[Federal Register Volume 63, Number 175 (Thursday, September 10, 1998)]
[Notices]
[Page 48515]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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.
Date and Time: The meeting will be held on October 6, 1998, from
8:30 a.m. to 5 p.m.
Location: Holiday Inn--Silver Spring, Kennedy Grand Ballroom, 8777
Georgia 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, 301-827-7001, 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: The committee will discuss new drug applications (NDA) N21-
003 (100-milligram (mg) tablets) and NDA N21-004 (5 mg/milliliter oral
solution) for lamivudine (Epivir HBV, Glaxo Wellcome, Inc.) for the
treatment of chronic hepatitis B.
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 September 28,
1998. Oral presentations from the public will be scheduled between
approximately 11 a.m. and 12 m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before September 28, 1998, 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: September 1, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-24241 Filed 9-9-98; 8:45 am]
BILLING CODE 4160-01-F
