Document ID: FDA-2009-N-0664-0096
Agency: fda
Document Type: Notice
Title: Meetings: Pediatric Advisory Committee
Posted Date: 2009-10-06T04:00Z

[Federal Register: October 6, 2009 (Volume 74, Number 192)]
[Notices]               
[Page 51289-51290]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06oc09-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
Pediatric Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pediatric Advisory Committee.

[[Page 51290]]

    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on Tuesday, December 8, 
2009, from 8 a.m. to 6 p.m.
    Location: Hilton, Washington, DC/Rockville Executive Meeting 
Center, Plaza Ballroom, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: Doreen Kezer, Office of Medical and Scientific 
Programs (HF-33), Office of the Commissioner, Food and Drug 
Administration, 5600 Fishers Lane, 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. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    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), Zemuron (rocuronium bromide), 
Cancidas (caspofungin acetate), Cardiolite (technetium Tc99 sestamibi), 
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). The committee will also 
receive a brief update on atypical antipsychotic drugs as requested by 
the Pediatric Advisory Committee Meeting on November 18, 2008.
    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/AdvisoryCommittees/Calendar/
default.htm. Scroll down to the appropriate advisory committee link.
    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 contact person on or before 
Tuesday, November 24, 2009. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. Those desiring to 
make formal oral presentations should notify the contact person 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 on or before Monday, November 16, 2009. Time 
allotted for each presentation may be limited. If the number of 
registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by Tuesday, November 17, 2009.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Doreen Kezer at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 1, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-24013 Filed 10-5-09; 8:45 am]

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