[Federal Register Volume 63, Number 124 (Monday, June 29, 1998)]
[Notices]
[Page 35238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17212]
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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). At least one
portion of the meeting will be closed 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 July 14 and 15, 1998,
from 8:30 a.m. to 5 p.m.
Location: Bethesda Holiday Inn, Versailles Ballrooms I and II, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Rhonda W. Stover, or John B. Schupp, 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: On July 14, 1998, the committee will hear presentations
concerning general regulatory issues from the Division of Antiviral
Drug Products.
Procedure: On July 14, 1998, from 8:30 a.m. to 1 p.m. the meeting
is open to the public. 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
July 6, 1998. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 m. on July 14, 1998. Time allotted
for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before July 6,
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.
Closed Committee Deliberations: On July 14, 1998, from 1 p.m to 5
p.m., and on July 15 from 8:30 a.m. to 5 p.m., the meeting will be
closed to permit discussion and review of trade secret and/or
confidential commercial information (5 U.S.C. 552b(c)(4)). The meeting
will discuss information relevant to pending investigational new drug
applications and drug development plans.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C., app. 2).
Dated: June 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17212 Filed 6-26-98; 8:45 am]
BILLING CODE 4160-01-F
