[Federal Register: October 17, 2000 (Volume 65, Number 201)]
[Notices]
[Page 61340-61341]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17oc00-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee for Pharmaceutical Science; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Advisory Committee for Pharmaceutical Science.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 15 and 16,
2000, from 8:30 a.m. to 5:30 p.m.
Location: University of Maryland, Shady Grove Campus, Auditorium,
9640 Gudelsky Dr., Rockville, MD 20850.
Contact Person: Nancy Chamberlin, Center for Drug Evaluation and
Research (HFD 21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, or e-mail: CHAMBERLINN@cder.fda.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12539. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On November 15, 2000, the committee will: (1) Discuss
approaches to reducing the regulatory burden for chemistry,
manufacturing, and controls supplements; and (2) hear reports and
provide direction to the Advisory Committee for Pharmaceutical
Science's Subcommittee on Orally Inhaled and Nasal Drug Products, and
to the Subcommittee on Nonclinical Studies. On November 16, 2000, the
committee will: (1) Discuss the FDA guidance entitled ``A Guidance for
Industry, Waiver of In Vivo Bioavailability and Bioequivalence Studies
for Immediate-Release Solid Oral Dosage Forms Based on a
Biopharmaceutics Classification System,'' see the FDA Internet web
address http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/3618fnl.htm under the heading of
``Biopharmaceutic Guidances;'' the FDA draft guidance entitled ``A
Guidance for Industry, BA and BE Studies for Orally Administered Drug
Products-General Considerations,'' see the FDA Internet
[[Page 61341]]
web address http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/2762dft.htm under the heading of
``Biopharmaceutic Draft Guidances;'' and the FDA draft guidance
entitled ``A Guidance for Industry, Average, Population, and Individual
Approaches to Establishing Bioequivalence,'' see the FDA Internet web
address http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/1716dft.htm under the heading of
``Biopharmaceutic Draft Guidances;'' (2) provide comments and advice to
the Clinical Pharmacology Modeling and Simulation Working Group; (3)
receive updates on both FDA intramural research and the Product Quality
Research Institute; and (4) provide advice on scientific issues
specific to generic drugs.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person by November 6,
2000. Oral presentations from the public will be scheduled between
approximately 1 p.m. to 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before November 6, 2000, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their
presentation.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: October 5, 2000.
Bernard A. Schwetz,
Acting Deputy Commissioner.
[FR Doc. 00-26606 Filed 10-16-00; 8:45 am]
BILLING CODE 4160-01-F