[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Notices]
[Page 59793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29561]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Antiviral Drugs Advisory Committee and the
Nonprescription 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 and the
Nonprescription Drugs Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on December 1, 1998, 8:30
a.m. to 5 p.m.
Location: Holiday Inn, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Rhonda W. Stover or Sandra L. Titus, 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: The committees will jointly discuss new drug application
(NDA) N20-629, to switch penciclovir (Denavir, SmithKline
Beecham) topical cream from prescription status to over-the-counter
status for the treatment of recurrent herpes labialis (cold sores) in
immunocompetent adults.
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 November 24,
1998. 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 November 24, 1998, 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: October 27, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-29561 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F
