Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration Start Printed 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Inc.) proposed for the maintenance of abstinence from alcohol in patients with alcohol dependence who have withdrawn from alcohol and want to maintain their abstinence.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).Start Signature
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