[Federal Register Volume 65, Number 100 (Tuesday, May 23, 2000)]
[Notices]
[Page 33330]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Psychopharmacological 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: Psychopharmacological 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 19, 2000, 8 a.m. to 
5 p.m.
    Location: Holiday Inn, Versailles Ballrooms I, II, and III, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Sandra L. Titus or LaNise S. Giles, Center for Drug 
Evaluation and Research (HFD-21), 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-
7001, or e-mail [email protected], 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 the safety and efficacy of new 
drug application (NDA) 20-825, ZeldoxTM (ziprasidone 
hydrochloride capsules, Pfizer, Inc.), proposed for the management of 
psychotic disorders.
    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 17, 2000. 
Oral presentations from the public will be scheduled on July 19, 2000, 
between approximately 1 p.m. to 2 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 17, 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: May 11, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-12855 Filed 5-22-00; 8:45 am]
BILLING CODE 4160-01-F