[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Notices]
[Page 32620]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15761]
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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: Psychopharmacologic Drugs Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA regulatory issues.
Date and Time: The meeting will be held on July 14, 1997, 8:30 a.m.
to 5 p.m.
Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.
Contact Person: Rhonda W. Stover or Robinette Taylor, 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 12544. Please call the Information Line for
up-to-date information on this meeting.
Agenda: The committee will consider proposals to reduce the
frequency of required white blood cell count monitoring for
Clozaril (clozapine), new drug application (NDA) 19-758,
Sandoz Pharmaceutical Corp.
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 7, 1997.
Oral 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 7, 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: June 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations
[FR Doc. 97-15761 Filed 6-13-97; 8:45 am]
BILLING CODE 4160-01-F
