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48656 Federal Register / Vol. 72, No.

164 / Friday, August 24, 2007 / Notices

and clearance under 44 U.S.C. 3507. An 1061, Rockville, MD 20852. All Under current1 21 CFR 207.20,
agency may not conduct or sponsor, and comments should be identified with the manufacturers, repackers, and relabelers
a person is not required to respond to, docket number found in brackets in the that engage in the manufacture,
a collection of information unless it heading of this document. preparation, propagation, compounding,
displays a currently valid OMB control FOR FURTHER INFORMATION CONTACT: or processing of human or veterinary
number. OMB has now approved the Elizabeth Berbakos, Office of the Chief drugs and biological products, including
information collection and has assigned Information Officer (HFA 250), Food bulk drug substances and bulk drug
OMB control number 0910–0601. The and Drug Administration, 5600 Fishers substances for prescription
approval expires on May 31, 2010. A Lane, Rockville, MD 20857, 301–827– compounding, and drug premixes as
copy of the supporting statement for this 1482. well as finished dosage forms, whether
information collection is available on prescription or over-the-counter, are
the Internet at SUPPLEMENTARY INFORMATION: Under the required to register their establishment.
ohrms/dockets. The standards can be PRA (44 U.S.C. 3501–3520), Federal In addition, manufacturers, repackers,
viewed on the Internet at http:// agencies must obtain approval from the and relabelers are required to submit a Office of Management and Budget listing of every drug or biological
06d0246/06d-0246-gdl0002-vol1.pdf. (OMB) for each collection of product in commercial distribution.
information they conduct or sponsor. Owners or operators of establishments
Dated: August 17, 2007.
‘‘Collection of information’’ is defined that distribute, under their own label or
Jeffrey Shuren,
in 44 U.S.C. 3502(3) and 5 CFR trade name, a drug product
Assistant Commissioner for Policy. 1320.3(c) and includes agency requests manufactured by a registered
[FR Doc. E7–16708 Filed 8–23–07; 8:45 am] or requirements that members of the establishment are not required either to
BILLING CODE 4160–01–S public submit reports, keep records, or register or list. However, distributors
provide information to a third party. may elect to submit drug listing
Section 3506(c)(2)(A) of the PRA (44 information in lieu of the registered
DEPARTMENT OF HEALTH AND U.S.C. 3506(c)(2)(A)) requires Federal establishment that manufactures the
HUMAN SERVICES agencies to provide a 60-day notice in drug product. Foreign drug
the Federal Register concerning each establishments must also comply with
Food and Drug Administration the establishment registration and
proposed collection of information,
[Docket No. 2007N–0323] including each proposed extension of an product listing requirements if they
existing collection of information, import or offer for import their products
Agency Information Collection before submitting the collection to OMB into the United States.
Activities: Proposed Collection; for approval. To comply with this Under current §§ 207.21 and 207.22,
Comment Request; Registration of requirement, FDA is publishing notice establishments, both domestic and
Producers of Drugs and Listing of of the proposed collection of foreign, must register with FDA by
Drugs in Commercial Distribution information set forth in this document. submitting Form FDA–2656
With respect to the following (Registration of Drug Establishment)
AGENCY: Food and Drug Administration,
collection of information, FDA invites within 5 days after beginning the
comments on these topics: (1) Whether manufacture of drugs or biologicals, or
ACTION: Notice. within 5 days after the submission of a
the proposed collection of information
SUMMARY: The Food and Drug is necessary for the proper performance drug application or biological license
Administration (FDA) is announcing an of FDA’s functions, including whether application. In addition, establishments
opportunity for public comment on the must register annually by returning,
the information will have practical
proposed collection of certain within 30 days of receipt from FDA,
utility; (2) the accuracy of FDA’s
information by the agency. Under the Form FDA–2656e (Annual Update of
estimate of the burden of the proposed
Paperwork Reduction Act of 1995 (the Drug Establishment) (Note: This form is
collection of information, including the
PRA), Federal agencies are required to no longer mailed to registrants by FDA;
validity of the methodology and
publish notice in the Federal Register updating registration information is
assumptions used; (3) ways to enhance
estimated in table 1 of this document by
concerning each proposed collection of the quality, utility, and clarity of the
the information submitted annually on
information, including each proposed information to be collected; and (4)
Form FDA–2656). Changes in individual
extension of an existing collection of ways to minimize the burden of the
ownership, corporate or partnership
information, and to allow 60 days for collection of information on
public comment in response to the respondents, including through the use 1This notice requests comments on the
notice. This notice solicits comments on of automated collection techniques, information collection in current part 207. In the
requirements governing the registration when appropriate, and other forms of Federal Register of Augst 29, 2006 (71 FR 51276),
of producers of drugs and listing of information technology. FDA proposed to revise part 207. The proposed
revisions would reorganize, consolidate, clarify,
drugs in commercial distribution. and modify current regulations concerning who
Registration of Producers of Drugs and
DATES: Submit written or electronic must register establishments and list, and describes
Listing of Drugs in Commercial when and how to register and list and what
comments on the collection of Distribution—21 CFR Part 207 (OMB information must be submitted for registration and
information by October 23, 2007. Control Number 0910–0045—Extension) listing. In addition, the proposal would make
ADDRESSES: Submit electronic certain changes to the National Drug Code (NDC)
comments on the collection of Under section 510 of the Federal system and would require the appropriate NDC
information to: Food, Drug, and Cosmetic Act (the act), number to appear on the labels for drugs subject to
the listing requirements. The proposed regulations
dockets/ecomments or http:// (21 U.S.C. 360), FDA is authorized to
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generally also require the electronic submission of Submit written establish a system for registration of all registration and most listing information. The
comments on the collection of producers of drugs and for listing of August 29, 2006, proposed rule requested
drugs in commercial distribution. To comments on the information collection for revised
information to the Division of Dockets part 207. When the proposal is finalized, the
Management (HFA 305), Food and Drug implement section 510 of the act, FDA information collection for revised part 207 will
Administration, 5630 Fishers Lane, Rm. issued part 207 (21 CFR part 207). replace the information collection in this notice.

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Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices 48657

structure, location, or drug-handling must, depending on the type of product listing of the active ingredients for all
activity must be submitted as being listed, include any new drug listed drugs or biological products
amendments to registration under application number or biological subject to an approved application or
current § 207.26 within 5 days of such establishment license number, copies of license.
changes. Distributors that elect to current labeling and a sampling of Under current § 207.30,
submit drug listing information must advertisements, a quantitative listing of establishments must update their
submit a Form FDA–2656 to FDA and the active ingredient for each drug or product listing information by using
a copy of the completed form to the biological product not subject to an Form FDA–2657 and/or Form FDA–
registered establishment that approved application or license, the 2658 every June and December or, at the
manufactured the product to obtain a National Drug Code number, and any discretion of the establishment, when
labeler code. Establishments must, drug imprinting information. any change occurs. These updates must
within 5 days of beginning the In addition to the product listing include the following information: (1) A
manufacture of drugs or biologicals, information required on Form FDA– listing of all drug or biological products
submit to FDA a listing for every drug 2657, FDA may also require, under introduced for commercial distribution
or biological product in commercial current § 207.31, a copy of all that have not been included in any
distribution at that time by using Form advertisements and a quantitative listing previously submitted list; (2) all drug or
FDA–2657 (Drug Product Listing). of all ingredients for each listed drug or biological products formerly listed for
Private label distributors may elect to biological product not subject to an which commercial distribution has been
submit to FDA a listing of every drug approved application or license; the discontinued; (3) all drug or biological
product they place in commercial basis for a determination, by the products for which a notice of
distribution. Registered establishments establishment, that a listed drug or discontinuance was submitted and for
must submit to FDA drug product biological product is not subject to which commercial distribution has been
listing for those private label marketing or licensing approval resumed; and (4) any material change in
distributors who do not elect to submit requirements; and a list of certain drugs any information previously submitted.
listing information by using Form FDA– or biological products containing a No update is required if no changes
2658 (Registered Establishments’ Report particular ingredient. FDA may also have occurred since the previously
of Private Label Distributors). request, but not require, the submission submitted list.
Under current § 207.25, product of a qualitative listing of the inactive FDA estimates the annual information
listing information submitted to FDA by ingredients for all listed drugs or collection burden for current part 207 as
domestic and foreign manufacturers biological products, and a quantitative follows:


Number of
No. of Total annual Hours per
Form responses per re- Total hours
respondents responses response

(1) Form FDA–2656 - Registration of

Drug Establishment (New registra-
tions, including new labeler codes
for private label distributors) 39 14.72 574 2.50 1,435

(2) Form FDA–2656 - Annual Update

of Drug Establishment (Update of
registration information) 3,256 2.99 9,763 2.50 24,407.50

(3) Form FDA–2657 - Drug Product

Listing (New drug listings) 1,567 6.57 10,301 2.50 25,752.50

(4) Form FDA–2658 - Registered Es-

tablishments’ Report of Private
Label Distributors (New listings for
private label distributor drugs) 146 10.06 1,469 2.50 3,672.50

(5) Form FDA–2657 and Form FDA–

2658 - (June and December up-
dates of all listing information) 1,677 11.21 18,797 2.50 46,992.50

Total 102,260
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48658 Federal Register / Vol. 72, No. 164 / Friday, August 24, 2007 / Notices

Dated: August 20, 2007. Dockets Management (HFA–305), Food can be published in the Federal
Jeffrey Shuren, and Drug Administration, 5630 Fishers Register, and FDA believes that the
Assistant Commissioner for Policy. Lane, rm. 1061, Rockville, MD 20852. Internet is accessible to more people
[FR Doc. E7–16795 Filed 8–23–07; 8:45 am] Please include the appropriate docket than the Federal Register.
number as listed in table 1 of this In accordance with section 515(d)(4)
document when submitting a written and (e)(2) of the Federal Food, Drug, and
request. See the SUPPLEMENTARY Cosmetic Act (the act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
HUMAN SERVICES access to the summaries of safety and
order approving, denying, or
effectiveness data.
withdrawing approval of a PMA will
continue to include a notice of
[Docket Nos. 2007M–0244 and 2007M–0263] Nathaniel L. Geary, Center for Biologics opportunity to request review of the
Evaluation and Research (HFM–17), order under section 515(g) of the act.
Medical Devices Regulated by the Food and Drug Administration, suite The 30-day period for requesting
Center for Biologics Evaluation and 200N, 1401 Rockville Pike, Rockville,
administrative reconsideration of an
Research; Availability of Summaries of MD 20852–1448, 301–827–6210.
FDA action under § 10.33(b) (21 CFR
Safety and Effectiveness Data for SUPPLEMENTARY INFORMATION: 10.33(b)) for notices announcing
Premarket Approval Applications I. Background approval of a PMA begins on the day the
AGENCY: Food and Drug Administration, In the Federal Register of January 30, notice is placed on the Internet. Section
HHS. 1998 (63 FR 4571), FDA published a 10.33(b) provides that FDA may, for
ACTION: Notice. final rule that revised 21 CFR 814.44(d) good cause, extend this 30-day period.
and 814.45(d) to discontinue individual Reconsideration of a denial or
SUMMARY: The Food and Drug publication of PMA approvals and withdrawal of approval of a PMA may
Administration (FDA) is publishing a denials in the Federal Register, be sought only by the applicant; in these
list of premarket approval applications providing instead to post this cases, the 30-day period will begin
(PMAs) that have been approved by the information on the Internet at http:// when the applicant is notified by FDA
Center for Biologics Evaluation and In addition, the in writing of its decision.
Research (CBER). This list is intended to regulations provide that FDA publish a The following is a list of PMAs
inform the public of the availability quarterly list of available safety and approved by CBER for which summaries
through the Internet and FDA’s Division effectiveness summaries of PMA of safety and effectiveness data were
of Dockets Management of summaries of approvals and denials that were placed on the Internet from April 1,
safety and effectiveness data of announced during the quarter. FDA 2007, through June 30, 2007. There were
approved PMAs. believes that this procedure expedites no denial actions during this period.
ADDRESSES: Submit written requests for public notification of these actions The list provides the manufacturer’s
copies of summaries of safety and because announcements can be placed name, the product’s generic name or the
effectiveness data to the Division of on the Internet more quickly than they trade name, and the approval date.

2007, THROUGH JUNE 30, 2007
PMA No./Docket No. Applicant Trade name Approval date

BP060002/0/2007M–0244 Abbott Molecular, Inc. Abbott RealTime HIV–1 Amplification Reagent Kit, Abbott RealTime May 11, 2007
HIV–1 Calibrator Kit, and Abbott RealTime HIV–1 Control Kit

BP050069/0/2007M–0263 Roche Molecular Sys- COBAS AmpliPrep/COBAS TaqmanHIV–1 Test, 48 Tests, COBAS May 11, 2007
tems, Inc. Ampliprep/COBAS Taqman Wash Reagent, 5.1.L


Persons with access to the Internet SUMMARY: The Food and Drug
may obtain the documents at http:// Food and Drug Administration Administration (FDA) is announcing the availability of a document entitled
Dated: August 17, 2007. [Docket No. 1999D–1878 (formerly Docket ‘‘Guidance for Industry: ‘Lookback’ for
Jeffrey Shuren, No. 99D–1878)] Hepatitis C Virus (HCV): Product
Quarantine, Consignee Notification,
Assistant Commissioner for Policy.
‘‘Guidance for Industry: ‘Lookback’ for Further Testing, Product Disposition,
[FR Doc. E7–16706 Filed 8–23–07; 8:45 am] and Notification of Transfusion
Hepatitis C Virus (HCV): Product
BILLING CODE 4160–01–S Quarantine, Consignee Notification, Recipients Based on Donor Test Results
Further Testing, Product Disposition, Indicating Infection with HCV,’’ dated
and Notification of Transfusion August 2007. The guidance document
Recipients Based on Donor Test provides recommendations for
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Results Indicating Infection with HCV;’’ complying with the HCV ‘‘Lookback’’
Availability requirements. This guidance document
finalizes the guidance entitled, ‘‘Draft
AGENCY: Food and Drug Administration, Guidance for Industry: Current Good
HHS. Manufacturing Practice for Blood and

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