[Federal Register: April 14, 2003 (Volume 68, Number 71)]
[Page 17958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Antiviral Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 May 13 and 14, 2003, 
from 8 a.m. to 5 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: On May 13, 2003, the committee will discuss new drug 
applications (NDA) 21-567 and 21-568, REYATAZ (atazanavir sulfate) 
capsules and powder for oral use, Bristol-Myers Squibb Co., proposed 
for the treatment of human immunodeficiency virus (HIV) infection in 
combination with other antiretroviral agents. On May 14, 2003, the 
committee will discuss supplemental new drug application (SNDA) 20-550/
S-019, VALTREX (valacyclovir hydrochloride) caplets, GlaxoSmithKline, 
proposed for reduction of the risk of transmission of genital herpes 
with the use of suppressive therapy.
    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 May 6, 2003. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on May 13, 2003, and between 
approximately 11 a.m. and 12 noon on May 14, 2003. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 6, 2003, 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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Tara Turner at least 
7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 7, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-9031 Filed 4-11-03; 8:45 am]