02-26616. Psychopharmacologic Drugs Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 November 4, 2002, from 8 a.m. to 4:30 p.m.

Location: Holiday Inn, the Ballroom, Two Montgomery Village Ave., Gaithersburg, MD, 301-948-8900.

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, or e-mail [e-mail], 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 supplemental new drug application S-047, Clozaril, (clozapine, Novartis Pharmaceuticals Corp.) proposed for the treatment of suicidality in patients with schizophrenia or schizoaffective disorder. The purpose of this meeting is to discuss the findings and regulatory implications for the InterSePT Study, a study that compared clozapine and olanzapine on the outcome of emergent suicidal behavior and thinking in schizophrenic and schizoaffective patients who were judged to be at risk of suicide. Background material for this meeting will be posted no later than 24 hours before the meeting at the Psychopharmacologic Drugs Advisory Committee Docket site: 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 October 24, 2002. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. each day. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 24, 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: October 10, 2002.

Linda Arey Skladany,

Senior Associate Commissioner for External Relations.