[Federal Register Volume 62, Number 78 (Wednesday, April 23, 1997)]
[Notices]
[Page 19763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10476]
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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 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 with
Representation from the Endocrinologic and Metabolic Drugs Advisory
Committee.
General Function of the Committee: The committee reviews and
evaluates available data concerning the safety and effectiveness of
over-the-counter (nonprescription) human drug products for use in the
treatment of a broad spectrum of human symptoms and diseases.
Date and Time: The meeting will be held on May 13, 1997, 8:30 a.m.
to 5 p.m. An open public hearing portion is scheduled from 8:30 a.m. to
9:30 a.m.
Location: Holiday Inn--Bethesda, Versailles Ballrooms I and II,
8120 Wisconsin Ave., Bethesda, MD.
Contact Person: Andrea Neal or Angie Whitacre, 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), code 12541. Please call the Information Line for
up-to-date information on this meeting.
Agenda: The committee will hear presentations and discuss data
submitted regarding the switch from prescription to over-the-counter
status of new drug application (NDA) 16-640/S072, Questran
Powder (cholestyramine resin) and NDA 19-669/S020, Questran
Light (cholestyramine resin with aspartame), Bristol Myers Squibb, for
the reduction of elevated serum cholesterol.
Procedure: 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 May 8, 1997. Those desiring to make formal
presentations should notify the contact person before May 8, 1997, 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: April 17, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-10476 Filed 4-22-97; 8:45 am]
BILLING CODE 4160-01-F
