[Federal Register: May 9, 2003 (Volume 68, Number 90)]
[Notices]               
[Page 25049]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my03-94]                         

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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 (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 June 16, 2003, from 8 
a.m. to 5 p.m.
    Location: Marriott Washingtonian Center, Grand Ballroom, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: Jayne E. Peterson, 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: petersonj@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: On June 16, 2003, the committee will discuss the white 
blood cell (WBC) monitoring schedule for patients being treated long-
term with clozapine. Currently, the WBC monitoring schedule is weekly 
for the first 6 months of continuous therapy and biweekly thereafter. 
The committee will consider the question of whether the frequency of 
WBC monitoring can be diminished further following some period of 
biweekly monitoring. When available, background materials for this 
meeting will be posted 1-business day prior to the meeting on the FDA 
Web site at: www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the 
year 2003 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 June 9, 2003. 
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 June 9, 2003, 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 Jayne Peterson 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: May 5, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-11649 Filed 5-8-03; 8:45 am]

BILLING CODE 4160-01-S