[Federal Register: August 23, 2004 (Volume 69, Number 162)]
[Notices]               
[Page 51853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23au04-53]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0330]

 
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee 
and the PediatricAdvisory 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 joint meeting of the Psychopharmacologic Drugs 
Advisory Committee and the Pediatric Advisory Committee. This meeting 
was announced in the Federal Register of August 4, 2004 (69 FR 47157). 
The amendment is being made to reflect changes in the Addresses 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, 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 4, 2004, 
FDA announced that a joint meeting of the Psychopharmacologic Drugs 
Advisory Committee and the Pediatric Advisory Committee would be held 
on September 13 and 14, 2004. On page 47157, in the third column, the 
Addresses and on page 47158, in the second column, the Procedure 
portions are amended to read as follows:
    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 

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, 5630 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.
    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 
as stated in the Addresses section of this document. 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 4:30 p.m. on 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. Docket ``2004N-0330--Suicidality in Clinical Trials for 
Antidepressant Drugs in Pediatric Patients'' will remain open for 
public submissions until July 29, 2005.
    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: August 13, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning..
[FR Doc. 04-19224 Filed 8-18-04; 12:34 pm]

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