[Federal Register: October 31, 2003 (Volume 68, Number 211)]
[Notices]
[Page 62088]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc03-68]
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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: patelA@cder.fda.gov, 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