[Federal Register Volume 66, Number 172 (Wednesday, September 5, 2001)]
[Notices]
[Page 46464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-22166]


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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 3 and 4, 2001, 
from 8:30 a.m. to 5 p.m.
    Location: The Town Center Hotel, Maryland Ballroom, 8727 Colesville 
Rd., Silver Spring, MD.
    Contact: 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: [email protected], 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 3, 2001, the committee will discuss new drug 
application (NDA) 21-356, VireadTM (tenofovir disoproxil 
fumarate) Tablets, Gilead Sciences, Inc., proposed for the treatment of 
human immunodeficiency virus (HIV) infection. On October 4, 2001, the 
committee will discuss NDA 21-266, VfendTM (voriconazole) 
Tablets and NDA 21-267, VfendTM I.V. (voriconazole) for 
infusion, Pfizer Global Research and Development, proposed for the 
treatment of invasive aspergillosis, serious Candida infections, 
infections caused by Scedosporium spp. and Fusarium  spp., rare and 
refractory infections, and empirical treatment of febrile neutropenia.
    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 26, 
2001. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on both days. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 26, 
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: August 28, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-22166 Filed 9-4-01; 8:45 am]
BILLING CODE 4160-01-S