[Federal Register Volume 68, Number 211 (Friday, October 31, 2003)]
[Notices]
[Page 62088]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Psychopharmacologic Drugs Advisory Committee and the Pediatric 
Subcommittee of the Anti-Infective 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 Committees: Psychopharmacologic Drugs Advisory Committee 
and the Pediatric Subcommittee of the Anti-Infective 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 February 2, 2004, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Versailles Ballrooms, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Anuja Patel, 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, FAX: 301-827-6776 or e-mail: [email protected], or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 12544 or 12532. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The Psychopharmacologic Drugs Advisory Committee and the 
Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee 
will discuss reports of the occurrence of suicidality (both suicidal 
ideation and suicide attempts) in clinical trials for various 
antidepressant drugs in pediatric patients with major depressive 
disorder (MDD). The committee will consider optimal approaches to the 
analysis of data from these trials, and the results of analyses 
conducted to date, with regard to the question of what regulatory 
action may be needed pertinent to the clinical use of these products in 
pediatric patients. The committee will also consider further research 
needs to address questions on this topic.
    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 January 26, 
2004. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. to 9:15 a.m., and 1 p.m. to 1:30 p.m. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
January 26, 2004, 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 Anuja Patel 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 23, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-27394 Filed 10-30-03; 8:45 am]
BILLING CODE 4160-01-S