[Federal Register: October 18, 2002 (Volume 67, Number 202)]
[Page 64401]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 64401]]



Food and Drug Administration

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 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 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 
    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.
[FR Doc. 02-26616 Filed 10-17-02; 8:45 am]