[Federal Register: February 2, 2001 (Volume 66, Number 23)]
[Notices]               
[Page 8805]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02fe01-68]                         

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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 February 27, 2001, 9 
a.m. to 5:30 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village 
Ave., Gaithersburg, MD.
    Contact Person: Tara P. Turner, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane 
(for express delivery 5630 Fishers Lane, rm. 1093), Rockville, MD 
20857, 301-827-7001, e-mail: TurnerT@cder.fda.gov, 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 application (NDA) 
21-304, valganciclovir hydrochloride tablets, 450mg, Syntex (U.S.A.) 
LLC, proposed for treatment of cytomegalovirus retinitis in patients 
with acquired immunodeficiency syndrome (AIDS).
    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 February 
20, 2001. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 20, 
2001, 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: January 18, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-2788 Filed 2-1-01; 8:45 am]
BILLING CODE 4160-01-S