[Federal Register: April 5, 2002 (Volume 67, Number 66)]
[Notices]               
[Page 16405-16406]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ap02-71]                         

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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

[[Page 16406]]

(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 May 10, 2002, from 8 
a.m. to 4:30 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD, 301-652-2000.
    Contact Person: Sandra Titus, 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: Tituss@cder.fda.gov, 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 efficacy of new drug 
application (NDA) 21-431, acamprosate, (Lipha Pharmaceuticals, Inc.) 
proposed for the maintenance of abstinence from alcohol in patients 
with alcohol dependence who have withdrawn from alcohol and want to 
maintain their abstinence. On May 9, 2002, the background material for 
this meeting will be posted at the Psychopharmacologic Drugs Advisory 
Committee docket site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year ``2002'' and scroll down to 
``Psychopharmacologic Drugs Advisory Committee''.)
    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 May 1, 2002. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before May 1, 2002, 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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Sandra Titus at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 27, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
Relations.
[FR Doc. 02-8195 Filed 4-4-02; 8:45 am]
BILLING CODE 4160-01-S