[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with alcohol dependence who have withdrawn from alcohol and want to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://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