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Pediatric Advisory Committee; Amendment of Notice

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.



The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal Register of October 6, 2009 (74 FR 51289). The amendment is being made to reflect a change in the Agenda portion of the document. There are no other changes.

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Doreen Kezer, Office of Medical and Scientific Programs, Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane (HF-33), rm. 14-65, Rockville, MD 20857, 301-827-1249, 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.

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In the Federal Register of October 6, 2009, FDA announced that a meeting of the Pediatric Advisory Committee would be held on December 8, 2009. On page 51290, in the first column, the Agenda portion of the document is changed to read as follows:

Agenda: On December 8, 2009, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Abilify (aripiprazole), Argatroban (argatroban), Orencia (abatacept), Humira (adalimumab), Cancidas (caspofungin acetate), Evicel—fibrin sealant (human), Artiss—fibrin sealant (human), Voluven—6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, Reyataz (atazanavir sulfate), Kaletra (lopinavir/ ritonavir), Aptivus (tipranavir), Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin), Ventolin HFA (albuterol sulfate). An update to address some of the committee's questions from the Pediatric Advisory Committee meeting of November 18, 2008, on atypical antipsychotic drugs will be provided. In addition to Abilify (aripiprazole), Risperidal (risperidone), Zyprexa (olanzapine), Geodon (ziprasidone), and Seroquel (quetiapine) will be included. Two products (Zemuron (rocuronium bromide) and Cardiolite (technetium Tc99m sestamibi) previously planned for presentation at this meeting are rescheduled for a later date.

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.

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Dated: October 27, 2009.

David Horowitz,

Assistant Commissioner for Policy.

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[FR Doc. E9-26262 Filed 10-30-09; 8:45 am]