[Federal Register Volume 69, Number 7 (Monday, January 12, 2004)]
[Notices]
[Pages 1748-1749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-502]


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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; Amendment 
of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of the meeting of the Psychopharmacologic Drugs Advisory 
Committee and the Pediatric Subcommittee of the Anti-Infective Drugs 
Advisory Committee. This meeting was announced in the Federal Register 
of October 31, 2003 (68 FR 62088). The amendment is being made to 
reflect a change in the Contact Person for the FDA advisory committee 
telephone line extension codes (namely from 5-digit to a 10-digit 
format), Agenda, and Procedure portions of the document. There are no 
other changes.

FOR FURTHER INFORMATION CONTACT: 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].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 31, 2003 
(68 FR 62088), FDA announced that a meeting of the Psychopharmacologic 
Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-
Infective Drugs Advisory Committee will be held on February 2, 2004. On 
page 62088, in the second and third columns, the Contact Person, 
Agenda, and Procedure portions of the meeting are amended to read as 
follows:
    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,

[[Page 1749]]

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 3014512544. 
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 anti-
depressant drugs in pediatric patients with major depressive disorder 
(MDD). The committee will consider optimal approaches to the analysis 
of data from these trials as well as further research needs to address 
these issues. The committee will not be considering options for 
definitive regulatory action at this meeting because definitive 
analyses of the data have not been completed. This topic will be 
covered in a second meeting to be scheduled by summer 2004.
    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 9:30 a.m. to 11:30 a.m., and 2 p.m. to 2:30 p.m.
    This notice is given under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: January 5, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-502 Filed 1-9-04; 8:45 am]
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