E8-4156. Pediatric Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 Peña, Office of the Commissioner (HF-33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3340, e-mail: carlos.Peñ[e-mail], 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.