[Federal Register: April 14, 2003 (Volume 68, Number 71)]
[Notices]
[Page 17958]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap03-62]
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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 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
outlets.
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]
BILLING CODE 4160-01-S