[Federal Register Volume 62, Number 96 (Monday, May 19, 1997)]
[Notices]
[Pages 27261-27262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 regulatory issues.
Date and Time: The meeting will be held on July 14 and 15, 1997,
8:30 a.m. to 5 p.m..
Location: Armory Place, rm. 204, 925 Wayne Ave., Silver Spring, MD.
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, 301-443-5455, or 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: On July 14 and 15, 1997, the committee will discuss the
utility of plasma human immunodeficiency virus (HIV) RNA measurement as
an endpoint in clinical trials for drugs to treat HIV infection. In
light of the rapid changes
[[Page 27262]]
in knowledge about the pathophysiology of HIV infection, the advances
in the technologies to quantify HIV in plasma and the evolution of
antiviral therapy, FDA is soliciting opinions and advice from the
advisory committee on this topic.
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 July 7, 1997.
Oral presentations from the public will be scheduled on July 14, 1997,
between approximately 11 a.m. to 12 m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 7, 1997, 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: May 13, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-13022 Filed 5-16-97; 8:45 am]
BILLING CODE 4160-01-F
