65FR38293 Nonprescription Drugs Advisory Committee; Notice of Meeting
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Posting-number: Volume 65, Issue 119, Page 38293
[Federal Register: June 20, 2000 (Volume 65, Number 119)]
[Notices]
[Page 38293]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jn00-82]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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: Nonprescription 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 12, 2000, 1 p.m. to
5:30 p.m.
Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: 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 e-mail: Tit...@cder.fda.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 12541. Please call the Information
Line for up-to-date information on this meeting.
Agenda: The committee will discuss the remarketing and labeling of
the Today<Register> Vaginal Contraceptive Sponge, new drug application
(NDA) 18-683, Allendale Pharmaceuticals. This product was approved by
FDA in 1983, but has not been marketed since January 1995.
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 July 6, 2000.
Oral presentations from the public will be scheduled between
approximately 1:15 p.m. and 2:15 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before July 6, 2000, 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: June 9, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-15428 Filed 6-19-00; 8:45 am]
BILLING CODE 4160-01-F