[Federal Register: September 10, 1999 (Volume 64, Number 175)]
[Notices]               
[Page 49192]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se99-116]                         


[[Page 49192]]

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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). At least one 
portion of the meeting will be closed 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 4, 1999, 8 a.m. 
to 5 p.m., and on October 5, 1999, 8 a.m. to 12 m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, 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: On October 4, 1999, presentations and committee discussions 
will address issues related to the potential applicability of 
information from non-U.S. studies of prevention of perinatal human 
immunodeficiency virus transmission to U.S. clinical settings.
    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 27, 
1999. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on October 4, 1999. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 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.
    Closed Committee Deliberations: On October 4, 1999, from 2 p.m to 5 
p.m., and on October 5, 1999, from 8 a.m. to 12 m., the meeting will be 
closed to permit discussion and review of trade secret and/or 
confidential commercial information relevant to pending investigational 
new drug applications and drug development plans (5 U.S.C. 552b(c)(4)).
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 2, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-23465 Filed 9-9-99; 8:45 am]
BILLING CODE 4160-01-F