Document ID: FDA-2008-N-0038-0017
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee; Amendment of Notice
Posted Date: 2008-03-05T05:00Z

[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Notices]               
[Page 11929]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr08-82]                         

[[Page 11929]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Pediatric 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 meeting of the Pediatric Advisory Committee. This 
meeting was originally announced in the Federal Register of January 25, 
2008 (73 FR 4581). The amendment is being made to reflect a change in 
the Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Carlos Pe[ntilde]a, Office of the 
Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-3340, e-mail: 
carlos.Pe[ntilde]a@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 
8732310001. Please call the Information Line for up-to-date information 
on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 25, 2008, 
FDA announced that a meeting of the Pediatric Advisory Committee would 
be held on March 25, 2008. On page 4581, in the third column, the 
Agenda portion of document is changed to read as follows:
    Agenda: On March 25, 2008, the Pediatric Advisory Committee will 
hear and discuss reports by the agency, as mandated in section 17 of 
the Best Pharmaceuticals for Children Act, on adverse event reports for 
TOPROL XL (metoprolol), BREVIBLOC (esmolol HCl), LOTENSIN (benazepril), 
COREG (carvedilol), COLAZAL (balsalazide), ELOXATIN (oxaliplatin), 
CELEBREX (celecoxib), and SUPRANE (desflurane). The Pediatric Advisory 
Committee will also hear an update on TRILEPTAL (oxcarbazepine) and the 
FDA Amendments Act of 2007.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and scroll down to the appropriate advisory committee 
link.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: February 26, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-4156 Filed 3-4-08; 8:45 am]

BILLING CODE 4160-01-S