[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Page 47157-47158]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



[Docket No. 2004N-0330]

Food and Drug Administration

Joint Meeting of the Psychopharmacologic Drugs Advisory Committee 
and the Pediatric 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 Committees: Psychopharmacologic Drugs Advisory Committee 
and the Pediatric Advisory Committee.
    General Function of the Committees: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 13, 2004, from 
8 a.m. to 6:30 p.m. and on September 14, 2004, from 8 a.m. to 5 p.m.
    Addresses: Electronic comments should be submitted to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
 Select ``2004N-0330--Suicidality in

[[Page 47158]]

Clinical Trials for Antidepressant Drugs in Pediatric Patients'' and 
follow the prompts to submit your statement. Written comments should be 
submitted to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5600 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Comments received by August 23, 2004, will be provided to the committee 
before the meeting. Comments received after August 23, 2004, will be 
reviewed by FDA's decision makers.
    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, e-mail: patelA@cder.fda.gov, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512544. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The Psychopharmacologic Drugs Advisory Committee and the 
Pediatric 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 and other psychiatric disorders. Preliminary 
risk data based on the classification of these adverse event reports by 
the pharmaceutical sponsors of these products were presented at the 
joint meeting of the Psychopharmacologic Drugs Advisory Committee and 
the Pediatric Subcommittee of the Anti-Infective Drugs Advisory 
Committee held on February 2, 2004. Since that meeting, experts in 
pediatric suicidality, assembled by Columbia University, have 
independently classified these reported events, and FDA has conducted 
an analysis of these data. On September 13 and 14, 2004, the committees 
will consider the results of FDA's analysis of these independently 
classified events and will consider what further regulatory action may 
be needed with regard to the clinical use of these products in 
pediatric patients. The committees 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 Division of Dockets Management 
before August 23, 2004, as previously stated (see Addresses). Oral 
presentations from the public will be scheduled between approximately 2 
p.m. to 6 p.m. on September 13, 2004. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before August 27, 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 
    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 301-
827-7001, 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: July 29, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17822 Filed 7-30-04; 3:41 pm]