[Federal Register Volume 66, Number 6 (Tuesday, January 9, 2001)]
[Notices]
[Pages 1685-1686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-532]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Psychopharmacologic 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: Psychopharmacologic 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 February 14 and 15, 
2001, 8 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Sandra I. Titus or Lauren W. Parcover, Center for 
Drug Evaluation and Research (HFD 21), Food and Drug Administration, 
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), 
Rockville, MD 20857, 301-827-7001, 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: On February 14, 2001, the committee will consider the 
safety and efficacy of new drug application (NDA) 21-253, 
Zyprexa (olanzapine intramuscular, Eli Lilly, Inc.), proposed 
for the rapid control of agitation. On February 15, 2001, the committee 
will consider the safety and efficacy of NDA 20-919, 
ZeldoxTM (ziprasidone mesylate intramuscular, Pfizer, Inc.), 
proposed for the acute control and short-term management of the 
agitated psychotic patient.
    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 February 7, 
2001. Oral presentations from the public will be scheduled each day 
between approximately 1 p.m. to 1:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 2, 2001,

[[Page 1686]]

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: December 28, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-532 Filed 1-8-01; 8:45 am]
BILLING CODE 4160-01-F