[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Notices]
[Pages 45973-45974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21729]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99N-2670 ]
Antiviral Drugs Advisory Committee; 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: Antiviral Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
[[Page 45974]]
Dates and Time: The meeting will be held on November 2 and 3, 1999,
from 8:30 a.m. to 5 p.m. Interested persons and organizations may
submit written comments by September 30, 1999, to the Dockets
Management Branch (address below).
Location and Addresses: Holiday Inn, The Ballrooms, Two Montgomery
Village Ave., Gaithersburg, MD. Submit written comments to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Contact Person: Rhonda W. Stover or John B. Schupp, Center for Drug
Evaluation and Research, (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7001, or the FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12531. Please call the Information Line for
up-to-date information on this meeting.
Agenda: Presentations and committee discussions will address issues
related to testing for development of resistant human immunodeficiency
virus (HIV-1), with an emphasis on its potential role in antiretroviral
drug development. The primary objectives of these deliberations are to
obtain advisory committee recommendations on the amount and type of
resistance data needed to support both preclinical and clinical
development of antiretroviral drugs and product labeling. This 2-day
meeting will explore the following scientific issues: (1) Performance
characteristics of genotypic and phenotypic assays, (2) definitions of
antiviral drug resistance, (3) relationships between the development of
mutations or reduced susceptibility and treatment outcome, and (4)
available evidence supporting the clinical utility of testing for the
development of antiviral drug resistance. In order to prepare
presentations and discussions for the meeting, the agency is requesting
interested persons to submit in writing the following types of relevant
data, information, and views:
Pre-clinical and/or clinical trial data on the
relationship between the development of HIV mutations and changes in
susceptibility to antiviral therapies.
Prospective or retrospective clinical trial data on the
relationship between genotype and/or phenotype and treatment outcome.
Proposals for incorporating HIV resistance testing in
clinical trial design.
Proposals for utilizing information derived from HIV
resistance testing to support product labeling.
These submissions should contain the following docket number, 99N-
2670, and should be made to the Dockets Management Branch address
provided previously in this document.
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 October 27,
1999. Oral presentation from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on November 3, 1999. Time allotted for
each presentation may be limited. Written submissions may be made to
the contact person by October 27, 1999. Those desiring to make formal
oral presentations should notify the contact person before October 27,
1999, 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: August 13, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-21729 Filed 8-20-99; 8:45 am]
BILLING CODE 4160-01-F
