[Federal Register: September 10, 1998 (Volume 63, Number 175)]
[Notices]               
[Page 48515]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se98-98]

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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