U.S.C. 371; 5 U.S.C. 552, 552a. discovery, and part 20 of this chapter
(the public information regulations).
otherwise noted.
(4) Apply to personnel records main-
tained by the Division of Human Re-
sources Management, Food and Drug
Subpart A—General Provisions Administration, except as provided in
§ 21.1 Scope. § 21.32. Such records are subject to reg-
ulations of the Office of Personnel
(a) This part establishes procedures Management in 5 CFR parts 293, 294,
to implement the Privacy Act of 1974 (5 and 297.
U.S.C. 552a). It applies to records about
individuals that are maintained, col- [42 FR 15626, Mar. 22, 1977, as amended at 46
lected, used, or disclosed by the Food FR 8457, Jan. 27, 1981; 50 FR 52278, Dec. 23,
1985]
and Drug Administration and con-
tained in Privacy Act Record Systems.
§ 21.3 Definitions.
(b) This part does not:
(1) Apply to Food and Drug Adminis- As used in this part:
tration record systems that are not (a) Individual means a natural living
Privacy Act Record Systems or make person who is a citizen of the United
available to an individual records that States or an alien lawfully admitted
may include references to him but that for permanent residence. Individual
are not retrieved by his name or other does not include sole proprietorships,
personal identifier, whether or not con- partnerships, or corporations engaged
tained in a Privacy Act Record Sys- in the production or distribution of
tem. part 20 of this chapter (the public products regulated by the Food and
information regulations) and other reg- Drug Administration or with which the
ulations referred to therein determine Food and Drug Administration has
when records are made available in business dealings. Any such business
such cases. enterprise that is identified by the
(2) Make any records available to name of one or more individuals is not
persons other than (i) individuals who an individual within the meaning of
are the subjects of the records, (ii) per- this part. Employees of regulated busi-
sons accompanying such individuals ness enterprises are considered individ-
under § 21.43, (iii) persons provided uals. Accordingly, physicians and other
records pursuant to individual consent health professionals who are engaged
under § 21.72, or (iv) persons acting on in business as proprietors of establish-
behalf of such individuals as legal ments regulated by the Food and Drug
guardians under § 21.75. Part 20 of this Administration are not considered in-
chapter (the public information regula- dividuals; however, physicians and
307
§ 21.10 21 CFR Ch. I (4–1–19 Edition)
other health professionals who are en- § 21.10 Policy concerning records
gaged in clinical investigations, em- about individuals.
ployed by regulated enterprises, or the Information about individuals in
subjects of records concerning their Food and Drug Administration records
own health, e.g., exposure to excessive shall be collected, maintained, used,
radiation, are considered individuals. and disseminated so as to protect the
Food and Drug Administration employ- right to privacy of the individual to
ees, consultants, and advisory com- the fullest possible extent consistent
mittee members, State and local offi- with laws relating to disclosure of in-
cials, and consumers are considered information to the general public, the
dividuals. law enforcement responsibilities of the
(b) Records about individuals means agency, and administrative and pro-
items, collections, or groupings of in- gram management needs.
formation about individuals contained
in Privacy Act Record Systems, includ- Subpart B—Food and Drug Ad-
ing, but not limited to education, fi-
nancial transactions, medical history,
ministration Privacy Act
criminal history, or employment his- Record Systems
tory, that contain names or personal § 21.20 Procedures for notice of Food
identifiers. and Drug Administration Privacy
(c) Privacy Act Record System means a Act Record Systems.
system of records about individuals (a) The Food and Drug Administra-
under the control of the Food and Drug tion shall issue in the FEDERAL REG-
Administration from which informa- ISTER on or before August 30 of each
tion is retrieved by individual names or year a notice concerning each Privacy
other personal identifiers. The term in- Act Record System as defined in
cludes such a system of records wheth- § 21.3(c) that is not covered by a notice
er subject to a notice published by the published by the Department, the Of-
Food and Drug Administration, the De- fice of Personnel Management, or an-
partment, or another agency. Where other agency.
records are retrieved only by personal (b) The notice shall include the fol-
identifiers other than individual lowing information:
names, a system of records is not a Pri- (1) The name and location(s) of the
vacy Act Record System if the Food system.
and Drug Administration cannot, by (2) The categories of individuals
reference to information under its con- about whom records are maintained in
trol, or by reference to records of con- the system.
tractors that are subject to this part (3) The categories of records main-
under § 21.30, ascertain the identity of tained in the system.
individuals who are the subjects of the (4) The authority for the system.
records. (5) Each routine use of the records
(d) Personal identifiers includes indi- contained in the system (i.e., use out-
vidual names, identifying numbers, side the Department of Health and
symbols, or other identifying designa- Human Services that is compatible
tions assigned to individuals. Personal with the purpose for which the records
identifiers does not include names, num- were collected and described in the no-
bers, symbols, or other identifying des- tice) including the categories of users
ignations that identify products, estab- and the purposes of such use.
lishments, or actions. (6) The policies and practices of the
(e) Personnel records means any per- Food and Drug Administration regard-
sonal information maintained in a Pri- ing storage, retrievability (i.e., how the
vacy Act Record System that is needed records are indexed and what intra-
for personnel management programs or agency uses are made of the records),
processes such as staffing, employee access controls, retention, and disposal
development, retirement, and griev- of the records in that system.
ances and appeals. (7) The title and business address of
(f) Department means Department of the official who is responsible for the
Health and Human Services. system of records.
308
(8) The notification procedure, i.e., as to create the potential for greater
the address of the FDA Privacy Act Co- access, such as adding a telecommuni-
ordinator, whom any individual can cations capability.
contact to seek notification whether (c) The Food and Drug Administra-
the system contains a record about tion shall issue a notice of its intention
him/her. to establish new Privacy Act Record
(9) The record access and contest pro- Systems in accordance with paragraph
cedures, which shall be the same as the (d) of this section and § 21.20(b).
notification procedure except that a (d) Notices under paragraphs (b) and
reference shall be included to any ex- (c) of this section shall be published in
emption from access and contest. the FEDERAL REGISTER for comment at
(10) Where any records in the system least 30 days prior to implementation
are subject to an exemption under of the proposed changes or establish-
§ 21.61, a reference to this exemption. ment of new systems. Interested per-
(11) The categories of sources of sons shall have the opportunity to sub-
records in the system. mit written data, views, or arguments
on such proposed new uses or systems.
FR 8457, Jan. 27, 1981]
Subpart C—Requirements for
§ 21.21 Changes in systems and new Specific Categories of Records
systems.
(a) The Food and Drug Administra- § 21.30 Records of contractors.
tion shall notify the designated De- (a) Systems of records that are re-
partment official, the Office of Man- quired to be operated, or as a matter of
agement and Budget (Information Sys- practical necessity must be operated,
tems Division), and the Congress of by contractors to accomplish Food and
proposals to change or establish Pri- Drug Administration functions, from
vacy Act Record Systems in accord- which information is retrieved by indi-
ance with procedures of the Depart- vidual names or other personal identi-
ment and the Office of Management fiers, may be subject to the provisions
and Budget. of this part. If the contract is agreed to
(b) The Food and Drug Administra- on or after September 27, 1975, the
tion shall issue a notice, in accordance criminal penalties set forth in 5 U.S.C.
with paragraph (d) of this section and 552a(i) are applicable to such con-
§ 21.20(b), of any change in a Privacy tractor, and any employee of such con-
Act Record System which: tractor, for disclosures prohibited in
(1) Increases the number or types of § 21.71 or for maintenance of a system
individuals about whom records are of records without notice as required in
maintained; § 21.20.
(2) Expands the type or amount of in- (b) A contract is considered to ac-
formation about individuals that is complish a Food and Drug Administra-
maintained; tion function if the proposal or activity
(3) Increases the number of cat- it supports is principally operated on
egories of agencies or other persons behalf of and is under the direct man-
who may have access to those records; agement of the Food and Drug Admin-
(4) Alters the manner in which the istration. Systems of records from
records are organized so as to change which information is retrieved by indi-
the nature or scope of those records, vidual names or other personal identi-
such as the combining of two or more fiers and that are operated under con-
existing systems; tracts to accomplish Food and Drug
(5) Modifies the way in which the sys- Administration functions are deemed
tem operates or its location(s) in a to be maintained by the agency and
manner that alters the process by shall be subject to the procedures and
which individuals can exercise their requirements of this part.
rights under this part, such as the ways (c) A contract is not considered to ac-
in which they seek access or request complish a Food and Drug Administra-
amendment of a record; or tion function if the program or activity
(6) Changes the equipment configura- it supports is not principally operated

tion on which the system is operated so on behalf of, or is not under the direct
309
§ 21.31 21 CFR Ch. I (4–1–19 Edition)
management of, the Food and Drug Ad- contract or as a matter of practical ne-
ministration. For example, this part cessity. If such operation will be re-
does not apply to systems of records: quired, the solicitation and contract
(1) Operated under contract with the shall include the following clause, or a
Food and Drug Administration by clause of similar effect:
State or local government agencies, or
Whenever the contractor or any of his em-
organizations representing such agen- ployees is required by this contract to oper-
cies, when such agencies or organiza- ate a system of records from which informa-
tions are also performing State or local tion is retrieved by individual names or
government functions. other personal identifiers in order to accom-
(2) Operated by contractors with the plish a Food and Drug Administration func-
Food and Drug Administration by indi- tion, the contractor and every employee is
viduals or organizations whose primary considered to be an employee of the Food
and Drug Administration and shall operate
function is delivery of health services,
such system of records in accordance with
such as hospitals, physicians, phar- the Privacy Act of 1974 (5 U.S.C. 552a), regu-
macists, and other health profes- lations of the Food and Drug Administration
sionals, and that report information in 21 CFR part 21, and rules of conduct that
concerning products, e.g., injuries or apply to Food and Drug Administration em-
product defects, to the Food and Drug ployees who work with such systems of
Administration. Before such contrac- records. The contractor and his employees
tors submit information to the Food are subject to the criminal penalties set
forth in 5 U.S.C. 552a(i) for violations of the
and Drug Administration, the names
Privacy Act.
and other personal identifiers of pa-
tients or research subjects in any med- § 21.31 Records stored by the National
ical or similar report, test, study, or Archives and Records Administra-
other research project shall be deleted, tion.
unless the contract provides otherwise. (a) Food and Drug Administration
If the Food and Drug Administration records that are stored, processed, and
subsequently needs the names of such serviced by the National Archives and
individuals, a separate request will be Records Administration in accordance
made. with 44 U.S.C. 3103 shall be considered
(3) Relating to individuals whom the to be maintained by the Food and Drug
contractor employs, or with whom the Administration. The National Archives
contractor otherwise deals, in the and Records Administration shall not
course of providing goods and services disclose the record except to author-
to the Food and Drug Administration. ized Food and Drug Administration
(4) Operated under grants. employees.
(d) The requirements of this part
(b) Each Food and Drug Administra-
shall apply when a contractor who op-
tion record pertaining to an identifi-
erates a system of records not subject
able individual that was transferred to
to this part reports to the Food and
the National Archives of the United
Drug Administration information that
States as a record determined by the
is a system of records about individuals
National Archives to have sufficient
from which personal information is re-
historical or other value to warrant its
trieved by names or other personal
continued preservation shall be consid-
identifiers. Where the information
ered to be maintained by the National
would be a new Privacy Act Record
Archives and shall not be subject to
System, or a change in an existing Pri-
the provisions of this part.
vacy Act Record System of a type de-
scribed in § 21.21, the Food and Drug [42 FR 15626, Mar. 22, 1977, as amended at 50
Administration shall comply with the FR 52278, Dec. 23, 1985]
requirements of § 21.21.
(e) The Food and Drug Administra- § 21.32 Personnel records.
tion will review all contracts before (a) Present and former Food and
award to determine whether operation Drug Administration employees desir-
of a system from which information is ing access to personnel records about
retrieved by individual names or other themselves should consult system no-
personal identifiers will be required of tices applicable to the agency’s per-

the contractor, by the terms of the sonnel records that are published by
310
the Office of Personnel Management be made by the Associate Commis-

and the Department as well as any no- sioner for Management and Operations
tice issued by the Food and Drug Ad- or his or her designate; and
ministration. (ii) Appeals of refusals under para-
(b)(1) The procedures of the Office of graph (b)(3)(i) of this section may be
Personnel Management at 5 CFR parts made to the Office of Personnel Man-
293, 294, and 297 rather than the proce- agement in accordance with 5 CFR
dures in § 21.33 and subparts D through 297.108(g)(3) and 297.113(b).
F of this part, govern systems of per- (c) Any other Privacy Act Record
sonnel records about Food and Drug Systems that contain personnel
Administration employees that are records, or records that otherwise con-
subject to notice published by the Of- cern agency employees, that are main-
fice of Personnel Management, i.e., tained by offices of the Food and Drug
systems that: Administration rather than the Divi-
(i) The Office of Personnel Manage- sion of Human Resources Management
ment maintains. but which are not subject to the De-
(ii) Are maintained by the Division of partment’s notice for personnel records
Human Resources Management, Food in operating offices are subject to this
and Drug Administration. part, except that refusals under this
(iii) Are maintained by Department part to grant access to or amend
Regional Offices, concerning field em- records about present or former em-
ployees. ployees shall be made by the Associate
(2) The Office of Personnel Manage- Commissioner for Management and Op-
ment’s procedures may, if necessary, be erations rather than the Associate
supplemented in the Food and Drug Commissioner for Public Affairs.
Administration Staff Manual Guide. (d) The following procedures shall
Current Food and Drug Administration govern requests under the Privacy Act
employees should mail or deliver writ- for personnel records that are main-
ten requests under the Privacy Act for tained by the operating offices of the
access to personnel records described in Food and Drug Administration in
this paragraph to the Office of Per- which employees work:
sonnel Management in accordance with (1) An employee shall upon request be
5 CFR 297.106, the Director, Division of told whether records about him are
Human Resources Management HR– maintained. An employee shall be
BETHPL RM7114, HFA–705, 7700 Wis- given access to records about himself
consin Ave., 7th & 8th floors, Bethesda, that are subject to this paragraph in
MD 20814, or the personnel officer in response to an oral or written request
the servicing HHS Regional Personnel and through informal procedures, rath-
Office. An employee may consult with er than the procedures specified in
or direct his or her request to the FDA §§ 21.40 through 21.43.
Privacy Act Coordinator (the Privacy (2) Employee identity may be
Act Coordinator is part of the Freedom verified, if necessary, by an FDA ID
of Information Staff, the address for card rather than in accordance with
which is located on the Agency Web § 21.44.
site at http://www.fda.gov). Requests for (3) Generally no fee shall be charged
access to personnel records of former for records requested under this para-
employees that are located in Federal graph. However, in cases where the
Records Centers should be directed to records requested are voluminous, a fee
the Office of Personnel Management. may be charged in accordance with
Requests under the Privacy Act for § 21.45.
amendment of personnel records should (4) Records that are subject to this
be directed to these same officials who paragraph shall be available for access
are responsible for access to personnel to an individual, except to the extent
records under this paragraph. that access is refused by the Associate
(3) With respect to records subject to Commissioner for Management and Op-
paragraph (b)(1) of this section: erations or his or her designate on the
(i) Refusal to grant access to a grounds that the record is subject to an
record, or refusal to amend a record exemption under § 21.61 or 5 CFR

upon request of an employee, shall only 297.111.
311
§ 21.33 21 CFR Ch. I (4–1–19 Edition)
(5) Requests under the Privacy Act sure to an individual of medical

for amendment of records subject to records about himself under part 20 of
this paragraph should be directed to this chapter, in addition to or in lieu of
the Director, Division of Human Re- the procedures in paragraph (b)(1), that
sources Management (HFA–400). Such are not inconsistent with § 21.41(f).
requests shall be reviewed in accord-
ance with subpart E of this part. Re- Subpart D—Procedures for Notifi-
fusal to amend a record subject to this
paragraph (d)(5) shall only be made by
cation of and Access to
the Associate Commissioner for Man- Records in Privacy Act Record
agement and Operations or his or her Systems
designate.
§ 21.40 Procedures for submitting re-
(6) Appeals of refusals under para- quests for notification and access.
graph (d) (4) or (5) of this section may
be made to the Commissioner of Food (a) An individual may request that
and Drugs, except where the Associate the Food and Drug Administration no-
Commissioner for Management and Op- tify him whether a Privacy Act Record
erations or his or her designate indi- System contains records about him
cates with his or her refusal that the that are retrieved by reference to his
appeal should be made to the Office of name or other personal identifier. An
Personnel Management. individual may at the same time, or
(7) Disclosures of records subject to after receiving notification that such a
this paragraph are subject to subpart G record about him exists, requests that
of this part. he be given access to the record.
(b) An individual desiring notifica-
FR 8457, Jan. 27, 1981; 50 FR 52278, Dec. 23, tion or access to records shall mail or
1985; 76 FR 31470, June 1, 2011; 79 FR 68115, deliver a request for records in any
Nov. 14, 2014] Food and Drug Administration Privacy
Act Records System to the FDA Pri-
§ 21.33 Medical records. vacy Act Coordinator (address is lo-
(a) In general, an individual is enti- cated on the agency web site at http://
tled to have access to any medical www.gov.fda).
records about himself in Privacy Act (c) Requests shall be in writing and
Record Systems maintained by the shall name the Privacy Act Record
Food and Drug Administration. System or Systems concerning which
(b) The Food and Drug Administra- the individual requests notification of
tion may apply the following special whether there are records about him
procedures in disclosing medical that are retrieved by reference to his
records to an individual: name or other personal identifier. To
(1) The agency may review the help assure a prompt response, an indi-
records to determine whether disclo- vidual should indicate that he is mak-
sure of the record to the individual who ing a ‘‘Privacy Act Request’’ on the en-
is the subject of the records might have velope and in a prominent manner in
an adverse effect on him. If it is deter- the letter.
mined that disclosure is not likely to (d) An individual who merely wishes
have an adverse effect on the indi- to be notified whether a Privacy Act
vidual, the record shall be disclosed to Record System contains a record about
him. If it is determined that disclosure him ordinarily need not provide any
is very likely to have an adverse effect verification of his identity other than
on the individual, he may be requested his name. The mere fact that the Food
to designate, in writing, a representa- and Drug Administration has a record
tive to whom the record shall be dis- about an individual in any of its Pri-
closed. Such representative may be a vacy Act Records Systems would not
physician, other health professional, or be likely to constitute a clearly unwar-
other responsible person who would be ranted invasion of personal privacy.
willing to review the record and discuss Where mere disclosure of the fact that
it with the individual. a record about the individual exists
(2) The availability of the record may would be a clearly unwarranted inva-
be subject to any procedures for disclo- sion of personal privacy, further
312
verification of the identity of the indi- responsible for the handling of Privacy
vidual shall be required. Act requests received by the Food and
(e) An individual who requests that Drug Administration. Requests mailed
he be given access to a copy of records or delivered to any other office shall be
about himself, if any exist, should indi- promptly redirected to the FDA Pri-
cate whether he prefers (1) to have cop- vacy Act Coordinator. Where this pro-
ies of any such records mailed to him cedure would unduly delay the agen-
in accordance with § 21.43(a)(1), which cy’s response, however, the agency em-
may involve a fee under § 21.45, includ- ployee who received the request should
ing information to verify his identity
consult with the FDA Privacy Act Co-
under § 21.44 or (2) to use the procedures
ordinator and obtain advice as to
for access in person under § 21.43(a)(2).
(f) A request for notification and ac- whether the employee can respond to
cess may be submitted under this sub- the request directly.
part concerning any Privacy Act (d) Upon receipt of a request by the
Record System that is exempt under FDA Privacy Act Coordinator, a record
§ 21.61, as indicated in the notice for the shall promptly be made that a request
system. An individual seeking access has been received and the date.
to records under § 21.65(b)(2) to inves- (e) A letter in accordance with § 21.42
tigatory records compiled for law en- responding to the request for notifica-
forcement purposes other than crimi- tion shall issue as promptly as possible
nal law enforcement purposes should after receipt of the request by the Food
submit a description of the right, ben- and Drug Administration. Upon deter-
efit, or privilege that he believes he mination by the Division of Freedom of
was denied as the result of the Food Information (address is located on the
and Drug Administration’s mainte- agency web site at http://www.gov.fda)
nance of the records. Where the system that a request for access to records is
is exempt under § 21.61, and access to appropriately treated as a request
the requested records is not granted under part 20 of this chapter rather
under § 21.65, the request shall be han- than part 21, or under both parts, the
dled under the provisions of part 20 of
time limitations prescribed in § 21.41
this chapter (the public information
shall apply. In any case, access to
regulations).
available records shall be provided as
[42 FR 15626, Mar. 22, 1977, as amended at 46 promptly as possible.
FR 8458, Jan. 27, 1981; 50 FR 52278, Dec. 23,
(f) Except as provided in § 21.32, an in-
1985; 76 FR 31470, June 1, 2011; 79 FR 68115,
Nov. 14, 2014] dividual’s access to records about him/
herself that are retrieved by his/her
§ 21.41 Processing of requests. name or other personal identifiers and
(a) An individual or his guardian contained in any Privacy Act Record
under § 21.75 shall not be required to System may only be denied by the As-
show any justification or need to ob- sociate Commissioner for Public Af-
tain notification under § 21.42 or access fairs or his or her designate. An indi-
to a record under § 21.43. vidual shall not be denied access to any
(b) The Food and Drug Administra- record that is otherwise available to
tion will determine whether a request him/her under this part except on the
by an individual for records about him- grounds that it is exempt under
self is appropriately treated as a re- § 21.65(a)(2), that it was compiled in rea-
quest under this subpart, or under the sonable anticipation of court litigation
provision of part 20 of this chapter (the of formal administrative proceedings,
public information regulations), or or to the extent that it is exempt or
both. Where appropriate, the Food and prohibited from disclosure because it
Drug Administration will consult with includes a trade secret or commercial
the individual concerning the appro- or financial information that is privi-
priate treatment of the request. leged or confidential information the
(c) The FDA Privacy Act Coordinator
disclosure of which would constitute a
in the Division of Freedom of Informa-
clearly unwarranted invasion of per-

tion (address is located on the agency
web site at http://www.gov.fda) shall be sonal privacy of another individual.
313
§ 21.42 21 CFR Ch. I (4–1–19 Edition)
(g) The FDA Privacy Act Coordinator named Privacy Act Record System is
shall ensure that records are main- not exempt from individual access and
tained of the number, status, and dis- contest under § 21.61, or the system is
position of requests under this subpart, exempt but access is allowed or re-
including the number of requests for quired under § 21.65, the letter shall in-
records exempt from access under this form him that the records exist and
subpart and other information required shall either:
for purposes of the annual report to (i) Enclose a copy of the records
Congress under the Privacy Act. These under § 21.43(a)(1) or indicate that the
temporary administrative management records will be sent under separate
records shall not be considered to be cover, where there has been adequate
Privacy Act Record Systems. All verification of the identity of the indi-
records required to be kept under this vidual under § 21.44 and the fees under
paragraph shall only include request- § 21.45 do not exceed $25, or
ing individuals’ names or personal (ii) Inform the individual of the pro-
identifiers for so long as any request cedures to obtain access to the records
for notification, access, or amendment by mail or in person under § 21.43(a)(2),
is pending. The identity of individuals as well as the approximate dates by
making request under this subpart which the requested records can be pro-
shall be regarded as confidential and vided (if the records are not then avail-
shall not be disclosed under part 20 of able), the locations at which access in
this chapter (the public information person may be had, and the informa-
regulations) to any other person or tion needed, if any, to verify the iden-
agency except as is necessary for the tity of the individual under § 21.44.
processing of requests under this sub- (3) If the named Privacy Act Record
part. System contains records about the in-
[42 FR 15626, Mar. 22, 1977, as amended at 46 dividual that are retrieved by his name
FR 8458, Jan. 27, 1981; 76 FR 31470, June 1, or other personal identifier, and the
2011; 79 FR 68115, Nov. 14, 2014] system is exempt from individual ac-
cess and contest under § 21.61 and ac-
§ 21.42 Responses to requests. cess is not allowed or required under
(a) The FDA shall respond to an indi- § 21.65, the letter should inform him
vidual’s request for notification as to that the records are exempted from ac-
whether a Privacy Act Record System cess and contest by § 21.61. The letter
contains records about him that are re- shall also inform him if the records
trieved by his name or other personal sought are not available because they
identifier by sending a letter under this were compiled in reasonable anticipa-
paragraph. tion of court litigation or formal ad-
(1) If there are no records about the ministrative proceedings or are other-
individual that are retrieved by his wise not available under § 21.41(b).
name or other personal identifier in Where appropriate, the letter shall also
the named Privacy Act Record System, indicate whether the records are avail-
or the requester is not an ‘‘individual’’ able under part 20 of this chapter (the
under § 21.3(a), the letter shall so state. public information regulations), and it
Where appropriate, the letter shall in- may disclose the records in accordance
dicate that the Food and Drug Admin- with part 20.
istration’s public information regula- (4) If the named Privacy Act Record
tions in part 20 of this chapter pre- System contains records about the in-
scribe general rules governing the dividual that are retrieved by his name
availability of information to members or other personal identifier, but a final
of the public, and that a request may determination has not yet been made
be made in accordance with part 20 of with respect to disclosure of all of the
this chapter for records that are not re- records covered by the request, e.g., be-
trieved by the requester’s name or cause it is necessary to consult another
other personal identifier from a Pri- person or agency having an interest in
vacy Act Record System. the confidentiality of the records, the
(2) If there are records about the indi- letter shall explain the circumstances
vidual that are retrieved by his name and indicate when a final answer will
or other personal identifier and the be given.
314
(b) Except as provided in § 21.32, ac- portion of the records, with the
cess to a record may only be denied by nondisclosable information blocked
the Associate Commissioner for Public out. Where the individual is not given
Affairs or his or her designate. If access a copy of the record to retain, no
to any record is denied wholly or in charge shall be made for the cost of
substantial part, the letter shall state copying a record to make it available
the right of the individual to appeal to to an individual who reviews a record
the Commissioner of Food and Drugs. in person under this paragraph.
(c) If a request for a copy of the (b) An individual may request that a
records will result in a fee of more than record be disclosed to or discussed in
$25, the letter shall specify or estimate the presence of another individual,
the fee involved. Where the individual such as an attorney. The individual
has requested a copy of any records may be required to furnish a written
about him and copying the records statement authorizing the disclosure
would result in a fee of over $50, the or discussion in such other individual’s
Food and Drug Administration shall presence.
require advance deposit as well as pay- (c) The Food and Drug Administra-
ment of any amount not yet received tion will make every reasonable effort
as a result of any previous request by to assure that records made available
the individual for a record about him- under this section can be understood
self, under this subpart or part 20 of by the individual, such as by providing
this chapter (the public information an oral or written explanation of the
regulations) before the records are records.
made available. If the fee is less than
$50, prepayment shall not be required
FR 8458, Jan. 27, 1981; 69 FR 17290, Apr. 2,
unless payment has not yet been re- 2004; 76 FR 31470, June 1, 2011; 79 FR 68115,
ceived for records disclosed as a result Nov. 14, 2014]
of a previous request by the individual
for a record about himself under this § 21.44 Verification of identity.
subpart or part 20 of this chapter. (a) An individual seeking access to
[42 FR 15626, Mar. 22, 1977, as amended at 46 records in a Privacy Act Record Sys-
FR 8458, Jan. 27, 1981] tem may be required to comply with
reasonable requirements to enable the
§ 21.43 Access to requested records. Food and Drug Administration to de-
(a) Access may be granted to re- termine his identity. The identifica-
quested records by: tion required shall be suitable consid-
(1) Mailing a copy of the records to ering the nature of the records sought.
the requesting individual, or No identification shall be required to
(2) Permitting the requesting indi- receive access to information that is
vidual to review the records in person required to be disclosed to any member
between 9 a.m. and 4 p.m. at the office of the public under part 20 of this chap-
of the FDA Privacy Act Coordinator, ter (the public information regula-
at the Division of Freedom of Informa- tions).
tion Public Reading Room (address is (b) An individual who appears in per-
located on the agency’s web site at son for access to records about himself
http://www.fda.gov), or at any Food and shall be required to provide at least
Drug Administration field office, listed one document to identify himself, e.g.,
in part 5, subpart M of this chapter, or driver’s license, passport, or alien or
at another location or time upon which voter registration card to verify his
the Food and Drug Administration and identity. If an individual does not have
the individual agree. Arrangement for any such document or requests access
such review can be made by consulta- to records about himself without ap-
tion between the FDA Privacy Act Co- pearing in person under circumstances
ordinator and the individual. An indi- in which his identity cannot be verified
vidual seeking to review records in per- from the request itself, he shall be re-
son shall generally be permitted access quired to certify in writing that he is
to the file copy, except that where the the individual he claims to be and that
records include nondisclosable infor- he understands that the knowing and

mation, a copy shall be made of that willful request for or acquisition of a
315
§ 21.45 21 CFR Ch. I (4–1–19 Edition)
record pertaining to an individual processing of the copies, and be given

under false pretenses is a criminal of- an opportunity to amend his request.
fense subject to a $5,000 fine. Payment shall be made by check or
(c) In making requests under § 21.75, a money order made payable to the
parent of a minor child or legal guard- ‘‘Food and Drug Administration,’’ and
ian of an incompetent individual may shall be sent to the Accounting Branch
be required to verify his relationship to (HFA–120), Food and Drug Administra-
the minor child or the incompetent in- tion, 5600 Fishers Lane, Rockville, MD
dividual, in addition to verifying his 20857. Advance deposit shall be required
own identity, by providing a copy of where the total amount exceeds $50.
the minor’s birth certificate, a court
order, or other evidence of guardian- FR 9038, Mar. 3, 1989]
ship.
(d) Where an individual seeks access
to particularly sensitive records, such Subpart E—Procedures for Re-
as medical records, the individual may quests for Amendment of
be required to provide additional infor- Records
mation beyond that specified in para-
graph (b) or (c) of this section, such as § 21.50 Procedures for submitting re-
the individual’s years of attendance at quests for amendment of records.
a particular educational institution, (a) An individual who received access
rank attained in the uniformed serv- to a record about himself under sub-
ices, date or place of birth, names of part D of this part may request that
parents, an occupation, or the specific the record be amended if he believes
times the individual received medical that the record or an item of informa-
treatment. tion is not accurate, relevant to a Food
and Drug Administration purpose,
§ 21.45 Fees. timely, or complete.
(a) Where applicable, fees for copying (b) Amendments under this subpart
records shall be charged in accordance shall not violate existing statute, regu-
with the schedule set forth in this sec- lation, or administrative procedure.
tion. Fees may only be charged where (1) This subpart does not permit al-
an individual has requested that a copy teration of evidence presented in the
be made of a record to which he is course of judicial proceedings or Food
granted access. No fee may be charged and Drug Administration adjudicatory
for making a search of a Privacy Act or rule making proceedings or collat-
Record System whether the search is eral attack upon that which has al-
manual, mechanical, or electronic. ready been the subject of any such pro-
Where a copy of the record must be ceedings.
made to provide access to the record, (2) If the accuracy, relevancy, timeli-
e.g., computer printout where no ness, or completeness of the records
screen reading is available, the copy may be contested in any other pending
shall be made available to the indi- or imminent agency proceeding, the
vidual without cost. Where a medical Food and Drug Administration may
record is made available to a represent- refer the individual to the other pro-
ative designated by the individual ceeding as the appropriate means to
under § 21.33, no fee will be charged. obtain relief. If the accuracy, rel-
(b) The fee schedule is as follows: evance, timeliness, or completeness of
(1) Copying of records susceptible to a record is, or has been, an issue in an-
photocopying—$.10 per page. other agency proceeding, the request
(2) Copying of records not susceptible under this section shall be disposed of
to photocopying, e.g., punch cards or in accordance with the decision in the
magnetic tapes—at actual cost to the other proceeding, absent unusual cir-
determined on a case-by-case basis. cumstances.
(3) No charge will be made if the (c) Requests to amend records shall
total amount of copying for an indi- be submitted, in writing, to the FDA
vidual does not exceed $25. Privacy Act Coordinator in accordance
(c) When a fee is to be assessed, the with § 21.40(b). Such requests shall in-
individual shall be notified prior to the clude information sufficient to enable
316
the Food and Drug Administration to additional 30 working days if notice is

locate the record, a brief description of provided to the individual explaining
the items of information requested to the circumstances of the delay.
be amended, and the reasons why the (c) The officials charged with review-
record should be amended together ing a record to determine how to re-
with any appropriate documentation or spond to a request to amend it, shall
arguments in support of the requested assess its accuracy, relevance to a
amendment. An edited copy of the Food and Drug Administration pur-
record showing the described amend-
pose, timeliness, or completeness. The
ment may be included. Verification of
determination shall be made in the
identity should be provided in accord-
ance with § 21.44. light of the purpose for which the
(d) Written acknowledgement of the records or system is used, the agency’s
receipt of a request to amend a record need for the record, and the possible
shall be provided within 10 working adverse consequences to the individual
days to the individual who requested from the record if not amended. When-
the amendment. Such acknowledge- ever the Food and Drug Administration
ment may request any additional infor- receives a request for deletion of a
mation needed to verify identity or record, or portions of a record, it shall
make a determination. No acknowl- consider anew whether the contested
edgement need be made if the request information in the record is relevant
can be reviewed, processed, and the in- and necessary to a Food and Drug Ad-
dividual notified of the agency’s agree- ministration purpose.
ment with the request or refusal within (d) If the Food and Drug Administra-
the 10-day period. tion agrees with an individual’s re-
[42 FR 15626, Mar. 22, 1977, as amended at 46 quest, it shall take the following ac-
FR 8459, Jan. 27, 1981] tions:
(1) So inform the individual in writ-
§ 21.51 Responses to requests for
amendment of records. ing.
(2) In accordance with statute, regu-
(a) The Food and Drug Administra- lation, or procedure, amend the record
tion shall take one of the following ac- to make it accurate, relevant to a Food
tions on a request for amendment of
and Drug Administration purpose,
records as promptly as possible:
timely, or complete, making note of
(1) Amend any portion of the record
which the agency has determined, the date and fact of the amendment.
based upon a preponderance of the evi- (3) If an accounting was made under
dence, is not accurate, relevant to a § 21.71(d) of a disclosure of the record
Food and Drug Administration pur- under § 21.71(a), provide a copy of the
pose, timely, or complete, and, in ac- record as amended, to all previous re-
cordance with paragraph (d)(3) of this cipients of the record.
section, inform the individual and pre- [42 FR 15626, Mar. 22, 1977, as amended at 46
vious recipients of the record that has FR 8459, Jan. 27, 1981]
been amended of the amendment.
(2) Inform the individual of its re- § 21.52 Administrative appeals of re-
fusal to amend any portion of the fusals to amend records.
record in the manner requested, the
(a) If an individual disagrees with a
reason for the refusal, and the oppor-
refusal under § 21.51(a)(2) to amend a
tunity for administrative appeal to the
record, he or she may appeal that re-
Commissioner of Food and Drugs. Ex-
cept as provided in § 21.32, such refusal fusal to the Commissioner of Food and
may only be issued by the Associate Drugs,(see the address on the agency’s
Commissioner for Public Affairs or his web site at http://www.fda.gov).
or her designate. (b) If, upon appeal, the Commissioner
(3) Where another agency was the upholds the refusal to amend the
source of and has control of the record, record as requested, he shall inform the
refer the request to that agency. individual:
(b) The agency may, for good cause, (1) Of his decision and the reasons for
extend the period for taking action an it.
317
§ 21.53 21 CFR Ch. I (4–1–19 Edition)
(2) Of the individual’s right to file (b) In any subsequent disclosure

with the Food and Drug Administra- under § 21.70 or § 21.71(a), provide a copy
tion a concise statement of the individ- of the statement of disagreement and,
ual’s reasons for disagreeing with the if the Food and Drug Administration
agency’s decision not to amend the deems it appropriate, a concise state-
record as requested. ment of the agency’s reasons for not
(3) That the statement of disagree- making the amendment(s) requested.
ment will be made available to all per- While the individual shall have access
sons listed in an accounting as having to any such statement, it shall not be
previously received the record and any subject to a request for amendment
person to whom the record is subse- under § 21.50.
quently disclosed together with, in the (c) If an accounting was made under
discretion of the Food and Drug Ad- § 21.71(d) and (e) of a disclosure of the
ministration, a brief statement sum- record under § 21.71(a), provide to all
marizing its reasons for refusing to previous recipients of the record a copy
amend the record. Any individual who of the statement of disagreement and
includes false information in the state- the agency statement, if any.
ment of disagreement filed with the
Food and Drug Administration may be § 21.54 Amended or disputed records
received from other agencies.
subject to penalties under 18 U.S.C.
1001, the False Reports to the Govern- Whenever the Food and Drug Admin-
ment Act. istration is notified that a record that
(4) That the individual has a right to it received from another agency was
seek judicial review of the refusal to amended or is the subject of a state-
amend the record. ment of disagreement, the Food and
(c) If the Commissioner on adminis- Drug Administration shall:
trative appeal or a court on judicial re- (a) Discard the record, or clearly note
view determines that the record should the amendment or the fact of disagree-
be amended in accordance with the in- ment in its copy of the record, and
dividual’s request, the Food and Drug (b) Refer persons who subsequently
Administration shall proceed in ac- request the record to the agency that
cordance with § 21.51(d). provided it.
(d) A final determination on the indi- (c) If an accounting was made under
vidual’s administrative appeal of the § 21.71 (d) and (e) of the disclosure of
initial refusal to amend the record the record under § 21.71(a), inform all
shall be concluded within 30 working previous recipients of the record about
days of the request for such review the amendment or provide to them the
under paragraph (a) of this section, un- statement of disagreement and the
less the Commissioner extends such pe- agency statement, if any.
riod for good cause and informs the in-
dividual in writing of the reasons for Subpart F—Exemptions
the delay and of the approximate date
on which a decision of the appeal can § 21.60 Policy.
be expected. It is the policy of the Food and Drug
[42 FR 15626, Mar. 22, 1977, as amended at 50 Administration that record systems
FR 52278, Dec. 23, 1985; 79 FR 68115, Nov. 14, should be exempted from the Privacy
2014] Act only to the extent essential to the
performance of law enforcement func-
§ 21.53 Notation and disclosure of dis- tions under the laws that are adminis-
puted records. tered and enforced by the Food and
When an individual has filed a state- Drug Administration or that govern
ment of disagreement under the agency.
§ 21.52(b)(2), the Food and Drug Admin-
istration shall: § 21.61 Exempt systems.
(a) Mark any portion of the record (a) Investigatory records compiled
that is disputed to assure that the for law enforcement purposes, includ-
record will clearly show that portion is ing criminal law enforcement purposes,
disputed whenever the record is dis- in the Food and Drug Administration
closed. Privacy Act Record Systems listed in
318
paragraph (b) of this section are ex- (2) Regulated Industry Employee En-
empt from the following provisions of forcement Records—HHS/FDA/ACMO/
the Privacy Act (5 U.S.C. 552a) and of 09–10–002.
this part: (3) Employee Conduct Investigative
(1) Such records are exempt from 5 Records—HHS/FDA/ACMO/09–10–0013.
U.S.C. 552a(c)(3) and § 21.71(e)(4), requir- (c) The system described in para-
ing that an individual be provided with graph (b)(3) of this section includes in-
the accounting of disclosures of records vestigatory records compiled solely for
about himself from a Privacy Act the purpose of determining suitability,
Record System. eligibility, or qualification for Federal
(2) Except where access is required civilian employment, military service,
under 5 U.S.C. 552a(k)(2) and Federal contracts, and access to classi-
§ 21.65(a)(2), (such records are exempt fied information. These records are ex-
from 5 U.S.C. 552a(d)(1) through (4) and empt from disclosure under 5 U.S.C.
(f)) and §§ 21.40 through 21.54, requiring 552a(k)(5) to the extent that the disclo-
procedures for an individual to be given sure would reveal the identity of a
notification of and access to records source who furnished information to
about himself in a Privacy Act Record the Government under a promise of
confidentiality, which must be an ex-
System and to be allowed to challenge
press promise if the information was
the accuracy, relevance, timeliness,
furnished after September 27, 1975. Any
and completeness of such records.
individual who is refused access to a
(3) Such records are exempt from 5 record that would reveal a confidential
U.S.C. 552a(e)(4)(G) and (H) and source shall be advised in a general
§ 21.20(b)(1) requiring inclusion in the way that the record includes informa-
notice for the system of information tion that would reveal a confidential
about agency procedures for notifica- source.
tion, access, and contest. (d) Records in the following Food and
(4) Such records are exempt from 5 Drug Administration Privacy Act
U.S.C. 552a(e)(3) requiring that individ- Records Systems are exempt under 5
uals asked to supply information be U.S.C. 552a(k)(2) and (k)(5) from the
provided a form outlining the author- provisions enumerated in paragraph
ity for the request, the purposes for (a)(1) through paragraph (a)(3) of this
which the information will be used, the section: FDA Records Related to Re-
routine uses in the notice for the Pri- search Misconduct Proceedings, HHS/
vacy Act Record System, and the con- FDA/OC, 09–10–0020.
sequences to the individual of not pro-
viding the information, but only with FR 8459, Jan. 27, 1981; 50 FR 52278, Dec. 23,
respect to records compiled by the 1985; 78 FR 39186, July 1, 2013]
Food and Drug Administration in a
criminal law enforcement investiga- § 21.65 Access to records in exempt
tion where the conduct of the inves- systems.
tigation would be prejudiced by such (a) Where a Privacy Act Record Sys-
procedures. tem is exempt and the requested
(b) Records in the following Food and records are unavailable under § 21.61, an
Drug Administration Privacy Act individual may nevertheless make a re-
Record Systems that concern individ- quest under § 21.40 for notification con-
uals who are subject to Food and Drug cerning whether any records about him
Administration enforcement action exist and request access to such
and consist of investigatory records records where they are retrieved by his
compiled for law enforcement purposes, name or other personal identifier.
including criminal law enforcement (b) An individual making a request
purposes, are exempt under 5 U.S.C. under paragraph (a) of this section;
552a(j)(2) and (k)(2) from the provisions (1) May be given access to the records
enumerated in paragraph (a) of this where available under part 20 of this
section: chapter (the public information regula-
(1) Bio-research Monitoring Informa- tions) or the Commissioner may, in his

tion System—HHS/FDA/09–10–0010. discretion, entertain a request under
319
§ 21.70 21 CFR Ch. I (4–1–19 Edition)
any or all of the provisions of §§ 21.40 (1) To the individual who is the sub-
through 21.54; and ject of the record, or his legal guardian
(2) Shall be given access upon request under § 21.75;
if the records requested are subject to (2) To a third party pursuant to a
5 U.S.C. 552a(k)(2) and not to 5 U.S.C. written request by, or within a written
552a(j)(2) (i.e., because they consist of consent of, the individual to whom the
investigatory material compiled for record pertains, or his legal guardian
law enforcement purposes other than under § 21.75;
criminal law enforcement purposes) (3) To any person:
and maintenance of the records re- (i) Where the names and other identi-
sulted in denial to the individual of fying information are first deleted, and
any right, benefit, or privilege to which under circumstances in which the re-
he would otherwise be entitled by Fed- cipient is unlikely to know the iden-
eral law, or for which he would other- tity of the subject of the record;
wise be eligible. An individual given (ii) Where disclosure is required by
access to a record under this paragraph part 20 of this chapter (the public infor-
(b)(2) is not entitled to seek amend- mation regulations); or
(4) Within the Department of Health
ment under subpart E of this part. The
and Human Services to officers and em-
FDA may refuse to disclose a record
ployees who have a need for the record
that would reveal the identity of a
in the performance of their duties in
source who furnished information to
connection with the laws administered
the Government under a promise of
and enforced by the Food and Drug Ad-
confidentiality, which must be an ex- ministration or that govern the agen-
press promise if the information was cy. For purposes of this section, offi-
furnished on or after September 27, cers or employees of the Department
1975. Any individual refused access to a shall include the following categories
record that would reveal a confidential of individuals, who shall thereafter be
source shall be advised in a general subject to the same restrictions with
way that the record contains informa- respect to disclosure as any Food and
tion that would reveal a confidential Drug Administration employee: Food
source. and Drug Administration consultants
(c) The Commissioner shall not make and advisory committees, State and
available any record that is prohibited local government employees for use
from public disclosure under § 20.82(b) only in their work with the Food and
of this chapter. Drug Administration, and contractors
(d) Discretionary disclosure of a and their employees to the extent that
record pursuant to paragraph (b)(1) of the records of such contractors are sub-
this section shall not set a precedent ject to the requirements of this part
for discretionary disclosure of a simi- under § 21.30.
lar or related record and shall not obli- (b) No accounting is required for any
gate the Commissioner to exercise his disclosure or use under paragraph (a) of
discretion to disclose any other record this section.
in a system that is exempt under
§ 21.61. § 21.71 Disclosure of records in Pri-
vacy Act Record Systems; account-
ing required.
Subpart G—Disclosure of Records (a) Except as provided in § 21.70, a
in Privacy Act Record Systems record about an individual that is con-
to Persons Other Than the tained in a Privacy Act Record System
Subject Individual shall not be disclosed by any method of
communication except under any of
§ 21.70 Disclosure and intra-agency the following circumstances, which are
use of records in Privacy Act subject to the limitations of para-
Record Systems; no accounting re- graphs (b) and (c) of this section and to
quired.
the accounting requirement of para-
(a) A record about an individual graph (d) of this section:
which is contained in a Privacy Act (1) To those officers and employees of

Record System may be disclosed: the agency which maintains the record
320
who have a need for the record in the (12) To a consumer reporting agency
perfomance of their duties; in accordance with section 3(d) of the
(2) Required under section 552 of the Federal Claims Collection Act of 1966
Freedom of Information Act; (31 U.S.C. 952(d)). (This ‘‘Special Disclo-
(3) For a routine use as described in sure’’ statement does not apply to any
the routine use section of each specific FDA system of records.)
system notice; (b) The Food and Drug Administra-
(4) To the Bureau of Census for pur- tion may in its discretion refuse to
poses of planning or carrying out a cen- make a disclosure permitted under
sus or survey or related activity pursu- paragraph (a) of this section, if the dis-
ant to the provisions of title 13 of the closure would in the judgment of the
U.S. Code; agency, invade the privacy of the indi-
(5) To a recipient who has provided vidual or be inconsistent with the pur-
the agency with advance adequate pose for which the information was col-
written assurance that the record will lected.
be used solely as a statistical research (c) The Food and Drug Administra-
or reporting record, and that the tion may require any person requesting
record is to be transferred in a form a disclosure of a record under para-
that is not individually identifiable; graph (a) of this section to provide:
(6) To the National Archives and (1) Information about the purposes to
Records Administration of the United which the disclosed record is to be put,
States as a record which has sufficient and
historical or other value to warrant its (2) A written statement certifying
continued preservation by the U.S. that the record will be used only for
Government, or to the Archivist of the the stated purposes and will not be fur-
United States or his or her designee for ther disclosed without the written per-
evaluation to determine whether the mission of the Food and Drug Adminis-
record has such value; tration.
(7) To another agency or to an instru- Under 5 U.S.C. 552a(i)(3), any person
mentality of any government jurisdic- who knowingly or willfully requests or
tion within or under the control of the obtains any record concerning an indi-
United States for a civil or criminal vidual from an agency under false pre-
law enforcement activity if the activ- tenses shall be guilty of a misdemeanor
ity is authorized by law, and if the and fined not more than $5,000. Such
head of the agency or instrumentality person may also be subject to prosecu-
has made a written request to the tion under the False Reports to the
agency which maintains the record Government Act, 18 U.S.C. 1001.
specifying the particular portion de- (d) An accounting shall be made, in
sired and the law enforcement activity accordance with paragraph (e) of this
for which the record is sought; section, of any disclosure under para-
(8) To a person pursuant to a showing graph (a) of this section of a record
of compelling circumstances affecting that is not a disclosure under § 21.70.
the health or safety of an individual if, (e) Where an accounting is required
upon such disclosure, notification is under paragraph (d) of this section, the
transmitted to the last known address Food and Drug Administration shall:
of such individual; (1) Record the name and address of
(9) To either House of Congress or, to the person or agency to whom the dis-
the extent of matter within its juris- closure is made and the date, nature,
diction, any committee or sub- and purpose of the disclosure. The ac-
committee thereof, any joint com- counting shall not be considered a Pri-
mittee of Congress or subcommittee of vacy Act Record System.
any such joint committee; (2) Retain the accounting for 5 years
(10) To the Comptroller General, or or for the life of the record, whichever
any of his or her authorized representa- is longer, following the disclosure.
tives in the course of the performance (3) Notify those recipients listed in
of the duties of the General Accounting the accounting of amendments or dis-
Office; putes concerning the records pre-
(11) Pursuant to the order of a court viously disclosed to them pursuant to

of competent jurisdiction; or § 21.51(d)(3), § 21.53(c), or § 21.54(c).
321
§ 21.72 21 CFR Ch. I (4–1–19 Edition)
(4) Except when the record is exempt a means of accounting for the disclo-
from individual access and contest sure, they shall be retained as provided
under § 21.61 or to the extent that the in § 21.71(e)(2).
accounting describes a transfer for a
law enforcement purpose pursuant to § 21.73 Accuracy, completeness, timeli-
paragraph (a)(7) of this section, make ness, and relevance of records dis-
the accounting available to the indi- closed from Privacy Act Record
vidual to whom the record pertains, in Systems.
accordance with procedures of subpart (a) The Food and Drug Administra-
D of this part. tion shall make reasonable efforts to
(f) A single accounting may be used assure that a record about an indi-
to cover disclosure(s) that consist of a vidual in a Privacy Act Record System
continuing dialogue between two agen- is accurate, relevant to a Food and
cies over a prolonged period, such as
Drug Administration purpose, timely,
discussion of an enforcement action be-
and complete before such record is dis-
tween the Food and Drug Administra-
closed under § 21.71.
tion and the Department of Justice. In
such cases, a general notation may be (b) Paragraph (a) of this section shall
made that, as of a certain date, con- not apply to disclosures that are re-
tract was initiated, to continue until quired under part 20 of this chapter
resolution of the matter. (the public information regulations) or
made to other Federal Government de-
partments and agencies. Where appro-
FR 52278, Dec. 23, 1985; 54 FR 9038, Mar. 3,
1989] priate, the letter disclosing the infor-
mation shall indicate that the Food
§ 21.72 Individual consent to disclo- and Drug Administration has not re-
sure of records to other persons. viewed the record to assure that it is
(a) Individuals may consent to disclo- accurate, relevant, timely, and com-
sure of records about themselves to plete.
other persons in several ways, for ex-
ample: § 21.74 Providing notice that a record
(1) An individual may give consent at is disputed.
the time that the information is col- Whenever an individual has filed a
lected for disclosure for specific pur- statement of disagreement with the
poses or to specific persons. Food and Drug Administration con-
(2) An individual may give consent cerning a refusal to amend a record
for disclosure of his records to a spe- under § 21.51(a)(2) or with another agen-
cific person.
cy that provides the record to the Food
(3) An individual may request the
and Drug Administration, the Food and
Food and Drug Administration to tran-
scribe a specific record for submission Drug Administration shall in any sub-
to another person. sequent disclosure under this subpart
(b) In each case the consent shall be provide a copy of the statement of dis-
in writing and shall specify the indi- agreement and a concise statement by
vidual, organizational unit, or class of the agency, if one has been prepared, of
individuals or organizational units to the reasons for not making the amend-
whom the record may be disclosed, ment(s) requested.
which record may be disclosed, and, if
applicable, for what time period. A § 21.75 Rights of legal guardians.
blanket consent to release all of an in- For the purposes of this part, the par-
dividual’s records to unspecified indi- ent of any individual who is a minor or
viduals or organizational units will not the legal guardian of any individual
be honored. Verification of the identity who has been declared to be incom-
of the individual and, where applicable, petent due to physical or mental inca-
of the person to whom the record is to pacity or age by a court of competent
be disclosed shall be made in accord- jurisdiction may act on behalf of the
ance with § 21.44. Consent documents
individual.
shall be retained for a period of at least
2 years. If such documents are used as
322
PART 25—ENVIRONMENTAL Subpart A—General Provisions

IMPACT CONSIDERATIONS
§ 25.1 Purpose.
Subpart A—General Provisions The National Environmental Policy
Act of 1969 (NEPA), as amended, directs
Sec. that, to the fullest extent possible, the
25.1 Purpose. policies, regulations, and public laws of
25.5 Terminology. the United States shall be interpreted
25.10 Policies and NEPA planning.
and administered in accordance with
the policies set forth in NEPA. All
Subpart B—Agency Actions Requiring
agencies of the Federal Government
Environmental Consideration
shall comply with the procedures in
25.15 General procedures. section 102(2) of NEPA except where
25.16 Public health and safety emergencies. compliance would be inconsistent with
25.20 Actions requiring preparation of an other statutory requirements. The reg-
environmental assessment. ulations in this part implement section
25.21 Extraordinary circumstances. 102(2) of NEPA in a manner that is con-
25.22 Actions requiring the preparation of sistent with FDA’s authority under the
an environmental impact statement. Federal Food, Drug, and Cosmetic Act
and the Public Health Service Act.
Subpart C—Categorical Exclusions This part also supplements the regula-
25.30 General. tions for implementing the procedural
25.31 Human drugs and biologics. provisions of NEPA that were pub-
25.32 Foods, food additives, and color addi- lished by the Council on Environ-
tives. mental Quality (CEQ) in 40 CFR parts
25.33 Animal drugs. 1500 through 1508 and the procedures in-
25.34 Devices and electronic products. cluded in the ‘‘HHS General Adminis-
25.35 Tobacco product applications. tration Manual, part 30: Environmental
Protection’’ (45 FR 76519 to 76534, No-
Subpart D—Preparation of Environmental vember 19, 1980).
Documents
§ 25.5 Terminology.
25.40 Environmental assessments.
(a) Definitions that apply to the
25.41 Findings of no significant impact.
25.42 Environmental impact statements.
terms used in this part are set forth in
25.43 Records of decision.
the CEQ regulations under 40 CFR part
25.44 Lead and cooperating agencies.
1508. The terms and the sections of 40
25.45 Responsible agency official. CFR part 1508 in which they are defined
follow:
Subpart E—Public Participation and (1) Categorical exclusion (40 CFR
Notification of Environmental Documents 1508.4).
(2) Cooperating agency (40 CFR
25.50 General information. 1508.5).
25.51 Environmental assessments and find- (3) Cumulative impact (40 CFR
ings of no significant impact. 1508.7).
25.52 Environmental impact statements. (4) Effects (40 CFR 1508.8).
(5) Environmental assessment (EA)
Subpart F—Other Requirements
(40 CFR 1508.9).
25.60 Environmental effects abroad of major (6) Environmental document (40 CFR
agency actions. 1508.10).
AUTHORITY: 21 U.S.C. 321–393; 42 U.S.C. 262, (7) Environmental impact statement
263b–264; 42 U.S.C. 4321, 4332; 40 CFR parts (EIS) (40 CFR 1508.11).
1500–1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 (8) Federal agency (40 CFR 1508.12).
Comp., p. 531–533 as amended by E.O. 11991, 42 (9) Finding of no significant impact
FR 26967, 3 CFR, 1978 Comp., p. 123–124 and (40 CFR 1508.13).
E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. (10) Human environment (40 CFR
356–360. 1508.14).
SOURCE: 62 FR 40592, July 29, 1997, unless (11) Lead agency (40 CFR 1508.16).
otherwise noted. (12) Legislation (40 CFR 1508.17).
323
§ 25.10 21 CFR Ch. I (4–1–19 Edition)
(13) Major Federal action (40 CFR (9) GRAS—Generally recognized as

1508.18). safe.
(14) Mitigation (40 CFR 1508.20). (10) HACCP—Hazard analysis critical
(15) NEPA process (40 CFR 1508.21). control point.
(16) Notice of intent (40 CFR 1508.22). (11) IDE—Investigational device ex-
(17) Proposal (40 CFR 1508.23). emption.
(18) Scope (40 CFR 1508.25). (12) IND—Investigational new drug
(19) Significantly (40 CFR 1508.27). application.
(b) The following terms are defined (13) INAD—Investigational new ani-
solely for the purpose of implementing mal drug application.
the supplemental procedures provided
(14) NADA—New animal drug applica-
by this part and are not necessarily ap-
tion.
plicable to any other statutory or regu-
latory requirements: (15) NDA—New drug application.
(1) Abbreviated application applies to (16) NEPA—National Environmental
an abbreviated new drug application Policy Act of 1969.
and an abbreviated new animal drug (17) OTC—Over-the-counter.
application. (18) PDP—Product development pro-
(2) Active moiety means the molecule tocol.
or ion, excluding those appended por- (19) PMA—Premarket approval appli-
tions of the molecule that cause the cation.
drug to be an ester, salt (including a
salt with hydrogen or coordination FR 399, Jan. 5, 1999; 69 FR 17291, Apr. 2, 2004]
bonds), or other noncovalent derivative
(such as a complex chelate or clath- § 25.10 Policies and NEPA planning.
rate) of the molecule responsible for
the physiological or pharmacological (a) All FDA’s policies and programs
action of the drug substance. will be planned, developed, and imple-
(3) Agency means the Food and Drug mented to achieve the policies declared
Administration (FDA). by NEPA and required by CEQ’s regula-
(4) Increased use of a drug or biologic tions to ensure responsible stewardship
product may occur if the drug will be of the environment for present and fu-
administered at higher dosage levels, ture generations.
for longer duration or for different in- (b) Assessment of environmental fac-
dications than were previously in ef- tors continues throughout planning
fect, or if the drug is a new molecular and is integrated with other program
entity. The term ‘‘use’’ also encom- planning at the earliest possible time
passes disposal of FDA-regulated arti- to ensure that planning and decisions
cles by consumers. reflect environmental values, to avoid
(5) Responsible agency official means delays later in the process, and to
the agency decisionmaker designated avoid potential conflicts.
in the delegated authority for the un- (c) For actions initiated by the agen-
derlying actions. cy, the NEPA process will begin when
(c) The following acronyms are used the agency action under consideration
in this part: is first identified. For actions initiated
(1) CEQ—Council on Environmental by applicants or petitioners, NEPA
Quality. planning begins when FDA receives
(2) CGMP—Current good manufac- from an applicant or petitioner an EA
turing practice. or a claim that a categorical exclusion
(3) EA—Environmental assessment. applies, or when FDA personnel consult
(4) EIS—Environmental impact state- with applicants or petitioners on the
ment. NEPA-related aspects of their re-
(5) The act—Federal Food, Drug, and quested actions. FDA may issue a pub-
Cosmetic Act. lic call for environmental data or oth-
(6) FIFRA—Federal Insecticide, Fun- erwise consult with affected individ-
gicide, and Rodenticide Act. uals or groups when a contemplated ac-
(7) FONSI—Finding of no significant tion in which it is or may be involved
impact. poses potential significant environ-

(8) GLP—Good laboratory practice. mental effects.
324
(d) Environmental documents shall fied, resulting in a decision not to pre-

concentrate on timely and significant pare an EIS, the responsible agency of-
issues, not amass needless detail. ficial will prepare a FONSI in accord-
(e) If a proposed action for which an ance with § 25.41.
EIS will be prepared involves possible (c) Classes of actions that individ-
environmental effects that are required ually or cumulatively do not signifi-
to be considered under statutes or Ex- cantly affect the quality of the human
ecutive Orders other than those re- environment ordinarily are excluded
ferred to under ‘‘Authority’’ in this from the requirement to prepare an EA
part, these effects shall be considered or an EIS. The classes of actions that
in the NEPA review, consistent with 40 qualify as categorical exclusions are
CFR 1502.25 and the HHS General Ad- set forth in §§ 25.30, 25.31, 25.32, 25.33,
ministration Manual, part 30: Environ- 25.34, or 25.35.
mental Protection. (d) A person submitting an applica-
tion or petition of a type subject to
Subpart B—Agency Actions Re- categorical exclusion under §§ 25.30,
quiring Environmental Consid- 25.31, 25.32, 25.33, 25.34, or 25.35, or pro-
eration posing to dispose of an article as pro-
vided in § 25.30(d) or 25.32(h), is not re-
§ 25.15 General procedures. quired to submit an EA if the person
states that the action requested quali-
(a) All applications or petitions re-
fies for a categorical exclusion, citing
questing agency action require the sub-
the particular categorical exclusion
mission of an EA or a claim of categor-
that is claimed, and states that to the
ical exclusion. A claim of categorical
exclusion shall include a statement of applicant’s knowledge, no extraor-
compliance with the categorical exclu- dinary circumstances exist.
sion criteria and shall state that to the [62 FR 40592, July 29, 1997, as amended at 80
applicant’s knowledge, no extraor- FR 57535, Sept. 24, 2015]
dinary circumstances exist. Failure to
submit an adequate EA for an applica- § 25.16 Public health and safety emer-
tion or petition requesting action by gencies.
the agency of a type specified in § 25.20, There are certain regulatory actions
unless the agency can determine that that, because of their immediate im-
the action qualifies for exclusion under portance to the public health or safety,
§§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35 may make full adherence to the proce-
is sufficient grounds for FDA to refuse dural provisions of NEPA and CEQ’s
to file or approve the application or pe- regulations impossible. For such ac-
tition. An EA adequate for filing is one tions, the responsible agency official
that addresses the relevant environ- shall consult with CEQ about alter-
mental issues. An EA adequate for ap- native arrangements before the action
proval is one that contains sufficient is taken, or after the action is taken, if
information to enable the agency to de- time does not permit prior consulta-
termine whether the proposed action tion with CEQ.
may significantly affect the quality of
the human environment. § 25.20 Actions requiring preparation
(b) The responsible agency officials of an environmental assessment.
will evaluate the information con- Any proposed action of a type speci-
tained in the EA to determine whether fied in this section normally requires
it is accurate and objective, whether at least the preparation of an EA, un-
the proposed action may significantly less it is an action in a specific class
affect the quality of the human envi- that qualifies for exclusion under
ronment, and whether an EIS will be §§ 25.30, 25.31, 25.32, 25.33, 25.34, or 25.35:
prepared. If significant effects requir- (a) Major recommendations or re-
ing the preparation of an EIS are iden- ports made to Congress on proposals
tified, FDA will prepare an EIS for the for legislation in instances where the
action in accordance with the proce- agency has primary responsibility for
dures in subparts D and E of this part. the subject matter involved.
If significant effects requiring the (b) Destruction or other disposition

preparation of an EIS are not identi- of articles condemned after seizure or
325
§ 25.21 21 CFR Ch. I (4–1–19 Edition)
whose distribution or use has been en- supplements to such applications, and
joined, unless categorically excluded in actions on IND’s, unless categorically
§§ 25.30(d) or 25.32(h). excluded in § 25.31 (a), (b), (c), (e), or (l).
(c) Destruction or other disposition (m) Approval of NADA’s, abbreviated
of articles following detention or recall applications, supplements, actions on
at agency request, unless categorically INAD’s, and granting of requests for
excluded in §§ 25.30(d) or 25.32(h). determination of eligibility for index-
(d) Disposition of FDA laboratory ing, unless categorically excluded
waste materials, unless categorically under § 25.33 (a), (c), (d), or (e).
excluded in § 25.30(m). (n) Approval of PMA’s for medical de-
(e) Intramural and extramural re- vices, notices of completion of PDP’s
search supported in whole or in part for medical devices, authorizations to
through contracts, other agreements, commence clinical investigation under
or grants, unless categorically ex- an approved PDP, or applications for
cluded in § 25.30 (e) or (f). an IDE, unless categorically excluded
(f) Establishment by regulation of la- in § 25.34.
beling requirements, a standard, or a (o) Issuance of an order finding a to-
monograph, unless categorically ex- bacco product substantially equivalent
cluded in §§ 25.30(k) or 25.31 (a), (b), (c), under the Federal Food, Drug, and Cos-
(h), (i), or (j), or 25.32 (a) or (p). metic Act, or granting of a request for
(g) Issuance, amendment, and en- an exemption under 21 CFR part 1107
forcement of FDA regulations, or an from the requirement of demonstrating
exemption or variance from FDA regu- substantial equivalence, unless cat-
lations, unless categorically excluded egorically excluded under § 25.35.
in § 25.30 (h), (i), or (j), or § 25.32 (e), (g), (p) Issuance of an order authorizing
(n), or (p). marketing of a new tobacco product
(h) Withdrawal of existing approvals under section 910 of the Federal Food,
of FDA-approved articles, unless cat- Drug, and Cosmetic Act or an order au-
egorically excluded in §§ 25.31 (d) or (k), thorizing marketing of a modified risk
25.32(m), or 25.33 (g) or (h). tobacco product under section 911 of
(i) Approval of food additive petitions the Federal Food, Drug, and Cosmetic
and color additive petitions, approval Act, unless categorically excluded
of requests for exemptions for inves- under § 25.35.
tigational use of food additives, the [62 FR 40592, July 29, 1997, as amended at 65
granting of requests for exemption FR 30355, May 11, 2000; 72 FR 69118, Dec. 6,
from regulation as a food additive 2007; 80 FR 57535, Sept. 24, 2015; 81 FR 55047,
under § 170.39 of this chapter, and al- Aug. 17, 2016]
lowing notifications submitted under
21 U.S.C. 348(h) to become effective, un- § 25.21 Extraordinary circumstances.
less categorically excluded in § 25.32(b), As required under 40 CFR 1508.4, FDA
(c), (i), (j), (k), (l), (o), (q), or (r). will require at least an EA for any spe-
(j) Establishment of a tolerance for cific action that ordinarily would be
unavoidable poisonous or deleterious excluded if extraordinary cir-
substances in food or in packaging ma- cumstances indicate that the specific
terials to be used for food. proposed action may significantly af-
(k) Establishment or amendment of a fect the quality of the human environ-
regulation for a food substance as ment (see 40 CFR 1508.27 for examples
GRAS under the conditions of its in- of significant impacts). Examples of
tended use for humans or animals such extraordinary circumstances in-
under parts 182, 184, 186, 582, or 584 of clude:
this chapter, or establishment or (a) Actions for which available data
amendment of a regulation for a prior- establish that, at the expected level of
sanctioned food ingredient, as defined exposure, there is the potential for se-
in §§ 170.3(l) and 181.5(a) of this chapter, rious harm to the environment; and
unless categorically excluded in (b) Actions that adversely affect a
§ 25.32(f), (i), (j), (k), or (r). species or the critical habitat of a spe-
(l) Approval of NDA’s, abbreviated cies determined under the Endangered
applications, applications for mar- Species Act or the Convention on

keting approval of a biologic product, International Trade in Endangered
326
Species of Wild Flora and Fauna to be sult in the introduction of any sub-
endangered or threatened or wild flora stance into the environment.
or fauna that are entitled to special (f) Extramural contracts, other
protection under some other Federal agreements, and grants for research for
law. such purposes as to develop analytical
methods or other test methodologies.
§ 25.22 Actions requiring the prepara- (g) Activities of voluntary Federal-
tion of an environmental impact
statement. State cooperative programs, including
issuance of model regulations proposed
(a) There are no categories of agency for State adoption.
actions that routinely significantly af- (h) Issuance, amendment, or revoca-
fect the quality of the human environ- tion of procedural or administrative
ment and that therefore ordinarily re- regulations and guidance documents,
quire the preparation of an EIS.
including procedures for submission of
(b) EIS’s are prepared for agency ac- applications for product development,
tions when evaluation of data or infor- testing and investigational use, and ap-
mation in an EA or otherwise available
proval.
to the agency leads to a finding by the
(i) Corrections and technical changes
responsible agency official that a pro-
posed action may significantly affect in regulations.
the quality of the human environment. (j) Issuance of CGMP regulations,
HACCP regulations, establishment
standards, emergency permit control
Subpart C—Categorical regulations, GLP regulations, and
Exclusions issuance or denial of permits, exemp-
tions, variances, or stays under these
§ 25.30 General.
regulations.
The classes of actions listed in this (k) Establishment or repeal by regu-
section and §§ 25.31 through 25.35 are lation of labeling requirements for
categorically excluded and, therefore, marketed articles if there will be no in-
ordinarily do not require the prepara- crease in the existing levels of use or
tion of an EA or an EIS: change in the intended uses of the
(a) Routine administrative and man- product or its substitutes.
agement activities, including inspec- (l) Routine maintenance and minor
tions, and issuance of field compliance construction activities such as:
programs, program circulars, or field
(1) Repair to or replacement of equip-
investigative assignments.
ment or structural components (e.g.,
(b) Recommendation for an enforce-
door, roof, or window) of facilities con-
ment action to be initiated in a Fed-
trolled by FDA;
eral court.
(2) Lease extensions, renewals, or
(c) Agency requests for initiation of
recalls. succeeding leases;
(d) Destruction or disposition of any (3) Construction or lease construc-
FDA-regulated article condemned after tion of 10,000 square feet or less of oc-
seizure or the distribution or use of cupiable space;
which has been enjoined or following (4) Relocation of employees into ex-
detention or recall at agency request if isting owned or currently leased space;
the method of destruction or disposi- (5) Acquisition of 20,000 square feet or
tion of the article, including packaging less of occupiable space in a structure
material, is in compliance with all that was substantially completed be-
Federal, State, and local requirements. fore the issuance of solicitation for of-
(e) Extramural contracts, other fers; and
agreements, or grants for statistical (6) Acquisition of between 20,000
and epidemiological studies, surveys square feet and 40,000 square feet of oc-
and inventories, literature searches, cupiable space if it constitutes less
and report and manual preparation, or than 40 percent of the occupiable space
any other studies that will not result in a structure that was substantially
in the production or distribution of any completed before the solicitation for

substance and, therefore, will not re- offers.
327
§ 25.31 21 CFR Ch. I (4–1–19 Edition)
(m) Disposal of low-level radioactive (i) Revocation of a license for a bio-

waste materials (as defined in the Nu- logic product.
clear Regulatory Commission regula- (j) Action on an application for mar-
tions at 10 CFR 61.2) and chemical keting approval for marketing of a bio-
waste materials generated in the lab- logic product for transfusable human
oratories serviced by the contracts ad- blood or blood components and plasma.
ministered by FDA, if the waste is dis-
posed of in compliance with all applica- FR 26697, May 13, 1998; 64 FR 399, Jan. 5, 1999;
ble Federal, State, and local require- 70 FR 14980, Mar. 24, 2005]
ments.
§ 25.32 Foods, food additives, and color
FR 56479, Sept. 19, 2000; 80 FR 57535, Sept. 24,
additives.
2015] The classes of actions listed in this
section are categorically excluded and,
§ 25.31 Human drugs and biologics. therefore, ordinarily do not require the
The classes of actions listed in this preparation of an EA or an EIS:
section are categorically excluded and, (a) Issuance, amendment, or repeal of
therefore, ordinarily do not require the a food standard.
preparation of an EA or an EIS: (b) Action on a request for exemption
(a) Action on an NDA, abbreviated for investigational use of a food addi-
application, application for marketing tive if the food additive to be shipped
approval of a biologic product, or a under the request is intended to be
supplement to such applications, or ac- used for clinical studies or research.
tion on an OTC monograph, if the ac- (c) Approval of a color additive peti-
tion does not increase the use of the tion to change a provisionally listed
active moiety. color additive to permanent listing for
(b) Action on an NDA, abbreviated use in food, drugs, devices, or cos-
application, or a supplement to such metics.
applications, or action on an OTC (d) Testing and certification of
monograph, if the action increases the batches of a color additive.
use of the active moiety, but the esti- (e) Issuance of an interim food addi-
mated concentration of the substance tive regulation.
at the point of entry into the aquatic (f) Establishment or amendment of a
environment will be below 1 part per regulation for a food substance as
billion. GRAS under the conditions of its in-
(c) Action on an NDA, abbreviated tended use for humans or animals
application, application for marketing under parts 182, 184, 186, 582, or 584 of
approval of a biologic product, or a this chapter, and establishment or
supplement to such applications, or ac- amendment of a regulation for a prior-
tion on an OTC monograph, for sub- sanctioned food ingredient, as defined
stances that occur naturally in the en- in §§ 170.3(l) and 181.5(a) of this chapter,
vironment when the action does not if the substance or food ingredient is
alter significantly the concentration or already marketed in the United States
distribution of the substance, its me- for the proposed use.
tabolites, or degradation products in (g) Issuance and enforcement of regu-
the environment. lations relating to the control of com-
(d) Withdrawal of approval of an NDA municable diseases or to interstate
or an abbreviated application. conveyance sanitation under parts 1240
(e) Action on an IND. and 1250 of this chapter.
(f) Testing and release by the Food (h) Approval of a request for diver-
and Drug Administration of lots or sion of adulterated or misbranded food
batches of a licensed biologic product. for humans or animals to use as animal
(g) Establishment of bioequivalence feeds.
requirements for a human drug or a (i) Approval of a food additive peti-
comparability determination for a bio- tion, establishment or amendment of a
logic product subject to licensing. regulation for a food substance as
(h) Issuance, revocation, or amend- GRAS under the conditions of its in-
ment of a standard for a biologic prod- tended use for humans or animals
uct. under parts 182, 184, 186, 582, or 584 of
328
this chapter, the granting of a request uct(s) present in food derived from new
for exemption from regulation as a plant varieties.
food additive under § 170.39 of this chap- (p) Issuance, amendment, or revoca-
ter, or allowing a notification sub- tion of a regulation in response to a
mitted under 21 U.S.C. 348(h) to become reference amount petition as described
effective, when the substance is present in § 101.12(h) of this chapter, a nutrient
in finished food-packaging material at content claim petition as described in
not greater than 5 percent-by-weight § 101.69 of this chapter, a health claim
and is expected to remain with finished petition as described in § 101.70 of this
food-packaging material through use chapter, or a petition pertaining to the
by consumers or when the substance is label declaration of ingredients as de-
a component of a coating of a finished scribed in § 10.30 of this chapter.
food-packaging material. (q) Approval of a food additive peti-
(j) Approval of a food additive petition, the granting of a request for ex-
tion, establishment or amendment of a emption from regulation as a food ad-
regulation for a food substance as ditive under § 170.39 of this chapter, or
GRAS under the conditions of its in- allowing a notification submitted
tended use for humans or animals under 21 U.S.C. 348(h) to become effec-
under parts 182, 184, 186, 582, or 584 of tive for a substance registered by the
this chapter, the granting of a request Environmental Protection Agency
for exemption from regulation as a under FIFRA for the same use re-
food additive under § 170.39 of this chap- quested in the petition, request for ex-
ter, or allowing a notification sub- emption, or notification.
mitted under 21 U.S.C. 348(h) to become (r) Approval of a food additive peti-
effective, when the substance is to be tion or color additive petition, estab-
used as a component of a food-contact lishment or amendment of a regulation
surface of permanent or for a food substance as GRAS under the
semipermanent equipment or of an- conditions of its intended use for hu-
other food-contact article intended for mans or animals under parts 182, 184,
repeated use. 186, 582, or 584 of this chapter, or allow-
(k) Approval of a food additive peti- ing a notification submitted under 21
tion or color additive petition, estab- U.S.C. 348(h) to become effective for a
lishment or amendment of a regulation substance that occurs naturally in the
for a food substance as GRAS under the environment, when the action does not
conditions of its intended use for hu- alter significantly the concentration or
mans or animals under parts 182, 184, distribution of the substance, its me-
186, 582, or 584 of this chapter, or allow- tabolites, or degradation products in
ing a notification submitted under 21 the environment.
U.S.C. 348(h) to become effective, for
substances added directly to food that [62 FR 40592, July 29, 1997, as amended at 65
are intended to remain in food through FR 30355, May 11, 2000; 76 FR 59248, Sept. 26,
2011; 81 FR 55047, Aug. 17, 2016]
ingestion by consumers and that are
not intended to replace macronutrients § 25.33 Animal drugs.
in food.
(l) Approval of a petition for color ad- The classes of actions listed in this
ditives used in contact lenses, sutures, section are categorically excluded and,
filaments used as supporting haptics in therefore, ordinarily do not require the
intraocular lenses, bone cement, and in preparation of an EA or an EIS:
other FDA-regulated products having (a) Action on an NADA, abbreviated
similarly low levels of use. application, request for determination
(m) Action to prohibit or otherwise of eligibility for indexing, a supple-
restrict or reduce the use of a sub- ment to such applications, or a modi-
stance in food, food packaging, or cos- fication of an index listing, if the ac-
metics. tion does not increase the use of the
(n) Issuance, amendment, or revoca- drug. Actions to which this categorical
tion of a regulation pertaining to in- exclusion applies may include:
fant formulas. (1) An animal drug to be marketed
(o) Approval of a food additive peti- under the same conditions of approval
tion for the intended expression prod- as a previously approved animal drug;
329
§ 25.34 21 CFR Ch. I (4–1–19 Edition)
(2) A combination of previously ap- nates animal feed uses of a food addi-
proved animal drugs; tive.
(3) A new premix or other formula- [62 FR 40592, July 29, 1997, as amended at 71
tion of a previously approved animal FR 74782, Dec. 13, 2006; 72 FR 69119, Dec. 6,
drug; 2007]
(4) Changes specified in § 514.8(b)(3),
(b)(4), or (c)(3) of this chapter; § 25.34 Devices and electronic prod-
(5) A change of sponsor; ucts.
(6) A previously approved animal The classes of actions listed in this
drug to be contained in medicated feed section are categorically excluded and,
blocks under § 510.455 of this chapter or therefore, ordinarily do not require the
as a liquid feed supplement under § 558.5 preparation of an EA or an EIS:
of this chapter; or (a) Action on a device premarket no-
(7) Approval of a drug for use in ani- tification submission under subpart E
mal feeds if such drug has been ap- of part 807 of this chapter.
proved under § 514.2 or 514.9 of this (b) Classification or reclassification
chapter for other uses. of a device under part 860 of this chap-
(b) [Reserved] ter, including the establishment of spe-
(c) Action on an NADA, abbreviated cial controls, if the action will not re-
application, request for determination sult in increases in the existing levels
of eligibility for indexing, a supple- of use of the device or changes in the
ment to such applications, or a modi- intended use of the device or its sub-
fication of an index listing, for substitutes.
stances that occur naturally in the en- (c) Issuance, amendment, or repeal of
vironment when the action does not a standard for a class II medical device
alter significantly the concentration or or an electronic product, and issuance
distribution of the substance, its me- of exemptions or variances from such a
tabolites, or degradation products in standard.
the environment. (d) Approval of a PMA or a notice of
(d) Action on an NADA, abbreviated completion of a PDP or amended or
application, request for determination supplemental applications or notices
of eligibility for indexing, a supple- for a class III medical device if the de-
ment to such applications, or a modi- vice is of the same type and for the
fication of an index listing, for: same use as a previously approved de-
(1) Drugs intended for use in nonfood vice.
animals; (e) Changes in the PMA or a notice of
(2) Anesthetics, both local and gen- completion of a PDP for a class III
eral, that are individually adminis- medical device that do not require sub-
tered; mission of an amended or supplemental
(3) Nonsystemic topical and oph- application or notice.
thalmic animal drugs; (f) Issuance of a restricted device reg-
(4) Drugs for minor species, including ulation if it will not result in increases
wildlife and endangered species, when in the existing levels of use or changes
the drug has been previously approved in the intended uses of the product or
for use in another or the same species its substitutes.
where similar animal management (g) Action on an application for an
practices are used; and IDE or an authorization to commence a
(5) Drugs intended for use under preclinical investigation under an ap-
scription or veterinarian’s order for proved PDP.
therapeutic use in terrestrial species. (h) Issuance of a regulation exempt-
(e) Action on an INAD. ing from preemption a requirement of
(f) Action on an application sub- a State or political subdivision con-
mitted under section 512(m) of the act. cerning a device, or a denial of an ap-
(g) Withdrawal of approval of an plication for such exemption.
NADA or an abbreviated NADA or re- (i) Approval of humanitarian device
moval of a new animal drug from the exemption under subpart H of part 814
index. of this chapter.
(h) Withdrawal of approval of a food [62 FR 40592, July 29, 1997, as amended at 70
additive petition that reduces or elimi- FR 69277, Nov. 15, 2005]
330
§ 25.35 Tobacco product applications. shall be prepared for each action not
The classes of actions listed in this categorically excluded in § 25.30, § 25.31,
section are categorically excluded and, § 25.32, § 25.33, or § 25.34, or § 25.35. The
therefore, normally do not require the EA shall focus on relevant environ-
preparation of an EA or an EIS: mental issues relating to the use and
(a) Issuance of an order finding a to- disposal from use of FDA-regulated ar-
bacco product substantially equivalent ticles and shall be a concise, objective,
under section 910(a)(2)(B) of the Fed- and well-balanced document that al-
eral Food, Drug, and Cosmetic Act; lows the public to understand the agen-
(b) Issuance of an order finding a to- cy’s decision. If potentially adverse en-
bacco product not substantially equiv- vironmental impacts are identified for
alent under section 910(a) of the Fed- an action or a group of related actions,
eral Food, Drug, and Cosmetic Act, de- the EA shall discuss any reasonable al-
nial of a request for an exemption ternative course of action that offers
under 21 CFR part 1107 from the re- less environmental risk or that is envi-
quirement of demonstrating substan- ronmentally preferable to the proposed
tial equivalence, issuance of an order action. The use of a scientifically justi-
under section 910(c) of the Federal fied tiered testing approach, in which
Food, Drug, and Cosmetic Act that a testing may be stopped when the re-
new tobacco product may not be intro- sults suggest that no significant im-
duced or delivered for introduction into pact will occur, is an acceptable ap-
interstate commerce, or issuance of an proach.
order under section 911 of the Federal (b) Generally, FDA requires an appli-
Food, Drug, and Cosmetic Act that a cant to prepare an EA and make nec-
modified risk tobacco product may not essary corrections to it. Ultimately,
be introduced or delivered for introduc- FDA is responsible for the scope and
tion into interstate commerce; content of EA’s and may include addi-
(c) Rescission or temporary suspen- tional information in environmental
sion of an order authorizing the mar- documents when warranted.
keting of a new tobacco product under (c) Information concerning the na-
section 910 of the Federal Food, Drug, ture and scope of information that an
and Cosmetic Act; applicant or petitioner shall submit in
(d) Rescission of an order authorizing an EA may be obtained from the center
the marketing of a modified risk to- or other office of the agency having re-
bacco product under section 911 of the sponsibility for the action that is the
Federal Food, Drug, and Cosmetic Act; subject of the environmental evalua-
and tion. Applicants and petitioners are en-
(e) Rescission of an order granting an couraged to submit proposed protocols
exemption request under § 1107.1 of this for environmental studies for technical
chapter. review by agency staff. Applicants and
petitioners also are encouraged to con-
[80 FR 57535, Sept. 24, 2015] sult applicable FDA EA guidance docu-
ments, which provide additional advice
Subpart D—Preparation of on how to comply with FDA regula-
Environmental Documents tions.
(d) Consistent with 40 CFR 1500.4(j)
§ 25.40 Environmental assessments. and 1502.21, EA’s may incorporate by
(a) As defined by CEQ in 40 CFR reference information presented in
1508.9, an EA is a concise public docu- other documents that are available to
ment that serves to provide sufficient FDA and to the public.
evidence and analysis for an agency to (e) The agency evaluates the infor-
determine whether to prepare an EIS mation contained in an EA and any
or a FONSI. The EA shall include brief public input to determine whether it is
discussions of the need for the pro- accurate and objective, whether the
posal, of alternatives as required by proposed action may significantly af-
section 102(2)(E) of NEPA, of the envi- fect the quality of the human environ-
ronmental impacts of the proposed ac- ment, and whether an EIS or a FONSI
tion and alternatives, and a listing of will be prepared. The responsible agen-
agencies and persons consulted. An EA cy official examines the environmental
331
§ 25.41 21 CFR Ch. I (4–1–19 Edition)
risks of the proposed action and the al- introduce the supplement into the ad-
ternative courses of action, selects a ministrative record.
course of action, and ensures that any
necessary mitigating measures are im- § 25.43 Records of decision.
plemented as a condition for approving (a) In cases requiring environmental
the selected course of action. impact statements, at the time of its
[62 FR 40592, July 29, 1997, as amended at 69 decision, the agency shall prepare a
FR 17291, Apr. 2, 2004; 80 FR 57535, Sept. 24, concise public record of decision.
2015] (b) The record of decision shall:
(1) State what the decision was;
§ 25.41 Findings of no significant im-
pact. (2) Identify and discuss alternatives
considered by the agency in reaching
(a) As defined by the CEQ regulations
its decision;
(40 CFR 1508.13), a FONSI is a document
(3) State whether all practicable
prepared by a Federal agency stating
briefly why an action, not otherwise means to avoid or minimize environ-
excluded, will not significantly affect mental harm have been adopted, and if
the human environment and for which, not, why not; and
therefore, an EIS will not be prepared. (4) Summarize the program for moni-
A FONSI includes the EA or a sum- toring and enforcing the practicable
mary of it and a reference to any other means adopted to avoid or minimize
related environmental documents. the environmental harm.
(b) The agency official(s) responsible
for approving the FONSI will sign the § 25.44 Lead and cooperating agencies.
document, thereby establishing that For actions requiring the preparation
the official(s) approve(s) the conclusion of an EIS, FDA and other affected Fed-
not to prepare an EIS for the action eral agencies will agree which will be
under consideration. the lead agency and which will be the
cooperating agencies. The responsibil-
§ 25.42 Environmental impact state- ities of lead agencies and cooperating
ments. agencies are described in the CEQ regu-
(a) As defined by CEQ regulations (40 lations (40 CFR 1501.5 and 1501.6, respec-
CFR 1508.11) and section 102(2)(C) of tively). If an action affects more than
NEPA, an EIS should be a clear, con- one center within FDA, the Commis-
cise, and detailed written statement sioner of Food and Drugs will designate
describing: one of these units to be responsible for
(1) The environmental impacts of a coordinating the preparation of any re-
proposed action; quired environmental documentation.
(2) Any adverse effects that cannot be
avoided if the action is implemented; § 25.45 Responsible agency official.
(3) Alternatives to the action; (a) The responsible agency official
(4) The relationship between local
prepares the environmental documents
short-term uses of the environment
or ensures that they are prepared.
and the maintenance and enhancement
(b) The responsible agency official
of long-term productivity; and
will weigh any environmental impacts
(5) Any irreversible and irretrievable
of each alternative course of action, in-
commitments of resources that would
cluding possible mitigation measures,
be involved in the proposed action
and will balance environmental im-
should it be implemented.
(b) The CEQ regulations (40 CFR pacts with the agency’s objectives in
1501.7 and part 1502) describe the proc- choosing an appropriate course of ac-
ess for determining the scope of an EIS tion. The weighing of any environ-
and provide detailed requirements for mental impacts of alternatives in se-
the preparation of draft and final lecting a final course of action will be
EIS’s. CEQ format and procedures for reflected in the agency’s record of for-
preparing EIS shall be followed. mal decisionmaking as required by 40
(c) Under the conditions prescribed in CFR 1505.2.
40 CFR 1502.9, the agency will prepare a [62 FR 40592, July 29, 1997, as amended at 69
supplement for a draft or final EIS and FR 17291, Apr. 2, 2004]
332
Subpart E—Public Participation not be included in the portion of envi-

and Notification of Environ- ronmental documents that is made
mental Documents public. When such data and informa-
tion are pertinent to the environ-
§ 25.50 General information. mental review of a proposed action, an
(a) To the extent actions are not pro- applicant or petitioner shall submit
tected from disclosure by existing law such data and information separately
applicable to the agency’s operation, in a confidential section and shall sum-
FDA will involve the public in pre- marize the confidential data and infor-
paring and implementing its NEPA mation in the EA to the extent pos-
procedures and will provide public no- sible.
tice of NEPA-related hearings, public (b) FONSI’s and EA’s will be avail-
meetings, and the availability of envi- able to the public in accordance with 40
ronmental documents. CFR 1506.6 as follows:
(b) Many FDA actions involving in- (1) When the proposed action is the
vestigations, review, and approval or subject of a notice of proposed rule-
market authorization of applications, making or a notice of filing published
and premarket notifications for human in the FEDERAL REGISTER, the notice
drugs, animal drugs, biologic products, shall state that no EIS is necessary
devices, and tobacco products are pro- and that the FONSI and the EA are
tected from disclosure under the Trade available for public inspection at
Secret Act, 18 U.S.C. 1905, and section FDA’s Division of Dockets Manage-
301(j) of the Federal Food, Drug, and ment. If the responsible agency official
Cosmetic Act. These actions are also is unable to complete environmental
protected from disclosure under FDA’s
consideration of the proposed action
regulations including part 20,
before a notice of filing of a food or
§§ 312.130(a), 314.430(b), 514.11(b),
514.12(a), 601.50(a), 601.51(a), 807.95(b), color additive petition is required to be
812.38(a), and 814.9(b) of this chapter. published under the act, and if the sub-
Even the existence of applications for sequent environmental analysis leads
human drugs, animal drugs, biologic to the conclusion that no EIS is nec-
products, devices, and tobacco products essary, the final regulation rather than
is protected from disclosure under the notice of filing shall state that no
these regulations. Therefore, unless the EIS is necessary and that the FONSI
existence of applications for human and the EA are available upon request
drugs, animal drugs, biologic products, and filed in FDA’s Division of Dockets
tobacco products, or premarket notifi- Management.
cation for devices has been made pub- (2) For actions for which notice is not
licly available, the release of the envi- published in the FEDERAL REGISTER,
ronmental document before approval the FONSI and the EA shall be made
or authorization of human drugs, ani- available to the public upon request ac-
mal drugs, biologic products, devices cording to the procedures in 40 CFR
and tobacco products is inconsistent 1506.6.
with statutory requirements imposed (3) For a limited number of actions,
on FDA. Appropriate environmental the agency may make the FONSI and
documents, comments, and responses
EA available for public review (includ-
will be included in the administrative
ing review by State and areawide infor-
record to the extent allowed by appli-
mation clearinghouses) for 30 days be-
cable laws.
fore the agency makes its final deter-
[62 FR 40592, July 29, 1997, as amended at 80 mination whether to prepare an EIS
FR 57535, Sept. 24, 2015] and before the action may begin, as de-
scribed in 40 CFR 1501.4(e). This proce-
§ 25.51 Environmental assessments
and findings of no significant im- dure will be followed when the pro-
pact. posed action is, or is closely similar to,
one that normally requires an EIS or
(a) Data and information that are
protected from disclosure by 18 U.S.C. when the proposed action is one with-
1905 or 21 U.S.C. 331(j) or 360j(c) shall out precedent.
333
§ 25.52 21 CFR Ch. I (4–1–19 Edition)
§ 25.52 Environmental impact state- Subpart F—Other Requirements

ments.
§ 25.60 Environmental effects abroad
(a) If FDA determines that an EIS is of major agency actions.
necessary for an action involving in-
vestigations, approvals, or market au- (a) In accordance with Executive
thorizations for drugs, animal drugs, Order 12114, ‘‘Environmental Effects
Abroad of Major Federal Actions’’ of
biologic products, devices, or tobacco
January 4, 1979 (44 FR 1957, January 9,
products, an EIS will be prepared but
1979), the responsible agency official, in
will become available only at the time analyzing actions under his or her pro-
of the approval or market authoriza- gram, shall consider the environmental
tion of the product. The EIS will in all effects abroad, including whether the
other respects conform to the require- actions involve:
ments for EIS’s as specified in 40 CFR (1) Potential environmental effects
part 1502 and 1506.6(f). on the global commons and areas out-
(b) Comments on the EIS may be sub- side the jurisdiction of any nation, e.g.,
mitted after the approval or market oceans and the upper atmosphere.
authorization of the drug, animal drug, (2) Potential environmental effects
biologic product, device, or tobacco on a foreign nation not participating
product. Those comments can form the with or otherwise involved in an FDA
basis for the Agency to consider begin- activity.
ning an action to withdraw the ap- (3) The export of products (or emis-
proval or market authorization of ap- sions) that in the United States are
plications for a drug, animal drug, bio- prohibited or strictly regulated be-
logic product, or tobacco product, or to cause their effects on the environment
withdraw premarket notifications or create a serious public health risk.
(4) Potential environmental effects
premarket approval applications for
on natural and ecological resources of
devices.
global importance designated under the
(c) In those cases where the existence Executive Order.
of applications and premarket notifica- (b) Before deciding on any action
tions for drugs, animal drugs, biologic falling into the categories specified in
products, devices, or tobacco products paragraph (a) of this section, the re-
has already been disclosed before the sponsible agency official shall deter-
Agency approves the action, the Agen- mine, in accordance with section 2–3 of
cy will ensure appropriate public in- the Executive Order, whether such ac-
volvement consistent with 40 CFR tions may have a significant environ-
1506.6 and part 1503 in preparing and mental effect abroad.
implementing the NEPA procedures re- (c) If the responsible agency official
lated to preparing EISs while following determines that an action may have a
its own disclosure requirements includ- significant environmental effect
ing those listed in part 20 and abroad, the responsible agency official
§§ 312.130(b), 314.430(d), 514.11(d), shall determine, in accordance with
514.12(b), 601.51(d), 807.95(e), 812.38(b), section 2–4 (a) and (b) of the Executive
and 814.9(d) of this chapter. Order, whether the subject action calls
(d) Draft and final EIS’s, comments, for:
and responses will be included in the (1) An EIS;
(2) A bilateral or multilateral envi-
administrative record and will be
ronmental study; or
available from the Division of Dockets
(3) A concise environmental review.
Management (HFA–305), Food and Drug (d) In preparing environmental docu-
Administration, 5630 Fishers Lane, rm. ments under this subpart, the respon-
1061, Rockville, MD 20852. sible official shall:
[62 FR 40592, July 29, 1997, as amended at 68 (1) Determine, as provided in section
FR 24879, May 9, 2003; 80 FR 57535, Sept. 24, 2–5 of the Executive Order, whether
2015] proposed actions are subject to the ex-
emptions, exclusions, and modification
in contents, timing, and availability of

documents.
334
(2) Coordinate all communications APPENDIX E TO SUBPART A OF PART 26—ELE-

with foreign governments concerning MENTS TO BE CONSIDERED IN DEVELOPING
A TWO-WAY ALERT SYSTEM.
environmental agreements and other
arrangements in implementing the Ex- Subpart B—Specific Sector Provisions for
ecutive Order. Medical Devices
PART 26—MUTUAL RECOGNITION 26.31 Purpose.

26.32 Scope.
OF PHARMACEUTICAL GOOD 26.33 Product coverage.
MANUFACTURING PRACTICE RE- 26.34 Regulatory authorities.
PORTS, MEDICAL DEVICE QUAL- 26.35 Length and purpose of transition pe-
ITY SYSTEM AUDIT REPORTS, AND riod.
26.36 Listing of CAB’s.
CERTAIN MEDICAL DEVICE 26.37 Confidence building activities.
PRODUCT EVALUATION REPORTS: 26.38 Other transition period activities.
UNITED STATES AND THE EURO- 26.39 Equivalence assessment.
PEAN COMMUNITY 26.40 Start of the operational period.
26.41 Exchange and endorsement of quality
system evaluation reports.
Sec. 26.42 Exchange and endorsement of product
26.0 General. evaluation reports.
26.43 Transmission of quality system eval-
Subpart A—Specific Sector Provisions for uation reports.
Pharmaceutical Good Manufacturing 26.44 Transmission of product evaluation re-
Practices ports.
26.45 Monitoring continued equivalence.
26.1 Definitions. 26.46 Listing of additional CAB’s.
26.2 Purpose. 26.47 Role and composition of the Joint Sec-
26.3 Scope. toral Committee.
26.4 Product coverage. 26.48 Harmonization.
26.5 Length of transition period. 26.49 Regulatory cooperation.
26.6 Equivalence assessment. 26.50 Alert system and exchange of
26.7 Participation in the equivalence assess- postmarket vigilance reports.
ment and determination. APPENDIX A TO SUBPART B OF PART 26—REL-
26.8 Other transition activities. EVANT LEGISLATION, REGULATIONS, AND
26.9 Equivalence determination. PROCEDURES.
26.10 Regulatory authorities not listed as APPENDIX B TO SUBPART B OF PART 26—SCOPE
currently equivalent. OF PRODUCT COVERAGE.
26.11 Start of operational period. APPENDIXES C–F TO SUBPART B OF PART 26
26.12 Nature of recognition of inspection re- [RESERVED]
ports.
26.13 Transmission of postapproval inspec- Subpart C—‘‘Framework’’ Provisions
tion reports.
26.14 Transmission of preapproval inspec- 26.60 Definitions.
tion reports. 26.61 Purpose of this part.
26.15 Monitoring continued equivalence. 26.62 General obligations.
26.16 Suspension. 26.63 General coverage of this part.
26.17 Role and composition of the Joint Sec- 26.64 Transitional arrangements.
toral Committee. 26.65 Designating authorities.
26.66 Designation and listing procedures.
26.18 Regulatory collaboration.
26.67 Suspension of listed conformity as-
26.19 Information relating to quality as-
sessment bodies.
pects.
26.68 Withdrawal of listed conformity as-
26.20 Alert system.
sessment bodies.
26.21 Safeguard clause. 26.69 Monitoring of conformity assessment
APPENDIX A TO SUBPART A OF PART 26—LIST bodies.
OF APPLICABLE LAWS, REGULATIONS, AND 26.70 Conformity assessment bodies.
ADMINISTRATIVE PROVISIONS. 26.71 Exchange of information.
APPENDIX B TO SUBPART A OF PART 26—LIST 26.72 Sectoral contact points.
OF AUTHORITIES. 26.73 Joint Committee.
APPENDIX C TO SUBPART A OF PART 26—INDIC- 26.74 Preservation of regulatory authority.
ATIVE LIST OF PRODUCTS COVERED BY 26.75 Suspension of recognition obligations.
SUBPART A. 26.76 Confidentiality.
APPENDIX D TO SUBPART A OF PART 26—CRI- 26.77 Fees.

TERIA FOR ASSESSING EQUIVALENCE FOR 26.78 Agreements with other countries.
POST- AND PREAPPROVAL. 26.79 Territorial application.
335
§ 26.0 21 CFR Ch. I (4–1–19 Edition)
26.80 Entry into force, amendment, and ter- Subpart A—Specific Sector Provi-
mination.
26.81 Final provisions.
sions for Pharmaceutical
Good Manufacturing Prac-
AUTHORITY: 5 U.S.C. 552; 15 U.S.C. 1453, 1454, tices
1455; 18 U.S.C. 1905; 21 U.S.C. 321, 331, 351, 352,
355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, § 26.1 Definitions.
360i, 360j, 360l, 360m, 371, 374, 381, 382, 383, 393;
42 U.S.C. 216, 241, 242l, 262, 264, 265. (a) Enforcement means action taken
by an authority to protect the public
SOURCE: 63 FR 60141, Nov. 6, 1998, unless from products of suspect quality, safe-
otherwise noted. ty, and effectiveness or to assure that
products are manufactured in compli-
§ 26.0 General. ance with appropriate laws, regula-
This part substantially reflects rel- tions, standards, and commitments
evant provisions of the framework made as part of the approval to market
agreement and its sectoral annexes on a product.
pharmaceutical good manufacturing (b) Equivalence of the regulatory sys-
practices (GMP’s) and medical devices tems means that the systems are suffi-
of the ‘‘Agreement on Mutual Recogni- ciently comparable to assure that the
tion Between the United States of process of inspection and the ensuing
inspection reports will provide ade-
America and the European Commu-
quate information to determine wheth-
nity’’ (the MRA), signed at London
er respective statutory and regulatory
May 18, 1998. For codification purposes, requirements of the authorities have
certain provisions of the MRA have been fulfilled. Equivalence does not re-
been modified for use in this part. This quire that the respective regulatory
modification is done for purposes of systems have identical procedures.
clarity only and shall not affect the (c) Good Manufacturing Practices
text of the MRA concluded between the (GMP’s). [The United States has clari-
United States and the European Com- fied its interpretation that under the
munity (EC), or the rights and obliga- MRA, paragraph (c)(1) of this section
tions of the United States or the EC has to be understood as the U.S. defini-
under that agreement. Whereas the tion and paragraph (c)(2) as the EC def-
parties to the MRA are the United inition.]
States and EC, this part is relevant (1) GMP’s mean the requirements
only to the Food and Drug Administra- found in the legislations, regulations,
tion’s (FDA’s) implementation of the and administrative provisions for
MRA, including the sectoral annexes methods to be used in, and the facili-
ties or controls to be used for, the man-
reflected in subparts A and B of this
ufacturing, processing, packing, and/or
part. This part does not govern imple-
holding of a drug to assure that such
mentation of the MRA by the EC, drug meets the requirements as to safe-
which will implement the MRA in ac- ty, and has the identity and strength,
cordance with its internal procedures, and meets the quality and purity char-
nor does this part address implementa- acteristics that it purports or is rep-
tion of the MRA by other concerned resented to possess.
U.S. Federal agencies. For purposes of (2) GMP’s are that part of quality as-
this part, the terms ‘‘party’’ or ‘‘par- surance which ensures that products
ties,’’ where relevant to FDA’s imple- are consistently produced and con-
mentation of the MRA, should be controlled to quality standards. For the
sidered as referring to FDA only. If the purpose of this subpart, GMP’s include,
parties to the MRA subsequently therefore, the system whereby the
amend or terminate the MRA, FDA manufacturer receives the specifica-
will modify this part accordingly, tions of the product and/or process
using appropriate administrative pro- from the marketing authorization/
cedures. product authorization or license holder
or applicant and ensures the product is
made in compliance with its specifica-
tions (qualified person certification in

the EC).
336
(d) Inspection means an onsite evalua- or animal use, intermediates and start-
tion of a manufacturing facility to de- ing materials (as referred to in the Eu-
termine whether such manufacturing ropean Community (EC)) and to drugs
facility is operating in compliance for human or animal use, biological
with GMP’s and/or commitments made products for human use, and active
as part of the approval to market a pharmaceutical ingredients (as referred
product. to in the United States), only to the
(e) Inspection report means the writ- extent they are regulated by the au-
ten observations and GMP’s compli- thorities of both parties as listed in ap-
ance assessment completed by an au- pendix B of this subpart.
thority listed in appendix B of this sub- (b) Human blood, human plasma,
part. human tissues and organs, and veteri-
(f) Regulatory system means the body nary immunologicals (under 9 CFR
of legal requirements for GMP’s, in- 101.2, ‘‘veterinary immunologicals’’ are
spections, and enforcements that en- referred to as ‘‘veterinary biologicals’’)
sure public health protection and legal are excluded from the scope of this sub-
authority to assure adherence to these part. Human plasma derivatives (such
requirements. as immunoglobulins and albumin), in-
[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, vestigational medicinal products/new
1999] drugs, human radiopharmaceuticals,
and medicinal gases are also excluded
§ 26.2 Purpose. during the transition phase; their situ-
The provisions of this subpart govern ation will be reconsidered at the end of
the exchange between the parties and the transition period. Products regu-
normal endorsement by the receiving lated by the Food and Drug Adminis-
regulatory authority of official good tration’s Center for Biologics Evalua-
manufacturing practices (GMP’s) in- tion and Research or Center for Drug
spection reports after a transitional pe- Evaluation and Research as devices are
riod aimed at determination of the not covered under this subpart.
equivalence of the regulatory systems (c) Appendix C of this subpart con-
of the parties, which is the cornerstone tains an indicative list of products cov-
of this subpart. ered by this subpart.
§ 26.3 Scope. [63 FR 60141, Nov. 6, 1998, as amended at 70
FR 14980, Mar. 24, 2005]
(a) The provisions of this subpart
shall apply to pharmaceutical inspec- § 26.5 Length of transition period.
tions carried out in the United States
and Member States of the European A 3-year transition period will start
Community (EC) before products are immediately after the effective date
marketed (hereafter referred to as described in § 26.80(a).
‘‘preapproval inspections’’) as well as
§ 26.6 Equivalence assessment.
during their marketing (hereafter re-
ferred to as ‘‘postapproval inspec- (a) The criteria to be used by the par-
tions’’). ties to assess equivalence are listed in
(b) Appendix A of this subpart names appendix D of this subpart. Informa-
the laws, regulations, and administration pertaining to the criteria under
tive provisions governing these inspec- European Community (EC) competence
tions and the good manufacturing prac- will be provided by the EC.
tices (GMP’s) requirements. (b) The authorities of the parties will
(c) Appendix B of this subpart lists establish and communicate to each
the authorities participating in activi- other their draft programs for assess-
ties under this subpart. ing the equivalence of the respective
(d) Sections 26.65, 26.66, 26.67, 26.68, regulatory systems in terms of quality
26.69, and 26.70 of subpart C of this part assurance of the products and con-
do not apply to this subpart. sumer protection. These programs will
be carried out, as deemed necessary by
§ 26.4 Product coverage. the regulatory authorities, for post-
(a) The provisions of this subpart will and preapproval inspections and for
apply to medicinal products for human various product classes or processes.
337
§ 26.7 21 CFR Ch. I (4–1–19 Edition)
(c) The equivalence assessment shall § 26.10 Regulatory authorities not list-
include information exchanges (included as currently equivalent.
ing inspection reports), joint training, Authorities not currently listed as
and joint inspections for the purpose of equivalent, or not equivalent for cer-
assessing regulatory systems and the tain types of inspections, product
authorities’ capabilities. In conducting classes or processes may apply for re-
the equivalence assessment, the parties consideration of their status once the
will ensure that efforts are made to
necessary corrective measures have
save resources.
been taken or additional experience is
(d) Equivalence assessment for au- gained.
thorities added to appendix B of this
subpart after the effective date de- § 26.11 Start of operational period.
scribed in § 26.80(a) will be conducted as
described in this subpart, as soon as (a) The operational period shall start
practicable. at the end of the transition period and
its provisions apply to inspection re-
§ 26.7 Participation in the equivalence ports generated by authorities listed as
assessment and determination. equivalent for the inspections per-
The authorities listed in appendix B formed in their territory.
of this subpart will actively participate (b) In addition, when an authority is
in these programs to build a sufficient not listed as equivalent based on ade-
body of evidence for their equivalence quate experience gained during the
determination. Both parties will exer- transition period, the Food and Drug
cise good faith efforts to complete Administration (FDA) will accept for
equivalence assessment as expedi- normal endorsement (as provided in
tiously as possible to the extent the re- § 26.12) inspection reports generated as
sources of the authorities allow. a result of inspections conducted joint-
ly by that authority on its territory
§ 26.8 Other transition activities. and another authority listed as equiva-
As soon as possible, the authorities lent, provided that the authority of the
will jointly determine the essential in- Member State in which the inspection
formation which must be present in in- is performed can guarantee enforce-
spection reports and will cooperate to ment of the findings of the inspection
develop mutually agreed inspection re- report and require that corrective
port format(s). measures be taken when necessary.
FDA has the option to participate in
§ 26.9 Equivalence determination. these inspections, and based on experi-
(a) Equivalence is established by hav- ence gained during the transition pe-
ing in place regulatory systems cov- riod, the parties will agree on proce-
ering the criteria referred to in appen- dures for exercising this option.
dix D of this subpart, and a dem- (c) In the European Community (EC),
onstrated pattern of consistent per- the qualified person will be relieved of
formance in accordance with these cri- responsibility for carrying the controls
teria. A list of authorities determined laid down in Article 22 paragraph 1(b)
as equivalent shall be agreed to by the of Council Directive 75/319/EEC (see ap-
Joint Sectoral Committee at the end of pendix A of this subpart) provided that
the transition period, with reference to these controls have been carried out in
any limitation in terms of inspection the United States and that each batch/
type (e.g., postapproval or preapproval) lot is accompanied by a batch certifi-
or product classes or processes. cate (in accordance with the World
(b) The parties will document insuffi- Health Organization Certification
cient evidence of equivalence, lack of Scheme on the Quality of Medicinal
opportunity to assess equivalence or a Products) issued by the manufacturer
determination of nonequivalence, in certifying that the product complies
sufficient detail to allow the authority with requirements of the marketing
being assessed to know how to attain authorization and signed by the person
equivalence. responsible for releasing the batch/lot.
338
§ 26.12 Nature of recognition of inspec- Medicinal Products (EMEA). If the au-

tion reports. thority receiving the request cannot
(a) Inspection reports (containing in- carry out the inspection as requested,
formation as established under § 26.8), the requesting authority shall have the
including a good manufacturing prac- right to conduct the inspection.
tice (GMP) compliance assessment, (c) Reports of preapproval inspec-
prepared by authorities listed as equiv- tions will be sent within 45-calendar
alent, will be provided to the authority days of the request that transmitted
of the importing party. Based on the the appropriate information and de-
determination of equivalence in light tailed the precise issues to be addressed
of the experience gained, these inspec- during the inspection. A shorter time
tion reports will normally be endorsed may be necessary in exceptional cases
by the authority of the importing and these will be described in the re-
party, except under specific and delin-
quest.
eated circumstances. Examples of such
circumstances include indications of § 26.15 Monitoring continued equiva-
material inconsistencies or inadequa- lence.
cies in an inspection report, quality de-
fects identified in the postmarket sur- Monitoring activities for the purpose
veillance or other specific evidence of of maintaining equivalence shall in-
serious concern in relation to product clude review of the exchange of inspec-
quality or consumer safety. In such tion reports and their quality and
cases, the authority of the importing timeliness; performance of a limited
party may request clarification from number of joint inspections; and the
the authority of the exporting party conduct of common training sessions.
which may lead to a request for rein-
spection. The authorities will endeavor § 26.16 Suspension.
to respond to requests for clarification (a) Each party has the right to con-
in a timely manner. test the equivalence of a regulatory au-
(b) Where divergence is not clarified thority. This right will be exercised in
in this process, an authority of the im- an objective and reasoned manner in
porting country may carry out an in-
writing to the other party.
spection of the production facility.
(b) The issue shall be discussed in the
§ 26.13 Transmission of postapproval Joint Sectoral Committee promptly
inspection reports. upon such notification. Where the
Postapproval good manufacturing Joint Sectoral Committee determines
practice (GMP) inspection reports con- that verification of equivalence is re-
cerning products covered by this sub- quired, it may be carried out jointly by
part will be transmitted to the author- the parties in a timely manner, under
ity of the importing country within 60- § 26.6.
calendar days of the request. Should a (c) Efforts will be made by the Joint
new inspection be needed, the inspec- Sectoral Committee to reach unani-
tion report will be transmitted within mous consent on the appropriate ac-
90-calendar days of the request. tion. If agreement to suspend is
reached in the Joint Sectoral Com-
§ 26.14 Transmission of preapproval
inspection reports. mittee, an authority may be suspended
immediately thereafter. If no agree-
(a) A preliminary notification that ment is reached in the Joint Sectoral
an inspection may have to take place Committee, the matter is referred to
will be made as soon as possible. the Joint Committee as described in
(b) Within 15-calendar days, the rel-
§ 26.73. If no unanimous consent is
evant authority will acknowledge re-
reached within 30 days after such noti-
ceipt of the request and confirm its
ability to carry out the inspection. In fication, the contested authority will
the European Community (EC), re- be suspended.
quests will be sent directly to the rel- (d) Upon the suspension of authority
evant authority, with a copy to the Eu- previously listed as equivalent, a party
ropean Agency for the Evaluation of
339
§ 26.17 21 CFR Ch. I (4–1–19 Edition)
is no longer obligated to normally en- technical regulations or inspection

dorse the inspection reports of the sus- procedures and to provide the oppor-
pended authority. A party shall con- tunity to comment on such proposals.
tinue to normally endorse the inspec- (b) The parties shall notify each
tion reports of that authority prior to other in writing of any changes to ap-
suspension, unless the authority of the pendix B of this subpart.
receiving party decides otherwise based
on health or safety considerations. The § 26.19 Information relating to quality
suspension will remain in effect until aspects.
unanimous consent has been reached The authorities will establish an ap-
by the parties on the future status of propriate means of exchanging infor-
that authority. mation on any confirmed problem re-
§ 26.17 Role and composition of the ports, corrective actions, recalls, re-
Joint Sectoral Committee. jected import consignments, and other
regulatory and enforcement problems
(a) A Joint Sectoral Committee is set for products subject to this subpart.
up to monitor the activities under both
the transitional and operational phases § 26.20 Alert system.
of this subpart.
(b) The Joint Sectoral Committee (a) The details of an alert system will
will be cochaired by a representative of be developed during the transitional
the Food and Drug Administration period. The system will be maintained
(FDA) for the United States and a rep- in place at all times. Elements to be
resentative of the European Commu- considered in developing such a system
nity (EC) who each will have one vote. are described in appendix E of this sub-
Decisions will be taken by unanimous part.
consent. (b) Contact points will be agreed be-
(c) The Joint Sectoral Committee’s tween both parties to permit authori-
functions will include: ties to be made aware with the appro-
(1) Making a joint assessment, which priate speed in case of quality defect,
must be agreed by both parties, of the recalls, counterfeiting, and other prob-
equivalence of the respective authori- lems concerning quality, which could
ties; necessitate additional controls or sus-
(2) Developing and maintaining the pension of the distribution of the prod-
list of equivalent authorities, including uct.
any limitation in terms of inspecting
type or products, and communicating § 26.21 Safeguard clause.
the list to all authorities and the Joint Each party recognizes that the im-
Committee; porting country has a right to fulfill
(3) Providing a forum to discuss its legal responsibilities by taking ac-
issues relating to this subpart, includ- tions necessary to ensure the protec-
ing concerns that an authority may be tion of human and animal health at the
no longer equivalent and opportunity level of protection it deems appro-
to review product coverage; and priate. This includes the suspension of
(4) Consideration of the issue of sus- the distribution, product detention at
pension. the border of the importing country,
(d) The Joint Sectoral Committee withdrawal of the batches and any re-
shall meet at the request of either quest for additional information or in-
party and, unless the cochairs other- spection as provided in § 26.12.
wise agree, at least once each year. The
Joint Committee will be kept informed APPENDIX A TO SUBPART A OF PART 26—
of the agenda and conclusions of meet- LIST OF APPLICABLE LAWS, REGULA-
ings of the Joint Sectoral Committee. TIONS, AND ADMINISTRATIVE PROVI-
SIONS
§ 26.18 Regulatory collaboration.
(a) The parties and authorities shall 1. For the European Community (EC):
inform and consult one another, as per-
[Copies of EC documents may be obtained

mitted by law, on proposals to intro- from the European Document Research, 1100
duce new controls or to change existing 17th St. NW., suite 301, Washington, DC 20036.
340
Food and Drug Administration, HHS Pt. 26, Subpt. A, App. C
EC documents may be viewed on the Euro- APPENDIX B TO SUBPART A OF PART 26—
pean Commission Pharmaceuticals Units LIST OF AUTHORITIES
web site at http://dg3.eudra.org.]
Council Directive 65/65/EEC of 26 January 1. For the United States: In the United
1965 on the approximation of provisions laid States, the regulatory authority is the
down by law, regulation, or administrative Food and Drug Administration.
action relating to proprietary medicinal
2. For the European Community: In the Eu-
products as extended, widened, and amended.
ropean Community, the regulatory au-
Council Directive 75/319/EEC of 20 May 1975 thorities are the following:
on the approximation of provisions laid down
by law, regulation or administrative action Belgium: Inspection générale de la
relating to proprietary medicinal products Pharmacie, Algemene Farmaceutische
as extended, widened and amended. Inspectie.
Council Directive 81/851/EEC of 28 September Denmark: Laegemiddelstyrelsen.
1981 on the approximation of the laws of the Germany: Bundesministerium für Gesund-
Member States relating to veterinary medic- heit for immunologicals: Paul-Ehrlich-
inal products, as widened and amended. Institut, Federal Agency for Sera and Vac-
cines.
Commission Directive 91/356/EEC of 13 June
Greece: EqnιkwV WrganιsμwV Farμakwu, Min-
1991 laying down the principles and guide-
istry of Health and Welfare, National Drug
lines of good manufacturing practice for me-
Organization (E.O.F).
dicinal products for human use.
Spain: For medicinal products for human
Commission Directive 91/412/EEC of 23 July use: Ministerio de Sanidad y Consumo,
1991 laying down the principles and guide- Subdirección General de Control
lines of good manufacturing practice for vet- Farmacéutico. For medicinal products for
erinary medicinal products. veterinary use: Ministerio de Agricultura,
Council Regulation EEC No 2309/93 of 22 July Pesca y Alimentación (MAPA), Dirección
1993 laying down Community procedures for General de la Producción Agraria.
the authorization and supervision of medic- France: For medicinal products for human
inal products for human and veterinary use use: Agence du Médicament. For veterinary
and establishing a European Agency for the medicinal products: Agence Nationale du
Evaluation of Medicinal Products. Médicament Vétérinaire.
Council Directive 92/25/EEC of 31 March 1992 Ireland: Irish Medicines Board.
on the wholesale distribution of medicinal Italy: For medicinal products for human use:
products for human use. Ministero della Sanità, Dipartimento
Guide to Good Distribution Practice (94/C 63/ Farmaci e Farmacovigilanza. For medicinal
03). products for veterinary use: Ministero della
Current version of the Guide to Good Manu- Sanità, Dipartimento alimenti e nutrizione e
facturing Practice, Rules Governing Medic- sanità pubblica veterinaria-Div. IX.
inal Products in the European Community, Luxembourg: Division de la Pharmacie et
des Médicaments.
Volume IV.
Netherlands: Staat der Nederlanden.
2. For the United States: Austria: Bundesministerium für Arbeit, Ge-
sundheit und Soziales.
[Copies of FDA documents may be obtained Portugal: Instituto da Farmácia e do
from the Government Printing Office, 1510 H Medicamento (INFARMED).
St. NW., Washington, DC 20005. FDA docu- Finland: Lääkelaitos/Läkemedelsverket (Na-
ments, except the FDA Compliance Program tional Agency for Medicines).
Guidance Manual, may be viewed on FDA’s Sweden: Läkemedelsverket-Medical Prod-
Internet web site at http://www.fda.gov.] ucts Agency.
Relevant sections of the United States Fed- United Kingdom: For human use and veteri-
eral Food, Drug, and Cosmetic Act and the nary (non-immunologicals): Medicines Con-
United States Public Health Service Act. trol Agency. For veterinary immunologicals:
Relevant sections of Title 21, United States Veterinary Medicines Directorate.
Code of Federal Regulations (CFR) Parts 1– European Community: Commission of the
99, Parts 200–299, Parts 500–599, and Parts 600– European Communities. European Agency
799. for the Evaluation of Medicinal Products
Relevant sections of the FDA Investigations (EMEA).
Operations Manual, the FDA Regulatory
Procedures Manual, the FDA Compliance APPENDIX C TO SUBPART A OF PART 26—
Policy Guidance Manual, the FDA Compli- INDICATIVE LIST OF PRODUCTS COV-
ance Program Guidance Manual, and other ERED BY SUBPART A
FDA guidances.
Recognizing that precise definition of medic-
inal products and drugs are to be found in
341
Pt. 26, Subpt. A, App. D 21 CFR Ch. I (4–1–19 Edition)
the legislation referred to above, an indic- IV. Conduct of inspections:
ative list of products covered by this ar-
rangement is given below: A. Adequate preinspection preparation, in-
—human medicinal products including pre- cluding appropriate expertise of investigator/
scription and nonprescription drugs; team, review of firm/product and databases,
—human biologicals including vaccines, and availability of appropriate inspection
and immunologicals; equipment.
—veterinary pharmaceuticals, including B. Adequate conduct of inspection, including
prescription and nonprescription drugs, statutory access to facilities, effective re-
with the exclusion of veterinary sponse to refusals, depth and competence of
immunologicals (Under 9 CFR 101.2 ‘‘vet- evaluation of operations, systems and docu-
erinary immunologicals’’ are referred to mentation; collection of evidence; appro-
as ‘‘veterinary biologicals’’); priate duration of inspection and complete-
—premixes for the preparation of veteri- ness of written report of observations to firm
nary medicated feeds (EC), Type A medi- management.
cated articles for the preparation of vet- C. Adequate postinspection activities, in-
erinary medicated feeds (United States); cluding completeness of inspectors’ report,
—intermediate products and active phar- inspection report review where appropriate,
maceutical ingredients or bulk pharma- and conduct of followup inspections and
ceuticals (United States)/starting mate- other activities where appropriate, assurance
rials (EC). of preservation and retrieval of records.
APPENDIX D TO SUBPART A OF PART 26— V. Execution of regulatory enforcement ac-
CRITERIA FOR ASSESSING EQUIVA- tions to achieve corrections, designed to
LENCE FOR POST- AND prevent future violations, and to remove
PREAPPROVAL products found in violation of require-
ments from the market.
I. Legal/Regulatory authority and structures
and procedures providing for post- and VI. Effective use of surveillance systems:
preapproval:
A. Sampling and analysis.
A. Appropriate statutory mandate and juris- B. Recall monitoring.
diction. C. Product defect reporting system.
B. Ability to issue and update binding re-
D. Routine surveillance inspections.
quirements on GMP’s and guidance docu-
E. Verification of approved manufacturing
ments.
process changes to marketing authoriza-
C. Authority to make inspections, review
and copy documents, and to take samples tions/approved applications.
and collect other evidence.
VII. Additional specific criteria for
D. Ability to enforce requirements and to re-
preapproval inspections:
move products found in violation of such re-
quirements from the market. A. Satisfactory demonstration through a
E. Substantive current good manufacturing jointly developed and administered training
requirements. program and joint inspections to assess the
F. Accountability of the regulatory author- regulatory authorities’ capabilities.
ity. B. Preinspection preparation includes the re-
G. Inventory of current products and manu- view of appropriate records, including site
facturers. plans and drug master file or similar docu-
H. System for maintaining or accessing in- mentation to enable adequate inspections.
spection reports, samples and other analyt- C. Ability to verify chemistry, manufac-
ical data, and other firm/product informa-
turing, and control data supporting an appli-
tion relating to matters covered by subpart
cation is authentic and complete.
A of this part.
D. Ability to assess and evaluate research
II. Mechanisms in place to assure appro- and development data as scientifically
priate professional standards and avoid- sound, especially transfer technology of
ance of conflicts of interest. pilot, scale up and full scale production
batches.
III. Administration of the regulatory E. Ability to verify conformity of the onsite
authority: processes and procedures with those de-
A. Standards of education/qualification and scribed in the application.
training. F. Review and evaluate equipment installa-
B. Effective quality assurance systems meas- tion, operational and performance qualifica-
ures to ensure adequate job performance. tion data, and evaluate test method valida-
C. Appropriate staffing and resources to en- tion.
force laws and regulations.
342
APPENDIX E TO SUBPART A OF PART 26— Subpart B—Specific Sector

ELEMENTS TO BE CONSIDERED IN DE- Provisions for Medical Devices
VELOPING A TWO-WAY ALERT SYS-
TEM § 26.31 Purpose.
1. Documentation (a) The purpose of this subpart is to
specify the conditions under which a
—Definition of a crisis/emergency and under party will accept the results of quality
what circumstances an alert is required system-related evaluations and inspec-
—Standard Operating Procedures (SOP’s)
tions and premarket evaluations of the
—Mechanism of health hazards evaluation
other party with regard to medical de-
and classification
vices as conducted by listed conformity
—Language of communication and trans-
mission of information
assessment bodies (CAB’s) and to pro-
vide for other related cooperative ac-
2. Crisis Management System tivities.
(b) This subpart is intended to evolve
—Crisis analysis and communication mecha-
nisms as programs and policies of the parties
—Establishment of contact points evolve. The parties will review this
—Reporting mechanisms subpart periodically, in order to assess
progress and identify potential en-
3. Enforcement Procedures hancements to this subpart as Food
—Followup mechanisms
and Drug Administration (FDA) and
—Corrective action procedures European Community (EC) policies
evolve over time.
4. Quality Assurance System
§ 26.32 Scope.
—Pharmacovigilance programme
—Surveillance/monitoring of implementa- (a) The provisions of this subpart
tion of corrective action shall apply to the exchange and, where
appropriate, endorsement of the fol-
5. Contact Points lowing types of reports from con-
For the purpose of subpart A of this part, the formity assessment bodies (CAB’s) as-
contact points for the alert system will be: sessed to be equivalent:
(1) Under the U.S. system, surveil-
A. For the European Community: lance/postmarket and initial/
the Executive Director of the European preapproval inspection reports;
Agency for the Evaluation of Medicinal (2) Under the U.S. system, premarket
Products, 7, Westferry Circus, Canary Wharf, (510(k)) product evaluation reports;
UK - London E14 4HB, England. Telephone (3) Under the European Community
44–171–418 8400, Fax 418–8416. (EC) system, quality system evaluation
reports; and
B. For the United States :
(4) Under the EC system, EC type ex-
Biologics:Food and Drug Administration, amination and verification reports.
Center for Biologics Evaluation and Re- (b) Appendix A of this subpart names
search, Document Control Center, 10903 New the legislation, regulations, and re-
Hampshire Ave., Bldg. 71, Rm. G112, Silver lated procedures under which:
Spring, MD 20993–0002, telephone: 240–402–
(1) Products are regulated as medical
9153, FAX: 301–595–1302.
devices by each party;
Human Drugs: Director, Office of Compli-
ance, 10903 New Hampshire Ave., Silver
(2) CAB’s are designated and con-
Spring, MD 20993–0002, phone: 301–796–3100, firmed; and
fax: 301–847–8747. (3) These reports are prepared.
Veterinary Drugs: Director, Office of Sur- (c) For purposes of this subpart,
veillance and Compliance (HFV–200), MPN II, equivalence means that: CAB’s in the
7500 Standish Pl., Rockville, MD 20855–2773, EC are capable of conducting product
phone: 301–827–6644, fax: 301–594–1807. and quality systems evaluations
against U.S. regulatory requirements
FR 48775, Aug. 11, 2004; 74 FR 13112, Mar. 26, in a manner equivalent to those con-
ducted by FDA; and CAB’s in the
2009; 80 FR 18090, Apr. 3, 2015]

United States are capable of con-
ducting product and quality systems
343
§ 26.33 21 CFR Ch. I (4–1–19 Edition)
evaluations against EC regulatory rein reports to be exchanged under this

quirements in a manner equivalent to subpart.
those conducted by EC CAB’s.
§ 26.36 Listing of CAB’s.
§ 26.33 Product coverage. Each party shall designate con-
(a) There are three components to formity assessment bodies (CAB’s) to
this subpart each covering a discrete participate in confidence building ac-
range of products: tivities by transmitting to the other
(1) Quality System Evaluations. U.S.- party a list of CAB’s which meet the
type surveillance/postmarket and ini- criteria for technical competence and
tial/preapproval inspection reports and independence, as identified in appendix
European Community (EC)-type qual- A of this subpart. The list shall be ac-
ity system evaluation reports will be companied by supporting evidence.
exchanged with regard to all products Designated CAB’s will be listed in ap-
regulated under both U.S. and EC law pendix D of this subpart for participa-
as medical devices. tion in the confidence building activi-
(2) Product Evaluation. U.S.-type pre- ties once confirmed by the importing
market (510(k)) product evaluation re- party. Nonconfirmation would have to
ports and EC-type-testing reports will be justified based on documented evi-
be exchanged only with regard to those dence.
products classified under the U.S. sys-
tem as Class I/Class II-Tier 2 medical § 26.37 Confidence building activities.
devices which are listed in appendix B (a) At the beginning of the transi-
of this subpart. tional period, the Joint Sectoral Group
(3) Postmarket Vigilance Reports. will establish a joint confidence build-
Postmarket vigilance reports will be ing program calculated to provide suf-
exchanged with regard to all products ficient evidence of the capabilities of
regulated under both U.S. and EC law the designated conformity assessment
as medical devices. bodies (CAB’s) to perform quality sys-
(b) Additional products and proce- tem or product evaluations to the spec-
dures may be made subject to this sub- ifications of the parties.
part by agreement of the parties. (b) The joint confidence building pro-
gram should include the following ac-
§ 26.34 Regulatory authorities. tions and activities:
The regulatory authorities shall have (1) Seminars designed to inform the
the responsibility of implementing the parties and CAB’s about each party’s
provisions of this subpart, including regulatory system, procedures, and re-
the designation and monitoring of con- quirements;
formity assessment bodies (CAB’s). (2) Workshops designed to provide the
Regulatory authorities will be speci- parties with information regarding re-
fied in appendix C of this subpart. Each quirements and procedures for the des-
party will promptly notify the other ignation and surveillance of CAB’s;
party in writing of any change in the (3) Exchange of information about re-
regulatory authority for a country. ports prepared during the transition
period;
§ 26.35 Length and purpose of transi- (4) Joint training exercises; and
tion period. (5) Observed inspections.
There will be a 3-year transition pe- (c) During the transition period, any
riod immediately following the date significant problem that is identified
described in § 26.80(a). During the tran- with a CAB may be the subject of coop-
sition period, the parties will engage in erative activities, as resources allow
confidence-building activities for the and as agreed to by the regulatory au-
purpose of obtaining sufficient evi- thorities, aimed at resolving the prob-
dence to make determinations con- lem.
cerning the equivalence of conformity (d) Both parties will exercise good
assessment bodies (CAB’s) of the other faith efforts to complete the confidence
party with respect to the ability to building activities as expeditiously as
perform quality system and product possible to the extent that the re-
evaluations or other reviews resulting sources of the parties allow.
344
(e) Both the parties will each prepare (c) Decisions concerning the equiva-
annual progress reports which will de- lence of CAB’s must be agreed to by
scribe the confidence building activi- both parties.
ties undertaken during each year of the
transition period. The form and con- § 26.40 Start of the operational period.
tent of the reports will be determined (a) The operational period will start
by the parties through the Joint Sec- at the end of the transition period after
toral Committee. the parties have developed the list of
conformity assessment bodies (CAB’s)
§ 26.38 Other transition period activi- found to be equivalent. The provisions
ties. of §§ 26.40, 26.41, 26.42, 26.43, 26.44, 26.45,
(a) During the transition period, the and 26.46 will apply only with regard to
parties will jointly determine the nec- listed CAB’s and only to the extent of
essary information which must be any specifications and limitations con-
present in quality system and product tained on the list with regard to a
evaluation reports. CAB.
(b) The parties will jointly develop a (b) The operational period will apply
notification and alert system to be to quality system evaluation reports
used in case of defects, recalls, and and product evaluation reports gen-
other problems concerning product erated by CAB’s listed in accordance
quality that could necessitate addi- with this subpart for the evaluations
tional actions (e.g., inspections by the performed in the respective territories
parties of the importing country) or of the parties, except if the parties
suspension of the distribution of the agree otherwise.
product.
§ 26.41 Exchange and endorsement of
§ 26.39 Equivalence assessment. quality system evaluation reports.
(a) In the final 6 months of the tran- (a) Listed European Community (EC)
sition period, the parties shall proceed conformity assessment bodies (CAB’s)
to a joint assessment of the equiva- will provide FDA with reports of qual-
lence of the conformity assessment ity system evaluations, as follows:
bodies (CAB’s) that participated in the (1) For preapproval quality system
confidence building activities. CAB’s evaluations, EC CAB’s will provide full
will be determined to be equivalent reports; and
provided they have demonstrated pro- (2) For surveillance quality system
ficiency through the submission of a evaluations, EC CAB’s will provide ab-
sufficient number of adequate reports. breviated reports.
CAB’s may be determined to be equiva- (b) Listed U.S. CAB’s will provide to
lent with regard to the ability to per- the EC Notified Body of the manufac-
form any type of quality system or turer’s choice:
product evaluation covered by this sub- (1) Full reports of initial quality sys-
part and with regard to any type of tem evaluations;
product covered by this subpart. The (2) Abbreviated reports of quality
parties shall develop a list contained in systems surveillance audits.
appendix E of this subpart of CAB’s de- (c) If the abbreviated reports do not
termined to be equivalent, which shall provide sufficient information, the im-
contain a full explanation of the scope porting party may request additional
of the equivalency determination, in- clarification from the CAB.
cluding any appropriate limitations, (d) Based on the determination of
with regard to performing any type of equivalence in light of the experience
quality system or product evaluation. gained, the quality system evaluation
(b) The parties shall allow CAB’s not reports prepared by the CAB’s listed as
listed for participation in this subpart, equivalent will normally be endorsed
or listed for participation only as to by the importing party, except under
certain types of evaluations, to apply specific and delineated circumstances.
for participation in this subpart once Examples of such circumstances in-
the necessary measures have been clude indications of material inconsist-
taken or sufficient experience has been encies or inadequacies in a report,

gained, in accordance with § 26.46. quality defects identified in
345
§ 26.42 21 CFR Ch. I (4–1–19 Edition)
postmarket surveillance or other spe- 60-calendar days of a request by the im-

cific evidence of serious concern in reporting party. Should a new inspection
lation to product quality or consumer be requested, the time period shall be
safety. In such cases, the importing extended by an additional 30-calendar
party may request clarification from days. A party may request a new in-
the exporting party which may lead to spection, for cause, identified to the
a request for reinspection. The parties other party. If the exporting party can-
will endeavor to respond to requests for not perform an inspection within a
clarification in a timely manner. specified period of time, the importing
Where divergence is not clarified in party may perform an inspection on its
this process, the importing party may own.
carry out the quality system evalua-
tion. § 26.44 Transmission of product eval-
uation reports.
§ 26.42 Exchange and endorsement of Transmission of product evaluation
product evaluation reports. reports will take place according to the
(a) European Community (EC) con- importing party’s specified procedures.
formity assessment bodies (CAB’s) list-
ed for this purpose will, subject to the § 26.45 Monitoring continued equiva-
specifications and limitations on the lence.
list, provide to FDA 510(k) premarket Monitoring activities will be carried
notification assessment reports pre- out in accordance with § 26.69.
pared to U.S. medical device require-
ments. § 26.46 Listing of additional CAB’s.
(b) U.S. CAB’s will, subject to the (a) During the operational period, ad-
specifications and limitations on the ditional conformity assessment bodies
list, provide to the EC Notified Body of (CAB’s) will be considered for equiva-
the manufacturer’s choice, type exam- lence using the procedures and criteria
ination, and verification reports pre- described in §§ 26.36, 26.37, and 26.39,
pared to EC medical device require- taking into account the level of con-
ments. fidence gained in the overall regu-
(c) Based on the determination of latory system of the other party.
equivalence in light of the experience (b) Once a designating authority con-
gained, the product evaluation reports siders that such CAB’s, having under-
prepared by the CAB’s listed as equiva- gone the procedures of §§ 26.36, 26.37,
lent will normally be endorsed by the and 26.39, may be determined to be
importing party, except under specific equivalent, it will then designate those
and delineated circumstances. Exam- bodies on an annual basis. Such proce-
ples of such circumstances include in- dures satisfy the procedures of § 26.66(a)
dications of material inconsistencies, and (b).
inadequacies, or incompleteness in a (c) Following such annual designa-
product evaluation report, or other tions, the procedures for confirmation
specific evidence of serious concern in of CAB’s under § 26.66(c) and (d) shall
relation to product safety, perform- apply.
ance, or quality. In such cases, the im-
porting party may request clarification § 26.47 Role and composition of the
from the exporting party which may Joint Sectoral Committee.
lead to a request for a reevaluation. (a) The Joint Sectoral Committee for
The parties will endeavor to respond to this subpart is set up to monitor the
requests for clarification in a timely activities under both the transitional
manner. Endorsement remains the re- and operational phases of this subpart.
sponsibility of the importing party. (b) The Joint Sectoral Committee
will be cochaired by a representative of
§ 26.43 Transmission of quality system the Food and Drug Administration
evaluation reports. (FDA) for the United States and a rep-
Quality system evaluation reports resentative of the European Commu-
covered by § 26.41 concerning products nity (EC) who will each have one vote.
covered by this subpart shall be trans- Decisions will be taken by unanimous

mitted to the importing party within consent.
346
Food and Drug Administration, HHS Pt. 26, Subpt. B, App. A
(c) The Joint Sectoral Committee’s tive actions, or recalls. These reports
functions will include: are regarded as part of ongoing inves-
(1) Making a joint assessment of the tigations.
equivalence of conformity assessment (b) Contact points will be agreed be-
bodies (CAB’s); tween both parties to permit authori-
(2) Developing and maintaining the ties to be made aware with the appro-
list of equivalent CAB’s, including any priate speed in case of quality defect,
limitation in terms of their scope of batch recalls, counterfeiting and other
activities and communicating the list problems concerning quality, which
to all authorities and the Joint Com- could necessitate additional controls
mittee described in subpart C of this or suspension of the distribution of the
part; product.
(3) Providing a forum to discuss
issues relating to this subpart, includ- APPENDIX A TO SUBPART B OF PART 26—
ing concerns that a CAB may no longer RELEVANT LEGISLATION, REGULA-
be equivalent and opportunity to re- TIONS, AND PROCEDURES.
view product coverage; and 1. For the European Community (EC) the fol-
(4) Consideration of the issue of sus- lowing legislation applies to § 26.42(a) of
pension. this subpart:
§ 26.48 Harmonization. [Copies of EC documents may be obtained
from the European Document Research, 1100
During both the transitional and 17th St. NW., suite 301, Washington, DC
operational phases of this subpart, 20036.]
both parties intend to continue to par- a. Council Directive 90/385/EEC of 20 June
ticipate in the activities of the Global 1990 on active implantable medical devices
Harmonization Task Force (GHTF) and OJ No. L 189, 20.7. 1990, p. 17. Conformity
utilize the results of those activities to assessment procedures.
the extent possible. Such participation Annex 2 (with the exception of section 4)
Annex 4
involves developing and reviewing doc-
Annex 5
uments developed by the GHTF and b. Council Directive 93/42/EEC of 14 June 1993
jointly determining whether they are on Medical Devices OJ No. L 169,12.7.1993, p.1.
applicable to the implementation of Conformity assessment procedures.
this subpart. Annex 2 (with the exception of section 4)
Annex 3
§ 26.49 Regulatory cooperation. Annex 4
(a) The parties and authorities shall Annex 5
Annex 6
inform and consult with one another,
as permitted by law, of proposals to in- 2. For the United States, the following
troduce new controls or to change ex- legislation applies to § 26.32(a):
isting technical regulations or inspec- [Copies of FDA documents may be obtained
tion procedures and to provide the op- from the Government Printing Office, 1510 H
portunity to comment on such pro- St. NW., Washington, DC 20005. FDA docu-
posals. ments may be viewed on FDA’s Internet web
(b) The parties shall notify each site at http://www.fda.gov.]
other in writing of any changes to ap- a. The Federal Food, Drug and Cosmetic Act,
pendix A of this subpart. 21 U.S.C. 321 et seq.
b. The Public Health Service Act, 42 U.S.C.
§ 26.50 Alert system and exchange of 201 et seq.
postmarket vigilance reports. c. Regulations of the United States Food and
Drug Administration found at 21 CFR, in
(a) An alert system will be set up particular, Parts 800 to 1299.
during the transition period and main- d. Medical Devices; Third Party Review of
tained thereafter by which the parties Selected Premarket Notifications; Pilot Pro-
will notify each other when there is an gram, 61 FR 14789–14796 (April 3, 1996).
immediate danger to public health. e. Draft Guidance Document on Accredited
Persons Program, 63 FR 28392 (May 22, 1998).
Elements of such a system will be de-
f. Draft Guidance for Staff, Industry and
scribed in an appendix F of this sub- Third Parties, Third Party Programs under
part. As part of that system, each
the Sectoral Annex on Medical Devices to

party shall notify the other party of the Agreement on Mutual Recognition Be-
any confirmed problem reports, correc- tween the United States of America and the
347
Pt. 26, Subpt. B, App. B 21 CFR Ch. I (4–1–19 Edition)
European Community (MRA), 63 FR 36240 order for the parties to gain the requisite
(July 2, 1998). experience.
g. Guidance Document on Use of Standards, The corresponding additional product lists
63 FR 9561 (February 25, 1998). will be phased in on an annual basis. The
parties may consult with industry and other
APPENDIX B TO SUBPART B OF PART 26— interested parties in determining which
SCOPE OF PRODUCT COVERAGE products will be added.
1. Initial Coverage of the Transition Period 3. Commencement of the Operational Period

a. At the commencement of the oper-
Upon entry into force of this subpart as de-
ational period, product coverage shall ex-
scribed in § 26.80 (it is understood that the
tend to all Class I/II products covered
date of entry into force will not occur prior
during the transition period.
to June 1, 1998, unless the parties decide oth-
b. FDA will expand the program to cat-
erwise), products qualifying for the transi-
egories of Class II devices as is consistent
tional arrangements under this subpart in-
with the results of the pilot, and with
clude:
FDA’s ability to write guidance docu-
a. All Class I products requiring premarket
ments if the device pilot for the third
evaluations in the United States—see
party review of medical devices is suc-
Table 1.
cessful. The MRA will cover to the max-
b. Those Class II products listed in Table 2. imum extent feasible all Class II devices
listed in Table 3 for which FDA-accred-
2. During the Transition Period
ited third party review is available in the
The parties will jointly identify additional United States.
product groups, including their related ac-
cessories, in line with their respective prior- 4. Unless explicitly included by joint deci-
ities as follows: sion of the parties, this part does not cover
a. Those for which review may be based any U.S. Class II-tier 3 or any Class III
primarily on written guidance which the product under either system.
parties will use their best efforts to pre- [The lists of medical devices included in
pare expeditiously; and these tables are subject to change as a result
b. Those for which review may be based of the Food and Drug Administration Mod-
primarily on international standards, in ernization Act of 1997.]
TABLE 1—CLASS I PRODUCTS REQUIRING PREMARKET EVALUATIONS IN THE UNITED STATES,
INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD 1
21 CFR Section No. Regulation Name
Product Code—Device Name
Anesthesiology Panel (21 CFR part 868)

868.1910 ............................................. Esophageal Stethoscope
BZW—Stethoscope, Esophageal
868.5620 ............................................. Breathing Mouthpiece
BYP—Mouthpiece, Breathing
868.5640 ............................................. Medicinal Nonventilatory Nebulizer (Atomizer)
CCQ—Nebulizer, Medicinal, Nonventilatory (Atomizer)
868.5675 ............................................. Rebreathing Device
BYW—Device, Rebreathing
868.5700 ............................................. Nonpowered Oxygen Tent
FOG—Hood, Oxygen, Infant
BYL—Tent, Oxygen
868.6810 ............................................. Tracheobronchial Suction Catheter
BSY—Catheters, Suction, Tracheobronchial
Cardiovascular Panel
(None).
Dental Panel (21 CFR part 872)
872.3400 ............................................. Karaya and Sodium Borate With or Without Acacia Denture Adhesive
KOM—Adhesive, Denture, Acacia and Karaya With Sodium Borate
872.3700 ............................................. Dental Mercury (U.S.P.)
ELY—Mercury
872.4200 ............................................. Dental Handpiece and Accessories
EBW—Controller, Food, Handpiece and Cord
EFB—Handpiece, Air-Powered, Dental
EFA—Handpiece, Belt and/or Gear Driven, Dental
EGS—Handpiece, Contra- and Right-Angle Attachment, Dental
EKX—Handpiece, Direct Drive, AC-Powered

EKY—Handpiece, Water-Powered
872.6640 ............................................. Dental Operative Unit and Accessories
348
Food and Drug Administration, HHS Pt. 26, Subpt. B, App. B

INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING OF TRANSITION PERIOD 1—Continued
EIA—Unit, Operative Dental

Ear, Nose, and Throat Panel (21 CFR Part
874)
874.1070 ............................................. Short Increment Sensitivity Index (SISI) Adapter
ETR—Adapter, Short Increment Sensitivity Index (SISI)
874.1500 ............................................. Gustometer
ETM—Gustometer
874.1800 ............................................. Air or Water Caloric Stimulator
KHH—Stimulator, Caloric-Air
ETP—Stimulator, Caloric-Water
874.1925 ............................................. Toynbee Diagnostic Tube
ETK—Tube, Toynbee Diagnostic
874.3300 ............................................. Hearing Aid
LRB—Face Plate Hearing-Aid
ESD—Hearing-aid, Air-Conduction
874.4100 ............................................. Epistaxis Balloon
EMX—Balloon, Epistaxis
874.5300 ............................................. ENT Examination and Treatment Unit
ETF—Unit, Examining/Treatment, ENT
874.5550 ............................................. Powered Nasal Irrigator
KMA—Irrigator, Powered Nasal
874.5840 ............................................. Antistammering Device
KTH—Device, Anti-Stammering
Gastroenterology—Urology Panel (21 CFR
Part 876)
876.5160 ............................................. Urological Clamp for Males
FHA—Clamp, Penile
876.5210 ............................................. Enema Kit
FCE—Kit, Enema, (for Cleaning Purpose)
876.5250 ............................................. Urine Collector and Accessories
FAQ—Bag, Urine Collection, Leg, for External Use
General Hospital Panel (21 CFR Part 880)
880.5270 ............................................. Neonatal Eye Pad
FOK—Pad, Neonatal Eye
880.5420 ............................................. Pressure Infusor for an I.V. Bag
KZD—Infusor, Pressure, for I.V. Bags
880.5680 ............................................. Pediatric Position Holder
FRP—Holder, Infant Position
880.6250 ............................................. Patient Examination Glove
LZB—Finger Cot
FMC—Glove, Patient Examination
LYY—Glove, Patient Examination, Latex
LZA—Glove, Patient Examination, Poly
LZC—Glove, Patient Examination, Speciality
LYZ—Glove, Patient Examination, Vinyl
880.6375 ............................................. Patient Lubricant
KMJ—Lubricant, Patient
880.6760 ............................................. Protective Restraint
BRT—Restraint, Patient, Conductive
FMQ—Restraint, Protective
Neurology Panel (21 CFR Part 882)
882.1030 ............................................. Ataxiagraph
GWW—Ataxiagraph
882.1420 ............................................. Electroencephalogram (EEG) Signal Spectrum Analyzer
GWS—Analyzer, Spectrum, Electroencephalogram Signal
882.4060 ............................................. Ventricular Cannula
HCD—Cannula, Ventricular
882.4545 ............................................. Shunt System Implantation Instrument
GYK—Instrument, Shunt System Implantation
882.4650 ............................................. Neurosurgical Suture Needle
HAS—Needle, Neurosurgical Suture
882.4750 ............................................. Skull Punch
GXJ—Punch, Skull
Obstetrics and Gynecology Panel
(None).
Ophthalmology Panel (21 CFR Part 886)
886.1780 ............................................. Retinoscope

HKM—Retinoscope, Battery-Powered
886.1940 ............................................. Tonometer Sterilizer
349

HKZ—Sterilizer, Tonometer
886.4070 ............................................. Powered Corneal Burr
HQS—Burr, Corneal, AC-Powered
HOG—Burr, Corneal, Battery-Powered
HRG—Engine, Trephine, Accessories, AC-Powered
HFR—Engine, Trephine, Accessories, Battery-Powered
HLD—Engine, Trephine, Accessories, Gas-Powered
886.4370 ............................................. Keratome
HNO—Keratome, AC-Powered
HMY—Keratome, Battery-Powered
886.5850 ............................................. Sunglasses (Nonprescription)
HQY—Sunglasses (Nonprescription Including Photosensitive)
Orthopedic Panel (21 CFR Part 888)
888.1500 ............................................. Goniometer
KQX—Goniometer, AC-Powered
888.4150 ............................................. Calipers for Clinical Use
KTZ—Caliper
Physical Medicine Panel (21 CFR Part 890)
890.3850 ............................................. Mechanical Wheelchair
LBE—Stroller, Adaptive
IOR—Wheelchair, Mechanical
890.5180 ............................................. Manual Patient Rotation Bed
INY—Bed, Patient Rotation, Manual
890.5710 ............................................. Hot or Cold Disposable Pack
IMD—Pack, Hot or Cold, Disposable
Radiology Panel (21 CFR Part 892)
892.1100 ............................................. Scintillation (Gamma) Camera
IYX—Camera, Scintillation (Gamma)
892.1110 ............................................. Positron Camera
IZC—Camera, Positron
892.1300 ............................................. Nuclear Rectilinear Scanner
IYW—Scanner, Rectilinear, Nuclear
892.1320 ............................................. Nuclear Uptake Probe
IZD—Probe, Uptake, Nuclear
892.1330 ............................................. Nuclear Whole Body Scanner
JAM—Scanner, Whole Body, Nuclear
892.1410 ............................................. Nuclear Electrocardiograph Synchronizer
IVY—Synchronizer, Electrocardiograph, Nuclear
892.1890 ............................................. Radiographic Film Illuminator
IXC—Illuminator, Radiographic-Film
JAG—Illuminator, Radiographic-Film, Explosion-Proof
892.1910 ............................................. Radiographic Grid
IXJ—Grid, Radiographic
892.1960 ............................................. Radiographic Intensifying Screen
EAM—Screen, Intensifying, Radiographic
892.1970 ............................................. Radiographic ECG/Respirator Synchronizer
IXO—Synchronizer, ECG/Respirator, Radiographic
892.5650 ............................................. Manual Radionuclide Applicator System
IWG—System, Applicator, Radionuclide, Manual
General and Plastic Surgery Panel (21 CFR
Part 878)
878.4200 ............................................. Introduction/Drainage Catheter and Accessories
KGZ—Accessories, Catheter
GCE—Adaptor, Catheter
FGY—Cannula, Injection
GBA—Catheter, Balloon Type
GBZ—Catheter, Cholangiography
GBQ—Catheter, Continuous Irrigation
GBY—Catheter, Eustachian, General & Plastic Surgery
JCY—Catheter, Infusion
GBX—Catheter, Irrigation
GBP—Catheter, Multiple Lumen
GBO—Catheter, Nephrostomy, General & Plastic Surgery
GBN—Catheter, Pediatric, General & Plastic Surgery
GBW—Catheter, Peritoneal
GBS—Catheter, Ventricular, General & Plastic Surgery
GCD—Connector, Catheter
GCC—Dilator, Catheter
GCB—Needle, Catheter
878.4320 ............................................. Removable Skin Clip
350

FZQ—Clip, Removable (Skin)

878.4460 ............................................. Surgeon’s Gloves
KGO—Surgeon’s Gloves
878.4680 ............................................. Nonpowered, Single Patient, Portable Suction Apparatus
GCY—Apparatus, Suction, Single Patient Use, Portable, Nonpowered
878.4760 ............................................. Removable Skin Staple
GDT—Staple, Removable (Skin)
878.4820 ............................................. AC-Powered, Battery-Powered, and Pneumatically Powered Surgical Instru-
ment Motors and Accessories/Attachments
GFG—Bit, Surgical
GFA—Blade, Saw, General & Plastic Surgery
DWH—Blade, Saw, Surgical, Cardiovascular
BRZ—Board, Arm (With Cover)
GFE—Brush, Dermabrasion
GFF—Bur, Surgical, General & Plastic Surgery
KDG—Chisel (Osteotome)
GFD—Dermatome
GFC—Driver, Surgical, Pin
GFB—Head, Surgical, Hammer
GEY—Motor, Surgical Instrument, AC-Powered
GET—Motor, Surgical Instrument, Pneumatic Powered
DWI—Saw, Electrically Powered
KFK—Saw, Pneumatically Powered
HAB—Saw, Powered, and Accessories
878.4960 ............................................. Air or AC-Powered Operating Table and Air or AC-Powered Operating Chair &
Accessories
GBB—Chair, Surgical, AC-Powered
FQO—Table, Operating-Room, AC-Powered
GDC—Table, Operating-Room, Electrical
FWW—Table, Operating-Room, Pneumatic
JEA—Table, Surgical with Orthopedic Accessories, AC-Powered
880.5090 ............................................. Liquid Bandage
KMF—Bandage, Liquid
1Descriptive information on product codes, panel codes, and other medical device identifiers may be viewed on FDA’s Internet
Web Site at http://www.fda.gov/cdrh/prodcode.html.
TABLE 2—CLASS II MEDICAL DEVICES INCLUDED IN SCOPE OF PRODUCT COVERAGE AT BEGINNING

OF TRANSITION PERIOD (UNITED STATES TO DEVELOP GUIDANCE DOCUMENTS IDENTIFYING U.S. RE-
QUIREMENTS AND EUROPEAN COMMUNITY (EC) TO IDENTIFY STANDARDS NEEDED TO MEET EC RE-
QUIREMENTS) 1
Panel 21 CFR Section No. Regulation Name
RA ....................... 892.1000 .......................... Magnetic Resonance Diagnostic Device

MOS—COIL, Magnetic Resonance, Specialty
LNH—System, Nuclear Magnetic Resonance Imaging
LNI—System, Nuclear Magnetic Resonance Spectroscopic
Diagnostic Ultrasound:
RA ....................... 892.1540 .......................... Nonfetal Ultrasonic Monitor
JAF—Monitor, Ultrasonic, Nonfetal
RA ....................... 892.1550 .......................... Ultrasonic Pulsed Doppler Imaging System
IYN—System, Imaging, Pulsed Doppler, Ultrasonic
RA ....................... 892.1560 .......................... Ultrasonic Pulsed Echo Imaging System
IYO—System, Imaging, Pulsed Echo, Ultrasonic
RA ....................... 892.1570 .......................... Diagnostic Ultrasonic Transducer
ITX—Transducer, Ultrasonic, Diagnostic
Diagnostic X-Ray Im-
aging Devices (ex-
cept mammographic
x-ray systems):
RA ....................... 892.1600 .......................... Angiographic X-Ray System
IZI—System, X-Ray, Angiographic
RA ....................... 892.1650 .......................... Image-Intensified Fluoroscopic X-Ray System
MQB—Solid State X-Ray Imager (Flat Panel/Digital Imager)

JAA—System, X-Ray, Fluoroscopic, Image-Intensified
RA ....................... 892.1680 .......................... Stationary X-Ray System
351

QUIREMENTS) 1—Continued
KPR—System, X-Ray, Stationary

RA ....................... 892.1720 .......................... Mobile X-Ray System
IZL—System, X-Ray, Mobile
RA ....................... 892.1740 .......................... Tomographic X-Ray System
IZF—System, X-Ray, Tomographic
RA ....................... 892.1750 .......................... Computed Tomography X-Ray System
JAK—System, X-Ray, Tomography, Computed
ECG-Related Devices:
CV ....................... 870.2340 .......................... Electrocardiograph
DPS—Electrocardiograph
MLC—Monitor, ST Segment
CV ....................... 870.2350 .......................... Electrocardiograph Lead Switching Adaptor
DRW—Adaptor, Lead Switching, Electrocardiograph
CV ....................... 870.2360 .......................... Electrocardiograph Electrode
DRX—Electrode, Electrocardiograph
CV ....................... 870.2370 .......................... Electrocardiograph Surface Electrode Tester
KRC—Tester, Electrode, Surface, Electrocardiographic
NE ....................... 882.1400 .......................... Electroencephalograph
GWQ—Electroencephalograph
HO ....................... 880.5725 .......................... Infusion Pump (external only)
MRZ—Accessories, Pump, Infusion
FRN—Pump, Infusion
LZF—Pump, Infusion, Analytical Sampling
MEB—Pump, Infusion, Elastomeric
LZH—Pump, Infusion, Enteral
MHD—Pump, Infusion, Gallstone Dissolution
LZG—Pump, Infusion, Insulin
MEA—Pump, Infusion, PCA
Ophthalmic Instru-
ments:
OP ....................... 886.1570 .......................... Ophthalmoscope
HLI—Ophthalmoscope, AC-Powered
HLJ—Ophthalmoscope, Battery-Powered
OP ....................... 886.1780 .......................... Retinoscope
HKL—Retinoscope, AC-Powered
OP ....................... 886.1850 .......................... AC-Powered Slit-Lamp Biomicroscope
HJO—Biomicroscope, Slit-Lamp, AC-Powered
OP ....................... 886.4150 .......................... Vitreous Aspiration and Cutting Instrument
MMC—Dilator, Expansive Iris (Accessory)
HQE—Instrument, Vitreous Aspiration and Cutting, AC-Powered
HKP—Instrument, Vitreous Aspiration and Cutting, Battery-Powered
MLZ—Vitrectomy, Instrument Cutter
OP ....................... 886.4670 .......................... Phacofragmentation System
HQC—Unit, Phacofragmentation
SU ....................... 878.4580 .......................... Surgical Lamp
HBI—Illuminator, Fiberoptic, Surgical Field
FTF—Illuminator, Nonremote
FTG—Illuminator, Remote
HJE—Lamp, Fluorescein, AC-Powered
FQP—Lamp, Operating-Room
FTD—Lamp, Surgical
GBC—Lamp, Surgical, Incandescent
FTA—Light, Surgical, Accessories
FSZ—Light, Surgical, Carrier
FSY—Light, Surgical, Ceiling Mounted
FSX—Light, Surgical, Connector
FSW—Light, Surgical, Endoscopic
FST—Light, Surgical, Fiberoptic
FSS—Light, Surgical, Floor Standing
FSQ—Light, Surgical, Instrument
NE ....................... 882.5890 .......................... Transcutaneous Electrical Nerve Stimulator for Pain Relief
GZJ—Stimulator, Nerve, Transcutaneous, For Pain Relief
Noninvasive Blood Pressure Measurement Devices:
CV ....................... 870.1120 .......................... Blood Pressure Cuff
DXQ—Cuff, Blood-Pressure
CV ....................... 870.1130 .......................... Noninvasive Blood Pressure Measurement System (except
nonoscillometric)
352

QUIREMENTS) 1—Continued
DXN—System, Measurement, Blood-Pressure, Noninvasive

HO ....................... 880.6880 .......................... Steam Sterilizer (greater than 2 cubic feet)
FLE—Sterilizer, Steam
Clinical Thermometers:
HO ....................... 880.2910 .......................... Clinical Electronic Thermometer (except tympanic or pacifier)
FLL—Thermometer, Electronic, Clinical
AN ....................... 868.5630 .......................... Nebulizer
CAF—Nebulizer (Direct Patient Interface)
Hypodermic Needles
and Syringes (ex-
cept antistick and
self-destruct):
HO ....................... 880.5570 .......................... Hypodermic Single Lumen Needle
MMK—Container, Sharpes
FMI—Needle, Hypodermic, Single Lumen
MHC—Port, Intraosseous, Implanted
HO ....................... 880.5860 .......................... Piston Syringe
FMF—Syringe, Piston
Selected Dental Mate-
rials:
DE ....................... 872.3060 .......................... Gold-Based Alloys and Precious Metal Alloys for Clinical Use
EJT—Alloy, Gold Based, For Clinical Use
EJS—Alloy, Precious Metal, For Clinical Use
DE ....................... 872.3200 .......................... Resin Tooth Bonding Agent
KLE—Agent, Tooth Bonding, Resin
DE ....................... 872.3275 .......................... Dental Cement
EMA—Cement, Dental
EMB—Zinc Oxide Eugenol
DE ....................... 872.3660 .......................... Impression Material
ELW—Material, Impression
DE ....................... 872.3690 .......................... Tooth Shade Resin Material
EBF—Material, Tooth Shade, Resin
DE ....................... 872.3710 .......................... Base Metal Alloy
EJH—Metal, Base
Latex Condoms:
OB ....................... 884.5300 .......................... Condom
HIS—Condom
TABLE 3—MEDICAL DEVICES FOR POSSIBLE INCLUSION IN SCOPE OF PRODUCT COVERAGE DURING
OPERATIONAL PERIOD 1
Product Family 21 CFR Section No Device Name Tier
Anesthesiology Panel
Anesthesia Devices ................... 868.5160 ............... Gas machine for anesthesia or analgesia ............................ 2
868.5270 ............... Breathing system heater ....................................................... 2
868.5440 ............... Portable oxygen generator .................................................... 2
868.5450 ............... Respiratory gas humidifier .................................................... 2
868.5630 ............... Nebulizer ............................................................................... 2
868.5710 ............... Electrically powered oxygen tent .......................................... 2
868.5880 ............... Anesthetic vaporizer .............................................................. 2
Gas Analyser ............................. 868.1040 ............... Powered Algesimeter ............................................................ 2
868.1075 ............... Argon gas analyzer ............................................................... 2
868.1400 ............... Carbon dioxide gas analyzer ................................................ 2
868.1430 ............... Carbon monoxide gas analyzer ............................................ 2
868.1500 ............... Enflurane gas analyzer ......................................................... 2
868.1620 ............... Halothane gas analyzer ........................................................ 2
868.1640 ............... Helium gas analyzer ............................................................. 2
868.1670 ............... Neon gas analyzer ................................................................ 2
868.1690 ............... Nitrogen gas analyzer ........................................................... 2
868.1700 ............... Nitrous oxide gas analyzer ................................................... 2
868.1720 ............... Oxygen gas analyzer ............................................................ 2

868.1730 ............... Oxygen uptake computer ...................................................... 2
Peripheral Nerve Stimulators ..... 868.2775 ............... Electrical peripheral nerve stimulator .................................... 2
353
OPERATIONAL PERIOD 1—Continued
Respiratory Monitoring ............... 868.1750 ............... Pressure plethysmograph ..................................................... 2

868.1760 ............... Volume plethysmograph ....................................................... 2
868.1780 ............... Inspiratory airway pressure meter ........................................ 2
868.1800 ............... Rhinoanemometer ................................................................. 2
868.1840 ............... Diagnostic spirometer ........................................................... 2
868.1850 ............... Monitoring spirometer ........................................................... 2
868.1860 ............... Peak-flow meter for spirometry ............................................. 2
868.1880 ............... Pulmonary-function data calculator ....................................... 2
868.1890 ............... Predictive pulmonary-function value calculator .................... 2
868.1900 ............... Diagnostic pulmonary-function interpretation calculator ....... 2
868.2025 ............... Ultrasonic air embolism monitor ........................................... 2
868.2375 ............... Breathing frequency monitor (except apnea detectors) ....... 2
868.2480 ............... Cutaneous carbon dioxide (PcCO2) monitor ........................ 2
868.2500 ............... Cutaneous oxygen monitor (for an infant not under gas an- 2
esthesia).
868.2550 ............... Pneumotachomometer .......................................................... 2
868.2600 ............... Airway pressure monitor ....................................................... 2
868.5665 ............... Powered percussor ............................................................... 2
868.5690 ............... Incentive spirometer .............................................................. 2
Ventilator .................................... 868.5905 ............... Noncontinuous ventilator (IPPB) ........................................... 2
868.5925 ............... Powered emergency ventilator ............................................. 2
868.5935 ............... External negative pressure ventilator ................................... 2
868.5895 ............... Continuous ventilator ............................................................ 2
868.5955 ............... Intermittent mandatory ventilation attachment ...................... 2
868.6250 ............... Portable air compressor ........................................................ 2
Cardiovascular Panel
Cardiovascular Diagnostic ......... 870.1425 ............... Programmable diagnostic computer ..................................... 2
870.1450 ............... Densitometer ......................................................................... 2
870.2310 ............... Apex cardiograph (vibrocardiograph) .................................... 2
870.2320 ............... Ballistocardiograph ................................................................ 2
870.2340 ............... Electrocardiograph ................................................................ 2
870.2350 ............... Electrocardiograph lead switching adaptor ........................... 1
870.2360 ............... Electrocardiograph electrode ................................................ 2
870.2370 ............... Electrocardiograph surface electrode tester ......................... 2
870.2400 ............... Vectorcardiograph ................................................................. 1
870.2450 ............... Medical cathode-ray tube display ......................................... 1
870.2675 ............... Oscillometer .......................................................................... 2
870.2840 ............... Apex cardiographic transducer ............................................. 2
870.2860 ............... Heart sound transducer ........................................................ 2
Cardiovascular Monitoring ......... ........................... Valve, pressure relief, cardiopulmonary bypass.
354
870.1100 ............... Blood pressure alarm ............................................................ 2

870.1110 ............... Blood pressure computer ...................................................... 2
870.1120 ............... Blood pressure cuff ............................................................... 2
870.1130 ............... Noninvasive blood pressure measurement system .............. 2
870.1140 ............... Venous blood pressure manometer ...................................... 2
870.1220 ............... Electrode recording catheter or electrode recording probe .. 2
870.1270 ............... Intracavitary phonocatheter system ...................................... 2
870.1875 ............... Stethoscope (electronic) ....................................................... 2
870.2050 ............... Biopotential amplifier and signal conditioner ........................ 2
870.2060 ............... Transducer signal amplifier and conditioner ......................... 2
870.2100 ............... Cardiovascular blood flow-meter .......................................... 2
870.2120 ............... Extravascular blood flow probe ............................................. 2
870.2300 ............... Cardiac monitor (including cardiotachometer and rate 2
alarm).
870.2700 ............... Oximeter ................................................................................ 2
870.2710 ............... Ear oximeter .......................................................................... 2
870.2750 ............... Impedance phlebograph ....................................................... 2
870.2770 ............... Impedance plethysmograph .................................................. 2
870.2780 ............... Hydraulic, pneumatic, or photoelectric plethysmographs ..... 2
870.2850 ............... Extravascular blood pressure transducer ............................. 2
870.2870 ............... Catheter tip pressure transducer .......................................... 2
870.2880 ............... Ultrasonic transducer ............................................................ 2
870.2890 ............... Vessel occlusion transducer ................................................. 2
870.2900 ............... Patient transducer and electrode cable (including con- 2
nector).
870.2910 ............... Radiofrequency physiological signal transmitter and re- 2
ceiver.
870.2920 ............... Telephone electrocardiograph transmitter and receiver ....... 2
870.4205 ............... Cardiopulmonary bypass bubble detector ............................ 2
870.4220 ............... Cardiopulmonary bypass heart-lung machine console ......... 2
870.4240 ............... Cardiovascular bypass heat exchanger ................................ 2
870.4250 ............... Cardiopulmonary bypass temperature controller .................. 2
870.4300 ............... Cardiopulmonary bypass gas control unit ............................ 2
870.4310 ............... Cardiopulmonary bypass coronary pressure gauge ............. 2
870.4330 ............... Cardiopulmonary bypass on-line blood gas monitor ............ 2
870.4340 ............... Cardiopulmonary bypass level sensing monitor and/or con- 2
trol.
870.4370 ............... Roller-type cardiopulmonary bypass blood pump ................ 2
870.4380 ............... Cardiopulmonary bypass pump speed control ..................... 2
870.4410 ............... Cardiopulmonary bypass in-line blood gas sensor ............... 2
Cardiovascular Therapeutic ....... 870.5050 ............... Patient care suction apparatus ............................................. 2
870.5900 ............... Thermal regulation system .................................................... 2
Defibrillator ................................. 870.5300 ............... DC-defibrillator (including paddles) ....................................... 2
870.5325 ............... Defibrillator tester .................................................................. 2
Echocardiograph ........................ 870.2330 ............... Echocardiograph ................................................................... 2
Pacemaker & Accessories ......... 870.1750 ............... External programmable pacemaker pulse generator ........... 2
870.3630 ............... Pacemaker generator function analyzer ............................... 2
870.3640 ............... Indirect pacemaker generator function analyzer .................. 2
870.3720 ............... Pacemaker electrode function tester .................................... 2
Miscellaneous ............................ 870.1800 ............... Withdrawal-infusion pump ..................................................... 2
870.2800 ............... Medical magnetic tape recorder ........................................... 2
None ...................... Batteries, rechargeable, class II devices.
Dental Panel
Dental Equipment ...................... 872.1720 ............... Pulp tester ............................................................................. 2
872.1740 ............... Caries detection device ......................................................... 2
872.4120 ............... Bone cutting instrument and accessories ............................. 2
872.4465 ............... Gas-powered jet injector ....................................................... 2
872.4475 ............... Spring-powered jet injector ................................................... 2
872.4600 ............... Intraoral ligature and wire lock .............................................. 2
872.4840 ............... Rotary scaler ......................................................................... 2
872.4850 ............... Ultrasonic scaler .................................................................... 2
872.4920 ............... Dental electrosurgical unit and accessories ......................... 2
872.6070 ............... Ultraviolet activator for polymerization .................................. 2

872.6350 ............... Ultraviolet detector ................................................................ 2
Dental Material ........................... 872.3050 ............... Amalgam alloy ....................................................................... 2
355
872.3060 ............... Gold-based alloys and precious metal alloys for clinical use 2
872.3200 ............... Resin tooth bonding agent .................................................... 2
872.3250 ............... Calcium hydroxide cavity liner .............................................. 2
872.3260 ............... Cavity varnish ........................................................................ 2
872.3275 ............... Dental cement (other than zinc oxide-eugenol) .................... 2
872.3300 ............... Hydrophilic resin coating for dentures .................................. 2
872.3310 ............... Coating material for resin fillings .......................................... 2
872.3590 ............... Preformed plastic denture tooth ............................................ 2
872.3660 ............... Impression material ............................................................... 2
872.3690 ............... Tooth shade resin material ................................................... 2
872.3710 ............... Base metal alloy .................................................................... 2
872.3750 ............... Bracket adhesive resin and tooth conditioner ...................... 2
872.3760 ............... Denture relining, repairing, or rebasing resin ....................... 2
872.3765 ............... Pit and fissure sealant and conditioner ................................ 2
872.3770 ............... Temporary crown and bridge resin ....................................... 2
872.3820 ............... Root canal filling resin (other than chloroform use) ............. 2
872.3920 ............... Porcelain tooth ...................................................................... 2
Dental X-ray ............................... 872.1800 ............... Extraoral source x-ray system .............................................. 2
872.1810 ............... Intraoral source x-ray system ............................................... 2
Dental Implants .......................... 872.4880 ............... Intraosseous fixation screw or wire ...................................... 2
872.3890 ............... Endodontic stabilizing splint .................................................. 2
Orthodontic ................................. 872.5470 ............... Orthodontic plastic bracket ................................................... 2
Ear/Nose/Throat Panel
Diagnostic Equipment ................ 874.1050 ............... Audiometer ............................................................................ 2
874.1090 ............... Auditory impedance tester .................................................... 2
874.1120 ............... Electronic noise generator for audiometric testing ............... 2
874.1325 ............... Electroglottograph ................................................................. 2
874.1820 ............... Surgical nerve stimulator/locator ........................................... 2
Hearing Aids .............................. 874.3300 ............... Hearing aid (for bone-conduction) ........................................ 2
874.3310 ............... Hearing aid calibrator and analysis system .......................... 2
874.3320 ............... Group hearing aid or group auditory trainer ......................... 2
874.3330 ............... Master hearing aid ................................................................ 2
Surgical Equipment .................... 874.4250 ............... Ear, nose, and throat electric or pneumatic surgical drill ..... 1
874.4490 ............... Argon laser for otology, rhinology, and laryngology ............. 2
874.4500 ............... Ear, nose, and throat microsurgical carbon dioxide laser .... 2
Gastroenterology/Urology Panel
Endoscope (including 876.1500 ............... Endoscope and accessories ................................................. 2
angioscopes, laparscopes,
ophthalmic endoscopes).
876.4300 ............... Endoscopic electrosurgical unit and accessories ................. 2
Gastroenterology ........................ 876.1725 ............... Gastrointestinal motility monitoring system .......................... 1
Hemodialysis .............................. 876.5600 ............... Sorbent regenerated dialysate delivery system for hemo- 2
dialysis.
876.5630 ............... Peritoneal dialysis system and accessories ......................... 2
876.5665 ............... Water purification system for hemodialysis .......................... 2
876.5820 ............... Hemodialysis system and accessories ................................. 2
876.5830 ............... Hemodialyzer with disposable insert (kiil-type) ..................... 2
Lithotriptor .................................. 876.4500 ............... Mechanical lithotriptor ........................................................... 2
Urology Equipment .................... 876.1620 ............... Urodynamics measurement system ...................................... 2
876.5320 ............... Nonimplanted electrical continence device ........................... 2
876.5880 ............... Isolated kidney perfusion and transport system and acces- 2
sories.
General Hospital Panel
Infusion Pumps and Systems .... 880.2420 ............... Electronic monitor for gravity flow infusion systems ............. 2
880.2460 ............... Electrically powered spinal fluid pressure monitor ............... 2
880.5430 ............... Nonelectrically powered fluid injector ................................... 2
880.5725 ............... Infusion pump ........................................................................ 2
Neonatal Incubators ................... 880.5400 ............... Neonatal incubator ................................................................ 2
880.5410 ............... Neonatal transport incubator ................................................. 2
880.5700 ............... Neonatal phototherapy unit ................................................... 2
Piston Syringes .......................... 880.5570 ............... Hypodermic single lumen needle .......................................... 1
880.5860 ............... Piston syringe (except antistick) ........................................... 1
880.6920 ............... Syringe needle introducer ..................................................... 2
Miscellaneous ............................ 880.2910 ............... Clinical electronic thermometer ............................................. 2
880.2920 ............... Clinical mercury thermometer ............................................... 2
880.5100 ............... AC-powered adjustable hospital bed .................................... 1
880.5500 ............... AC-powered patient lift .......................................................... 2
880.6880 ............... Steam sterilizer (greater than 2 cubic feet) .......................... 2
Neurology Panel
882.1020 ............... Rigidity analyzer .................................................................... 2

882.1610 ............... Alpha monitor ........................................................................ 2
Neuro-Diagnostic ....................... 882.1320 ............... Cutaneous electrode ............................................................. 2
356
882.1340 ............... Nasopharyngeal electrode .................................................... 2

882.1350 ............... Needle electrode ................................................................... 2
882.1400 ............... Electroencephalograph ......................................................... 2
882.1460 ............... Nystagmograph ..................................................................... 2
882.1480 ............... Neurological endoscope ........................................................ 2
882.1540 ............... Galvanic skin response measurement device ...................... 2
882.1550 ............... Nerve conduction velocity measurement device .................. 2
882.1560 ............... Skin potential measurement device ...................................... 2
882.1570 ............... Powered direct-contact temperature measurement device .. 2
882.1620 ............... Intracranial pressure monitoring device ................................ 2
882.1835 ............... Physiological signal amplifier ................................................ 2
882.1845 ............... Physiological signal conditioner ............................................ 2
882.1855 ............... Electroencephalogram (EEG) telemetry system ................... 2
882.5050 ............... Biofeedback device ............................................................... 2
Echoencephalography ............... 882.1240 ............... Echoencephalograph ............................................................ 2
RPG ........................................... 882.4400 ............... Radiofrequency lesion generator .......................................... 2
Neuro Surgery ............................ none ...................... Electrode, spinal epidural ...................................................... 2
882.4305 ............... Powered compound cranial drills, burrs, trephines, and 2
their accessories.
882.4310 ............... Powered simple cranial drills burrs, trephines, and their ac- 2
cessories.
882.4360 ............... Electric cranial drill motor ...................................................... 2
882.4370 ............... Pneumatic cranial drill motor ................................................ 2
882.4560 ............... Stereotaxic instrument .......................................................... 2
882.4725 ............... Radiofrequency lesion probe ................................................ 2
882.4845 ............... Powered rongeur ................................................................... 2
882.5500 ............... Lesion temperature monitor .................................................. 2
Stimulators ................................. 882.1870 ............... Evoked response electrical stimulator .................................. 2
882.1880 ............... Evoked response mechanical stimulator .............................. 2
882.1890 ............... Evoked response photic stimulator ....................................... 2
882.1900 ............... Evoked response auditory stimulator .................................... 2
882.1950 ............... Tremor transducer ................................................................. 2
882.5890 ............... Transcutaneous electrical nerve stimulator for pain relief .... 2
Obstetrics/Gynecology Panel
Fetal Monitoring ......................... 884.1660 ............... Transcervical endoscope (amnioscope) and accessories .... 2
884.1690 ............... Hysteroscope and accessories (for performance standards) 2
884.2225 ............... Obstetric-gynecologic ultrasonic imager ............................... 2
884.2600 ............... Fetal cardiac monitor ............................................................ 2
884.2640 ............... Fetal phonocardiographic monitor and accessories ............. 2
884.2660 ............... Fetal ultrasonic monitor and accessories ............................. 2
884.2675 ............... Fetal scalp circular (spiral) electrode and applicator ............ 1
884.2700 ............... Intrauterine pressure monitor and accessories .................... 2
884.2720 ............... External uterine contraction monitor and accessories .......... 2
884.2740 ............... Perinatal monitoring system and accessories ...................... 2
884.2960 ............... Obstetric ultrasonic transducer and accessories .................. 2
Gynecological Surgery Equip- 884.1720 ............... Gynecologic laparoscope and accessories .......................... 2
ment.
884.4160 ............... Unipolar endoscopic coagulator-cutter and accessories ...... 2
884.4550 ............... Gynecologic surgical laser .................................................... 2
884.4120 ............... Gynecologic electrocautery and accessories ....................... 2
884.5300 ............... Condom ................................................................................. 2
Ophthalmic Implants .................. 886.3320 ............... Eye sphere implant ............................................................... 2
Contact Lens .............................. 886.1385 ............... Polymethylmethacrylate (PMMA) diagnostic contact lens .... 2
886.5916 ............... Rigid gas permeable contact lens (daily wear only) ............. 2
Diagnostic Equipment ................ 886.1120 ............... Opthalmic camera ................................................................. 1
886.1220 ............... Corneal electrode .................................................................. 1
886.1250 ............... Euthyscope (AC-powered) .................................................... 1
886.1360 ............... Visual field laser instrument .................................................. 1
886.1510 ............... Eye movement monitor ......................................................... 1
886.1570 ............... Ophthalmoscope ................................................................... 1
886.1630 ............... AC-powered photostimulator ................................................. 1
886.1640 ............... Ophthalmic preamplifier ........................................................ 1
886.1670 ............... Ophthalmic isotope uptake probe ......................................... 2
886.1780 ............... Retinoscope (AC-powered device) ....................................... 1
886.1850 ............... AC-powered slit lamp biomicroscope ................................... 1
886.1930 ............... Tonometer and accessories .................................................. 2
886.1945 ............... Transilluminator (AC-powered device) .................................. 1
886.3130 ............... Ophthalmic conformer ........................................................... 2
(Diagnostic/Surgery Equipment) 886.4670 ............... Phacofragmentation system .................................................. 2
Ophthalmic Implants .................. 886.3340 ............... Extraocular orbital implant .................................................... 2

886.3800 ............... Scleral shell ........................................................................... 2
Surgical Equipment .................... 880.5725 ............... Infusion pump (performance standards) ............................... 2
357
886.3100 ............... Ophthalmic tantalum clip ....................................................... 2

886.3300 ............... Absorbable implant (scleral buckling method) ...................... 2
886.4100 ............... Radiofrequency electrosurgical cautery apparatus ............... 2
886.4115 ............... Thermal cautery unit ............................................................. 2
886.4150 ............... Vitreous aspiration and cutting instrument ........................... 2
886.4170 ............... Cryophthalmic unit ................................................................ 2
886.4250 ............... Ophthalmic electrolysis unit (AC-powered device) ............... 1
886.4335 ............... Operating headlamp (AC-powered device) .......................... 1
886.4390 ............... Ophthalmic laser ................................................................... 2
886.4392 ............... Nd:YAG laser for posterior capsulotomy .............................. 2
886.4400 ............... Electronic metal locator ......................................................... 1
886.4440 ............... AC-powered magnet ............................................................. 1
886.4610 ............... Ocular pressure applicator .................................................... 2
886.4690 ............... Ophthalmic photocoagulator ................................................. 2
886.4790 ............... Ophthalmic sponge ............................................................... 2
886.5100 ............... Ophthalmic beta radiation source ......................................... 2
none ...................... Ophthalmoscopes, replacement batteries, hand-held .......... 1
Orthopedic Panel
Implants ...................................... 888.3010 ............... Bone fixation cerclage ........................................................... 2
888.3020 ............... Intramedullary fixation rod ..................................................... 2
888.3030 ............... Single/multiple component metallic bone fixation appliances 2
and accessories.
888.3040 ............... Smooth or threaded metallic bone fixation fastener ............. 2
888.3050 ............... Spinal interlaminal fixation orthosis ...................................... 2
888.3060 ............... Spinal intervertebral body fixation orthosis ........................... 2
Surgical Equipment .................... 888.1240 ............... AC-powered dynamometer ................................................... 2
888.4580 ............... Sonic surgical instrument and accessories/attachments ...... 2
none ...................... Accessories, fixation, spinal interlaminal .............................. 2
none ...................... Accessories, fixation, spinal intervertebral body ................... 2
none ...................... Monitor, pressure, intracompartmental ................................. 1
none ...................... Orthosis, fixation, spinal intervertebral fusion ....................... 2
none ...................... Orthosis, spinal pedicle fixation.
none ...................... System, cement removal extraction ...................................... 1
Physical Medicine Panel
Diagnostic Equipment or (Ther- 890.1225 ............... Chronaximeter ....................................................................... 2
apy) Therapeutic Equipment.
890.1375 ............... Diagnostic electromyograph .................................................. 2
890.1385 ............... Diagnostic electromyograph needle electrode ...................... 2
890.1450 ............... Powered reflex hammer ........................................................ 2
890.1850 ............... Diagnostic muscle stimulator ................................................ 2
or (Therapy) ............................... 890.5850 ............... Powered muscle stimulator ................................................... 2
Therapeutic Equipment .............. 890.5100 ............... Immersion hydrobath ............................................................ 2
890.5110 ............... Paraffin bath .......................................................................... 2
890.5500 ............... Infrared lamp ......................................................................... 2
890.5720 ............... Water circulating hot or cold pack ........................................ 2
890.5740 ............... Powered heating pad ............................................................ 2
Radiology Panel
MRI ............................................. 892.1000 ............... Magnetic resonance diagnostic device ................................. 2
Ultrasound Diagnostic ................ 884.2660 ............... Fetal ultrasonic monitor and accessories ............................. 2
892.1540 ............... Nonfetal ultrasonic monitor.
892.1560 ............... Ultrasonic pulsed echo imaging system ............................... 2
892.1570 ............... Diagnostic ultrasonic transducer ........................................... 2
892.1550 ............... Ultrasonic pulsed doppler imaging system.
Angiographic .............................. 892.1600 ............... Angiographic x-ray system .................................................... 2
Diagnostic X-Ray ....................... 892.1610 ............... Diagnostic x-ray beam-limiting device .................................. 2
892.1620 ............... Cine or spot fluorographic x-ray camera .............................. 2
892.1630 ............... Electrostatic x-ray imaging system ....................................... 2
892.1650 ............... Image-intensified fluoroscopic x-ray system ......................... 2
892.1670 ............... Spot film device ..................................................................... 2
892.1680 ............... Stationary x-ray system ........................................................ 2
892.1710 ............... Mammographic x-ray system ................................................ 2
892.1720 ............... Mobile x-ray system .............................................................. 2
892.1740 ............... Tomographic x-ray system .................................................... 1
892.1820 ............... Pneumoencephalographic chair ............................................ 2
892.1850 ............... Radiographic film cassette .................................................... 1
892.1860 ............... Radiographic film/cassette changer ...................................... 1
892.1870 ............... Radiographic film/cassette changer programmer ................. 2
892.1900 ............... Automatic radiographic film processor .................................. 2
892.1980 ............... Radiologic table ..................................................................... 1

CT Scanner ................................ 892.1750 ............... Computed tomography x-ray system .................................... 2
Radiation Therapy ...................... 892.5050 ............... Medical charged-particle radiation therapy system .............. 2
358
892.5300 ............... Medical neutron radiation therapy system ............................ 2

892.5700 ............... Remote controlled radionuclide applicator system ............... 2
892.5710 ............... Radiation therapy beam-shaping block ................................ 2
892.5730 ............... Radionuclide brachytherapy source ...................................... 2
892.5750 ............... Radionuclide radiation therapy system ................................. 2
892.5770 ............... Powered radiation therapy patient support assembly .......... 2
892.5840 ............... Radiation therapy simulation system .................................... 2
892.5930 ............... Therapeutic x-ray tube housing assembly ............................ 1
Nuclear Medicine ....................... 892.1170 ............... Bone densitometer ................................................................ 2
892.1200 ............... Emission computed tomography system .............................. 2
892.1310 ............... Nuclear tomography system ................................................. 1
892.1390 ............... Radionuclide rebreathing system .......................................... 2
General/Plastic Surgery Panel
Surgical Lamps .......................... 878.4630 ............... Ultraviolet lamp for dermatologic disorders .......................... 2
890.5500 ............... Infrared lamp ......................................................................... 2
878.4580 ............... Surgical lamp ........................................................................ 2
Electrosurgical Cutting Equip- 878.4810 ............... Laser surgical instrument for use in general and plastic sur- 2
ment. gery and in dermatology.
878.4400 ............... Electrosurgical cutting and coagulation device and acces- 2
sories.
Miscellaneous ............................ 878.4780 ............... Powered suction pump ......................................................... 2
[63 FR 60141, Nov. 6, 1998; 64 FR 16348, Apr. 5, 1999]
APPENDIXES C–F TO SUBPART B OF PART and Related Activities—General Vocab-

26 [RESERVED] ulary of the International Organization
for Standardization (ISO) and the
Subpart C—‘‘Framework’’ International Electrotechnical Com-
Provisions mission (IEC)’’ (ISO/IEC Guide 2) (1996
edition), which is incorporated by ref-
§ 26.60 Definitions. erence in accordance with 5 U.S.C.
552(a) and 1 CFR part 51. Copies are
(a) The following terms and defini-
tions shall apply to this subpart only: available from the International Orga-
nization for Standardization, 1, rue de
(1) Designating Authority means a
body with power to designate, monitor, Varembé, Case postale 56, CH–1211
suspend, remove suspension of, or with- Genève 20, Switzerland, or on the Inter-
draw conformity assessment bodies as net at http://www.iso.ch or may be ex-
specified under this part. amined at the Food and Drug Adminis-
(2) Designation means the identifica- tration’s Medical Library, 5600 Fishers
tion by a designating authority of a Lane, rm. 11B–40, Rockville, MD 20857,
conformity assessment body to perform or at the National Archives and
conformity assessment procedures Records Administration (NARA). For
under this part. information on the availability of this
(3) Regulatory Authority means a gov- material at NARA, call 202–741–6030, or
ernment agency or entity that exer- go to: http://www.archives.gov/
cises a legal right to control the use or federallregister/
sale of products within a party’s juris- codeloflfederallregulations/
diction and may take enforcement ac- ibrllocations.html. In the event of an
tion to ensure that products marketed inconsistency between the ISO/IEC
within its jurisdiction comply with Guide 2 and definitions in this part, the
legal requirements. definitions in this part shall prevail.
(b) Other terms concerning con-
§ 26.61 Purpose of this part.
formity assessment used in this part
shall have the meaning given elsewhere This part specifies the conditions by
in this part or in the definitions con- which each party will accept or recog-
tained in ‘‘Guide 2: Standardization nize results of conformity assessment
359
§ 26.62 21 CFR Ch. I (4–1–19 Edition)
procedures, produced by the other par- the assurance offered by the receiving
ty’s conformity assessment bodies party’s own procedures.
(CAB’s) or authorities, in assessing
conformity to the importing party’s re- § 26.63 General coverage of this part.
quirements, as specified on a sector- (a) This part applies to conformity
specific basis in subparts A and B of assessment procedures for products
this part, and to provide for other re- and/or processes and to other related
lated cooperative activities. The objec- cooperative activities as described in
tive of such mutual recognition is to this part.
provide effective market access (b) Subparts A and B of this part may
throughout the territories of the par- include:
ties with regard to conformity assess- (1) A description of the relevant leg-
ment for all products covered under islative, regulatory, and administra-
this part. If any obstacles to such active provisions pertaining to the con-
cess arise, consultations will promptly formity assessment procedures and
be held. In the absence of a satisfactory technical regulations;
outcome of such consultations, the (2) A statement on the product scope
party alleging its market access has and coverage;
been denied may, within 90 days of (3) A list of designating authorities;
such consultation, invoke its right to (4) A list of agreed conformity assess-
terminate the ‘‘Agreement on Mutual ment bodies (CAB’s) or authorities or a
Recognition Between the United States source from which to obtain a list of
of America and the European Commu- such bodies or authorities and a state-
nity,’’ from which this part is derived, ment of the scope of the conformity as-
in accordance with § 26.80. sessment procedures for which each has
been agreed;
§ 26.62 General obligations. (5) The procedures and criteria for
(a) The United States shall, as speci- designating the CAB’s;
fied in subparts A and B of this part, (6) A description of the mutual rec-
accept or recognize results of specified ognition obligations;
procedures, used in assessing con- (7) A sectoral transition arrange-
formity to specified legislative, regu- ment;
latory, and administrative provisions (8) The identity of a sectoral contact
of the United States, produced by the point in each party’s territory; and
other party’s conformity assessment (9) A statement regarding the estab-
bodies (CAB’s) and/or authorities. lishment of a Joint Sectoral Com-
(b) The European Community (EC) mittee.
and its Member States shall, as speci- (c) This part shall not be construed
fied in subparts A and B of this part, to entail mutual acceptance of stand-
accept or recognize results of specified ards or technical regulations of the
procedures, used in assessing con- parties and, unless otherwise specified
formity to specified legislative, regu- in subpart A or B of this part, shall not
latory, and administrative provisions entail the mutual recognition of the
of the EC and its Member States, pro- equivalence of standards or technical
duced by the other party’s CAB’s and/ regulations.
or authorities.
(c) Where sectoral transition ar- § 26.64 Transitional arrangements.
rangements have been specified in sub- The parties agree to implement the
parts A and B of this part, the obliga- transitional commitments on con-
tions in paragraphs (a) and (b) of this fidence building as specified in sub-
section will apply following the suc- parts A and B of this part.
cessful completion of those sectoral (a) The parties agree that each sec-
transition arrangements, with the un- toral transitional arrangement shall
derstanding that the conformity as- specify a time period for completion.
sessment procedures utilized assure (b) The parties may amend any tran-
conformity to the satisfaction of the sitional arrangement by mutual agree-
receiving party, with applicable legis- ment.
lative, regulatory, and administrative (c) Passage from the transitional

provisions of that party, equivalent to phase to the operational phase shall
360
proceed as specified in subparts A and § 26.67 Suspension of listed conformity

B of this part, unless either party docu- assessment bodies.
ments that the conditions provided in The following procedures shall apply
such subpart for a successful transition with regard to the suspension of a con-
are not met. formity assessment body (CAB) listed
in subpart B of this part.
§ 26.65 Designating authorities.
(a) A party shall notify the other
The parties shall ensure that the des- party of its contestation of the tech-
ignating authorities specified in sub- nical competence or compliance of a
part B of this part have the power and CAB listed in subpart B of this part
competence in their respective terri- and the contesting party’s intent to
tories to carry out decisions under this suspend such CAB. Such contestation
part to designate, monitor, suspend, re- shall be exercised when justified in an
move suspension of, or withdraw con- objective and reasoned manner in writ-
formity assessment bodies (CAB’s). ing to the other party;
(b) The CAB shall be given prompt
§ 26.66 Designation and listing proce- notice by the other party and an oppor-
dures. tunity to present information in order
The following procedures shall apply to refute the contestation or to correct
with regard to the designation of con- the deficiencies which form the basis of
formity assessment bodies (CAB’s) and the contestation;
the inclusion of such bodies in the list (c) Any such contestation shall be
of CAB’s in subpart B of this part: discussed between the parties in the
(a) The designating authority identi- Joint Sectoral Committee described in
fied in subpart B of this part shall des- subpart B of this part. If there is no
ignate CAB’s in accordance with the Joint Sectoral Committee, the con-
procedures and criteria set forth in testing party shall refer the matter di-
subpart B of this part; rectly to the Joint Committee. If
(b) A party proposing to add a CAB to agreement to suspend is reached by the
the list of such bodies in subpart B of Joint Sectoral Committee or, if there
this part shall forward its proposal of is no Joint Sectoral Committee, by the
one or more designated CAB’s in writ- Joint Committee, the CAB shall be sus-
ing to the other party with a view to a pended;
decision by the Joint Committee; (d) Where the Joint Sectoral Com-
(c) Within 60 days following receipt of mittee or Joint Committee decides
that verification of technical com-
the proposal, the other party shall in-
petence or compliance is required, it
dicate its position regarding either its
shall normally be carried out in a time-
confirmation or its opposition. Upon
ly manner by the party in whose terri-
confirmation, the inclusion in subpart
tory the body in question is located,
B of this part of the proposed CAB or
but may be carried out jointly by the
CAB’s shall take effect; and
parties in justified cases;
(d) In the event that the other party
(e) If the matter has not been re-
contests on the basis of documented solved by the Joint Sectoral Com-
evidence the technical competence or mittee within 10 days of the notice of
compliance of a proposed CAB, or indi- contestation, the matter shall be re-
cates in writing that it requires an ad- ferred to the Joint Committee for a de-
ditional 30 days to more fully verify cision. If there is no Joint Sectoral
such evidence, such CAB shall not be Committee, the matter shall be re-
included on the list of CAB’s in subpart ferred directly to the Joint Committee.
B of this part. In this instance, the If no decision is reached by the Joint
Joint Committee may decide that the Committee within 10 days of the refer-
body concerned be verified. After the ral to it, the CAB shall be suspended
completion of such verification, the upon the request of the contesting
proposal to list the CAB in subpart B party;
may be resubmitted to the other party. (f) Upon the suspension of a CAB list-
ed in subpart B of this part, a party is
361
§ 26.68 21 CFR Ch. I (4–1–19 Edition)
no longer obligated to accept or recog- sults of conformity assessment proce-

nize the results of conformity assess- dures performed by that CAB prior to
ment procedures performed by that withdrawal, unless a regulatory au-
CAB subsequent to suspension. A party thority of the party decides otherwise
shall continue to accept the results of based on health, safety, and environ-
conformity assessment procedures per- mental considerations or failure to sat-
formed by that CAB prior to suspen- isfy other requirements within the
sion, unless a regulatory authority of scope of subpart B of this part.
the party decides otherwise based on
health, safety or environmental consid- § 26.69 Monitoring of conformity as-
erations or failure to satisfy other re- sessment bodies.
quirements within the scope of subpart The following shall apply with regard
B of this part; and to the monitoring of conformity assess-
(g) The suspension shall remain in ef- ment bodies (CAB’s) listed in subpart B
fect until agreement has been reached of this part:
by the parties upon the future status of (a) Designating authorities shall as-
that body. sure that their CAB’s listed in subpart
B of this part are capable and remain
§ 26.68 Withdrawal of listed conformity capable of properly assessing con-
assessment bodies. formity of products or processes, as ap-
The following procedures shall apply plicable, and as covered in subpart B of
with regard to the withdrawal from this part. In this regard, designating
subpart B of this part of a conformity authorities shall maintain, or cause to
assessment body (CAB): maintain, ongoing surveillance over
(a) A party proposing to withdraw a their CAB’s by means of regular audit
CAB listed in subpart B of this part or assessment;
shall forward its proposal in writing to (b) The parties undertake to compare
the other party; methods used to verify that the CAB’s
(b) Such CAB shall be promptly noti- listed in subpart B of this part comply
fied by the other party and shall be with the relevant requirements of sub-
provided a period of at least 30 days part B of this part. Existing systems
from receipt to provide information in for the evaluation of CAB’s may be
order to refute or to correct the defi- used as part of such comparison proce-
ciencies which form the basis of the dures;
proposed withdrawal; (c) Designating authorities shall con-
(c) Within 60 days following receipt of sult as necessary with their counter-
the proposal, the other party shall in- parts, to ensure the maintenance of
dicate its position regarding either its confidence in conformity assessment
confirmation or its opposition. Upon procedures. With the consent of both
confirmation, the withdrawal from the parties, this consultation may include
list in subpart B of this part of the CAB joint participation in audits/inspec-
shall take effect; tions related to conformity assessment
(d) In the event the other party op- activities or other assessments of
poses the proposal to withdraw by sup- CAB’s listed in subpart B of this part;
porting the technical competence and and
compliance of the CAB, the CAB shall (d) Designating authorities shall con-
not at that time be withdrawn from sult, as necessary, with the relevant
the list of CAB’s in subpart B of this regulatory authorities of the other
part. In this instance, the Joint Sec- party to ensure that all technical re-
toral Committee or the Joint Com- quirements are identified and are satis-
mittee may decide to carry out a joint factorily addressed.
verification of the body concerned.
After the completion of such § 26.70 Conformity assessment bodies.
verification, the proposal for with- Each party recognizes that the con-
drawal of the CAB may be resubmitted formity assessment bodies (CAB’s) list-
to the other party; and ed in subpart B of this part fulfill the
(e) Subsequent to the withdrawal of a conditions of eligibility to assess con-
CAB listed in subpart B of this part, a formity in relation to its requirements

party shall continue to accept the re- as specified in subpart B of this part.
362
The parties shall specify the scope of prised of appropriate regulatory au-
the conformity assessment procedures thorities and others deemed necessary.
for which such bodies are listed. (c) The United States and the EC
shall each have one vote in the Joint
§ 26.71 Exchange of information. Committee. The Joint Committee shall
(a) The parties shall exchange infor- make its decisions by unanimous con-
mation concerning the implementation sent. The Joint Committee shall deter-
of the legislative, regulatory, and ad- mine its own rules and procedures.
ministrative provisions identified in (d) The Joint Committee may con-
subparts A and B of this part. sider any matter relating to the effec-
(b) Each party shall notify the other tive functioning of that agreement. In
party of legislative, regulatory, and ad- particular it shall be responsible for:
ministrative changes related to the
(1) Listing, suspension, withdrawal
subject matter of this part at least 60
and verification of conformity assess-
days before their entry into force.
Where considerations of safety, health ment bodies (CAB’s) in accordance with
or environmental protection require that agreement;
more urgent action, a party shall no- (2) Amending transitional arrange-
tify the other party as soon as prac- ments in the sectoral annexes to that
ticable. agreement;
(c) Each party shall promptly notify (3) Resolving any questions relating
the other party of any changes to its to the application of that agreement
designating authorities and/or con- not otherwise resolved in the respec-
formity assessment bodies (CAB’s). tive Joint Sectoral Committees;
(d) The parties shall exchange infor- (4) Providing a forum for discussion
mation concerning the procedures used of issues that may arise concerning the
to ensure that the listed CAB’s under implementation of that agreement;
their responsibility comply with the (5) Considering ways to enhance the
legislative, regulatory, and administra- operation of that agreement;
tive provisions outlined in subpart B of (6) Coordinating the negotiation of
this part. additional sectoral annexes to that
(e) Regulatory authorities identified agreement; and
in subparts A and B of this part shall (7) Considering whether to amend
consult as necessary with their coun- that agreement in accordance with
terparts, to ensure the maintenance of § 26.80.
confidence in conformity assessment
(e) When a party introduces new or
procedures and to ensure that all tech-
additional conformity assessment pro-
nical requirements are identified and
are satisfactorily addressed. cedures affecting a sectoral annex to
that agreement, the parties shall dis-
§ 26.72 Sectoral contact points. cuss the matter in the Joint Com-
Each party shall appoint and confirm mittee with a view to bringing such
in writing contact points to be respon- new or additional procedures within
sible for activities under subparts A the scope of that agreement and the
and B of this part. relevant sectoral annex.
§ 26.73 Joint Committee. § 26.74 Preservation of regulatory au-

thority.
(a) A Joint Committee consisting of
representatives of the United States (a) Nothing in this part shall be con-
and the European Community (EC) will strued to limit the authority of a party
be established. The Joint Committee to determine, through its legislative,
shall be responsible for the effective regulatory, and administrative meas-
functioning of the ‘‘Agreement on Mu- ures, the level of protection it con-
tual Recognition Between the United siders appropriate for safety; for pro-
States of America and the European tection of human, animal, or plant life
Community,’’ from which this part is or health; for the environment; for con-
derived. sumers; and otherwise with regard to
(b) The Joint Committee may estab- risks within the scope of the applicable
lish Joint Sectoral Committees com- subpart A or B of this part.
363
§ 26.75 21 CFR Ch. I (4–1–19 Edition)
(b) Nothing in this part shall be con- (b) In particular, neither party shall
strued to limit the authority of a regu- disclose to the public, nor permit a
latory authority to take all appro- conformity assessment body (CAB) to
priate and immediate measures when- disclose to the public, information ex-
ever it ascertains that a product may: changed under this part that con-
(1) Compromise the health or safety stitutes trade secrets, confidential
of persons in its territory; commercial or financial information,
(2) Not meet the legislative, regu- or information that relates to an ongo-
latory, or administrative provisions ing investigation.
within the scope of the applicable sub- (c) A party or a CAB may, upon ex-
part A or B of this part; or changing information with the other
(3) Otherwise fail to satisfy a require- party or with a CAB of the other party,
ment within the scope of the applicable designate the portions of the informa-
subpart A or B of this part. Such meas- tion that it considers to be exempt
ures may include withdrawing the from disclosure.
products from the market, prohibiting (d) Each party shall take all pre-
their placement on the market, re- cautions reasonably necessary to pro-
stricting their free movement, initi- tect information exchanged under this
ating a product recall, and preventing part from unauthorized disclosure.
the recurrence of such problems, in-
cluding through a prohibition on im- § 26.77 Fees.
ports. If the regulatory authority takes Each party shall endeavor to ensure
such action, it shall inform its counter- that fees imposed for services under
part authority and the other party this part shall be commensurate with
within 15 days of taking such action, the services provided. Each party shall
providing its reasons. ensure that, for the sectors and con-
formity assessment procedures covered
§ 26.75 Suspension of recognition obli- under this part, it shall charge no fees
gations. with respect to conformity assessment
Either party may suspend its obliga- services provided by the other party.
tions under subpart A or B of this part,
in whole or in part, if: § 26.78 Agreements with other coun-
(a) A party suffers a loss of market tries.
access for the party’s products within Except where there is written agree-
the scope of subpart A or B of this part ment between the parties, obligations
as a result of the failure of the other contained in mutual recognition agree-
party to fulfill its obligations under ments concluded by either party with a
this part; party not a party to the agreement
(b) The adoption of new or additional from which this part is derived (a third
conformity assessment requirements as party) shall have no force and effect
referenced in § 26.73(e) results in a loss with regard to the other party in terms
of market access for the party’s prod- of acceptance of the results of con-
ucts within the scope of subpart B of formity assessment procedures in the
this part because conformity assess- third party.
ment bodies (CAB’s) designated by the
party in order to meet such require- § 26.79 Territorial application.
ments have not been recognized by the The agreement from which this part
party implementing the requirements; is derived shall apply, on the one hand,
or to the territories in which the Treaty
(c) The other party fails to maintain establishing the European Community
legal and regulatory authorities capa- (EC) is applied, and under the condi-
ble of implementing the provisions of tions laid down in that Treaty and, on
this part. the other hand, to the territory of the
United States.
§ 26.76 Confidentiality.
(a) Each party agrees to maintain, to § 26.80 Entry into force, amendment,
the extent required under its laws, the and termination.
confidentiality of information ex- (a) The ‘‘Agreement on Mutual Rec-

changed under this part. ognition Between the United States of
364
America and the European Commu- annexes added pursuant to § 26.80(b),

nity,’’ from which this part is derived, shall form an integral part of the
including its sectoral annexes on tele- ‘‘Agreement on Mutual Recognition
communication equipment, electro- Between the United States of America
magnetic compatibility, electrical and the European Community,’’ from
safety, recreational craft, pharma- which this part is derived.
ceutical Good Manufacturing Practices (b) For a given product or sector, the
(GMP) inspections, and medical devices provisions contained in subparts A and
shall enter into force on the first day B of this part shall apply in the first
of the second month following the date place, and the provisions of subpart C
on which the parties have exchanged of this part in addition to those provi-
letters confirming the completion of sions. In the case of any inconsistency
their respective procedures for the between the provisions of subpart A or
entry into force of that agreement. B of this part and subpart C of this
(b) That agreement including any part, subpart A or B shall prevail, to
sectoral annex may, through the Joint the extent of that inconsistency.
Committee, be amended in writing by (c) The agreement from which this
the parties to that agreement. Those part is derived shall not affect the
parties may add a sectoral annex upon rights and obligations of the parties
the exchange of letters. Such annex under any other international agree-
shall enter into force 30 days following ment.
the date on which those parties have (d) In the case of subpart B of this
exchanged letters confirming the com- part, the parties shall review the sta-
pletion of their respective procedures tus of such subpart at the end of 3
for the entry into force of the sectoral years from the date described in
annex. § 26.80(a).
(c) Either party to that agreement
may terminate that agreement in its PART 50—PROTECTION OF HUMAN
entirety or any individual sectoral SUBJECTS
annex thereof by giving the other party
to that agreement 6-months notice in Subpart A—General Provisions
writing. In the case of termination of
one or more sectoral annexes, the par- Sec.
ties to that agreement will seek to 50.1 Scope.
50.3 Definitions.
achieve by consensus to amend that
agreement, with a view to preserving Subpart B—Informed Consent of Human
the remaining Sectoral Annexes, in ac- Subjects
cordance with the procedures in this
section. Failing such consensus, that 50.20 General requirements for informed
agreement shall terminate at the end consent.
50.23 Exception from general requirements.
of 6 months from the date of notice.
50.24 Exception from informed consent re-
(d) Following termination of that quirements for emergency research.
agreement in its entirety or any indi- 50.25 Elements of informed consent.
vidual sectoral annex thereof, a party 50.27 Documentation of informed consent.
to that agreement shall continue to ac-
cept the results of conformity assess- Subpart C [Reserved]
ment procedures performed by con-
formity assessment bodies under that Subpart D—Additional Safeguards for
agreement prior to termination, unless Children in Clinical Investigations
a regulatory authority in the party de- 50.50 IRB duties.
cides otherwise based on health, safety 50.51 Clinical investigations not involving
and environmental considerations or greater than minimal risk.
failure to satisfy other requirements 50.52 Clinical investigations involving
within the scope of the applicable sec- greater than minimal risk but presenting
toral annex. the prospect of direct benefit to indi-
vidual subjects.
§ 26.81 Final provisions. 50.53 Clinical investigations involving
greater than minimal risk and no pros-

(a) The sectoral annexes referred to pect of direct benefit to individual sub-
in § 26.80(a), as well as any new sectoral jects, but likely to yield generalizable
365
§ 50.1 21 CFR Ch. I (4–1–19 Edition)
knowledge about the subjects’ disorder Regulations are to chapter I of title 21,
or condition. unless otherwise noted.
50.54 Clinical investigations not otherwise
approvable that present an opportunity [45 FR 36390, May 30, 1980; 46 FR 8979, Jan. 27,
to understand, prevent, or alleviate a se- 1981, as amended at 63 FR 26697, May 13, 1998;
rious problem affecting the health or 64 FR 399, Jan. 5, 1999; 66 FR 20597, Apr. 24,
welfare of children. 2001]
50.55 Requirements for permission by par-
ents or guardians and for assent by chil- § 50.3 Definitions.
dren. As used in this part:
50.56 Wards. (a) Act means the Federal Food,
AUTHORITY: 21 U.S.C 321, 343, 346, 346a, 348, Drug, and Cosmetic Act, as amended
350a, 350b, 352, 353, 355, 360, 360c–360f, 360h– (secs. 201–902, 52 Stat. 1040 et seq. as
360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b– amended (21 U.S.C. 321–392)).
263n. (b) Application for research or mar-
SOURCE: 45 FR 36390, May 30, 1980, unless keting permit includes:
otherwise noted. (1) A color additive petition, de-
scribed in part 71.
Subpart A—General Provisions (2) A food additive petition, described
in parts 171 and 571.
§ 50.1 Scope. (3) Data and information about a sub-
(a) This part applies to all clinical instance submitted as part of the proce-
vestigations regulated by the Food and dures for establishing that the sub-
stance is generally recognized as safe
Drug Administration under sections
for use that results or may reasonably
505(i) and 520(g) of the Federal Food,
be expected to result, directly or indi-
Drug, and Cosmetic Act, as well as
rectly, in its becoming a component or
clinical investigations that support ap- otherwise affecting the characteristics
plications for research or marketing of any food, described in §§ 170.30 and
permits for products regulated by the 570.30.
Food and Drug Administration, includ- (4) Data and information about a food
ing foods, including dietary supple- additive submitted as part of the proce-
ments, that bear a nutrient content dures for food additives permitted to be
claim or a health claim, infant for- used on an interim basis pending addi-
mulas, food and color additives, drugs tional study, described in § 180.1.
for human use, medical devices for (5) Data and information about a sub-
human use, biological products for stance submitted as part of the proce-
human use, and electronic products. dures for establishing a tolerance for
Additional specific obligations and unavoidable contaminants in food and
commitments of, and standards of con- food-packaging materials, described in
duct for, persons who sponsor or mon- section 406 of the act.
itor clinical investigations involving (6) An investigational new drug appli-
particular test articles may also be cation, described in part 312 of this
found in other parts (e.g., parts 312 and chapter.
812). Compliance with these parts is in- (7) A new drug application, described
tended to protect the rights and safety in part 314.
of subjects involved in investigations (8) Data and information about the
filed with the Food and Drug Adminis- bioavailability or bioequivalence of
tration pursuant to sections 403, 406, drugs for human use submitted as part
409, 412, 413, 502, 503, 505, 510, 513–516, of the procedures for issuing, amend-
518–520, 721, and 801 of the Federal ing, or repealing a bioequivalence re-
Food, Drug, and Cosmetic Act and sec- quirement, described in part 320.
tions 351 and 354–360F of the Public (9) Data and information about an
Health Service Act. over-the-counter drug for human use
(b) References in this part to regu- submitted as part of the procedures for
latory sections of the Code of Federal classifying these drugs as generally
recognized as safe and effective and not

misbranded, described in part 330.
366
(10) Data and information about a formula notification under section

prescription drug for human use sub- 412(c) of the Federal Food, Drug, and
mitted as part of the procedures for Cosmetic Act.
classifying these drugs as generally (24) Data and information submitted
recognized as safe and effective and not in a petition for a nutrient content
misbranded, described in this chapter. claim, described in § 101.69 of this chap-
(11) [Reserved] ter, or for a health claim, described in
(12) An application for a biologics li- § 101.70 of this chapter.
cense, described in part 601 of this (25) Data and information from inves-
chapter.
tigations involving children submitted
(13) Data and information about a bi-
in a new dietary ingredient notifica-
ological product submitted as part of
the procedures for determining that li- tion, described in § 190.6 of this chapter.
censed biological products are safe and (c) Clinical investigation means any
effective and not misbranded, described experiment that involves a test article
in part 601. and one or more human subjects and
(14) Data and information about an in that either is subject to requirements
vitro diagnostic product submitted as for prior submission to the Food and
part of the procedures for establishing, Drug Administration under section
amending, or repealing a standard for 505(i) or 520(g) of the act, or is not sub-
these products, described in part 809. ject to requirements for prior submis-
(15) An Application for an Investiga- sion to the Food and Drug Administra-
tional Device Exemption, described in tion under these sections of the act,
part 812. but the results of which are intended to
(16) Data and information about a be submitted later to, or held for in-
medical device submitted as part of the spection by, the Food and Drug Admin-
procedures for classifying these de- istration as part of an application for a
vices, described in section 513. research or marketing permit. The
(17) Data and information about a term does not include experiments that
medical device submitted as part of the are subject to the provisions of part 58
procedures for establishing, amending, of this chapter, regarding nonclinical
or repealing a standard for these de-
laboratory studies.
vices, described in section 514.
(18) An application for premarket ap- (d) Investigator means an individual
proval of a medical device, described in who actually conducts a clinical inves-
section 515. tigation, i.e., under whose immediate
(19) A product development protocol direction the test article is adminis-
for a medical device, described in sec- tered or dispensed to, or used involv-
tion 515. ing, a subject, or, in the event of an in-
(20) Data and information about an vestigation conducted by a team of in-
electronic product submitted as part of dividuals, is the responsible leader of
the procedures for establishing, amend- that team.
ing, or repealing a standard for these (e) Sponsor means a person who initi-
products, described in section 358 of the ates a clinical investigation, but who
Public Health Service Act. does not actually conduct the inves-
(21) Data and information about an tigation, i.e., the test article is admin-
electronic product submitted as part of istered or dispensed to or used involv-
the procedures for obtaining a variance ing, a subject under the immediate di-
from any electronic product perform- rection of another individual. A person
ance standard, as described in § 1010.4. other than an individual (e.g., corpora-
(22) Data and information about an tion or agency) that uses one or more
electronic product submitted as part of of its own employees to conduct a clin-
the procedures for granting, amending, ical investigation it has initiated is
or extending an exemption from a radi-
considered to be a sponsor (not a spon-
ation safety performance standard, as
sor-investigator), and the employees
described in § 1010.5.
(23) Data and information about a are considered to be investigators.
clinical study of an infant formula (f) Sponsor-investigator means an indi-

when submitted as part of an infant vidual who both initiates and actually
367
§ 50.20 21 CFR Ch. I (4–1–19 Edition)
conducts, alone or with others, a clin- any individual related by blood or af-
ical investigation, i.e., under whose im- finity whose close association with the
mediate direction the test article is ad- subject is the equivalent of a family re-
ministered or dispensed to, or used in- lationship.
volving, a subject. The term does not (n) Assent means a child’s affirmative
include any person other than an indi- agreement to participate in a clinical
vidual, e.g., corporation or agency. investigation. Mere failure to object
(g) Human subject means an indi- should not, absent affirmative agree-
vidual who is or becomes a participant ment, be construed as assent.
in research, either as a recipient of the (o) Children means persons who have
test article or as a control. A subject not attained the legal age for consent
may be either a healthy human or a pa- to treatments or procedures involved
tient. in clinical investigations, under the ap-
(h) Institution means any public or plicable law of the jurisdiction in
private entity or agency (including which the clinical investigation will be
Federal, State, and other agencies). conducted.
The word facility as used in section (p) Parent means a child’s biological
520(g) of the act is deemed to be syn- or adoptive parent.
onymous with the term institution for (q) Ward means a child who is placed
purposes of this part. in the legal custody of the State or
(i) Institutional review board (IRB) other agency, institution, or entity,
means any board, committee, or other consistent with applicable Federal,
group formally designated by an insti- State, or local law.
tution to review biomedical research (r) Permission means the agreement of
involving humans as subjects, to apparent(s) or guardian to the participa-
prove the initiation of and conduct tion of their child or ward in a clinical
periodic review of such research. The investigation.
term has the same meaning as the (s) Guardian means an individual who
phrase institutional review committee as is authorized under applicable State or
used in section 520(g) of the act. local law to consent on behalf of a
(j) Test article means any drug (in- child to general medical care.
cluding a biological product for human [45 FR 36390, May 30, 1980, as amended at 46
use), medical device for human use, FR 8950, Jan. 27, 1981; 54 FR 9038, Mar. 3, 1989;
human food additive, color additive, 56 FR 28028, June 18, 1991; 61 FR 51528, Oct. 2,
electronic product, or any other article 1996; 62 FR 39440, July 23, 1997; 64 FR 399, Jan.
subject to regulation under the act or 5, 1999; 64 FR 56448, Oct. 20, 1999; 66 FR 20597,
under sections 351 and 354–360F of the Apr. 24, 2001; 78 FR 12950, Feb. 26, 2013]
Public Health Service Act (42 U.S.C. 262
and 263b–263n). Subpart B—Informed Consent of
(k) Minimal risk means that the prob- Human Subjects
ability and magnitude of harm or dis-
comfort anticipated in the research are SOURCE: 46 FR 8951, Jan. 27, 1981, unless
not greater in and of themselves than otherwise noted.
those ordinarily encountered in daily
life or during the performance of rou- § 50.20 General requirements for in-
tine physical or psychological exami- formed consent.
nations or tests. Except as provided in §§ 50.23 and
(l) Legally authorized representative 50.24, no investigator may involve a
means an individual or judicial or human being as a subject in research
other body authorized under applicable covered by these regulations unless the
law to consent on behalf of a prospec- investigator has obtained the legally
tive subject to the subject’s effective informed consent of the sub-
particpation in the procedure(s) in- ject or the subject’s legally authorized
volved in the research. representative. An investigator shall
(m) Family member means any one of seek such consent only under cir-
the following legally competent per- cumstances that provide the prospec-
sons: Spouse; parents; children (includ- tive subject or the representative suffi-
ing adopted children); brothers, sisters, cient opportunity to consider whether

and spouses of brothers and sisters; and or not to participate and that minimize
368
the possibility of coercion or undue in- working days after the use of the test
fluence. The information that is given article.
to the subject or the representative (d)(1) Under 10 U.S.C. 1107(f) the
shall be in language understandable to President may waive the prior consent
the subject or the representative. No requirement for the administration of
informed consent, whether oral or writ- an investigational new drug to a mem-
ten, may include any exculpatory lan- ber of the armed forces in connection
guage through which the subject or the with the member’s participation in a
representative is made to waive or ap- particular military operation. The
pear to waive any of the subject’s legal
statute specifies that only the Presi-
rights, or releases or appears to release
dent may waive informed consent in
the investigator, the sponsor, the insti-
tution, or its agents from liability for this connection and the President may
negligence. grant such a waiver only if the Presi-
dent determines in writing that obtain-
[46 FR 8951, Jan. 27, 1981, as amended at 64 ing consent: Is not feasible; is contrary
FR 10942, Mar. 8, 1999]
to the best interests of the military
§ 50.23 Exception from general re- member; or is not in the interests of
quirements. national security. The statute further
provides that in making a determina-
(a) The obtaining of informed consent
shall be deemed feasible unless, before tion to waive prior informed consent
use of the test article (except as pro- on the ground that it is not feasible or
vided in paragraph (b) of this section), the ground that it is contrary to the
both the investigator and a physician best interests of the military members
who is not otherwise participating in involved, the President shall apply the
the clinical investigation certify in standards and criteria that are set
writing all of the following: forth in the relevant FDA regulations
(1) The human subject is confronted for a waiver of the prior informed con-
by a life-threatening situation necessi- sent requirements of section 505(i)(4) of
tating the use of the test article. the Federal Food, Drug, and Cosmetic
(2) Informed consent cannot be ob- Act (21 U.S.C. 355(i)(4)). Before such a
tained from the subject because of an determination may be made that ob-
inability to communicate with, or obtaining informed consent from mili-
tain legally effective consent from, the tary personnel prior to the use of an in-
subject. vestigational drug (including an anti-
(3) Time is not sufficient to obtain biotic or biological product) in a spe-
consent from the subject’s legal rep- cific protocol under an investigational
resentative. new drug application (IND) sponsored
(4) There is available no alternative by the Department of Defense (DOD)
method of approved or generally recog- and limited to specific military per-
nized therapy that provides an equal or sonnel involved in a particular mili-
greater likelihood of saving the life of tary operation is not feasible or is con-
the subject. trary to the best interests of the mili-
(b) If immediate use of the test arti-
tary members involved the Secretary
cle is, in the investigator’s opinion, re-
of Defense must first request such a de-
quired to preserve the life of the sub-
termination from the President, and
ject, and time is not sufficient to ob-
certify and document to the President
tain the independent determination re-
quired in paragraph (a) of this section that the following standards and cri-
in advance of using the test article, the teria contained in paragraphs (d)(1)
determinations of the clinical investi- through (d)(4) of this section have been
gator shall be made and, within 5 work- met.
ing days after the use of the article, be (i) The extent and strength of evi-
reviewed and evaluated in writing by a dence of the safety and effectiveness of
physician who is not participating in the investigational new drug in rela-
the clinical investigation. tion to the medical risk that could be
(c) The documentation required in encountered during the military oper-
paragraph (a) or (b) of this section ation supports the drug’s administra-
shall be submitted to the IRB within 5 tion under an IND.
369
§ 50.23 21 CFR Ch. I (4–1–19 Edition)
(ii) The military operation presents a (ix) Medical records of members in-
substantial risk that military per- volved in the military operation will
sonnel may be subject to a chemical, accurately document the receipt by
biological, nuclear, or other exposure members of the notification required
likely to produce death or serious or by paragraph (d)(1)(viii) of this section.
life-threatening injury or illness. (x) Medical records of members in-
(iii) There is no available satisfac- volved in the military operation will
tory alternative therapeutic or preven- accurately document the receipt by
tive treatment in relation to the in- members of any investigational new
tended use of the investigational new drugs in accordance with FDA regula-
drug. tions including part 312 of this chapter.
(iv) Conditioning use of the inves- (xi) DOD will provide adequate fol-
tigational new drug on the voluntary lowup to assess whether there are bene-
participation of each member could ficial or adverse health consequences
significantly risk the safety and health that result from the use of the inves-
of any individual member who would tigational product.
decline its use, the safety of other mili- (xii) DOD is pursuing drug develop-
tary personnel, and the accomplish- ment, including a time line, and mar-
ment of the military mission. keting approval with due diligence.
(v) A duly constituted institutional (xiii) FDA has concluded that the in-
review board (IRB) established and op- vestigational new drug protocol may
erated in accordance with the require- proceed subject to a decision by the
ments of paragraphs (d)(2) and (d)(3) of President on the informed consent
this section, responsible for review of waiver request.
the study, has reviewed and approved (xiv) DOD will provide training to the
the investigational new drug protocol appropriate medical personnel and po-
and the administration of the inves- tential recipients on the specific inves-
tigational new drug without informed tigational new drug to be administered
consent. DOD’s request is to include prior to its use.
the documentation required by (xv) DOD has stated and justified the
§ 56.115(a)(2) of this chapter. time period for which the waiver is
(vi) DOD has explained: needed, not to exceed one year, unless
(A) The context in which the inves- separately renewed under these stand-
tigational drug will be administered, ards and criteria.
e.g., the setting or whether it will be (xvi) DOD shall have a continuing ob-
self-administered or it will be adminis- ligation to report to the FDA and to
tered by a health professional; the President any changed cir-
(B) The nature of the disease or con- cumstances relating to these standards
dition for which the preventive or and criteria (including the time period
therapeutic treatment is intended; and referred to in paragraph (d)(1)(xv) of
(C) To the extent there are existing this section) or that otherwise might
data or information available, informa- affect the determination to use an in-
tion on conditions that could alter the vestigational new drug without in-
effects of the investigational drug. formed consent.
(vii) DOD’s recordkeeping system is (xvii) DOD is to provide public notice
capable of tracking and will be used to as soon as practicable and consistent
track the proposed treatment from with classification requirements
supplier to the individual recipient. through notice in the FEDERAL REG-
(viii) Each member involved in the ISTER describing each waiver of in-
military operation will be given, prior formed consent determination, a sum-
to the administration of the investiga- mary of the most updated scientific in-
tional new drug, a specific written information on the products used, and
formation sheet (including information other pertinent information.
required by 10 U.S.C. 1107(d)) con- (xviii) Use of the investigational drug
cerning the investigational new drug, without informed consent otherwise
the risks and benefits of its use, poten- conforms with applicable law.
tial side effects, and other pertinent in- (2) The duly constituted institutional
formation about the appropriate use of review board, described in paragraph

the product. (d)(1)(v) of this section, must include at
370
least 3 nonaffiliated members who make the determinations and later cer-
shall not be employees or officers of tify in writing all of the following:
the Federal Government (other than (i) The human subject is confronted
for purposes of membership on the IRB) by a life-threatening situation necessi-
and shall be required to obtain any tating the use of the investigational in
necessary security clearances. This vitro diagnostic device to identify a
IRB shall review the proposed IND pro- chemical, biological, radiological, or
tocol at a convened meeting at which a nuclear agent that would suggest a ter-
majority of the members are present rorism event or other public health
including at least one member whose emergency.
primary concerns are in nonscientific (ii) Informed consent cannot be ob-
areas and, if feasible, including a ma- tained from the subject because:
jority of the nonaffiliated members. (A) There was no reasonable way for
The information required by the person directing that the specimen
§ 56.115(a)(2) of this chapter is to be probe collected to know, at the time the
vided to the Secretary of Defense for specimen was collected, that there
further review. would be a need to use the investiga-
(3) The duly constituted institutional tional in vitro diagnostic device on
review board, described in paragraph that subject’s specimen; and
(d)(1)(v) of this section, must review (B) Time is not sufficient to obtain
and approve: consent from the subject without risk-
(i) The required information sheet; ing the life of the subject.
(ii) The adequacy of the plan to dis- (iii) Time is not sufficient to obtain
seminate information, including dis- consent from the subject’s legally au-
tribution of the information sheet to thorized representative.
potential recipients, on the investiga- (iv) There is no cleared or approved
tional product (e.g., in forms other available alternative method of diag-
than written); nosis, to identify the chemical, biologi-
(iii) The adequacy of the information cal, radiological, or nuclear agent that
and plans for its dissemination to provides an equal or greater likelihood
health care providers, including poten- of saving the life of the subject.
tial side effects, contraindications, po- (2) If use of the investigational device
tential interactions, and other perti- is, in the opinion of the investigator
nent considerations; and (e.g., clinical laboratory director or
(iv) An informed consent form as re- other responsible person), required to
quired by part 50 of this chapter, in preserve the life of the subject, and
those circumstances in which DOD de- time is not sufficient to obtain the
termines that informed consent may be independent determination required in
obtained from some or all personnel in- paragraph (e)(1) of this section in ad-
volved. vance of using the investigational de-
(4) DOD is to submit to FDA sum- vice, the determinations of the investi-
maries of institutional review board gator shall be made and, within 5 work-
meetings at which the proposed pro- ing days after the use of the device, be
tocol has been reviewed. reviewed and evaluated in writing by a
(5) Nothing in these criteria or stand- physician who is not participating in
ards is intended to preempt or limit the clinical investigation.
FDA’s and DOD’s authority or obliga- (3) The investigator must submit the
tions under applicable statutes and written certification of the determina-
regulations. tions made by the investigator and an
(e)(1) Obtaining informed consent for independent physician required in
investigational in vitro diagnostic de- paragraph (e)(1) or (e)(2) of this section
vices used to identify chemical, bio- to the IRB and FDA within 5 working
logical, radiological, or nuclear agents days after the use of the device.
will be deemed feasible unless, before (4) An investigator must disclose the
use of the test article, both the investi- investigational status of the in vitro
gator (e.g., clinical laboratory director diagnostic device and what is known
or other responsible individual) and a about the performance characteristics
physician who is not otherwise partici- of the device in the report to the sub-
pating in the clinical investigation ject’s health care provider and in any
371
§ 50.24 21 CFR Ch. I (4–1–19 Edition)
report to public health authorities. The to determine the safety and effective-
investigator must provide the IRB with ness of particular interventions.
the information required in § 50.25 (ex- (2) Obtaining informed consent is not
cept for the information described in feasible because:
§ 50.25(a)(8)) and the procedures that (i) The subjects will not be able to
will be used to provide this information give their informed consent as a result
to each subject or the subject’s legally of their medical condition;
authorized representative at the time (ii) The intervention under investiga-
the test results are provided to the sub- tion must be administered before con-
ject’s health care provider and public sent from the subjects’ legally author-
health authorities. ized representatives is feasible; and
(5) The IRB is responsible for ensur- (iii) There is no reasonable way to
ing the adequacy of the information re- identify prospectively the individuals
quired in section 50.25 (except for the likely to become eligible for participa-
information described in § 50.25(a)(8)) tion in the clinical investigation.
and for ensuring that procedures are in (3) Participation in the research
place to provide this information to holds out the prospect of direct benefit
each subject or the subject’s legally au- to the subjects because:
thorized representative. (i) Subjects are facing a life-threat-
(6) No State or political subdivision ening situation that necessitates inter-
of a State may establish or continue in vention;
effect any law, rule, regulation or (ii) Appropriate animal and other
other requirement that informed con- preclinical studies have been con-
sent be obtained before an investiga- ducted, and the information derived
tional in vitro diagnostic device may from those studies and related evidence
be used to identify chemical, biologi- support the potential for the interven-
cal, radiological, or nuclear agent in tion to provide a direct benefit to the
suspected terrorism events and other individual subjects; and
potential public health emergencies (iii) Risks associated with the inves-
that is different from, or in addition to, tigation are reasonable in relation to
the requirements of this regulation. what is known about the medical con-
[46 FR 8951, Jan. 27, 1981, as amended at 55 dition of the potential class of subjects,
FR 52817, Dec. 21, 1990; 64 FR 399, Jan. 5, 1999; the risks and benefits of standard ther-
64 FR 54188, Oct. 5, 1999; 71 FR 32833, June 7, apy, if any, and what is known about
2006; 76 FR 36993, June 24, 2011] the risks and benefits of the proposed
intervention or activity.
§ 50.24 Exception from informed con- (4) The clinical investigation could
sent requirements for emergency not practicably be carried out without
research. the waiver.
(a) The IRB responsible for the re- (5) The proposed investigational plan
view, approval, and continuing review defines the length of the potential
of the clinical investigation described therapeutic window based on scientific
in this section may approve that inves- evidence, and the investigator has com-
tigation without requiring that in- mitted to attempting to contact a le-
formed consent of all research subjects gally authorized representative for
be obtained if the IRB (with the con- each subject within that window of
currence of a licensed physician who is time and, if feasible, to asking the le-
a member of or consultant to the IRB gally authorized representative con-
and who is not otherwise participating tacted for consent within that window
in the clinical investigation) finds and rather than proceeding without con-
documents each of the following: sent. The investigator will summarize
(1) The human subjects are in a life- efforts made to contact legally author-
threatening situation, available treat- ized representatives and make this in-
ments are unproven or unsatisfactory, formation available to the IRB at the
and the collection of valid scientific time of continuing review.
evidence, which may include evidence (6) The IRB has reviewed and ap-
obtained through randomized placebo- proved informed consent procedures

controlled investigations, is necessary and an informed consent document
372
consistent with § 50.25. These proce- remains incapacitated, a legally au-

dures and the informed consent docu- thorized representative of the subject,
ment are to be used with subjects or or if such a representative is not rea-
their legally authorized representa- sonably available, a family member, of
tives in situations where use of such the subject’s inclusion in the clinical
procedures and documents is feasible. investigation, the details of the inves-
The IRB has reviewed and approved tigation and other information con-
procedures and information to be used tained in the informed consent docu-
when providing an opportunity for a ment. The IRB shall also ensure that
family member to object to a subject’s there is a procedure to inform the sub-
participation in the clinical investiga- ject, or if the subject remains incapaci-
tion consistent with paragraph (a)(7)(v) tated, a legally authorized representa-
of this section. tive of the subject, or if such a rep-
(7) Additional protections of the resentative is not reasonably available,
rights and welfare of the subjects will a family member, that he or she may
be provided, including, at least: discontinue the subject’s participation
(i) Consultation (including, where ap- at any time without penalty or loss of
propriate, consultation carried out by benefits to which the subject is other-
the IRB) with representatives of the wise entitled. If a legally authorized
communities in which the clinical in- representative or family member is
vestigation will be conducted and from told about the clinical investigation
which the subjects will be drawn; and the subject’s condition improves,
(ii) Public disclosure to the commu- the subject is also to be informed as
nities in which the clinical investiga- soon as feasible. If a subject is entered
tion will be conducted and from which into a clinical investigation with
the subjects will be drawn, prior to ini- waived consent and the subject dies be-
tiation of the clinical investigation, of fore a legally authorized representative
plans for the investigation and its risks or family member can be contacted, in-
and expected benefits; formation about the clinical investiga-
(iii) Public disclosure of sufficient in- tion is to be provided to the subject’s
formation following completion of the legally authorized representative or
clinical investigation to apprise the family member, if feasible.
community and researchers of the (c) The IRB determinations required
study, including the demographic char- by paragraph (a) of this section and the
acteristics of the research population, documentation required by paragraph
and its results; (e) of this section are to be retained by
(iv) Establishment of an independent the IRB for at least 3 years after com-
data monitoring committee to exercise pletion of the clinical investigation,
oversight of the clinical investigation; and the records shall be accessible for
and inspection and copying by FDA in ac-
(v) If obtaining informed consent is cordance with § 56.115(b) of this chap-
not feasible and a legally authorized ter.
representative is not reasonably avail- (d) Protocols involving an exception
able, the investigator has committed, to the informed consent requirement
if feasible, to attempting to contact under this section must be performed
within the therapeutic window the sub- under a separate investigational new
ject’s family member who is not a le- drug application (IND) or investiga-
gally authorized representative, and tional device exemption (IDE) that
asking whether he or she objects to the clearly identifies such protocols as pro-
subject’s participation in the clinical tocols that may include subjects who
investigation. The investigator will are unable to consent. The submission
summarize efforts made to contact of those protocols in a separate IND/
family members and make this infor- IDE is required even if an IND for the
mation available to the IRB at the same drug product or an IDE for the
time of continuing review. same device already exists. Applica-
(b) The IRB is responsible for ensur- tions for investigations under this sec-
ing that procedures are in place to in- tion may not be submitted as amend-
form, at the earliest feasible oppor- ments under §§ 312.30 or 812.35 of this
tunity, each subject, or if the subject chapter.
373
§ 50.25 21 CFR Ch. I (4–1–19 Edition)
(e) If an IRB determines that it can- where further information may be ob-
not approve a clinical investigation be- tained.
cause the investigation does not meet (7) An explanation of whom to con-
the criteria in the exception provided tact for answers to pertinent questions
under paragraph (a) of this section or about the research and research sub-
because of other relevant ethical con- jects’ rights, and whom to contact in
cerns, the IRB must document its find- the event of a research-related injury
ings and provide these findings prompt- to the subject.
ly in writing to the clinical investi- (8) A statement that participation is
gator and to the sponsor of the clinical voluntary, that refusal to participate
investigation. The sponsor of the clin- will involve no penalty or loss of bene-
ical investigation must promptly dis- fits to which the subject is otherwise
close this information to FDA and to entitled, and that the subject may dis-
the sponsor’s clinical investigators who continue participation at any time
are participating or are asked to par- without penalty or loss of benefits to
ticipate in this or a substantially which the subject is otherwise entitled.
equivalent clinical investigation of the (b) Additional elements of informed con-
sponsor, and to other IRB’s that have sent. When appropriate, one or more of
been, or are, asked to review this or a the following elements of information
substantially equivalent investigation shall also be provided to each subject:
by that sponsor. (1) A statement that the particular
treatment or procedure may involve
[61 FR 51528, Oct. 2, 1996]
risks to the subject (or to the embryo
§ 50.25 Elements of informed consent. or fetus, if the subject is or may be-
come pregnant) which are currently
(a) Basic elements of informed consent. unforeseeable.
In seeking informed consent, the fol- (2) Anticipated circumstances under
lowing information shall be provided to which the subject’s participation may
each subject: be terminated by the investigator
(1) A statement that the study in- without regard to the subject’s con-
volves research, an explanation of the sent.
purposes of the research and the ex- (3) Any additional costs to the sub-
pected duration of the subject’s partici- ject that may result from participation
pation, a description of the procedures in the research.
to be followed, and identification of (4) The consequences of a subject’s
any procedures which are experi- decision to withdraw from the research
mental. and procedures for orderly termination
(2) A description of any reasonably of participation by the subject.
foreseeable risks or discomforts to the (5) A statement that significant new
subject. findings developed during the course of
(3) A description of any benefits to the research which may relate to the
the subject or to others which may rea- subject’s willingness to continue par-
sonably be expected from the research. ticipation will be provided to the sub-
(4) A disclosure of appropriate alter- ject.
native procedures or courses of treat- (6) The approximate number of sub-
ment, if any, that might be advan- jects involved in the study.
tageous to the subject. (c) When seeking informed consent
(5) A statement describing the ex- for applicable clinical trials, as defined
tent, if any, to which confidentiality of in 42 U.S.C. 282(j)(1)(A), the following
records identifying the subject will be statement shall be provided to each
maintained and that notes the possi- clinical trial subject in informed con-
bility that the Food and Drug Adminis- sent documents and processes. This
tration may inspect the records. will notify the clinical trial subject
(6) For research involving more than that clinical trial information has been
minimal risk, an explanation as to or will be submitted for inclusion in
whether any compensation and an ex- the clinical trial registry databank
planation as to whether any medical under paragraph (j) of section 402 of the
treatments are available if injury oc- Public Health Service Act. The state-
curs and, if so, what they consist of, or ment is: ‘‘A description of this clinical
374
trial will be available on http:// the summary, and the person actually
www.ClinicalTrials.gov, as required by obtaining the consent shall sign a copy
U.S. Law. This Web site will not in- of the summary. A copy of the sum-
clude information that can identify mary shall be given to the subject or
you. At most, the Web site will include the representative in addition to a
a summary of the results. You can copy of the short form.
search this Web site at any time.’’
(d) The informed consent require- [46 FR 8951, Jan. 27, 1981, as amended at 61
FR 57280, Nov. 5, 1996]
ments in these regulations are not in-
tended to preempt any applicable Fed-
eral, State, or local laws which require Subpart C [Reserved]
additional information to be disclosed
for informed consent to be legally ef- Subpart D—Additional Safeguards
fective. for Children in Clinical Inves-
(e) Nothing in these regulations is in-
tended to limit the authority of a phy-
tigations
sician to provide emergency medical
care to the extent the physician is per- SOURCE: 66 FR 20598, Apr. 24, 2001, unless
mitted to do so under applicable Fed- otherwise noted.
eral, State, or local law.
§ 50.50 IRB duties.
[46 FR 8951, Jan. 27, 1981, as amended at 76
FR 270, Jan. 4, 2011] In addition to other responsibilities
assigned to IRBs under this part and
§ 50.27 Documentation of informed part 56 of this chapter, each IRB must
consent. review clinical investigations involving
(a) Except as provided in § 56.109(c), children as subjects covered by this
informed consent shall be documented subpart D and approve only those clin-
by the use of a written consent form ical investigations that satisfy the cri-
approved by the IRB and signed and teria described in § 50.51, § 50.52, or
dated by the subject or the subject’s le- § 50.53 and the conditions of all other
gally authorized representative at the applicable sections of this subpart D.
time of consent. A copy shall be given
to the person signing the form. § 50.51 Clinical investigations not in-
(b) Except as provided in § 56.109(c), volving greater than minimal risk.
the consent form may be either of the Any clinical investigation within the
following: scope described in §§ 50.1 and 56.101 of
(1) A written consent document that this chapter in which no greater than
embodies the elements of informed minimal risk to children is presented
consent required by § 50.25. This form may involve children as subjects only
may be read to the subject or the sub- if the IRB finds that:
ject’s legally authorized representa- (a) No greater than minimal risk to
tive, but, in any event, the investigator children is presented; and
shall give either the subject or the rep- (b) Adequate provisions are made for
resentative adequate opportunity to soliciting the assent of the children
read it before it is signed. and the permission of their parents or
(2) A short form written consent docu- guardians as set forth in § 50.55.
ment stating that the elements of in-
formed consent required by § 50.25 have [78 FR 12951, Feb. 26, 2013]
been presented orally to the subject or
the subject’s legally authorized rep- § 50.52 Clinical investigations involv-
resentative. When this method is used, ing greater than minimal risk but
there shall be a witness to the oral presenting the prospect of direct
benefit to individual subjects.
presentation. Also, the IRB shall ap-
prove a written summary of what is to Any clinical investigation within the
be said to the subject or the represent- scope described in §§ 50.1 and 56.101 of
ative. Only the short form itself is to this chapter in which more than mini-
be signed by the subject or the rep- mal risk to children is presented by an
resentative. However, the witness shall intervention or procedure that holds

sign both the short form and a copy of out the prospect of direct benefit for
375
§ 50.53 21 CFR Ch. I (4–1–19 Edition)
the individual subject, or by a moni- § 50.54 Clinical investigations not oth-

toring procedure that is likely to con- erwise approvable that present an
tribute to the subject’s well-being, may opportunity to understand, prevent,
involve children as subjects only if the or alleviate a serious problem af-
fecting the health or welfare of chil-
IRB finds that: dren.
(a) The risk is justified by the antici-
pated benefit to the subjects; If an IRB does not believe that a clin-
ical investigation within the scope de-
(b) The relation of the anticipated
scribed in §§ 50.1 and 56.101 of this chap-
benefit to the risk is at least as favor- ter and involving children as subjects
able to the subjects as that presented meets the requirements of § 50.51,
by available alternative approaches; § 50.52, or § 50.53, the clinical investiga-
and tion may proceed only if:
(c) Adequate provisions are made for (a) The IRB finds that the clinical in-
soliciting the assent of the children vestigation presents a reasonable op-
and permission of their parents or portunity to further the under-
guardians as set forth in § 50.55. standing, prevention, or alleviation of
a serious problem affecting the health
FR 12951, Feb. 26, 2013]
or welfare of children; and
(b) The Commissioner of Food and
§ 50.53 Clinical investigations involv- Drugs, after consultation with a panel
ing greater than minimal risk and of experts in pertinent disciplines (for
no prospect of direct benefit to in- example: science, medicine, education,
dividual subjects, but likely to yield ethics, law) and following opportunity
generalizable knowledge about the for public review and comment, deter-
subjects’ disorder or condition. mines either:
Any clinical investigation within the (1) That the clinical investigation in
scope described in §§ 50.1 and 56.101 of fact satisfies the conditions of § 50.51,
§ 50.52, or § 50.53, as applicable, or
this chapter in which more than mini-
(2) That the following conditions are
mal risk to children is presented by an
met:
intervention or procedure that does not (i) The clinical investigation presents
hold out the prospect of direct benefit a reasonable opportunity to further the
for the individual subject, or by a mon- understanding, prevention, or allevi-
itoring procedure that is not likely to ation of a serious problem affecting the
contribute to the well-being of the sub- health or welfare of children;
ject, may involve children as subjects (ii) The clinical investigation will be
only if the IRB finds that: conducted in accordance with sound
(a) The risk represents a minor in- ethical principles; and
crease over minimal risk; (iii) Adequate provisions are made
(b) The intervention or procedure for soliciting the assent of children and
presents experiences to subjects that the permission of their parents or
are reasonably commensurate with guardians as set forth in § 50.55.
those inherent in their actual or ex- [66 FR 20598, Apr. 24, 2001, as amended at 78
pected medical, dental, psychological, FR 12951, Feb. 26, 2013]
social, or educational situations;
(c) The intervention or procedure is § 50.55 Requirements for permission
by parents or guardians and for as-
likely to yield generalizable knowledge sent by children.
about the subjects’ disorder or condi-
tion that is of vital importance for the (a) In addition to the determinations
understanding or amelioration of the required under other applicable sec-
subjects’ disorder or condition; and tions of this subpart D, the IRB must
determine that adequate provisions are
(d) Adequate provisions are made for
made for soliciting the assent of the
soliciting the assent of the children
children when in the judgment of the
and permission of their parents or
IRB the children are capable of pro-
guardians as set forth in § 50.55.
viding assent.
[66 FR 20598, Apr. 24, 2001, as amended at 78 (b) In determining whether children
FR 12951, Feb. 26, 2013] are capable of providing assent, the
376
IRB must take into account the ages, legal responsibility for the care and
maturity, and psychological state of custody of the child.
the children involved. This judgment (f) Permission by parents or guard-
may be made for all children to be in- ians must be documented in accordance
volved in clinical investigations under with and to the extent required by
a particular protocol, or for each child, § 50.27.
as the IRB deems appropriate. (g) When the IRB determines that as-
(c) The assent of the children is not a sent is required, it must also determine
necessary condition for proceeding whether and how assent must be docu-
with the clinical investigation if the mented.
IRB determines:
(1) That the capability of some or all
FR 12951, Feb. 26, 2013]
of the children is so limited that they
cannot reasonably be consulted, or § 50.56 Wards.
(2) That the intervention or proce-
dure involved in the clinical investiga- (a) Children who are wards of the
tion holds out a prospect of direct ben- State or any other agency, institution,
efit that is important to the health or or entity can be included in clinical in-
well-being of the children and is avail- vestigations approved under § 50.53 or
able only in the context of the clinical § 50.54 only if such clinical investiga-
investigation. tions are:
(d) Even where the IRB determines (1) Related to their status as wards;
that the subjects are capable of assent- or
ing, the IRB may still waive the assent (2) Conducted in schools, camps, hos-
requirement if it finds and documents pitals, institutions, or similar settings
that: in which the majority of children in-
(1) The clinical investigation involved as subjects are not wards.
volves no more than minimal risk to (b) If the clinical investigation is ap-
the subjects; proved under paragraph (a) of this sec-
(2) The waiver will not adversely af- tion, the IRB must require appoint-
fect the rights and welfare of the sub- ment of an advocate for each child who
jects; is a ward.
(3) The clinical investigation could (1) The advocate will serve in addi-
not practicably be carried out without tion to any other individual acting on
the waiver; and behalf of the child as guardian or in
(4) Whenever appropriate, the sub- loco parentis.
jects will be provided with additional (2) One individual may serve as advo-
pertinent information after participa- cate for more than one child.
tion. (3) The advocate must be an indi-
(e) In addition to the determinations vidual who has the background and ex-
required under other applicable sec- perience to act in, and agrees to act in,
tions of this subpart D, the IRB must the best interest of the child for the
determine, in accordance with and to duration of the child’s participation in
the extent that consent is required the clinical investigation.
under part 50, that the permission of (4) The advocate must not be associ-
each child’s parents or guardian is ated in any way (except in the role as
granted. advocate or member of the IRB) with
(1) Where parental permission is to be the clinical investigation, the investi-
obtained, the IRB may find that the gator(s), or the guardian organization.
permission of one parent is sufficient
for clinical investigations to be con- PART 54—FINANCIAL DISCLOSURE
ducted under § 50.51 or § 50.52. BY CLINICAL INVESTIGATORS
(2) Where clinical investigations are
covered by § 50.53 or § 50.54 and permis- Sec.
sion is to be obtained from parents, 54.1 Purpose.
both parents must give their permis- 54.2 Definitions.
sion unless one parent is deceased, un-
54.3 Scope.
known, incompetent, or not reasonably 54.4 Certification and disclosure require-
available, or when only one parent has ments.
377
§ 54.1 21 CFR Ch. I (4–1–19 Edition)
54.5 Agency evaluation of financial inter- outcome, such as compensation that is
ests. explicitly greater for a favorable result
54.6 Recordkeeping and record retention. or compensation to the investigator in
AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 353, the form of an equity interest in the
355, 360, 360c–360j, 371, 372, 373, 374, 375, 376, sponsor of a covered study or in the
379; 42 U.S.C. 262. form of compensation tied to sales of
SOURCE: 63 FR 5250, Feb. 2, 1998, unless oth- the product, such as a royalty interest.
erwise noted. (b) Significant equity interest in the
sponsor of a covered study means any
§ 54.1 Purpose. ownership interest, stock options, or
(a) The Food and Drug Administra- other financial interest whose value
tion (FDA) evaluates clinical studies cannot be readily determined through
submitted in marketing applications, reference to public prices (generally,
required by law, for new human drugs interests in a nonpublicly traded cor-
and biological products and marketing poration), or any equity interest in a
applications and reclassification peti- publicly traded corporation that ex-
tions for medical devices. ceeds $50,000 during the time the clin-
(b) The agency reviews data gen- ical investigator is carrying out the
erated in these clinical studies to de- study and for 1 year following comple-
termine whether the applications are tion of the study.
approvable under the statutory re- (c) Proprietary interest in the tested
quirements. FDA may consider clinical product means property or other finan-
studies inadequate and the data inad- cial interest in the product including,
equate if, among other things, appro- but not limited to, a patent, trade-
priate steps have not been taken in the mark, copyright or licensing agree-
design, conduct, reporting, and anal- ment.
ysis of the studies to minimize bias. (d) Clinical investigator means only a
One potential source of bias in clinical listed or identified investigator or sub-
studies is a financial interest of the investigator who is directly involved in
clinical investigator in the outcome of the treatment or evaluation of re-
the study because of the way payment search subjects. The term also includes
is arranged (e.g., a royalty) or because the spouse and each dependent child of
the investigator has a proprietary in- the investigator.
terest in the product (e.g., a patent) or (e) Covered clinical study means any
because the investigator has an equity study of a drug or device in humans
interest in the sponsor of the covered submitted in a marketing application
study. This section and conforming or reclassification petition subject to
regulations require an applicant whose this part that the applicant or FDA re-
submission relies in part on clinical lies on to establish that the product is
data to disclose certain financial ar- effective (including studies that show
rangements between sponsor(s) of the equivalence to an effective product) or
covered studies and the clinical inves- any study in which a single investi-
tigators and certain interests of the gator makes a significant contribution
clinical investigators in the product to the demonstration of safety. This
under study or in the sponsor of the would, in general, not include phase l
covered studies. FDA will use this in- tolerance studies or pharmacokinetic
formation, in conjunction with infor- studies, most clinical pharmacology
mation about the design and purpose of studies (unless they are critical to an
the study, as well as information ob- efficacy determination), large open
tained through on-site inspections, in safety studies conducted at multiple
the agency’s assessment of the reli- sites, treatment protocols, and parallel
ability of the data. track protocols. An applicant may con-
sult with FDA as to which clinical
§ 54.2 Definitions. studies constitute ‘‘covered clinical
For the purposes of this part: studies’’ for purposes of complying
(a) Compensation affected by the out- with financial disclosure requirements.
come of clinical studies means compensa- (f) Significant payments of other sorts
tion that could be higher for a favor- means payments made by the sponsor
able outcome than for an unfavorable of a covered study to the investigator
378
or the institution to support activities device exemption regulations must

of the investigator that have a mone- provide the sponsor of the study with
tary value of more than $25,000, exclu- sufficient accurate information needed
sive of the costs of conducting the clin- to allow subsequent disclosure or cer-
ical study or other clinical studies, tification. The applicant is required to
(e.g., a grant to fund ongoing research, submit for each clinical investigator
compensation in the form of equipment who participates in a covered study, ei-
or retainers for ongoing consultation ther a certification that none of the fi-
or honoraria) during the time the clin- nancial arrangements described in § 54.2
ical investigator is carrying out the exist, or disclose the nature of those
study and for 1 year following the com- arrangements to the agency. Where the
pletion of the study. applicant acts with due diligence to ob-
(g) Applicant means the party who tain the information required in this
submits a marketing application to section but is unable to do so, the ap-
FDA for approval of a drug, device, or plicant shall certify that despite the
biologic product. The applicant is re- applicant’s due diligence in attempting
sponsible for submitting the appro- to obtain the information, the appli-
priate certification and disclosure cant was unable to obtain the informa-
statements required in this part. tion and shall include the reason.
(h) Sponsor of the covered clinical study (a) The applicant (of an application
means the party supporting a par- submitted under sections 505, 506,
ticular study at the time it was carried 510(k), 513, or 515 of the Federal Food,
out. Drug, and Cosmetic Act, or section 351
[63 FR 5250, Feb. 2, 1998, as amended at 63 FR of the Public Health Service Act) that
72181, Dec. 31, 1998] relies in whole or in part on clinical
studies shall submit, for each clinical
§ 54.3 Scope. investigator who participated in a cov-
The requirements in this part apply ered clinical study, either a certifi-
to any applicant who submits a mar- cation described in paragraph (a)(1) of
keting application for a human drug, this section or a disclosure statement
biological product, or device and who described in paragraph (a)(3) of this
submits covered clinical studies. The section.
applicant is responsible for making the (1) Certification: The applicant cov-
appropriate certification or disclosure ered by this section shall submit for all
statement where the applicant either clinical investigators (as defined in
contracted with one or more clinical § 54.2(d)), to whom the certification ap-
investigators to conduct the studies or plies, a completed Form FDA 3454 at-
submitted studies conducted by others testing to the absence of financial in-
not under contract to the applicant. terests and arrangements described in
paragraph (a)(3) of this section. The
§ 54.4 Certification and disclosure re- form shall be dated and signed by the
quirements. chief financial officer or other respon-
For purposes of this part, an appli- sible corporate official or representa-
cant must submit a list of all clinical tive.
investigators who conducted covered (2) If the certification covers less
clinical studies to determine whether than all covered clinical data in the ap-
the applicant’s product meets FDA’s plication, the applicant shall include in
marketing requirements, identifying the certification a list of the studies
those clinical investigators who are covered by this certification.
full-time or part-time employees of the (3) Disclosure Statement: For any
sponsor of each covered study. The ap- clinical investigator defined in § 54.2(d)
plicant must also completely and accu- for whom the applicant does not sub-
rately disclose or certify information mit the certification described in para-
concerning the financial interests of a graph (a)(1) of this section, the appli-
clinical investigator who is not a full- cant shall submit a completed Form
time or part-time employee of the FDA 3455 disclosing completely and ac-
sponsor for each covered clinical study. curately the following:
Clinical investigators subject to inves- (i) Any financial arrangement en-

tigational new drug or investigational tered into between the sponsor of the
379
§ 54.5 21 CFR Ch. I (4–1–19 Edition)
covered study and the clinical investi- interest (including the potential in-
gator involved in the conduct of a cov- crease in the value of the interest if
ered clinical trial, whereby the value of the product is approved) and steps that
the compensation to the clinical inves- have been taken to minimize the po-
tigator for conducting the study could tential for bias.
be influenced by the outcome of the (b) Effect of study design. In assessing
study; the potential of an investigator’s finan-
(ii) Any significant payments of cial interests to bias a study, FDA will
other sorts from the sponsor of the cov- take into account the design and pur-
ered study, such as a grant to fund on- pose of the study. Study designs that
going research, compensation in the utilize such approaches as multiple in-
form of equipment, retainer for ongo- vestigators (most of whom do not have
ing consultation, or honoraria; a disclosable interest), blinding, objec-
(iii) Any proprietary interest in the tive endpoints, or measurement of
tested product held by any clinical in- endpoints by someone other than the
vestigator involved in a study; investigator may adequately protect
(iv) Any significant equity interest in against any bias created by a
the sponsor of the covered study held disclosable financial interest.
by any clinical investigator involved in (c) Agency actions to ensure reliability
any clinical study; and of data. If FDA determines that the fi-
(v) Any steps taken to minimize the nancial interests of any clinical inves-
potential for bias resulting from any of tigator raise a serious question about
the disclosed arrangements, interests, the integrity of the data, FDA will
or payments. take any action it deems necessary to
(b) The clinical investigator shall ensure the reliability of the data in-
provide to the sponsor of the covered cluding:
study sufficient accurate financial in- (1) Initiating agency audits of the
formation to allow the sponsor to sub- data derived from the clinical investi-
mit complete and accurate certifi- gator in question;
cation or disclosure statements as re- (2) Requesting that the applicant
quired in paragraph (a) of this section. submit further analyses of data, e.g., to
The investigator shall promptly update evaluate the effect of the clinical in-
this information if any relevant vestigator’s data on overall study out-
changes occur in the course of the income;
vestigation or for 1 year following com- (3) Requesting that the applicant
pletion of the study. conduct additional independent studies
(c) Refusal to file application. FDA to confirm the results of the ques-
may refuse to file any marketing appli- tioned study; and
cation described in paragraph (a) of (4) Refusing to treat the covered clin-
this section that does not contain the ical study as providing data that can
information required by this section or be the basis for an agency action.
a certification by the applicant that
the applicant has acted with due dili- § 54.6 Recordkeeping and record re-
gence to obtain the information but tention.
was unable to do so and stating the (a) Financial records of clinical inves-
reason. tigators to be retained. An applicant who
[63 FR 5250, Feb. 2, 1998; 63 FR 35134, June 29, has submitted a marketing application
1998, as amended at 64 FR 399, Jan. 5, 1999] containing covered clinical studies
shall keep on file certain information
§ 54.5 Agency evaluation of financial pertaining to the financial interests of
interests. clinical investigators who conducted
(a) Evaluation of disclosure statement. studies on which the application relies
FDA will evaluate the information dis- and who are not full or part-time em-
closed under § 54.4(a)(2) about each cov- ployees of the applicant, as follows:
ered clinical study in an application to (1) Complete records showing any fi-
determine the impact of any disclosed nancial interest or arrangement as de-
financial interests on the reliability of scribed in § 54.4(a)(3)(i) paid to such
the study. FDA may consider both the clinical investigators by the sponsor of
size and nature of a disclosed financial the covered study.
380
(2) Complete records showing signifi- 56.121 Disqualification of an IRB or an insti-

cant payments of other sorts, as de- tution.
scribed in § 54.4(a)(3)(ii), made by the 56.122 Public disclosure of information re-
sponsor of the covered clinical study to garding revocation.
the clinical investigator. 56.123 Reinstatement of an IRB or an insti-
tution.
(3) Complete records showing any fi-
56.124 Actions alternative or additional to
nancial interests held by clinical inves- disqualification.
tigators as set forth in § 54.4(a)(3)(iii)
and (a)(3)(iv). AUTHORITY: 21 U.S.C. 321, 343, 346, 346a, 348,
(b) Requirements for maintenance of 350a, 350b, 351, 352, 353, 355, 360, 360c–360f, 360h,
clinical investigators’ financial records. 360i, 360j, 360hh–360ss, 371, 379e, 381; 42 U.S.C.
216, 241, 262.
(1) For any application submitted for a
covered product, an applicant shall re- SOURCE: 46 FR 8975, Jan. 27, 1981, unless
tain records as described in paragraph otherwise noted.
(a) of this section for 2 years after the
date of approval of the application. Subpart A—General Provisions
(2) The person maintaining these
records shall, upon request from any § 56.101 Scope.
properly authorized officer or employee
(a) This part contains the general
of FDA, at reasonable times, permit
standards for the composition, oper-
such officer or employee to have access
ation, and responsibility of an Institu-
to and copy and verify these records.
tional Review Board (IRB) that reviews
clinical investigations regulated by the
PART 56—INSTITUTIONAL REVIEW Food and Drug Administration under
BOARDS sections 505(i) and 520(g) of the act, as
well as clinical investigations that sup-
Subpart A—General Provisions port applications for research or mar-
Sec.
keting permits for products regulated
56.101 Scope. by the Food and Drug Administration,
56.102 Definitions. including foods, including dietary sup-
56.103 Circumstances in which IRB review is plements, that bear a nutrient content
required. claim or a health claim, infant for-
56.104 Exemptions from IRB requirement. mulas, food and color additives, drugs
56.105 Waiver of IRB requirement. for human use, medical devices for
56.106 Registration. human use, biological products for
human use, and electronic products.
Subpart B—Organization and Personnel
Compliance with this part is intended
56.107 IRB membership. to protect the rights and welfare of
human subjects involved in such inves-
Subpart C—IRB Functions and Operations tigations.
56.108 IRB functions and operations. (b) References in this part to regu-
56.109 IRB review of research. latory sections of the Code of Federal
56.110 Expedited review procedures for cer- Regulations are to chapter I of title 21,
tain kinds of research involving no more unless otherwise noted.
than minimal risk, and for minor
changes in approved research. [46 FR 8975, Jan. 27, 1981, as amended at 64
56.111 Criteria for IRB approval of research. FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]
56.112 Review by institution.
56.113 Suspension or termination of IRB ap- § 56.102 Definitions.
proval of research. As used in this part:
56.114 Cooperative research.
(a) Act means the Federal Food,
Subpart D—Records and Reports Drug, and Cosmetic Act, as amended
(secs. 201–902, 52 Stat. 1040 et seq., as
56.115 IRB records. amended (21 U.S.C. 321–392)).
(b) Application for research or mar-
Subpart E—Administrative Actions for
keting permit includes:
Noncompliance
(1) A color additive petition, de-
56.120 Lesser administrative actions. scribed in part 71.
381
§ 56.102 21 CFR Ch. I (4–1–19 Edition)
(2) Data and information regarding a (14) Data and information regarding a
substance submitted as part of the pro- medical device for human use sub-
cedures for establishing that a submitted as part of the procedures for es-
stance is generally recognized as safe tablishing, amending, or repealing a
for a use which results or may reason- standard for such device, described in
ably be expected to result, directly or part 861.
indirectly, in its becoming a compo- (15) An application for premarket ap-
nent or otherwise affecting the charac- proval of a medical device for human
teristics of any food, described in use, described in section 515 of the act.
§ 170.35. (16) A product development protocol
(3) A food additive petition, described for a medical device for human use, de-
in part 171. scribed in section 515 of the act.
(4) Data and information regarding a (17) Data and information regarding
food additive submitted as part of the an electronic product submitted as
procedures regarding food additives part of the procedures for establishing,
permitted to be used on an interim amending, or repealing a standard for
basis pending additional study, de- such products, described in section 358
scribed in § 180.1. of the Public Health Service Act.
(5) Data and information regarding a (18) Data and information regarding
substance submitted as part of the pro- an electronic product submitted as
cedures for establishing a tolerance for part of the procedures for obtaining a
unavoidable contaminants in food and variance from any electronic product
food-packaging materials, described in performance standard, as described in
section 406 of the act. § 1010.4.
(6) An investigational new drug appli- (19) Data and information regarding
cation, described in part 312 of this an electronic product submitted as
chapter. part of the procedures for granting,
amending, or extending an exemption
(7) A new drug application, described
from a radiation safety performance
in part 314.
standard, as described in § 1010.5.
(8) Data and information regarding
(20) Data and information regarding
the bioavailability or bioequivalence of
an electronic product submitted as
drugs for human use submitted as part
part of the procedures for obtaining an
of the procedures for issuing, amend-
exemption from notification of a radi-
ing, or repealing a bioequivalence re-
ation safety defect or failure of compli-
quirement, described in part 320.
ance with a radiation safety perform-
(9) Data and information regarding ance standard, described in subpart D
an over-the-counter drug for human of part 1003.
use submitted as part of the procedures (21) Data and information about a
for classifying such drugs as generally clinical study of an infant formula
recognized as safe and effective and not when submitted as part of an infant
misbranded, described in part 330. formula notification under section
(10) An application for a biologics li- 412(c) of the Federal Food, Drug, and
cense, described in part 601 of this Cosmetic Act.
chapter. (22) Data and information submitted
(11) Data and information regarding a in a petition for a nutrient content
biological product submitted as part of claim, described in § 101.69 of this chap-
the procedures for determining that liter, and for a health claim, described in
censed biological products are safe and § 101.70 of this chapter.
effective and not misbranded, as de- (23) Data and information from inves-
scribed in part 601 of this chapter. tigations involving children submitted
(12) An Application for an Investiga- in a new dietary ingredient notifica-
tional Device Exemption, described in tion, described in § 190.6 of this chapter.
part 812. (c) Clinical investigation means any
(13) Data and information regarding a experiment that involves a test article
medical device for human use sub- and one or more human subjects, and
mitted as part of the procedures for that either must meet the require-
classifying such devices, described in ments for prior submission to the Food
part 860. and Drug Administration under section
382
505(i) or 520(g) of the act, or need not comfort anticipated in the research are
meet the requirements for prior sub- not greater in and of themselves than
mission to the Food and Drug Adminis- those ordinarily encountered in daily
tration under these sections of the act, life or during the performance of rou-
but the results of which are intended to tine physical or psychological exami-
be later submitted to, or held for in- nations or tests.
spection by, the Food and Drug Admin- (j) Sponsor means a person or other
istration as part of an application for a entity that initiates a clinical inves-
research or marketing permit. The tigation, but that does not actually
term does not include experiments that conduct the investigation, i.e., the test
must meet the provisions of part 58, re- article is administered or dispensed to,
garding nonclinical laboratory studies. or used involving, a subject under the
The terms research, clinical research, immediate direction of another indi-
clinical study, study, and clinical inves- vidual. A person other than an indi-
tigation are deemed to be synonymous vidual (e.g., a corporation or agency)
for purposes of this part. that uses one or more of its own em-
(d) Emergency use means the use of a ployees to conduct an investigation
test article on a human subject in a that it has initiated is considered to be
life-threatening situation in which no a sponsor (not a sponsor-investigator),
standard acceptable treatment is avail- and the employees are considered to be
able, and in which there is not suffi- investigators.
cient time to obtain IRB approval. (k) Sponsor-investigator means an in-
(e) Human subject means an indi- dividual who both initiates and actu-
vidual who is or becomes a participant ally conducts, alone or with others, a
in research, either as a recipient of the clinical investigation, i.e., under whose
test article or as a control. A subject immediate direction the test article is
may be either a healthy individual or a administered or dispensed to, or used
patient. involving, a subject. The term does not
(f) Institution means any public or include any person other than an indi-
private entity or agency (including vidual, e.g., it does not include a cor-
Federal, State, and other agencies). poration or agency. The obligations of
The term facility as used in section a sponsor-investigator under this part
520(g) of the act is deemed to be syn- include both those of a sponsor and
onymous with the term institution for those of an investigator.
purposes of this part. (l) Test article means any drug for
(g) Institutional Review Board (IRB) human use, biological product for
means any board, committee, or other human use, medical device for human
group formally designated by an insti- use, human food additive, color addi-
tution to review, to approve the initi- tive, electronic product, or any other
ation of, and to conduct periodic re- article subject to regulation under the
view of, biomedical research involving act or under sections 351 or 354–360F of
human subjects. The primary purpose the Public Health Service Act.
of such review is to assure the protec- (m) IRB approval means the deter-
tion of the rights and welfare of the mination of the IRB that the clinical
human subjects. The term has the investigation has been reviewed and
same meaning as the phrase institu- may be conducted at an institution
tional review committee as used in sec- within the constraints set forth by the
tion 520(g) of the act. IRB and by other institutional and
(h) Investigator means an individual Federal requirements.
who actually conducts a clinical inves- [46 FR 8975, Jan. 27, 1981, as amended at 54
tigation (i.e., under whose immediate FR 9038, Mar. 3, 1989; 56 FR 28028, June 18,
direction the test article is adminis- 1991; 64 FR 399, Jan. 5, 1999; 64 FR 56448, Oct.
tered or dispensed to, or used involv- 20, 1999; 65 FR 52302, Aug. 29, 2000; 66 FR 20599,
ing, a subject) or, in the event of an in- Apr. 24, 2001; 74 FR 2368, Jan. 15, 2009]
vestigation conducted by a team of in-
dividuals, is the responsible leader of § 56.103 Circumstances in which IRB
that team. review is required.
(i) Minimal risk means that the prob- (a) Except as provided in §§ 56.104 and
ability and magnitude of harm or dis- 56.105, any clinical investigation which
383
§ 56.104 21 CFR Ch. I (4–1–19 Edition)
must meet the requirements for prior (d) Taste and food quality evalua-
submission (as required in parts 312, tions and consumer acceptance studies,
812, and 813) to the Food and Drug Ad- if wholesome foods without additives
ministration shall not be initiated un- are consumed or if a food is consumed
less that investigation has been re- that contains a food ingredient at or
viewed and approved by, and remains below the level and for a use found to
subject to continuing review by, an be safe, or agricultural, chemical, or
IRB meeting the requirements of this environmental contaminant at or
part. below the level found to be safe, by the
(b) Except as provided in §§ 56.104 and Food and Drug Administration or ap-
56.105, the Food and Drug Administra- proved by the Environmental Protec-
tion may decide not to consider in sup- tion Agency or the Food Safety and In-
port of an application for a research or spection Service of the U.S. Depart-
marketing permit any data or informa- ment of Agriculture.
tion that has been derived from a clin-
ical investigation that has not been ap- [46 FR 8975, Jan. 27, 1981, as amended at 56
FR 28028, June 18, 1991]
proved by, and that was not subject to
initial and continuing review by, an § 56.105 Waiver of IRB requirement.
IRB meeting the requirements of this
part. The determination that a clinical On the application of a sponsor or
investigation may not be considered in sponsor-investigator, the Food and
support of an application for a research Drug Administration may waive any of
or marketing permit does not, how- the requirements contained in these
ever, relieve the applicant for such a regulations, including the require-
permit of any obligation under any ments for IRB review, for specific re-
other applicable regulations to submit search activities or for classes of re-
the results of the investigation to the search activities, otherwise covered by
Food and Drug Administration. these regulations.
(c) Compliance with these regula-
tions will in no way render inapplicable Subpart B—Organization and
pertinent Federal, State, or local laws Personnel
or regulations.
§ 56.106 Registration.
[46 FR 8975, Jan. 27, 1981; 46 FR 14340, Feb. 27,
1981] (a) Who must register? Each IRB in the
United States that reviews clinical in-
§ 56.104 Exemptions from IRB require- vestigations regulated by FDA under
ment. sections 505(i) or 520(g) of the act and
The following categories of clinical each IRB in the United States that re-
investigations are exempt from the reviews clinical investigations that are
quirements of this part for IRB review: intended to support applications for re-
(a) Any investigation which com- search or marketing permits for FDA-
menced before July 27, 1981 and was regulated products must register at a
subject to requirements for IRB review site maintained by the Department of
under FDA regulations before that Health and Human Services (HHS). (A
date, provided that the investigation research permit under section 505(i) of
remains subject to review of an IRB the act is usually known as an inves-
which meets the FDA requirements in tigational new drug application (IND),
effect before July 27, 1981. while a research permit under section
(b) Any investigation commenced be- 520(g) of the act is usually known as an
fore July 27, 1981 and was not otherwise investigational device exemption
subject to requirements for IRB review (IDE).) An individual authorized to act
under Food and Drug Administration on the IRB’s behalf must submit the
regulations before that date. registration information. All other
(c) Emergency use of a test article, IRBs may register voluntarily.
provided that such emergency use is re- (b) What information must an IRB reg-
ported to the IRB within 5 working ister? Each IRB must provide the fol-
days. Any subsequent use of the test lowing information:
article at the institution is subject to (1) The name, mailing address, and
IRB review. street address (if different from the
384
mailing address) of the institution op- that information within 90 days of the
erating the IRB and the name, mailing change. An IRB’s decision to review
address, phone number, facsimile num- new types of FDA-regulated products
ber, and electronic mail address of the (such as a decision to review studies
senior officer of that institution who is pertaining to food additives whereas
responsible for overseeing activities the IRB previously reviewed studies
performed by the IRB; pertaining to drug products), or to dis-
(2) The IRB’s name, mailing address, continue reviewing clinical investiga-
street address (if different from the tions regulated by FDA is a change
mailing address), phone number, fac- that must be reported within 30 days of
simile number, and electronic mail ad- the change. An IRB’s decision to dis-
dress; each IRB chairperson’s name, band is a change that must be reported
phone number, and electronic mail ad- within 30 days of permanent cessation
dress; and the name, mailing address, of the IRB’s review of research. All
phone number, facsimile number, and other information changes may be re-
electronic mail address of the contact ported when the IRB renews its reg-
person providing the registration infor- istration. The revised information
mation. must be sent to FDA either electroni-
(3) The approximate number of active cally or in writing in accordance with
protocols involving FDA-regulated paragraph (d) of this section.
products reviewed. For purposes of this [74 FR 2368, Jan. 15, 2009, as amended at 78
rule, an ‘‘active protocol’’ is any pro- FR 16401, Mar. 15, 2013]
tocol for which an IRB conducted an
initial review or a continuing review at § 56.107 IRB membership.
a convened meeting or under an expe- (a) Each IRB shall have at least five
dited review procedure during the pre- members, with varying backgrounds to
ceding 12 months; and promote complete and adequate review
(4) A description of the types of FDA- of research activities commonly con-
regulated products (such as biological ducted by the institution. The IRB
products, color additives, food addi- shall be sufficiently qualified through
tives, human drugs, or medical devices) the experience and expertise of its
involved in the protocols that the IRB members, and the diversity of the
reviews. members, including consideration of
(c) When must an IRB register? Each race, gender, cultural backgrounds, and
IRB must submit an initial registra- sensitivity to such issues as commu-
tion. The initial registration must nity attitudes, to promote respect for
occur before the IRB begins to review a its advice and counsel in safeguarding
clinical investigation described in the rights and welfare of human sub-
paragraph (a) of this section. Each IRB jects. In addition to possessing the pro-
must renew its registration every 3 fessional competence necessary to re-
years. IRB registration becomes effec- view the specific research activities,
tive after review and acceptance by the IRB shall be able to ascertain the
HHS. acceptability of proposed research in
(d) Where can an IRB register? Each terms of institutional commitments
IRB may register electronically and regulations, applicable law, and
through http://ohrp.cit.nih.gov/efile. If an standards of professional conduct and
IRB lacks the ability to register elec- practice. * * * The IRB shall therefore
tronically, it must send its registration include persons knowledgeable in these
information, in writing, to the Office of areas. If an IRB regularly reviews re-
Good Clinical Practice, Office of Spe- search that involves a vulnerable cat-
cial Medical Programs, Food and Drug egory of subjects, such as children,
Administration, 10903 New Hampshire prisoners, pregnant women, or handi-
Ave., Bldg. 32, Rm. 5129, Silver Spring, capped or mentally disabled persons,
MD 20993. consideration shall be given to the in-
(e) How does an IRB revise its registra- clusion of one or more individuals who
tion information? If an IRB’s contact or are knowledgeable about and experi-
chair person information changes, the enced in working with those subjects.
IRB must revise its registration infor- (b) Every nondiscriminatory effort
mation by submitting any changes in will be made to ensure that no IRB
385
§ 56.108 21 CFR Ch. I (4–1–19 Edition)
consists entirely of men or entirely of nate apparent immediate hazards to

women, including the instituton’s con- the human subjects.
sideration of qualified persons of both (b) Follow written procedures for en-
sexes, so long as no selection is made suring prompt reporting to the IRB,
to the IRB on the basis of gender. No appropriate institutional officials, and
IRB may consist entirely of members the Food and Drug Administration of:
of one profession. (1) Any unanticipated problems involv-
(c) Each IRB shall include at least ing risks to human subjects or others;
one member whose primary concerns (2) any instance of serious or con-
are in the scientific area and at least tinuing noncompliance with these reg-
one member whose primary concerns ulations or the requirements or deter-
are in nonscientific areas. minations of the IRB; or (3) any sus-
(d) Each IRB shall include at least pension or termination of IRB ap-
one member who is not otherwise affili- proval.
ated with the institution and who is (c) Except when an expedited review
not part of the immediate family of a procedure is used (see § 56.110), review
person who is affiliated with the insti- proposed research at convened meet-
tution. ings at which a majority of the mem-
(e) No IRB may have a member par- bers of the IRB are present, including
ticipate in the IRB’s initial or con- at least one member whose primary
tinuing review of any project in which concerns are in nonscientific areas. In
the member has a conflicting interest, order for the research to be approved,
except to provide information re- it shall receive the approval of a ma-
quested by the IRB. jority of those members present at the
(f) An IRB may, in its discretion, in- meeting.
vite individuals with competence in
special areas to assist in the review of
FR 28028, June 18, 1991; 67 FR 9585, Mar. 4,
complex issues which require expertise 2002]
beyond or in addition to that available
on the IRB. These individuals may not § 56.109 IRB review of research.
vote with the IRB. (a) An IRB shall review and have au-
[46 FR 8975, Jan. 27, 1981, as amended at 56 thority to approve, require modifica-
FR 28028, June 18, 1991; 56 FR 29756, June 28, tions in (to secure approval), or dis-
1991; 78 FR 16401, Mar. 15, 2013] approve all research activities covered
by these regulations.
Subpart C—IRB Functions and (b) An IRB shall require that infor-
Operations mation given to subjects as part of in-
formed consent is in accordance with
§ 56.108 IRB functions and operations. § 50.25. The IRB may require that infor-
In order to fulfill the requirements of mation, in addition to that specifically
these regulations, each IRB shall: mentioned in § 50.25, be given to the
(a) Follow written procedures: (1) For subjects when in the IRB’s judgment
conducting its initial and continuing the information would meaningfully
review of research and for reporting its add to the protection of the rights and
findings and actions to the investigator welfare of subjects.
and the institution; (2) for determining (c) An IRB shall require documenta-
which projects require review more tion of informed consent in accordance
often than annually and which projects with § 50.27 of this chapter, except as
need verification from sources other follows:
than the investigator that no material (1) The IRB may, for some or all sub-
changes have occurred since previous jects, waive the requirement that the
IRB review; (3) for ensuring prompt re- subject, or the subject’s legally author-
porting to the IRB of changes in re- ized representative, sign a written con-
search activity; and (4) for ensuring sent form if it finds that the research
that changes in approved research, dur- presents no more than minimal risk of
ing the period for which IRB approval harm to subjects and involves no proce-
has already been given, may not be ini- dures for which written consent is nor-
tiated without IRB review and ap- mally required outside the research
proval except where necessary to elimi- context; or
386
(2) The IRB may, for some or all sub- compliance with part 50, subpart D of
jects, find that the requirements in this chapter, at the time of its initial
§ 50.24 of this chapter for an exception review of the research. When some or
from informed consent for emergency all of the subjects in a study that was
research are met. ongoing on April 30, 2001, are children,
(d) In cases where the documentation an IRB must conduct a review of the
requirement is waived under paragraph research to determine compliance with
(c)(1) of this section, the IRB may re- part 50, subpart D of this chapter, ei-
quire the investigator to provide sub- ther at the time of continuing review
jects with a written statement regard- or, at the discretion of the IRB, at an
ing the research. earlier date.
(e) An IRB shall notify investigators
and the institution in writing of its de- FR 51529, Oct. 2, 1996; 66 FR 20599, Apr. 24,
cision to approve or disapprove the pro- 2001; 78 FR 12951, Feb. 26, 2013]
posed research activity, or of modifica-
tions required to secure IRB approval § 56.110 Expedited review procedures
of the research activity. If the IRB de- for certain kinds of research involv-
cides to disapprove a research activity, ing no more than minimal risk, and
it shall include in its written notifica- for minor changes in approved re-
tion a statement of the reasons for its search.
decision and give the investigator an (a) The Food and Drug Administra-
opportunity to respond in person or in tion has established, and published in
writing. For investigations involving the FEDERAL REGISTER, a list of cat-
an exception to informed consent under egories of research that may be re-
§ 50.24 of this chapter, an IRB shall viewed by the IRB through an expe-
promptly notify in writing the investi- dited review procedure. The list will be
gator and the sponsor of the research amended, as appropriate, through peri-
when an IRB determines that it cannot odic republication in the FEDERAL REG-
approve the research because it does ISTER.
not meet the criteria in the exception (b) An IRB may use the expedited re-
provided under § 50.24(a) of this chapter view procedure to review either or both
or because of other relevant ethical of the following: (1) Some or all of the
concerns. The written notification research appearing on the list and
shall include a statement of the rea- found by the reviewer(s) to involve no
sons for the IRB’s determination. more than minimal risk, (2) minor
(f) An IRB shall conduct continuing changes in previously approved re-
review of research covered by these search during the period (of 1 year or
regulations at intervals appropriate to less) for which approval is authorized.
the degree of risk, but not less than Under an expedited review procedure,
once per year, and shall have authority the review may be carried out by the
to observe or have a third party ob- IRB chairperson or by one or more ex-
serve the consent process and the re- perienced reviewers designated by the
search. IRB chairperson from among the mem-
(g) An IRB shall provide in writing to bers of the IRB. In reviewing the re-
the sponsor of research involving an search, the reviewers may exercise all
exception to informed consent under of the authorities of the IRB except
§ 50.24 of this chapter a copy of infor- that the reviewers may not disapprove
mation that has been publicly disclosed the research. A research activity may
under § 50.24(a)(7)(ii) and (a)(7)(iii) of be disapproved only after review in ac-
this chapter. The IRB shall provide cordance with the nonexpedited review
this information to the sponsor procedure set forth in § 56.108(c).
promptly so that the sponsor is aware (c) Each IRB which uses an expedited
that such disclosure has occurred. review procedure shall adopt a method
Upon receipt, the sponsor shall provide for keeping all members advised of re-
copies of the information disclosed to search proposals which have been ap-
FDA. proved under the procedure.
(h) When some or all of the subjects (d) The Food and Drug Administra-
in a study are children, an IRB must tion may restrict, suspend, or termi-
determine that the research study is in nate an institution’s or IRB’s use of
387
§ 56.111 21 CFR Ch. I (4–1–19 Edition)
the expedited review procedure when (6) Where appropriate, the research
necessary to protect the rights or wel- plan makes adequate provision for
fare of subjects. monitoring the data collected to en-
sure the safety of subjects.
FR 28029, June 18, 1991] (7) Where appropriate, there are ade-
quate provisions to protect the privacy
§ 56.111 Criteria for IRB approval of of subjects and to maintain the con-
research. fidentiality of data.
(a) In order to approve research cov- (b) When some or all of the subjects,
ered by these regulations the IRB shall such as children, prisoners, pregnant
determine that all of the following re- women, handicapped, or mentally dis-
quirements are satisfied: abled persons, or economically or edu-
(1) Risks to subjects are minimized: cationally disadvantaged persons, are
(i) By using procedures which are con- likely to be vulnerable to coercion or
sistent with sound research design and undue influence additional safeguards
which do not unnecessarily expose sub- have been included in the study to pro-
jects to risk, and (ii) whenever appro- tect the rights and welfare of these
priate, by using procedures already subjects.
being performed on the subjects for di- (c) In order to approve research in
agnostic or treatment purposes. which some or all of the subjects are
(2) Risks to subjects are reasonable children, an IRB must determine that
in relation to anticipated benefits, if all research is in compliance with part
any, to subjects, and the importance of 50, subpart D of this chapter.
the knowledge that may be expected to
result. In evaluating risks and benefits,
FR 28029, June 18, 1991; 66 FR 20599, Apr. 24,
the IRB should consider only those 2001]
risks and benefits that may result from
the research (as distinguished from § 56.112 Review by institution.
risks and benefits of therapies that
subjects would receive even if not par- Research covered by these regula-
ticipating in the research). The IRB tions that has been approved by an IRB
should not consider possible long-range may be subject to further appropriate
effects of applying knowledge gained in review and approval or disapproval by
the research (for example, the possible officials of the institution. However,
effects of the research on public policy) those officials may not approve the re-
as among those research risks that fall search if it has not been approved by
within the purview of its responsi- an IRB.
bility. § 56.113 Suspension or termination of
(3) Selection of subjects is equitable. IRB approval of research.
In making this assessment the IRB
should take into account the purposes An IRB shall have authority to sus-
of the research and the setting in pend or terminate approval of research
which the research will be conducted that is not being conducted in accord-
and should be particularly cognizant of ance with the IRB’s requirements or
the special problems of research in- that has been associated with unex-
volving vulnerable populations, such as pected serious harm to subjects. Any
children, prisoners, pregnant women, suspension or termination of approval
handicapped, or mentally disabled per- shall include a statement of the rea-
sons, or economically or educationally sons for the IRB’s action and shall be
disadvantaged persons. reported promptly to the investigator,
(4) Informed consent will be sought appropriate institutional officials, and
from each prospective subject or the the Food and Drug Administration.
subject’s legally authorized representa-
tive, in accordance with and to the ex- § 56.114 Cooperative research.
tent required by part 50. In complying with these regulations,
(5) Informed consent will be appro- institutions involved in multi-institu-
priately documented, in accordance tional studies may use joint review, re-
with and to the extent required by liance upon the review of another
§ 50.27. qualified IRB, or similar arrangements
388
aimed at avoidance of duplication of ef- investigation in support of an applica-

fort. tion for a research or marketing per-
mit if the institution or the IRB that
Subpart D—Records and Reports reviewed the investigation refuses to
allow an inspection under this section.
§ 56.115 IRB records.
(a) An institution, or where appro- FR 28029, June 18, 1991; 67 FR 9585, Mar. 4,
priate an IRB, shall prepare and main- 2002]
tain adequate documentation of IRB
activities, including the following:
(1) Copies of all research proposals re-
Subpart E—Administrative Actions
viewed, scientific evaluations, if any, for Noncompliance
that accompany the proposals, ap-
§ 56.120 Lesser administrative actions.
proved sample consent documents,
progress reports submitted by inves- (a) If apparent noncompliance with
tigators, and reports of injuries to sub- these regulations in the operation of an
jects. IRB is observed by an FDA investi-
(2) Minutes of IRB meetings which gator during an inspection, the inspec-
shall be in sufficient detail to show attor will present an oral or written sum-
tendance at the meetings; actions mary of observations to an appropriate
taken by the IRB; the vote on these ac- representative of the IRB. The Food
tions including the number of members and Drug Administration may subse-
voting for, against, and abstaining; the quently send a letter describing the
basis for requiring changes in or dis- noncompliance to the IRB and to the
approving research; and a written sum- parent institution. The agency will re-
mary of the discussion of controverted quire that the IRB or the parent insti-
issues and their resolution. tution respond to this letter within a
(3) Records of continuing review ac- time period specified by FDA and de-
tivities. scribe the corrective actions that will
(4) Copies of all correspondence be- be taken by the IRB, the institution, or
tween the IRB and the investigators. both to achieve compliance with these
(5) A list of IRB members identified regulations.
by name; earned degrees; representa- (b) On the basis of the IRB’s or the
tive capacity; indications of experience institution’s response, FDA may sched-
such as board certifications, licenses, ule a reinspection to confirm the ade-
etc., sufficient to describe each mem- quacy of corrective actions. In addi-
ber’s chief anticipated contributions to tion, until the IRB or the parent insti-
IRB deliberations; and any employ- tution takes appropriate corrective ac-
ment or other relationship between tion, the Agency may require the IRB
each member and the institution; for to:
example: full-time employee, part-time
(1) Withhold approval of new studies
employee, a member of governing panel
subject to the requirements of this part
or board, stockholder, paid or unpaid
that are conducted at the institution
consultant.
or reviewed by the IRB;
(6) Written procedures for the IRB as
required by § 56.108 (a) and (b). (2) Direct that no new subjects be
(7) Statements of significant new added to ongoing studies subject to
findings provided to subjects, as re- this part; or
quired by § 50.25. (3) Terminate ongoing studies subject
(b) The records required by this regu- to this part when doing so would not
lation shall be retained for at least 3 endanger the subjects.
years after completion of the research, (c) When the apparent noncompliance
and the records shall be accessible for creates a significant threat to the
inspection and copying by authorized rights and welfare of human subjects,
representatives of the Food and Drug FDA may notify relevant State and
Administration at reasonable times Federal regulatory agencies and other
and in a reasonable manner. parties with a direct interest in the
(c) The Food and Drug Administra- Agency’s action of the deficiencies in
tion may refuse to consider a clinical the operation of the IRB.
389
§ 56.121 21 CFR Ch. I (4–1–19 Edition)
(d) The parent institution is pre- (d) The Food and Drug Administra-
sumed to be responsible for the oper- tion will not approve an application for
ation of an IRB, and the Food and Drug a research permit for a clinical inves-
Administration will ordinarily direct tigation that is to be under the review
any administrative action under this of a disqualified IRB or that is to be
subpart against the institution. How- conducted at a disqualified institution,
ever, depending on the evidence of re- and it may refuse to consider in sup-
sponsibility for deficiencies, deter- port of a marketing permit the data
mined during the investigation, the from a clinical investigation that was
Food and Drug Administration may re- reviewed by a disqualified IRB as con-
strict its administrative actions to the ducted at a disqualified institution, un-
IRB or to a component of the parent less the IRB or the parent institution
institution determined to be respon- is reinstated as provided in § 56.123.
sible for formal designation of the IRB.
[46 FR 8975, Jan. 27, 1981, as amended at 81 § 56.122 Public disclosure of informa-
FR 19035, Apr. 4, 2016] tion regarding revocation.
A determination that the Food and
§ 56.121 Disqualification of an IRB or Drug Administration has disqualified
an institution.
an institution and the administrative
(a) Whenever the IRB or the institu- record regarding that determination
tion has failed to take adequate steps are disclosable to the public under part
to correct the noncompliance stated in 20.
the letter sent by the agency under
§ 56.120(a), and the Commissioner of § 56.123 Reinstatement of an IRB or an
Food and Drugs determines that this institution.
noncompliance may justify the dis- An IRB or an institution may be re-
qualification of the IRB or of the par- instated if the Commissioner deter-
ent institution, the Commissioner will mines, upon an evaluation of a written
institute proceedings in accordance
submission from the IRB or institution
with the requirements for a regulatory
that explains the corrective action
hearing set forth in part 16.
that the institution or IRB plans to
(b) The Commissioner may disqualify
take, that the IRB or institution has
an IRB or the parent institution if the
provided adequate assurance that it
Commissioner determines that:
will operate in compliance with the
(1) The IRB has refused or repeatedly
standards set forth in this part. Notifi-
failed to comply with any of the regu-
cation of reinstatement shall be pro-
lations set forth in this part, and
vided to all persons notified under
(2) The noncompliance adversely af-
§ 56.121(c).
fects the rights or welfare of the
human subjects in a clinical investiga- § 56.124 Actions alternative or addi-
tion. tional to disqualification.
(c) If the Commissioner determines
that disqualification is appropriate, Disqualification of an IRB or of an
the Commissioner will issue an order institution is independent of, and nei-
that explains the basis for the deter- ther in lieu of nor a precondition to,
mination and that prescribes any ac- other proceedings or actions authorized
tions to be taken with regard to ongo- by the act. The Food and Drug Admin-
ing clinical research conducted under istration may, at any time, through
the review of the IRB. The Food and the Department of Justice institute
Drug Administration will send notice any appropriate judicial proceedings
of the disqualification to the IRB and (civil or criminal) and any other appro-
the parent institution. Other parties priate regulatory action, in addition to
with a direct interest, such as sponsors or in lieu of, and before, at the time of,
and clinical investigators, may also be or after, disqualification. The agency
sent a notice of the disqualification. In may also refer pertinent matters to an-
addition, the agency may elect to pub- other Federal, State, or local govern-
lish a notice of its action in the FED- ment agency for any action that that
ERAL REGISTER. agency determines to be appropriate.
390
PART 58—GOOD LABORATORY Subpart K—Disqualification of Testing

PRACTICE FOR NONCLINICAL Facilities
LABORATORY STUDIES 58.200 Purpose.
58.202 Grounds for disqualification.
Subpart A—General Provisions 58.204 Notice of and opportunity for hearing
on proposed disqualification.
Sec. 58.206 Final order on disqualification.
58.1 Scope. 58.210 Actions upon disqualification.
58.3 Definitions. 58.213 Public disclosure of information re-
58.10 Applicability to studies performed garding disqualification.
under grants and contracts. 58.215 Alternative or additional actions to
58.15 Inspection of a testing facility. disqualification.
58.217 Suspension or termination of a test-
Subpart B—Organization and Personnel ing facility by a sponsor.
58.219 Reinstatement of a disqualified test-
58.29 Personnel. ing facility.
58.31 Testing facility management. AUTHORITY: 21 U.S.C. 342, 346, 346a, 348, 351,
58.33 Study director. 352, 353, 355, 360, 360b–360f, 360h–360j, 371, 379e,
58.35 Quality assurance unit. 381; 42 U.S.C. 216, 262, 263b–263n.
SOURCE: 43 FR 60013, Dec. 22, 1978, unless
Subpart C—Facilities otherwise noted.
58.41 General.
58.43 Animal care facilities. Subpart A—General Provisions
58.45 Animal supply facilities.
58.47 Facilities for handling test and con- § 58.1 Scope.
trol articles. (a) This part prescribes good labora-
58.49 Laboratory operation areas.
tory practices for conducting nonclin-
58.51 Specimen and data storage facilities.
ical laboratory studies that support or
Subpart D—Equipment are intended to support applications
for research or marketing permits for
58.61 Equipment design. products regulated by the Food and
58.63 Maintenance and calibration of equip- Drug Administration, including food
ment. and color additives, animal food addi-
tives, human and animal drugs, med-
Subpart E—Testing Facilities Operation ical devices for human use, biological
58.81 Standard operating procedures. products, and electronic products.
58.83 Reagents and solutions. Compliance with this part is intended
58.90 Animal care. to assure the quality and integrity of
the safety data filed pursuant to sec-
Subpart F—Test and Control Articles tions 406, 408, 409, 502, 503, 505, 506, 510,
512–516, 518–520, 721, and 801 of the Fed-
58.105 Test and control article characteriza-
tion.
eral Food, Drug, and Cosmetic Act and
58.107 Test and control article handling. sections 351 and 354–360F of the Public
58.113 Mixture of articles with carriers. Health Service Act.
(b) References in this part to regu-
Subpart G—Protocol for and Conduct of a latory sections of the Code of Federal
Nonclinical Laboratory Study Regulations are to chapter I of title 21,
unless otherwise noted.
58.120 Protocol.
58.130 Conduct of a nonclinical laboratory [43 FR 60013, Dec. 22, 1978, as amended at 52
study. FR 33779, Sept. 4, 1987; 64 FR 399, Jan. 5, 1999]
Subparts H–I [Reserved] § 58.3 Definitions.

As used in this part, the following
Subpart J—Records and Reports terms shall have the meanings speci-
58.185 Reporting of nonclinical laboratory fied:
study results. (a) Act means the Federal Food,
Drug, and Cosmetic Act, as amended
58.190 Storage and retrieval of records and

data. (secs. 201–902, 52 Stat. 1040 et seq., as
58.195 Retention of records. amended (21 U.S.C. 321–392)).
391
§ 58.3 21 CFR Ch. I (4–1–19 Edition)
(b) Test article means any food addi- (7) Data and information regarding
tive, color additive, drug, biological an over-the-counter drug for human
product, electronic product, medical use, submitted as part of the proce-
device for human use, or any other ar- dures for classifying such drugs as gen-
ticle subject to regulation under the erally recognized as safe and effective
act or under sections 351 and 354–360F and not misbranded, described in part
of the Public Health Service Act. 330.
(c) Control article means any food ad- (8) Data and information about a sub-
ditive, color additive, drug, biological stance submitted as part of the proce-
product, electronic product, medical dures for establishing a tolerance for
device for human use, or any article unavoidable contaminants in food and
other than a test article, feed, or water food-packaging materials, described in
that is administered to the test system parts 109 and 509.
in the course of a nonclinical labora- (9) [Reserved]
tory study for the purpose of estab- (10) A Notice of Claimed Investigational
lishing a basis for comparison with the Exemption for a New Animal Drug, de-
test article. scribed in part 511.
(d) Nonclinical laboratory study means (11) A new animal drug application, de-
in vivo or in vitro experiments in scribed in part 514.
which test articles are studied prospec- (12) [Reserved]
tively in test systems under laboratory (13) An application for a biologics li-
conditions to determine their safety. cense, described in part 601 of this chap-
The term does not include studies uti- ter.
lizing human subjects or clinical stud- (14) An application for an investiga-
ies or field trials in animals. The term tional device exemption, described in
does not include basic exploratory part 812.
studies carried out to determine (15) An Application for Premarket Ap-
whether a test article has any poten- proval of a Medical Device, described in
tial utility or to determine physical or section 515 of the act.
chemical characteristics of a test arti- (16) A Product Development Protocol for
cle. a Medical Device, described in section
515 of the act.
(e) Application for research or mar-
(17) Data and information regarding a
keting permit includes:
medical device submitted as part of the
(1) A color additive petition, de- procedures for classifying such devices,
scribed in part 71. described in part 860.
(2) A food additive petition, described (18) Data and information regarding a
in parts 171 and 571. medical device submitted as part of the
(3) Data and information regarding a procedures for establishing, amending,
substance submitted as part of the pro- or repealing a performance standard
cedures for establishing that a sub- for such devices, described in part 861.
stance is generally recognized as safe (19) Data and information regarding
for use, which use results or may rea- an electronic product submitted as
sonably be expected to result, directly part of the procedures for obtaining an
or indirectly, in its becoming a compo- exemption from notification of a radi-
nent or otherwise affecting the charac- ation safety defect or failure of compli-
teristics of any food, described in ance with a radiation safety perform-
§§ 170.35 and 570.35. ance standard, described in subpart D
(4) Data and information regarding a of part 1003.
food additive submitted as part of the (20) Data and information regarding
procedures regarding food additives an electronic product submitted as
permitted to be used on an interim part of the procedures for establishing,
basis pending additional study, de- amending, or repealing a standard for
scribed in § 180.1. such product, described in section 358
(5) An investigational new drug appli- of the Public Health Service Act.
cation, described in part 312 of this (21) Data and information regarding
chapter. an electronic product submitted as
(6) A new drug application, described part of the procedures for obtaining a
in part 314. variance from any electronic product
392
performance standard as described in study and are necessary for the recon-
§ 1010.4. struction and evaluation of the report
(22) Data and information regarding of that study. In the event that exact
an electronic product submitted as transcripts of raw data have been pre-
part of the procedures for granting, pared (e.g., tapes which have been tran-
amending, or extending an exemption scribed verbatim, dated, and verified
from any electronic product perform- accurate by signature), the exact copy
ance standard, as described in § 1010.5. or exact transcript may be substituted
(23) A premarket notification for a for the original source as raw data.
food contact substance, described in Raw data may include photographs,
part 170, subpart D, of this chapter. microfilm or microfiche copies, com-
(f) Sponsor means: puter printouts, magnetic media, in-
(1) A person who initiates and sup- cluding dictated observations, and re-
ports, by provision of financial or other corded data from automated instru-
resources, a nonclinical laboratory ments.
study; (l) Quality assurance unit means any
(2) A person who submits a nonclin- person or organizational element, ex-
ical study to the Food and Drug Ad- cept the study director, designated by
ministration in support of an applica- testing facility management to per-
tion for a research or marketing perform the duties relating to quality as-
mit; or surance of nonclinical laboratory stud-
(3) A testing facility, if it both initi- ies.
ates and actually conducts the study. (m) Study director means the indi-
(g) Testing facility means a person vidual responsible for the overall con-
who actually conducts a nonclinical duct of a nonclinical laboratory study.
laboratory study, i.e., actually uses the (n) Batch means a specific quantity
test article in a test system. Testing fa- or lot of a test or control article that
cility includes any establishment re- has been characterized according to
quired to register under section 510 of § 58.105(a).
the act that conducts nonclinical lab- (o) Study initiation date means the
oratory studies and any consulting lab- date the protocol is signed by the study
oratory described in section 704 of the director.
act that conducts such studies. Testing (p) Study completion date means the
facility encompasses only those oper- date the final report is signed by the
ational units that are being or have study director.
been used to conduct nonclinical lab- [43 FR 60013, Dec. 22, 1978, as amended at 52
oratory studies. FR 33779, Sept. 4, 1987; 54 FR 9039, Mar. 3,
(h) Person includes an individual, 1989; 64 FR 56448, Oct. 20, 1999; 67 FR 35729,
partnership, corporation, association, May 21, 2002]
scientific or academic establishment,
government agency, or organizational § 58.10 Applicability to studies per-
unit thereof, and any other legal enti- formed under grants and contracts.
ty. When a sponsor conducting a non-
(i) Test system means any animal, clinical laboratory study intended to
plant, microorganism, or subparts be submitted to or reviewed by the
thereof to which the test or control ar- Food and Drug Administration utilizes
ticle is administered or added for the services of a consulting laboratory,
study. Test system also includes appro- contractor, or grantee to perform an
priate groups or components of the sys- analysis or other service, it shall no-
tem not treated with the test or con- tify the consulting laboratory, con-
trol articles. tractor, or grantee that the service is
(j) Specimen means any material depart of a nonclinical laboratory study
rived from a test system for examina- that must be conducted in compliance
tion or analysis. with the provisions of this part.
(k) Raw data means any laboratory
worksheets, records, memoranda, § 58.15 Inspection of a testing facility.
notes, or exact copies thereof, that are (a) A testing facility shall permit an
the result of original observations and authorized employee of the Food and
activities of a nonclinical laboratory Drug Administration, at reasonable
393
§ 58.29 21 CFR Ch. I (4–1–19 Edition)
times and in a reasonable manner, to contamination of test systems and test

inspect the facility and to inspect (and and control articles.
in the case of records also to copy) all (f) Any individual found at any time
records and specimens required to be to have an illness that may adversely
maintained regarding studies within affect the quality and integrity of the
the scope of this part. The records in- nonclinical laboratory study shall be
spection and copying requirements excluded from direct contact with test
shall not apply to quality assurance systems, test and control articles and
unit records of findings and problems, any other operation or function that
or to actions recommended and taken. may adversely affect the study until
(b) The Food and Drug Administra- the condition is corrected. All per-
tion will not consider a nonclinical lab- sonnel shall be instructed to report to
oratory study in support of an applica- their immediate supervisors any health
tion for a research or marketing per- or medical conditions that may reason-
mit if the testing facility refuses to ably be considered to have an adverse
permit inspection. The determination effect on a nonclinical laboratory
that a nonclinical laboratory study study.
will not be considered in support of an
application for a research or marketing § 58.31 Testing facility management.
permit does not, however, relieve the For each nonclinical laboratory
applicant for such a permit of any obli- study, testing facility management
gation under any applicable statute or shall:
regulation to submit the results of the (a) Designate a study director as de-
study to the Food and Drug Adminis- scribed in § 58.33, before the study is
tration. initiated.
(b) Replace the study director
Subpart B—Organization and promptly if it becomes necessary to do
Personnel so during the conduct of a study.
(c) Assure that there is a quality as-
§ 58.29 Personnel. surance unit as described in § 58.35.
(a) Each individual engaged in the (d) Assure that test and control arti-
conduct of or responsible for the super- cles or mixtures have been appro-
vision of a nonclinical laboratory study priately tested for identity, strength,
shall have education, training, and ex- purity, stability, and uniformity, as
perience, or combination thereof, to applicable.
enable that individual to perform the (e) Assure that personnel, resources,
assigned functions. facilities, equipment, materials, and
(b) Each testing facility shall main- methodologies are available as sched-
tain a current summary of training and uled.
experience and job description for each (f) Assure that personnel clearly un-
individual engaged in or supervising derstand the functions they are to per-
the conduct of a nonclinical laboratory form.
study. (g) Assure that any deviations from
(c) There shall be a sufficient number these regulations reported by the qual-
of personnel for the timely and proper ity assurance unit are communicated
conduct of the study according to the to the study director and corrective ac-
protocol. tions are taken and documented.
(d) Personnel shall take necessary [43 FR 60013, Dec. 22, 1978, as amended at 52
personal sanitation and health pre- FR 33780, Sept. 4, 1987]
cautions designed to avoid contamina-
tion of test and control articles and § 58.33 Study director.
test systems. For each nonclinical laboratory
(e) Personnel engaged in a nonclin- study, a scientist or other professional
ical laboratory study shall wear cloth- of appropriate education, training, and
ing appropriate for the duties they per- experience, or combination thereof,
form. Such clothing shall be changed shall be identified as the study direc-
as often as necessary to prevent micro- tor. The study director has overall re-
biological, radiological, or chemical sponsibility for the technical conduct
394
of the study, as well as for the inter- records of each periodic inspection
pretation, analysis, documentation and showing the date of the inspection, the
reporting of results, and represents the study inspected, the phase or segment
single point of study control. The of the study inspected, the person per-
study director shall assure that: forming the inspection, findings and
(a) The protocol, including any problems, action recommended and
change, is approved as provided by taken to resolve existing problems, and
§ 58.120 and is followed. any scheduled date for reinspection.
(b) All experimental data, including
Any problems found during the course
observations of unanticipated re-
of an inspection which are likely to af-
sponses of the test system are accu-
rately recorded and verified. fect study integrity shall be brought to
(c) Unforeseen circumstances that the attention of the study director and
may affect the quality and integrity of management immediately.
the nonclinical laboratory study are (4) Periodically submit to manage-
noted when they occur, and corrective ment and the study director written
action is taken and documented. status reports on each study, noting
(d) Test systems are as specified in any problems and the corrective ac-
the protocol. tions taken.
(e) All applicable good laboratory (5) Determine that no deviations
practice regulations are followed. from approved protocols or standard
(f) All raw data, documentation, pro- operating procedures were made with-
tocols, specimens, and final reports are out proper authorization and docu-
transferred to the archives during or at mentation.
the close of the study. (6) Review the final study report to
[43 FR 60013, Dec. 22, 1978; 44 FR 17657, Mar. assure that such report accurately de-
23, 1979] scribes the methods and standard oper-
ating procedures, and that the reported
§ 58.35 Quality assurance unit.
results accurately reflect the raw data
(a) A testing facility shall have a of the nonclinical laboratory study.
quality assurance unit which shall be (7) Prepare and sign a statement to
responsible for monitoring each study be included with the final study report
to assure management that the facili-
which shall specify the dates inspec-
ties, equipment, personnel, methods,
tions were made and findings reported
practices, records, and controls are in
conformance with the regulations in to management and to the study direc-
this part. For any given study, the tor.
quality assurance unit shall be entirely (c) The responsibilities and proce-
separate from and independent of the dures applicable to the quality assur-
personnel engaged in the direction and ance unit, the records maintained by
conduct of that study. the quality assurance unit, and the
(b) The quality assurance unit shall: method of indexing such records shall
(1) Maintain a copy of a master be in writing and shall be maintained.
schedule sheet of all nonclinical lab- These items including inspection dates,
oratory studies conducted at the test- the study inspected, the phase or seg-
ing facility indexed by test article and ment of the study inspected, and the
containing the test system, nature of name of the individual performing the
study, date study was initiated, cur- inspection shall be made available for
rent status of each study, identity of inspection to authorized employees of
the sponsor, and name of the study di- the Food and Drug Administration.
rector. (d) A designated representative of the
(2) Maintain copies of all protocols Food and Drug Administration shall
pertaining to all nonclinical laboratory
have access to the written procedures
studies for which the unit is respon-
established for the inspection and may
sible.
(3) Inspect each nonclinical labora- request testing facility management to
tory study at intervals adequate to as- certify that inspections are being im-
sure the integrity of the study and plemented, performed, documented,

maintain written and properly signed
395
§ 58.41 21 CFR Ch. I (4–1–19 Edition)
and followed-up in accordance with § 58.45 Animal supply facilities.

this paragraph.
There shall be storage areas, as need-
[43 FR 60013, Dec. 22, 1978, as amended at 52 ed, for feed, bedding, supplies, and
FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, equipment. Storage areas for feed and
2002] bedding shall be separated from areas
housing the test systems and shall be
Subpart C—Facilities protected against infestation or con-
tamination. Perishable supplies shall
§ 58.41 General. be preserved by appropriate means.
Each testing facility shall be of suit- [43 FR 60013, Dec. 22, 1978, as amended at 52
able size and construction to facilitate FR 33780, Sept. 4, 1987]
the proper conduct of nonclinical lab-
oratory studies. It shall be designed so § 58.47 Facilities for handling test and
control articles.
that there is a degree of separation
that will prevent any function or activ- (a) As necessary to prevent contami-
ity from having an adverse effect on nation or mixups, there shall be sepa-
the study. rate areas for:
(1) Receipt and storage of the test
[52 FR 33780, Sept. 4, 1987] and control articles.
(2) Mixing of the test and control ar-
§ 58.43 Animal care facilities.
ticles with a carrier, e.g., feed.
(a) A testing facility shall have a suf- (3) Storage of the test and control ar-
ficient number of animal rooms or ticle mixtures.
areas, as needed, to assure proper: (1) (b) Storage areas for the test and/or
Separation of species or test systems, control article and test and control
(2) isolation of individual projects, (3) mixtures shall be separate from areas
quarantine of animals, and (4) routine housing the test systems and shall be
or specialized housing of animals. adequate to preserve the identity,
(b) A testing facility shall have a strength, purity, and stability of the
number of animal rooms or areas sepa- articles and mixtures.
rate from those described in paragraph
(a) of this section to ensure isolation of § 58.49 Laboratory operation areas.
studies being done with test systems or Separate laboratory space shall be
test and control articles known to be provided, as needed, for the perform-
biohazardous, including volatile sub- ance of the routine and specialized pro-
stances, aerosols, radioactive mate- cedures required by nonclinical labora-
rials, and infectious agents. tory studies.
(c) Separate areas shall be provided, [52 FR 33780, Sept. 4, 1987]
as appropriate, for the diagnosis, treat-
ment, and control of laboratory animal § 58.51 Specimen and data storage fa-
diseases. These areas shall provide ef- cilities.
fective isolation for the housing of ani- Space shall be provided for archives,
mals either known or suspected of limited to access by authorized per-
being diseased, or of being carriers of sonnel only, for the storage and re-
disease, from other animals. trieval of all raw data and specimens
(d) When animals are housed, facili- from completed studies.
ties shall exist for the collection and
disposal of all animal waste and refuse Subpart D—Equipment
or for safe sanitary storage of waste be-
fore removal from the testing facility. § 58.61 Equipment design.
Disposal facilities shall be so provided
Equipment used in the generation,
and operated as to minimize vermin in-
measurement, or assessment of data
festation, odors, disease hazards, and
and equipment used for facility envi-
environmental contamination.
ronmental control shall be of appro-
[43 FR 60013, Dec. 22, 1978, as amended at 52 priate design and adequate capacity to
FR 33780, Sept. 4, 1987] function according to the protocol and
396
shall be suitably located for operation, ating procedures shall be authorized by

inspection, cleaning, and maintenance. the study director and shall be docu-
[52 FR 33780, Sept. 4, 1987]
mented in the raw data. Significant
changes in established standard oper-
§ 58.63 Maintenance and calibration of ating procedures shall be properly au-
equipment. thorized in writing by management.
(a) Equipment shall be adequately in- (b) Standard operating procedures
spected, cleaned, and maintained. shall be established for, but not limited
Equipment used for the generation, to, the following:
measurement, or assessment of data (1) Animal room preparation.
shall be adequately tested, calibrated (2) Animal care.
and/or standardized. (3) Receipt, identification, storage,
(b) The written standard operating handling, mixing, and method of sam-
procedures required under § 58.81(b)(11) pling of the test and control articles.
shall set forth in sufficient detail the (4) Test system observations.
methods, materials, and schedules to (5) Laboratory tests.
be used in the routine inspection, (6) Handling of animals found mori-
cleaning, maintenance, testing, cali- bund or dead during study.
bration, and/or standardization of (7) Necropsy of animals or post-
equipment, and shall specify, when ap- mortem examination of animals.
propriate, remedial action to be taken (8) Collection and identification of
in the event of failure or malfunction specimens.
of equipment. The written standard op- (9) Histopathology.
erating procedures shall designate the (10) Data handling, storage, and re-
person responsible for the performance trieval.
of each operation. (11) Maintenance and calibration of
(c) Written records shall be main- equipment.
tained of all inspection, maintenance, (12) Transfer, proper placement, and
testing, calibrating and/or standard- identification of animals.
izing operations. These records, con- (c) Each laboratory area shall have
taining the date of the operation, shall immediately available laboratory
describe whether the maintenance op- manuals and standard operating proce-
erations were routine and followed the dures relative to the laboratory proce-
written standard operating procedures. dures being performed. Published lit-
Written records shall be kept of non- erature may be used as a supplement to
routine repairs performed on equip- standard operating procedures.
ment as a result of failure and mal- (d) A historical file of standard oper-
function. Such records shall document ating procedures, and all revisions
the nature of the defect, how and when thereof, including the dates of such re-
the defect was discovered, and any revisions, shall be maintained.
medial action taken in response to the [43 FR 60013, Dec. 22, 1978, as amended at 52
defect. FR 33780, Sept. 4, 1987]
FR 33780, Sept. 4, 1987; 67 FR 9585, Mar. 4, § 58.83 Reagents and solutions.
2002] All reagents and solutions in the lab-
oratory areas shall be labeled to indi-
Subpart E—Testing Facilities cate identity, titer or concentration,
Operation storage requirements, and expiration
date. Deteriorated or outdated re-
§ 58.81 Standard operating procedures. agents and solutions shall not be used.
(a) A testing facility shall have
standard operating procedures in writ- § 58.90 Animal care.
ing setting forth nonclinical laboratory (a) There shall be standard operating
study methods that management is procedures for the housing, feeding,
satisfied are adequate to insure the handling, and care of animals.
quality and integrity of the data gen- (b) All newly received animals from
erated in the course of a study. All de- outside sources shall be isolated and
viations in a study from standard oper- their health status shall be evaluated
397
§ 58.105 21 CFR Ch. I (4–1–19 Edition)
in accordance with acceptable veteri- (i) If any pest control materials are
nary medical practice. used, the use shall be documented.
(c) At the initiation of a nonclinical Cleaning and pest control materials
laboratory study, animals shall be free that interfere with the study shall not
of any disease or condition that might be used.
interfere with the purpose or conduct
of the study. If, during the course of [43 FR 60013, Dec. 22, 1978, as amended at 52
the study, the animals contract such a FR 33780, Sept. 4, 1987; 54 FR 15924, Apr. 20,
1989; 56 FR 32088, July 15, 1991; 67 FR 9585,
disease or condition, the diseased ani-
Mar. 4, 2002]
mals shall be isolated, if necessary.
These animals may be treated for dis-
ease or signs of disease provided that Subpart F—Test and Control
such treatment does not interfere with Articles
the study. The diagnosis, authoriza-
tions of treatment, description of § 58.105 Test and control article char-
treatment, and each date of treatment acterization.
shall be documented and shall be re- (a) The identity, strength, purity,
tained. and composition or other characteris-
(d) Warm-blooded animals, excluding tics which will appropriately define the
suckling rodents, used in laboratory test or control article shall be deter-
procedures that require manipulations mined for each batch and shall be docu-
and observations over an extended pe- mented. Methods of synthesis, fabrica-
riod of time or in studies that require
tion, or derivation of the test and con-
the animals to be removed from and re-
trol articles shall be documented by
turned to their home cages for any rea-
son (e.g., cage cleaning, treatment, the sponsor or the testing facility. In
etc.), shall receive appropriate identi- those cases where marketed products
fication. All information needed to spe- are used as control articles, such prod-
cifically identify each animal within ucts will be characterized by their la-
an animal-housing unit shall appear on beling.
the outside of that unit. (b) The stability of each test or con-
(e) Animals of different species shall trol article shall be determined by the
be housed in separate rooms when nec- testing facility or by the sponsor ei-
essary. Animals of the same species, ther: (1) Before study initiation, or (2)
but used in different studies, should concomitantly according to written
not ordinarily be housed in the same standard operating procedures, which
room when inadvertent exposure to provide for periodic analysis of each
control or test articles or animal batch.
mixup could affect the outcome of ei- (c) Each storage container for a test
ther study. If such mixed housing is or control article shall be labeled by
necessary, adequate differentiation by name, chemical abstract number or
space and identification shall be made. code number, batch number, expiration
(f) Animal cages, racks and accessory date, if any, and, where appropriate,
equipment shall be cleaned and sani-
storage conditions necessary to main-
tized at appropriate intervals.
tain the identity, strength, purity, and
(g) Feed and water used for the ani-
composition of the test or control arti-
mals shall be analyzed periodically to
ensure that contaminants known to be cle. Storage containers shall be as-
capable of interfering with the study signed to a particular test article for
and reasonably expected to be present the duration of the study.
in such feed or water are not present at (d) For studies of more than 4 weeks’
levels above those specified in the pro- duration, reserve samples from each
tocol. Documentation of such analyses batch of test and control articles shall
shall be maintained as raw data. be retained for the period of time pro-
(h) Bedding used in animal cages or vided by § 58.195.
pens shall not interfere with the pur-
pose or conduct of the study and shall
FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,

be changed as often as necessary to 2002]
keep the animals dry and clean.
398
§ 58.107 Test and control article han- dicates the objectives and all methods
dling. for the conduct of the study. The pro-
Procedures shall be established for a tocol shall contain, as applicable, the
system for the handling of the test and following information:
control articles to ensure that: (1) A descriptive title and statement
(a) There is proper storage. of the purpose of the study.
(b) Distribution is made in a manner (2) Identification of the test and con-
designed to preclude the possibility of trol articles by name, chemical ab-
contamination, deterioration, or dam- stract number, or code number.
age. (3) The name of the sponsor and the
(c) Proper identification is main- name and address of the testing facil-
tained throughout the distribution ity at which the study is being con-
process. ducted.
(d) The receipt and distribution of (4) The number, body weight range,
each batch is documented. Such docu- sex, source of supply, species, strain,
mentation shall include the date and substrain, and age of the test system.
quantity of each batch distributed or (5) The procedure for identification of
returned. the test system.
(6) A description of the experimental
§ 58.113 Mixtures of articles with car- design, including the methods for the
riers. control of bias.
(a) For each test or control article (7) A description and/or identification
that is mixed with a carrier, tests by of the diet used in the study as well as
appropriate analytical methods shall solvents, emulsifiers, and/or other ma-
be conducted: terials used to solubilize or suspend the
(1) To determine the uniformity of test or control articles before mixing
the mixture and to determine, periodi- with the carrier. The description shall
cally, the concentration of the test or include specifications for acceptable
control article in the mixture. levels of contaminants that are reason-
(2) To determine the stability of the ably expected to be present in the die-
test and control articles in the mixture tary materials and are known to be ca-
as required by the conditions of the pable of interfering with the purpose or
study either: conduct of the study if present at lev-
(i) Before study initiation, or els greater than established by the
(ii) Concomitantly according to writ- specifications.
ten standard operating procedures (8) Each dosage level, expressed in
which provide for periodic analysis of milligrams per kilogram of body
the test and control articles in the weight or other appropriate units, of
mixture. the test or control article to be admin-
(b) [Reserved] istered and the method and frequency
(c) Where any of the components of of administration.
the test or control article carrier mix- (9) The type and frequency of tests,
ture has an expiration date, that date analyses, and measurements to be
shall be clearly shown on the con- made.
tainer. If more than one component has (10) The records to be maintained.
an expiration date, the earliest date (11) The date of approval of the pro-
shall be shown. tocol by the sponsor and the dated sig-
[43 FR 60013, Dec. 22, 1978, as amended at 45 nature of the study director.
FR 24865, Apr. 11, 1980; 52 FR 33781, Sept. 4, (12) A statement of the proposed sta-
1987] tistical methods to be used.
(b) All changes in or revisions of an
Subpart G—Protocol for and Con- approved protocol and the reasons
duct of a Nonclinical Labora- therefore shall be documented, signed
tory Study by the study director, dated, and main-
tained with the protocol.
§ 58.120 Protocol.

(a) Each study shall have an ap- FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,
proved written protocol that clearly in- 2002]
399
§ 58.130 21 CFR Ch. I (4–1–19 Edition)
§ 58.130 Conduct of a nonclinical lab- which the study was initiated and com-
oratory study. pleted.
(a) The nonclinical laboratory study (2) Objectives and procedures stated
shall be conducted in accordance with in the approved protocol, including any
the protocol. changes in the original protocol.
(b) The test systems shall be mon- (3) Statistical methods employed for
itored in conformity with the protocol. analyzing the data.
(c) Specimens shall be identified by (4) The test and control articles iden-
test system, study, nature, and date of tified by name, chemical abstracts
collection. This information shall be number or code number, strength, pu-
located on the specimen container or rity, and composition or other appro-
shall accompany the specimen in a priate characteristics.
manner that precludes error in the re- (5) Stability of the test and control
cording and storage of data. articles under the conditions of admin-
(d) Records of gross findings for a istration.
specimen from postmortem observa- (6) A description of the methods used.
tions should be available to a patholo- (7) A description of the test system
gist when examining that specimen used. Where applicable, the final report
histopathologically. shall include the number of animals
(e) All data generated during the con- used, sex, body weight range, source of
duct of a nonclinical laboratory study, supply, species, strain and substrain,
except those that are generated by age, and procedure used for identifica-
automated data collection systems, tion.
shall be recorded directly, promptly, (8) A description of the dosage, dos-
and legibly in ink. All data entries age regimen, route of administration,
shall be dated on the date of entry and and duration.
signed or initialed by the person enter- (9) A description of all circumstances
ing the data. Any change in entries that may have affected the quality or
shall be made so as not to obscure the integrity of the data.
original entry, shall indicate the rea- (10) The name of the study director,
son for such change, and shall be dated the names of other scientists or profes-
and signed or identified at the time of sionals, and the names of all super-
the change. In automated data collec- visory personnel, involved in the study.
tion systems, the individual respon- (11) A description of the trans-
sible for direct data input shall be iden- formations, calculations, or operations
tified at the time of data input. Any performed on the data, a summary and
change in automated data entries shall analysis of the data, and a statement
be made so as not to obscure the origi- of the conclusions drawn from the
nal entry, shall indicate the reason for analysis.
change, shall be dated, and the respon- (12) The signed and dated reports of
sible individual shall be identified. each of the individual scientists or
other professionals involved in the
study.
FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,
2002] (13) The locations where all speci-
mens, raw data, and the final report
are to be stored.
Subparts H–I [Reserved] (14) The statement prepared and
signed by the quality assurance unit as
Subpart J—Records and Reports described in § 58.35(b)(7).
(b) The final report shall be signed
§ 58.185 Reporting of nonclinical lab- and dated by the study director.
oratory study results.
(c) Corrections or additions to a final
(a) A final report shall be prepared report shall be in the form of an
for each nonclinical laboratory study amendment by the study director. The
and shall include, but not necessarily amendment shall clearly identify that
be limited to, the following: part of the final report that is being
(1) Name and address of the facility added to or corrected and the reasons
performing the study and the dates on for the correction or addition, and
400
shall be signed and dated by the person the nonclinical laboratory study were
responsible. submitted, is approved by the Food and
Drug Administration. This require-
FR 33781, Sept. 4, 1987] ment does not apply to studies sup-
porting investigational new drug appli-
§ 58.190 Storage and retrieval of cations (IND’s) or applications for in-
records and data. vestigational device exemptions
(a) All raw data, documentation, pro- (IDE’s), records of which shall be gov-
tocols, final reports, and specimens erned by the provisions of paragraph
(except those specimens obtained from (b)(2) of this section.
mutagenicity tests and wet specimens (2) A period of at least 5 years fol-
of blood, urine, feces, and biological lowing the date on which the results of
fluids) generated as a result of a non- the nonclinical laboratory study are
clinical laboratory study shall be resubmitted to the Food and Drug Ad-
tained. ministration in support of an applica-
(b) There shall be archives for orderly tion for a research or marketing per-
storage and expedient retrieval of all mit.
raw data, documentation, protocols, (3) In other situations (e.g., where
specimens, and interim and final re- the nonclinical laboratory study does
ports. Conditions of storage shall mini- not result in the submission of the
mize deterioration of the documents or study in support of an application for a
specimens in accordance with the re- research or marketing permit), a pe-
quirements for the time period of their riod of at least 2 years following the
retention and the nature of the docu- date on which the study is completed,
ments or specimens. A testing facility terminated, or discontinued.
may contract with commercial ar-
(c) Wet specimens (except those
chives to provide a repository for all
specimens obtained from mutagenicity
material to be retained. Raw data and
tests and wet specimens of blood,
specimens may be retained elsewhere
provided that the archives have spe- urine, feces, and biological fluids),
cific reference to those other locations. samples of test or control articles, and
(c) An individual shall be identified specially prepared material, which are
as responsible for the archives. relatively fragile and differ markedly
(d) Only authorized personnel shall in stability and quality during storage,
enter the archives. shall be retained only as long as the
(e) Material retained or referred to in quality of the preparation affords eval-
the archives shall be indexed to permit uation. In no case shall retention be re-
expedient retrieval. quired for longer periods than those set
forth in paragraphs (a) and (b) of this
[43 FR 60013, Dec. 22, 1978, as amended at 52 section.
FR 33781, Sept. 4, 1987; 67 FR 9585, Mar. 4,
2002] (d) The master schedule sheet, copies
of protocols, and records of quality as-
§ 58.195 Retention of records. surance inspections, as required by
(a) Record retention requirements set § 58.35(c) shall be maintained by the
forth in this section do not supersede quality assurance unit as an easily ac-
the record retention requirements of cessible system of records for the pe-
any other regulations in this chapter. riod of time specified in paragraphs (a)
(b) Except as provided in paragraph and (b) of this section.
(c) of this section, documentation (e) Summaries of training and experi-
records, raw data and specimens per- ence and job descriptions required to be
taining to a nonclinical laboratory maintained by § 58.29(b) may be re-
study and required to be made by this tained along with all other testing fa-
part shall be retained in the archive(s) cility employment records for the
for whichever of the following periods length of time specified in paragraphs
is shortest: (a) and (b) of this section.
(1) A period of at least 2 years fol- (f) Records and reports of the mainte-
lowing the date on which an applica- nance and calibration and inspection of
tion for a research or marketing per- equipment, as required by § 58.63(b) and

mit, in support of which the results of (c), shall be retained for the length of
401
§ 58.200 21 CFR Ch. I (4–1–19 Edition)
time specified in paragraph (b) of this (a) The testing facility failed to com-
section. ply with one or more of the regulations
(g) Records required by this part may set forth in this part (or any other reg-
be retained either as original records ulations regarding such facilities in
or as true copies such as photocopies, this chapter);
microfilm, microfiche, or other accu- (b) The noncompliance adversely af-
rate reproductions of the original fected the validity of the nonclinical
records. laboratory studies; and
(h) If a facility conducting nonclin- (c) Other lesser regulatory actions
ical testing goes out of business, all (e.g., warnings or rejection of indi-
raw data, documentation, and other vidual studies) have not been or will
material specified in this section shall probably not be adequate to achieve
be transferred to the archives of the compliance with the good laboratory
sponsor of the study. The Food and practice regulations.
Drug Administration shall be notified
in writing of such a transfer. § 58.204 Notice of and opportunity for
hearing on proposed disqualifica-
[43 FR 60013, Dec. 22, 1978, as amended at 52 tion.
FR 33781, Sept. 4, 1987; 54 FR 9039, Mar. 3,
1989] (a) Whenever the Commissioner has
information indicating that grounds
exist under § 58.202 which in his opinion
Subpart K—Disqualification of justify disqualification of a testing fa-
Testing Facilities cility, he may issue to the testing fa-
cility a written notice proposing that
§ 58.200 Purpose.
the facility be disqualified.
(a) The purposes of disqualification (b) A hearing on the disqualification
are: shall be conducted in accordance with
(1) To permit the exclusion from con- the requirements for a regulatory hear-
sideration of completed studies that ing set forth in part 16 of this chapter.
were conducted by a testing facility
which has failed to comply with the re- § 58.206 Final order on disqualifica-
quirements of the good laboratory tion.
practice regulations until it can be (a) If the Commissioner, after the
adequately demonstrated that such regulatory hearing, or after the time
noncompliance did not occur during, or for requesting a hearing expires with-
did not affect the validity or accept- out a request being made, upon an
ability of data generated by, a par- evaluation of the administrative record
ticular study; and of the disqualification proceeding,
(2) To exclude from consideration all makes the findings required in § 58.202,
studies completed after the date of dis- he shall issue a final order disquali-
qualification until the facility can sat- fying the facility. Such order shall in-
isfy the Commissioner that it will conclude a statement of the basis for that
duct studies in compliance with such determination. Upon issuing a final
regulations. order, the Commissioner shall notify
(b) The determination that a nonclin- (with a copy of the order) the testing
ical laboratory study may not be con- facility of the action.
sidered in support of an application for (b) If the Commissioner, after a regu-
a research or marketing permit does latory hearing or after the time for re-
not, however, relieve the applicant for questing a hearing expires without a
such a permit of any obligation under request being made, upon an evalua-
any other applicable regulation to sub- tion of the administrative record of the
mit the results of the study to the disqualification proceeding, does not
Food and Drug Administration. make the findings required in § 58.202,
he shall issue a final order terminating
§ 58.202 Grounds for disqualification. the disqualification proceeding. Such
The Commissioner may disqualify a order shall include a statement of the
testing facility upon finding all of the basis for that determination. Upon
following: issuing a final order the Commissioner
402
shall notify the testing facility and lieves that such disclosure would fur-
provide a copy of the order. ther the public interest or would pro-
mote compliance with the good labora-
§ 58.210 Actions upon disqualification. tory practice regulations set forth in
(a) Once a testing facility has been this part. Such notice, if given, shall
disqualified, each application for a re- include a copy of the final order issued
search or marketing permit, whether under § 58.206(a) and shall state that the
approved or not, containing or relying disqualification constitutes a deter-
upon any nonclinical laboratory study mination by the Food and Drug Admin-
conducted by the disqualified testing istration that nonclinical laboratory
facility may be examined to determine studies performed by the facility will
whether such study was or would be es- not be considered by the Food and
sential to a decision. If it is determined Drug Administration in support of any
that a study was or would be essential, application for a research or marketing
the Food and Drug Administration permit. If such notice is sent to an-
shall also determine whether the study other Federal Government agency, the
is acceptable, notwithstanding the dis- Food and Drug Administration will
qualification of the facility. Any study recommend that the agency also con-
done by a testing facility before or sider whether or not it should accept
after disqualification may be presumed
nonclinical laboratory studies per-
to be unacceptable, and the person re-
formed by the testing facility. If such
lying on the study may be required to
notice is sent to any other person, it
establish that the study was not af-
shall state that it is given because of
fected by the circumstances that led to
the disqualification, e.g., by submit- the relationship between the testing fa-
ting validating information. If the cility and the person being notified and
study is then determined to be unac- that the Food and Drug Administra-
ceptable, such data will be eliminated tion is not advising or recommending
from consideration in support of the that any action be taken by the person
application; and such elimination may notified.
serve as new information justifying the (b) A determination that a testing fa-
termination or withdrawal of approval cility has been disqualified and the ad-
of the application. ministrative record regarding such de-
(b) No nonclinical laboratory study termination are disclosable to the pub-
begun by a testing facility after the lic under part 20 of this chapter.
date of the facility’s disqualification
shall be considered in support of any § 58.215 Alternative or additional ac-
application for a research or marketing tions to disqualification.
permit, unless the facility has been re- (a) Disqualification of a testing facil-
instated under § 58.219. The determina- ity under this subpart is independent
tion that a study may not be consid- of, and neither in lieu of nor a pre-
ered in support of an application for a condition to, other proceedings or ac-
research or marketing permit does not, tions authorized by the act. The Food
however, relieve the applicant for such and Drug Administration may, at any
a permit of any obligation under any time, institute against a testing facil-
other applicable regulation to submit ity and/or against the sponsor of a non-
the results of the study to the Food clinical laboratory study that has been
and Drug Administration. submitted to the Food and Drug Ad-
[43 FR 60013, Dec. 22, 1978, as amended at 59 ministration any appropriate judicial
FR 13200, Mar. 21, 1994] proceedings (civil or criminal) and any
other appropriate regulatory action, in
§ 58.213 Public disclosure of informa- addition to or in lieu of, and prior to,
tion regarding disqualification. simultaneously with, or subsequent to,
(a) Upon issuance of a final order dis- disqualification. The Food and Drug
qualifying a testing facility under Administration may also refer the
§ 58.206(a), the Commissioner may no- matter to another Federal, State, or
tify all or any interested persons. Such local government law enforcement or
notice may be given at the discretion regulatory agency for such action as
of the Commissioner whenever he be- that agency deems appropriate.
403
§ 58.217 21 CFR Ch. I (4–1–19 Edition)
(b) The Food and Drug Administra- Commissioner reasons why it believes
tion may refuse to consider any par- it should be reinstated and a detailed
ticular nonclinical laboratory study in description of the corrective actions it
support of an application for a research has taken or intends to take to assure
or marketing permit, if it finds that that the acts or omissions which led to
the study was not conducted in accord- its disqualification will not recur. The
ance with the good laboratory practice Commissioner may condition rein-
regulations set forth in this part, with- statement upon the testing facility
out disqualifying the testing facility being found in compliance with the
that conducted the study or under- good laboratory practice regulations
taking other regulatory action. upon an inspection. If a testing facility
is reinstated, the Commissioner shall
§ 58.217 Suspension or termination of so notify the testing facility and all or-
a testing facility by a sponsor.
ganizations and persons who were noti-
Termination of a testing facility by a fied, under § 58.213 of the disqualifica-
sponsor is independent of, and neither tion of the testing facility. A deter-
in lieu of nor a precondition to, pro- mination that a testing facility has
ceedings or actions authorized by this been reinstated is disclosable to the
subpart. If a sponsor terminates or sus- public under part 20 of this chapter.
pends a testing facility from further
participation in a nonclinical labora- PART 60—PATENT TERM
tory study that is being conducted as
part of any application for a research RESTORATION
or marketing permit that has been sub-
mitted to any Center of the Food and
Drug Administration (whether ap- Sec.
proved or not), it shall notify that Cen- 60.1 Scope.
ter in writing within 15 working days 60.2 Purpose.
of the action; the notice shall include a 60.3 Definitions.
statement of the reasons for such ac-
Subpart B—Eligibility Assistance
tion. Suspension or termination of a
testing facility by a sponsor does not 60.10 FDA assistance on eligibility.
relieve it of any obligation under any
other applicable regulation to submit Subpart C—Regulatory Review Period
the results of the study to the Food Determinations
and Drug Administration. 60.20 FDA action on regulatory review pe-
[43 FR 60013, Dec. 22, 1978, as amended at 50 riod determinations.
FR 8995, Mar. 6, 1985] 60.22 Regulatory review period determina-
tions.
§ 58.219 Reinstatement of a disquali- 60.24 Revision of regulatory review period
fied testing facility. determinations.
60.26 Final action on regulatory review pe-
A testing facility that has been dis- riod determinations.
qualified may be reinstated as an ac- 60.28 Time frame for determining regu-
ceptable source of nonclinical labora- latory review periods.
tory studies to be submitted to the
Food and Drug Administration if the Subpart D—Due Diligence Petitions
Commissioner determines, upon an 60.30 Filing, format, and content of peti-
evaluation of the submission of the tions.
testing facility, that the facility can 60.32 Applicant response to petition.
adequately assure that it will conduct 60.34 FDA action on petitions.
future nonclinical laboratory studies in 60.36 Standard of due diligence.
compliance with the good laboratory
practice regulations set forth in this Subpart E—Due Diligence Hearings
part and, if any studies are currently 60.40 Request for hearing.
being conducted, that the quality and 60.42 Notice of hearing.
integrity of such studies have not been 60.44 Hearing procedures.
seriously compromised. A disqualified 60.46 Administrative decision.
testing facility that wishes to be so re- AUTHORITY: 21 U.S.C. 348, 355, 360e, 360j, 371,
instated shall present in writing to the 379e; 35 U.S.C. 156; 42 U.S.C. 262.
404
SOURCE: 53 FR 7305, Mar. 7, 1988, unless oth- United States Patent and Trademark
erwise noted. Office to implement those parts of the
EDITORIAL NOTE: Nomenclature changes to law which are under that agency’s ju-
part 60 appear at 68 FR 24879, May 9, 2003. risdiction. These regulations shall be
construed in light of these objectives.
§ 60.3 Definitions.
§ 60.1 Scope.
(a) The definitions contained in 35
(a) This part sets forth procedures U.S.C. 156 apply to those terms when
and requirements for the Food and used in this part.
Drug Administration’s review of appli- (b) The following definitions of terms
cations for the extension of the term of
apply to this part:
certain patents under 35 U.S.C. 156.
Patent term restoration is available (1) The term Act means the Federal
for certain patents related to drug Food, Drug, and Cosmetic Act (secs.
products (as defined in 35 U.S.C. 201–901, 52 Stat. 1040 et seq. as amended
156(f)(2)), and to medical devices, food (21 U.S.C. 301–392)).
additives, or color additives subject to (2) Active ingredient means any com-
regulation under the Federal Food, ponent that is intended to furnish
Drug, and Cosmetic Act or the Public pharmacological activity or other di-
Health Service Act. Food and Drug Ad- rect effect in the diagnosis, cure, miti-
ministration actions in this area in- gation, treatment, or prevention of dis-
clude: ease, or to affect the structure or any
(1) Assisting the United States Pat- function of the body of man or of ani-
ent and Trademark Office in deter- mals. The term includes those compo-
mining eligibility for patent term res- nents that may undergo chemical
toration; change in the manufacture of the drug
(2) Determining the length of a prod-
product and be present in the drug
uct’s regulatory review period;
product in a modified form intended to
(3) If petitioned, reviewing and ruling
on due diligence challenges to the Food furnish the specified activity or effect.
and Drug Administration’s regulatory (3) Applicant means any person who
review period determinations; and submits an application or an amend-
(4) Conducting hearings to review ini- ment or supplement to an application
tial Food and Drug Administration under 35 U.S.C. 156 seeking patent term
findings on due diligence challenges. restoration.
(b) References in this part to the (4) Application means an application
Code of Federal Regulations are to for patent term restoration submitted
chapter I of title 21, unless otherwise under 35 U.S.C. 156.
noted. (5) Clinical investigation or study
[53 FR 7305, Mar. 7, 1988, as amended at 57 FR means any experiment that involves a
56261, Nov. 27, 1992] test article and one or more subjects
and that is either subject to require-
§ 60.2 Purpose. ments for prior submission to the Food
(a) The purpose of this part is to es- and Drug Administration under section
tablish a thorough yet efficient process 505(i), 512(j), or 520(g) of the Federal
for the Food and Drug Administration Food, Drug, and Cosmetic Act, or is
review of patent term restoration ap- not subject to the requirements for
plications. To achieve this purpose, the prior submission to FDA under those
regulations are intended to: sections of the Federal Food, Drug, and
(1) Facilitate determinations of pat- Cosmetic Act, but the results of which
ent term restoration eligibility and
are intended to be submitted later to,
regulatory review period length, and
(2) Ensure that parties interested in or held for inspection by, FDA as part
due diligence challenges will have an of an application for a research or mar-
opportunity to participate in that keting permit. The term does not in-
process, including informal hearings. clude experiments that are subject to
(b) The regulations are intended to the provisions of part 58 regarding non-
complement those promulgated by the clinical laboratory studies.
405
§ 60.10 21 CFR Ch. I (4–1–19 Edition)
(6) Color additive means any sub- (16) Animal drug product means the
stance that meets the definition in sec- active ingredient of a new animal drug
tion 201(t) of the Act and which is sub- (as that term is used in the Act) that is
ject to premarketing approval under not primarily manufactured using re-
section 721 of the Act. combinant deoxyribonucleic acid
(7) Due diligence petition means a peti- (DNA), recombinant ribonucleic acid
tion submitted under § 60.30(a). (RNA), hybridoma technology, or other
(8) FDA means the Food and Drug processes involving site-specific ge-
Administration. netic manipulation techniques, includ-
(9) Food additive means any substance ing any salt or ester of the active in-
that meets the definition in section gredient, as a single entity or in com-
201(s) of the Act and which is subject to bination with another active ingre-
premarketing approval under section dient.
409 of the Act. [53 FR 7305, Mar. 7, 1988, as amended at 57 FR
(10) Human drug product means the 56261, Nov. 27, 1992; 64 FR 399, Jan. 5, 1999]
active ingredient of a new drug or
human biologic product (as those terms Subpart B—Eligibility Assistance
are used in the Act and the Public
Health Service Act), including any salt § 60.10 FDA assistance on eligibility.
or ester of the active ingredient, as a (a) Upon written request from the
single entity or in combination with U.S. Patent and Trademark Office,
another active ingredient. FDA will assist the U.S. Patent and
(11) Marketing applicant means any Trademark Office in determining
person who submits an application for whether a patent related to a product
premarketing approval by FDA under: is eligible for patent term restoration
(i) Section 505(b) of the Act or section as follows:
351 of the Public Health Service Act (1) Verifying whether the product
(human drug products); was subject to a regulatory review pe-
(ii) Section 515 of the Act (medical riod before its commercial marketing
devices); or use;
(iii) Section 409 or 721 of the Act (2) For human drug products, food ad-
(food and color additives); or ditives, color additives, and medical
(iv) Section 512 of the Act (animal devices, determining whether the per-
drug products). mission for commercial marketing or
(12) Marketing application means an use of the product after the regulatory
application for: review period is the first permitted
(i) Human drug products submitted commercial marketing or use of the
under section 505(b) of the Act or sec- product either:
tion 351 of the Public Health Service (i) Under the provision of law under
Act; which the regulatory review period oc-
(ii) Medical devices submitted under curred; or
section 515 of the Act; (ii) Under the process claimed in the
(iii) Food and color additives sub- patent when the patent claims a meth-
mitted under section 409 or 721 of the od of manufacturing the product that
Act; or primarily uses recombinant
(iv) Animal drug products submitted deoxyribonucleic acid (DNA) tech-
under section 512 of the Act. nology in the manufacture of the prod-
(13) Medical device means any article uct;
that meets the definition in section (3) For animal drug products, deter-
201(h) of the Act and which is subject mining whether the permission for
to premarketing approval under sec- commercial marketing or use of the
tion 515 of the Act. product after the regulatory review pe-
(14) Product means a human drug riod:
product, animal drug product, medical (i) Is the first permitted commercial
device, food additive, or color additive, marketing or use of the product; or
as those terms are defined in this sec- (ii) Is the first permitted commercial
tion. marketing or use of the product for ad-
(15) PTO means the United States ministration to a food-producing ani-

Patent and Trademark Office. mal, whichever is applicable, under the
406
provision of law under which the regu- (c) FDA will also publish the regu-
latory review period occurred; latory review period determination in
(4) Informing the U.S. Patent and the FEDERAL REGISTER. The notice will
Trademark Office whether the patent include the following:
term restoration application was sub- (1) The name of the applicant;
mitted within 60 days after the product (2) The trade name and generic name
was approved for marketing or use, or, (if applicable) of the product;
if the product is an animal drug ap- (3) The number of the patent for
proved for use in a food-producing ani- which an extension of the term is
mal, verifying whether the application sought;
was filed within 60 days of the first ap- (4) The approved indications or uses
proval for marketing or use in a food- for the product;
producing animal; and (5) An explanation of any discrep-
ancies between the dates in the appli-
(5) Providing the U.S. Patent and
cation and FDA records;
Trademark Office with any other infor-
(6) Where appropriate, an explanation
mation relevant to the U.S. Patent and
that FDA has no record in which to re-
Trademark Office’s determination of
view the date(s) contained in the appli-
whether a patent related to a product
cation; and
is eligible for patent term restoration. (7) The regulatory review period de-
(b) FDA will notify the U.S. Patent termination, including a statement of
and Trademark Office of its findings in the length of the testing and approval
writing, send a copy of this notifica- phases and the dates used in calcu-
tion to the applicant, and file a copy of lating each phase.
the notification in the docket estab-
lished for the application in FDA’s Di- [53 FR 7305, Mar. 7, 1988, as amended at 59 FR
14364, Mar. 28, 1994]
vision of Dockets Management (HFA–
305), 5630 Fishers Lane, rm. 1061, Rock- § 60.22 Regulatory review period de-
ville, MD 20852. terminations.
[57 FR 56261, Nov. 27, 1992] In determining a product’s regu-
latory review period, which consists of
Subpart C—Regulatory Review the sum of the lengths of a testing
Period Determinations phase and an approval phase, FDA will
review the information in each applica-
§ 60.20 FDA action on regulatory re- tion using the following definitions of
view period determinations. the testing phase and the approval
phase for that class of products.
(a) FDA will consult its records and (a) For human drugs:
experts to verify the dates contained in (1) The testing phase begins on the
the application and to determine the date an exemption under section 505(i)
length of the product’s regulatory re- of the Act becomes effective (or the
view period under § 60.22. The applica- date an exemption under former sec-
tion shall contain information relevant tion 507(d) of the Act became effective)
to the determination of the regulatory for the approved human drug product
review period as stated in the ‘‘Guide- and ends on the date a marketing ap-
lines for Extension of Patent Term plication under section 351 of the Pub-
Under 35 U.S.C. 156’’ published on Octo- lic Health Service Act or section 505 of
ber 9, 1984, in PTO’s Official Gazette and the act is initially submitted to FDA
as required by 37 CFR chapter I. (or was initially submitted to FDA
(b) After determining the length of under former section 507 of the Act),
the regulatory review period, FDA will and
notify PTO in writing of its determina- (2) The approval phase begins on the
tion, send a copy of this determination date a marketing application under
to the applicant, and file a copy of the section 351 of the Public Health Service
determination in the docket estab- Act or section 505(b) of the Act is ini-
lished for the application in FDA’s Di- tially submitted to FDA (or was ini-
vision of Dockets Management (HFA– tially submitted under former section
305), 5630 Fishers Lane, rm. 1061, Rock- 507 of the Act) and ends on the date the
ville, MD 20852. application is approved.
407
§ 60.22 21 CFR Ch. I (4–1–19 Edition)
(b) For food and color additives: the Act and ends on the date the appli-
(1) The testing phase begins on the cation is approved; or
date a major health or environmental (ii) Begins on the date a notice of
effects test is begun and ends on the completion of a product development
date a petition relying on the test and protocol is initially submitted under
requesting the issuance of a regulation section 515 of the Act and ends on the
for use of the additive under section 409 date the protocol is declared to be com-
or 721 of the Act is initially submitted pleted.
to FDA. (d) For animal drugs:
(2) The approval phase begins on the (1) The testing phase begins on the
date a petition requesting the issuance date a major health or environmental
of a regulation for use of the additive effects test is begun or the date on
under section 409 or 721 of the Act is which the agency acknowledges the fil-
initially submitted to FDA and ends ing of a notice of claimed investiga-
upon whichever of the following occurs tional exemption for a new animal
last: drug, whichever is earlier, and ends on
(i) The regulation for the additive be- the date a marketing application under
comes effective; or section 512 of the Act is initially sub-
(ii) Objections filed against the regu- mitted to FDA.
lation that result in a stay of effective- (2) The approval phase begins on the
ness are resolved and commercial mar- date a marketing application under
keting is permitted; or section 512 of the Act is initially sub-
(iii) Proceedings resulting from ob- mitted to FDA and ends on the date
jections to the regulation, after com- the application is approved.
mercial marketing has been permitted (e) For purposes of this section, a
and later stayed pending resolution of ‘‘major health or environmental effects
the proceedings, are finally resolved test’’ may be any test which:
and commercial marketing is per- (1) Is reasonably related to the eval-
mitted. uation of the product’s health or envi-
(c) For medical devices: ronmental effects, or both:
(1) The testing phase begins on the (2) Produces data necessary for mar-
date a clinical investigation on humans keting approval; and
is begun and ends on the date an appli- (3) Is conducted over a period of no
cation for premarket approval of the less than 6 months duration, excluding
device or a notice of completion of a time required to analyze or evaluate
product development protocol is ini- test results.
tially submitted under section 515 of (f) For purposes of determining the
the Act. For purposes of this part, a regulatory review period for any prod-
clinical investigation is considered to uct, a marketing application, a notice
begin on whichever of the following of completion of a product develop-
dates applies: ment protocol, or a petition is initially
(i) If an investigational device ex- submitted on the date it contains suffi-
emption (IDE) under section 520(g) of cient information to allow FDA to
the Act is required, the effective date commence review of the application. A
of the exemption. marketing application, a notice of
(ii) If an IDE is not required, but in- completion of a product development
stitutional review board (IRB) approval protocol, or a petition is approved on
under section 520(g)(3) of the Act is re- the date FDA sends the applicant a let-
quired, the IRB approval date. ter informing it of the approval or, by
(iii) If neither an IDE nor IRB ap- order declares a product development
proval is required, the date on which protocol to be completed, or, in the
the device is first used with human case of food and color additives, on the
subjects as part of a clinical investiga- effective date of the final rule listing
tion to be filed with FDA to secure pre- the additive for use as published in the
market approval of the device. FEDERAL REGISTER or, in the case of a
(2) The approval phase either: new animal drug in a Category II Type
(i) Begins on the date an application A medicated article, on the date of
for premarket approval of the device is publication in the FEDERAL REGISTER

initially submitted under section 515 of of the notice of approval pursuant to
408
section 512(i) of the Act. For purposes ISTER, including a statement giving the
of this section, the regulatory review reasons for the revision.
period for an animal drug shall mean
[53 FR 7305, Mar. 7, 1988, as amended at 59 FR
either the regulatory review period re- 14364, Mar. 28, 1994; 67 FR 9585, Mar. 4, 2002]
lating the drug’s approval for use in
nonfood-producing animals or the regu- § 60.26 Final action on regulatory re-
latory review period relating to the view period determinations.
drug’s approval for use in food-pro- (a) FDA will consider a regulatory re-
ducing animals, whichever is applica- view period determination to be final
ble. upon expiration of the 180-day period
[53 FR 7305, Mar. 7, 1988, as amended at 57 FR for filing a due diligence petition under
56262, Nov. 27, 1992; 64 FR 400, Jan. 5, 1999] § 60.30 unless FDA receives:
(1) New information from PTO
§ 60.24 Revision of regulatory review records, FDA records, or FDA centers
period determinations. that affects the regulatory review pe-
(a) Any person may request a revi- riod determination;
sion of the regulatory review period de- (2) A request under § 60.24 for revision
termination within 60 days after its of the regulatory review period deter-
initial publication in the FEDERAL mination;
REGISTER. The request shall be sent to (3) A due diligence petition filed
the Division of Dockets Management under § 60.30; or
(HFA–305), Food and Drug Administra- (4) A request for a hearing filed under
tion, 5630 Fishers Lane, rm. 1061, Rock- § 60.40.
ville, MD 20852. The request shall speci- (b) FDA will notify PTO that the reg-
fy the following: ulatory review period determination is
(1) The type of action requested; final upon:
(2) The identity of the product; (1) The expiration of the 180-day pe-
(3) The identity of the applicant; riod for filing a due diligence petition;
(4) The FDA docket number; and or
(5) The basis for the request for revi- (2) If FDA has received a request for
sion, including any documentary evi- a revision, a due diligence petition, or
dence. a request for a hearing, upon resolution
(b) Unless the applicant is the person of the request for a revision, the peti-
requesting the revision, the applicant tion, or the hearing, whichever is later.
shall respond to the request within 15 FDA will send a copy of the notifica-
tion to the applicant and file a copy of
days. In responding to the request, the
the notification in the docket estab-
applicant may submit information
lished for the application in FDA’s Di-
which is relevant to the events during
vision of Dockets Management (HFA–
the regulatory review period but which
305), 5630 Fishers Lane, rm. 1061, Rock-
was not included in the original patent
ville, MD 20852.
term restoration application. A request
for a revision is not equivalent to a due [53 FR 7305, Mar. 7, 1988, as amended at 59 FR
diligence petition under § 60.30 or a re- 14364, Mar. 28, 1994]
quest for a hearing under § 60.40. If no
response is submitted, FDA will decide § 60.28 Time frame for determining
the matter on the basis of the informa- regulatory review periods.
tion in the patent term restoration ap- (a) FDA will determine the regu-
plication, request for revision, and latory review period for a product
FDA records. within 30 days of the receipt of a writ-
(c) FDA shall apply the provisions of ten request from PTO for such a deter-
§ 60.22 in considering the request for a mination and a copy of the patent term
revision of the regulatory review pe- restoration application.
riod determination. lf FDA revises its (b) FDA may extend the 30-day period
prior determination, FDA will notify if:
PTO of the revision, send a copy of this (1) A related FDA action that may af-
notification to the applicant, and pub- fect the regulatory review period deter-
lish the revision in the FEDERAL REG- mination is pending; or
409
§ 60.30 21 CFR Ch. I (4–1–19 Edition)
(2) PTO requests that FDA tempo- § 60.32 Applicant response to petition.
rarily suspend the determination proc-
(a) The applicant shall file with FDA
ess; or
a written response to the petition no
(3) PTO or FDA receives new infor-
later than 30 days after the applicant’s
mation about the product that war-
receipt of a copy of the petition.
rants an extension of the time required
for the determination of the regulatory (b) The applicant’s response may
review period. present additional facts and cir-
(c) This section does not apply to ap- cumstances to address the assertions in
plications withdrawn by the applicant the petition, but shall be limited to the
or applications that PTO determines issue of whether the applicant acted
are ineligible for patent term restora- with due diligence during the regu-
tion. latory review period. The applicant’s
response may include documents that
were not in the original patent exten-
Subpart D—Due Diligence sion application.
Petitions (c) If the applicant does not respond
§ 60.30 Filing, format, and content of to the petition, FDA will decide the
petitions. matter on the basis of the information
submitted in the patent term restora-
(a) Any person may file a petition tion application, due diligence peti-
with FDA, no later than 180 days after tion, and FDA records.
the publication of a regulatory review
period determination under § 60.20, that § 60.34 FDA action on petitions.
challenges FDA’s determination by al-
leging that the applicant for patent (a) Within 90 days after FDA receives
term restoration did not act with due a petition filed under § 60.30(a), the
diligence in seeking FDA approval of agency will either deny the petition
the product during the regulatory re- under paragraph (b) or (c) of this sec-
view period. tion or investigate and determine
(b) The petition shall be filed in ac- under § 60.36 whether the applicant
cordance with § 10.20, under the docket acted with due diligence during the
number of the FEDERAL REGISTER no- regulatory review period. FDA will
tice of the agency’s regulatory review publish its due diligence determination
period determination, and shall be in in the FEDERAL REGISTER, notify PTO
the format specified in § 10.30. The peti- of the due diligence determination in
tion shall contain the information writing, and send copies of the notice
specified in § 10.30 and any additional to PTO, the applicant, and the peti-
information required by this subpart. If tioner.
any provision of § 10.20 or § 10.30 is in- (b) FDA may deny a due diligence pe-
consistent with any provision of this tition without considering the merits
part, FDA will consider the petition in of the petition if:
accordance with this part. (1) The petition is not filed in accord-
(c) The petition shall claim that the ance with § 60.30;
applicant did not act with due dili- (2) The petition is not filed in accord-
gence during some part of the regu- ance with § 10.20;
latory review period and shall set forth (3) The petition does not contain the
sufficient facts, including dates if pos- information required by § 10.30;
sible, to merit an investigation by FDA (4) The petition fails to contain infor-
of whether the applicant acted with mation or allegations upon which it
due diligence. may reasonably be determined that the
(d) The petition shall contain a cer- applicant did not act with due dili-
tification that the petitioner has gence during the applicable regulatory
served a true and complete copy of the review period; or
petition upon the applicant by certified (5) The petition fails to allege a suffi-
or registered mail (return receipt re- cient total amount of time during
quested) or by personal delivery. which the applicant did not exercise
[53 FR 7305, Mar. 7, 1988, as amended at 67 FR due diligence such that, even if the pe-
9585, Mar. 4, 2002] tition were granted, the petition would
410
not affect the maximum patent exten- mail (return receipt requested) or by
sion the applicant sought in the appli- personal delivery.
cation. (c) The request shall state whether
the requesting party seeks a hearing
§ 60.36 Standard of due diligence. within 30 days or 60 days of FDA’s re-
(a) In determining the due diligence ceipt of the request.
of an applicant, FDA will examine the
[53 FR 7305, Mar. 7, 1988, as amended at 67 FR
facts and circumstances of the appli- 9585, Mar. 4, 2002]
cant’s actions during the regulatory re-
view period to determine whether the § 60.42 Notice of hearing.
applicant exhibited that degree of at-
tention, continuous directed effort, and Ten days before the hearing, FDA
timeliness as may reasonably be ex- will notify the requesting party, the
pected from, and are ordinarily exer- applicant, and the petitioner, orally or
cised by, a person during a regulatory in writing, of the date, time, and loca-
review period. FDA will take into con- tion of the hearing. The agency will
sideration all relevant factors, such as provide the requesting party, the appli-
the amount of time between the ap- cant, and the petitioner with an oppor-
proval of an investigational exemption tunity to participate as a party in the
or research permit and the commence- hearing.
ment of a clinical investigation and
§ 60.44 Hearing procedures.
the amount of time required to conduct
a clinical investigation. The due diligence hearing shall be
(b) For purposes of this part, the ac- conducted in accordance with this part,
tions of the marketing applicant shall supplemented by the nonconflicting
be imputed to the applicant for patent procedures in part 16. During the due
term restoration. The actions of an diligence hearing, the applicant and
agent, attorney, contractor, employee, the petitioner shall enjoy all the rights
licensee, or predecessor in interest of and privileges accorded a person re-
the marketing applicant or applicant questing a hearing under part 16. The
for patent term restoration shall be standard of due diligence set forth in
imputed to the applicant for patent § 60.36 will apply in the due diligence
term restoration. hearing. The party requesting the due
diligence hearing shall have the burden
Subpart E—Due Diligence of proof at the hearing.
Hearings § 60.46 Administrative decision.
§ 60.40 Request for hearing. Within 30 days after the completion
(a) Any person may request, not later of the due diligence hearing, the Com-
than 60 days after the publication missioner will affirm or revise the de-
under § 60.34(a) of FDA’s due diligence termination made under § 60.34(a) and
determination, that FDA conduct an will publish the due diligence redeter-
informal hearing on the due diligence mination in the FEDERAL REGISTER, no-
determination. tify PTO of the redetermination, and
(b) The request for a hearing under send copies of the notice to PTO and to
this section shall: the requesting party, the applicant,
(1) Be sent by mail, personal delivery, and the petitioner.
or any other mode of written commu-
nication to the Division of Dockets PART 70—COLOR ADDITIVES
Management and filed under the rel-
evant product file; Subpart A—General Provisions
(2) Specify the facts and the action
that are the subject of the hearing; Sec.
70.3 Definitions.
(3) Provide the name and address of
70.5 General restrictions on use of color ad-
the person requesting the hearing; and ditives.
(4) Certify that the requesting party 70.10 Color additives in standardized foods
has served a true and complete copy of
and new drugs.

the request upon the petitioner and the 70.11 Related substances.
applicant by certified or registered 70.19 Fees for listing.
411
§ 70.3 21 CFR Ch. I (4–1–19 Edition)
Subpart B—Packaging and Labeling less the customary or reasonably fore-

seeable handling or use of the con-
70.20 Packaging requirements for straight
colors (other than hair dyes).
tainer may reasonably be expected to
70.25 Labeling requirements for color addi- result in the transmittal of the color to
tives (other than hair dyes). the contents of the package or any part
thereof. Food ingredients such as cher-
Subpart C—Safety Evaluation ries, green or red peppers, chocolate,
and orange juice which contribute
70.40 Safety factors to be considered.
70.42 Criteria for evaluating the safety of their own natural color when mixed
color additives. with other foods are not regarded as
70.45 Allocation of color additives. color additives; but where a food sub-
70.50 Application of the cancer clause of stance such as beet juice is delib-
section 721 of the act. erately used as a color, as in pink lem-
70.51 Advisory committee on the applica- onade, it is a color additive. Food ingre-
tion of the anticancer clause.
dients as authorized by a definitions
70.55 Request for scientific studies.
and standard of identity prescribed by
AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348, regulations pursuant to section 401 of
351, 360b, 361, 371, 379e. the act are color additives, where the in-
SOURCE: 42 FR 15636, Mar. 22, 1977, unless gredients are specifically designated in
otherwise noted. the definitions and standards of iden-
tity as permitted for use for coloring
Subpart A—General Provisions purposes. An ingredient of an animal
feed whose intended function is to im-
§ 70.3 Definitions. part, through the biological processes
(a) Secretary means the Secretary of of the animal, a color to the meat,
Health and Human Services. milk, or eggs of the animal is a color
(b) Department means the Department additive and is not exempt from the re-
of Health and Human Services. quirements of the statute. This defini-
(c) Commissioner means the Commis- tion shall apply whether or not such
sioner of Food and Drugs. ingredient has nutritive or other func-
(d) Act means the Federal Food, tions in addition to the property of im-
Drug, and Cosmetic Act as amended. parting color. An ingested drug the in-
(e) Color Certification Branch means tended function of which is to impart
the unit established within the Food color to the human body is a color addi-
and Drug Administration located in tive. For the purposes of this part, the
the Center for Food Safety and Applied term color includes black, white, and
Nutrition, charged with the responsi- intermediate grays, but substances in-
bility for the mechanics of the certifi- cluding migrants from packaging ma-
cation procedure hereinafter described, terials which do not contribute any
and including the examination of sam- color apparent to the naked eye are not
ples of color additives subject to cer- color additives.
tification. (g) For a material otherwise meeting
(f) A color additive is any material, the definition of color additive to be ex-
not exempted under section 201(t) of empt from section 721 of the act, on the
the act, that is a dye, pigment, or basis that it is used (or intended to be
other substance made by a process of used) solely for a purpose or purposes
synthesis or similar artifice, or ex- other than coloring, the material must
tracted, isolated, or otherwise derived, be used in a way that any color im-
with or without intermediate or final parted is clearly unimportant insofar
change of identity, from a vegetable, as the appearance, value, market-
animal, mineral, or other source and ability, or consumer acceptability is
that, when added or applied to a food, concerned. (It is not enough to warrant
drug, or cosmetic or to the human body exemption if conditions are such that
or any part thereof, is capable (alone or the primary purpose of the material is
through reaction with another sub- other than to impart color.)
stance) of imparting a color thereto. (h) The exemption that applies to a
Substances capable of imparting a pesticide chemical, soil or plant nutri-
color to a container for foods, drugs, or ent, or other agricultural chemical,

cosmetics are not color additives un- where its coloring effect results solely
412
from its aiding, retarding, or otherwise pose of obtaining certification of such

affecting directly or indirectly, the quantity.
growth or other natural physiological (q) The term batch number means the
processes of produce of the soil, applies number assigned to a batch by the per-
only to color developed in such product son who requests certification thereof.
through natural physiological proc- (r) The term lot number means an
esses such as enzymatic action. If the identifying number or symbol assigned
pesticide chemical, soil or plant nutri- to a batch by the Food and Drug Ad-
ent, or other agricultural chemical ministration.
itself acts as a color or carries as an in-
(s) The term area of the eye means the
gredient a color, and because of this
area enclosed with in the circum-
property colors the produce of the soil,
ference of the supra-orbital ridge and
it is a color additive and is not exempt.
(i) Safe means that there is con- the infra-orbital ridge, including the
vincing evidence that establishes with eyebrow, the skin below the eyebrow,
reasonable certainty that no harm will the eyelids and the eyelashes, and con-
result from the intended use of the junctival sac of the eye, the eyeball,
color additive. and the soft areolar tissue that lies
(j) The term straight color means a within the perimeter of the infra-or-
color additive listed in parts 73, 74, and bital ridge.
81 of this chapter, and includes lakes (t) The term package means the im-
and such substances as are permitted mediate container in which a color ad-
by the specifications for such color. ditive or color additive mixture has
(k) The term mixture means a color been packed for shipment or delivery.
additive made by mixing two or more If the package is then packed in a ship-
straight colors, or one or more straight ping carton or other protective con-
colors and one or more diluents. tainer, such container shall not be con-
(l) The term lake means a straight sidered to be the immediate container.
color extended on a substratum by ad- In the case of color additive mixtures
sorption, coprecipitation, or chemical for household use containing less than
combination that does not include any 15 percent pure color, when two or
combination of ingredients made by more containers of 3 ounces each or
simple mixing process. less, each containing a different color,
(m) The term diluent means any com- are distributed as a unit, the imme-
ponent of a color additive mixture that diate container for such unit shall be
is not of itself a color additive and has considered to be the package as defined
been intentionally mixed therein to fa- in this section.
cilitate the use of the mixture in color-
(u) The hair dye exemption in section
ing foods, drugs, or cosmetics or in
601(a) of the act applies to coal tar hair
coloring the human body. The diluent
dyes intended for use in altering the
may serve another functional purpose
in the foods, drugs, or cosmetics, as for color of the hair and which are, or
example sweetening, flavoring, which bear or contain, color additives
emulsifying, or stabilizing, or may be a derived from coal tar with the sen-
functional component of an article in- sitization potential of causing skin ir-
tended for coloring the human body. ritation in certain individuals and pos-
(n) The term substratum means the sible blindness when used for dyeing
substance on which the pure color in a the eyelashes or eyebrows. The exemp-
lake is extended. tion is permitted with the condition
(o) The term pure color means the that the label of any such article bear
color contained in a color additive, ex- conspicuously the statutory caution
clusive of any intermediate or other and adequate directions for prelimi-
component, or of any diluent or sub- nary patch-testing. The exemption
stratum contained therein. does not apply to coloring ingredients
(p) The term batch means a homo- in hair dyes not derived from coal tar,
geneous lot of color additive or color and it does not extend to poisonous or
additive mixture produced by an iden- deleterious diluents that may be intro-
tified production operation, which is duced as wetting agents, hair condi-

set apart and held as a unit for the pur- tions, emulsifiers, or other components
413
§ 70.5 21 CFR Ch. I (4–1–19 Edition)
in a color shampoo, rinse, tint, or simi- color additive does not provide for such
lar dual-purpose cosmetic that alter use, shall be considered to be a color
the color of the hair. additive not listed under parts 73, 74,
(v) The terms externally applied drugs and 81 of this chapter, even though
and externally applied cosmetics mean such color additive is certified and/or
drugs or cosmetics applied only to ex- listed for other uses.
ternal parts of the body and not to the
lips or any body surface covered by mu- § 70.10 Color additives in standardized
cous membrane. foods and new drugs.
[42 FR 15636, Mar. 22, 1977, as amended at 61 (a) Standardized foods. (1) Where a pe-
FR 14478, Apr. 2, 1996] tition is received for issuance or
amendment of a regulation estab-
§ 70.5 General restrictions on use of lishing a definition and standard of
color additives.
identity for a food under section 401 of
(a) Color additives for use in the area of the act, which proposes the inclusion of
the eye. No listing or certification of a a color additive in the standardized
color additive shall be considered to food, the provisions of the regulations
authorize the use of any such color ad- in part 71 of this chapter shall apply
ditive in any article intended for use in with respect to the information that
the area of the eye unless such listing must be submitted with respect to the
or certification of such color additive safety of the color additive (if such in-
specifically provides for such use. Any formation has not previously been sub-
color additive used in or on any article mitted and safety of the color additive
intended for use in the area of the eye, for the intended use has not been al-
the listing or certification of which ready established), and the petition
color additive does not provide for such must show also that the use of the
use, shall be considered to be a color color additive in the standardized food
additive not listed under parts 73, 74, would be in conformance with section
and 81 of this chapter, even though 401 of the act or with the terms of a
such color additive is certified and/or temporary permit issued under § 130.17
listed for other uses. of this chapter.
(b) Color additives for use in injections.
(2) If a petition for a definition and
No listing or certification of a color ad-
standard of identity contains a pro-
ditive shall be considered to authorize
the use of any such color additive in posal for a color additive regulation,
any article intended for use in injec- and the petitioner fails to designate it
tions unless such listing or certifi- as such, the Commissioner, upon deter-
cation of such color additive specifi- mining that the petition includes a
cally provides for such use. Any color proposal for a color additive regula-
additive used in or on any article in- tion, shall so notify the petitioner and
tended for use in injections, the listing shall thereafter proceed in accordance
or certification of which color additive with the regulations in part 71 of this
does not provide for such use, shall be chapter.
considered to be a color additive not (3) A regulation will not be issued al-
listed under parts 73, 74, and 81 of this lowing the use of a color additive in a
chapter, even though such color addi- food for which a definition and stand-
tive is certified and/or listed for other ard of identity is established, unless its
uses. issuance is in conformance with sec-
(c) Color additives for use in surgical tion 401 of the act or with the terms of
sutures. No listing or certification of a a temporary permit issued under
color additive shall be considered to § 130.17 of this chapter. When the con-
authorize the use of any such color ad- templated use of such additive com-
ditive in any article intended for use as plies with the terms of a temporary
a surgical suture unless such listing or permit, the color additive regulation
certification of such color additive spe- will be conditioned on such compliance
cifically provides for such use. Any and will expire with the expiration of
color additive used in or on any article the temporary permit.
intended for use as a surgical suture, (b) New drugs. (1) Where an applica-
the listing or certification of which tion for a new drug is received and this
414
application proposes, for coloring pur- cholinesterase inhibition) produced by

poses only, the inclusion of a color ad- such substance.
ditive, the provisions of the regulations
in part 71 of this chapter shall apply § 70.19 Fees for listing.
with respect to the information that (a) Each petition for the listing of a
must be submitted about the safety of color additive shall be accompanied by
the color additive, if such information a deposit of $3,000.00 if the proposal is
has not previously been submitted and for listing the color additive for use
safety of the color additive for the in- generally in or on foods, in or on drugs,
tended use has not already been estab- and in or on cosmetics.
lished. (b) If the petition for the listing is for
(2) If an application for a new drug use in or on foods only, the deposit
inferentially contains a proposal for a shall be $3,000.00.
color additive regulation, and the ap- (c) If the petition for the listing is for
plicant fails to designate it as such, the use in or on drugs and/or cosmetics
Commissioner, upon determining that only, the deposit shall be $2,600.00.
the application includes a proposal for (d) The provisions of paragraphs (a),
a color additive regulation, shall so no- (b), and (c) of this section shall be ap-
tify the applicant and shall thereafter plicable, whether or not the proposal
proceed in accordance with the regula- contemplates any tolerances, limita-
tions in part 71 of this chapter. tions, or other restrictions placed upon
(3) Where a petition for a color addi- the use of the color additive.
tive must be filed in accordance with (e) If a petition proposing the
paragraph (b)(2) of this section, the issuance of a regulation is withdrawn
date of filing of the color additive peti- before it is finally accepted for filing,
tion shall be considered as the date of the deposit, less a $600.00 fee for cler-
filing of the new-drug application. ical handling and administrative and
[42 FR 15636, Mar. 22, 1977, as amended at 64 technical review, shall be returned to
FR 400, Jan. 5, 1999] the petitioner.
(f) If a petition proposing the
§ 70.11 Related substances. issuance of a regulation is withdrawn
(a) Different color additives may within 30 days after filing, the deposit,
cause similar or related pharma- less $1,800.00 if the petition is covered
cological or biological effects, and, in by paragraph (a) or (b) of this section,
the absence of evidence to the con- and less $1,600.00, if the petition is cov-
trary, those that do so will be considered by paragraph (c) of this section,
ered to have additive toxic effects. shall be returned to the petitioner.
(b) Food additives may also cause (g) When a petition is withdrawn
pharmacological or biological effects after filing and resubmitted within 6
similar or related to such effects months, it shall be accompanied by a
caused by color additives, and, in the deposit of $1,800.00 for a petition filed
absence of evidence to the contrary, under paragraph (a) or (b) of this sec-
those that do so will be considered as tion, and $1,600.00 for a petition filed
having additive toxic effects. under paragraph (c) of this section. If a
(c) Pesticide chemicals may also petition is resubmitted after 6 months,
cause pharmacological or biological efit shall be accompanied by the deposit
fects similar or related to such effects that would be required if it were being
caused by color additives, and, in the submitted for the first time.
absence of evidence to the contrary, (h) When the resubmission pertains
those that do so will be considered to to a petition that had been withdrawn
have additive toxic effects. before acceptance for filing, a new ad-
(d) In establishing tolerances for vance deposit shall be made in full as
color additives, the Commissioner will prescribed in paragraph (a), (b), or (c)
take into consideration, among other of this section.
things, the amount of any common (i) After a color additive has been
component permitted in other color ad- listed, any request for an amendment
ditives, in food additives, and in pes- or additional tolerance shall be accom-
ticide chemical residues as well as the panied by a deposit of $1,800.00 for use
similar biological activity (such as in the items specified in paragraphs (a)
415
§ 70.20 21 CFR Ch. I (4–1–19 Edition)
and (b) of this section, or $1,600.00 for Food and Drug Administration, collect-
use in items specified in paragraph (c) ible at par at Washington, DC All de-
of this section. posits and fees shall be forwarded to
(j) The fee for services in listing a the Center for Food Safety and Applied
diluent under § 80.35 for use in color ad- Nutrition (HFS–200), Food and Drug
ditive mixtures shall be $250.00. Administration, 5001 Campus Dr., Col-
(k) Objections and request for public lege Park, MD 20740, whereupon after
hearing under section 721(d) of the act making appropriate record thereof
or section 203(d)(2)(C) of Pub. L. 86–618 they will be transmitted to the Treas-
(74 Stat. 404; 21 U.S.C. 379e, note) shall urer of the United States for deposit in
be accompanied by a filing fee of the special account ‘‘Salaries and Ex-
$250.00. penses, Certification, Inspection, and
(l) In the event of a referral of a peti- Other Services, Food and Drug Admin-
tion under this section to an advisory istration.’’
committee, all costs related thereto (q) The Commissioner of Food and
(including personal compensation of Drugs may waive or refund such fees in
committee members, travel materials, whole or in part when in his judgment
and other costs) shall be borne by the such action will promote the public in-
person or organization requesting the terest.
referral, such costs to be assessed on (r) Any person who believes that pay-
the basis of actual cost to the Govern- ment of these fees will work a hardship
ment: Provided, That the compensation on him may petition the Commissioner
of such costs shall include personal of Food and Drugs to waive or refund
compensation of advisory committee the fees.
members at a rate not to exceed $75.00 [42 FR 15636, Mar. 22, 1977, as amended at 54
per member per day. FR 24890, June 12, 1989; 61 FR 14478, Apr. 2,
(m) In the case of requests of refer- 1996; 66 FR 56035, Nov. 6, 2001; 81 FR 49895,
rals to advisory committees, a special July 29, 2016]
advance deposit shall be made in the
amount of $2,500.00. Where required, Subpart B—Packaging and
further advance in increments of Labeling
$2,500.00 each shall be made upon re-
quest of the Commissioner of Food and § 70.20 Packaging requirements for
Drugs. All deposits for referrals to ad- straight colors (other than hair
visory committees in excess of actual dyes).
expenses shall be refunded to the de- Straight colors shall be packaged in
positor. containers which prevent changes in
(n) All requests for pharmacological composition. Packages shall be sealed
or other scientific studies shall be ac- so that they cannot be opened without
companied by an advance deposit of breaking the seal. An unavoidable
$5,000.00. Further advance deposits change in moisture content caused by
shall be made upon request of the Com- the ordinary and customary exposure
missioner of Food and Drugs when nec- that occurs in good storage, packing,
essary to prevent arrears in such cost. and distribution practice is not consid-
Any deposits in excess of actual ex- ered a change in composition. If the
penses will be refunded to the deposi- packaging material is a food additive it
tor. If a request is denied the advance shall be authorized by an appropriate
deposit will be refunded less such costs regulation in parts 170 through 189 of
as are incurred for review of the re- this chapter.
quest.
(o) The person who files a petition for § 70.25 Labeling requirements for
judicial review of an order under sec- color additives (other than hair
tion 721(d) of the act shall pay the dyes).
costs of preparing a transcript of the (a) General labeling requirements. All
record on which the order is based. color additives shall be labeled with
(p) All deposits and fees required by sufficient information to assure their
the regulations in this section shall be safe use and to allow a determination
paid by money order, bank draft or cer- of compliance with any limitations im-
tified check drawn to the order of the posed by this part and parts 71, 73, 74,
416
80, and 81 of this chapter. In addition to such code number will be used in lieu
all other information required by the of the lot number.
act, labels for color additives, except
those in a form suitable for coloring Subpart C—Safety Evaluation
the human body, shall state:
(1) The name of the straight color or § 70.40 Safety factors to be considered.
the name of each ingredient com- In accordance with section
prising the color additive, if it is a 721(b)(5)(A)(iii) of the act, the following
mixture. safety factor will be applied in deter-
(2) A statement indicating general mining whether the proposed use of a
limitations for the use of the color ad- color additive will be safe: Except
ditive, such as ‘‘for food use only’’; ‘‘for where evidence is submitted which jus-
food, drug, and cosmetic use’’; ‘‘for use tifies use of a different safety factor, a
in drugs for external application only.’’ safety factor of 100 to 1 will be used in
(3) Where regulations issued impose applying animal experimentation data
quantitative limitations for a general to man; that is, a color additive for use
or specific use of a straight color, the by man will not be granted a tolerance
amount of each such straight color in that will exceed 1/100th of the max-
terms of weight per unit/volume or per- imum no-effect level for the most sus-
cent by weight. ceptible experimental animals tested.
(4) An expiration date if stability The various species of experimental
animals used in the tests shall conform
data require it.
to good pharmacological practice.
(b) Special labeling for color additives
with tolerances. Where tolerances are § 70.42 Criteria for evaluating the safe-
imposed for a general or specific use of ty of color additives.
a color additive, the label shall in addi- (a) In deciding whether a petition is
tion provide directions for use of the complete and suitable for filing and in
color additive which if followed will reaching a decision on any petition
preclude the food, drug, or cosmetic to filed, the Commissioner will apply the
which it is added from containing an ‘‘safe-for-use’’ principle. This will re-
amount of the color additive in excess quire the presentation of all needed
of the tolerance. scientific data in support of a proposed
(c) Special labeling for color additives listing to assure that each listed color
with other limitations. If use of the color additive will be safe for its intended
additive is subject to other limitations use or uses in or on food, drugs, or cos-
prescribed in this part, such limita- metics. The Commissioner may list a
tions shall be stated on the label of the color additive for use generally in or on
color additive by a plain and con- food, in or on drugs, or in or on cos-
spicuous statement. Examples of such metics when he finds from the data
limitation statements are: ‘‘Do not use presented that such additive is suitable
in products used in the area of the and may safely be employed for such
eye’’; ‘‘Do not use for coloring drugs general use; he may list an additive
for injection.’’ only for more limited use or uses for
(d) Special labeling for color additives which it is proven suitable and may
not exempt from certification. Color addi- safely be employed; and he is author-
tives not exempt from the certification ized to prescribe broadly the conditions
procedures shall in addition include in under which the additive may be safely
the labeling the lot number assigned by employed for such use or uses. This
the Color Certification Branch, except may allow the use of a particular dye,
that in the case of any mixture for pigment, or other substance with cer-
household use which contains not more tain diluents, but not with others, or at
than 15 percent of pure color and which a higher concentration with some than
is in packages containing not more with others.
than 3 ounces there appears on the (b) The safety for external color addi-
label, a code number which the manu- tives will normally be determined by
facturer has identified with the lot tests for acute oral toxicity, primary
number by giving to the Food and Drug irritation, sensitization, subacute der-
Administration written notice that mal toxicity on intact and abraded
417
§ 70.45 21 CFR Ch. I (4–1–19 Edition)
skin, and carcinogenicity by skin ap- determine whether, based on the judg-
plication. The Commissioner may ment of appropriately qualified sci-
waive any of such tests if data before entists, cancer has been induced and
him otherwise establish that such test whether the color additive, including
is not required to determine safety for its components or impurities, was the
the use proposed. causative substance. If it is his judg-
(c) Upon written request describing ment that the data do not establish
the proposed use of a color additive and these facts, the cancer clause is not ap-
the proposed experiments to determine plicable; and if the data considered as a
its safety, the Commissioner will ad- whole establish that the color additive
vise a person who wishes to establish will be safe under the conditions that
the safety of a color additive whether can be specified in the applicable regu-
he believes the experiments planned lation, it may be listed for such use.
will yield data adequate for an evalua- But if in the judgment of the Commis-
tion of the safety of the additive. sioner, based on information from
§ 70.45 Allocation of color additives. qualified scientists, cancer has been in-
duced, no regulation may issue which
Whenever, in the consideration of a permits its use.
petition or a proposal to list a color ad- (b) Color additives that will not be in-
ditive or to alter an existing listing, gested. Whenever the scientific data be-
the data before the Commissioner fail
fore the Commissioner suggest the pos-
to show that it would be safe to list the
sibility that the color additive, includ-
color additive for all the uses proposed
ing its components or impurities, has
or at the levels proposed, the Commis-
induced cancer in man or animals by
sioner will notify the petitioner and
routes other than ingestion, the Com-
other interested persons by publication
missioner shall determine whether,
in the FEDERAL REGISTER that it is nec-
based on the judgment of appropriately
essary to allocate the safe tolerance for
qualified scientists, the test suggesting
the straight color in the color additive
the possibility of carcinogenesis is ap-
among the competing needs. This no-
tice shall call for the presentation of propriate for the evaluation of the
data by all interested persons on which color additive for a use which does not
the allocation can be made in accord- involve ingestion, cancer has been in-
ance with section 721(b)(8) of the act. duced, and the color additive, including
The time for acting upon the petition its components or impurities, was the
shall be stayed until such data are pre- causative substance. If it is his judg-
sented, whereupon the time limits ment that the data do not establish
shall begin to run anew. As promptly these facts, the cancer clause is not ap-
as possible after presentation of the plicable to preclude external drug and
data, the Commissioner will, by order, cosmetic uses, and if the data as a
announce the allocation and the toler- whole establish that the color additive
ance limitations. will be safe under conditions that can
be specified in the regulations, it may
§ 70.50 Application of the cancer be listed for such use. But if, in the
clause of section 721 of the act. judgment of the Commissioner, based
(a) Color additives that may be ingested. on information from qualified sci-
Whenever (1) the scientific data before entists, the test is an appropriate one
the Commissioner (either the reports for the consideration of safety for the
from the scientific literature or the re- proposed external use, and cancer has
sults of biological testing) suggest the been induced by the color additive, in-
possibility that the color additive including its components or impurities,
cluding its components or impurities no regulation may issue which permits
has induced cancer when ingested by its use in external drugs and cosmetics.
man or animal; or (2) tests which are (c) Color additives for use as an ingre-
appropriate for the evaluation of the dient of feed for animals that are raised
safety of additives in food suggest that for food production. Color additives that
the color additive, including its compo- are an ingredient of the feed for ani-
nents or impurities, induces cancer in mals raised for food production and
man or animal, the Commissioner shall that have the potential to contaminate
418
human food with residues whose con- additive for which a regulation has
sumption could present a risk of cancer issued.
to people must satisfy the require- 71.25 Condition for certification.
ments of subpart E of part 500 of this 71.26 Revocation of exemption from certifi-
chapter. cation.
71.27 Listing and exemption from certifi-
[42 FR 15636, Mar. 22, 1977, as amended at 43 cation on the Commissioner’s initiative.
FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, 71.30 Procedure for filing objections to regu-
1987] lations.
71.37 Exemption of color additives for inves-
§ 70.51 Advisory committee on the ap- tigational use.
plicability of the anticancer clause.
AUTHORITY: 21 U.S.C. 321, 342, 348, 351, 355,
All requests for and procedures gov- 360, 360b–360f, 360h–360j, 361, 371, 379e, 381; 42
erning any advisory committee on the U.S.C. 216, 262.
anticancer clause shall be subject to
the provisions of part 14 of this chap- SOURCE: 42 FR 15639, Mar. 22, 1977, unless
ter, and particularly subpart H of that otherwise noted.
part.
§ 70.55 Request for scientific studies.
The Commissioner will consider re- § 71.1 Petitions.
quests by any interested person who (a) Any interested person may pro-
desires the Food and Drug Administra- pose the listing of a color additive for
tion to conduct scientific studies to use in or on any food, drug, or cosmetic
support a petition for a regulation for or for coloring the human body. Such
a color additive. If favorably acted proposal shall be made in a petition in
upon, such studies will be limited to the form prescribed in paragraph (c) of
pharmacological investigations, stud- this section. The petition shall be sub-
ies of the chemical and physical struc- mitted in triplicate (quadruplicate, if
ture of the color additive, and methods
intended uses include uses in meat,
of analysis of the pure color additive
meat food product, or poultry product).
(including impurities) and its identi-
If any part of the material submitted is
fication and determination in foods,
drugs, or cosmetics, as the case may in a foreign language, it shall be ac-
be. All requests for such studies shall companied by an accurate and com-
be accompanied by the fee prescribed plete English translation. The peti-
in § 70.19. tioner shall state the post-office ad-
dress in the United States to which
published notices or orders issued or
PART 71—COLOR ADDITIVE
objections filed pursuant to section 721
PETITIONS of the act may be sent.
Subpart A—General Provisions (b) Pertinent information may be in-
corporated in, and will be considered as
Sec. part of, a petition on the basis of spe-
71.1 Petitions. cific reference to such information sub-
71.2 Notice of filing of petition. mitted to and retained in the files of
71.4 Samples; additional information.
the Food and Drug Administration.
71.6 Extension of time for studying peti-
tions; substantive amendments; with- However, any reference to unpublished
drawal of petitions without prejudice. information furnished by a person
71.15 Confidentiality of data and informa- other than the applicant will not be
tion in color additive petitions. considered unless use of such informa-
71.18 Petition for exemption from certifi- tion is authorized in a written state-
cation. ment signed by the person who sub-
mitted the information. Any reference
Subpart B—Administrative Action on
Petitions to published information offered in
support of a color additive petition
71.20 Publication of regulation. should be accompanied by reprints or

71.22 Deception as a basis for refusing to photostatic copies of such references.
issue regulations; deceptive use of a color
419
§ 71.1 21 CFR Ch. I (4–1–19 Edition)
(c) Petitions shall include the fol- stance should be identified by its common or
lowing data and be submitted in the usual name and its complete chemical name,
following form: using structural formulas when necessary for
specific identification. If any proprietary
lllllllll (Date) preparation is used as a component, the pro-
Name of petitioner lllllllllllll prietary name should be followed by a com-
Post-office address lllllllllllll plete quantitive statement of composition.
Name of color additive and proposed use ll Reasonable alternatives for any listed sub-
stance may be specified.
Office of Food Additive Safety (HFS–200), If the petitioner does not himself perform
Center for Food Safety and Applied Nutri- all the manufacturing, processing, and pack-
tion, ing operations for a color additive, the peti-
Food and Drug Administration, tioner shall identify each person who will
5001 Campus Dr., perform a part of such operations and des-
College Park, MD 20740 ignate the part.
Dear Sir: The petition shall include stability data,
Petitioner submits this pursuant to sec-
and, if the data indicate that it is needed to
tion 721(b)(1) of the Federal Food, Drug, and
insure the identity, strength, quality, or pu-
Cosmetic Act requesting listing by the Com-
rity of the color additive, the expiration pe-
missioner of the color additive lllll as
riod that will be employed as well as any
suitable and safe for use in or on lllll
packaging and labeling precautions needed
subject to the conditions that lllllll.
to preserve stability.
[Petitioner may propose a listing for general
use in food, drugs, or cosmetics or, if such B. The amount of the color additive pro-
general listing is not believed suitable and posed for use and the color effect intended to
safe, the petitioner shall describe the condi- be achieved, together with all directions,
tions under which he believes the additive recommendations, and suggestions regarding
can be safely used and for which it will be the proposed use, as well as specimens of the
suitable. These conditions may include toler- labeling proposed for the color additive. If
ance limitations, specifications as to the the color effect results or may reasonably be
manner in which the additive may be added expected to result from use of the color addi-
or used, and directions and other labeling or tive in packaging material, the petitioner
packaging safeguards that should be applied. shall show how this may occur and what res-
The level of use proposed should not be high- idues may reasonably be anticipated.
er than reasonably required to accomplish Typewritten or other draft-labeling copy
the intended color effect.] will be accepted for consideration of the pe-
Attached hereto, in triplicate (quadru- tition provided final printed labeling iden-
plicate, if intended uses include uses in tical in content to the draft copy is sub-
meat, meat food product, or poultry prod- mitted as soon as available, and prior to the
uct), and constituting a part of this petition marketing of the color additive. The printed
are the following: labeling shall conform in prominence and
A. The name and all pertinent information conspicuousness with the requirements of
concerning the color additive, including the act.
chemical identity and composition of the If the color additive is one for which a tol-
color additive, its physical, chemical, and bi- erance limitation is required to assure its
ological properties, and specifications pre- safety, the level of use proposed should be no
scribing its component(s) and identifying higher than the amount reasonably required
and limiting the reaction byproducts and to accomplish the intended physical or other
other impurities. technical effect, even though the safety data
The petition shall contain a description of may support a higher tolerance. If the safety
the chemical and physical tests relied upon data will not support the use of the amount
to identify the color additive and shall con- of the color additive reasonably needed to
tain a full description of the methods used accomplish the desired color effect, the re-
in, and the facilities and controls used for, quested tolerance will not be established. Pe-
the production of the color additive. These titioners are expected to propose the use of
shall establish that it is a substance of re- color additives in accordance with sound
producible composition. Alternative methods color chemistry.
and controls and variations in methods and C.1. A description of practicable methods
controls, within reasonable limits, that do to determine the pure color and all inter-
not affect the characteristics of the sub- mediates, subsidiary colors, and other com-
stance or the reliability of the controls may ponents of the color additive.
be specified. 2. A description of practicable methods to
The petition shall supply a list of all sub- determine the amount of the color additive
stances used in the synthesis, extraction, or in any raw, processed, and/or finished food,
other method of preparation of any straight drug, or cosmetic in which use of the color
color, regardless of whether they undergo additive is proposed. (The tests proposed
chemical change in the process. Each sub- shall be those that can be used for food, drug,
420
or cosmetic control purposes and can be ap- Yours very truly,
plied with consistent results by any properly (Petitioner) lllllllllllllllll
equipped laboratory and trained personnel.) By lllllll (Indicate authority)
3. A description of methods for identifica-
tion and determination of any substance J. The petitioner is required to submit ei-
formed in or on such food, drug, or cosmetic ther a claim for categorical exclusion under
because of the use of the color additive. (If it § 25.30 or 25.32 of this chapter or an environ-
is the petitioner’s view that any such meth- mental assessment under § 25.40 of this chap-
od would not be needed, under the terms of ter.
section 721(b)(5)(A)(iv), a statement shall be
submitted in lieu of methods as to the basis
(d) The petitioner will be notified of
for such view.) the date on which his petition is filed;
D. Full reports of investigation made with and an incomplete petition, or one that
respect to the safety of the color additive. has not been submitted in triplicate,
(A petition will be regarded as incomplete will be retained but not filed. A peti-
unless it includes full reports of adequate tion shall be retained but shall not be
tests reasonably applicable to show whether filed if any of the data listed in the
or not the color additive will be safe for its above form are lacking or are not set
intended use. The reports ordinarily should
include detailed data derived from appro-
forth so as to be readily understood or
priate animal and other biological experi- if the prescribed fee has not been sub-
ments in which the methods used and the re- mitted. The petitioner will be notified
sults obtained are clearly set forth. The peti- in what respects his petition is incom-
tion shall not omit without explanation any plete.
data that would influence the evaluation of (e) The petition must be signed by
the safety of the color additive). the petitioner or by his attorney or au-
E. Complete data which will allow the
Commissioner to consider, among other
thorized agent, who is a resident of the
things, the probable consumption of, and/or United States.
other relevant exposure from the additive (f) The data specified under the sev-
and of any substance formed in or on food, eral lettered headings should be sub-
drugs, or cosmetics because of such additive; mitted on separate sheets or sets of
and the cumulative effect, if any, of such ad- sheets, suitably identified. If such data
ditive in the diet of man or animals, taking have already been submitted with an
into account the same or any chemically or
earlier application, the present peti-
pharmacologically related substance or sub-
stances in the diet including, but not limited tion may incorporate it by specific ref-
to food additives and pesticide chemicals for erence to the earlier petition.
which tolerances or exemptions from toler- (g) If nonclinical laboratory studies
ances have been established. are involved, petitions filed with the
F. Proposed tolerances and other limita- Commissioner under section 721(b) of
tions on the use of the color additive, if tol- the act shall include with respect to
erances and limitations are required in order each nonclinical study contained in the
to insure its safety. A petitioner may include
a proposed regulation.
petition, either a statement that the
G. If exemption from batch certification is study was conducted in compliance
requested, the reasons why it is believed with the good laboratory practice regu-
such certification is not necessary (including lations set forth in part 58 of this chap-
supporting data to establish the safety of the ter, or, if the study was not conducted
intended use). in compliance with such regulations, a
H. If submitting a petition to alter an ex- brief statement of the reason for the
isting regulation issued pursuant to section noncompliance.
721(b) of the act, full information on each
proposed change that is to be made in the
(h) [Reserved]
original regulation must be submitted. The (i) If clinical investigations involving
petition may omit statements made in the human subjects are involved, petitions
original petition concerning which no filed with the Commissioner under sec-
change is proposed. A supplemental petition tion 721(b) of the act shall include
must be submitted for any change beyond statements regarding each such clin-
the variations provided for in the original ical investigation contained in the pe-
petition and the regulation issued on the
basis of the original petition.
tition that it either was conducted in
I. The prescribed fee of $llllll for ad- compliance with the requirements for
institutional review set forth in part 56
mitting the color additive to listing is en-

closed (unless there is an advance deposit of this chapter, or was not subject to
adequate to cover the fee). such requirements in accordance with
421
§ 71.2 21 CFR Ch. I (4–1–19 Edition)
§§ 56.104 or 56.105, and that it was con- be made in accordance with § 70.10(b)(3)
ducted in compliance with the require- of this chapter.
ments for informed consent set forth in (b) The Commissioner will cause to
part 50 of this chapter. be published in the FEDERAL REGISTER
(j)(1) If intended uses of the color ad- within 30 days from the date of filing of
ditive include uses in meat, meat food such petition a notice of the filing, the
product, or poultry product subject to name of the petitioner, and a brief de-
regulation by the U.S. Department of scription of the proposal in general
Agriculture (USDA) under the Poultry
terms. A copy of the notice will be
Products Inspection Act (PPIA) (21
mailed to the petitioner when the
U.S.C. 451 et seq.) or the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et original document is signed.
seq.), FDA shall, upon filing of the peti- [42 FR 15639, Mar. 22, 1977, as amended at 64
tion, forward a copy of the petition or FR 400, Jan. 5, 1999]
relevant portions thereof to the Food
Safety and Inspection Service, USDA, § 71.4 Samples; additional information.
for simultaneous review under the The Commissioner may request sam-
PPIA and FMIA.
ples of the color additive, articles used
(2) FDA will ask USDA to advise
as components thereof, or of the food,
whether the proposed meat and poultry
uses comply with the FMIA and PPIA drug, or cosmetic in which the color
or, if not, whether use of the substance additive is proposed to be used, or
would be permitted in products under which comprises the color additive, and
USDA jurisdiction under specified con- any additional information needed to
ditions or restrictions. clarify a submitted method or other as-
pect of a petition at any time while a
FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27,
petition is under consideration. The
1981; 50 FR 7491, Feb. 22, 1985; 50 FR 16668, Commissioner shall specify in the re-
Apr. 26, 1985; 54 FR 24890, June 12, 1989; 61 FR quest for a sample of the color addi-
14478, Apr. 2, 1996; 62 FR 40598, July 29, 1997; tive, or articles used as components
65 FR 51762, Aug. 25, 2000; 66 FR 56035, Nov. 6, thereof, or of the food, drug, or cos-
2001; 81 FR 49895, July 29, 2016]
metic in which the color additive is
§ 71.2 Notice of filing of petition. proposed to be used, or which com-
prises the color additive, a quantity
(a) Except where the petition in-
deemed adequate to permit tests of an-
volves a new drug, the Commissioner,
alytical methods to determine quan-
within 15 days after receipt, will notify
the petitioner of acceptance or non- tities of the color additive present in
acceptance of a petition, and if not ac- products for which it is intended to be
cepted the reasons therefor. If accept- used or adequate for any study or in-
ed, the date of the notification letter vestigation reasonably required with
sent to petitioner becomes the date of respect to the safety of the color addi-
filing for the purposes of section tive or the physical or technical effect
721(d)(1) of the act. If the petitioner de- it produces. The date used for com-
sires, he may supplement a deficient puting the 90-day limit for the purposes
petition after being notified regarding of section 721(d)(1) of the act shall be
deficiencies. If the supplementary ma- moved forward 1 day for each day, after
terial or explanation of the petition is mailing date of the request, taken by
deemed acceptable, petitioner shall be the petitioner to submit the informa-
notified. The date of such notification tion and/or sample. If the information
becomes the date of filing. If the peti- or sample is requested a reasonable
tioner does not wish to supplement or time in advance of the 180 days, but is
explain the petition and requests in not submitted within such 180 days
writing that it be filed as submitted, after filing of the petition, the petition
the petition shall be filed and the peti-
will be considered withdrawn without
tioner so notified. The date of such no-
prejudice.
tification becomes the date of filing.
Where the petition involves a new

drug, notification to the petitioner will
422
§ 71.6 Extension of time for studying plete. In such cases, the petitioner may
petitions; substantive amendments; withdraw the petition pending its clari-
withdrawal of petitions without fication or the obtaining of additional
prejudice. data. This withdrawal will be without
(a) Extension of time for studying peti- prejudice to a future filing. Upon re-
tions. If the Commissioner determines filing, the time limitation will begin to
that additional time is needed to study run anew from the date of refiling.
and investigate the petition, he shall (2) At any time before the order pro-
by written notice to the petitioner ex- vided for in § 71.20 has been forwarded
tend the 90-day period for not more to the FEDERAL REGISTER for publica-
than 180 days after the filing of the pe- tion the petitioner may withdraw the
tition. petition without prejudice to a future
(b) Substantive amendments. After a filing. Upon refiling, the time limita-
petition has been filed, the petitioner tion will begin to run anew.
may submit additional information or [42 FR 15636, Mar. 22, 1977, as amended at 43
data in support thereof. In such cases, FR 60021, Dec. 22, 1978; 46 FR 8952, Jan. 27,
if the Commissioner determines that 1981; 50 FR 7491, Feb. 22, 1985]
the additional information or data
amounts to a substantive amendment, § 71.15 Confidentiality of data and in-
the petition as amended will be given a formation in color additive peti-
new filing date, and the time limitations.
tion will begin to run anew. If nonclin- (a) The following data and informa-
ical laboratory studies are involved, tion in a color additive petition are
additional information and data sub- available for public disclosure, unless
mitted in support of filed petitions extraordinary circumstances are
shall include, with respect to each non- shown, after the notice of filing of the
clinical laboratory study contained in petition is published in the FEDERAL
the petition, either a statement that REGISTER or, if the petition is not
the study was conducted in compliance promptly filed because of deficiencies
with the requirements set forth in part in it, after the petitioner is informed
58 of this chapter, or, if the study was that it will not be filed because of the
not conducted in compliance with such deficiencies involved:
regulations, a brief statement of the (1) All safety and functionality data
reason for the noncompliance. If clin- and information submitted with or in-
ical investigations involving human corporated by reference in the petition.
subjects are involved, additional infor- (2) A protocol for a test or study, un-
mation or data submitted in support of less it is shown to fall within the ex-
filed petitions shall include statements emption established for trade secrets
regarding each such clinical investiga- and confidential commercial informa-
tion from which the information or tion in § 20.61 of this chapter.
data are derived, that it either was (3) Adverse reaction reports, product
conducted in compliance with the re- experience reports, consumer com-
quirements for institutional review set plaints, and other similar data and in-
forth in part 56 of this chapter, or was formation, after deletion of:
not subject to such requirements in ac- (i) Names and any information that
cordance with § 56.104 or § 56.105, and would identify the person using the
that it was conducted in compliance product.
with the requirements for informed (ii) Names and any information that
consent set forth in part 50 of this would identify any third party involved
chapter. with the report, such as a physician or
(c) Withdrawal of petitions without hospital or other institution.
prejudice. (1) In some cases the Com- (4) A list of all ingredients contained
missioner may notify the petitioner in a color additive, whether or not it is
that the petition, while technically in descending order of predominance. A
complete, is inadequate to justify the particular ingredient or group of ingre-
establishment of a regulation or the dients shall be deleted from any such
regulation requested by petitioner. list prior to public disclosure if it is
This may be due to the fact that the shown to fall within the exemption es-
data are not sufficiently clear or com- tablished in § 20.61 of this chapter, and
423
§ 71.18 21 CFR Ch. I (4–1–19 Edition)
a notation shall be made that any such tion shall show why such certification
ingredient list is incomplete. is not necessary for the protection of
(5) An assay method or other analyt- public health.
ical method, unless it serves no regu-
latory or compliance purpose and is Subpart B—Administrative Action
shown to fall within the exemption es- on Petitions
tablished in § 20.61 of this chapter.
(6) All records showing the Food and § 71.20 Publication of regulation.
Drug Administration’s testing of or ac-
tion on a particular lot of a certifiable The Commissioner will forward for
color additive. publication in the FEDERAL REGISTER,
(b) The following data and informa- within 90 days after filing of the peti-
tion in a color additive petition are not tion (or within 180 days if the time is
available for public disclosure unless extended as provided for in section
they have been previously disclosed to 721(d)(1) of the act):
the public as defined in § 20.81 of this (a) A regulation listing in part 73 or
chapter or they relate to a product or 74 of this chapter the color additive on
ingredient that has been abandoned the appropriate list or lists as provided
and they no longer represent a trade under section 721(b)(1).
secret or confidential commercial or fi- (1) Such a regulation may list the
nancial information as defined in § 20.61 color additive for use generally in or on
of this chapter: foods, drugs, or cosmetics or for use in
(1) Manufacturing methods or proc- coloring the human body, as the case
esses, including quality control proce- may be, or may prescribe the condi-
dures. tions under which the color additive
(2) Production, sales, distribution, may be safely used (including, but not
and similar data and information, ex- limited to, specifications as to the par-
cept that any compilation of such data ticular food, drug, or cosmetic or class-
and information aggregated and pre- es of food, drugs, or cosmetics in or on
pared in a way that does not reveal which such color additive may be used,
data or information which is not avail- or for the material intended for color-
able for public disclosure under this ing the human body; the maximum
provision is available for public disclo- quantity of any straight color or dil-
sure. uent that may be used or permitted to
(3) Quantitative or semiquantitative remain in or on such food, drug, or cos-
formulas. metic or article intended for coloring
(c) All correspondence and written the human body; the manner in which
summaries of oral discussions relating such color additive may be added to or
to a color additive petition are avail- used in or on such food, drug, or cos-
able for public disclosure in accordance metic or for coloring the human body;
with the provisions of part 20 of this and any directions or other labeling or
chapter when the color additive regula- packing requirements for such color
tion is published in the FEDERAL REG- additives deemed necessary to assure
ISTER. the safety of such use).
(d) For purposes of this regulation, (2) Such regulations shall list the
safety and functionality data include color additive only for the use or uses
all studies and tests of a color additive for which it has been found suitable
on animals and humans and all studies and for which it may safely be em-
and tests on a color additive for iden- ployed. Alternatively, the Commis-
tity, stability, purity, potency, per- sioner shall by order deny the petition,
formance, and usefulness. and notify the petitioner of such order
and the reasons therefor.
§ 71.18 Petition for exemption from (3) The regulation shall list any use
certification. or uses in meat, meat food product, or
A manufacturer, packer, or dis- poultry product subject to the Federal
tributor of a color additive or color ad- Meat Inspection Act (FMIA) (21 U.S.C.
ditive mixture may petition for an ex- 601 et seq.) or the Poultry Products In-
emption from certification pursuant to spection (PPIA) (21 U.S.C. 451 et seq.)
part 10 of this chapter. Any such peti- for which the color additive has been
424
found suitable and for which it may shall state in detail the specifications
safely be employed. that shall be met by the color additive.
(b) Whenever the Commissioner finds (b) Each order shall state a period of
that batch certification is not nec- time after which use of a color additive
essary for the protection of the public subject to batch certification but not
health he will, by order, exempt the from a batch certified by procedure
color additive from the certification prescribed in this section would result
procedure. In determining whether cer- in adulteration of the product in which
tification of a color additive is nec- it is used.
essary, the Commissioner will consider
the composition of the additive, its § 71.26 Revocation of exemption from
manufacturing process, possible impu- certification.
rities, its toxic potential, control and If information becomes available to
analytical procedures necessary to as- the Commissioner that a color additive
sure compliance with the listing speci- that has been granted exemption from
fications, and the variability of its certification should not, for the protec-
composition. tion of the public health, be so exempt-
[42 FR 15639, Mar. 22, 1977, as amended at 65 ed, such exemption will be canceled by
FR 51762, Aug. 25, 2000] a notice published in the FEDERAL REG-
ISTER.
§ 71.22 Deception as a basis for refus-
ing to issue regulations; deceptive § 71.27 Listing and exemption from
use of a color additive for which a certification on the Commissioner’s
regulation has issued. initiative.
The Commissioner shall refuse to Where a petition for a regulation to
issue a regulation listing a color addi- list a color additive has not been re-
tive, if in his judgment the data before ceived and the Commissioner has avail-
him show that such proposed use would able facts which demonstrate that a
promote deception of the consumer or color additive should be listed and/or
would result in misbranding or adulter- that certification procedure is not nec-
ation within the meaning of the act. essary in order to protect the public
Such a finding shall be by order pub- health, he may list such color additive
lished in the FEDERAL REGISTER sub-
by appropriate regulation and listing
ject to the filing of objections and a re-
in part 73 or 74 of this chapter.
quest for a hearing by adversely af-
fected parties. The issuance of a regu- § 71.30 Procedure for filing objections
lation for a color additive authorizing to regulations.
its use generally in or on a food, drug,
or cosmetic shall not be construed as (a) Objections and hearings relating
authorization to use the color additive to color additive regulations under sec-
in a manner that may promote deception 721 (b) and (c) of the act shall be
tion or conceal damage or inferiority. governed by parts 10, 12, 13, 14, 15, 16,
The use of a color additive to promote and 19 of this chapter.
deception or conceal damage or inferi- (b) The fees specified in § 70.19 of this
ority shall be considered as the use of chapter shall be applicable.
a color additive for which no regula-
tion has issued pursuant to section § 71.37 Exemption of color additives
721(b) of the act, even though the regu- for investigational use.
lation is effective for other uses. (a) A shipment or other delivery of a
color additive or of a food, drug, or cos-
§ 71.25 Condition for certification. metic containing such a color additive
(a) When the Commissioner cannot for investigational use by experts
conclude from the information before qualified to determine safety shall be
him that there is a basis for exempting exempt from the requirements of sec-
a color additive from the requirement tion 402(c), 501(a), or 601(e) of the act,
of batch certification, he will so order provided that the color additive or the
by appropriate listing in part 74 of this food, drug, or cosmetic containing the

chapter. The Commissioner’s order color additive bears a label which
425
states prominently, ‘‘Caution—Con- 73.165 Ferrous lactate.

tains new color additive—For inves- 73.169 Grape color extract.
tigational use only.’’ No animals used 73.170 Grape skin extract (enocianina).
73.185 Haematococcus algae meal.
in such investigations, or their prod- 73.200 Synthetic iron oxide.
ucts, such as milk or eggs, shall be 73.250 Fruit juice.
used for food purposes, unless the spon- 73.260 Vegetable juice.
sor or the investigator has submitted 73.275 Dried algae meal.
to the Commissioner data dem- 73.295 Tagetes (Aztec marigold) meal and
onstrating that such use will be con- extract.
sistent with the public health, and the 73.300 Carrot oil.
73.315 Corn endosperm oil.
Commissioner, proceeding as he would
73.340 Paprika.
in a matter involving section 409(i) of 73.345 Paprika oleoresin.
the act, has notified the sponsor or in- 73.350 Mica-based pearlescent pigments.
vestigator that the proposed disposi- 73.352 Paracoccus pigment.
tion for food is authorized. Any person 73.355 Phaffia yeast.
who contests a refusal to grant such 73.450 Riboflavin.
authorization shall have an oppor- 73.500 Saffron.
tunity for a regulatory hearing before 73.530 Spirulina extract.
73.575 Titanium dioxide.
the Food and Drug Administration pur-
73.585 Tomato lycopene extract; tomato ly-
suant to part 16 of this chapter. copene concentrate.
(b) The person who introduced such 73.600 Turmeric.
shipment or who delivers the color ad- 73.615 Turmeric oleoresin.
ditive or a food, drug, or cosmetic con-
taining such an additive into interstate Subpart B—Drugs
commerce shall maintain adequate
73.1001 Diluents in color additive mixtures
records showing the name and post-of- for drug use exempt from certification.
fice address of the expert to whom the 73.1010 Alumina (dried aluminum hydrox-
color additive is shipped, date, quan- ide).
tity, and batch or code mark of each 73.1015 Chromium-cobalt-aluminum oxide.
shipment and delivery for a period of 2 73.1025 Ferric ammonium citrate.
years after such shipment and delivery. 73.1030 Annatto extract.
Upon the request of a properly author- 73.1070 Calcium carbonate.
73.1075 Canthaxanthin.
ized employee of the Department, at
73.1085 Caramel.
reasonable times, he shall make such 73.1095 b-Carotene.
records available for inspection and 73.1100 Cochineal extract; carmine.
copying. 73.1125 Potassium sodium copper
chlorophyllin (chlorophyllin-copper com-
PART 73—LISTING OF COLOR AD- plex).
73.1150 Dihydroxyacetone.
DITIVES EXEMPT FROM CERTIFI- 73.1162 Bismuth oxychloride.
CATION 73.1200 Synthetic iron oxide.
73.1298 Ferric ammonium ferrocyanide.
Subpart A—Foods 73.1299 Ferric ferrocyanide.
73.1326 Chromium hydroxide green.
Sec. 73.1327 Chromium oxide greens.
73.1 Diluents in color additive mixtures for 73.1329 Guanine.
food use exempt from certification. 73.1350 Mica-based pearlescent pigments.
73.30 Annatto extract. 73.1375 Pyrogallol.
73.35 Astaxanthin. 73.1400 Pyrophyllite.
73.37 Astaxanthin dimethyldisuccinate. 73.1410 Logwood extract.
73.40 Dehydrated beets (beet powder). 73.1496 Mica.
73.50 Ultramarine blue. 73.1530 Spirulina extract.
73.70 Calcium carbonate. 73.1550 Talc.
73.75 Canthaxanthin. 73.1575 Titanium dioxide.
73.85 Caramel. 73.1645 Aluminum powder.
73.90 b-Apo-8′-carotenal. 73.1646 Bronze powder.
73.95 b-Carotene. 73.1647 Copper powder.
73.100 Cochineal extract; carmine. 73.1991 Zinc oxide.
73.125 Sodium copper chlorophyllin.
73.140 Toasted partially defatted cooked Subpart C—Cosmetics

cottonseed flour.
73.160 Ferrous gluconate. 73.2030 Annatto.
426
73.2085 Caramel. 73.3121 Poly(hydroxyethyl methacrylate)-
73.2087 Carmine. dye copolymers.
73.2095 b-Carotene. 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-
73.2110 Bismuth citrate. dihydro-5-methyl-2-phenyl-3H-pyrazol-3-
73.2120 Disodium EDTA-copper. one.
73.2125 Potassium sodium copper 73.3123 6-Ethoxy-2-(6-ethoxy-3-
chlorophyllin (chlorophyllin-copper com- oxobenzo[b]thien-2(3H)-ylidene)
plex). benzo[b]thiophen-3 (2H)-one.
73.2150 Dihydroxyacetone. 73.3124 Phthalocyanine green.
73.2162 Bismuth oxychloride. 73.3125 Iron oxides.
73.2180 Guaiazulene. 73.3126 Titanium dioxide.
73.2190 Henna. 73.3127 Vinyl alcohol/methyl methacrylate-
73.2250 Iron oxides. dye reaction products.
73.2298 Ferric ammonium ferrocyanide. 73.3128 Mica-based pearlescent pigments.
73.2299 Ferric ferrocyanide. 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-
73.2326 Chromium hydroxide green. oxoallyl)amino]-2-
73.2327 Chromium oxide greens. sulfonatophenyl]amino]-9,10-dihydro-9,10-
73.2329 Guanine. dioxoanthracene-2-sulfonate.
73.2396 Lead acetate.
AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348,
73.2400 Pyrophyllite.
351, 352, 355, 361, 362, 371, 379e.
73.2496 Mica.
73.2500 Silver. SOURCE: 42 FR 15643, Mar. 22, 1977, unless
73.2575 Titanium dioxide. otherwise noted.
73.2645 Aluminum powder.
EDITORIAL NOTE: Nomenclature changes to
73.2646 Bronze powder. part 73 appear at 66 FR 66742, Dec. 27, 2001.
73.2647 Copper powder.
73.2725 Ultramarines.
73.2775 Manganese violet. Subpart A—Foods
73.2991 Zinc oxide.
73.2995 Luminescent zinc sulfide. § 73.1 Diluents in color additive mix-
tures for food use exempt from cer-
Subpart D—Medical Devices tification.
73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-
The following substances may be
anthracenedione bis(2-methyl-2-prope- safely used as diluents in color additive
noic)ester copolymers. mixtures for food use exempt from cer-
73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10- tification, subject to the condition that
anthracenedione. each straight color in the mixture has
73.3106 1,4-Bis[4-(2-methacryloxyethyl) been exempted from certification or, if
phenylamino]anthraquinone copolymers. not so exempted, is from a batch that
73.3107 Carbazole violet. has previously been certified and has
73.3110 Chlorophyllin-copper complex, oil not changed in composition since cer-
soluble.
73.3110a Chromium-cobalt-aluminum oxide.
tification. If a specification for a par-
73.3111 Chromium oxide greens. ticular diluent is not set forth in this
73.3112 C.I. Vat Orange 1. part 73, the material shall be of a pu-
73.3115 2-[[2,5-Diethoxy-4-[(4- rity consistent with its intended use.
methylphenyl)thiol]phenyl]azo]-1,3,5- (a) General use. (1) Substances that
benzenetriol. are generally recognized as safe under
73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] the conditions set forth in section
naphth [2′,3′:6,7] indolo [2,3-c] carbazole- 201(s) of the act.
5,10,15,17,22,24-hexone.
(2) Substances meeting the defini-
73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-
anthracenediyl) bisbenzamide.
tions and specifications set forth under
73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18- subchapter B of this chapter, and
anthrazinetetrone. which are used only as prescribed by
73.3120 16,17-Dimethoxydinaphtho [1,2,3- such regulations.
cd:3′,2′,1′-lm] perylene-5,10-dione. (3) The following:
427
§ 73.1 21 CFR Ch. I (4–1–19 Edition)
Substances Definitions and specifications Restrictions
Calcium disodium EDTA (calcium diso- Contains calcium disodium ethyl- May be used in aqueous solutions and
dium ethyl- enediamine- tetraacetate). enediamine- tetraacetate dihydrate aqueous dispersions as a preservative
(CAS Reg. No. 6766–87–6) as set and sequestrant in color additive mixtures
forth in the Food Chemicals Codex, intended only for ingested use; the color
3d ed., p. 50, 1981. additive mixture (solution or dispersion)
may contain not more than 1 percent by
weight of the diluent (calculated as anhy-
drous calcium disodium ethyl-
enediamine-tetraacetate).
Castor oil ................................................. As set forth in U.S.P. XVI ..................... Not more than 500 p.p.m. in the finished
food. Labeling of color additive mixtures
containing castor oil shall bear adequate
directions for use that will result in a food
meeting this restriction.
Dioctylsodium sulfosuccinate .................. As set forth in sec. 172.810 of this Not more than 9 p.p.m. in the finished food.
chapter. Labeling of color additive mixtures con-
taining dioctylsodium sulfosuccinate shall
bear adequate directions for use that will
result in a food meeting this restriction.
Disodium EDTA (disodium ethyl- Contains disodium ethyl- enediamine- May be used in aqueous solutions and
enediamine- tetraacetate). tetraacetate dihydrate (CAS Reg. No. aqueous dispersions as a preservative
6381–92–6) as set forth in the Food and sequestrant in color additive mixtures
Chemicals Codex, 3d ed., p. 104, intended only for ingested use; the color
1981. additive mixture (solution or dispersion)
may contain not more than 1 percent by
weight of the diluent (calculated as anhy-
drous disodium ethyl- enediamine-
tetraacetate).
(b) Special use—(1) Diluents in color let form, gum, and confectionery. Items
additive mixtures for marking food—(i) listed in paragraph (a) of this section
Inks for marking food supplements in tab- and the following:
Alcohol, SDA–3A .................................... As set forth in 26 CFR pt. 212 ............. No residue.
n-Butyl alcohol ........................................ ............................................................... Do.
Cetyl alcohol ........................................... As set forth in N.F. XI ........................... Do.
Cyclohexane ........................................... ............................................................... Do.
Ethyl cellulose ......................................... As set forth in sec. 172.868 of this
chapter.
Ethylene glycol monoethyl ether ............. ............................................................... Do.
Isobutyl alcohol ....................................... ............................................................... Do.
Isopropyl alcohol ..................................... ............................................................... Do.
Polyoxyethylene sorbitan monooleate As set forth in sec. 172.840 of this
(polysorbate 80). chapter.
Polyvinyl acetate ..................................... Molecular weight, minimum 2,000.
Polyvinylpyrrolidone ................................ As set forth in sec. 173.55 of this chap-
ter.
Rosin and rosin derivatives .................... As set forth in sec. 172.615 of this
chapter.
Shellac, purified ...................................... Food grade.
(ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this sec-
tion and the following:
Acetone ................................................... As set forth in N.F. XI ........................... No residue.

Alcohol, SDA–3A .................................... As set forth in 26 CFR pt. 212 ............. Do.
Benzoin ................................................... As set forth in U.S.P. XVI.
Copal, Manila .......................................... .
Ethyl acetate ........................................... As set forth in N.F. XI ........................... Do.
Ethyl cellulose ......................................... As set forth in sec. 172.868 of this
chapter.
Methylene chloride .................................. ............................................................... Do.
Polyvinylpyrrolidone ................................ As set forth in sec. 173.55 of this chap-
ter.
Rosin and rosin derivatives .................... As set forth in sec. 172.615 of this
chapter.
428
Silicon dioxide ......................................... As set forth in sec. 172.480 of this Not more than 2 pct of the ink solids.
chapter.
Terpene resins, natural ........................... As set forth in sec. 172.615 of this
chapter.
Terpene resins, synthetic ........................ Polymers of a- and b-pinene.
(2) Diluents in color additive mixtures Ethylene glycol distearate.

for coloring shell eggs. Items listed in Japan wax.
paragraph (a) of this section and the Limed rosin.
following, subject to the condition that Naphtha.
there is no penetration of the color ad- Pentaerythritol ester of fumaric acid-rosin
ditive mixture or any of its compo- adduct.
nents through the eggshell into the Polyethylene glycol 6000 (as identified in
egg: § 172.820 of this chapter).
Polyvinyl alcohol.
Alcohol, denatured, formula 23A (26 CFR Rosin and rosin derivatives (as identified in
part 212), Internal Revenue Service. § 172.615 of this chapter).
Damar gum (resin).
Diethylene glycol distearate. (3) Miscellaneous special uses. Items
Dioctyl sodium sulfosuccinate. listed in paragraph (a) of this section
Ethyl cellulose (as identified in § 172.868 of
and the following:
this chapter).
Polyvinylpyrrolidone ................................ As set forth in sec. 173.55 of this chap- In or as food-tablet coatings; limit, not more
ter. than 0.1 pct in the finished food; labeling
of color additive mixtures containing
polyvinylpyrrolidone shall bear adequate
directions for use that will result in a food
meeting this restriction.
[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 69 FR 24511, May 4, 2004]
§ 73.30 Annatto extract. hol, methylene chloride, trichloro-

(a) Identity. (1) The color additive ethylene.
annatto extract is an extract prepared (2) Color additive mixtures for food
from annatto seed, Bixa orellana L., use made with annatto extract may
using any one or an appropriate com- contain only diluents that are suitable
bination of the food-grade extractants and that are listed in this subpart as
listed in paragraph (a)(1) (i) and (ii) of safe in color additive mixtures for
this section: coloring foods.
(i) Alkaline aqueous solution, alka- (b) Specifications. Annatto extract, in-
line propylene glycol, ethyl alcohol or cluding pigments precipitated there-
alkaline solutions thereof, edible vege- from, shall conform to the following
table oils or fats, mono- and specifications:
diglycerides from the glycerolysis of (1) Arsenic (as As), not more than 3
edible vegetable oils or fats. The alka- parts per million; lead as Pb, not more
line alcohol or aqueous extracts may than 10 parts per million.
be treated with food-grade acids to pre- (2) When solvents listed under para-
cipitate annatto pigments, which are graph (a)(1)(ii) of this section are used,
separated from the liquid and dried, annatto extract shall contain no more
with or without intermediate recrys- solvent residue than is permitted of the
tallization, using the solvents listed corresponding solvents in spice
under paragraph (a)(1)(ii) of this sec- oleoresins under applicable food addi-
tion. Food-grade alkalis or carbonates tive regulations in parts 170 through
may be added to adjust alkalinity. 189 of this chapter.
(ii) Acetone, ethylene dichloride, (c) Uses and restrictions. Annatto ex-
hexane, isopropyl alcohol, methyl alco- tract may be safely used for coloring
429
§ 73.35 21 CFR Ch. I (4–1–19 Edition)
foods generally, in amounts consistent Assay, minimum 96 percent.

with good manufacturing practice, ex- (c) Uses and restrictions. Astaxanthin
cept that it may not be used to color may be safely used in the feed of
foods for which standards of identity salmonid fish in accordance with the
have been promulgated under section
following prescribed conditions:
401 of the act unless added color is au-
(1) The color additive is used to en-
thorized by such standards.
(d) Labeling. The label of the color ad- hance the pink to orange-red color of
ditive and any mixtures prepared the flesh of salmonid fish.
therefrom and intended solely or in (2) The quantity of color additive in
part for coloring purposes shall con- feed is such that the color additive
form to the requirements of § 70.25 of shall not exceed 80 milligrams per kilo-
this chapter. Labels shall bear informa- gram (72 grams per ton) of finished
tion showing that the color is derived feed.
from annatto seed. The requirements of (d) Labeling requirements. (1) The la-
§ 70.25(a) of this chapter that all ingre- beling of the color additive and any
dients shall be listed by name shall not premixes prepared therefrom shall bear
be construed as requiring the declara- expiration dates for the sealed and
tion of residues of solvents listed in open container (established through
paragraph (a)(1)(ii) of this section. generally accepted stability testing
(e) Exemption from certification. Cer- methods), other information required
tification of this color additive is not by § 70.25 of this chapter, and adequate
necessary for the protection of the pub- directions to prepare a final product
lic health and therefore batches thereof complying with the limitations pre-
are exempt from the certification re- scribed in paragraph (c) of this section.
quirements of section 721(c) of the act. (2) The presence of the color additive
in finished fish feed prepared according
§ 73.35 Astaxanthin. to paragraph (c) of this section shall be
(a) Identity. (1) The color additive declared in accordance with § 501.4 of
astaxanthin is 3, 3′-dihydroxy-b, b-caro- this chapter.
tene-4, 4′-dione. (3) The presence of the color additive
(2) Astaxanthin may be added to the in salmonid fish that have been fed
fish feed only as a component of a sta- feeds containing astaxanthin shall be
bilized color additive mixture. Color declared in accordance with
additive mixtures for fish feed use §§ 101.22(k)(2) and 101.100(a)(2) of this
made with astaxanthin may contain chapter.
only those diluents that are suitable (e) Exemption from certification. Cer-
and are listed in this subpart as safe tification of this color additive is not
for use in color additive mixtures for necessary for the protection of the pub-
coloring foods. lic health, and therefore batches there-
(b) Specifications. Astaxanthin shall of are exempt from the certification re-
conform to the following specifications quirements of section 721(c) of the act.
and shall be free from impurities other
than those named to the extent that [60 FR 18738, Apr. 13, 1995]
such impurities may be avoided by
§ 73.37 Astaxanthin
good manufacturing practice: dimethyldisuccinate.
Physical state, solid.
(a) Identity. (1) The color additive
0.05 percent solution in chloroform, complete
and clear. astaxanthin dimethyldisuccinate is
Absorption maximum wavelength 484–493 3,3′-bis(4-methoxy-1,4-dioxobutoxy)-b,b-
nanometers (in chloroform). carotene–4,4′-dione.
Residue on ignition, not more than 0.1 per- (2) Astaxanthin dimethyldisuccinate
cent. may be added to the fish feed only as a
Total carotenoids other than astaxanthin, component of a stabilized mixture.
not more than 4 percent.
Color additive mixtures for fish feed
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million. use made with astaxanthin
dimethyldisuccinate may contain only
Mercury, not more than 1 part per million.

Heavy metals, not more than 10 parts per those diluents that are suitable and are
million. listed in this subpart as safe for use in
430
color additive mixtures for coloring (2) The presence of the color additive
foods. in finished fish feed prepared according
(b) Specifications. Astaxanthin to paragraph (c) of this section shall be
dimethyldisuccinate shall conform to declared in accordance with § 501.4 of
the following specifications and shall this chapter.
be free from impurities other than (3) The presence of the color additive
those named to the extent that such in salmonid fish that have been fed
impurities may be avoided by good feeds containing astaxanthin
manufacturing practice: dimethyldisuccinate shall be declared
(1) Physical state, solid. in accordance with §§ 101.22(b), (c), and
(2) 0.05 percent solution in chloro- (k)(2), and 101.100(a)(2) of this chapter.
form, complete and clear. (e) Exemption from certification. Cer-
(3) Absorption maximum wavelength tification of this color additive is not
484–493 nanometers (in chloroform). necessary for the protection of the pub-
(4) Residue on ignition, not more lic health, and therefore batches there-
than 0.1 percent. of are exempt from the certification re-
(5) Total carotenoids other than quirements of section 721(c) of the act.
astaxanthin dimethyldisuccinate, not
[74 FR 57251, Nov. 5, 2009]
more than 4 percent.
(6) Lead, not more than 5 milligrams § 73.40 Dehydrated beets (beet pow-
per kilogram (mg/kg) (5 parts per mil- der).
lion).
(7) Arsenic, not more than 2 mg/kg (2 (a) Identity. (1) The color additive de-
parts per million). hydrated beets is a dark red powder
(8) Mercury, not more than 1 mg/kg (1 prepared by dehydrating sound, ma-
part per million). ture, good quality, edible beets.
(9) Heavy metals, not more than 10 (2) Color additive mixtures made
mg/kg (10 parts per million). with dehydrated beets may contain as
(10) Assay including astaxanthin diluents only those substances listed in
dimethyldisuccinate, astaxanthin this subpart as safe and suitable for use
monomethylsuccinate, and in color additive mixtures for coloring
astaxanthin, minimum 96 percent. foods.
(c) Uses and restrictions. Astaxanthin (b) Specifications. The color additive
dimethyldisuccinate may be safely shall conform to the following speci-
used in the feed of salmonid fish in ac- fications:
cordance with the following prescribed Volatile matter, not more than 4 percent.
conditions: Acid insoluble ash, not more than 0.5 per-
(1) The color additive is used to en- cent.
hance the pink to orange-red color of Lead (as Pb), not more than 10 parts per mil-
the flesh of salmonid fish. lion.
(2) The quantity of astaxanthin Arsenic (as As), not more than 1 part per
dimethyldisuccinate in the finished million.
Mercury (as Hg), not more than 1 part per
feed, when used alone or in combina-
million.
tion with other astaxanthin color addi-
tive sources listed in this part 73, shall (c) Uses and restrictions. Dehydrated
not exceed 110 milligrams per kilogram beets may be safely used for the color-
(mg/kg), which is equivalent to 80 mg/ ing of foods generally in amounts con-
kg astaxanthin (72 grams per ton). sistent with good manufacturing prac-
(d) Labeling requirements. (1) The la- tice, except that it may not be used to
beling of the color additive and any color foods for which standards of iden-
premixes prepared therefrom shall bear tity have been promulgated under sec-
expiration dates for the sealed and tion 401 of the act, unless the use of
open container (established through added color is authorized by such
generally accepted stability testing standards.
methods), other information required (d) Labeling. The label of the color ad-
by § 70.25 of this chapter, and adequate ditive and any mixtures prepared
directions to prepare a final product therefrom intended solely or in part for
complying with the limitations pre- coloring purposes shall conform to the
scribed in paragraph (c) of this section. requirements of § 70.25 of this chapter.
431
§ 73.50 21 CFR Ch. I (4–1–19 Edition)
(e) Exemption from certification. Cer- (b) Specifications. The color additive
tification of this color additive is not meets the specifications of the Food
necessary for the protection of the pub- Chemicals Codex, 10th ed. (2016), pp.
lic health, and therefore batches there- 213–214 (calcium carbonate) and p. 754
of are exempt from the certification re- (limestone, ground), which is incor-
quirements of section 721(c) of the act. porated by reference. The Director of
the Office of the Federal Register ap-
§ 73.50 Ultramarine blue.
proves this incorporation by reference
(a) Identity. The color additive ultra- in accordance with 5 U.S.C. 552(a) and 1
marine blue is a blue pigment obtained CFR part 51. You may obtain copies
by calcining a mixture of kaolin, sul- from the United States Pharmacopeial
fur, sodium carbonate, and carbon at Convention, 12601 Twinbrook Pkwy.,
temperatures above 700 °C. Sodium sul- Rockville, MD 20852 (internet address
fate and silica may also be incor- http://www.usp.org). Copies may be ex-
porated in the mixture in order to vary amined at the Food and Drug Adminis-
the shade. The pigment is a complex tration’s Main Library, 10903 New
sodium aluminum sulfo-silicate having Hampshire Ave., Bldg. 2, Third Floor,
the approximate formula Na7Ai6Si6O24
Silver Spring, MD 20993, 301–796–2039, or
S3 .
at the National Archives and Records
(b) Specifications. Ultramarine blue
Administration (NARA). For informa-
shall conform to the following speci-
fications: tion on the availability of this mate-
rial at NARA, call 202–741–6030, or go
Lead (as Pb), not more than 10 parts per mil- to: http://www.archives.gov/
lion. federallregister/
Arsenic (as As), not more than 1 part per
million. codeloflfederallregulations/cfr/
Mercury (as Hg), not more than 1 part per ibrllocations.html.
million. (c) Uses and restrictions. Calcium car-
(c) Uses and restrictions. The color ad- bonate may be safely used in amounts
ditive ultramarine blue may be safely consistent with good manufacturing
used for coloring salt intended for ani- practice to color soft and hard candies
mal feed subject to the restriction that and mints, and in inks used on the sur-
the quantity of ultramarine blue does face of chewing gum, except that it
not exceed 0.5 percent by weight of the may not be used to color chocolate for
salt. which standards of identity have been
(d) Labeling requirements. The color promulgated under section 401 of the
additive shall be labeled in accordance Federal Food, Drug, and Cosmetic Act
with the requirements of § 70.25 of this unless added color is authorized by
chapter. such standards.
(e) Exemption from certification. Cer- (d) Labeling requirements. The label of
tification of this color additive is not the color additive and of any mixtures
necessary for the protection of the pub- prepared therefrom intended solely or
lic health, and therefore batches therein part for coloring purposes must con-
of are exempt from the certification re- form to the requirements of § 70.25 of
quirements of section 721(c) of the act. this chapter.
(e) Exemption from certification. Cer-
§ 73.70 Calcium carbonate. tification of this color additive is not
(a) Identity. (1) The color additive cal- necessary for the protection of the pub-
cium carbonate is a fine, white powder lic health, and, therefore, batches
consisting essentially of calcium car- thereof are exempt from the certifi-
bonate (CaCO3) prepared either by cation requirements of section 721(c) of
grinding naturally occurring limestone the Federal Food, Drug, and Cosmetic
or synthetically, by precipitation. Act.
(2) Color additive mixtures for food
use made with calcium carbonate may [82 FR 51557, Nov. 7, 2017]
contain only those diluents that are
suitable and that are listed in this sub- § 73.75 Canthaxanthin.
part as safe for use in color additive (a) Identity. (1) The color additive
mixtures for coloring foods. canthaxanthin is b-carotene-4,4′-dione.
432
(2) Color additive mixtures for food (ii) The color additive is used to en-
use made with canthaxanthin may con- hance the pink to orange-red color of
tain only those diluents that are suit- the flesh of salmonid fish; and
able and that are listed in this subpart (iii) The quantity of color additive in
as safe for use in color additive mix- feed shall not exceed 80 milligrams per
tures for coloring foods. kilogram (72 grams per ton) of finished
(b) Specifications. Canthaxanthin feed.
shall conform to the following speci- (d) Labeling requirements. (1) The la-
fications and shall be free from impuri- beling of the color additive and any
ties other than those named to the ex- mixture prepared therefrom intended
tent that such other impurities may be solely or in part for coloring purposes
avoided by good manufacturing prac- shall conform to the requirements of
tice: § 70.25 of this chapter.
(2) For purposes of coloring fish, the
Physical state, solid. labeling of the color additive and any
1 percent solution in chloroform, complete premixes prepared therefrom shall bear
and clear.
expiration dates (established through
Melting range (decomposition), 207 °C. to 212
°C. (corrected).
generally accepted stability testing
Loss on drying, not more than 0.2 percent.
methods) for the sealed and open con-
Residue on ignition, not more than 0.2 per- tainer, other information required by
cent. § 70.25 of this chapter, and adequate di-
Total carotenoids other than trans- rections to prepare a final product
canthaxanthin, not more than 5 percent. complying with the limitations pre-
Lead, not more than 10 parts per million. scribed in paragraph (c)(3) of this sec-
Arsenic, not more than 3 parts per million. tion.
Mercury, not more than 1 part per million. (3) The presence of the color additive
Assay, 96 to 101 percent. in finished fish feed prepared according
to paragraph (c)(3) of this section shall
(c) Use and restrictions. (1) The color be declared in accordance with § 501.4 of
additive canthaxanthin may be safely this chapter.
used for coloring foods generally sub- (4) The presence of the color additive
ject to the following restrictions: in salmonid fish that have been fed
(i) The quantity of canthaxanthin feeds containing canthaxanthin shall
does not exceed 30 milligrams per be declared in accordance with
pound of solid or semisolid food or per §§ 101.22(b), (c), and (k)(2), and
pint of liquid food; and 101.100(a)(2) of this chapter.
(ii) It may not be used to color foods (e) Exemption from certification. Cer-
for which standards of identity have tification of this color additive is not
been promulgated under section 401 of necessary for the protection of the pub-
the act unless added color is authorized lic health, and therefore batches there-
by such standards. of are exempt from the certification re-
(2) Canthaxanthin may be safely used quirements of section 721(c) of the act.
in broiler chicken feed to enhance the
yellow color of broiler chicken skin in FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27,
accordance with the following condi- 1998]
tions: The quantity of canthaxanthin
incorporated in the feed shall not ex- § 73.85 Caramel.
ceed 4.41 milligrams per kilogam (4 (a) Identity. (1) The color additive
grams per ton) of complete feed to sup- caramel is the dark-brown liquid or
plement other known sources of xan- solid material resulting from the care-
thophyll and associated carotenoids to fully controlled heat treatment of the
accomplish the intended effect. following food-grade carbohydrates:
(3) Canthaxanthin may be safely used
in the feed of salmonid fish in accord- Dextrose.
ance with the following prescribed con- Invert sugar.
Lactose.
ditions: Malt sirup.
(i) Canthaxanthin may be added to
Molasses.
the fish feed only in the form of a sta- Starch hydrolysates and fractions thereof.
bilized color additive mixture; Sucrose.
433
§ 73.90 21 CFR Ch. I (4–1–19 Edition)
(2) The food-grade acids, alkalis, and lic health and therefore batches thereof
salts listed in this subparagraph may are exempt from the certification re-
be employed to assist caramelization, quirements of section 721(c) of the act.
in amounts consistent with good manu-
facturing practice. § 73.90 β-Apo-8′-carotenal.
(i) Acids: (a) Identity. (1) The color additive is
Acetic acid. b-apo-8′-carotenal.
Citric acid. (2) Color additive mixtures for food
Phosphoric acid. use made with b-apo-8′-carotenal may
Sulfuric acid. contain only diluents that are suitable
Sulfurous acid. and that are listed in this subpart as
(ii) Alkalis: safe in color additive mixtures for
coloring foods.
Ammonium hydroxide.
Calcium hydroxide U.S.P.
(b) Specifications. b-Apo-8′-carotenal
Potassium hydroxide. shall conform to the following speci-
Sodium hydroxide. fications:
(iii) Salts: Ammonium, sodium, or Physical state, solid.
potassium carbonate, bicarbonate, 1 percent solution in chloroform, clear.
phosphate (including dibasic phosphate Melting point (decomposition), 136 °C.–140 °C.
(corrected).
and monobasic phosphate), sulfate, and Loss of weight on drying, not more than 0.2
sulfite. percent.
(3) Polyglycerol esters of fatty acids, Residue on ignition, not more than 0.2 per-
identified in § 172.854 of this chapter, cent.
may be used as antifoaming agents in Lead (as Pb), not more than 10 parts per mil-
amounts not greater than that re- lion.
quired to produce the intended effect. Arsenic (as As), not more than 1 part per
(4) Color additive mixtures for food million.
use made with caramel may contain Assay (spectrophotometric), 96–101 percent.
only diluents that are suitable and (c) Uses and restrictions. The color ad-
that are listed in this subpart as safe in ditive b-apo-8′-carotenal may be safely
color additive mixtures for coloring used for coloring foods generally, sub-
foods. ject to the following restrictions:
(b) Specifications. Caramel shall con- (1) The quantity of b-apo-8′-carotenal
form to the following specifications: does not exceed 15 milligrams per
Lead (as Pb), not more than 10 parts per mil- pound of solid or semisolid food or 15
lion. milligrams per pint of liquid food.
Arsenic (as As), not more than 3 parts per (2) It may not be used to color foods
million. for which standards of identity have
Mercury (as Hg), not more than 0.1 part per been promulgated under section 401 of
million. the act unless added color is authorized
(c) Uses and restrictions. Caramel may by such standards.
be safely used for coloring foods gen- (d) Labeling. The label of the color ad-
erally, in amounts consistent with ditive and any mixtures prepared
good manufacturing practice, except therefrom and intended solely or in
that it may not be used to color foods part for coloring purposes shall con-
for which standards of identity have form to the requirements of § 70.25 of
been promulgated under section 401 of this chapter.
the act unless added color is authorized (e) Exemption from certification. Cer-
by such standards. tification of this color additive is not
(d) Labeling. The label of the color ad- necessary for the protection of the pub-
ditive and any mixtures prepared lic health and therefore batches thereof
therefrom and intended solely or in are exempt from the certification re-
part for coloring purposes shall con- quirements of section 721(c) of the act.
form to the requirements of § 70.25 of
this chapter. § 73.95 β-Carotene.
(e) Exemption from certification. Cer- (a) Identity. (1) The color additive is
tification of this color additive is not b-carotene prepared synthetically or

necessary for the protection of the pub- obtained from natural sources.
434
(2) Color additive mixtures for food (3) Color additive mixtures for food
use made with b-carotene may contain use made with cochineal extract or car-
only diluents that are suitable and mine may contain only diluents that
that are listed in this subpart as safe in are suitable and that are listed in this
color additive mixtures for coloring subpart as safe in color additive mix-
foods. tures for coloring foods.
(b) Specifications. b-carotene shall (b) Specifications. (1) Cochineal ex-
conform to the following specifica- tract shall conform to the following
tions: specifications:
Physical state, solid. pH, not less than 5.0 and not more than 5.5 at
1 percent solution in chloroform, clear. 25 °C.
Loss of weight on drying, not more than 0.2 Protein (N × 6.25), not more than 2.2 percent.
percent. Total solids, not less than 5.7 and not more
than 6.3 percent.
Residue on ignition, not more than 0.2 per-
Methyl alcohol, not more than 150 parts per
cent.
million.
Lead (as Pb), not more than 10 parts per mil-
lion.
lion.
Arsenic (as As), not more than 3 parts per Arsenic (as As), not more than 1 part per
million. million.
Assay (spectrophotometric), 96–101 percent. Carminic acid, not less than 1.8 percent.
(c) Uses and restrictions. The color ad- (2) Carmine shall conform to the fol-
ditive b-carotene may be safely used lowing specifications:
for coloring foods generally, in
Volatile matter (at 135 °C. for 3 hours), not
amounts consistent with good manu-
more than 20.0 percent.
facturing practice, except that it may Ash, not more than 12.0 percent.
not be used to color those foods for Lead (as Pb), not more than 10 parts per mil-
which standards of identity have been lion.
promulgated under section 401 of the Arsenic (as As), not more than 1 part per
act unless added color is authorized by million.
such standards. Carminic acid, not less than 50.0 percent.
(d) Labeling. The label of the color ad- Carmine and cochineal extract shall be
ditive and any mixtures prepared pasteurized or otherwise treated to de-
therefrom and intended solely or in stroy all viable Salmonella microorga-
part for coloring purposes shall con- nisms. Pasteurization or such other
form to the requirements of § 70.25 of treatment is deemed to permit the add-
this chapter. ing of safe and suitable substances
(e) Exemption from certification. Cer- (other than chemical preservatives)
tification of this color additive is not that are essential to the method of pas-
necessary for the protection of the pub- teurization or other treatment used.
lic health and therefore batches thereof For the purposes of this paragraph,
are exempt from the certification re- safe and suitable substances are those
quirements of section 721(c) of the act. substances that perform a useful func-
tion in the pasteurization or other
§ 73.100 Cochineal extract; carmine.
treatment to render the carmine and
(a) Identity. (1) The color additive cochineal extract free of viable Sal-
cochineal extract is the concentrated monella microorganisms, which sub-
solution obtained after removing the stances are not food additives as de-
alcohol from an aqueous-alcoholic ex- fined in section 201(s) of the act or, if
tract of cochineal (Dactylopius coccus they are food additives as so defined,
costa (Coccus cacti L.)). The coloring are used in conformity with regula-
principle is chiefly carminic acid. tions established pursuant to section
(2) The color additive carmine is the 409 of the act.
aluminum or calcium-aluminum lake (c) Uses and restrictions. Carmine and
on an aluminum hydroxide substrate of cochineal extract may be safely used
the coloring principles, chiefly car- for coloring foods generally in amounts
minic acid, obtained by an aqueous ex- consistent with good manufacturing
traction of cochineal (Dactylopius coc- practice, except that they may not be
cus costa (Coccus cacti L.)). used to color foods for which standards
435
§ 73.125 21 CFR Ch. I (4–1–19 Edition)
of identity have been promulgated (3) Total copper, not less than 4 per-
under section 401 of the act unless cent and not more than 6 percent.
added color is authorized by such (4) Free copper, not more than 200
standards. parts per million.
(d) Labeling requirements. (1) The label (5) Lead (as Pb), not more than 10
of the color additives and any mixtures parts per million.
intended solely or in part for coloring (6) Arsenic (as As), not more than 3
purposes prepared therefrom shall con- parts per million.
form to the requirements of § 70.25 of (7) Mercury (as Hg), not more than
this chapter. 0.5 part per million.
(2) The label of food products in- (8) Ratio of absorbance at 405 nano-
tended for human use, including but- meters (nm) to absorbance at 630 nm,
ter, cheese, and ice cream, that contain not less than 3.4 and not more than 3.9.
cochineal extract or carmine shall spe- (9) Total copper chlorophyllins, not
cifically declare the presence of the less than 95 percent of the sample dried
color additive by listing its respective
at 100 °C for 1 hour.
common or usual name, ‘‘cochineal ex-
(c) Uses and restrictions. Sodium cop-
tract’’ or ‘‘carmine,’’ in the statement
per chlorophyllin may be safely used to
of ingredients in accordance with § 101.4
color citrus-based dry beverage mixes
of this chapter.
(e) Exemption from certification. Cer- in an amount not exceeding 0.2 percent
tification of these color additives is in the dry mix.
not necessary for the protection of the (d) Labeling requirements. The label of
public health, and therefore batches the color additive and any mixtures
thereof are exempt from the certifi- prepared therefrom shall conform to
cation requirements of section 721(c) of the requirements of § 70.25 of this chap-
the act. ter.
[42 FR 15643, Mar. 22, 1977, as amended at 74 tification of this color additive is not
FR 216, Jan. 5, 2009] necessary for the protection of the pub-
§ 73.125 Sodium copper chlorophyllin. lic health, and therefore batches there-
of are exempt from the certification re-
(a) Identity. (1) The color additive so- quirements of section 721(c) of the act.
dium copper chlorophyllin is a green to
black powder prepared from chloro- [67 FR 35431, May 20, 2002]
phyll by saponification and replace-
ment of magnesium by copper. Chloro- § 73.140 Toasted partially defatted
cooked cottonseed flour.
phyll is extracted from alfalfa
(Medicago sativa) using any one or a (a) Identity. (1) The color additive
combination of the solvents acetone, toasted partially defatted cooked cot-
ethanol, and hexane. tonseed flour is a product prepared as
(2) Color additive mixtures made follows: Food quality cottonseed is
with sodium copper chlorophyllin may delinted and decorticated; the meats
contain only those diluents that are are screened, aspirated, and rolled;
suitable and are listed in this subpart moisture is adjusted, the meats heated,
as safe for use in color additive mix- and the oil expressed; the cooked meats
tures for coloring foods. are cooled, ground, and reheated to ob-
(b) Specifications. Sodium copper tain a product varying in shade from
chlorophyllin shall conform to the fol- light to dark brown.
lowing specifications and shall be free (2) Color additive mixtures for food
from impurities other than those use made with toasted partially
named to the extent that such impuri- defatted cooked cottonseed flour may
ties may be avoided by good manufac- contain only diluents that are suitable
turing practice: and that are listed in this subpart as
(1) Moisture, not more than 5.0 per- safe in color additive mixtures for
cent. coloring foods.
(2) Solvent residues (acetone, eth- (b) Specifications. Toasted partially
anol, and hexane), not more than 50 defatted cooked cottonseed flour shall
parts per million, singly or, in com- conform to the following specifica-
bination. tions:
436
Arsenic: It contains no added arsenic com- (d) Labeling. The label of the color ad-
pound and therefore may not exceed a ditive shall conform to the require-
maximum natural background level of 0.2
part per million total arsenic, calculated
ments of § 70.25 of this chapter.
as As. (e) Exemption from certification. Cer-
Lead (as Pb), not more than 10 parts per mil- tification of this color additive is not
lion. necessary for the protection of the pub-
Free gossypol content, not more than 450 lic health, and therefore batches there-
parts per million.
(c) Uses and restrictions. The color ad- quirements of section 721(c) of the act.
ditive toasted partially defatted
cooked cottonseed flour may be safely [42 FR 15643, Mar. 22, 1977, as amended at 47
FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984]
used for coloring foods generally, in
§ 73.165 Ferrous lactate.
facturing practice, except that it may
not be used to color foods for which (a) Identity. The color additive fer-
standards of identity have been pro- rous lactate is the ferrous lactate de-
mulgated under section 401 of the act, fined in § 184.1311 of this chapter.
unless added color is authorized by (b) Specifications. Ferrous lactate
such standards. shall meet the specifications given in
(d) Labeling. The label of the color ad- the Food Chemicals Codex, 4th ed.
ditive and any mixtures prepared (1996), pp. 154 to 155, which is incor-
therefrom and intended solely or in porated by reference in accordance
part for coloring purposes shall con- with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the National
this chapter.
Academy Press, 2101 Constitution Ave.
tification of this color additive is not NW., Washington, DC 20418, or may be
necessary for the protection of the pub- examined at the Food and Drug Admin-
lic health and therefore batches thereof istration’s Main Library, 10903 New
are exempt from the certification re- Hampshire Ave., Bldg. 2, Third Floor,
quirements of section 721(c) of the act. Silver Spring, MD 20993, 301–796–2039, or
at the National Archives and Records
§ 73.160 Ferrous gluconate. Administration (NARA). For informa-
(a) Identity. The color additive fer- tion on the availability of this mate-
rous gluconate is the ferrous gluconate rial at NARA, call 202–741–6030, or go
defined in the Food Chemicals Codex, to: http://www.archives.gov/
3d Ed. (1981), pp. 122–123, which is incor- federallregister/
porated by reference. Copies may be codeloflfederallregulations/
obtained from the National Academy ibrllocations.html.
Press, 2101 Constitution Ave. NW., (c) Uses and restrictions. Ferrous lac-
Washington, DC 20418, or at the Na- tate may be safely used in amounts
tional Archives and Records Adminis- consistent with good manufacturing
tration (NARA). For information on practice for the coloring of ripe olives.
the availability of this material at
(d) Labeling. The label of the color ad-
NARA, call 202–741–6030, or go to: http://
ditive shall conform to the require-
www.archives.gov/federallregister/
codeloflfederallregulations/ ments of § 70.25 of this chapter.
ibrllocations.html. (e) Exemption from certification. Cer-
(b) Specifications. Ferrous gluconate tification of this color additive is not
shall meet the specifications given in necessary for the protection of the pub-
the Food Chemicals Codex, 3d Ed. lic health, and therefore batches there-
(1981), which is incorporated by ref- of are exempt from the certification re-
erence. The availability of this incor- quirements of section 721(c) of the Fed-
poration by reference is given in para- eral Food, Drug, and Cosmetic Act (the
graph (a) of this section. act).
(c) Uses and restrictions. Ferrous glu-
[61 FR 40319, Aug. 2, 1996, as amended at 66
conate may be safely used in amounts
FR 66742, Dec. 27, 2001; 81 FR 5590, Feb. 3,

consistent with good manufacturing 2016]
practice for the coloring of ripe olives.
437
§ 73.169 21 CFR Ch. I (4–1–19 Edition)
§ 73.169 Grape color extract. § 73.170 Grape skin extract

(enocianina).
grape color extract is an aqueous solu- (a) Identity. (1) The color additive
tion of anthocyanin grape pigments grape skin extract (enocianina) is a
made from Concord grapes or a dehy- purplish-red liquid prepared by the
drated water soluble powder prepared aqueous extraction (steeping) of the
fresh deseeded marc remaining after
from the aqueous solution. The aque-
grapes have been pressed to produce
ous solution is prepared by extracting
grape juice or wine. It contains the
the pigments from precipitated lees
common components of grape juice;
produced during the storage of Concord namely, anthocyanins, tartaric acid,
grape juice. It contains the common tannins, sugars, minerals, etc., but not
components of grape juice, namely in the same proportions as found in
anthocyanins, tartrates, malates, sug- grape juice. During the steeping proc-
ars, and minerals, etc., but not in the ess, sulphur dioxide is added and most
same proportion as found in grape of the extracted sugars are fermented
juice. The dehydrated water soluble to alcohol. The extract is concentrated
powder is prepared by spray drying the by vacuum evaporation, during which
aqueous solution containing added practically all of the alcohol is re-
malto-dextrin. moved. A small amount of sulphur di-
(2) Color additive mixtures for food oxide may be present.
use made with grape color extract may (2) Color additive mixtures for food
contain only those diluents listed in use made with grape skin extract
this subpart as safe and suitable in (enocianina) may contain only those
color additive mixtures for coloring diluents listed in this subpart as safe
foods. and suitable in color additive mixtures
(b) Specifications. Grape color extract for coloring foods.
shall conform to the following speci- (b) Specifications. Grape skin extract
(enocianina) shall conform to the fol-
fications: Pesticide residues, not more
lowing specifications:
than permitted in or on grapes by regu-
lations promulgated under section 408 Pesticide residues, not more than permitted
of the Federal Food, Drug, and Cos- in or on grapes by regulations promulgated
under section 408 of the Federal Food,
metic Act. Lead (as Pb), not more than
Drug, and Cosmetic Act.
10 parts per million. Arsenic (as As), Lead (as Pb), not more than 10 parts per mil-
not more than 1 part per million. lion.
(c) Uses and restrictions. Grape color Arsenic (as As), not more than 1 part per
extract may be safely used for the million.
coloring of nonbeverage food, except (c) Uses and restrictions. Grape skin
that it may not be used to color foods extract (enocianina) may be safely
for which standards of identity have used for the coloring of still and car-
been promulgated under section 401 of bonated drinks and ades, beverage
the act, unless the use of added color is bases, and alcoholic beverages subject
authorized by such standards. to the following restrictions:
(d) Labeling. The color additive and (1) It may not be used to color foods
any mixtures prepared therefrom infor which standards of identity have
tended solely or in part for coloring been promulgated under section 401 of
purposes shall bear, in addition to the the act unless artificial color is author-
other information required by the act, ized by such standards.
labeling in accordance with the provi- (2) Its use in alcoholic beverages
sions of § 70.25 of this chapter. shall be in accordance with the provi-
(e) Exemption from certification. Cer- sions of parts 4 and 5, title 27 CFR.
tification of this color additive is not (d) Labeling requirements. The label of
necessary for the protection of the pub- the color additive and any mixtures
lic health, and therefore batches are prepared therefrom intended solely or
in part for coloring purposes shall con-
exempt from the certification require-
ments of section 721(c) of the Act.

this chapter. The common or usual
[46 FR 47532, Sept. 29, 1981] name of the color additive is ‘‘grape
438
skin extract’’ followed, if desired, by generally accepted stability testing

‘‘(enocianina)’’. methods), other information required
(e) Exemption from certification. Cer- by § 70.25 of this chapter, and adequate
tification of this color additive is not directions to prepare a final product
necessary for the protection of the pub- complying with the limitations pre-
lic health, and therefore batches there- scribed in paragraph (c) of this section.
of are exempt from the certification re- (2) The presence of the color additive
quirements of section 721(c) of the act. in finished fish feed prepared according
to paragraph (c) of this section shall be
§ 73.185 Haematococcus algae meal. declared in accordance with § 501.4 of
(a) Identity. (1) The color additive this chapter.
haematococcus algae meal consists of (3) The presence of the color additive
the comminuted and dried cells of the in salmonid fish that have been fed
alga Haematococcus pluvialis. feeds containing haematococcus algae
(2) Haematococcus algae meal may meal shall be declared in accordance
be added to the fish feed only as a com- with §§ 101.22(b), (c), and (k)(2), and
ponent of a stabilized color additive 101.100(a)(2) of this chapter.
mixture. Color additive mixtures for (e) Exemption from certification. Cer-
fish feed use made with haematococcus tification of this color additive is not
algae meal may contain only those necessary for the protection of the pub-
diluents that are suitable and are list- lic health, and therefore batches there-
ed in this subpart as safe for use in of are exempt from the certification re-
color additive mixtures for coloring quirements of section 721(c) of the act.
foods. [65 FR 41584, July 6, 2000]
(b) Specifications. Haematococcus
algae meal shall conform to the fol- § 73.200 Synthetic iron oxide.
lowing specifications and shall be free (a) Identity. (1) The color additive
from impurities other than those synthetic iron oxide consists of any
named to the extent that such impuri- one or any combination of syn-
ties may be avoided by good manufac- thetically prepared iron oxides, includ-
turing practice: ing the hydrated forms. It is free from
Physical state, solid. admixture with other substances.
Lead, not more than 5 parts per million. (2) Color additive mixtures for food
Arsenic, not more than 2 parts per million. use made with synthetic iron oxide
Mercury, not more than 1 part per million.
may contain only those diluents that
Heavy metals (as Pb), not more than 10 parts
per million. are suitable and that are listed in this
Astaxanthin, not less than 1.5 percent. subpart as safe for use in color additive
mixtures for coloring foods.
(c) Uses and restrictions. (b) Specifications. (1) Synthetic iron
Haematococcus algae meal may be oxide for human food use shall conform
safely used in the feed of salmonid fish to the following specifications:
in accordance with the following pre-
scribed conditions: Arsenic (as As), not more than 3 milligrams
(1) The color additive is used to en- per kilogram (mg/kg) (3 parts per million
(ppm)).
hance the pink to orange-red color of
Lead (as Pb), not more than 5 mg/kg (5 ppm).
the flesh of salmonid fish. Mercury (as Hg), not more than 1 mg/kg (1
(2) The quantity of astaxanthin in ppm).
finished feed, from haematococcus
algae meal when used alone or in com- (2) Synthetic iron oxide for dog and
bination with other astaxanthin color cat food use shall conform to the fol-
additive sources listed in this part 73, lowing specifications:
shall not exceed 80 milligrams per kilo- Arsenic (as As), not more than 5 parts per
gram (72 grams per ton) of finished million.
feed. Lead (as Pb), not more than 20 parts per mil-
(d) Labeling requirements. (1) The la- lion.
beling of the color additive and any Mercury (as Hg), not more than 3 parts per
million.
premixes prepared therefrom shall bear
expiration dates for the sealed and (c) Uses and restrictions. (1) Synthetic
open container (established through iron oxide may be safely used for
439
§ 73.250 21 CFR Ch. I (4–1–19 Edition)
human food use subject to the fol- diluents only those substances listed in
lowing restrictions: this subpart as safe and suitable in
(i) In sausage casings intended for color additive mixtures for coloring
human consumption in an amount not foods.
exceeding 0.10 percent by weight of the (b) Uses and restrictions. Fruit juice
finished food. may be safely used for the coloring of
(ii) In soft and hard candy, mints, foods generally, in amounts consistent
and chewing gum at levels consistent with good manufacturing practice, ex-
with good manufacturing practice, except that it may not be used to color
cept that it may not be used to color foods for which standards of identity
foods for which standards of identity have been promulgated under section
have been issued under section 401 of
401 of the act, unless the use of added
color is authorized by such standards.
Act, unless the use of the added color is
authorized by such standards. (c) Labeling. The color additive and
(iii) In dietary supplement tablets any mixtures intended solely or in part
and capsules, including coatings and for coloring purposes prepared there-
printing inks, such that the total from shall bear, in addition to the
amount of elemental iron per day for other information required by the act,
labeled dosages does not exceed 5 milli- labeling in accordance with the provi-
grams. sions of § 70.25 of this chapter.
(2) Synthetic iron oxide may be safe- (d) Exemption from certification. Cer-
ly used for the coloring of dog and cat tification of this color additive is not
foods in an amount not exceeding 0.25 necessary for the protection of the pub-
percent by weight of the finished food. lic health, and therefore batches there-
(d) Labeling requirements. The label of of are exempt from the certification re-
the color additive and any mixture pre- quirements of section 721(c) of the act.
pared therefrom intended solely or in
part for coloring purposes shall con- FR 52629, Oct. 10, 1995]
this chapter. § 73.260 Vegetable juice.
tification of this color additive is not (a) Identity. (1) The color additive
necessary for the protection of the pub- vegetable juice is prepared either by
lic health, and therefore batches there- expressing the juice from mature vari-
of are exempt from the certification re- eties of fresh, edible vegetables, or by
quirements of section 721(c) of the act. the water infusion of the dried vege-
table. The color additive may be con-
centrated or dried. The definition of
FR 10578, Mar. 7, 1994; 80 FR 14842, Mar. 20,
2015; 83 FR 54872, Nov. 1, 2018] vegetable juice in this paragraph is for
the purpose of identity as a color addi-
§ 73.250 Fruit juice. tive only, and shall not be construed as
(a) Identity. (1) The color additive a standard of identity under section 401
fruit juice is prepared either by ex- of the act. However, where a standard
pressing the juice from mature vari- of identity for a particular vegetable
eties of fresh, edible fruits, or by the juice has been promulgated under sec-
water infusion of the dried fruit. The tion 401 of the act, it shall conform to
color additive may be concentrated or such standard.
dried. The definition of fruit juice in (2) Color additive mixtures made
this paragraph is for the purpose of with vegetable juice may contain as
identity as a color additive only and diluents only those substances listed in
shall not be construed as a standard of this subpart as safe and suitable in
identity under section 401 of the act. color additive mixtures for coloring
However, where a standard of identity foods.
for a particular fruit juice has been (b) Uses and restrictions. Vegetable
promulgated under section 401 of the juice may be safely used for the color-
act, it shall conform to such standard. ing of foods generally, in amounts con-
(2) Color additive mixtures made sistent with good manufacturing prac-
with fruit juice may contain as tice, except that it may not be used to
440
color foods for which standards of iden- (2) Adequate directions to provide a
tity have been promulgated under sec- final product complying with the limi-
tion 401 of the act, unless the use of tations prescribed in paragraph (b) of
added color is authorized by such this section.
standards. (d) Exemption from certification. Cer-
(c) Labeling. The color additive and tification of this color additive is not
any mixtures intended solely or in part necessary for the protection of the pub-
for coloring purposes prepared there- lic health and therefore batches thereof
from shall bear, in addition to the are exempt from the certification re-
other information required by the act, quirements of section 721(c) of the act.
labeling in accordance with the provi-
sions of § 70.25 of this chapter. § 73.295 Tagetes (Aztec marigold) meal
(d) Exemption from certification. Cer- and extract.
necessary for the protection of the pub- tagetes (Aztec marigold) meal is the
lic health, and therefore batches there- dried, ground flower petals of the Aztec
of are exempt from the certification re- marigold (Tagetes erecta L.) mixed with
quirements of section 721(c) of the act. not more than 0.3 percent ethoxyquin.
[42 FR 15643, Mar. 22, 1977, as amended at 60 (2) The color additive tagetes (Aztec
FR 52629, Oct. 10, 1995] marigold) extract is a hexane extract
of the flower petals of the Aztec mari-
§ 73.275 Dried algae meal. gold (Tagetes erecta L.). It is mixed with
(a) Identity. The color additive dried an edible vegetable oil, or with an edi-
algae meal is a dried mixture of algae ble vegetable oil and a hydrogenated
cells (genus Spongiococcum, separated edible vegetable oil, and not more than
from its culture broth), molasses, 0.3 percent ethoxyquin. It may also be
cornsteep liquor, and a maximum of 0.3 mixed with soy flour or corn meal as a
percent ethoxyquin. The algae cells are carrier.
produced by suitable fermentation, (b) Specifications. (1) Tagetes (Aztec
under controlled conditions, from a marigold) meal is free from admixture
pure culture of the genus with other plant material from
Spongiococcum. Tageteserecta L. or from plant material
(b) Uses and restrictions. The color ad- or flowers of any other species of
ditive dried algae meal may be safely plants.
used in chicken feed in accordance (2) Tagetes (Aztec marigold) extract
with the following prescribed condi- shall be prepared from tagetes (Aztec
tions: marigold) petals meeting the specifica-
(1) The color additive is used to en- tions set forth in paragraph (b)(1) of
hance the yellow color of chicken skin this section and shall conform to the
and eggs. following additional specifications:
(2) The quantity of the color additive Melting point .......................... 53.5–55.0 °C.
Iodine value ........................... 132–145.
incorporated in the feed is such that Saponification value ............... 175–200.
the finished feed: Acid value .............................. 0.60–1.20.
(i) Is supplemented sufficiently with Titer ........................................ 35.5–37.0 °C.
Unsaponifiable matter ............ 23.0 percent–27.0 percent.
xanthophyll and associated carotenoids Hexane residue ...................... Not more than 25 p.p.m.
so as to accomplish the intended effect
described in paragraph (b)(1) of this All determinations, except the hexane
section; and residue, shall be made on the initial ex-
(ii) Meets the tolerance limitation tract of the flower petals (after drying
for ethoxyquin in animal feed pre- in a vacuum oven at 60 °C. for 24 hours)
scribed in § 573.380 of this chapter. prior to the addition of the oils and
(c) Labeling. The label of the color ad- ethoxyquin. The hexane determination
ditives and any premixes prepared shall be made on the color additive
therefrom shall bear in addition to the after the addition of the vegetable oils,
information required by § 70.25 of this hydrogenated vegetable oils, and
chapter. ethoxyquin.
(1) A statement of the concentrations (c) Uses and restrictions. The color ad-
of xanthophyll and ethoxyquin con- ditives tagetes (Aztec marigold) meal

tained therein. and extract may be safely used in
441
§ 73.300 21 CFR Ch. I (4–1–19 Edition)
chicken feed in accordance with the (b) Specifications. Carrot oil shall con-
following prescribed conditions: tain no more than 25 parts per million
(1) The color additives are used to en- of hexane.
hance the yellow color of chicken skin (c) Uses and restrictions. Carrot oil
and eggs. may be safely used for coloring foods
(2) The quantity of the color addi- generally, in amounts consistent with
tives incorporated in the feed is such good manufacturing practice, except
that the finished feed: that it may not be used to color foods
(i) Is supplemented sufficiently with for which standards of identity have
xanthophyll and associated carotenoids been promulgated under section 401 of
so as to accomplish the intended effect the act unless the use of added color is
described in paragraph (c)(1) of this authorized by such standards.
section; and (d) Labeling requirements. The label of
(ii) Meets the tolerance limitation the color additive and any mixtures
for ethoxyquin in animal feed pre- prepared therefrom intended solely or
scribed in § 573.380 of this chapter. in part for coloring purposes shall con-
(d) Labeling requirements. The label of form to the requirements of § 70.25 of
the color additives and any premixes this chapter.
prepared therefrom shall bear, in addi- (e) Exemption from certification. Cer-
tion to the information required by tification of this color additive is not
§ 70.25 of this chapter: necessary for the protection of the pub-
(1) A statement of the concentrations lic health, and therefore batches there-
of xanthophyll and ethoxyquin con- of are exempt from the certification re-
tained therein. quirements of section 721(c) of the act.
(2) Adequate directions to provide a § 73.315 Corn endosperm oil.
final product complying with the limi-
tations prescribed in paragraph (c) of (a) Identity. (1) The color additive
this section. corn endosperm oil is a reddish-brown
(e) Exemption from certification. Cer- liquid composed chiefly of glycerides,
tification of this color additive is not fatty acids, sitosterols, and carotenoid
necessary for the protection of the pub- pigments obtained by isopropyl alcohol
lic health, and therefore batches there- and hexane extraction from the gluten
of are exempt from the certification re- fraction of yellow corn grain. The defi-
quirements of section 721(c) of the act. nition of corn endosperm oil in this
paragraph is for the purpose of defini-
§ 73.300 Carrot oil. tion as a color additive only and shall
not be construed as a food standard of
identity under section 401 of the act.
carrot oil is the liquid or the solid por-
tion of the mixture or the mixture
use made with corn endosperm oil may
itself obtained by the hexane extrac-
contain only those diluents listed in
tion of edible carrots (Daucus carota L.)
this subpart as safe and suitable in
with subsequent removal of the hexane
color additive mixtures for coloring
by vacuum distillation. The resultant
foods.
mixture of solid and liquid extractives
consists chiefly of oils, fats, waxes, and (b) Specifications. Corn endosperm oil
carrotenoids naturally occurring in conforms to the following specifica-
carrots. The definition of carrot oil in tions:
this paragraph is for the purpose of Total fatty acids, not less than 85 percent.
identity as a color additive only and Iodine value, 118 to 134.
shall not be construed as setting forth Saponification value, 165 to 185.
an official standard for carrot oil or Unsaponifiable matter, not more than 14 per-
carrot oleoresin under section 401 of cent.
the act. Hexane, not more than 25 parts per million.
(2) Color additive mixtures for food Isopropyl alcohol, not more than 100 parts
per million.
use made with carrot oil may contain
only those diluents listed in this sub- (c) Uses and restrictions. The color ad-
part as safe and suitable in color addi- ditive corn endosperm oil may be safe-
tive mixtures for coloring foods. ly used in chicken feed in accordance
442
with the following prescribed condi- necessary for the protection of the pub-
tions: lic health, and therefore batches there-
(1) The color additive is used to en- of are exempt from the certification re-
hance the yellow color of chicken skin quirements of section 721(c) of the act.
and eggs.
(2) The quantity of the color additive § 73.345 Paprika oleoresin.
incorporated in the feed is such that (a) Identity. (1) The color additive pa-
the finished feed is supplemented suffi-
prika oleoresin is the combination of
ciently with xanthophyll and associ-
flavor and color principles obtained
ated carotenoids so as to accomplish
the intended effect described in para- from paprika (Capsicum annuum L.) by
graph (c)(1) of this section. extraction, using any one or a com-
(d) Labeling requirements. The label of bination of the following solvents:
the color additive and any premixes Acetone Isopropyl alcohol
prepared therefrom shall bear, in addi- Ethyl alcohol Methyl alcohol
tion to the information required by Ethylene dichloride Methylene chloride
§ 70.25 of this chapter, a statement of Hexane Trichloroethylene
the concentration of xanthophyll con-
tained therein. The definition of paprika oleoresin in
(e) Exemption from certification. Cer- this paragraph is for the purpose of
tification of this color additive is not identity as a color additive only, and
necessary for the protection of the pub- shall not be construed as setting forth
lic health, and therefore batches there- an official standard for paprika oleo-
of are exempt from the certification re- resin under section 401 of the act.
quirements of section 721(c) of the act. (2) Color additive mixtures made
with paprika oleoresin may contain as
§ 73.340 Paprika.
diluents only those substances listed in
(a) Identity. (1) The color additive pa- this subpart as safe and suitable in
prika is the ground dried pod of mild color additive mixtures for coloring
capsicum (Capsicum annuum L.). The foods.
definition of paprika in this paragraph
(b) Specifications. Paprika oleoresin
is for the purpose of identity as a color
shall contain no more residue of the
additive only and shall not be con-
solvents listed in paragraph (a)(1) of
strued as setting forth an official
standard for paprika under section 401 this section than is permitted of the
of the act. corresponding solvents in spice
(2) Color additive mixtures made oleoresins under applicable food addi-
with paprika may contain as diluents tive regulations in parts 170 through
only those substances listed in this 189 of this chapter.
subpart as safe and suitable in color (c) Uses and restrictions. Paprika oleo-
additive mixtures for coloring foods. resin may be safely used for the color-
(b) Uses and restrictions. Paprika may ing of foods generally in amounts con-
be safely used for the coloring of foods sistent with good manufacturing prac-
generally, in amounts consistent with tice, except that it may not be used to
good manufacturing practice, except color foods for which standards of iden-
that it may not be used to color foods tity have been promulgated under sec-
for which standards of identity have tion 401 of the act, unless the use of
been promulgated under section 401 of added color is authorized by such
the act, unless the use of added color is standards.
authorized by such standards. (d) Labeling. The color additive and
(c) Labeling. The color additive and any mixtures intended solely or in part
any mixtures intended solely or in part
for coloring purposes prepared there-
for coloring purposes prepared there-
from shall bear, in addition to the
from shall bear, in addition to the
other information required by the act,
other information required by the act,
labeling in accordance with the provi- labeling in accordance with the provi-
sions of § 70.25 of this chapter. sions of § 70.25 of this chapter.
(d) Exemption from certification. Cer- (e) Exemption from certification. Cer-
tification of this color additive is not tification of this color additive is not
443
§ 73.350 21 CFR Ch. I (4–1–19 Edition)
necessary for the protection of the pub- juices, fruit juice drinks, and soft
lic health, and therefore batches there- drinks).
of are exempt from the certification re- (iii) In egg decorating kits used for
quirements of section 721(c) of the act. coloring the shells of eggs in amounts
consistent with good manufacturing
§ 73.350 Mica-based pearlescent pig- practice.
ments. (2) The color additive may not be
(a) Identity. (1) The color additive is used to color foods for which standards
formed by depositing titanium salts of identity have been issued under sec-
onto mica, followed by heating to tion 401 of the act, unless the use of the
produce titanium dioxide on mica. added color is authorized by such
Mica used to manufacture the color ad- standards.
ditive shall conform in identity to the (d) Labeling. The label of the color ad-
requirements of § 73.1496(a)(1). ditive and of any mixture prepared
(2) Color additive mixtures for food therefrom intended solely or in part for
use made with mica-based pearlescent coloring purposes shall conform to the
pigments may contain only those requirements of § 70.25 of this chapter.
diluents listed in this subpart as safe (e) Exemption from certification. Cer-
and suitable for use in color additive tification of this color additive is not
mixtures for coloring food. necessary for the protection of the pub-
(b) Specifications. Mica-based pearl- lic health and therefore batches thereof
escent pigments shall conform to the are exempt from the certification re-
following specifications and shall be quirements of section 721(c) of the act.
free from impurities other than those [71 FR 31929, June 2, 2006, as amended at 78
named to the extent that such other FR 35117, June 12, 2013; 80 FR 32307, June 8,
impurities may be avoided by good 2015; 80 FR 58602, Sept. 30, 2015]
manufacturing practice:
(1) Lead (as Pb), not more than 4 § 73.352 Paracoccus pigment.
parts per million (ppm). (a) Identity. (1) The color additive
(2) Arsenic (as As), not more than 3 paracoccus pigment consists of the
ppm. heat-killed, dried cells of a nonpatho-
(3) Mercury (as Hg), not more than 1 genic and nontoxicogenic strain of the
ppm. bacterium Paracoccus carotinifaciens
(c) Uses and restrictions. (1) The sub- and may contain added calcium car-
stance listed in paragraph (a) of this bonate to adjust the astaxanthin level.
section may be safely used as a color (2) Color additive mixtures for fish
additive in food as follows: feed use made with paracoccus pigment
(i) In amounts up to 1.25 percent, by may contain only those diluents that
weight, in the following foods: Cereals, are suitable and are listed in this sub-
confections and frostings, gelatin des- part as safe for use in color additive
serts, hard and soft candies (including mixtures for coloring foods.
lozenges), nutritional supplement tab- (b) Specifications. Paracoccus pigment
lets and gelatin capsules, and chewing shall conform to the following speci-
gum. fications and shall be free from impuri-
(ii) In amounts up to 0.07 percent, by ties, other than those named, to the ex-
weight, in the following: tent that such impurities may be
(A) Distilled spirits containing not avoided by good manufacturing prac-
less than 18 percent and not more than tice:
25 percent alcohol by volume. (1) Physical state, solid.
(B) Cordials, liqueurs, flavored alco- (2) Lead, not more than 5 milligrams
holic malt beverages, wine coolers, and per kilogram (mg/kg) (5 parts per mil-
cocktails. lion (ppm)).
(C) Non-alcoholic cocktail mixes and (3) Arsenic, not more than 2 mg/kg (2
mixers, such as margarita mix, Bloody ppm).
Mary mix, and daiquiri mix, but ex- (4) Mercury, not more than 1 mg/kg (1
cluding eggnog, tonic water, and bev- ppm).
erages that are typically consumed (5) Heavy metals (as Pb), not more
without added alcohol (e.g., fruit than 10 mg/kg (10 ppm).
444
(6) Astaxanthin, not less than 1.75 and are listed in this subpart as safe
percent. for use in color additive mixtures for
(c) Uses and restrictions. Paracoccus coloring foods.
pigment may be safely used in the feed (b) Specifications. Phaffia yeast shall
of salmonid fish in accordance with the conform to the following specifications
following prescribed conditions: and shall be free from impurities other
(1) The color additive is used to en- than those named to the extent that
hance the pink to orange-red color of such impurities may be avoided by
the flesh of salmonid fish. good manufacturing practice:
(2) The quantity of astaxanthin in
Physical state, solid.
finished feed, from paracoccus pigment Lead, not more than 5 parts per million.
when used alone or in combination Arsenic, not more than 2 parts per million.
with other astaxanthin color additive Mercury, not more than 1 part per million.
sources listed in this part 73, shall not Heavy metals (as Pb), not more than 10 parts
exceed 80 mg/kg (72 grams per ton) of per million.
finished feed. Astaxanthin, not less than 0.4 percent.
(d) Labeling requirements. (1) The la- (c) Uses and restrictions. Phaffia yeast
beling of the color additive and any may be safely used in the feed of
premixes prepared therefrom shall bear salmonid fish in accordance with the
expiration dates for the sealed and following prescribed conditions:
open container (established through (1) The color additive is used to en-
generally accepted stability testing hance the pink to orange-red color of
methods), other information required the flesh of salmonid fish.
by § 70.25 of this chapter, and adequate (2) The quantity of astaxanthin in
directions to prepare a final product finished feed, from phaffia yeast when
complying with the limitations pre- used alone or in combination with
scribed in paragraph (c) of this section. other astaxanthin color additive
(2) The presence of the color additive sources listed in this part 73, shall not
in finished fish feed prepared according exceed 80 milligrams per kilogram (72
to paragraph (c) of this section shall be grams per ton) of finished feed.
declared in accordance with § 501.4 of (d) Labeling requirements. (1) The la-
this chapter. beling of the color additive and any
(3) The presence of the color additive premixes prepared therefrom shall bear
in salmonid fish that have been fed expiration dates for the sealed and
feeds containing paracoccus pigment open container (established through
shall be declared in accordance with generally accepted stability testing
§§ 101.22(b), (c), and (k)(2), and methods), other information required
101.100(a)(2) of this chapter. by § 70.25 of this chapter, and adequate
(e) Exemption from certification. Cer- directions to prepare a final product
tification of this color additive is not complying with the limitations pre-
necessary for the protection of the pub- scribed in paragraph (c) of this section.
lic health, and therefore, batches (2) The presence of the color additive
thereof are exempt from the certifi- in finished fish feed prepared according
cation requirements of section 721(c) of to paragraph (c) of this section shall be
the act. declared in accordance with § 501.4 of
[74 FR 58845, Nov. 16, 2009] this chapter.
(3) The presence of the color additive
§ 73.355 Phaffia yeast. in salmonid fish that have been fed
(a) Identity. (1) The color additive feeds containing phaffia yeast shall be
phaffia yeast consists of the killed, declared in accordance with §§ 101.22(b),
dried cells of a nonpathogenic and (c), and (k)(2) and 101.100(a)(2) of this
nontoxicogenic strain of the yeast chapter.
Phaffia rhodozyma. (e) Exemption from certification. Cer-
(2) Phaffia yeast may be added to the tification of this color additive is not
fish feed only as a component of a sta- necessary for the protection of the pub-
bilized color additive mixture. Color lic health, and therefore batches there-
additive mixtures for fish feed use of are exempt from the certification re-
made with phaffia yeast may contain quirements of section 721(c) of the act.
only those diluents that are suitable [65 FR 41587, July 6, 2000]
445
§ 73.450 21 CFR Ch. I (4–1–19 Edition)
§ 73.450 Riboflavin. an official standard for saffron under

section 401 of the act.
(a) Identity. (1) The color additive ri-
(2) Color additive mixtures made
boflavin is the riboflavin defined in the
with saffron may contain as diluents
Food Chemicals Codex, 3d Ed. (1981),
only those substances listed in this
pp. 262–263, which is incorporated by
subpart as safe and suitable in color
reference. Copies may be obtained from
additive mixtures for coloring foods.
the National Academy Press, 2101 Con-
(b) Uses and restrictions. Saffron may
stitution Ave. NW., Washington, DC
be safely used for the coloring of foods
20418, or at the National Archives and
generally, in amounts consistent with
Records Administration (NARA). For
good manufacturing practice, except
information on the availability of this
that it may not be used to color foods
material at NARA, call 202–741–6030, or
for which standards of identity have
go to: http://www.archives.gov/
been promulgated under section 401 of
federallregister/
the act, unless the use of added color is
codeloflfederallregulations/
authorized by such standards.
ibrllocations.html.
(c) Labeling. The color additive and
any mixtures intended solely or in part
with riboflavin may contain as diluents for coloring purposes prepared there-
only those substances listed in this from shall bear, in addition to the
subpart as safe and suitable for use in other information required by the act,
color additive mixtures for coloring labeling in accordance with the provi-
foods. sions of § 70.25 of this chapter.
(b) Specifications. Riboflavin shall (d) Exemption from certification. Cer-
meet the specifications given in the tification of this color additive is not
Food Chemicals Codex, 3d Ed. (1981), necessary for the protection of the pub-
which is incorporated by reference. The lic health, and therefore batches there-
availability of this incorporation by of are exempt from the certification re-
reference is given in paragraph (a)(1) of quirements of section 721(c) of the act.
this section.
(c) Uses and restrictions. Riboflavin § 73.530 Spirulina extract.
may be safely used for the coloring of
foods generally, in amounts consistent
spirulina extract is prepared by the fil-
with good manufacturing practice; ex-
tered aqueous extraction of the dried
cept that it may not be used to color
biomass of Arthrospira platensis. The
foods for which standards of identity
color additive contains phycocyanins
have been promulgated under section
as the principal coloring components.
color is authorized by such standards.
use made with spirulina extract may
suitable and are listed in this subpart
as safe for use in color additive mix-
(e) Exemption from certification. Cer- tures for coloring foods.
tification of this color additive is not (b) Specifications. Spirulina extract
necessary for the protection of the pub- must conform to the following speci-
lic health, and therefore batches there- fications and must be free from impuri-
of are exempt from the certification re- ties, other than those named, to the ex-
quirements of section 721(c) of the Act. tent that such other impurities may be
[42 FR 15643, Mar. 22, 1977, as amended at 47 avoided by good manufacturing prac-
FR 947, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] tice:
(1) Lead, not more than 2 milligrams
§ 73.500 Saffron. per kilogram (mg/kg) (2 part per mil-
(a) Identity. (1) The color additive saf- lion (ppm));
fron is the dried stigma of Crocus (2) Arsenic, not more than 2 mg/kg (2
sativus L. The definition of saffron in ppm);
this paragraph is for the purpose of (3) Mercury, not more than 1 mg/kg (1
identity as a color additive only, and ppm); and

shall not be construed as setting forth (4) Negative for microcystin toxin.
446
(c) Uses and restrictions. Spirulina ex- Mercury (as Hg), not more than 1 part per
tract may be safely used for coloring million.
confections (including candy and chew- Loss on ignition at 800 °C. (after drying for 3
hours at 105 °C.), not more than 0.5 percent.
ing gum), frostings, ice cream and fro- Water soluble substances, not more than 0.3
zen desserts, dessert coatings and top- percent.
pings, beverage mixes and powders, yo- Acid soluble substances, not more than 0.5
gurts, custards, puddings, cottage percent.
cheese, gelatin, breadcrumbs, ready-to- TiO2, not less than 99.0 percent after drying
eat cereals (excluding extruded cere- for 3 hours at 105 °C.
als), coating formulations applied to Lead, arsenic, and antimony shall be
dietary supplement tablets and cap- determined in the solution obtained by
sules, at levels consistent with good boiling 10 grams of the titanium diox-
manufacturing practice, and to season- ide for 15 minutes in 50 milliliters of
ally color the shells of hard-boiled 0.5N hydrochloric acid.
eggs, except that it may not be used to (c) Uses and restrictions. The color ad-
color foods for which standards of iden- ditive titanium dioxide may be safely
tity have been issued under section 401 used for coloring foods generally, sub-
of the Federal Food, Drug, and Cos- ject to the following restrictions:
metic Act, unless the use of the added (1) The quantity of titanium dioxide
color is authorized by such standards. does not exceed 1 percent by weight of
(d) Labeling requirements. The label of the food.
the color additive and of any mixture (2) It may not be used to color foods
prepared therefrom intended solely or for which standards of identity have
in part for coloring purposes must con- been promulgated under section 401 of
form to § 70.25 of this chapter. the act unless added color is authorized
(e) Exemption from certification. Cer- by such standards.
tification of this color additive is not (d) Labeling. The label of the color ad-
necessary for the protection of the pub- ditive and any mixtures intended sole-
lic health, and therefore batches there- ly or in part for coloring purposes pre-
of are exempt from the certification re- pared therefrom shall conform to the
quirements of section 721(c) of the Fed- requirements of § 70.25 of this chapter.
eral Food, Drug, and Cosmetic Act. (e) Exemption from certification. Cer-
[78 FR 49120, Aug. 13, 2013, as amended at 79 tification of this color additive is not
FR 20098, May 13, 2014; 80 FR 50765, Aug. 21, necessary for the protection of the pub-
2015; 82 FR 30734, July 3, 2017] lic health and therefore batches thereof
are exempt from the certification re-
§ 73.575 Titanium dioxide. quirements of section 721(c) of the act.
(a) Identity. (1) The color additive ti-
tanium dioxide is synthetically pre- § 73.585 Tomato lycopene extract; to-
mato lycopene concentrate.
pared TiO2, free from admixture with
other substances. (a) Identity. (1) The color additive to-
(2) Color additive mixtures for food mato lycopene extract is a red to dark
use made with titanium dioxide may brown viscous oleoresin extracted with
contain only those diluents that are ethyl acetate from tomato pulp fol-
suitable and that are listed in this sub- lowed by removal of the solvent by
part as safe in color additive mixtures evaporation. The pulp is produced from
for coloring foods, and the following: fresh, edible varieties of the tomato by
Silicon dioxide, SiO2 and/or aluminum removing the liquid. The main coloring
oxide, Al2 O3, as dispersing aids—not component is lycopene.
more than 2 percent total. (2) The color additive tomato lyco-
(b) Specifications. Titanium dioxide pene concentrate is a powder prepared
shall conform to the following speci- from tomato lycopene extract by re-
fications: moving most of the tomato lipids with
ethyl acetate and then evaporating off
the solvent.
lion.
Arsenic (as As), not more than 1 part per (3) Color additive mixtures made
with tomato lycopene extract or to-
million.
Antimony (as Sb), not more than 2 parts per mato lycopene concentrate may con-
million. tain only those diluents listed in this
447
§ 73.600 21 CFR Ch. I (4–1–19 Edition)
subpart as safe and suitable for use in necessary for the protection of the pub-
color additive mixtures for coloring lic health, and therefore batches there-
food. of are exempt from the certification re-
(b) Specifications. (1) Tomato lycopene quirements of section 721(c) of the act.
extract shall conform to the following [70 FR 43045, July 26, 2005, as amended at 81
specification: Lycopene, not less than FR 5590, Feb. 3, 2016; 81 FR 49895, July 29,
5.5 percent of oleoresin as determined 2016]
by the method entitled ‘‘Qualitative
Analysis of Lycopene, Its Isomers and § 73.600 Turmeric.
Other Carotenoids in Different Con- (a) Identity. (1) The color additive
centrations of Lyc-O-Mato ® (Tomato turmeric is the ground rhizome of
Oleoresin) and in Tomato Pulp by High Curcuma longa L. The definition of
Performance Liquid Chromatography turmeric in this paragraph is for the
(HPLC),’’ S.O.P. number : Lab/119/01, purpose of identity as a color additive
Revision 01, dated May 30, 2001, pub- only, and shall not be construed as set-
lished by LycoRed Natural Products ting forth an official standard for tur-
Industries, which is incorporated by meric under section 401 of the act.
reference, or an equivalent method. (2) Color additive mixtures made
The Director of the Office of the Fed- with turmeric may contain as diluents
eral Register approves this incorpora- only those substances listed in this
tion by reference in accordance with 5 subpart as safe and suitable in color
U.S.C. 552(a) and 1 CFR part 51. You additive mixtures for coloring foods.
may obtain a copy of the method from (b) Uses and restrictions. Turmeric
the Center for Food Safety and Applied may be safely used for the coloring of
Nutrition (HFS–200), Food and Drug foods generally, in amounts consistent
Administration, 5001 Campus Dr., Col- with good manufacturing practice, ex-
lege Park, MD 20740. You may inspect a cept that it may not be used to color
copy at theFood and Drug Administra- foods for which standards of identity
tion’s Main Library, 10903 New Hamp- have been promulgated under section
shire Ave., Bldg. 2, Third Floor, Silver 401 of the act, unless the use of added
Spring, MD 20993, 301–796–2039, or at the color is authorized by such standards.
National Archives and Records Admin- (c) Labeling. The color additive and
istration (NARA). For information on any mixtures intended solely or in part
the availability of this material at for coloring purposes prepared there-
NARA, call 202–741–6030, or go to: http:// from shall bear, in addition to the
www.archives.gov/federallregister/ other information required by the act,
codeloflfederallregulations/ labeling in accordance with the provi-
ibrllocations.html sions of § 70.25 of this chapter.
(2) Tomato lycopene concentrate (d) Exemption from certification. Cer-
shall conform to the following speci- tification of this color additive is not
fication: Lycopene, not less than 60 necessary for the protection of the pub-
percent of oleoresin as determined by lic health, and therefore batches there-
the method identified in paragraph of are exempt from the certification re-
(b)(1) of this section. quirements of section 721(c) of the act.
(c) Uses and restrictions. Tomato lyco-
pene extract and tomato lycopene con- § 73.615 Turmeric oleoresin.
centrate may be safely used for color- (a) Identity. (1) The color additive
ing foods generally in amounts con- turmeric oleoresin is the combination
sistent with good manufacturing prac- of flavor and color principles obtained
tice, except that they may not be used from turmeric (Curcuma longa L.) by
to color foods for which standards of extraction using any one or a combina-
identity have been issued under section tion of the following solvents:
color is authorized by such standards. Acetone Isopropyl alcohol
Ethyl alcohol Methyl alcohol
Ethylene dichloride Methylene chloride
ditive shall conform to the require- Hexane Trichloroethylene
(e) Exemption from certification. Cer- The definition of turmeric oleoresin in

tification of this color additive is not this paragraph is for the purpose of
448
identity as a color additive only, and (e) Exemption from certification. Cer-
shall not be construed as setting forth tification of this color additive is not
an official standard for turmeric oleo- necessary for the protection of the pub-
resin under section 401 of the act. lic health, and therefore batches there-
(2) Color additive mixtures made of are exempt from the certification re-
with turmeric oleoresin may contain as quirements of section 721(c) of the act.
diluents only those substances listed in
this subpart as safe and suitable in
color additive mixtures for coloring
Subpart B—Drugs
foods. § 73.1001 Diluents in color additive
(b) Specifications. Turmeric oleoresin mixtures for drug use exempt from
shall contain no more residue of the certification.
solvents listed under paragraph (a)(1)
of this section than is permitted for The following diluents may be safely
the corresponding solvents in spice used in color additive mixtures that
oleoresins under applicable food addi- are exempt from certification and
tive regulation in parts 170 through 189 which are to be used for coloring drugs,
of this chapter. subject to the condition that each
(c) Uses and restrictions. Turmeric ole- straight color in the mixture has been
oresin may be safely used for the color- exempted from certification or, if not
ing of foods generally, in amounts con- so exempted, is from a batch that has
sistent with good manufacturing prac- previously been certified and has not
tice, except that it may not be used to changed in composition since certifi-
color foods for which standards of iden- cation. Such listing of diluents is not
tity have been promulgated under sec- to be construed as superseding any of
tion 401 of the act, unless the use of the other requirements of the Federal
added color is authorized by such Food, Drug, and Cosmetic Act with re-
standards. spect to drugs, including new drugs. If
(d) Labeling. The color additive and a definition and specification for a par-
any mixtures intended solely or in part ticular diluent is not set forth in this
for coloring purposes prepared there- subpart, the material shall be of a pu-
from shall bear, in addition to the rity consistent with its intended use.
other information required by the act, (a) Ingested drugs—(1) General use.
labeling in accordance with the provi- Diluents listed in § 73.1(a) and the fol-
sions of § 70.25 of this chapter. lowing:
Alcohol, specially denatured .............................. As set forth in 26 CFR, pt. 212 .......... As set forth in 26 CFR, pt. 211.
Cetyl alcohol ....................................................... As set forth in N.F. XI.
Isopropyl alcohol ................................................ ........................................................ In color coatings for pharmaceutical
forms, no residue.
Polyoxyethylene (20) sorbitan monostearate As set forth in sec. 172.836 of this
(Polysorbate 60). chapter.
Polyoxyethylene (20) sorbitan tristearate (Poly- As set forth in sec. 172.838 of this
sorbate 65). chapter.
Polysorbate 80 ................................................... As set forth in sec. 172.840 of this
chapter.
Polyvinyl-pyrrolidone .......................................... As set forth in sec. 173.55 of this
chapter.
Sorbitan monooleate.
Sorbitan monostearate ....................................... As set forth in sec. 172.842 of this
chapter.
Sorbitan trioleate.
(2) Special use; inks for branding phar- (b) Externally applied drugs. Diluents
maceutical forms. Items listed in para- listed in paragraph (a)(1) of this section
graph (a)(1) of this section, and the following:
§ 73.1(b)(1)(i), and the following:
Substances Definitions and specifications
Ethyl lactate
Polyoxyethylene sorbitan monolaurate (20) Benzyl alcohol ............... As set forth in N.F. XI.
449
§ 73.1010 21 CFR Ch. I (4–1–19 Edition)
Substances Definitions and specifications mixture of chromium oxide, cobalt car-

bonate, and aluminum oxide. It may
Ethyl cellulose ............... As set forth in § 172.868 of this
chapter. contain small amounts (less than 1 per-
Hydroxyethyl cellulose. cent each) of oxides of barium, boron,
Hydroxypropyl cellulose As set forth in § 172.870 of this silicon, and nickel.
chapter.
(b) Specifications. Chromium-cobalt-
aluminum oxide shall conform to the
§ 73.1010 Alumina (dried aluminum hy- following specifications:
droxide).
Chromium, calculated as Cr2 O3, 34–37 per-
cent.
alumina (dried aluminum hydroxide) is
Cobalt, calculated as CoO, 29–34 percent.
a white, odorless, tasteless, amorphous Aluminum, calculated as AL2 O3, 29–35 per-
powder consisting essentially of alu- cent.
minum hydroxide (Al2 O3· XH2 O). Lead (as Pb), not more than 30 parts per mil-
(2) Color additive mixtures for drug lion.
use made with alumina (dried alu- Arsenic (as As), not more than 3 parts per
minum hydroxide) may contain only million.
those diluents listed in this subpart as Total oxides of aluminum, chromium, and
safe and suitable for use in color addi- cobalt not less than 97 percent.
tive mixtures for coloring drugs.
(b) Specifications. Alumina (dried alu- Lead and arsenic shall be determined
minum hydroxide) shall conform to the in the solution obtained by boiling 10
following specifications: grams of the chromium-cobalt-alu-
minum oxide for 15 minutes in 50 milli-
Acidity or alkalinity: Agitate 1 gram of the liters of 0.5 N hydrochloric acid.
color additive with 25 milliliters of water
and filter. The filtrate shall be neutral to
(c) Uses and restrictions. The color ad-
litmus paper. ditive chromium-cobalt-aluminum
Matter insoluble in dilute hydrochloric acid, oxide may be safely used for coloring
not more than 0.5 percent. linear polyethylene surgical sutures,
Lead (as Pb), not more than 10 parts per mil- United States Pharmacopeia (U.S.P.),
lion. for use in general surgery, subject to
Arsenic (as As), not more than 1 part per the following restrictions:
million.
Mercury (as Hg), not more than 1 part per (1) For coloring procedure, the color
million. additive is blended with the poly-
Aluminum oxide (Al2 O3), not less than 50 ethylene resin. The mixture is heated
percent. to a temperature of 500–550 °F. and ex-
(c) Uses and restrictions. Alumina truded through a fixed orifice. The fila-
(dried aluminum hydroxide) may be ments are cooled, oriented by drawing,
safely used in amounts consistent with and set by annealing.
good manufacturing practice to color (2) The quantity of the color additive
drugs generally. does not exceed 2 percent by weight of
(d) Labeling requirements. The label of the suture material.
the color additive and of any mixtures (3) The dyed suture shall conform in
prepared therefrom intended solely or all respects to the requirements of the
in part for coloring purposes shall con- U.S.P. XX (1980).
form to the requirements of § 70.25 of (4) When the sutures are used for the
this chapter. purpose specified in their labeling,
(e) Exemption from certification. Cer- there is no migration of the color addi-
tification of this color additive is not tive to the surrounding tissue.
necessary for the protection of the pub- (5) If the suture is a new drug, an ap-
lic health, and therefore batches there- proved new drug application, pursuant
of are exempt from the certification re- to section 505 of the Federal Food,
quirements of section 721(c) of the act. Drug, and Cosmetic Act, is in effect for
it.
§ 73.1015 Chromium-cobalt-aluminum (d) Labeling. The label of the color ad-
oxide. ditive shall conform to the require-
(a) Identity. The color additive chro- ments of § 70.25 of this chapter.
mium-cobalt-aluminum oxide is a blue- (e) Exemption from certification. Cer-

green pigment obtained by calcining a tification of this color additive is not
450
necessary for the protection of the pub- are exempt from the requirements of
lic health, and batches thereof are ex- section 721(c) of the act.
empt from the certification require-
ments of section 721(c) of the act. FR 10089, Mar. 19, 1984]
FR 10089, Mar. 19, 1984] § 73.1030 Annatto extract.
(a) Identity and specifications. (1) The
§ 73.1025 Ferric ammonium citrate. color additive annatto extract shall
(a) Identity. The color additive ferric conform in identity and specifications
ammonium citrate consists of complex to the requirements of § 73.30(a)(1) and
chelates prepared by the interaction of (b).
ferric hydroxide with citric acid in the (2) Color additive mixtures for drug
presence of ammonia. The complex use made with annatto extract may
chelates occur in brown and green contain only those diluents that are
forms, are deliquescent in air, and are suitable and that are listed in this sub-
reducible by light. part as safe in color additive mixtures
(b) Specifications. Ferric ammonium for coloring ingested drugs.
citrate shall conform to the following (b) Uses and restrictions. Annatto ex-
specifications and shall be free from tract may be safely used for coloring
impurities other than those named to drugs generally, including those in-
the extent that such impurities may be tended for use in the area of the eye, in
avoided by good manufacturing prac- amounts consistent with good manu-
tice: facturing practice.
(c) Labeling. The label of the color ad-
Iron (as Fe), not less than 14.5 percent and
ditive and any mixtures prepared
not more than 18.5 percent.
therefrom and intended solely or in
Lead (as Pb), not more than 20 p/m.
part for coloring purposes shall con-
Arsenic (as As), not more than 3 p/m.
(c) Uses and restrictions. Ferric ammo- this chapter. Labels shall bear informa-
nium citrate may be safely used in tion showing that the color is derived
combination with pyrogallol (as listed from annatto seed. The requirements of
in § 73.1375), for coloring plain and chro- § 70.25(a) of this chapter that all ingre-
mic catgut sutures for use in general dients shall be listed by name shall not
and ophthalmic surgery subject to the be construed as requiring the declara-
following conditions: tion of residues of solvents listed in
(1) The dyed suture shall conform in § 73.30(a)(1)(ii) of this chapter.
all respects to the requirements of the (d) Exemption from certification. Cer-
United States Pharmacopeia XX (1980). tification of this color additive is not
(2) The level of the ferric ammonium necessary for the protection of the pub-
citrate-pyrogallol complex shall not lic health and therefore batches thereof
exceed 3 percent of the total weight of are evempt from the certification re-
the suture material. quirements of section 721(c) of the act.
(3) When the sutures are used for the [42 FR 15643, Mar. 22, 1977, as amended at 42
purposes specified in their labeling, FR 36994, July 19, 1977]
there is no migration of the color addi-
tive to the surrounding tissue. § 73.1070 Calcium carbonate.
(4) If the suture is a new drug, an ap- (a) Identity. (1) The color additive cal-
proved new drug application, pursuant cium carbonate is a fine, white, syn-
to section 505 of the act, is in effect for thetically prepared powder consisting
it. essentially of precipitated calcium car-
(d) Labeling. The labeling of the bonate (CaCO3).
color-additive shall conform to the re- (2) Color additive mixtures for drug
quirements of § 70.25 of this chapter. use made with calcium carbonate may
(e) Exemption from certification. Cer- contain only those diluents listed in
tification of this color additive is not this subpart as safe and suitable for use
necessary for the protection of the pub- in color additive mixtures for coloring
lic health and therefore batches thereof drugs.
451
§ 73.1075 21 CFR Ch. I (4–1–19 Edition)
(b) Specifications. Calcium carbonate (2) The diluents in color additive

shall meet the specifications for pre- mixtures for drug use containing car-
cipitated calcium carbonate in the amel shall be limited to those listed in
United States Pharmacopeia XX (1980). this subpart as safe and suitable in
(c) Uses and restrictions. Calcium car- color additive mixtures for coloring
bonate may be safely used in amounts drugs.
consistent with good manudacturing (b) Uses and restrictions. Caramel may
practice to color drugs generally. be used for coloring ingested and topi-
(d) Labeling requirements. The label of cally applied drugs generally in
the color additive and of any mixtures amounts consistent with good manu-
prepared therefrom intended solely or facturing practice.
in part for coloring purposes shall con- (c) Exemption from certification. Cer-
form to the requirements of § 70.25 of tification of this color additive is not
this chapter. necessary for the protection of the pub-
(e) Exemption from certification. Cer- lic health and therefore batches thereof
tification of this color additive is not are exempt from the certification re-
necessary for the protection of the pub- quirement of section 721(c) of the act.
lic health, and therefore batches there-
of are exempt from the certification re- § 73.1095 β-Carotene.
quirements of section 721(c) of the act. (a) Identity and specifications. (1) The
[42 FR 15643, Mar. 22, 1977, as amended at 49 color additive b-carotene shall conform
FR 10089, Mar. 19, 1984] in identity and specifications to the re-
quirements of § 73.95(a)(1) and (b).
§ 73.1075 Canthaxanthin. (2) The diluents in color additive
(a) Identity and specifications. (1) The mixtures for drug use containing b-car-
color additive canthaxanthin shall con- otene are limited to those listed in this
form in identity and specifications to subpart as safe and suitable in color
the requirements of § 73.75(a)(1) and (b). additive mixtures for coloring ingested
(2) Color additive mixtures for in- drugs.
gested drug use made with (b) Uses and restrictions. The color ad-
canthaxanthin may contain only those ditive b-carotene may be safely used in
diluents that are suitable and that are coloring drugs generally, including
listed in this subpart as safe in color those intended for use in the area of
additive mixtures for coloring ingested the eye, in amounts consistent with
drugs. good manufacturing practice.
(b) Uses and restrictions. (c) Labeling requirements. The labeling
Canthaxanthin may be safely used for of the color additive and any mixtures
coloring ingested drugs generally in intended solely or in part for coloring
amounts consistent with good manu- purposes prepared therefrom shall con-
facturing practice. form to the requirements of § 70.25 of
(c) Labeling requirements. The label of this chapter.
the color additive and of any mixtures (d) Exemption from certification. Cer-
prepared therefrom intended solely or tification of this color additive is not
in part for coloring purposes shall con- necessary for the protection of the pub-
form to the requirements of § 70.25 of lic health, and therefore batches there-
this chapter. of are exempt from the certification re-
(d) Exemption from certification. Cer- quirements of section 721(c) of the act.
tification of this color additive is not [42 FR 15643, Mar. 22, 1977, as amended at 42
necessary for the protection of the pub- FR 33722, July 1, 1977]
of are exempt from the certification re- § 73.1100 Cochineal extract; carmine.
quirements of section 721(c) of the act. (a) Identity and specifications. (1) The
color additives cochineal extract and
§ 73.1085 Caramel. carmine shall conform in identity and
(a) Identity and specifications. (1) The specifications to the requirements of
color additive caramel shall conform in § 73.100(a) (1) and (2) and (b).
identity and specifications to the re- (2) Color additive mixtures for drug
quirements of § 73.85(a) (1), (2), and (3) use made with carmine and cochineal
and (b). extract may contain only those
452
diluents that are suitable and that are Ratio, absorbance at 405 mμ to absorbance at
listed in this subpart as safe in color 630 mμ, not less than 3.4 and not more than
additive mixtures for coloring drugs. 3.9.
Total color, not less than 75 percent.
(b) Uses and restrictions. Cochineal ex-
tract and carmine may be safely used (c) Uses and restrictions. Potassium
for coloring ingested and externally ap- sodium copper chlorophyllin may be
plied drugs in amounts consistent with safely used for coloring dentifrices that
good manufacturing practice. are drugs at a level not to exceed 0.1
(c) Labeling requirements. The label of percent. Authorization for this use
the color additives and any mixtures shall not be construed as waiving any
intended solely or in part for coloring of the requirements of section 505 of
purposes prepared therefrom shall con- the act with respect to the drug in
form to the requirements of § 70.25 of which it is used.
this chapter. (d) Labeling. The label of the color ad-
(d) Exemption from certification. Cer- ditive and any mixtures prepared
tification of these color additives is therefrom intended solely or in part for
not necessary for the protection of the coloring purposes shall conform to the
public health, and therefore batches requirements of § 70.25 of this chapter.
thereof are exempt from the certifi- (e) Exemption from certification. Cer-
cation requirements of section 721(c) of tification of this color additive is not
the act. necessary for the protection of the pub-
lic health and therefore batches thereof
§ 73.1125 Potassium sodium copper are exempt from the certification re-
chloropyhllin (chlorophyllin-copper quirements of section 721(c) of the act.
complex).
§ 73.1150 Dihydroxyacetone.
(a) Identity. (1) The color additive po-
tassium sodium copper chlorophyllin is (a) Identity. (1) The color additive
a green to black powder obtained from dihydroxyacetone is 1,3-dihydroxy-2-
chlorophyll by replacing the methyl propanone.
and phytyl ester groups with alkali and (2) Color additive mixtures for drug
replacing the magnesium with copper. use made with dihydroxyacetone may
The source of the chlorophyll is dehy- contain only those diluents that are
drated alfalfa. listed in this subpart as safe and suit-
able in color additive mixtures for
(2) Color additive mixtures for drug
coloring externally applied drugs.
use made with potassium sodium cop-
(b) Specifications. Dihydroxyacetone
per chlorophyllin may contain only
those diluents that are suitable and
fications and shall be free from impuri-
that are listed in this subpart as safe
ties other than those named to the ex-
for use in color additive mixtures for
tent that such impurities may be
coloring drugs.
avoided by good manufacturing prac-
(b) Specifications. Potassium sodium tice:
copper chlorophyllin shall conform to
the following specifications and shall Volatile matter (at 34.6 °C. for 3 hours at a
be free from impurities other than pressure of not more than 30 mm. mer-
those named to the extent that such cury), not more than 0.5 percent.
Residue on ignition, not more than 0.4 per-
other impurities may be avoided by cent.
good manufacturing practice: Lead (as Pb), not more than 20 parts per mil-
Moisture, not more than 5.0 percent. lion.
Arsenic (as As), not more than 3 parts per
Nitrogen, not more than 5.0 percent.
million.
pH of 1 percent solution, 9 to 11.
Iron (as Fe), not more than 25 parts per mil-
Total copper, not less than 4 percent and not lion.
more than 6 percent. 1,3-dihydroxy-2-propanone, not less than 98
Free copper, not more than 0.25 percent. percent.
Iron, not more than 0.5 percent.
Lead (as Pb)), not more than 20 parts per (c) Uses and restrictions.
Dihydroxyacetone may be safely used
million.
Arsenic (as As), not more than 5 parts per in amounts consistent with good manu-
million. facturing practice in externally applied
453
§ 73.1162 21 CFR Ch. I (4–1–19 Edition)
drugs intended solely or in part to im- purposes shall bear, in addition to any
part a color to the human body. Au- information required by law, labeling
thorization for this use shall not be in accordance with the provisions of
construed as waiving any of the re- § 70.25 of this chapter.
quirements of section 505 of the act (e) Exemption from certification. Cer-
with respect to the drug in which it is tification of this color additive is not
used. necessary for the protection of the pub-
(d) Labeling requirements. The label of lic health, and therefore batches there-
the color additive and any mixtures of are exempt from certification pursu-
prepared therefrom intended solely or ant to section 721(c) of the act.
in part for coloring purposes shall con-
form to the requirements of § 70.25 of [42 FR 52394, Sept. 30, 1977]
this chapter.
(e) Exemption from certification. Cer- § 73.1200 Synthetic iron oxide.
necessary for the protection of the pub- synthetic iron oxide consists of any
lic health and therefore batches thereof one or any combination of syn-
are exempt from the certification re- thetically prepared iron oxides, includ-
quirements of section 721(c) of the act. ing the hydrated forms. It is free from
§ 73.1162 Bismuth oxychloride. admixture with other substances.
(a) Identity. (1) The color additive bis- use made with synthetic iron oxide
muth oxychloride is a synthetically may contain only those diluents listed
prepared white or nearly white amor- in this subpart as safe and suitable in
phous or finely crystalline, odorless color additive mixtures for coloring
powder consisting principally of BiOCl. drugs.
(b) Specifications. Synthetic iron
use made with bismuth oxychloride
may contain only those diluents that oxide shall conform to the following
are suitable and that are listed in this specifications, all on an ‘‘as is’’ basis:
subpart as safe in color additive mix- Arsenic (as As), not more than 3 parts per
tures for coloring externally applied million.
drugs. Lead (as Pb), not more than 10 parts per mil-
(b) Specifications. The color additive lion.
bismuth oxychloride shall conform to Mercury (as Hg), not more than 3 parts per
the following specifications and shall million.
be free from impurities other than (c) Uses and restrictions. The color ad-
those named to the extent that such ditive synthetic iron oxide may be
other impurities may be avoided by safely used to color ingested or topi-
good manufacturing practice: cally applied drugs generally subject to
Volatile matter, not more than 0.5 percent. the restriction that if the color addi-
Lead (as Pb), not more than 20 parts per mil- tive is used in drugs ingested by man
lion. the amount consumed in accordance
with labeled or prescribed dosages shall
million.
Mercury (as Hg), not more than 1 part per not exceed 5 milligrams, calculated as
million. elemental iron, per day.
Bismuth oxychloride, not less than 98 per- (d) Labeling requirements. The label of
cent. the color additive and any mixtures in-
(c) Uses and restrictions. The color ad- tended solely or in part for coloring
ditive bismuth oxychloride may be purposes prepared therefrom shall con-
safely used in coloring externally ap- form to the requirements of § 70.25 of
plied drugs, including those intended this chapter.
for use in the area of the eye, in (e) Exemption from certification. Cer-
amounts consistent with good manu- tification of this color additive is not
facturing practice. necessary for the protection of the pub-
(d) Labeling. The color additive and lic health, and therefore batches there-
any mixture prepared therefrom in- of are exempt from certification re-
tended solely or in part for coloring quirements of section 721(c) of the act.
454
§ 73.1298 Ferric ammonium ferrocya- form to the requirements of § 70.25 of

nide. this chapter.
(a) Identity. (1) The color additive fer- (e) Exemption from certification. Cer-
ric ammonium ferrocyanide is the blue tification of this color additive is not
pigment obtained by oxidizing under necessary for the protection of the pub-
acidic conditions with sodium dichro- lic health, and therfore batches thereof
mate the acid digested precipitate re- are exempt from the certification re-
sulting from mixing solutions of fer- quirements of section 721(c) of the act.
rous sulfate and sodium ferrocyanide in [42 FR 38562, July 29, 1977, as amended at 44
the presence of ammonium sulfate. The FR 28322, May 15, 1979]
oxidized product is filtered, washed,
and dried. The pigment consists prin- § 73.1299 Ferric ferrocyanide.
cipally of ferric ammonium ferrocya- (a) Identity. (1) The color additive fer-
nide with smaller amounts of ferric ferric ferrocyanide is a ferric
rocyanide and ferric sodium ferrocya- hexacyanoferrate pigment character-
nide. ized by the structual formula
(2) Color additive mixtures for drug Fe4[Fe(CN)6]3·XH2O, which may contain
use made with ferric ammonium ferro- small amounts of ferric sodium ferro-
cyanide may contain only those cyanide and ferric potassium ferrocya-
diluents listed in this subpart as safe nide.
and suitable for use in color additive (2) Color additive mixtures for drug
mixtures for coloring drugs. use made with ferric ferrocyanide may
(b) Specifications. Ferric ammonium contain only those diluents listed in
ferrocyanide shall conform to the fol- this subpart as safe and suitable for use
lowing specifications and shall be free in color additive mixtures for coloring
of impurities other than those named drugs.
to the extent that the other impurities (b) Specifications. Ferric ferrocyanide
may be avoided by good manufacturing shall conform to the following speci-
practice: fications and shall be free from impuri-
Oxalic acid or its salts, not more than 0.1 tent that such impurities may be
percent. avoided by good manufacturing prac-
Water soluble matter, not more than 3 per-
tice:
cent.
Water soluble cyanide, not more than 10 Water soluble cyanide, not more than 10
parts per million. parts per million.
Volatile matter, not more than 4 percent. Lead (as Pb), not more than 20 parts per mil-
Lead (as Pb), not more than 20 parts per million.
lion. Arsenic (as As), not more than 3 parts per
Arsenic (as As), not more than 3 parts per million.
million. Nickel (as Ni), not more than 200 parts per
Nickel (as Ni), not more than 200 parts per million.
million. Cobalt (as Co), not more than 200 parts per
Cobalt (as Co), not more than 200 parts per million.
million. Mercury (as Hg), not more than 1 part per
million.
Oxalic acid, not more than 0.1 percent.
million.
Water soluble matter, not more than 3 per-
Total iron (as Fe corrected for volatile mat- cent.
ter), not less than 33 percent and not more Volatile matter, not more than 10 percent.
than 39 percent. Total iron (as Fe corrected for volatile mat-
(c) Uses and restrictions. Ferric ammo- ter), not less than 37 percent and not more
nium ferrocyanide may be safely used than 45 percent.
in amounts consistent with good manu- (c) Uses and restrictions. Ferric ferro-
facturing practice to color externally cyanide may be safely used in amounts
applied drugs, including those for use consistent with good manufacturing
in the area of the eye. practice to color externally applied
(d) Labeling requirements. The label of drugs including those intended for use
the color additive and of any mixtures in the area of the eye.
prepared therefrom intended solely or (d) Labeling requirements. The label of

in part for coloring purposes shall con- the color additive and of any mixtures
455
§ 73.1326 21 CFR Ch. I (4–1–19 Edition)
prepared therefrom intended solely or lic health, and therefore batches there-
in part for coloring purposes shall con- of are exempt from the certification re-
form to the requirements of § 70.25 of quirements of section 721(c) of the act.
this chapter.
(e) Exemption from certification. Cer- FR 59852, Nov. 22, 1977]
tification of this color additive is not
necessary for the protection of the pub- § 73.1327 Chromium oxide greens.
of are exempt from certification re-
chromium oxide greens is principally
quirements of section 721(c) of the act.
chromic sesquioxide (Cr2O3).
[43 FR 54235, Nov. 21, 1978] (2) Color additive mixtures for drug
use made with chromium oxide greens
§ 73.1326 Chromium hydroxide green. may contain only those diluents listed
(a) Identity. (1) The color additive in this subpart as safe and suitable for
chromium hydroxide green is prin- use in color additive mixtures for
cipally hydrated chromic sesquioxide coloring drugs.
(Cr2O3·XH2O). (b) Specifications. the color additive
(2) Color additive mixtures for drug chormium oxide greens shall conform
use made with chromium hydroxide to the following specifications and
green may contain only those diluents shall be free from impurities other
listed in this subpart as safe and suit- than those named to the extent that
able for use in color additive mixtures such impurities may be avoided by
for coloring drugs. good manufacturing practice:
(b) Specifications. Chromium hydrox- Chromium in 2% NaOH extract, not more
ide green shall conform to the fol- than 0.075% as Cr2O3 (based on sample
lowing specifications and shall be free weight).
from impurities other than those Arsenic (as As), not more than 3 parts per
named to the extent that such impuri- million.
ties may be avoided by good manufac- Lead (as Pb), not more than 20 parts per mil-
turing practice: lion.
Water soluble matter, not more than 2.5%. million.
Chromium in 2% NaOH extract, not more Cr2O3, not less than 95%.
than 0.1% as Cr2O3 (based on sample
weight). (c) Uses and restrictions. Chromium
Boron (as B2O3), not more than 8 percent. oxide greens is safe for use in coloring
Total volatile matter at 1000 °C, not more externally applied drugs, including
than 20%. those intended for use in the area of
Cr2O3 not less than 75%. eye, in amounts consistent with good
Lead (as Pb), not more than 20 parts per mil- manufacturing practice.
lion.
(d) Labeling. The color additive and
million. any mixture prepared therefrom in-
Mercury (as Hg), not more than 1 part per tended solely or in part for coloring
million. purposes shall bear, in addition to any
information required by law, labeling
(c) Uses and restrictions. Chromium in accordance with § 70.25 of this chap-
hydroxide green may be safely used in ter.
amounts consistent with good manu- (e) Exemption from certification. Cer-
facturing practice to color externally tification of this color additive is not
applied drugs, including those for use necessary for the protection of the pub-
in the area of the eye. lic health, and therefore batches therof
(d) Labeling requirements. The label of are exempt from certification pursuant
the color additive and of any mixtures to section 721(c) of the act.
prepared therefrom lintended solely or
in part for coloring purposes shall con- [42 FR 36451, July 15, 1977]
this chapter. § 73.1329 Guanine.
(e) Exemption from certification. Cer- (a) Identity. (1) The color additive
tification of this color additive is not guanine is the crystalline material ob-
necessary for the protection of the pub- tained from fish scales and consists
456
principally of the two purines, guanine mica; iron oxide on mica; titanium di-
and hypoxanthine. The guanine con- oxide and iron oxide on mica. Mica
tent will vary from 75 to 97 percent, used to manufacture the color additive
and the hypoxanthine will vary from 3 shall conform in identity to the re-
to 25 percent, depending on the par- quirements of § 73.1496(a)(1).
ticular fish and tissue from which the (2) Color additive mixtures for drug
crystals are derived. use made with mica-based pearlescent
(2) Color additive mixtures for drug pigments may contain only those
use made with guanine may contain diluents listed in this subpart as safe
only those diluents listed in this sub- and suitable for use in color additive
part as safe and suitable for use in mixtures for coloring ingested drugs.
color additive mixtures for coloring ex- (b) Specifications. Mica-based pearl-
ternally applied drugs. escent pigments shall conform to the
(b) Specifications. The color additive following specifications and shall be
guanine shall conform to the following free from impurities other than those
specifications and shall be free from named to the extent that such other
impurities other than those named to impurities may be avoided by good
the extent that such other impurities manufacturing practice:
may be avoided by good manufacturing (1) Lead (as Pb), not more than 4
practice: parts per million (ppm).
Guanine, not less than 75 percent. (2) Arsenic (as As), not more than 3
Hypoxanthine, not more than 25 percent. ppm.
Ash (ignition at 800 °C), not more than 2 per- (3) Mercury (as Hg), not more than 1
cent. ppm.
Lead (as Pb), not more than 20 parts per mil- (c) Uses and restrictions. Mica-based
lion. pearlescent pigments may be safely
used to color ingested drugs in
million.
Assay, not less than 96 percent total purines. amounts up to 3 percent, by weight, of
Mercury (as Hg), not more than 1 part per the final drug product. The maximum
million. amount of iron oxide to be used in pro-
ducing said pigments is not to exceed
(c) Uses and restrictions. Guanine is
55 percent, by weight, in the finished
safe for use in coloring externally ap-
pigment.
plied drugs, including those intended
for use in the area of the eye, in
ditive and of any mixture prepared
therefrom intended solely or in part for
facturing practice.
coloring purposes shall conform to the
requirements of § 70.25 of this chapter.
any mixture prepared therefrom in-
tended solely or in part for coloring
purposes shall bear, in addition to any
necessary for the protection of the pub-
in accordance with § 70.25 of this chap-
ter.
quirements of section 721(c) of the Fed-
eral Food, Drug, and Cosmetic Act.
necessary for the protection of the pub- [70 FR 42273, July 22, 2005. Redesignated at 72
lic health, and therefore batches therof FR 10357, Mar. 8, 2007]
are exempt from certification pursuant
to section 721(c) of the act. § 73.1375 Pyrogallol.
(a) Identity. The color additive pyro-
[42 FR 37537, July 22, 1977]
gallol is 1,2,3-trihydroxybenzene.
§ 73.1350 Mica-based pearlescent pig- (b) Specifications. Pyrogallol shall
ments. conform to the following specifications
(a) Identity. (1) The color additive is and shall be free from impurities other
formed by depositing titanium and/or than those named to the extent that
iron salts onto mica, followed by heat- such impurities may be avoided by
ing to produce one of the following good manufacturing practice:

combinations: Titanium dioxide on Melting point, between 130° and 133 °C.
457
§ 73.1400 21 CFR Ch. I (4–1–19 Edition)
Residue on ignition, not more than 0.1 per- (b) Specifications. Pyrophyllite shall
cent. conform to the following specifica-
Lead (as Pb), not more than 20 p/m (parts per tions:
million).
Arsenic (as As), not more than 3 p/m. Lead (as Pb), not more than 20 parts per mil-
lion.
(c) Uses and restrictions. Pyrogallol Arsenic (as As), not more than 3 parts per
may be safely used in combination million.
with ferric ammonium citrate (as list-
ed in § 73.1025), for coloring plain and Lead and arsenic shall be determined
chromic catgut sutures for use in gen- in the solution obtained by boiling 10
eral and ophthalmic surgery, subject to grams of the pyrophyllite for 15 min-
the following restrictions: utes in 50 milliliters of 0.5N hydro-
(1) The dyed suture shall conform in chloric acid.
all respects to the requirements of the (c) Uses and restrictions. Pyrophyllite
United States Pharmacopeia XX (1980). may be safely used in amounts con-
(2) The level of the ferric ammonium sistent with good manufacturing prac-
citrate-pyrogallol complex shall not tice to color drugs that are to be exter-
exceed 3 percent of the total weight of nally applied.
the suture material. (d) Labeling requirements. The labeling
(3) When the sutures are used for the of the color additive and any mixtures
purposes specified in their labeling, prepared therefrom intended solely or
there is no migration of the color addi- in part for coloring purposes shall con-
tive to the surrounding tissues. form to the requirements of § 70.25 of
(4) If the suture is a new drug, an ap- this chapter.
proved new drug application, pursuant (e) Exemption from certification. Cer-
to section 505 of the act, is in effect for tification of this color additive is not
it. necessary for the protection of the pub-
(d) Labeling. The label of the color ad- lic health, and therefore batches there-
ditive shall conform to the require- of are exempt from the certification re-
ments of § 70.25 of this chapter. quirements of section 721(c) of the act.
tification of this color additive is not § 73.1410 Logwood extract.
necessary for the protection of the pub- (a) Identity. The color additive
lic health and therefore batches thereof logwood extract is a reddish brown-to-
are exempt from the certification re- black solid material extracted from the
quirements of section 721(c) of the act. heartwood of the leguminous tree
[42 FR 15643, Mar. 22, 1977, as amended at 49 Haematoxylon campechianum. The ac-
FR 10089, Mar. 19, 1984] tive colorant substance is principally
hematein. The latent coloring material
§ 73.1400 Pyrophyllite. is the unoxidized or leuco form of he-
(a) Identity. (1) The color additive matein called hematoxylin. The leuco
pyrophyllite is a naturally occurring form is oxidized by air.
mineral substance consisting predomi- (b) Specifications. Logwood extract
nantly of a hydrous aluminum silicate, shall conform to the following speci-
Al2O3·4SiO2·H2 O, intimately mixed fications and shall be free from impuri-
with lesser amounts of finely divided ties other than those named to the ex-
silica, SiO2. Small amounts, usually tent that such imnurities may be
less than 3 percent, of other silicates, avoided by good manufacturing prac-
such as potassium aluminum silicate, tice:
may be present. Pyrophyllite may be Volatile matter (at 110 °C), not more than 15
identified and semiquantitatively de- percent.
termined by its characteristic X-ray Sulfated ash, not more than 20 percent.
powder diffraction pattern and by its Hematein, not less than 5 percent and not
optical properties. more than 20 percent.
lion.
with pyrophyllite are limited to those Arsenic (as As), not more than 4 parts per
listed in this subpart as safe and suit-
million.
able in color additive mixtures for Mercury (as Hg), not more than 3 parts per
coloring externally applied drugs. million.
458
(c) Use and restrictions. Logwood ex- Lead (as Pb), not more than 20 parts per mil-
tract may be safely used to color nylon lion.
66 (the copolymer of Arsenic (as As), not more than 3 parts per
hexamethylenediamine and adipic million.
acid), nylon 6 (the polymer of e-
million.
caprolactam), or silk non-absorable su-
tures for use in general and ophthalmic (c) Uses and restrictions. Mica may be
surgery subject to the following re- safely used in amounts consistent with
strictions: good manufacturing practice to color
(1) The quantity of color additive dentifrices and externally applied
does not exceed 1.0 percent by weight drugs, including those for use in the
of the suture. area of the eye.
(2) When the sutures are used for the (d) Labeling requirements. The label of
purposes specified in their labeling, the color additive and of any mixture
there is no migration of the color addi- prepared therefrom intended solely or
tive to the surrounding tissue. in part for coloring purposes shall con-
(3) If the suture is a new drug, an ap- form to the requirements of § 70.25 of
proved new drug application, pursuant this chapter.
to section 505 of the act, is in effect for (e) Exemption from certification. Cer-
it. tification of this color additive is not
(d) Labeling. The label of the color ad- necessary for the protection of the pub-
ditive shall conform to the require- lic health, and therefore batches therof
ments of § 70.25 of this chapter. are exempt from the certification re-
(e) Exemption from certification. Cer- quirements of section 721(c) of the act.
tification of this color additive is not [42 FR 38561, July 29, 1977, as amended at 52
necessary for the protection of the pub- FR 29665, Aug. 11, 1987]
of are exempt from the certification re- § 73.1530 Spirulina extract.
[42 FR 52393, Sept. 30, 1977; 43 FR 1490, Jan. spirulina extract is prepared by the fil-
10, 1978] tered aqueous extraction of the dried
biomass of Arthrospira platensis. The
§ 73.1496 Mica. color additive contains phycocyanins
(a) Identity. (1) The color additive as the principal coloring components.
mica is a white powder obtained from (2) Color additive mixtures for drug
the naturally occurring mineral, mus- use made with spirulina extract may
covite mica, consisting predominantly contain only those diluents that are
of a potassium aluminum silicate, suitable and are listed in this subpart
K2Al4(Al2Si6O20)(OH)4 or, alternatively, as safe for use in color additive mix-
H2KAl3 (SiO4)3. Mica may be identified tures for coloring ingested drugs.
and semiquantitatively determined by (b) Specifications. Spirulina extract
its characteristic X-ray diffraction pat- must conform to the following speci-
tern and by its optical properties. fications and must be free from impuri-
(2) Color additive mixtures for drug ties, other than those named, to the ex-
use made with mica may contain only tent that such other impurities may be
those diluents listed in this subpart as avoided by good manufacturing prac-
safe and suitable for use in color addi- tice:
tive mixtures for coloring drugs. (1) Lead, not more than 2 milligrams
(b) Specifications. Mica shall conform per kilogram (mg/kg) (2 parts per mil-
to the following specifications and lion (ppm));
shall be free from impurities other (2) Arsenic, not more than 2 mg/kg (2
than those named to the extent that ppm);
such other impurities may be avoided (3) Mercury, not more than 1 mg/kg (1
by good manufacturing practice: ppm); and
Fineness, 100 percent shall pass through a (4) Negative for microcystin toxin.
(c) Uses and restrictions. Spirulina ex-
100-mesh sieve.
Loss on ignition at 600–650 °C, not more than tract may be safely used for coloring
2 percent. coating formulations applied to drug
459
§ 73.1550 21 CFR Ch. I (4–1–19 Edition)
tablets and capsules, at levels con- of are exempt from the certification re-
sistent with good manufacturing prac- quirements of section 721(c) of the act.
tice. [42 FR 15643, Mar. 22, 1977, as amended at 49
(d) Labeling requirements. The label of FR 10089, Mar. 19, 1984]
the color additive and any mixture pre-
pared therefrom intended solely or in § 73.1575 Titanium dioxide.
part for coloring purposes shall con- (a) Identity and specifications. (1) The
form to the requirements of § 70.25 of color additive titanium dioxide shall
this chapter. conform in identity and specifications
(e) Exemption from certification. Cer- to the requirements of § 73.575(a)(1) and
tification of this color additive is not (b).
necessary for the protection of the pub- (2) Color additive mixtures for drug
lic health, and therefore batches there- use made with titanium dioxide may
of are exempt from the certification re- contain only those diluents that are
quirements of section 721(c) of the Fed- suitable and that are listed in this sub-
eral Food, Drug, and Cosmetic Act. part as safe in color additive mixtures
for coloring drugs, and the following:
[80 FR 50765, Aug. 21, 2015] Silicon dioxide, SiO2, and/or aluminum
oxide, Al2O3, as dispersing aids—not
§ 73.1550 Talc.
more than 2 percent total.
(a) Identity. (1) The color additive (b) Uses and restrictions. The color ad-
talc is a finely powdered, native, hy- ditive titanium dioxide may be used for
drous magnesium silicate sometimes coloring ingested and externally ap-
containing a small proportion of alu- plied drugs generally, in amounts con-
minum silicate. sistent with good manufacturing prac-
(2) Color additive mixtures for drug tice. External application includes use
use made with talc may contain only in the area of the eye.
those diluents listed in this subpart as (c) Labeling. The label of the color ad-
safe and suitable for use in color addi- ditive and any mixtures prepared
tive mixtures for coloring drugs. therefrom and intended solely or in
(b) Specifications. Talc shall meet the part for coloring purposes shall con-
specifications for talc in the United form to the requirements of § 70.25 of
States Pharmacopeia XX (1980) and the the chapter.
following: (d) Exemption from certification. Cer-
Lead (as Pb), not more than 20 parts per mil- necessary for the protection of the pub-
lion. lic health and therefore batches thereof
Arsenic (as As), not more than 3 parts per are exempt from the certification re-
million. quirements of section 721(c) of the act.
Lead and arsenic shall be determined § 73.1645 Aluminum powder.
in the solution obtained by boiling 10
grams of the talc for 15 minutes in 50 (a) Identity. (1) The color additive
milliliters of 0.5N hydrochloric acid. aluminum powder shall be composed of
finely divided particles of aluminum
(c) Uses and restrictions. Talc may be
prepared from virgin aluminum. It is
safely used in amounts consistent with
free from admixture with other sub-
good manufacturing practice to color stances.
drugs generally. (2) Color additive mixtures for exter-
(d) Labeling requirements. The label of nal drug use made with aluminum pow-
the color additive and of any mixtures der may contain only those diluents
prepared therefrom intended solely or listed in this subpart as safe and suit-
in part for coloring purposes shall con- able in color additive mixtures for
form to the requirements of § 70.25 of coloring externally applied drugs.
this chapter. (b) Specifications. Aluminum powder
(e) Exemption from certification. Cer- shall conform to the following speci-
tification of this color additive is not fications and shall be free from impuri-
necessary for the protection of the pub- ties other than those named to the ex-
lic health, and therefore batches there- tent that such impurities may be
460
avoided by good manufacturing prac- Mercury (as Hg), not more than 1 part per
tice: million
Aluminum (as Al), not more than 0.5 percent.
Fineness, 100 percent shall pass through a Tin (as Sn), not more than 0.5 percent.
200-mesh screen and 95 percent shall pass Copper (as Cu), not more than 95 percent and
through a 325-mesh screen. not less than 70 percent.
Mercury, not more than 1 part per million. Zinc (as Zn), not more than 30 percent.
Arsenic, not more than 3 parts per million. Maximum particle size 45μ (95 percent min-
Lead, not more than 20 parts per million. imum).
Aluminum, not less than 99 percent.
Aluminum, zinc, tin, and copper con-
(c) Uses and restrictions. Aluminum
tent shall be based on the weight of the
powder is safe for use in externally ap-
plied drugs, including those intended dried powder after being thoroughly
for use in the area of the eye, in washed with ether.
amounts consistent with good manu- (c) Uses and restrictions. Bronze pow-
facturing practice. der may be safely used in color exter-
(d) Labeling. The color additive and nally applied drugs, including those in-
any mixture prepared therefrom intended for use in the area of the eye, in
tended solely or in part for coloring amounts consistent with good manu-
purposes shall bear, in addition to any facturing practice.
information required by law, labeling (d) Labeling. The color additive and
in accordance with § 70.25 of this chap- any mixture prepared therefrom in-
ter. tended solely or in part for coloring
(e) Exemption from certification. Cer- purposes shall conform to the require-
tification of this color additive is not ments of § 70.25 of this chapter.
necessary for the protection of the pub- (e) Exemption from certification. Cer-
lic health, and therefore batches therof tification of the color additive is not
are exempt from certification pursuant necessary for the protection of the pub-
to section 721(c) of the act. lic health, and therefore batches there-
[42 FR 38563, July 29, 1977]
§ 73.1646 Bronze powder. [42 FR 33723, July 1, 1977]
§ 73.1647 Copper powder.
bronze powder is a very fine metallic
powder prepared from alloys consisting (a) Identity. (1) The color additive
principally of virgin electrolytic cop- copper powder is a very fine free-flow-
per and zinc with small amounts of the ing metallic powder prepared from vir-
virgin metals aluminum and tin. It gin electrolytic copper. It contains
contains small amounts of stearic or small amounts of stearic or oleic acid
oleic acid as lubricants. as lubricants.
(2) Color additive mixtures for drug (2) Color additive mixtures for drug
use made with bronze powder may con- use made with copper powder may con-
tain only those diluents listed in this tain only those diluents listed in this
subpart as safe and suitable for use in subpart as safe and suitable for use in
color additive mixtures for coloring ex- color additive mixtures for coloring ex-
ternally applied drugs. ternally applied drugs.
(b) Specifications. Bronze powder shall (b) Specifications. Copper powder shall
conform to the following specifications conform to the following specifications
and shall be free from impurities other and shall be free from impurities other
than those named to the extent that than those named to the extent that
such impurities may be avoided by such impurities may be avoided by
good manufacturing practice: good manufacturing practice:
Stearic or oleic acid, not more than 5 per- Stearic or oleic acid, not more than 5 per-
cent. cent.
Cadmium (as Cd), not more than 15 parts per Cadmium (as Cd), not more than 15 parts per
million. million.
Lead (as Pb), not more than 20 parts per mil- Lead (as Pb), not more than 20 parts per mil-
lion. lion.
Arsenic (as As), not more than 3 parts per Arsenic (as As), not more than 3 parts per
million. million.
461
§ 73.1991 21 CFR Ch. I (4–1–19 Edition)
Mercury (as Hg), not more than 1 part per cluding those used in the area of the
million. eye, in amounts consistent with good
Copper (as Cu), not less than 95 percent.
manufacturing practice.
Maximum particle size 45μ (95 percent min-
imum). (d) Labeling. The color additive and
any mixtues prepared therefrom in-
(c) Uses and restrictions. Copper pow- tended solely or in part for coloring
der may be safely used in coloring ex- purposes shall bear, in addition to any
ternally applied drugs, including those information required by law, labeling
intended for use in the area of the eye, in accordance with the provisions of
in amounts consistent with good manu- § 70.25 of this chapter.
facturing practice.
tended solely or in part for coloring necessary for the protection of the pub-
purposes shall conform to the require- lic health, and therefore batches therof
ments of § 70.25 of this chapter. are exempt from the certifiation pursu-
(e) Exemption from certification. Cer- ant to section 721(c) of the act.
tification of the color additive is not [42 FR 37537, July 22, 1977]
lic health, and therefore batches there- Subpart C—Cosmetics
quirements of section 721(c) of the act. § 73.2030 Annatto.
[42 FR 33723, July 1, 1977] (a) Identity and specification. The
color additive annatto shall conform in
§ 73.1991 Zinc oxide.
identify and specification to the re-
(a) Identity. (1) The color additive quirements for annatto extract in
zinc oxide is a white or yellow-white § 73.30(a) (1) and (b).
amorphous powder manufactured by (b) Use and restriction. The color addi-
the French process (described as the in- tive annatto may be safely used in
direct process whereby zinc metal iso- coloring cosmetics generally, including
lated from the zinc-containing ore is cosmetics intended for use in the area
vaporized and then oxidized). It is prin- of the eye, in amounts consistent with
cipally composed of Zn. good manufacturing practice.
use made with zinc oxide may contain
only those diluents listed in this sub-
part as safe and suitable in color addi-
tive mixtures for coloring externally
applied drugs.
(b) Specifications. Zinc oxide shall in accordance with the provisions of
conform to the following specifications § 70.25 of this chapter.
and shall be free from impurities other (d) Exemption from certification. Cer-
than those named to the extent that tification of this color additive is not
such impurities may be avoided by necessary for the protection of the pub-
good manufacturing practice: lic health, and therefore batches there-
Zinc oxide (as ZnO), not less than 99 percent. quirements of section 721(c) of the act.
Loss on ignition at 800 °C, not more than 1
percent. [42 FR 36994, July 19, 1977]
Cadmium (as Cd), not more than 15 parts per
million. § 73.2085 Caramel.
million. (a) Identity and specifications. The
Arsenic (as As), not more than 3 parts per color additive caramel shall conform in
million. identity and specifications to the re-
Lead (as Pb), not more than 20 parts per mil- quirements of § 73.85(a)(1), (2), and (3)
lion. and (b).
(c) Uses and restrictions. The color ad- (b) Uses and restrictions. Caramel is
ditive zinc oxide may be safely used for safe for use in coloring cosmetics gen-
coloring externally applied drugs, in- erally, including cosmetics applied to
462
the area of the eye, in amounts con- (b) Uses and restrictions. The color ad-
sistent with good manufacturing prac- ditive b-carotene may be safely used in
tice. coloring cosmetics generally, including
(c) Labeling requirements. The label of cosmetics intended for use in the area
the color additive and any mixtures in- of the eye, in amounts consistent with
tended solely or in part for coloring good manufacturing practices.
purposes prepared therefrom shall con- (c) Labeling. The color additive and
form to the requirements of § 70.25 of any mixture prepared therefrom in-
this chapter. tended solely or in part for coloring
(d) Exemption from certification. Cer- purposes shall bear, in addition to any
tification of this color additive is not information required by law, labeling
necessary for the protection of the pub- in accordance with the provisions of
lic health, and therefore batches there- § 70.25 of this chapter.
of are exempt from the certification re- (d) Exemption from certification. Cer-
quirement of section 721(c) of the act. tification of this color additive is not
[46 FR 38501, July 28, 1981] lic health, and therefore batches therof
are exempt from the certification pur-
§ 73.2087 Carmine. suant to section 721(c) of the act.
(a) Identity and specifications. The [42 FR 33722, July 1, 1977]
color additive carmine shall conform in
identity and specifications to the re- § 73.2110 Bismuth citrate.
quirements of § 73.100 (a)(2) and (b)(2). (a) Identity. The color additive bis-
(b) Use and restrictions. Carmine may muth citrate is the synthetically pre-
be safely used in cosmetics generally, pared crystalline salt of bismuth and
including cosmetics intended for use in citric acid, consisting principally of
the area of the eye, in amounts con- BiC6H5O7.
sistent with good manufacturing prac- (b) Specifications. The color additive
tices. bismuth citrate shall conform to the
(c) Labeling. (1) The color additive following specifications and shall be
and any mixture prepared therefrom free from impurities other than those
intended solely or in part for coloring named to the extent that those impuri-
purposes shall bear, in addition to any ties may be avoided by good manufac-
information required by law, labeling turing practice:
in accordance with the provisions of Bismuth citrate, not less than 97 percent.
§ 70.25 of this chapter. Mercury (as Hg), not more than 1 part per
(2) Cosmetics containing carmine million.
that are not subject to the require- Arsenic (as As), not more than 3 parts per
ments of § 701.3 of this chapter shall million.
specifically declare the presence of car- Lead (as Pb), not more than 20 parts per mil-
lion.
mine prominently and conspicuously at Volatile matter, not more than 1 percent.
least once in the labeling. For example:
‘‘Contains carmine as a color addi- (c) Uses and restrictions. The color ad-
tive.’’ ditive bismuth citrate may be safely
(d) Exemption from certification. Cer- used in cosmetics intended for coloring
tification of this color additive is not hair on the scalp, subject to the fol-
necessary for the protection of the pub- lowing restrictions:
lic health, and therefore batches there- (1) The amount of bismuth citrate in
of are exempt from the certification the cosmetic shall not be in excess of
pursuant to section 721(c) of the act. 2.0 percent (w/v).
(2) The cosmetic may not be used for
[42 FR 32228, June 24, 1977, as amended at 74 coloring eyelashes, eyebrows, or hair
FR 216, Jan. 5, 2009] on parts of the body other than the
scalp.
§ 73.2095 β-Carotene. (d) Labeling. (1) The label of the color
(a) Identity and specifications. The additive bismuth citrate shall bear, in
color additive b-carotene shall conform addition to any information required
in identity and specifications to the re- by law, labeling in accordance with the
quirements of § 73.95(a)(1) and (b). provisions of § 70.25 of this chapter.
463
§ 73.2120 21 CFR Ch. I (4–1–19 Edition)
(2) The label of a cosmetic containing lic health and therefore batches thereof
the color additive bismuth citrate shall are exempt from the requirements of
bear, in addition to other information section 721(c) of the act.
required by law, the following state-
ment, conspicuously displayed thereon: § 73.2125 Potassium sodium copper
chlorophyllin (chlorophyllin-copper
Keep this product out of children’s reach. complex).
Do not use on cut or abraded scalp. Do not
use to color eyelashes, eyebrows, or hair on (a) Identity and specifications. The
parts of the body other than the scalp. Wash color additive potassium sodium cop-
hands thoroughly after each use. per chlorophyllin shall conform in
(e) Exemption from certification. Cer- identity and specifications to the re-
tification of this color additive for the quirements of § 73.1125(a)(1) and (b).
prescribed use is not necessary for the (b) Uses and restrictions. Potassium
protection of the public health, and, sodium copper chlorophyllin may be
therefore, batches thereof are exempt safely used for coloring dentifrices that
from certification requirements of sec- are cosmetics subject to the following
tion 721(c) of the act. conditions:
(1) It shall not be used at a level in
[43 FR 44831, Sept. 29, 1978, as amended at 75 excess of 0.1 percent.
FR 14493, Mar. 26, 2010]
(2) It may be used only in combina-
§ 73.2120 Disodium EDTA-copper. tion with the following substances:
(a) Identity. The color additive diso- Water.
dium EDTA-copper is disodium [[N,N′- Glycerin.
1,2- ethanediylbis[N - (carboxymethyl) Sodium carboxymethylcellulose.
glycinato]] (4-)-N,N′,O,O′,ON,ON′] Tetrasodium pyrophosphate.
Sorbitol.
cuprate (2-).
Magnesium phosphate, tribasic.
(b) Specifications. Disodium EDTA-
Calcium carbonate.
copper shall conform to the following Calcium phosphate, dibasic.
specifications and shall be free from Sodium N-lauroyl sarcosinate.
impurities other than those named to Artificial sweeteners that are generally rec-
the extent that such impurities may be ognized as safe or that are authorized
avoided by good manufacturing prac- under subchapter B of this chapter.
tice: Flavors that are generally recognized as safe
or that are authorized under subchapter B
Total copper, not less than 13.5 percent. of this chapter.
Total (ethylene-dinitrilo) tetracetic acid,
Preservatives that are generally recognized
not less than 62.5 percent.
as safe or that are authorized under sub-
Free copper, not more than 100 parts per mil-
chapter B of this chapter.
lion.
Free disodium salt of (ethylene-dinitrilo) (c) Labeling. The label of the color ad-
tetraacetic acid, not more than 1.0 percent. ditive shall conform to the require-
Moisture, not more than 15 percent.
Water insoluble matter, not more than 0.2
percent. (d) Exemption from certification. Cer-
Lead (as Pb), not more than 20 parts per mil- tification of this color additive is not
lion. necessary for the protection of the pub-
Arsenic (as As), not more than 3 parts per lic health and therefore batches thereof
million. are exempt from the certification re-
(c) Uses and restrictions. Disodium quirements of section 721(c) of the act.
EDTA-copper may be safely used in
amounts consistent with good manu- § 73.2150 Dihydroxyacetone.
facturing practices in the coloring of (a) Identity and specifications. The
shampoos which are cosmetics. color additive dihydroxyacetone shall
(d) Labeling requirements. The labeling conform in identity and specifications
of the color additive shall conform to to the requirements of § 73.1150 (a)(1)
the requirements of § 70.25 of this chap- and (b).
ter. (b) Uses and restrictions.
(e) Exemption from certification. Cer- Dihydroxyacetone may be safely used
tification of this color additive is not in amounts consistent with good manu-
necessary for the protection of the pub- facturing practice in externally applied
464
cosmetics intended solely or in part to (2) Color additive mixtures of

impart a color to the human body. guaiazulene for cosmetic use may con-
(c) Labeling requirements. The labeling tain the following diluent:
of the color additive and any mixtures Polyethylene glycol-40 castor oil (PEG–40
prepared therefrom intended solely or castor oil).
in part for coloring purposes shall con- Saponification No., 60 to 70.
form to the requirements of § 70.25 of Hydroxyl No., 63 to 78.
this chapter. Acid No., 2.
(d) Exemption from certification. Cer- Specific gravity, 1.05 to 1.07.
tification of this color additive is not (b) Specifications. Guaiazulene shall
necessary for the protection of the pub- conform to the following specifications
lic health and therefore batches thereof and shall be free from impurities, other
are exempt from the requirements of than those named, to the extent that
section 721(c) of the act. such other impurities may be avoided
by good manufacturing practice.
§ 73.2162 Bismuth oxychloride.
Melting point, 30.5 °C to 31.5 °C.
(a) Identity and specifications. (1) The Lead (as Pb), not more than 20 parts per mil-
color additive bismuth oxychloride lion.
shall conform in identity and specifica- Arsenic (as As), not more than 3 parts per
tions to the requirements of million.
§ 73.1162(a)(1) and (b). Mercury (as Hg), not more than 1 part per
million.
(2) Color additive mixtures of bis- Total color, not less than 99 percent.
muth oxychloride may contain the fol-
lowing diluents: (c) Uses and restrictions. Guaiazulene
(i) For coloring cosmetics generally, may be safely used in externally ap-
only those diluents listed under plied cosmetics in amounts consistent
§ 73.1001(a)(1); with good manufacturing practice.
(ii) For coloring externally applied (d) Labeling. The label of the color ad-
cosmetics, only those diluents listed in ditive and any mixtures prepared
§ 73.1001(b) and, in addition, nitrocellu- therefrom intended solely or in part for
lose. coloring purposes shall conform to the
(b) Uses and restrictions. The color ad-
ditive bismuth oxychloride may be
tification of this color additive for the
safely used in coloring cosmetics gen-
prescribed use is not necessary for the
erally, including cosmetics intended
protection of the public health and
for use in the area of the eye, in
therefore batches thereof are exempt
from the certification requirements of
facturing practice.
section 721(c) of the act.
any mixture prepared therefrom in- § 73.2190 Henna.
purposes shall bear, in addition to any (a) Identity. The color additive henna
information required by law, labeling is the dried leaf and petiole of Lawsonia
in accordance with the provisions of alba Lam. (Lawsonia inermis L.). It may
§ 70.25 of this chapter. be identified by its characteristic odor
and by characteristic plant histology.
(d) Exemption from certification. Cer-
(b) Specifications. Henna shall con-
form to the following specifications:
lic health, and therefore batches there- It shall not contain more than 10 percent of
of are exempt from certification pursu- plant material from Lawsonia alba Lam.
ant to section 721(c) of the act. (Lawsonia inermis L.) other than the leaf
and petiole, and shall be free from admix-
[42 FR 52394, Sept. 30, 1977] ture with material from any other species
of plant.
§ 73.2180 Guaiazulene. Moisture, not more than 10 percent.
Total ash, not more than 15 percent.
(a) Identity. (1) The color additive,
Acid-insoluble ash, not more than 5 percent.

guaiazulene, is principally 1,4-di- Lead (as Pb), not more than 20 parts per mil-
methyl-7-isopropyl-azulene. lion.
465
§ 73.2250 21 CFR Ch. I (4–1–19 Edition)
Arsenic (as As), not more than 3 parts per § 73.2298 Ferric ammonium ferrocya-
million. nide.
(c) Uses and restrictions. The color ad- (a) Identity and specifications. The
ditive henna may be safely used for color additive ferric ammonium ferro-
coloring hair only. It may not be used cyanide shall conform in identify and
for coloring the eyelashes or eyebrows, specifications to the requirements of
or generally in the area of the eye. § 73.1298 (a)(1) and (b).
(d) Labeling. The label for henna shall (b) Uses and restrictions. Ferric ammo-
bear the information required by § 70.25 nium ferrocyanide is safe for use in
of this chapter and the following state- coloring externally applied cosmetics,
ments or their equivalent: including cosmetics applied to the area
‘‘Do not use in the area of the eye.’’ of the eye, in amounts consistent with
‘‘Do not use on cut or abraded scalp.’’ good manufacturing practice.
tification of this color additive for the
prescribed use is not necessary for the tended solely or in part for coloring
protection of the public health and purposes shall bear, in addition to any
therefore batches thereof are exempt information required by law, labeling
from the certification requirements of in accordance with § 70.25 of this chap-
section 721(c) of the act. ter.
§ 73.2250 Iron oxides. tification of this color additive is not
(a) Identity. The color additives iron necessary for the protection of the pub-
oxides consist of any one or any com- lic health, and therefore batches there-
bination of synthetically prepared iron of are exempt from the certification
oxides, including the hydrated forms. pursuant to section 721(c) of the act.
It is free from admixture with other [42 FR 38562, July 29, 1977, as amended at 43
substances. FR 6939, Feb. 17, 1978]
(b) Specifications. Iron oxides shall
conform to the following specifica- § 73.2299 Ferric ferrocyanide.
tions, all on an ‘‘as is’’ basis: (a) Identity and specifications. The
Arsenic (as As), not more than 3 parts per color additive ferric ferrocyanide shall
million. conform in identity and specifications
Lead (as Pb), not more than 10 parts per mil- to the requirements of § 73.1299(a)(1)
lion. and (b).
Mercury (as Hg), not more than 3 parts per (b) Uses and restrictions. Ferric ferro-
million.
cyanide is safe for use in coloring ex-
(c) Uses and restrictions. Iron oxides ternally applied cosmetics, including
are safe for use in coloring cosmetics cosmetics applied to the area of the
generally, including cosmetics applied eye, in amounts consistent with good
to the area of the eye, in amounts con- manufacturing practice.
sistent with good manufacturing prac- (c) Labeling. The color additive and
tice. any mixture prepared therefrom in-
(d) Labeling. The color additive and tended solely or in part for coloring
any mixture prepared therefrom in- purposes shall bear, in addition to any
tended solely or in part for coloring information required by law, labeling
purposes shall bear, in addition to any in accordance with § 70.25 of this chap-
information required by law, labeling ter.
in accordance with § 70.25 of this chap- (d) Exemption from certification. Cer-
ter. tification of this color additive is not
(e) Exemption from certification. Cer- necessary for the protection of the pub-
tification of this color additive is not lic health, and therefore batches there-
necessary for the protection of the pub- of are exempt from certification under
section 721(c) of the act.

of are exempt from certification pursu-
ant to section 721(c) of the act. [43 FR 54236, Nov. 21, 1978]
466
§ 73.2326 Chromium hydroxide green. identity and specifications to the re-

(a) Identity and specifications. The quirements of § 73.1329 (a)(1) and (b).
(2) Color additive mixtures of gua-
color additive chromium hydroxide
nine may contain the following
green shall conform in identity and
diluents:
specifications to the requirements of
(i) For coloring cosmetics generally,
§ 73.1326 (a)(1) and (b).
only those diluents listed under
(b) Uses and restrictions. Chromium
§ 73.1001(a)(1);
hydroxide green is safe for use in color-
(ii) For coloring externally applied
ing externally applied cosmetics, in-
cosmetics, only those diluents listed in
cluding those intended for use in the
§ 73.1001(b) and, in addition, nitrocellu-
area of the eye, in amounts consistent
lose.
with good manufacturing practice.
(b) Use and restrictions. The color ad-
ditive guanine may be safely used in
cosmetics generally, including cos-
metics intended for use in the area of
the eye, in amounts consistent with
good manufacturing practice.
in accordance with § 70.25 of this chap-
(c) Labeling requirements. The color
ter.
additive and any mixtures prepared
coloring purposes shall bear, in addi-
tion to any information required by
law, labeling in accordance with the
of are exempt from certification pursu-
provisions of § 70.25 of this chapter.
ant to section 721(c) of the act.
[42 FR 36452, July 15, 1977] tification of this color additive is not
§ 73.2327 Chromium oxide greens. lic health, and therefore batches there-
(a) Identity and specifications. The of are exempt from the certification
color additive chromium oxide greens pursuant to section 721(c) of the act.
shall conform in identify and specifica-
[42 FR 37537, July 22, 1977]
tions to the requirements of § 73.1327
(a)(1) and (b). § 73.2396 Lead acetate.
(b) Uses and restrictions. The color ad-
ditive chromium oxide greens may be (a) Identity. The color additive lead
safely used in externally applied cos- acetate is the trihydrate of lead (2+)
metics, including cosmetics intended salt of acetic acid. The color additive
for use in the area of the eye, in has the chemical formula
amounts consistent with good manu- Pb(OOCCH3)2·3H2O.
facturing practice. (b) Specifications. Lead acetate shall
(c) Labeling requirements. The color conform to the following specifications
additive and any mixtures prepared and shall be free from impurities other
therefrom intended solely or in part for than those named to the extent that
coloring purposes shall bear, in addi- such impurities may be avoided by
tion to any information required by good manufacturing practice:
law, labeling in accordance with the (1) Water-insoluble matter, not more
provisions of § 70.25 of this chapter. than 0.02 percent.
(d) Exemption from certification. Cer- (2) pH (30 percent solution weight to
tification of this color additive is not volume at 25 °C), not less than 4.7 and
necessary for the protection of the pub- not more than 5.8.
lic health, and therefore batches there- (3) Arsenic (as As), not more than 3
of are exempt from the certification parts per million.
(4) Lead acetate, not less than 99 per-
pursuant to section 721(c) of the act.
cent.
[42 FR 36452, July 15, 1977] (5) Mercury (as Hg), not more than 1
part per million.
§ 73.2329 Guanine. (c) Uses and restrictions. The color ad-
(a) Identity and specifications. (1) The ditive lead acetate may be safely used
color additive guanine shall conform in in cosmetics intended for coloring hair
467
§ 73.2400 21 CFR Ch. I (4–1–19 Edition)
on the scalp only, subject to the fol- conform to the requirements of § 70.25
lowing restrictions: of this chapter, and bear the following
(1) The amount of the lead acetate in statement or equivalent:
the cosmetic shall be such that the Wash thoroughly if the product
lead content, calculated as Pb, shall comes into contact with the skin.
not be in excess of 0.6 percent (weight (2) The label of the cosmetic con-
to volume). taining the color additive lead acetate,
(2) The cosmetic is not to be used for
in addition to other information re-
coloring mustaches, eyelashes, eye-
quired by the Federal Food, Drug, and
brows, or hair on parts of the body
other than the scalp. Cosmetic Act, shall bear the following
(d) Labeling requirements. (1) The label cautionary statement, conspicuously
of the color additive lead acetate shall displayed thereon:
CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not
use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches,
eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instruc-
tions carefully and wash hands thoroughly after each use.
(e) Exemption for certification. Certifi- identity and specifications to the re-
cation of this color additive for the quirements of § 73.1496(a)(1) and (b).
prescribed use is not necessary for the (b) Uses and restrictions. Mica is safe
protection of the public health and for use in coloring cosmetics generally,
therefore batches thereof are exempt including cosmetics applied to the area
from the certification requirements of of the eye, in amounts consistent with
section 721(c) of the Federal Food, good manufacturing practice.
Drug, and Cosmetic Act. (c) Labeling. The color additive and
[84 FR 12082, Apr. 1, 2019] any mixture prepared therefrom in-
§ 73.2400 Pyrophyllite. purposes shall bear, in addition to any
(a) Identity and specifications. The in accordance with of § 70.25 of this
color additive pyrophyllite shall con- chapter.
form in identity and specifications to
the requirements of § 73.1400 (a)(1) and
(b).
(b) Uses and restrictions. Pyrophyllite lic health, and therefore batches there-
may be safely used for coloring exter- of are exempt from the certification
nally applied cosmetics, in amounts pursuant to section 721(c) of the act.
consistent with good manufacturing
practice. [42 FR 38561, July 29, 1977]
(c) Labeling requirements. The labeling
of the color additive and any mixtures § 73.2500 Silver.
prepared therefrom intended solely or (a) Identity. (1) The color additive,
in part for coloring purposes shall con- silver, is a crystalline powder of high
form to all applicable requirements of purity silver prepared by the reaction
law, including the requirements of of silver nitrate with ferrous sulfate in
§ 70.25 of this chapter. the presence of nitric, phosphoric and
(d) Exemption from certification. Cer- sulfuric acids. Polyvinyl alcohol is
tification of this color additive is not used to prevent the agglomeration of
necessary for the protection of the pub- crystals and the formation of amor-
lic health and therefore batches thereof phous silver.
are exempt from the certification re- (2) Color additive mixtures of silver
quirements of section 721(c) of the act. may contain only those diluents listed
in § 73.1001(b) and, in addition, nitro-
§ 73.2496 Mica. cellulose.
(a) Identity and specifications. The (b) Specifications. Silver shall con-
color additive mica shall conform in form to the following specifications
468
and shall be free from impurities other § 73.2645 Aluminum powder.

than those named to the extent that (a) Identity and specifications. The
such other impurities may be avoided color additive aluminum powder shall
by good manufacturing practice: conform in identity and specifications
Lead (as Pb), not more than 10 parts per mil- to the requirements of § 73.1645 (a)(1)
lion. and (b).
Arsenic (as As), not more than 5 parts per (b) Uses and restrictions. Aluminum
million. powder may be safely used in coloring
Mercury (as Hg), not more than 1 part per externally applied cosmetics, including
million. cosmetics intended for use in the area
Silver (as Ag), not less than 99.9 percent. of the eye, in amounts consistent with
(c) Uses and restrictions. The color ad- (c) Labeling. The color additive and
ditive silver may be safely used for any mixture prepared therefrom in-
coloring fingernail polish at a level not tended solely or in part for coloring
to exceed 1 percent of the final product. purposes shall bear, in addition to any
(d) Labeling. The color additive and information required by law, labeling
any mixtures prepared therefrom in- in accordance with the provisions of
tended solely or in part for coloring § 70.25 of this chapter.
purposes shall bear, in addition to any (d) Exemption from certification. Cer-
other information required by law, la- tification of this color additive is not
beling in accordance with the provi- necessary for the protection of the pub-
sions of § 70.25 of this chapter. lic health, and therefore batches there-
(e) Exemption from certification. Cer- of are exempt from the certification
tification of this color additive is not pursuant to section 721(c) of the act.
necessary for the protection of the pub- [42 FR 38563, July 29, 1977]
lic health and therefore batches thereof
are exempt from the certification re- § 73.2646 Bronze powder.
quirements of section 721(c) of the act. (a) Identity and specifications. The
color additive bronze powder shall con-
[44 FR 65974, Nov. 16, 1979] form in identity and specifications to
the requirements of § 73.1646 (a)(1) and
§ 73.2575 Titanium dioxide. (b).
(a) Identity and specifications. The (b) Uses and restrictions. Bronze pow-
color additive titanium dioxide shall der may be safely used in coloring cos-
conform in identity and specifications metics generally, including cosmetics
to the requirements on § 73.575 (a)(1) intended for use in the area of the eye,
and (b). in amounts consistent with good manu-
(b) Uses and restrictions. The color ad- facturing practice.
ditive titanium dioxide may be safely (c) Labeling. The color additive and
used in cosmetics, including cosmetics any mixture prepared therefrom in-
intended for use in the area of the eye, tended solely or in part for coloring
purposes shall conform to the require-
in amounts consistent with good manu-
facturing practice.
(c) Labeling requirements. The color tification of the color additive is not
additive and any mixtures prepared necessary for the protection of the pub-
therefrom intended solely or in part for lic health, and therefore batches there-
coloring purposes shall bear, in addi- of are exempt from the certification re-
tion to any other information required quirements of section 721(c) of the act.
by law, labeling in accordance with the
[42 FR 33724, July 1, 1977]
provisions of § 70.25 of this chapter.
(d) Exemption from certification. Cer- § 73.2647 Copper powder.
(a) Identity and specifications. The
necessary for the protection of the pub- color additive copper powder shall con-
lic health, and therefore batches there- form in identity and specifications to
of are exempt from certification pursu- the requirements of § 73.1647 (a)(1) and
ant to section 721(c) of the act. (b).
469
§ 73.2725 21 CFR Ch. I (4–1–19 Edition)
(b) Uses and restrictions. Copper pow- tion to any other information required
der may be safely used in coloring cos- by law, labeling in accordance with
metics generally, including cosmetics § 70.25 of this chapter.
intended for use in the area of the eye, (e) Exemption from certification. Cer-
in amounts consistent with good manu- tification of this color additive is not
facturing practice. necessary for the protection of the pub-
(c) Labeling. The color additive and lic health, and therefore batches there-
any mixture prepared therefrom in- of are exempt from certification pursu-
tended solely or in part for coloring ant to section 721(c) of the act.
purposes shall conform to the require-
ments of § 70.25 of this chapter. § 73.2775 Manganese violet.
(d) Exemption from certification. Cer- (a) Identity. The color additive man-
tification of the color additive is not ganese violet is a violet pigment ob-
necessary for the protection of the pub- tained by reacting phosphoric acid, am-
lic health, and therefore batches there- monium dihydrogen orthophosphate,
of are exempt from the certification re- and manganese dioxide at tempera-
quirements of section 721(c) of the act. tures above 450 °F. The pigment is a
[42 FR 33724, July 1, 1977]
manganese ammonium pyrophosphate
complex having the approximate for-
§ 73.2725 Ultramarines. mula: Mn(III)NH4P2O7.
(b) Specifications. Manganese violet
(a) Identity. The color additives,
ultramarines (blue, green, pink, red,
and violet) are pigments obtained by
ties other than those named, to the ex-
calcining at temperatures above 700 °C.
tent that such other impurities may be
a mixture of kaolin, sulfur, sodium car-
bonate, silicious matter, sodium sul-
tice:
fate, and carbonaceous matter, but not
necessarily all these substances, to Ash (at 600 °C), not less than 81 percent.
produce a single color. The Volatile matter at 135 °C for 3 hours, not
ultramarines are complex sodium alu- more than 1 percent.
Water soluble substances, not more than 6
minum sulfosilicates having a typical percent.
formula Na(AlSiO)S with proportions pH of filtrate of 10 grams color additive
of each element varying with each (shaken occasionally for 2 hours with 100
color. milliliters of freshly boiled distilled
(b) Specifications. The ultramarines water), not more than 4.7 and not less than
shall conform to the following speci- 2.5.
fications and shall be free from impuri- Lead (as Pb), not more than 20 parts per mil-
ties other than those named, to the ex- lion.
tent that such other impurities may be million.
avoided by good manufacturing prac- Mercury (as Hg), not more than 1 part per
tice. million.
Total color, based on Mn content in ‘‘as is’’
sample, not less than 93 percent.
lion.
Arsenic (as As), not more than 3 parts per (c) Uses and restrictions. Manganese
million. violet is safe for use in coloring cos-
Mercury (as Hg), not more than 1 part per metics generally, including cosmetics
million.
applied to the area of the eye, in
(c) Uses and restrictions. The ultra- amounts consistent with good manu-
marine pigments may be safely used facturing practice.
for coloring externally applied cos- (d) Labeling. The color additive and
metics, including cosmetics intended any mixture prepared therefrom in-
for use in the area of the eye, in tended solely or in part for coloring
amounts consistent with good manu- purposes shall bear, in addition to any
facturing practice. information required by law, labeling
(d) Labeling requirements. The color in accordance with § 70.25 of this chap-
additives and any mixtures prepared ter.
therefrom intended solely or in part for (e) Exemption from certification. Cer-
coloring purposes shall bear, in addi- tification of this color additive is not
470
necessary for the protection of the pub- nail polish included under
lic health, and therefore batches there- § 720.4(c)(7)(ix) and (c)(8)(v) of this chap-
of are exempt from certification pursu- ter, respectively, to the following re-
ant to section 721(c) of the act. strictions:
(1) The amount of luminescent zinc
§ 73.2991 Zinc oxide. sulfide in facial makeup preparations
(a) Identity and specifications. The shall not exceed 10 percent by weight of
color additive zinc oxide shall conform the final product.
in identity and specifications to the re- (2) Facial makeup preparations con-
quirements of § 73.1991 (a)(1) and (b). taining luminescent zinc sulfide are in-
(b) Uses and restrictions. Zinc oxide tended for use only on limited, infre-
may be safely used in cosmetics, in- quent occasions, e.g., Halloween, and
cluding cosmetics intended for use in not for regular or daily use.
the area of the eye, in amounts con- (d) Labeling requirements. (1) The label
sistent with good manufacturing prac- of the color additive and any mixtures
tice. prepared therefrom shall bear expira-
(c) Labeling. The color additive and tion dates for the sealed and open con-
any mixture prepared therefrom in- tainer (established through generally
tended solely or in part for coloring accepted stability testing methods),
purposes shall bear, in addition to any other information required by § 70.25 of
information required by law, labeling this chapter, and adequate directions
in accordance with § 70.25 of this chap- to prepare a final product complying
ter. with the limitations prescribed in para-
(d) Exemption from certification. Cer- graph (c) of this section.
tification of this color additive is not (2) The label of a facial makeup prep-
necessary for the protection of the pub- aration containing the color additive
lic health, and therefore batches there- shall bear, in addition to other infor-
of are exempt from the certification mation required by the law, the fol-
pursuant to section 721(c) of the act. lowing statement conspicuously dis-
[42 FR 37538, July 22, 1977] played:
Do not use in the area of the eye.
§ 73.2995 Luminescent zinc sulfide. (e) Exemption from certification. Cer-
(a) Identity. The color additive lumi- tification of this color additive is not
nescent zinc sulfide is zinc sulfide con- necessary for the protection of the pub-
taining a copper activator. Following lic health, and therefore batches there-
excitation by daylight or a suitable ar- of are exempt from the certification re-
tificial light, luminescent zinc sulfide quirements of section 721(c) of the act.
produces a yellow-green phosphores- [65 FR 48377, Aug. 8, 2000; 65 FR 75158, Dec. 1,
cence with a maximum at 530 nano- 2000]
meters.
(b) Specifications. Luminescent zinc Subpart D—Medical Devices
sulfide shall conform to the following
specifications and shall be free from § 73.3100 1,4-Bis[(2-hydroxy-
impurities other than those named to ethyl)amino]-9,10-anthracenedione
the extent that such impurities may be bis(2-methyl-2-propenoic)ester co-
avoided by good manufacturing prac- polymers.
tice: (a) Identity. The color additives are
Zinc sulfide, not less than 99.8 percent. the copolymers formed as the reaction
Copper, 100±5 parts per million. product of 1,4-bis[(2-hydroxy-
Lead, not more than 20 parts per million. ethyl)amino]-9,10-anthracenedione
Arsenic, not more than 3 parts per million. bis(2-methyl-2-propenoic)ester (C.I. Re-
Mercury, not more than 1 part per million. active Blue 247) (CAS Reg. No. 109561–
Cadmium, not more than 15 parts per mil- 07–1) with one or more vinyl and/or
lion. acrylic monomers to form the contact
(c) Uses and restrictions. The color ad- lens material.
ditive luminescent zinc sulfide may be (b) Uses and restrictions. (1) The sub-
safely used for coloring externally ap- stances listed in paragraph (a) of this
plied facial makeup preparations and section may be used in amounts not to
471
§ 73.3105 21 CFR Ch. I (4–1–19 Edition)
exceed the minimum reasonably re- (d) Exemption from certification. Cer-
quired to accomplish the intended tification of this color additive is not
coloring effect. necessary for the protection of the pub-
(2) Authorization and compliance lic health, and therefore the color addi-
with these uses shall not be construed tive is exempt from the certification
as waiving any of the requirements of requirements of section 721(c) of the
sections 510(k), 515, and 520(g) of the act.
[49 FR 30066, July 26, 1984]
(the act) with respect to the contact
lens made from the color additives. § 73.3106 1,4-Bis[4-(2-
(c) Labeling. The label of the color ad- methacryloxyethyl)
ditives shall conform to the require- phenylamino]anthraquinone co-
ments of § 70.25 of this chapter. polymers.
(d) Exemption from certification. Cer- (a) Identity. The color additives are
tification of these color additives is the copolymers formed as the reaction
not necessary for the protection of the product of 1,4-bis[4-(2-
public health and therefore the color methacryloxyethyl)phenylamino]-
additives are exempt from the certifi- anthraquinone (C.I. Reactive Blue 246)
cation requirements of section 721(c) of (CAS Reg. No. 121888–69–5) with one or
the act. more vinyl and/or acrylic monomers to
[61 FR 51586, Oct. 3, 1996, as amended at 78 FR form the contact lens material.
19415, Apr. 1, 2013]] (b) Uses and restrictions. (1) The sub-
stances listed in paragraph (a) of this
§ 73.3105 1,4-Bis[(2- section may be used in amounts not to
methylphenyl)amino]-9,10-
anthracenedione. exceed the minimum reasonably re-
quired to accomplish the intended
(a) Identity. The color additive is 1,4- coloring effect.
bis[(2-methylphenyl)amino]-9,10- (2) Authorization and compliance
anthracenedione (CAS Reg. No. 6737–68– with these uses shall not be construed
4). as waiving any of the requirements of
(b) Uses and restrictions. (1) The sub- sections 510(k), 515, and 520(g) of the
stance listed in paragraph (a) of this Federal Food, Drug, and Cosmetic Act
section may be used as a color additive (the act) with respect to contact lenses
in contact lenses in amounts not to ex- made from the color additives.
ceed the minimum reasonably required
to accomplish the intended coloring ef-
ditives shall conform to the require-
fect.
(2) Authorization and compliance
with this use shall not be construed as
tification of these color additives is
waiving any of the requirements of sec-
not necessary for the protection of the
tions 510(k), 515, and 520(g) of the Fed-
public health and, therefore, the color
eral Food, Drug, and Cosmetic Act (the
additives are exempt from the certifi-
act). A person intending to introduce a
cation requirements of section 721(c) of
device containing 1,4-bis[(2-
the act.
methylphenyl)amino]-9,10-
anthracenedione listed under this sec- [58 FR 17507, Apr. 5, 1993, as amended at 60
tion into commerce shall submit to the FR 10497, Feb. 27, 1995; 78 FR 19415, Apr. 1,
Food and Drug Administration either a 2013]
premarket notification in accordance
with subpart E of part 807 of this chap- § 73.3107 Carbazole violet.
ter, if the device is not subject to pre- (a) Identity. The color additive is car-
market approval, or submit and receive bazole violet (Pigment Violet 23) (CAS
approval of an original or supplemental Reg. No. 6358–30–1, Colour Index No.
premarket approval application if the 51319).
device is subject to premarket ap- (b) Uses and restrictions. (1) The sub-
proval. stance listed in paragraph (a) of this
(c) Labeling. The label of the color ad- section may be used as a color additive
ditive shall conform to the require- in contact lenses in amounts not to ex-
ments of § 70.25 of this chapter. ceed the minimum reasonably required
472
Food and Drug Administration, HHS § 73.3110a
to accomplish the intended coloring ef- oil soluble (5 percent in palm oil, pea-
fect. nut oil, and hydrogenated peanut oil),
(2) Authorization for this use shall may be safely used to color
not be construed as waiving any of the polymethylmethacrylate bone cement.
requirements of sections 510(k), 515, Chlorophyllin-copper complex may be
and 520(g) of the Federal Food, Drug, used at levels that do not exceed 0.003
and Cosmetic Act (the act) with re- percent by weight of the bone cement.
spect to the contact lens in which the (2) Authorization for this use shall
color additive is used. not be construed as waiving any of the
(c) Labeling. The label of the color ad- requirements of sections 510(k), 515,
ditive shall conform to the require- and 520(g) of the Federal Food, Drug,
ments of § 70.25 of this chapter. and Cosmetic Act with respect to the
(d) Exemption from certification. Cer- polymethylmethacrylate bone cement
tification of this color additive is not in which chlorophyllin-copper complex,
necessary for the protection of the pub- oil soluble, is used.
lic health, and therefore the color addi-
tive is exempt from the certification
requirements of section 721(c) of the
act.
[53 FR 41324, Oct. 21, 1988] tification of this color additive is not
§ 73.3110 Chlorophyllin-copper com-
plex, oil soluble. lic health, and therefore the color addi-
(a) Identity. The color additve is requirements of section 721(c) of the
chlorophyllin-copper complex, oil solu- act.
ble. The chlorophyllin is obtained by
extraction from a mixture of fescue [48 FR 56370, Dec. 21, 1983]
and rye grasses. The chlorophyll is
acid-treated to remove chelated mag- § 73.3110a Chromium-cobalt-aluminum
nesium which is replaced with hydro- oxide.
gen, which is turn is replaced with cop- (a) Identity. The color additive chro-
per. This mixture is diluted to a 5 per- mium-cobalt-aluminum oxide (Pigment
cent concentration with a mixture of Blue 36) (CAS Reg. No. 68187–11–1, Col-
palm oil, peanut oil, and hydrogenated our Index No. 77343) shall conform in
peanut oil. identity and specifications to the re-
(b) Specifications. The color additive quirements of § 73.1015 (a) and (b).
chlorophyllin-copper complex, oil solu- (b) Uses and restrictions. (1) The sub-
ble (5 percent in palm oil, peanut oil, stance listed in paragraph (a) of this
and hydrogenated peanut oil), shall section may be used as a color additive
conform to the following specifications in contact lenses in amounts not to ex-
and shall be free from impurities other ceed the minimum reasonably required
than those named to the extent that to accomplish the intended coloring ef-
such other impurities may be avoided fect.
by current good manufacturing prac- (2) Authorization for this use shall
tice: not be construed as waiving any of the
Moisture, not more than 0.5 percent. requirements of sections 510(k), 515,
Nitrogen, not less than 0.2 percent and not and 520(g) of the Federal Food, Drug,
more than 0.3 percent. and Cosmetic Act (the act) with re-
Total copper, not less than 0.2 percent and spect to the contact lens in which the
color additive is used.
Free copper, not more than 200 parts per mil-
lion. (c) Labeling. The label of the color ad-
Lead, not more than 20 parts per million. ditive shall conform to the require-
Arsenic, not more than 5 parts per million. ments of § 70.25 of this chapter.
Sulfated ash, not more than 2.5 percent. (d) Exemption from certification. Cer-
Total color, not less than 4.5 percent and not tification of this color additive is not
(c) Uses and restrictions. (1) The color lic health, and therefore the color addi-
additive chlorophyllin-copper complex, tive is exempt from the certification
473
§ 73.3111 21 CFR Ch. I (4–1–19 Edition)
requirements of section 721(c) of the in accordance with subpart E of part

act. 807 of this chapter, if the device is not
[53 FR 41325, Oct. 21, 1988] subject to premarket approval, or sub-
mit and receive approval of an original
§ 73.3111 Chromium oxide greens. or supplemental premarket approval
(a) Identity and specifications. The application if the device is subject to
color additive chromium oxide greens premarket approval.
(chromic oxide) (CAS Reg. No. 1308–38– (c) Labeling. The label of the color ad-
9), Color Index No. 77288, shall conform ditive shall conform to the require-
in identity and specifications to the re- ments of § 70.25 of this chapter.
quirements of § 73.1327 (a)(1) and (b). (d) Exemption from certification. Cer-
(b) Uses and restrictions. (1) The sub- tification of this color additive is not
stance listed in paragraph (a) of this necessary for the protection of the pub-
section may be used as a color additive lic health, and therefore the color addi-
in contact lenses in amounts not to ex- tive is exempt from the certification
ceed the minimum reasonably required requirements of section 721(c) of the
to accomplish the intended coloring ef- act.
fect.
[50 FR 20407, May 16, 1985]
with this use shall not be construed as § 73.3115 2-[[2,5-Diethoxy-4-[(4-
waiving any of the requirements of sec- methylphenyl)thiol]phenyl]azo]-
tions 510(k), 515, and 520(g) of the Fed- 1,3,5-benzenetriol.
eral Food, Drug, and Cosmetic Act
with respect to the contact lenses in (a) Identity. The color additive2-[[2,5-
which the additive is used. diethoxy-4-[(4-
(c) Labeling. The label of the color ad- methylphenyl)thio]phenyl]azo]-1,3,5-
ditive shall conform to the require- benzenetriol is formed in situ in soft
ments of § 70.25 of this chapter. (hydrophilic) contact lenses.
(d) Exemption from certification. Cer- (b) Uses and restrictions. The color ad-
tification of this color additive is not ditive 2-[[2,5-diethoxy-4-[(4-
necessary for the protection of the pub- methylphenyl)thio]phenyl]azo]-1,3,5-
lic health, and therefore the color addi- benzenetriol may be safely used to
tive is exempt from the certification mark soft (hydrophilic) contact lenses
requirements of section 721(c) of the with the letter R or the letter L for
act. identification purposes subject to the
following restrictions:
[51 FR 24816, July 9, 1986]
(1) The quantity of the color additive
§ 73.3112 C.I. Vat Orange 1. does not exceed 1.1 × 10¥7 grams in a
soft (hydrophilic) contact lens.
(a) Identity. The color additive is C.I.
Vat Orange 1, Colour Index No. 59105. (2) When used as specified in the la-
(b) Uses and restrictions. (1) The sub- beling, there is no measurable migra-
stance listed in paragraph (a) of this tion of the color additive from the con-
section may be used as a color additive tact lens to the surrounding ocular tis-
in contact lenses in amounts not to ex- sue.
ceed the minimum reasonably required (3) Authorization for this use shall
to accomplish the intended coloring ef- not be construed as waiving any of the
fect. requirements of section 510(k) and 515
(2) Authorization for this use shall of the Federal Food, Drug, and Cos-
not be construed as waiving any of the metic Act with respect to the contact
requirements of sections 510(k), 515, lens in which the color additive is used.
and 520(g) of the Federal Food, Drug, (c) Labeling. The label of the color ad-
and Cosmetic Act (the act) with re- ditive shall conform to the require-
spect to the contact lens in which the ments of § 70.25 of this chapter.
color additive is used. A person intend- (d) Exemption from certification. Cer-
ing to introduce a device containing tification of this color additive is not
C.I. Vat Orange 1 into commerce shall necessary for the protection of the pub-
submit to the Food and Drug Adminis- lic health, and therefore the color addi-
tration either a premarket notification tive is exempt from the certification
474
requirements of section 721(c) of the contact lens in which the color addi-
act. tive is used.
[48 FR 22706, May 20, 1983]
§ 73.3117 16,23-Dihydrodinaphtho[2,3- ments of § 70.25 of this chapter.
a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3- (d) Exemption from certification. Cer-
c] carbazole-5,10,15,17,22,24-hexone. tification of this color additive is not
(a) Identity. The color additive is necessary for the protection of the pub-
16,23-dihydrodinaphtho [2,3- a:2′,3′-i] lic health, and therefore the color addi-
napth [2′,3′:6,7] indolo [2, 3-c] carbazole- tive is exempt from the certification
5,10, 15,17,22,24-hexone (CAS Reg. No. requirements of section 721(c) of the
2475–33–4), Colour Index No. 70800. act.
(b) Uses and restrictions. (1) The sub- [48 FR 31375, July 8, 1983]
stance listed in paragraph (a) of this
section may be used as a color additive § 73.3119 7,16-Dichloro-6,15-dihydro-
in contact lenses in amounts not to ex- 5,9,14,18-anthrazinetetrone.
ceed the minimum reasonably required (a) Identity. The color additive is 7,16-
to accomplish the intended coloring ef- dichloro-6,15-dihydro-5,9,14,18-
fect. anthrazinetetrone (CAS Reg. No. 130–
(2) Authorization for this use shall 20–1), Colour Index No. 69825.
not be construed as waiving any of the (b) Uses and restrictions. (1) The sub-
requirements of sections 510(k), 515, stance listed in paragraph (a) of this
and 520(g) of the Federal Food, Drug, section may be used as a color additive
and Cosmetic Act with respect to the in contact lenses in amounts not to ex-
contact lens in which the color addi- ceed the minimum reasonably required
tive is used. to accomplish the intended coloring ef-
(c) Labeling. The label of the color ad- fect.
ditive shall conform to the require- (2) Authorization for this use shall
ments of § 70.25 of this chapter. not be construed as waiving any of the
(d) Exemption from certification. Cer- requirements of sections 510(k), 515,
tification of this color additive is not and 520(g) of the Federal Food, Drug,
necessary for the protection of the pub- and Cosmetic Act with respect to the
lic health, and therefore the color addi- contact lens in which the color addi-
tive is exempt from the certification tive is used.
requirements of section 721(c) of the (c) Labeling. The label of the color ad-
act. ditive shall conform to the require-
[48 FR 31375, July 8, 1983]
§ 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo- tification of this color additive is not
1,5-anthracenediyl) bisbenzamide. necessary for the protection of the pub-
(a) Identity. The color additive is
N,N′-(9,10-dihydro-9,10-dioxo-1,5-
requirements of section 721(c) of the
anthracenediyl) bisbenzamide (CAS
act.
Reg. No. 82–18–8), Colour Index No.
61725. [48 FR 31376, July 8, 1983]
(b) Uses and restrictions. (1) The sub-
stance listed in paragraph (a) of this § 73.3120 16,17-Dimethoxydinaphtho
section may be used as a color additive [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-
in contact lenses in amounts not to ex- dione.
ceed the minimum reasonably required (a) Identity. The color additive is
to accomplish the intended coloring ef- 16,17-dimethoydinaphtho[1,2,3,-
fect. cd:3′,2′,1′-lm]perylene-5,10-dione (CAS
(2) Authorization for this use shall Reg. No. 128–58–5), Colour Index No.
not be construed as waiving any of the 59825.
requirements of sections 510(k), 515, (b) Uses and restrictions. (1) The sub-
and 520(g) of the Federal Food, Drug, stance listed in paragraph (a) of this
and Cosmetic Act with respect to the section may be used as a color additive
475
§ 73.3121 21 CFR Ch. I (4–1–19 Edition)
in contact lenses in amounts not to ex- (5) Reactive Blue No. 19 [2-anthra-
ceed the minimum reasonably required cene-sulfonic acid, 1-amino-9,10-
to accomplish the intended coloring ef- dihydro-9,10-dioxo-4-((3-((2-
fect. (sulfooxy)ethyl)sulfonyl)phenyl)amino)
(2) Authorization for this use shall -, disodium salt] (CAS Reg. No. 2580–78–
not be construed as waiving any of the 1);
requirements of sections 510(k), 515, (6) Reactive Blue No. 4 [2-
and 520(g) of the Federal Food, Drug, anthracenesulfonic acid, 1-amino-4-(3-
and Cosmetic Act with respect to the ((4,6-dichloro-s-triazin-2-yl)amino)-4-
contact lens in which the color addi- sulfoanilino)-9,10-dihydro-9,10-dioxo, di-
tive is used. sodium salt] (CAS Reg. No. 4499–01–8);
(c) Labeling. The label of the color ad- (7) C.I. Reactive Red 11 [5-((4,6-
ditive shall conform to the require- dichloro-1,3,5-triazin-2-yl)amino)-4-hy-
ments of § 70.25 of this chapter. droxy-3-((1-sulfo-2-naphthalenyl)azo)-2,
(d) Exemption from certification. Cer- 7-naphthalenedisulfonic acid, tri-
tification of this color additive is not sodium salt] (CAS Reg. No. 12226–08–3);
necessary for the protection of the pub- (8) C.I. Reactive Yellow 86 [1,3-
lic health, and therefore the color addi- benzenedisulfonic acid, 4-((5-
tive is exempt from the certification aminocarbonyl-1-ethyl-1,6-dihydro-2-
requirements of section 721(c) of the hydroxy-4-methyl-6-oxo-3-
act. pyridinyl)azo)-6-(4,6-dichloro-1,3,5-
triazin-2-yl)amino)-, disodium salt]
[48 FR 31376, July 8, 1983] (CAS Reg. No. 61951–86–8);
(9) C.I. Reactive Blue 163
§ 73.3121 Poly(hydroxyethyl methacry-
late)-dye copolymers. [triphenodioxazinedisulfonic acid, 6,13-
dichloro-3, 10-bis((4-((4.6-dichloro-1,3,5-
(a) Identity. The color additives are triazin-2-yl)amino) sulfophenyl)amino)-
formed by reacting one or more of the , tetrasodium salt] (CAS Reg. No.
reactive dyes listed in this paragraph 72847–56–4); and
with poly(hydroxyethyl methacrylate), (10) C.I. Reactive Red 180 [5-
so that the sulfate group (or groups) or (benzoylamino)-4-hydroxy-3-((1-sulfo-6-
chlorine substituent of the dye is re- ((2-(sulfooxy)ethyl)sulfonyl)-2-
placed by an ether linkage to naphthalenyl)azo)-2,7-
poly(hydroxyethyl methacrylate). The naphthalenedisulfonic acid,
dyes that may be used alone or in com- tetrasodium salt] (CAS Reg. No. 98114–
bination are 32–0).
(1) Reactive Black 5 [2,7- (b) Uses and restrictions. (1) The sub-
naphthalenedisulfonic acid, 4-amino-5- stances listed in paragraph (a) of this
hydroxy-3,6-bis((4-((2- section may be used to color contact
(sulfooxy)ethyl)sulfonyl)phenyl)azo)- lenses in amounts not to exceed the
tetrasodium salt] (CAS Reg. No. 17095– minimum reasonably required to ac-
24–8); complish the intended coloring effect.
(2) Reactive Blue 21 [copper, (29H,31H- (2) As part of the manufacturing
phthalocyaninato(2-)-N29,N30,N31,N32)-, process, the lenses containing the color
sulfo((4-((2- additives are thoroughly washed to re-
sulfooxy)ethyl)sulfonyl)phenyl)amino) move unbound reactive dyes.
sulfonyl derivs] (CAS Reg. No. 73049–92– (3) Authorization and compliance
0); with this use shall not be construed as
(3) Reactive Orange 78 [2- waiving any of the requirements of sec-
naphthalenesulfonic acid, 7- tions 510(k), 515, and 520(g) of the Fed-
(acetylamino)-4-hydroxy-3-((4-((2- eral Food, Drug, and Cosmetic Act (the
(sulfooxy)ethyl) sulfonyl)phenyl)azo)-] act). A person intending to introduce a
CAS Reg. No. 68189–39–9); device containing a poly(hydroxyethyl
(4) Reactive Yellow 15 methacrylate)-dye copolymer listed
[benzensulfonic acid, 4-(4,5-dihydro-4- under this section into commerce shall
((2-methoxy-5-methyl-4-((2- submit to the Food and Drug Adminis-
(sulfooxy)ethyl) sulfonyl)phenyl)azo)-3- tration either a premarket notification
methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS in accordance with subpart E of part

Reg. No. 60958–41–0); 807 of this chapter, if the device is not
476
subject to premarket approval, or sub- 2(3H)-ylidene)benzo[b]thiophen-3(2H)-

mit and receive approval of an original one (CAS Reg. No. 3263–31–8), Colour
or supplemental premarket approval Index No. 73335.
application if the device is subject to (b) Uses and restrictions. (1) The sub-
premarket approval. stance listed in paragraph (a) of this
(c) Labeling. The label of the color ad- section may be used as a color additive
ditives shall conform to the require- in contact lenses in amounts not to ex-
ments of § 70.25 of this chapter. ceed the minimum reasonably required
(d) Exemption from certification. Cer- to accomplish the intended coloring ef-
tification of these color additives is fect.
not necessary for the protection of the (2) Authorization for this use shall
public health, and therefore these color not be construed as waiving any of the
additives are exempt from the certifi- requirements of sections 510(k), 515,
cation requirements of section 721(c) of and 520(g) of the Federal Food, Drug,
the act. and Cosmetic Act with respect to the
[49 FR 373, Jan. 4, 1984; 49 FR 5094, Feb. 10, contact lens in which the color addi-
1984, as amended at 50 FR 9425, Mar. 8, 1985; tive is used.
50 FR 33338, Aug. 19, 1985; 50 FR 37845, Sept. (c) Labeling. The label of the color ad-
18, 1985; 50 FR 45993, Nov. 6, 1985; 58 FR 9541, ditive shall conform to the require-
Feb. 22, 1993] ments of § 70.25 of this chapter.
§ 73.3122 4-[(2,4-dimethylphenyl)azo]- tification of this color additive is not
2,4-dihydro-5-methyl-2-phenyl-3H- necessary for the protection of the pub-
pyrazol-3-one.
(a) Identity. The color additive is 4- tive is exempt from the certification
[(2,4-dimethylphenyl)azo]-2,4-dihydro-5- requirements of section 721(c) of the
methyl-2-phenyl-3H- pyrazol-3-one act.
(CAS Reg. No. 6407–78–9).
(b) Uses and restrictions. (1) The sub- [51 FR 11436, Apr. 3, 1986]
stances listed in paragraph (a) of this
§ 73.3124 Phthalocyanine green.
section may be used as a color additive
in contact lenses in amounts not to ex- (a) Identity. The color additive is
ceed the minimum reasonably required phthalocyanine green (CAS Reg. No.
to accomplish the intended coloring ef- 1328–53–6), Colour Index No. 74260.
fect. (b) Uses and restrictions. (1) The sub-
(2) Authorization for this use shall stance listed in paragraph (a) of this
not be construed as waiving any of the section may be used as a color additive
requirements of sections 510(k), 515, in contact lenses in amounts not to ex-
and 520(g) of the Federal Food, Drug, ceed the minimum reasonably required
and Cosmetic Act with respect to the to accomplish the intended coloring ef-
contact lens in which the color addi- fect.
tive is used. (2) Authorization for this use shall
(c) Labeling. The label of the color ad- not be construed as waiving any of the
ditive shall conform to the require- requirements of sections 510(k), 515,
ments of § 70.25 of this chapter. and 520(g) of the Federal Food, Drug,
(d) Exemption from certification. Cer- and Cosmetic Act with respect to the
tification of this color additive is not contact lens in which the additive is
necessary for the protection of the pub- used.
lic health, and therefore the color addi- (c) Labeling. The label of the color ad-
tive is exempt from the certification ditive shall conform to the require-
requirements of section 721(c) of the ments of § 70.25 of this chapter.
act. (d) Exemption from certification. Cer-
[51 FR 11432, Apr. 3, 1986]
§ 73.3123 6-Ethoxy-2-(6-ethoxy-3- lic health, and therefore the color addi-
oxobenzo[b]thien-2(3H)-ylidene) tive is exempt from the certification
benzo[b]thiophen-3 (2H)-one. requirements of section 721(c) of the
(a) Identity. The color additive is 6- act.

ethoxy-2-(6-ethoxy-3-oxobenzo [b]thien- [51 FR 11433, Apr. 3, 1986]
477
§ 73.3125 21 CFR Ch. I (4–1–19 Edition)
§ 73.3125 Iron oxides. (c) Labeling. The label of the color ad-
color additive iron oxides (CAS Reg.
No. 1332–37–2), Color Index No. 77491,
shall conform in identity and specifica- necessary for the protection of the pub-
tions to the requirements of § 73.2250 (a) lic health, and therefore the color addi-
and (b). tive is exempt from the certification
(b) Uses and restrictions. (1) The sub- requirements of section 721(c) of the
stance listed in paragraph (a) of this act.
section may be used as a color additive
in contact lenses in amounts not to ex- [51 FR 24816, July 9, 1986, as amended at 81
FR 75692, Nov. 1, 2016]
ceed the minimum reasonably required
to accomplish the intended coloring ef- § 73.3127 Vinyl alcohol/methyl meth-
fect. acrylate-dye reaction products.
(a) Identity. The color additives are
formed by reacting the dyes, either
waiving any of the requirements of sec-
alone or in combination, with a vinyl
tions 510(k), 515, and 520(g) of the Fed- alcohol/methyl methacrylate copoly-
eral Food, Drug, and Cosmetic Act mer, so that the sulfate groups of the
with respect to the contact lens in dyes are replaced by ether linkages to
which the additive is used. the vinyl alcohol/methyl methacrylate
(c) Labeling. The label of the color ad- copolymer. The dyes are:
ditive shall conform to the require- (1) C.I. Reactive Red 180 [5-
ments of § 70.25 of this chapter. (benzoylamino)-4-hydroxy-3-((1-sulfo-6-
(d) Exemption from certification. Cer- ((2-(sulfooxy)ethyl)sulfonyl)-2-
tification of this color additive is not naphthalenyl)azo)-2,7-
necessary for the protection of the pub- naphthalenedisulfonic acid,
lic health, and therefore the color addi- tetrasodium salt] (CAS Reg. No. 98114–
tive is exempt from the certification 32–0).
requirements of section 721(c) of the (2) C.I. Reactive Black 5 [2,7-
act. naphthalenedisulfonic acid, 4-amino-5-
hydroxy-3,6-bis((4-((2-
FR 24511, May 4, 2004]
(sulfooxy)ethyl)sulfonyl)phenyl)azo)-,
tetrasodium salt] (CAS Reg. No. 17095–
§ 73.3126 Titanium dioxide. 24–8).
(3) C.I. Reactive Orange 78 [2-
(a) Identity and specifications. The naphthalenesulfonic acid, 7-
color additive titanium dioxide (CAS (acetylamino)-4-hydroxy-3-((4-((2-
Reg. No. 13463–67–7), Color Index No. (sulfooxy)ethyl)sulfonyl)phenyl)azo)-]
77891, shall conform in identity and (CAS Reg. No. 68189–39–9).
specifications to the requirements of (4) C.I. Reactive Yellow 15
§ 73.575(a)(1) and (b). [benzenesulfonic acid, 4-(4,5-dihydro-4-
(b) Uses and restrictions. (1) The sub- ((2-methoxy-5-methyl-4-((2-
stance listed in paragraph (a) of this (sulfooxy)ethyl)sulfonyl)phenyl)azo)-3-
section may be used as a color additive methyl-5-oxo-1H-pyrazol-1-yl)-] (CAS
in contact lenses and intraocular lens Reg. No. 60958–41–0).
orientation marks in amounts not to (5) C.I. Reactive Blue No. 19 [2-
exceed the minimum reasonably re- anthracenesulfonic acid, 1-amino-9,10-
quired to accomplish the intended dihydro-9,10-dioxo-4-((3-((2-
coloring effect. (sulfooxy)ethyl)sulfonyl)phenyl)amino)
(2) Authorization and compliance -, disodium salt] (CAS Reg. No. 2580–78–
with this use shall not be construed as 1).
waiving any of the requirements of sec- (6) C.I. Reactive Blue 21 [copper,
tions 510(k), 515, and 520(g) of the Fed- (29H,31H-phthalocyaninato(2-)-N29, N30,
eral Food, Drug, and Cosmetic Act N31, N32)-, sulfo((4-((2-(sulfooxy)
with respect to the contact lenses in ethyl)sulfonyl)phenyl)amino)sulfonyl

which the additive is used. derivatives] (CAS Reg. No. 73049–92–0).
478
(b) Uses and restrictions. (1) The sub- minimum reasonably required to ac-
stances listed in paragraph (a) of this complish the intended coloring effect.
section may be used to color contact (2) Authorization and compliance
lenses in amounts not to exceed the with this use shall not be construed as
minimum reasonably required to ac- waiving any of the requirements of sec-
complish the intended coloring effect. tions 510(k), 515, and 520(g) of the Fed-
(2) As part of the manufacturing eral Food, Drug, and Cosmetic Act (the
process, the lenses containing the color act) with respect to the contact lenses
additives are thoroughly washed to rein which the additive is used.
move unbound reactive dye. (c) Labeling. The label of the color ad-
(3) Authorization and compliance ditive shall conform to the require-
with this use shall not be construed as ments in § 70.25 of this chapter.
waiving any of the requirements of sec- (d) Exemption from certification. Cer-
tions 510(k), 515, and 520(g) of the Fed- tification of this color additive is not
eral Food, Drug, and Cosmetic Act (the necessary for the protection of the pub-
act). A person intending to introduce a lic health, and therefore batches there-
device containing a vinyl alcohol/meth- of are exempt from the certification re-
yl methacrylate-dye reaction product quirements of section 721(c) of the act.
listed under this section into com-
merce shall submit to the Food and [67 FR 65312, Oct. 24, 2002]
Drug Administration either a pre-
market notification in accordance with § 73.3129 Disodium 1-amino-4-[[4-[(2-
subpart E of part 807 of this chapter, if bromo-1-oxoallyl)amino]-2-
sulfonatophenyl]amino]-9,10-
the device is not subject to premarket dihydro-9,10-dioxoanthracene-2-
approval, or submit and receive ap- sulfonate.
proval of an original or supplemental
premarket approval application if the (a) Identity. The color additive is di-
device is subject to premarket ap- sodium 1-amino-4-[[4-[(2-bromo-1-
proval. oxoallyl)amino]-2-
(c) Labeling. The label of the color ad- sulfonatophenyl]amino]-9,10-dihydro-
ditive shall conform to the require- 9,10-dioxoanthracene-2-sulfonate (Reac-
ments of § 70.25 of this chapter. tive Blue 69) (CAS Reg. No. 70209–99–3,
(d) Exemption from certification. Cer- Colour Index No. 612037).
tification of this color additive is not (b) Uses and restrictions. (1) The sub-
necessary for the protection of the pub- stance listed in paragraph (a) of this
lic health, and therefore, this color ad- section may be used as a color additive
ditive is exempt from the certification in contact lenses in amounts not to ex-
requirements of section 721(c) of the ceed the minimum reasonably required
act. to accomplish the intended coloring ef-
fect.
[58 FR 3227, Jan. 8, 1993, as amended at 58 FR (2) Authorization and compliance
17510, Apr. 5, 1993]
§ 73.3128 Mica-based pearlescent pig- waiving any of the requirements of sec-
ments. tions 510(k), 515, and 520(g) of the Fed-
eral Food, Drug, and Cosmetic Act
with respect to the contact lenses in
color additive is formed by depositing
which the additive is used.
titanium or iron salts from a basic so-
lution onto mica, followed by calci- (c) Labeling. The label of the color ad-
nation to produce titanium dioxide or ditive shall conform to the require-
iron oxides on mica. Mica used to man- ments in § 70.25 of this chapter.
ufacture the color additive shall con- (d) Exemption from certification. Cer-
form in identity and specifications to tification of this color additive is not
the requirements of § 73.1496(a)(1) and necessary for the protection of the pub-
(b). lic health, and therefore batches there-
(b) Uses and restrictions. (1) Mica- of are exempt from the certification re-
based pearlescent pigments listed in quirements of section 721(c) of the Fed-
paragraph (a) of this section may be eral Food, Drug, and Cosmetic Act.
used as a color additive in contact [76 FR 25235, May 4, 2011, as amended at 78

lenses in amounts not to exceed the FR 14664, Mar. 7, 2013]
479
PART 74—LISTING OF COLOR AD- 74.2208 D&C Green No. 8.

74.2254 D&C Orange No. 4.
DITIVES SUBJECT TO CERTIFI- 74.2255 D&C Orange No. 5.
CATION 74.2260 D&C Orange No. 10.
74.2261 D&C Orange No. 11.
Subpart A—Foods 74.2304 FD&C Red No. 4.
74.2306 D&C Red No. 6.
Sec. 74.2307 D&C Red No. 7.
74.101 FD&C Blue No. 1. 74.2317 D&C Red No. 17.
74.102 FD&C Blue No. 2. 74.2321 D&C Red No. 21.
74.203 FD&C Green No. 3. 74.2322 D&C Red No. 22.
74.250 Orange B. 74.2327 D&C Red No. 27.
74.302 Citrus Red No. 2. 74.2328 D&C Red No. 28.
74.303 FD&C Red No. 3. 74.2330 D&C Red No. 30.
74.340 FD&C Red No. 40. 74.2331 D&C Red No. 31.
74.705 FD&C Yellow No. 5. 74.2333 D&C Red No. 33.
74.706 FD&C Yellow No. 6. 74.2334 D&C Red No. 34.
74.2336 D&C Red No. 36.
Subpart B—Drugs 74.2340 FD&C Red No. 40.
74.2602 D&C Violet No. 2.
74.1101 FD&C Blue No. 1. 74.2602a Ext. D&C Violet No. 2.
74.1102 FD&C Blue No. 2. 74.2705 FD&C Yellow No. 5.
74.1104 D&C Blue No. 4. 74.2706 FD&C Yellow No. 6.
74.1109 D&C Blue No. 9. 74.2707 D&C Yellow No. 7.
74.1203 FD&C Green No. 3. 74.2707a Ext. D&C Yellow No. 7.
74.1205 D&C Green No. 5. 74.2708 D&C Yellow No. 8.
74.1254 D&C Orange No. 4.
74.1255 D&C Orange No. 5. Subpart D—Medical Devices
74.1260 D&C Orange No. 10.
74.1261 D&C Orange No. 11. 74.3045 [Phthalocyaninato(2-)] copper.
74.1303 FD&C Red No. 3. 74.3054 D&C Black No. 4.
74.1304 FD&C Red No. 4. 74.3102 FD&C Blue No. 2.
74.1306 D&C Red No. 6. 74.3106 D&C Blue No. 6.
74.1307 D&C Red No. 7. 74.3206 D&C Green No. 6.
74.1317 D&C Red No. 17. 74.3230 D&C Red No. 17.
74.1321 D&C Red No. 21. 74.3602 D&C Violet No. 2.
74.1322 D&C Red No. 22. 74.3708 D&C Yellow No. 8.
74.1327 D&C Red No. 27. 74.3710 D&C Yellow No. 10.
74.1328 D&C Red No. 28.
AUTHORITY: 21 U.S.C. 321, 341, 342, 343, 348,
74.1330 D&C Red No. 30.
351, 352, 355, 361, 362, 371, 379e.
74.1331 D&C Red No. 31.
74.1333 D&C Red No. 33. SOURCE: 42 FR 15654, Mar. 22, 1977, unless
74.1334 D&C Red No. 34. otherwise noted.
74.1336 D&C Red No. 36.
74.1339 D&C Red No. 39.
74.1340 FD&C Red No. 40.
Subpart A—Foods
74.1602 D&C Violet No. 2.
§ 74.101 FD&C Blue No. 1.
74.1705 FD&C Yellow No. 5.
74.1706 FD&C Yellow No. 6. (a) Identity. (1) The color additive
74.1707 D&C Yellow No. 7. FD&C Blue No. 1 is principally the di-
74.1707a Ext. D&C Yellow No. 7. sodium salt of ethyl [4-[p-[ethyl (m-
74.1708 D&C Yellow No. 8. sulfobenzyl) amino]-a-(o-sulfophenyl)
74.1710 D&C Yellow No. 10.
benzylidene] - 2,5 -cyclohexadien - 1 -
74.1711 D&C Yellow No. 11.
ylidene] (m-sulfobenzyl) ammonium hy-
Subpart C—Cosmetics droxide inner salt with smaller
amounts of the isomeric disodium salts
74.2052 D&C Black No. 2. of ethyl [4-[p-[ethyl(p-sulfobenzyl)
74.2053 D&C Black No. 3. amino]-a-(o-sulfophenyl) benzylidene]-
74.2101 FD&C Blue No. 1.
2,5-cyclohexadien-1-ylidene] (p-
74.2104 D&C Blue No. 4.
74.2151 D&C Brown No. 1. sulfobenzyl) ammonium hydroxide
inner salt and ethyl [4-[p-[ethyl (o-
74.2203 FD&C Green No. 3.

74.2205 D&C Green No. 5. sulfobenzyl) amino] - a - (o
74.2206 D&C Green No. 6. -sulfophenyl) benzylidene]-2,5-
480
cyclohexadien-1-ylidene] (o- § 74.102 FD&C Blue No. 2.

sulfobenzyl) ammonium hydroxide (a) Identity. (1) The color additive
inner salt. FD&C Blue No. 2 is principally the di-
(2) Color additive mixtures for food sodium salt of 2-(1,3-dihydro-3-oxo-5-
use (including dietary supplements) sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-
made with FD&C Blue No. 1 may con- oxo-1H-indole-5-sulfonic acid (CAS Reg.
tain only those diluents that are suit- No. 860–22–0) with smaller amounts of
able and that are listed in part 73 of the disodium salt of 2-(1,3-dihydro-3-
this chapter as safe for use in color ad- oxo-7-sulfo-2H-indol-2-ylidene)-2,3-
ditive mixtures for coloring foods. dihydro-3-oxo-1H-indole-5-sulfonic acid
(b) Specifications. FD&C Blue No. 1 (CAS Reg. No. 54947–75–0) and the so-
shall conform to the following speci- dium salt of 2-(1,3-dihydro-3-oxo-2H-
fications and shall be free from impuri- indol-2-ylidene)-2,3-dihydro-3-oxo-1H-
ties other than those named to the ex- indole-5-sulfonic acid (CAS Reg. No.
tent that such other impurities may be 605–18–5). Additionally, FD&C Blue No.
avoided by current good manufacturing 2 is obtained by heating indigo (or in-
practice: digo paste) in the presence of sulfuric
Sum of volatile matter (at 135 °C) and
acid. The color additive is isolated and
chlorides and sulfates (calculated as so- subjected to purification procedures.
dium salts), not more than 15.0 percent. The indigo (or indigo paste) used above
Water-insoluble matter, not more than 0.2 is manufactured by the fusion of N-
percent. phenylglycine (prepared from aniline
Leuco base, not more than 5 percent. and formaldehyde) in a molten mixture
Sum of o-, m-, and p-sulfobenzaldehydes, not of sodamide and sodium and potassium
more than 1.5 percent. hydroxides under ammonia pressure.
N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not The indigo is isolated and subjected to
more than 0.3 percent. purification procedures prior to
Subsidiary colors, not more than 6.0 percent. sulfonation.
Chromium (as Cr), not more than 50 parts (2) Color additive mixtures for food
per million. use (including dietary supplements)
Manganese (as Mn), not more than 100 parts made with FD&C Blue No. 2 may con-
per million.
tain only those diluents that are suit-
million.
able and that are listed in part 73 of
this chapter as safe for use in color ad-
lion. ditive mixtures for coloring foods.
Total color, not less than 85.0 percent. (b) Specifications. The color additive
FD&C Blue No. 2 shall conform to the
(c) Uses and restrictions. FD&C Blue following specifications and shall be
No. 1 may be safely used for coloring free from impurities other than those
foods (including dietary supplements) named to the extent that such other
generally in amounts consistent with impurities may be avoided by current
good manufacturing practice except good manufacturing practice:
that it may not be used to color foods
Sum of volatile matter at 135 °C (275 °F) and
for which standards of identity have chlorides and sulfates (calculated as so-
been promulgated under section 401 of dium salts), not more than 15 percent.
the act unless added color is authorized Water insoluble matter, not more than 0.4
by such standards. percent.
(d) Labeling. The label of the color ad- Isatin-5-sulfonic acid, not more than 0.4 per-
ditive and any mixtures prepared cent.
therefrom intended solely or in part for 5-Sulfoanthranilic acid, not more than 0.2
percent.
coloring purposes shall conform to the Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-
requirements of § 70.25 of this chapter. 2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-
(e) Certification. All batches of FD&C indole-5-sulfonic acid, not more than 18
Blue No. 1 shall be certified in accord- percent.
ance with regulations in part 80 of this Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-
chapter. 2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-
sulfonic acid, not more than 2 percent.

[42 FR 15654, Mar. 22, 1977, as amended at 58 Lead (as Pb), not more than 10 parts per mil-
FR 17511, Apr. 5, 1993] lion.
481
§ 74.203 21 CFR Ch. I (4–1–19 Edition)
Arsenic (as As), not more than 3 parts per with two molecules from a mixture
million. consisting principally of 3-
Mercury (as Hg), not more than 1 part per [(ethylphenylamino)methyl]
million.
Total color, not less than 85 percent. benzensulfonic acid, and smaller
amounts of 4-
(c) Uses and restrictions. The color ad-
[(ethylphenylamino)methyl]
ditive FD&C Blue No. 2 may be safely
used for coloring foods (including die- benzenesulfonic acid and 2-
tary supplements) generally in [(ethylphenylamino)methyl]
amounts consistent with current good benzenesulfonic acid to form the leuco
manufacturing practice except that it base. The leuco base is then oxidized
may not be used to color foods for with lead dioxide and acid or with di-
which standards of identity have been chromate and acid to form the dye. The
promulgated under section 401 of the intermediate 2-formyl-5-
Federal Food, Drug, and Cosmetic Act hydroxybenzenesulfonic acid is pre-
unless added color is authorized by pared by the potassium permanganate
such standards. oxidation of 2,2′-(1,2-ethenediyl)-bis(5-
(d) Labeling. The label of the color ad- aminobenzenesulfonic acid) to sodium
ditive and any mixtures prepared 5-amino-2-formylbenzenesulfonate.
therefrom intended solely or in part for This amine is diazotized and the result-
coloring purposes shall conform to the ing diazonium salt is hydrolyzed to the
requirements of § 70.25 of this chapter. desired 2-formyl-5-
(e) Certification. All batches of FD&C hydroxybenzenesulfonic acid.
Blue No. 2 shall be certified in accord- (2) Color additive mixtures for food
ance with regulations in part 80 of this use (including dietary supplements)
chapter. made with FD&C Green No. 3 may con-
[48 FR 5260, Feb. 4, 1983] tain only those diluents that are suit-
able and that are listed in part 73 of
§ 74.203 FD&C Green No. 3. this chapter as safe for use in color ad-
(a) Identity. (1) The color additive ditive mixtures for coloring food.
FD&C Green No. 3 is principally the (b) Specifications. The color additive
inner salt disodium salt of N-ethyl-N- FD&C Green No. 3 shall conform to the
[4-[[4-[ethyl[(3- following specifications and shall be
sulfophenyl)methyl]amino]phenyl](4- free from impurities other than those
hydroxy-2-sulfophenyl)methylene]-2,5- named to the extent that such other
cyclohexadien-1-ylidene]-3- impurities may be avoided by current
sulfobenzenemethanaminium hydrox- good manufacturing practice:
ide (CAS Reg. No. 2353–45–9); with Sum of volatile matter at 135 °C (275 °F) and
smaller amounts of the isomeric inner chlorides and sulfates (calculated as so-
salt disodium salt of N-ethyl-N-[4-[[4- dium salts), not more than 15 percent.
[ethyl[(3-sulfophenyl)methyl] Water-insoluble matter, not more than 0.2
amino]phenyl](4-hydroxy-2- percent.
sulfophenyl)methylene]-2,5- Leuco base, not more than 5 percent.
cyclohexadien-1-ylidene]-4- Sum of 2-,3-,4-formylbenzenesulfonic acids,
sodium salts, not more than 0.5 percent.
sulfobenzenemethanaminium hydrox-
Sum of 3- and 4-[[ethyl(4-
ide; of N-ethyl-N-[4-[[4-[ethyl[(4- sulfophenyl)amino]methyl]
sulfophenyl)methyl]amino]phenyl](4- benzenesulfonic acid, disodium salts, not
hydroxy-2-sulfophenyl)methylene]-2,5- more than 0.3 percent.
cyclohexadien-1-ylidene]-4- 2-Formyl-5-hydroxybenzenesulfonic acid, so-
sulfobenzenemethanaminium hydrox- dium salt, not more than 0.5 percent.
ide and of N-ethyl-N-[4-[[4-[ethyl[(2- Subsidiary colors, not more than 6 percent.
sulfophenyl)methyl]amino]phenyl](4- Chromium (as Cr), not more than 50 parts
hydroxy-2-sulfophenyl)methylene]-2,5- per million.
cyclohexadien-1-ylidene]-3-
million.
sulfobenzenemethanaminium hydrox- Lead (as Pb), not more than 10 parts per mil-
ide. Additionally, FD&C Green No. 3 is lion.
manufactured by the acid catalyzed

condensation of one molecule of 2- million.
formyl-5-hydroxybenzenesulfonic acid Total color, not less than 85 percent.
482
(c) Uses and restrictions. The color ad- (c) Uses and restrictions. Orange B
ditive FD&C Green No. 3 may be safely may be safely used for coloring the cas-
used for coloring foods (including die- ings or surfaces of frankfurters and
tary supplements) generally in sausages subject to the restriction that
amounts consistent with current good the quantity of the color additive does
manufacturing practice except that it not exceed 150 parts per million by
may not be used to color foods for weight of the finished food.
which standards of identity have been (d) Labeling requirements. The label of
promulgated under section 401 of the the color additive and any mixtures in-
act unless added color is authorized by tended solely or in part for coloring
such standards. purposes prepared therefrom shall con-
(d) Labeling. The label of the color ad- form to the requirements of § 70.25 of
ditive and any mixtures prepared this chapter.
therefrom intended solely or in part for (e) Certification. All batches of Orange
coloring purposes shall conform to the B shall be certified in accordance with
requirements of § 70.25 of this chapter. regulations promulgated under part 80
(e) Certification. All batches of FD&C of this chapter.
Green No. 3 shall be certified in accord-
§ 74.302 Citrus Red No. 2.
ance with regulations in part 80 of this
chapter. (a) Identity. (1) The color additive
Citrus Red No. 2 is principally 1–(2,5–
[47 FR 52143, Nov. 19, 1982; 47 FR 56489, Dec. dimethoxyphenylazo)-2-naphthol.
17, 1982]
(2) The following diluents may be
§ 74.250 Orange B. used in aqueous suspension, in the per-
centages specified, to facilitate appli-
(a) Identity. (1) The color additive Or- cation to oranges in accordance with
ange B is principally the disodium salt paragraph (c)(1) of this section:
of 1-(4-sulfophenyl)-3-ethylcarboxy-4-(4- (i) Suitable diluents used in accord-
sulfonaphthylazo)-5-hydro-xypyrazole. ance with § 73.1(a) of this chapter.
(2) The diluents in color additive (ii) Volatile solvents that leave no
mixtures for food use containing Or- residue after application to the orange.
ange B are limited to those listed in (iii) Salts of fatty acids meeting the
part 73 of this chapter as safe and suit- requirements of § 172.863 of this chap-
able in color additive mixtures for ter.
coloring foods. (iv) Sodium tripolyphosphate, not
(b) Specifications. Orange B shall con- more than 0.05 percent.
form to the following specifications: (b) Specifications. Citrus Red No. 2
Volatile matter (at 135 °C.), not more than
6.0 percent. fications and shall be free from impuri-
Chlorides and sulfates (calculated as the so- ties, other than those named, to the ex-
dium salts), not more than 7.0 percent. tent that such other impurities may be
Water insoluble matter, not more than 0.2 avoided by good manufacturing prac-
percent. tice:
1-(4-Sulfophenyl)-3-ethylcarboxy-5-
hydroxypyrazolone and 1-(4-sulfophenyl)-3- Volatile matter (at 100 °C.), not more than
carboxy-5-hydroxypyrazolone, not more 0.5 percent.
Water-soluble matter, not more than 0.3 per-
than 0.7 percent.
cent.
Naphthionic acid, not more than 0.2 percent.
Matter insoluble in carbon tetrachloride, not
Phenylhydrazine-p-sulfonic acid, not more
than 0.2 percent. Uncombined intermediates, not more than
The trisodium salt of 1-(4-sulfophenyl)-3- 0.05 percent.
carboxy-4-(4-sulfonaphthylazo)-5- Subsidiary dyes, not more than 2.0 percent.
hydroxypyrazole, not more than 6.0 per- Lead (as Pb), not more than 10 parts per mil-
cent. lion.
Other subsidiary dyes, not more than 1.0 per- Arsenic (as As), not more than 1 part per
cent. million.
Lead (as Pb), not more than 10 parts per mil- Total color, not less than 98 percent.
lion.
(c) Uses and restrictions. (1) Citrus Red
Arsenic (as As), not more than 1 part per

million. No. 2 shall be used only for coloring the
Total color, not less than 87.0 percent. skins of oranges that are not intended
483
§ 74.303 21 CFR Ch. I (4–1–19 Edition)
or used for processing (or if so used are Unhalogenated intermediates, total not
designated in the trade as Packinghouse more than 0.1 percent.
elimination) and that meet minimum Sodium iodide, not more than 0.4 percent.
Triiodoresorcinol, not more than 0.2 percent.
maturity standards established by or
2(2′,4′-Dihydroxy-3′, 5′-diiodobenzoyl) benzoic
under the laws of the States in which acid, not more than 0.2 percent.
the oranges are grown. Monoiodofluoresceins not more than 1.0 per-
(2) Oranges colored with Citrus Red cent.
No. 2 shall bear not more than 2.0 parts Other lower iodinated fluoresceins, not more
per million of such color additive, cal- than 9.0 percent.
culated on the basis of the weight of Lead (as Pb), not more than 10 parts per mil-
the whole fruit. lion.
(d) Labeling. The label of the color ad- million.
ditive and any mixtures prepared Total color, not less than 87.0 percent.
therefrom and intended solely or in
part for coloring purposes shall con- (c) Uses and restrictions. FD&C Red
form to the requirements of § 70.25 of No. 3 may be safely used for coloring
this chapter. To meet the requirements foods generally (including dietary sup-
of § 70.25 (b) and (c) of this chapter the plements) in amounts consistent with
label shall bear: good manufacturing practice except
(1) The statement (or its equivalent) that it may not be used to color foods
‘‘To be used only for coloring skins of for which standards of identity have
oranges.’’ been promulgated under section 401 of
the act unless added color is authorized
(2) Directions for use to limit the
by such standards.
amount of the color additive to not
more than 2.0 parts per million, cal-
culated on the basis of the weight of
the whole fruit.
(e) Certification. All batches of Citrus
Red No. 2 shall be certified in accord-
(e) Certification. All batches of FD&C
chapter.
§ 74.303 FD&C Red No. 3. chapter.
(a) Identity. (1) The color additive § 74.340 FD&C Red No. 40.
FD&C Red No. 3 is principally the (a) Identity. (1) The color additive
monohydrate of 9 (o- carboxyphenyl)-6- FD&C Red No. 40 is principally the di-
hydroxy - 2,4,5,7-tetraiodo-3H-xanthen- sodium salt of 6-hydroxy-5-[(2-
3-one, disodium salt, with smaller methoxy-5-methyl-4-sulfophenyl)azo]-2-
amounts of lower imdinated naphthalenesulfonic acid.
fluoresceins. (2) Color additive mixtures for food
(2) Color additive mixtures for food use (including dietary supplements)
use made with FD&C Red No. 3 may made with FD&C Red No. 40 may con-
contain only those diluents that are tain only those diluents that are suit-
suitable and that are listed in part 73 able and that are listed in part 73 of
of this chapter as safe for use in color this chapter as safe for use in color ad-
additive mixtures for coloring foods. ditive mixtures for coloring foods.
(b) Specifications. FD&C Red No. 3 (3) The listing of this color additive
shall conform to the following speci- includes lakes prepared as described in
fications and shall be free from impuri- § 82.51 of this chapter, except that the
ties other than those named to the ex- color additive used is FD&C Red No. 40
tent that such other impurities may be and the resultant lakes meet the speci-
avoided by good manufacturing prac- fication and labeling requirements pre-
tice: scribed by § 82.51 of this chapter.
Volatile matter (at 135 °C.) and chlorides and (b) Specifications. FD&C Red No. 40
sulfates (calculated as the sodium salts), shall conform to the following speci-
total not more than 13 percent.

Water-insoluble matter, not more than 0.2 ties other than those named to the ex-
percent. tent that such other impurities may be
484
avoided by good manufacturing prac- acid or with the methyl ester, the
tice: ethyl ester, or a salt of this carboxylic
Sum of volatile matter (at 135 °C.) and
acid. The resulting dye is purified and
chlorides and sulfates (calculated as so- isolated as the sodium salt.
dium salts), not more than 14.0 percent. (2) Color additive mixtures for food
Water-insoluble matter, not more than 0.2 use made with FD&C Yellow No. 5 may
percent. contain only those diluents that are
Higher sulfonated subsidiary colors (as so- suitable and that are listed in part 73
dium salts), not more than 1.0 percent. of this chapter as safe for use in color
Lower sulfonated subsidiary colors (as so-
dium salts), not more than 1.0 percent.
additive mixtures for coloring foods.
Disodium salt of 6-hydroxy-5-[(2-methoxy-5- (b) Specifications. FD&C Yellow No. 5
methyl-4-sulfophenyl) azo] -8-(2-methoxy-5- shall conform to the following speci-
methyl-4-sulfophenoxy)-2- fications and shall be free from impuri-
naphthalenesulfonic acid, not more than ties other than those named to the ex-
1.0 percent. tent that such other impurities may be
Sodium salt of 6-hydroxy-2- avoided by good manufacturing prac-
naphthalenesulfonic acid (Schaeffer’s salt),
tice:
4-Amino-5-methoxy-o- toluenesulfonic acid, Sum of volatile matter at 135 °C (275 °F) and
not more than 0.2 percent. chlorides and sulfates (calculated as so-
Disodium salt of 6,6′-oxybis (2-naphthalene- dium salts), not more than 13 percent.
sulfonic acid), not more than 1.0 percent. Water-insoluble matter, not more than 0.2
Lead (as Pb), not more than 10 parts per mil- percent.
lion. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-
Arsenic (as As), not more than 3 parts per sulfophenyl)hydrazono]-1H-pyrazol-1,3-
million. diyl]bis[benzenesulfonic acid], trisodium
Total color, not less than 85.0 percent. salt, not more than 1 percent.
(c) Uses and restrictions. FD&C Red 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-
4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr-
No. 40 may be safely used for coloring
azole-3-carboxylic acid, tetrasodium salt,
foods (including dietary supplements) not more than 1 percent.
generally in amounts consistent with Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-
good manufacturing practice except sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-
that it may not be used to color foods 1H-pyrazole-3-carboxylate, disodium salt,
for which standards of identity have not more than 1 percent.
been promulgated under section 401 of Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-
the act unless added color is authorized sulfophenyl)azo]-1H-pyrazole-3-carboxylic
by such standards. acid, disodium salt, and 4,5-dihydro-5-oxo-
4-(phenylazo)-1-(4-sulfophenyl)-1H-pyr-
azole-3-carboxylic acid, disodium salt, not
ditive and any lakes or mixtures pre- more than 0.5 percent.
pared therefrom intended solely or in 4-Aminobenzenesulfonic acid, sodium salt,
part for coloring purposes shall con- not more than 0.2 percent.
form to the requirements of § 70.25 of 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyr-
this chapter. azole-3-carboxylic acid, disodium salt, not
(e) Certification. All batches of FD&C more than 0.2 percent.
Red No. 40 and lakes thereof shall be Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-
certified in accordance with regula- sulfophenyl)-1H-pyrazole-3-carboxylate, so-
dium salt, not more than 0.1 percent.
tions in part 80 of this chapter.
4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic
§ 74.705 FD&C Yellow No. 5. acid], disodium salt, not more than 0.05
percent.
(a) Identity. (1) The color additive 4-Aminoazobenzene, not more than 75 parts
FD&C Yellow No. 5 is principally the per billion.
trisodium salt of 4,5-dihydro-5-oxo-1-(4- 4-Aminobiphenyl, not more than 5 parts per
sulfophenyl)-4-[4-sulfophenyl-azo]-1H- billion.
pyrazole-3-carboxylic acid (CAS Reg. Aniline, not more than 100 parts per billion.
Azobenzene, not more than 40 parts per bil-
No. 1934–21–0). To manufacture the ad-
lion.
ditive, 4-amino-benzenesulfonic acid is Benzidine, not more than 1 part per billion.
diazotized using hydrochloric acid and 1,3-Diphenyltriazene, not more than 40 parts
sodium nitrite. The diazo compound is
per billion.
coupled with 4,5-dihydro-5-oxo-1-(4- Lead (as Pb), not more than 10 parts per mil-
sulfophenyl)-1H-pyrazole-3-carboxylic lion.
485
§ 74.706 21 CFR Ch. I (4–1–19 Edition)
Arsenic (as As), not more than 3 parts per the diazo benzenesulfonic acid is cou-
million. pled with 3-hydroxy-2,7-
million.
naphthalenedisulfonic acid.
Total color, not less than 87 percent. (2) Color additive mixtures for food
use made with FD&C Yellow No. 6 may
(c) Uses and restrictions. FD&C Yellow
suitable and that are listed in part 73
foods (including dietary supplements)
of this chapter as safe for use in color
generally in amounts consistent with
good manufacturing practice, except additive mixtures for coloring foods.
that it may not be used to color foods (b) Specifications. The color additive
for which standards of identity have FD&C Yellow No. 6 shall conform to
been promulgated under section 401 of the following specifications and shall
the act unless added color is authorized be free from impurities other than
by such standards. those named to the extent that such
(d) Labeling requirements. (1) The label other impurities may be avoided by
of the color additive and any mixtures current good manufacturing practice:
intended solely or in part for coloring
purposes prepared therefrom shall con- chlorides and sulfates (calculated as so-
form to the requirements of § 70.25 of dium salts), not more than 13 percent.
this chapter. Water insoluble matter, not more than 0.2
(2) Foods for human use that contain percent.
FD&C Yellow No. 5, including butter, Sodium salt of 4-aminobenzenesulfonic acid,
cheese, and ice cream, shall specifi- not more than 0.2 percent.
cally declare the presence of FD&C Sodium salt of 6-hydroxy-2-
Yellow No. 5 by listing the color addi- naphthalenesulfonic acid, not more than
tive as FD&C Yellow No. 5 among the 0.3 percent.
list of ingredients. Disodium salt of 6,6′-oxybis[2-
(e) Certification. All batches of FD&C naphthalenesulfonic acid], not more than 1
Yellow No. 5 shall be certified in ac- percent.
cordance with regulations in part 80 of Disodium salt of 4,4′-(1-triazene-1,3-
this chapter. diyl)bis[benzenesulfonic acid], not more
than 0.1 percent.
[42 FR 15654, Mar. 22, 1977; 44 FR 17658, Mar. Sum of the sodium salt of 6-hydroxy-5-
23, 1979, as amended at 44 FR 37220, June 26, (phenylazo)-2-naphthalenesulfonic acid and
1979; 51 FR 24519, July 7, 1986] the sodium salt of 4-[(2-hydroxy-1-
naphthalenyl)azo]benzenesulfonic acid, not
§ 74.706 FD&C Yellow No. 6. more than 1 percent.
(a) Identity. (1) The color additive Sum of the trisodium salt of 3-hydroxy-4-[(4-
FD&C Yellow No. 6 is principally the sulfophenyl)azo]-2,7-naphthalenedisulfonic
disodium salt of 6-hydroxy-5-[(4- acid and other higher sulfonated subsidi-
sulfophenyl)azo]-2-naphthalenesulfonic aries, not more than 5 percent.
acid (CAS Reg. No. 2783–94–0). The tri- 4-Aminoazobenzene, not more than 50 parts
sodium salt of 3-hydroxy-4-[(4- per billion.
sulfophenyl)azo]-2,7- 4-Aminobiphenyl, not more than 15 parts per
naphthalenedisulfonic acid (CAS Reg. billion.
No. 50880–65–4) may be added in small Aniline, not more than 250 parts per billion.
amounts. The color additive is manu- Azobenzene, not more than 200 parts per bil-
lion.
factured by diazotizing 4-
Benzidine, not more than 1 part per billion.
aminobenzenesulfonic acid using hy-
1,3-Diphenyltriazene, not more than 40 parts
drochloric acid and sodium nitrite or per billion.
sulfuric acid and sodium nitrite. The 1-(Phenylazo)-2-naphthalenol, not more than
diazo compound is coupled with 6-hy- 10 parts per million.
droxy-2-naphthalene-sulfonic acid. The Lead (as Pb), not more than 10 parts per mil-
dye is isolated as the sodium salt and lion.
dried. The trisodium salt of 3-hydroxy- Arsenic (as As), not more than 3 parts per
4-[(4-sulfophenyl)azo]-2,7- million.
naphthalenedisulfonic acid which may

be blended with the principal color is million.
prepared in the same manner except Total color, not less than 87 percent.
486
(c) Uses and restrictions. The color ad- (2) FD&C Blue No. 1 Aluminum Lake
ditive FD&C Yellow No. 6 may be safe- may be safely used for coloring drugs
ly used for coloring foods (including di- intended for use in the area of the eye,
etary supplements) generally in in amounts consistent with current
amounts consistent with current good good manufacturing practice, subject
manufacturing practice, except that it to the restrictions on the use of color
may not be used to color foods for additives in § 70.5(b) and (c) of this
which standards of identity have been chapter.
promulgated under section 401 of the (d) Labeling. The label of the color ad-
act unless added color is authorized by ditive and any mixtures prepared
such standards. therefrom intended solely or in part for
(d) Labeling requirements. (1) The label coloring purposes shall conform to the
of the color additive and any mixtures requirements of § 70.25 of this chapter.
intended solely or in part for coloring (e) Certification. All batches of FD&C
purposes prepared therefrom shall con- Blue No. 1 shall be certified in accord-
form to the requirements of § 70.25 of ance with regulations in part 80 of this
this chapter. chapter.
(2) [Reserved] [47 FR 42565, Sept. 28, 1982, as amended at 59
(e) Certification. All batches of FD&C FR 7638, Feb. 16, 1994]
Yellow No. 6 shall be certified in ac-
cordance with regulations in part 80 of § 74.1102 FD&C Blue No. 2.
this chapter. (a) Identity. (1) The color additive
[51 FR 41782, Nov. 19, 1986, as amended at 52 FD&C Blue No. 2 shall conform in iden-
FR 21508, June 8, 1987; 53 FR 49138, Dec. 6, tity to the requirements of
1988] § 74.102(a)(1).
(2) Color additive mixtures for use in
Subpart B—Drugs ingested drugs made with FD&C Blue
No. 2 may contain only those diluents
§ 74.1101 FD&C Blue No. 1 that are suitable and that are listed in
(a) Identity. (1) For ingested drugs, part 73 of this chapter as safe for use in
the color additive FD&C Blue No. 1 color additive mixtures for coloring
shall conform in identity to the re- drugs.
quirements of § 74.101(a)(1). (b) The color additive FD&C Blue No.
(2) For externally applied drugs, the 2 for use in coloring ingested drugs
color additive FD&C Blue No. 1 shall shall conform to the specifications in
conform in identity to the require- § 74.102(b).
ments of § 74.2101(a). (c) The color additive FD&C Blue No.
(3) Color additive mixtures for drug 2 may be safely used for coloring in-
use made with FD&C Blue No. 1 may gested drugs in amounts consistent
contain only those diluents that are with current good manufacturing prac-
suitable and that are listed in part 73 tice.
of this chapter as safe for use in color (d) Labeling. The label of the color ad-
additive mixtures for coloring drugs. ditive and any mixtures prepared
(b) Specifications. (1) The color addi- therefrom intended solely or in part for
tive FD&C Blue No. 1 for use in color- coloring purposes shall conform to the
ing drugs generally shall conform in requirements of § 70.25 of this chapter.
specifications to the requirements of (e) Certification. All batches of FD&C
§ 74.101(b). Blue No. 2 shall be certified in accord-
(2) FD&C Blue No. 1 Aluminum Lake ance with regulations in part 80 of this
shall be prepared in accordance with chapter.
the requirements of § 82.51 of this chap- [48 FR 5260, Feb. 4, 1983, as amended at 49 FR
ter. 10090, Mar. 19, 1984; 64 FR 48290, Sept. 3, 1999]
(c) Uses and restrictions. (1) FD&C
Blue No. 1 may be safely used for color- § 74.1104 D&C Blue No. 4.
ing drugs, including drugs intended for (a) Identity. (1) The color additive
use in the area of the eye, in amounts D&C Blue No. 4 is principally the
consistent with current good manufac- diammonium salt of ethyl[4-[p[ethyl(m-

turing practice. sulfobenzyl)ami-no]-a-(o-
487
§ 74.1109 21 CFR Ch. I (4–1–19 Edition)
sulfophenyl)benzylidene]-2,5-cyclo- § 74.1109 D&C Blue No. 9.

hexadien-1-ylidene] (m- sulfobenzyl)
(a) Identity. The color additive D&C
ammonium hydroxide inner salt with
Blue No. 9 is principally 7,16-dichloro-
smaller amounts of the isomeric
6,15 - dihydro - 5,9,14,18 - anthrazine-
diammonium salts of ethyl [4-[p-
tetrone.
[ethyl(p- sulfobenzyl) amino]-a-(o-
sulfophenyl) benzylidene]-2,5- (b) Specifications. D&C Blue No. 9
cyclohexadien - 1-ylidene](p- shall conform to the following speci-
sulfobenzyl) ammonium hydroxide fications and shall be free from impuri-
inner salt and ethyl[4-[p-[ethyl (o- ties other than those named to the ex-
sulfobenzyl)amino]-a-(o- sulfophenyl) tent that such impurities may be
benzylidene]-2,5-cyclohexadien-1- avoided by good manufacturing prac-
ylidene] (o- sulfobenzyl) ammonium tice:
hydroxide inner salt. Volatile matter (at 135 °C.), not more than 3
(2) Color additive mixtures for use in percent.
externally applied drugs made with Matter extractable by alcoholic HCl (0.1 ml
D&C Blue No. 4 may contain only those of concentrated hydrochloric acid per 50 ml
diluents that are suitable and that are of 95 percent ethyl alcohol), not more than
listed in part 73 of this chapter for use 1 percent.
in color additive mixtures for coloring 2-Amino anthraquinone, not more than 0.2
percent.
externally applied drugs.
Organically combined chlorine in pure dye,
(b) Specifications. D&C Blue No. 4 13.0–14.8 percent.
shall conform to the following speci- Lead (as Pb), not more than 20 p/m.
fications and shall be free from impuri- Arsenic (as As), not more than 3 p/m.
ties other than those named to the ex- Total color, not less than 97 percent.
tent that such impurities may be
avoided by good manufacturing prac- (c) Uses and restrictions. D&C Blue No.
tice: 9 may be safely used for coloring cot-
ton and silk surgical sutures, including
Sum of volatile matter (at 135 °C) and sutures for ophthalmic use, subject to
chlorides and sulfates (calculated as so- the following restrictions:
dium salts), not more than 15 percent.
Water-insoluble matter, not more than 0.2 (1) The dyed suture shall conform in
percent. all respects to the requirements of the
Leuco base, not more than 5 percent. United States Pharmacopeia XX (1980).
Sum of o-, m, and p- sulfobenzaldehydes, am- (2) The quantity of the color additive
monium salt, not more than 1.5 percent. does not exceed 2.5 percent by weight
N-ethyl, N-(m- sulfobenzyl) sulfanilic acid of the suture.
ammonium salt, not more than 0.3 percent.
Subsidiary colors, not more than 6 percent. (3) When the sutures are used for the
Chromium (as Cr), not more than 50 parts purposes specified in their labeling, the
per million. color additive does not migrate to the
Lead (as Pb), not more than 20 parts per mil- surrounding tissue.
lion. (4) If the suture is a new drug, a new-
Arsenic (as As), not more than 3 parts per drug application approved pursuant to
million.
section 505 of the act is in effect for it.
million. (d) Labeling. The label of the color ad-
Total color, not less than 85 percent. ditive shall conform to the require-
(c) Uses and restrictions. D&C Blue No.
(e) Certification. All batches of D&C
4 may be safely used in externally ap-
Blue No. 9 shall be certified in accord-
plied drugs in amounts consistent with
chapter.
ditive and any mixtures prepared [42 FR 15654, Mar. 22, 1977, as amended at 49
therefrom intended solely or in part for FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1,
coloring purposes shall conform to the 1993]
(e) Certification. All batches of D&C § 74.1203 FD&C Green No. 3.
Blue No. 4 shall be certified in accord- (a) Identity and specifications. (1) The
ance with regulations in part 80 of this color additive FD&C Green No. 3 shall
chapter. conform in identity and specifications
488
to the requirements of § 74.203(a)(1) and Total color, not less than 80 percent.
(b). (2) D&C Green No. 5 for use in color-
ing drugs shall conform to the fol-
use made with FD&C Green No. 3 may
lowing specifications and shall be free
suitable and that are listed in part 73 from impurities other than those
of this chapter as safe for use in color named to the extent that such other
additive mixtures for coloring drugs. impurities may be avoided by current
(b) Uses and restrictions. The color ad- good manufacturing practice:
ditive FD&C Green No. 3 may be safely Sum of volatile matter (at 135 °C) and
used for coloring drugs generally in chlorides and sulfates (calculated as so-
amounts consistent with current good dium salts), not more than 20 percent.
manufacturing practice. Water-insoluble matter, not more than 0.2
(c) Labeling. The label of the color ad- percent.
ditive and any mixtures prepared 1,4-Dihydroxyanthraquinone, not more than
therefrom intended solely or in part for 0.2 percent.
coloring purposes shall conform to the Sulfonated toluidines, total not more than
requirements of § 70.25 of this chapter. 0.2 percent.
(d) Certification. All batches of FD&C p-Toluidine, not more than 0.0015 percent.
Green No. 3 shall be certified in accord- Sum of monosulfonated D&C Green No. 6 and
ance with regulations in part 80 of this Ext. D&C Violet No. 2, not more than 3 per-
chapter. cent.
[47 FR 52144, Nov. 19, 1982] lion.
§ 74.1205 D&C Green No. 5. million.
(a) Identity. (1) The color additive Mercury (as Hg), not more than 1 part per
D&C Green No. 5 is principally the di- million.
sodium salt of 2,2′-[(9,10-dihydro-9,10- Total color, not less than 80 percent.
dioxo-1,4-anthracenediyl)diimino]bis-
(c) Use and restrictions. (1) D&C Green
[5-methylbenzenesulfonic acid] (CAS
Reg. No. 4403–90–1). No. 5 may be safely used to color nylon
(2) Color additive mixtures for use in 66 (the copolymer of adipic acid and
drugs made with D&C Green No. 5 may hexamethylenediamine) and/or nylon
contain only those diluents that are 6[poly-(e-caprolactam)]nonabsorbable
suitable and those that are listed in surgical sutures for use in general sur-
part 73 of this chapter for use in color gery, subject to the following restric-
additive mixtures for coloring drugs. tions:
(b) Specifications. (1) D&C Green No. 5 (i) The quantity of color additive
for use in coloring surgical sutures does not exceed 0.6 percent by weight
shall conform to the following speci- of the suture.
fications and shall be free from impuri- (ii) When the sutures are used for the
ties other than those named to the ex- purposes specified in their labeling,
tent that such impurities may be there is no migration of the color addi-
avoided by current good manufacturing tive to the surrounding tissue.
practice: (iii) If the suture is a new drug, an
Sum of volatile matter (at 135 °C) and approved new drug application, under
chlorides and sulfates (calculated as so- section 505 of the act, is in effect for it.
dium salts), not more than 20 percent.
(2) D&C Green No. 5 may be safely
Water insoluble matter, not more than 0.2
percent. used for coloring drugs generally, in-
1,4-Dihydroxyanthraquinone, not more than cluding drugs intended for use in the
0.2 percent. area of the eye, in amounts consistent
2-Amino-m-toluenesulfonic acid, not more with current good manufacturing prac-
than 0.2 percent. tice.
Subsidiary colors, not more than 5 percent.
Lead (as Pb), not more than 10 parts per mil- (d) Labeling. The label of the color ad-
lion.
Arsenic (as As), not more than 3 parts per ments of § 70.25 of this chapter.
million.
489
§ 74.1206 21 CFR Ch. I (4–1–19 Edition)
(e) Certification. All batches of D&C sodium salt of 8-hydroxy-1,3,6-pyrene-

Green No. 5 shall be certified in accord- trisulfonic acid.
ance with regulations in part 80 of this (2) Color additive mixtures for use in
chapter. externally applied drugs made with
[47 FR 24284, June 4, 1982; 47 FR 27551, June D&C Green No. 8 may contain only
25, 1982, as amended at 59 FR 40805, Aug. 10, those diluents that are suitable and
1994] that are listed in part 73 of this chapter
for use in color additive mixtures for
§ 74.1206 D&C Green No. 6. coloring externally applied drugs.
(a) Identity. The color additive D&C (b) Specifications. D&C Green No. 8
Green No. 6 is 1,4-bis[(4- shall conform to the following speci-
methylphenyl)amino]-9,10- fications and shall be free from impuri-
anthracenedione (CAS. Reg. No. 128–80– ties other than those named to the ex-
3). tent that such impurities may be
(b) Specifications. The color additive avoided by good manufacturing prac-
D&C Green No. 6 for use in coloring ex- tices:
ternally applied drugs shall conform to Volatile matter (at 135 °C), not more than 15
the following specifications and shall percent.
be free from impurities other than Water-insoluble matter, not more than 0.2
those named to the extent that such percent.
other impurities may be avoided by Chlorides and sulfates (calculated as sodium
current good manufacturing practice: salt), not more than 20 percent.
The trisodium salt of 1,3,6-pyrenetrisulfonic
Volatile matter (at 135 °C), not more than 2.0 acid, not more than 6 percent.
percent. The tetrasodium salt of 1,3,6,8-
Water-soluble matter, not more than 0.3 per- pyrenetetrasulfonic acid, not more than 1
cent. percent.
Matter insoluble in carbon tetrachloride, not Pyrene, not more than 0.2 percent.
more than 1.5 percent. Lead (as Pb), not more than 20 parts per mil-
p-Toluidine, not more than 0.1 percent. lion.
1,4-Dihydroxyanthraquinone, not more than Arsenic (as As), not more than 3 parts per
0.2 percent. million.
1-Hydroxy-4-[(4-methylphenyl)amino]-9, 10- Mercury (as Hg), not more than 1 part per
anthracenedione, not more than 5.0 per- million.
cent. Total color, not less than 65 percent.
lion. (c) Uses and restrictions. D&C Green
Arsenic (as As), not more than 3 parts per No. 8 may be safely used in externally
million. applied drugs in amounts not exceeding
Mercury (as Hg), not more than 1 part per 0.01 percent by weight of the finished
million.
product.
Total color, not less than 96.0 percent.
(c) Uses and restrictions. The color additive and any mixtures prepared
ditive D&C Green No. 6 may be safely therefrom intended solely or in part for
used for coloring externally applied coloring purposes shall conform to the
drugs in amounts consistent with cur- requirements of § 70.25 of this chapter.
rent good manufacturing practice. (e) Certification. All batches of D&C
(d) Labeling. The label of the color ad- Green No. 8 shall be certified in accord-
ditive shall conform to the require- ance with regulations in part 80 of this
ments of § 70.25 of this chapter. chapter.
(e) Certification. All batches of D&C
Green No. 6 shall be certified in accord- § 74.1254 D&C Orange No. 4.
ance with regulations promulgated (a) Identity. (1) the color additive
under part 80 of this chapter. D&C Orange No. 4 is principally the so-
[42 FR 15654, Mar. 22, 1977, as amended at 47 dium salt of 4-[(2-hydroxy-1-
FR 14146, Apr. 2, 1982; 47 FR 24278, June 4, naphthalenyl)azo]benzenesulfonic acid.
1982; 51 FR 9784, Mar. 21, 1986] (2) Color additive mixtures for use in
externally applied drugs made with
§ 74.1208 D&C Green No. 8. D&C Orange No. 4 may contain only
(a) Identity. (1) The color additive those diluents that are suitable and
D&C Green No. 8 is principally the tri- that are listed in part 73 of this chapter
490
for use in color additive mixtures for is isolated and partially purified prior
coloring externally applied drugs. to bromination.
(b) Specifications. D&C Orange No. 4 (2) Color additive mixtures for drug
shall conform to the following speci- use made with D&C Orange No. 5 may
fications and shall be free from impuri- contain only those diluents that are
ties other than those named to the ex- suitable and that are listed in part 73
tent that such impurities may be of this chapter for use in color additive
avoided by good manufacturing prac- mixtures for coloring drugs.
tice. (b) Specifications. D&C Orange No. 5
Sum of volatile matter (at 135 °C) and shall conform to the following speci-
chlorides and sulfates (calculated as so- fications and shall be free from impuri-
dium salts), not more than 13 percent. ties other than those named to the ex-
Water-insoluble matter, not more than 0.2 tent that such impurities may be
percent.
2-Naphthol, not more than 0.4 percent.
Sulfanilic acid, sodium salt, not more than tice.
0.2 percent. 4′,5′-dibromofluorescein, not less than 50 per-
Subsidiary colors, not more than 3 percent. cent and not more than 65 percent.
4,4′-(Diazoamino)-dibenzenesulfonic acid, not
2′,4′,5′-tribromofluorescein, not less than 30
percent and not more than 40 percent.
2′,4′,5′,7′-tetrabromofluorescein, not more
lion.
than 10 percent.
million. Sum of 2′,4′-dibromofluorescein and 2′,5′-
Mercury (as Hg), not more than 1 part per dibromofluorescein, not more than 2 per-
million. cent.
Total color, not less than 87 percent. 4′–Bromofluorescein, not more than 2 per-
cent.
(c) Uses and restrictions. D&C Orange Fluorescein, not more than 1 percent.
No. 4 may be safely used for coloring Phthalic acid, not more than 1 percent.
externally applied drugs in amounts 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic
consistent with good manufacturing acid, not more than 0.5 percent.
practice. Brominated resorcinol, not more than 0.4
(d) Labeling. The label of the color ad- percent.
ditive and any mixtures prepared Sum of volatile matter (at 135 °C) and halides
therefrom intended solely or in part for and sulfates (calculated as sodium salts),
coloring purposes shall conform to the not more than 10 percent.
requirements of § 70.25 of this chapter. Insoluble matter (alkaline solution), not
(e) Certification. All batches of D&C more than 0.3 percent.
Orange No. 4 shall be certified in ac- Lead (as Pb), not more than 20 parts per mil-
cordance with regulations in part 80 of lion.
this chapter.
million.
[42 FR 52396, Sept. 30, 1977, as amended at 43 Mercury (as Hg), not more than 1 part per
FR 14642, Apr. 7, 1978; 46 FR 8461, Jan. 27, million.
1981] Total color, not less than 90 percent.
§ 74.1255 D&C Orange No. 5. (c) Uses and restrictions. D&C Orange
(a) Identity. (1) the color additive
D&C Orange No. 5 is a mixture con- mouthwashes and dentifrices that are
sisting principally the sodium salt of ingested drugs in amounts consistent
4′,5′-dibromofluorescein (CAS Reg. No. with current good manufacturing prac-
596–03–2) and 2′,4′,5′-tribromofluorescein tice. D&C Orange No. 5 may be safely
(CAS Reg. No. 25709–83–5) and 2′,4′,5′,7′- used in externally applied drugs in
tetrabromofluorescein (CAS Reg. No. amounts not exceeding 5 milligrams
15086–94–9). D&C Orange No. 5 is manu- per daily dose of the drug.
factured by brominating fluorescein (d) Labeling. The label of the color ad-
with elemental bromine. The fluores- ditive and any mixtures prepared
cein is manufactured by the acid con- therefrom intended solely or in part for
densation of resorcinol and phthalic coloring purposes shall conform to the

acid or its anhydride. The fluorescein requirements of § 70.25 of this chapter.
491
§ 74.1260 21 CFR Ch. I (4–1–19 Edition)
(e) Certification. All batches of D&C form to the requirements of § 70.25 of

Orange No. 5 shall be certified in ac- this chapter.
cordance with regulations in part 80 of (e) Certification. All batches of D&C
this chapter. Orange No. 10 shall be certified in ac-
[47 FR 44635, Nov. 2, 1982, as amended at 49 cordance with regulations in part 80 of
FR 13342, Apr. 4, 1984] this chapter.
[46 FR 18953, Mar. 27, 1981]
§ 74.1260 D&C Orange No. 10.
(a) Identity. (1) The color additive § 74.1261 D&C Orange No. 11.
D&C Orange No. 10 is a mixture con- (a) Identity. (1) The color additive
sisting principally of 4′,5′- D&C Orange No. 11 is a mixture con-
diiodofluorescein, 2′,4′,5′- sisting principally of the disodium
triiodofluorescein, and 2′,4′,5′,7′- salts of 4′,5′-diiodofluorescein, 2′,4′,5′-
tetraiodofluorescein. triiodofluorescein and 2′,4′,5′,7′-
(2) Color additive mixtures for drug tetraiodofluorescein.
use made with D&C Orange No. 10 may
use made with D&C Orange No. 11 may
this subpart as safe and suitable for use
in color additive mixtures for coloring
this subpart as safe and suitable for use
in color additive mixtures for coloring
(b) Specifications. D&C Orange No. 10
fications and shall be free from impuri- (b) Specifications. The color additive
ties other than those named to the ex- D&C Orange No. 11 shall conform to
tent that such other impurities may be the following specifications and shall
avoided by good manufacturing prac- be free from impurities other than
tice: those named to the extent that such
impurities may be avoided by good
Sum of volatile matter (at 135 °C) and halides manufacturing practice:
and sulfates (calculated as sodium salts),
not more than 8 percent. Sum of volatile matter (at 135 °C) and halides
Insoluble matter (alkaline solution), not and sulfates (calculated as sodium salts),
more than 0.5 percent. not more than 8 percent.
Phthalic acid, not more than 0.5 percent. Water-insoluble matter, not more than 0.5
2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic percent.
acid, not more than 0.5 percent. Phthalic acid, not more than 0.5 percent.
Fluorescein, not more than 1 percent. 2-[3′,5′-Diiodo-2′,4′-dihydroxybenzoyl] benzoic
4′-Iodofluorescein, not more than 3 percent. acid, sodium salt, not more than 0.5 per-
2′,4′-Diiodofluorescein and 2′,5′- cent.
diiodofluorescein, not more than 2 percent. Fluorescein, disodium salt, not more than 1
2′,4′,5′-Triiodofluorescein, not more than 35 percent.
percent. 4′-Iodofluorescein, disodium salt, not more
2′,4′,5′,7′-Tetraiodofluorescein, not more than than 3 percent.
10 percent. 2′,4′-Diiodofluorescein and 2′,5′-
4′,5′-Diiodofluorescein, not less than 60 per- diiodofluorescein, not more than 2 percent.
cent and not more than 95 percent. 2′,4′,5′-Triiodofluorescein, not more than 35
lion. 2′,4′,5′,7′-Tetraiodofluorescein, disodium salt,
million.
4′,5′-Diiodofluorescein, disodium salt, not
less than 60 percent and not more than 95
million.
percent.
(c) Uses and restrictions. D&C Orange lion.
No. 10 may be safely used for coloring Arsenic (as As), not more than 3 parts per
externally applied drugs in amounts million.
consistent with good manufacturing Mercury (as Hg), not more than 1 part per
million.
practice.
(d) Labeling requirements. The label of
the color additive and any mixtures (c) Uses and restrictions. D&C Orange
prepared therefrom intended solely or No. 11 may be safely used for coloring
in part for coloring purposes shall con- externally applied drugs in amounts
492
consistent with good manufacturing avoided by good manufacturing prac-

practice. tice:
(d) Labeling requirements. The label of
Sum of volatile matter (at 135 °C.) and
the color additive and any mixtures
chlorides and sulfates (calculated as so-
prepared therefrom intended solely or dium salts), not more than 13 percent.
in part for coloring purposes shall con- Water-insoluble matter, not more than 0.2
form to the requirements of § 70.25 of percent.
this chapter. 5-Amino-2,4-dimethyl-1-benzenesulfonic acid,
(e) Certification. All batches of D&C sodium salt, not more than 0.2 percent.
Orange No. 11 shall be certified in ac- 4-Hydroxy-1-naphthalenesulfonic acid, so-
cordance with regulations in part 80 of dium salt, not more than 0.2 percent.
this chapter. Subsidiary colors, not more than 2 percent.
[46 FR 18953, Mar. 27, 1981] Lead (as Pb), not more than 10 parts per mil-
lion.
§ 74.1303 FD&C Red No. 3. Arsenic (as As), not more than 3 parts per
million.
(a) Identity and specifications. (1) The Mercury (as Hg), not more than 1 part per
color additive FD&C Red No. 3 shall million.
conform in identity and specifications Total color, not less than 87 percent.
to the requirements of § 74.303(a)(1) and
(b). (c) Uses and restrictions. FD&C Red
(2) Color additive mixtures for in- No. 4 may be safely used in externally
gested drug used made with FD&C Red applied drugs in amounts consistent
No. 3 may contain only those diluents with good manufacturing practice.
that are suitable and that are listed in (d) Labeling. The label of the color ad-
part 73 of this chapter as safe for use in ditive and any mixtures prepared
color additive mixtures for coloring in- therefrom intended solely or in part for
gested drugs. coloring purposes shall conform to the
(b) Uses and restrictions. FD&C Red requirements of § 70.25 of this chapter.
No. 3 may be safely used for coloring (e) Certification. All batches of FD&C
ingested drugs in amounts consistent Red No. 4 shall be certified in accord-
with good manufacturing practice. ance with regulations in part 80 of this
(c) Labeling. The label of the color ad- chapter.
therefrom intended solely or in part for § 74.1306 D&C Red No. 6.
requirements of § 70.25 of this chapter. (a) Identity. (1) The color additive
(d) Certification. All batches of FD&C D&C Red No. 6 is principally the diso-
Red No. 3 shall be certified in accord- dium salt of 3-hydroxy-4-[(4-methyl-2-
ance with regulations in part 80 of this sulfophenyl)azo]-2-
chapter. naphthalenecarboxylic acid (CAS Reg.
§ 74.1304 FD&C Red No. 4. ditive, 2-amino-5-
(a) Identity. (1) The color additive methylbenzenesulfonic acid is
FD&C Red No. 4 is principally the diso- diazotized with hydrochloric acid and
dium salt of 3-[(2,4-dimethyl-5- sodium nitrite. The diazo compound is
sulfophenyl)azo] -4-hydroxy-1- coupled in alkaline medium with 3-hy-
naphthalenesulfonic acid. droxy-2-naphthalenecarboxylic acid.
(2) Color additive mixtures for use in The resulting dye precipitates as the
externally applied drugs made with disodium salt.
FD&C Red No. 4 may contain only (2) Color additive mixtures for drug
those diluents that are suitable and use made with D&C Red No. 6 may con-
that are listed in part 73 of this chapter tain only those diluents that are suit-
for use in color additive mixtures for able and that are listed in part 73 of
coloring externally applied drugs. this chapter as safe for use in color ad-
(b) Specifications. FD&C Red No. 4 ditive mixtures for coloring drugs.
shall conform to the following speci- (b) Specifications. The color additive
fications and shall be free from impuri- D&C Red No. 6 shall conform to the fol-
ties other than those named to the ex- lowing specifications and shall be free
tent that such impurities may be from impurities other than those
493
§ 74.1307 21 CFR Ch. I (4–1–19 Edition)
named to the extent that such impuri- able and that are listed in part 73 of
ties may be avoided by current good this chapter as safe for use in color ad-
manufacturing practice: ditive mixtures for coloring drugs.
(b) Specifications. The color additive
chlorides and sulfates (calculated as so- D&C Red No. 7 shall conform to the fol-
dium salts), not more than 10 percent. lowing specifications and shall be free
1-[(4-methylphenyl)azo]-2-naphthalenol, not from impurities other than those
more than 0.015 percent. named to the extent that such impuri-
2-Amino-5-methylbenzenesulfonic acid, so- ties may be avoided by current good
dium salt, not more than 0.2 percent. manufacturing practice:
3-Hydroxy-2-naphthalenecarboxylic acid, so-
dium salt, not more than 0.4 percent. Sum of volatile matter (at 135 °C) and
3-Hydroxy-4-[(4-methylphenyl)azo]-2- chlorides and sulfates (calculated as so-
naphthalenecarboxylic acid, sodium salt, dium salts), not more than 10 percent.
not more than 0.5 percent. 1-[(4-methylphenyl)azo]-2-naphthalenol, not
p- Toluidine, not more than 15 parts per mil- more than 0.015 percent.
lion. 2-Amino-5-methylbenzenesulfonic acid, cal-
Lead (as Pb), not more than 20 parts per mil- cium salt, not more than 0.2 percent.
lion. 3-Hydroxy-2-naphthalenecarboxylic acid, cal-
Arsenic (as As), not more than 3 parts per cium salt, not more than 0.4 percent.
million. 3-Hydroxy-4-[(4-methylphenyl)azo]-2-
Mercury (as Hg), not more than 1 part per naphthalenecarboxylic acid, calcium salt,
million. not more than 0.5 percent.
Total color, not less than 90 percent. p-Toluidine, not more than 15 parts per mil-
lion.
(c) Uses and restrictions. The color ad- Lead (as Pb), not more than 20 parts per mil-
ditive D&C Red No. 6 may be safely lion.
used for coloring drugs such that the Arsenic (as As), not more than 3 parts per
combined total of D&C Red No. 6 and million.
D&C Red No. 7 does not exceed 5 milli- Mercury (as Hg), not more than 1 part per
grams per daily dose of the drug. million.
ditive and any mixtures prepared (c) Uses and restrictions. The color ad-
therefrom intended solely or in part for ditive D&C Red No. 7 may be safely
coloring purposes shall conform to the used for coloring drugs such that the
requirements of § 70.25 of this chapter. combined total of D&C Red No. 6 and
(e) Certification. All batches of D&C D&C Red No. 7 does not exceed 5 milli-
Red No. 6 shall be certified in accord- grams per daily dose of the drug.
ance with regulations in part 80 of this (d) Labeling. The label of the color ad-
chapter. ditive and any mixtures prepared
FR 39923, July 6, 2012] coloring purposes shall conform to the
§ 74.1307 D&C Red No. 7. (e) Certification. All batches of D&C
D&C Red No. 7 is principally the cal-
chapter.
cium salt of 3-hydroxy-4-[(4-methyl-2-
sulfophenyl)azo]-2- [47 FR 57687, Dec. 28, 1982, as amended at 77
naphthalenecarboxylic acid (CAS Reg. FR 39923, July 6, 2012]
ditive, 2-amino-5- § 74.1317 D&C Red No. 17.
methylbenzenesulfonic acid is (a) Identity. (1) The color additive
diazotized with hydrochloric acid and D&C Red No. 17 is principally 1-[[4-
sodium nitrite. The diazo compound is (phenylazo)phenyl]azo]-2-naphthalenol.
coupled in alkaline medium with 3-hy- (2) Color additive mixtures for drug
droxy-2-naphthalenecarboxylic acid use made with D&C Red No. 17 may
and the resulting dye converted to the contain only those diluents that are
calcium salt with calcium chloride. suitable and that are listed in part 73
(2) Color additive mixtures for drug of this chapter as safe for use in color
use made with D&C Red No. 7 may con- additive mixtures for coloring exter-
tain only those diluents that are suit- nally applied drugs.
494
(b) Specifications. D&C Red No. 17 acid or its anhydride. The fluorescein
shall conform to the following speci- is isolated and partially purified prior
fications and shall be free from impuri- to bromination.
ties, other than those named, to the ex- (2) Color additive mixtures for drug
tent that such other impurities may be use made with D&C Red No. 21 may
avoided by good manufacturing prac- contain only those diluents that are
tice: suitable and that are listed in part 73
Volatile matter (at 135 °C), not more than 5 of this chapter as safe for use in color
percent. additive mixtures for coloring drugs.
Matter insoluble in both toluene and water (b) Specifications. The color additive
(color additive mixed in toluene and the
resultant residue isolated and mixed with D&C Red No. 21 shall conform to the
water to obtain the matter insoluble in following specifications and shall be
both toluene and water), not more than 0.5 free from impurities other than those
percent. named to the extent that such impuri-
Chlorides and sulfates (calculated as sodium ties may be avoided by current good
salts), not more than 3 percent.
Aniline, not more than 0.2 percent. manufacturing practice:
4-Aminoazobenzene, not more than 0.1 per- Sum of volatile matter (at 135 °C) and halides
cent. and sulfates (calculated as sodium salts),
2-Naphthol, not more than 0.2 percent.
1-(Phenylazo)-2-naphthol, not more than 3
percent. Insoluble matter (alkaline solution), not
1-[[2-(phenylazo) phenyl]azo]-2-naphthalenol, more than 0.5 percent.
not more than 2 percent. Phthalic acid, not more than 1 percent.
Lead (as Pb), not more than 20 parts per mil- 2-(3,5-Dibromo-2,4-dihydroxybenzoyl) benzoic
lion. acid, not more than 0.5 percent.
Arsenic (as As), not more than 3 parts per 2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester,
million. not more than 1 percent.
Mercury (as Hg), not more than 1 part per Brominated resorcinol, not more than 0.4
million. percent.
Fluorescein, not more than 0.2 percent.
(c) Uses and restrictions. D&C Red No. Sum of mono- and dibromofluoresceins, not
17 may be safely used in externally ap- more than 2 percent.
plied drugs in amounts consistent with Tribromofluoresceins, not more than 11 per-
good manufacturing practice. cent.
(d) Labeling. The label of the color ad- 2′,4′,5′,7′-Tetrabromofluorescein, not less
ditive and any mixtures prepared than 87 percent.
therefrom intended solely or in part for Lead (as Pb), not more than 20 parts per mil-
coloring purposes shall conform to the lion.
requirements of § 70.25 of this chapter. Arsenic (as As), not more than 3 parts per
(e) Certification. All batches of D&C million.
Red No. 17 shall be certified in accord- Mercury (as Hg), not more than 1 part per
million.
chapter.
[42 FR 15654, Mar. 22, 1977, as amended at 42 (c) Uses and restrictions. The color ad-
FR 27225, May 27, 1977] ditive D&C Red No. 21 may be safely
used for coloring drugs generally in
§ 74.1321 D&C Red No. 21. amounts consistent with current good
(a) Identity. (1) The color additive manufacturing practice.
D&C Red No. 21 is principally 2′,4′,5′,7′- (d) Labeling. The label of the color ad-
tetrabromofluorescein (CAS Reg. No. ditive and any mixtures prepared
15086–94–9), and may contain smaller therefrom intended solely or in part for
amounts of 2′,4′,5′-tribromofluorescein coloring purposes shall conform to the
(CAS Reg. No. 25709–83–5) and 2′,4′,7′- requirements of § 70.25 of this chapter.
tribromofluorescein (CAS Reg. No. (e) Certification. All batches of D&C
25709–84–6). The color additive is manu- Red No. 21 shall be certified in accord-
factured by brominating fluorescein ance with regulations in part 80 of this
with elemental bromine. The fluores-
chapter.
cein is manufactured by the acid con-
densation of resorcinol and phthalic [47 FR 53846, Nov. 30, 1982]
495
§ 74.1322 21 CFR Ch. I (4–1–19 Edition)
§ 74.1322 D&C Red No. 22. (c) Uses and restrictions. The color ad-
(a) Identity. (1) The color additive ditive D&C Red No. 22 may be safely
D&C Red No. 22 is principally the diso- used for coloring drugs generally in
dium salt of 2′,4′,5′7′- amounts consistent with current good
tetrabromofluorescein (CAS Reg. No. manufacturing practice.
17372–87–1) and may contain smaller (d) Labeling. The label of the color ad-
amounts of the disodium salts of 2′,4′,5′- ditive and any mixtures prepared
tribromofluorescein and 2′,4′,7′- therefrom intended solely or in part for
tribromofluorescein. The color additive coloring purposes shall conform to the
is manufactured by alkaline hydrolysis requirements of § 70.25 of this chapter.
of 2′,4′,5′,7′-tetrabromofluorescein. (e) Certification. All batches of D&C
2′,4′,5′,7′-Tetrabromofluorescein is man- Red No. 22 shall be certified in accord-
ufactured by brominating fluorescein ance with regulations in part 80 of this
with elemental bromine. The fluores- chapter.
cein is manufactured by the acid con- [47 FR 53846, Nov. 30, 1982]
densation of resorcinol and phthalic
acid or its anhydride. Fluorescein is § 74.1327 D&C Red No. 27.
isolated and partially purified prior to
bromination.
(2) Color additive mixtures for drug D&C Red No. 27 is principally 2′,4′,5′,7′-
use made with Red No. 22 may contain tetrabromo-4,5,6,7-
only those diluents that are suitable tetrachlorofluorescein (CAS Reg. No.
and that are listed in part 73 of this 13473-26-2). The color additive is manu-
chapter as safe for use in color additive factured by brominating 4,5,6,7-
mixtures for coloring drugs. tetrachlorofluorescein with elemental
(b) Specifications. The color additive bromine. The 4,5,6,7-
D&C Red No. 22 shall conform to the tetrachlorofluorescein is manufactured
following specifications and shall be by the acid condensation of resorcinol
free from impurities other than those and tetrachlorophthalic acid or its an-
named to the extent that such impuri- hydride. The 4,5,6,7-
ties may be avoided by current good tetrachlorofluorescein is isolated and
manufacturing practice: partially purified prior to bromination.
Sum of volatile matter (at 135 °C) and halides use made with D&C Red No. 27 may
and sulfates (calculated as soduim salts),
Water-insoluble matter not more than 0.5 suitable and that are listed in part 73
percent. of this chapter as safe for use in color
Disodium salt of phthalic acid, not more additive mixtures for coloring drugs.
than 1 percent. (b) Specifications. D&C Red No. 27
Sodium salt of 2-(3,5-Dibromo-2,4- shall conform to the following speci-
dihydroxybenzoyl)benzoic acid, not more fications and shall be free from impuri-
than 0.5 percent.
2′,4′,5′,7′-Tetrabromofluorescein, ethyl ester,
not more than 1 percent. tent that such impurities may be
Brominated resorcinol, not more than 0.4 avoided by current good manufacturing
percent. practice:
Sum of disodium salts of mono- and
dibromofluoresceins, not more than 2 per- Sum of volatile matter (at 135 °C) and halides
cent. and sulfates (calculated as sodium salts),
Sum of disodium salts of not more than 10 percent.
tribromofluoresceins, not more than 25 Insoluble matter (alkaline solution), not
percent. more than 0.5 percent.
Disodium salt of 2′,4′,5′,7′- Tetrachlorophthalic acid, not more than 1.2
Tetrabromofluorescein, not less than 72 percent.
percent. Brominated resorcinol, not more than 0.4
lion. 2,3,4,5-Tetrachloro-6-(3,5-dibromo-2,4-
Arsenic (as As), not more than 3 parts per dihydroxybenzoyl) benzoic acid, not more
million. than 0.7 percent.
Mercury (as Hg), not more than 1 part per 2′,4′,5′,7′-Tetrabromo-4,5,6,7-

million. tetrachlorofluorescein, ethyl ester, not
Total color, not less than 90 percent. more than 2 percent.
496
Lower halogenated subsidiary colors, not 2′,4′,5′,7′-Tetrabromo-4,5,6,7-
more than 4 percent. tetrachlorofluorescein, ethyl ester, not
Lead (as Pb), not more than 20 parts per mil- more than 2 percent.
lion. Lower halogenated subsidiary colors, not
Arsenic (as As), not more than 3 parts per more than 4 percent.
million. Lead (as Pb), not more than 20 parts per mil-
Mercury (as Hg), not more than 1 part per lion.
million. Arsenic (as As), not more than 3 parts per
Total color, not less than 90 percent. million.
(c) Uses and restrictions. D&C Red No. million.
27 may be safely used for coloring Total color, not less than 85 percent.
drugs generally in amounts consistent (c) Uses and restrictions. D&C Red No.
with current good manufacturing prac- 28 may be safely used for coloring
tice. drugs generally in amounts consistent
(d) Labeling. The label of the color ad- with current good manufacturing prac-
ditive and any mixtures prepared tice.
therefrom intended solely or in part for (d) Labeling. The label of the color ad-
coloring purposes shall conform to the ditive and any mixtures prepared
requirements of § 70.25 of this chapter. therefrom intended solely or in part for
(e) Certification. All batches of D&C coloring purposes shall conform to the
Red No. 27 shall be certified in accord- requirements of § 70.25 of this chapter.
ance with regulations in part 80 of this (e) Certification. All batches of D&C
chapter. Red No. 28 shall be certified in accord-
[47 FR 42567, Sept. 28, 1982; 47 FR 51106, Nov.
chapter.
12, 1982]
[47 FR 42568, Sept. 28, 1982]
§ 74.1328 D&C Red No. 28.
§ 74.1330 D&C Red No. 30.
D&C Red No. 28 is principally the diso- (a) Identity. (1) The color additive
dium salt of 2′,4′,5′,7′-tetrabromo-4,5,6,7- D&C Red No. 30 is principally 6-chloro-
tetrachlorofluorescein (CAS Reg. No. 2-(6-chloro-4-methyl-3-

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Title 21

Food and Drugs

Revised as of April 1, 2019

Containing a codification of documents

Published by the Office of the Federal Register

Legal Status and Use of Seals and Logos

Use of ISBN Prefix

U.S. GOVERNMENT PUBLISHING OFFICE

U.S. Superintendent of Documents • Washington, DC 20402–0001

Phone: toll-free (866) 512-1800; DC area (202) 512-1800

Chapter I—Food and Drug Administration, Department of Health

Table of CFR Titles and Chapters ....................................................... 551

Alphabetical List of Agencies Appearing in the CFR ......................... 571

List of CFR Sections Affected ............................................................. 581

To cite the regulations in

CHAPTER I—Food and Drug Administration, Department of

EDITORIAL NOTE: Nomenclature changes to chapter I appear at 66 FR 56035, Nov. 6, 2001, 69

58 Good laboratory practice for nonclinical labora-

PART 1—GENERAL ENFORCEMENT Subpart H—Registration of Food Facilities

1.101 Notification and recordkeeping. prior notice?

1.401 Who is entitled to appeal?

without the hazards being controlled or

Subpart M—Accreditation of Third-Party ACCREDITATION OF THIRD-PARTY

FDA? 1.656 What reports and notifications must

drawal of accreditation? a waiver?

201.62(e), 501.105(f), 701.13(f) and 801.62(e) cluded in that part.

[42 FR 15553, Mar. 22, 1977, as amended at 75

declaration is impracticable, or results from the type size, dual declaration,

codeloflfederallregulations/ ment requirement of § 101.7(f) of this

contents be located within the bottom context of the content declaration is

§ 1.70 Scope. Food means food as defined in section

Total ..................................................... 384

listed country without identifying the manufacturing practice or quality sys-

product. The records shall be made (e) Nonprofit food establishments in

the United States, the District of Co- additional manufacturing/processing is

farm mixed-type facilities, manufac- (1) Entities in which food is provided

(7) You will be considered registered firmation of your registration renewal.

number of the owner, operator, or who authorized submission of the reg-

convicted of a felony relating to impor- be governed by the procedures set out

(ii) For an article of food that is no ufacturing/processing that consists of

of the submitting firm, if applicable. If (7) The FDA Country of Production;

from different growers or different stead of the facility’s full address;

(4) The CBP entry identifier (e.g., (iii) Notwithstanding paragraphs

(17) Shipment information, as appli- (i) Section 1.281(a)(5)(iii) (quantity),

quirements of section 415 of the act. A an article of food is no longer subject

subpart if its sales of food it prepares consumers if the annual monetary

(1) Drying/dehydrating raw agricul- claiming the exemption. The number of

storage facilities, storage silos, grain food before transferring it to another

Nontransporter immediate previous erns, bars, lounges, catering facilities,

statutory provisions or regulations re- number or other identifier of the food

(11) Trailer initials/number; formation is contained in existing

(h) The maintenance of electronic verification or copying of any such re-

Subpart K—Administrative Deten- § 1.378 What criteria does FDA use to

authorized FDA representative believes whichever occurs first, unless other-

representative who approves the modi- firmatory testing or other evidentiary

other carrier, if their identities can be

chapter does not apply to a hearing senior to an FDA District Director.

Environmental pathogen means a (2) Has otherwise been designated by

Holding means storage of food and enizing, irradiating, labeling, milling,

public. Food is imported for personal in accordance with § 117.5(i) of this

§ 1.506 What foreign supplier packs the produce and significantly

than the grower of produce subject to tion regarding appropriate activities

manufacturing, processing, or pre- (3) The assurance specified in the ap-

subpart available promptly to an au- tain all of the information required by