Justia Regulation Tracker

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[Federal Register: November 2, 2009 (Volume 74, Number 210)]
[Notices]               
[Page 56652]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no09-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2009-N-0664]

 
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 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.

FOR FURTHER INFORMATION CONTACT:  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.

SUPPLEMENTARY INFORMATION:  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.

    Dated: October 27, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26262 Filed 10-30-09; 8:45 am]

BILLING CODE 4160-01-S