[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Pages 32619-32620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15637]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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This notice announces a forthcoming meeting of public advisory
committees of the Food and Drug Administration (FDA). This meeting will
be open to the public.
Name of Committees: Joint meeting of the Nonprescription Drugs
Advisory Committee and the Arthritis Advisory Committee with
Representation from the Peripheral and Central Nervous System Drugs
Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on July 15, 1997, 8:30 a.m.
to 5 p.m.
Location: Holiday Inn, Versailles Rooms I and II, 8120 Wisconsin
Ave., Bethesda, MD.
Contact Person: Andrea G. Neal or Kathleen R. Reedy, Center for
Drug Evaluation and Research (HFD-21), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), codes 12541 and 12532. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will hear presentations and discuss data
submitted regarding New Drug Application (NDA) 20-802, Excedrin Extra
Strength (acetaminophen, aspirin, caffeine) Tablets, Caplets, and
Geltabs, 250 milligrams (mg), 250 mg, and 65 mg, respectively, Bristol
Myers Squibb, for the pain of migraine.
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 3, 1997.
Oral
[[Page 32620]]
presentations from the public will be scheduled between approximately
8:30 a.m. and 9:30 a.m. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before July 3, 1997, and submit a brief statement on
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 6, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-15637 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F
