Professional Documents
Culture Documents
notice. This notice solicits comments on public submit reports, keep records, or Substantial Evidence of Effectiveness of
an information collection to meet provide information to a third party. New Animal Drug—21 CFR 514.4(a)
specified requirements for submitting Section 3506(c)(2)(A) of the PRA (44 (OMB Control Number 0910–0356)—
adequate and well-controlled studies to U.S.C. 3506(c)(2)(A)) requires Federal Extension
provide substantial evidence of agencies to provide a 60-day notice in Section 512(d)(1)(E) of the Federal
effectiveness for a new animal drug. the Federal Register concerning each Food Drug and Cosmetic Act (the act)
DATES: Submit written or electronic proposed collection of information, (21 U.S.C. 360b(d)(1)(E)) requires FDA
comments on the collection of including each proposed extension of an to issue an order refusing to approve a
information by January 2, 2007. existing collection of information, New Animal Drug Application (NADA),
ADDRESSES: Submit electronic before submitting the collection to OMB if there is a lack of substantial evidence
comments on the collection of for approval. To comply with this that a new animal drug will have the
information to: http://www.fda.gov/ requirement, FDA is publishing notice effect it is purported or represented to
dockets/ecomments. Submit written of the proposed collection of have under the conditions of use
comments on the collection of information set forth in this document. prescribed in the proposed labeling.
information to the Division of Dockets Therefore, substantial evidence must be
Management (HFA–305), Food and Drug With respect to the following
submitted to us as part of the NADA to
Administration, 5630 Fishers Lane, rm. collection of information, FDA invites
establish effectiveness of a drug. Section
1061, Rockville, MD 20852. All comments on these topics: (1) Whether
514.4(a) specifies requirements for
comments should be identified with the the proposed collection of information
submitting adequate and well-controlled
docket number found in brackets in the is necessary for the proper performance studies to provide substantial evidence
heading of this document. of FDA’s functions, including whether of effectiveness for a new animal drug.
FOR FURTHER INFORMATION CONTACT: the information will have practical This information collection requirement
Denver Presley, Office of the Chief utility; (2) the accuracy of FDA’s provides for submissions of substantial
Information Officer (HFA–250), Food estimate of the burden of the proposed evidence of effectiveness information
and Drug Administration, 5600 Fishers collection of information, including the via electronic submissions to the Center
Lane, Rockville, MD 20857, 301–827– validity of the methodology and for Veterinary Medicine.
1472. assumptions used; (3) ways to enhance We are continuously seeking ways
SUPPLEMENTARY INFORMATION: Under the the quality, utility, and clarity of the through advances in information
PRA (44 U.S.C. 3501–3520), Federal information to be collected; and (4) technology to reduce the burden on the
agencies must obtain approval from the ways to minimize the burden of the government and sponsors. We are
Office of Management and Budget collection of information on continuing to look at what information
(OMB) for each collection of respondents, including through the use can be submitted electronically and will
information they conduct or sponsor. of automated collection techniques, permit electronic submission of data to
‘‘Collection of information’’ is defined when appropriate, and other forms of NADA files as technology and resources
in 44 U.S.C. 3502(3) and 5 CFR information technology. permit.
1320.3(c) and includes agency requests FDA estimates the burden of this
or requirements that members of the collection of information as follows:
The estimate for the annual reporting DEPARTMENT OF HEALTH AND opportunity for public comment on the
burden for this collection of information HUMAN SERVICES proposed collection of certain
was derived from discussion with information by the agency. Under the
industry and agency records. Food and Drug Administration Paperwork Reduction Act of 1995 (the
Dated: October 27, 2006. [Docket No. 2006N–0430] PRA), Federal agencies are required to
publish notice in the Federal Register
Jeffrey Shuren,
Agency Information Collection concerning each proposed collection of
Assistant Commissioner for Policy. Activities; Proposed Collection; information, including each proposed
[FR Doc. E6–18432 Filed 11–1–06; 8:45 am] Comment Request; General Licensing extension of an existing collection of
BILLING CODE 4160–01–S Provisions: Biologics License information, and to allow 60 days for
Application, Changes to an Approved public comment in response to the
Application, Labeling, Revocation and notice. This notice solicits comments on
Suspension, Postmarketing Studies
the information collection related to
Status Reports, and Forms FDA 356h
general licensing provisions for
and 2567
biologics license applications (BLAs),
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices 64537
DATES:Submit written or electronic General Licensing Provisions: Biologics a product or all products. Section
comments on the collection of License Application, Changes to an 601.6(a) requires the licensee to notify
information by January 2, 2007. Approved Application, Labeling, selling agents and distributors upon
Revocation and Suspension, suspension of its license, and provide
ADDRESSES: Submit electronic Postmarketing Studies Status Reports, FDA of such notification.
comments on the collection of and Forms FDA 356h and 2567 (OMB Section 601.12(a)(2) requires,
information to: http://www.fda.gov/ Control Number 0910–0338)—Extension generally, that the holder of an
dockets/ecomments. Submit written approved BLA must assess the effects of
comments on the collection of Under section 351 of the Public
Health Service Act (the PHS Act) (42 a manufacturing change before
information to the Division of Dockets distributing a biological product made
Management (HFA–305), Food and Drug U.S.C. 262), manufacturers of biological
products must submit a license with the change. Section 601.12(a)(4)
Administration, 5630 Fishers Lane, rm. requires, generally, that the applicant
1061, Rockville, MD 20852. All application for FDA review and
approval before marketing a biological must promptly review all promotional
comments should be identified with the labeling and advertising to make it
docket number found in brackets in the product in interstate commerce.
Licenses may be issued only upon consistent with any labeling changes
heading of this document. implemented. Section 601.12(a)(5)
showing that the establishment and the
FOR FURTHER INFORMATION CONTACT: products for which a license is desired requires the applicant to include a list
Jonna Capezzuto, Office of the Chief meets standards prescribed in of all changes contained in the
Information Officer (HFA–250), Food regulations designed to ensure the supplement or annual report; for
and Drug Administration, 5600 Fishers continued safety, purity, and potency of supplements, this list must be provided
Lane, Rockville, MD 20857, 301–827– such products. All such licenses are in the cover letter. The burden estimates
4659. issued, suspended, and revoked as for § 601.12(a)(2) are included in the
prescribed by regulations in part 601 (21 estimates for supplements (§ 601.12(b)
SUPPLEMENTARY INFORMATION: Under the CFR part 601). and (c)) and annual reports
PRA (44 U.S.C. 3501–3520), Federal Section 130(a) of the Food and Drug (§ 601.12(d)). The burden estimates for
agencies must obtain approval from the Administration Modernization Act § 601.12(a)(4) are included in the
Office of Management and Budget (Public Law 105–115) amended the estimates under 601.12(f)(4) (Form FDA
(OMB) for each collection of Federal Food, Drug, and Cosmetic Act 2567) in table 1 of this document or
information they conduct or sponsor. (the act) by adding a new provision OMB control number 0910–0001
‘‘Collection of information’’ is defined (section 506B of the act (21 U.S.C. (expires May 31, 2008) since the
in 44 U.S.C. 3502(3) and 5 CFR 356b)) requiring reports of required information can also be
1320.3(c) and includes agency requests postmarketing studies for approved submitted with Form FDA 2253.
or requirements that members of the human drugs and licensed biological Section 601.12(b)(1) and (b)(3), (c)(1)
public submit reports, keep records, or products. Section 506B of the act and (c)(3), (c)(5), and (d)(1) and (d)(3)
provide information to a third party. provides FDA with additional authority require applicants to follow specific
Section 3506(c)(2)(A) of the PRA (44 to monitor the progress of postmarketing procedures to inform FDA of each
U.S.C. 3506(c)(2)(A)) requires Federal studies that applicants have made a change, in the product, production
agencies to provide a 60-day notice in commitment to conduct and requires process, quality controls, equipment,
the Federal Register concerning each the agency to make publicly available facilities, responsible personnel or
proposed collection of information, information that pertains to the status of labeling established in an approved
including each proposed extension of an these studies. license application. The appropriate
existing collection of information, Under section 506B(a) of the act, procedure depends on the potential for
before submitting the collection to OMB applicants that have committed to the change to have a substantial,
for approval. To comply with this conducting a postmarketing study for an moderate, or minimal adverse effect on
requirement, FDA is publishing notice approved human drug or licensed the identity, strength, quality, purity, or
of the proposed collection of biological product must submit to FDA potency of the products as they may
information set forth in this document. a status report of the progress of the relate to the safety or effectiveness of the
study or the reasons for the failure of the product. Under § 601.12(b)(4), an
With respect to the following applicant to conduct the study. This applicant may ask FDA to expedite its
collection of information, FDA invites report must be submitted within 1 year review of a supplement for public
comments on these topics: (1) Whether after the U.S. approval of the health reasons or if a delay in making
the proposed collection of information application and then annually until the the change described in it would impose
is necessary for the proper performance study is completed or terminated. an extraordinary hardship of the
of FDA’s functions, including whether Section 601.2(a) requires a applicant. The burden estimate for
the information will have practical manufacturer of a biological product to § 601.12(b)(4) is minimal and included
utility; (2) the accuracy of FDA’s submit an application with in the estimate under § 601.12(b)(1) and
estimate of the burden of the proposed accompanying information, including (b)(3) in table 1 of this document.
collection of information, including the labeling information, to FDA for Section 601.12(e) requires applicants
validity of the methodology and approval to market a product in to submit a protocol, or change to a
assumptions used; (3) ways to enhance interstate commerce. The container and protocol, as a supplement requiring
the quality, utility, and clarity of the package labeling requirements are FDA approval before distributing the
information to be collected; and (4) provided under §§ 610.60, 610.61, and product. Section 601.12(f)(1), (f)(2), and
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ways to minimize the burden of the 610.62. The estimate for these (f)(3) requires applicants to follow
collection of information on regulations is included in the estimate specific procedures to report labeling
respondents, including through the use under § 601.2(a) in table 1 of this changes to FDA. Section 601.12(f)(4)
of automated collection techniques, document.Section 601.5(a) requires a requires applicants to report to FDA
when appropriate, and other forms of licensee to submit to FDA notice of its advertising and promotional labeling
information technology. intention to discontinue manufacture of and any changes.
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64538 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices
Under § 601.14, the content of Section 601.25(b) requests interested FDA an analysis of available safety and
labeling required in § 201.100(d)(3) persons to submit, for review and efficacy data in the pediatric population
must be in electronic format and in a evaluation by an advisory review panel, and changes proposed in the labeling
form that FDA can process, review, and published and unpublished data and based on this information. Section
archive. This requirement is in addition information pertinent to a designated 601.28(c) requires sponsors to submit to
to the provisions of §§ 601.2(a) and category of biological products that have FDA a statement on the current status of
601.12(f). The burden estimate for been licensed prior to July 1, 1972. any postmarketing studies in the
§ 601.14 is minimal and included in the Section 601.26(f) requests that licensees pediatric population performed by, or
estimate under § 601.2(a) (BLAs) and submit to FDA a written statement on behalf of, the applicant. If the
601.12(f)(1), (f)(2), and (f)(3) intended to show that studies adequate postmarketing studies were required or
(supplements and annual reports) in and appropriate to resolve questions agreed to, the status of these studies is
table 1 of this document. raised about a biological product have to be reported under § 601.70, rather
Section 601.45 requires applicants of been undertaken for a product if then under this section.
biological products for serious or life- designated as requiring further study Sections 601.33 through 601.35 clarify
threatening illnesses to submit to the under the reclassification procedures. the information to be submitted in an
agency for consideration, during the Under § 601.25(b)(3), FDA estimates no application to FDA to evaluate the
pre-approval review period, copies of all burden for this regulation since all safety and effectiveness of in vivo
promotional materials, including requested data and information had radiopharmaceuticals. The burden
promotional labeling as well as been submitted by 1974. Under estimates for §§ 601.33 through 601.35
advertisements. § 601.26(f), FDA estimates no burden for are included in the burden estimate
In addition to §§ 601.2 and 601.12, this regulation since there are no under § 601.2(a) in table 1 of this
there are other regulations in parts 640, products designated to require further document, since these regulations deal
660, and 680 (21 CFR parts 640, 660, study and none are predicted in the with information to be provided in an
and 680) that relate to information to be future. However, based on the possible application.
submitted in a license application or reclassification of a product, the Section 601.70(b) requires each
supplement for certain blood or labeling for the product may need to be applicant of a licensed biological
allergenic products: §§ 640.6, 640.17, revised, or a manufacturer, on its own product to submit annually a report to
640.21(c), 640.22(c), 640.25(c), initiative, may deem it necessary for FDA on the status of postmarketing
640.56(c), 640.64(c), 640.74(a) and further study. As a result, any changes studies for each approved product
(b)(2), 660.51(a)(4), 680.1(b)(2)(iii), and to product labeling would be reported application. Each annual postmarketing
680.1(d). In table 1 of this document, the under § 601.12. status report must be accompanied by a
burden associated with the information Section 601.27(a) requires that completed transmittal Form FDA 2252
collection requirements in these applications for new biological products (approved under OMB control number
regulations is included in the burden contain data that are adequate to assess 0910–0001). Under § 601.70(d), two
estimate for § 601.2 and/or § 601.12. A the safety and effectiveness of the copies of the annual report shall be
regulation may be listed under more biological product for the claimed submitted to FDA.
than one section of § 601.12 due to the indications in pediatric subpopulations, Section 601.91(b)(3) requires
type of category under which a change and to support dosing and applicants to prepare and provide
to an approved application may be administration information. Section labeling with relevant information to
submitted. 601.27(b) provides that an applicant patient or potential patient for biological
There are also additional container may request a deferred submission of products approved under the subpart
and/or package labeling requirements some or all assessments of safety and when human efficacy studies are not
for certain licensed biological products: effectiveness required under § 601.27(a). ethical or feasible (or based on evidence
§ 640.70(a) for Source Plasma; Section 601.27(c) provides that an of effectiveness from studies in
§ 640.74(b)(3) and (b)(4) for Source applicant may request a full or partial animals). Section 601.93 provides that
Plasma Liquid; § 640.84(a) and (c) for waiver of the requirements under biological products approved under this
Albumin; § 640.94(a) for Plasma Protein § 601.27(a). The burden estimates for subpart are subject to the postmarketing
Fraction; § 660.2(c) for Antibody to § 601.27(a) are included in the burden recordkeeping and safety reporting
Hepatitis B Surface Antigen; § 660.28(a) estimate under § 601.2(a) in table 1 of applicable to all approved biological
and (b) for Blood Grouping Reagent; this document, since these regulations products. Section 601.94 requires
§ 660.35(a), (c through g), and (i through deal with information to be provided in applicants under this subpart to submit
m) for Reagent Red Blood Cells; § 660.45 an application. to the agency for consideration during
for Hepatitis B Surface Antigen; and Section 601.28 requires sponsors of preapproval review period copies of all
§ 660.55(a) and (b) for Anti-Human licensed biological products to submit promotional materials including
Globulin. The burden associated with the information in § 601.28(a), (b), and promotional labeling as well as
the additional labeling requirements for (c) to the Center for Biologics Evaluation advertisements. Under § 601.93, any
submission of a license application for and Research (CBER) or the Center for potential postmarketing reports and/or
these certain biological products is Drug Evaluation and Research (CDER) recordkeeping burdens would be
minimal because the majority of the each year, within 60 days of the included under the adverse experience
burden is associated with the anniversary date of approval of the reporting (AER) requirements under 21
requirements under § 610.60 through license. Section 601.28(a) requires CFR part 600 (OMB control number
§ 610.62 or § 809.10. Therefore, the sponsors to submit to FDA a brief 0910–0308; expires May 31, 2005).
burden estimates for these regulations summary stating whether labeling Therefore, any burdens associated with
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are included in the estimate under supplements for pediatric use have been these requirements would be reported
§ 610.60 through § 610.62 in table 1 of submitted and whether new studies in under the AER information collection
this document. The burden estimates the pediatric population to support requirements (OMB control number
associated with § 809.10 are approved appropriate labeling for the pediatric 0910–0308).
under OMB control number 0910–0485 population have been initiated. Section Section 610.11(g)(2) (21 CFR
(expires June 30, 2008). 601.28(b) requires sponsors to submit to 610.11(g)(2)) provides that a
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices 64539
estimated burden hours for submissions various submissions or notifications. majority of the burden for developing
to CDER using Form FDA 356h are The hours per response include the time the patient labeling is included under
reported under OMB control number estimated to prepare the various the reporting requirements for § 601.94,
0910–0001. submissions or notifications to FDA, therefore minimal burden is calculated
Form FDA 2567 ‘‘Transmittal of and, as applicable, the time required to for providing the guide to patients
Labels and Circulars’’ is used by fill out the appropriate form and collate under § 601.91(b)(3).
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64540 Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices
There were also 3,540 amendments to of 3,563 submissions) submitted using FDA estimates the burden of this
an unapproved application or Form FDA 356h. collection of information as follows:
supplement and 23 resubmissions (total
601.6(a) NA 1 21 21 .33 7
601.25(b)(3) NA 0 0 0 0 0
601.26(f) NA 0 0 0 0 0
601.27(b) NA 3 1 3 24 72
601.27(c) NA 7 1 7 8 56
680.1(c) NA 10 1 10 2 20
Amendments/Resubmis-
sions 356h 306 11.6 3,563 20 71,260
Total 335,806.5
1There are no capital costs or operating and maintenance costs associated with this collection of information.
2The reporting requirements under §§ 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.11(g)(2), 640.17, 640.25(c), 640.56(c), 640.74(b)(2),
660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a).
3The reporting requirements under §§ 640.70(a), 640.74(b)(3), and (b)(4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a) and (b), 660.35(a),
(c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under § 610.60 through 610.62.
4The reporting requirements under §§ 600.15(b), 610.11(g)(2), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c), 640.25(c), 640.56(c),
640.64(c), 640.74(a) and (b)(2), and 680.1(d) are included in the estimate under § 601.12(b).
5The reporting requirements under §§ 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under § 601.12(c).
6The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (f)(2).
7The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(3).
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Federal Register / Vol. 71, No. 212 / Thursday, November 2, 2006 / Notices 64541
601.91(b)(2)(iii) 1 1 1 1 1
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 25, 2006. Detailed information about security committee will discuss a report of
Jeffrey Shuren, procedures is located at http:// intramural research programs.
Assistant Commissioner for Policy. www.nih.gov/about/visitorsecurity.htm. Persons attending FDA’s advisory
[FR Doc. E6–18445 Filed 11–1–06; 8:45 am] Due to the limited available parking, committee meetings are advised that the
BILLING CODE 4160–01–S visitors are encouraged to use public agency is not responsible for providing
transportation. (FDA has verified the access to electrical outlets.
Web site addresses, but FDA is not FDA welcomes the attendance of the
DEPARTMENT OF HEALTH AND responsible for any subsequent changes public at its advisory committee
HUMAN SERVICES to the Web sites after this document meetings and will make every effort to
publishes in the Federal Register.) accommodate persons with physical
Food and Drug Administration Contact Person: Gail Dapolito or disabilities or special needs. If you
Rosanna Harvey, Center for Biologics require special accommodations due to
Cellular, Tissue and Gene Therapies a disability, please contact Gail Dapolito
Evaluation and Research, (HFM–71),
Advisory Committee; Notice of Meeting at least 7 days in advance of the
Food and Drug Administration, 1401
AGENCY: Food and Drug Administration, Rockville Pike, Rockville, MD, 20852, meeting.
HHS. 301–827–0314, or FDA Advisory
ACTION: Notice. Committee Information Line, 1–800– Notice of this meeting is given under
741–8138 (301–443–0572 in the the Federal Advisory Committee Act (5
This notice announces a forthcoming Washington, DC area), code U.S.C. app. 2).
meeting of a public advisory committee 3014512389. Please call the Information Dated: October 27, 2006.
of the Food and Drug Administration Line for up-to-date information on this Randall W. Lutter,
(FDA). At least one portion of the meeting.
meeting will be closed to the public. Associate Commissioner for Policy and
Agenda: On November 20, 2006, the Planning
Name of Committee: Cellular, Tissue
committee will meet in open session to [FR Doc. E6–18472 Filed 11–1–06; 8:45 am]
and Gene Therapies Advisory
hear updates of research programs in the
Committee. BILLING CODE 4160–01–S
Laboratory of Immunobiology and the
General Function of the Committee: Laboratory of Immunology, Office of
To provide advice and Biotechnology Products, Center for Drug DEPARTMENT OF HEALTH AND
recommendations to the agency on Evaluation and Research. HUMAN SERVICES
FDA’s regulatory issues. Procedure: On November 20, 2006,
Date and Time: The meeting will be from 2:15 p.m. to approximately 4:30 Food and Drug Administration
held by teleconference on November 20, p.m., the meeting is open to the public.
Interested persons may present data, Pediatric Oncology Subcommittee of
2006, from 2:15 p.m. to approximately
information, or views, orally or in the Oncologic Drugs Advisory
5 p.m.
writing, on issues pending before the Committee; Notice of Meeting
Location: National Institutes of Health
(NIH), Bldg. 29, rm. 121, 9000 Rockville committee. Written submissions may be AGENCY: Food and Drug Administration,
Pike, MD. This meeting will be held by made to the contact person on or before HHS.
teleconference. The public is welcome November 13, 2006. Oral presentations ACTION: Notice.
to attend the meeting at the specified from the public will be scheduled
location. A speakerphone will be between approximately 3:30 p.m. and This notice announces a forthcoming
provided at the specified location for 4:30 p.m. Time allotted for each meeting of a public advisory committee
public participation in the meeting. presentation may be limited. Those of the Food and Drug Administration
Important information about desiring to make formal oral (FDA). The meeting will be open to the
transportation, directions to the NIH presentations should notify the contact public.
campus, parking, and security person and submit a brief statement of Name of Committee: Pediatric
procedures is available on the Internet the general nature of the evidence or Oncology Subcommittee of the
at http://www.nih.gov/about/visitor/ arguments they wish to present, the Oncologic Drugs Advisory Committee.
index.htm. Visitors must show two names and addresses of proposed General Function of the Committee:
forms of identification, one of which participants, and an indication of the To provide advice and
must be a Government-issued photo approximate time requested to make recommendations to the agency on
identification such as a Federal their presentation on or before FDA’s regulatory issues.
employee badge, driver’s license, November 13, 2006. Date and Time: The meeting will be
passport, green card, etc. If you are Closed Committee Deliberations: On held on December 6, 2006, from 8:30
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planning to drive to and park on the November 20, 2006, from approximately a.m. to 5 p.m.
NIH campus, you must enter at the 4:30 p.m. to 5 p.m., the meeting will be Location: Food and Drug
South Dr. entrance of the campus which closed to permit discussion where Administration, Center for Drug
is located on Wisconsin Ave. (the disclosure would constitute a clearly Evaluation and Research Advisory
Medical Center Metro entrance), and unwarranted invasion of personal Committee Conference Room, rm. 1066,
allow extra time for vehicle inspection. privacy (5 U.S.C. 552b(c)(6)). The 5630 Fishers Lane, Rockville, MD.
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