Document ID: FDA-2010-N-0001-0138
Agency: fda
Document Type: Notice
Title: Meetings: Pediatric Advisory Committee
Posted Date: 2010-11-02T04:00Z

[Federal Register: November 2, 2010 (Volume 75, Number 211)]
[Notices]               
[Page 67378-67379]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02no10-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No FDA-2010-N-0001]

 
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.
    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 December 7, 2010, from 8 
a.m. to 6 p.m.
    Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd., Bethesda, 
MD 20814.
    Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics, 
Office of Special Medical Programs, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg 32, rm. 5154, 
Silver Spring, MD 20993, 301-796-0885, 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: 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 Prevista (darunavir ethanolate), PegIntron (peginterferon alfa-2b), 
Xyzal (levocetirizine dihydrochloride) tablet and solution, Flovent HFA 
(fluticasone propionate), Acanya Gel (clindamycin/benzoyl peroxide 
combination), Epiduo Gel (adapalene and benzoyl peroxide), Ulesfia 
Lotion 5% (benzyl alcohol), Axert (almotriptan), Gardasil (human 
papillomavirus quadrivalent types 6, 11, 16, 18, vaccine recombinant), 
Lamictal and Lamictal XR (lamotrigine), and Neulasta (pegfilgrastim). 
The committee will also receive a followup on Depakote ER (divalproex 
sodium). Committee members who participated in the Cardiovascular and 
Renal Drugs Advisory Committee and the Gastrointestinal Drugs Advisory 
Committee meetings held on July 29, 2010, and November 5, 2010, 
respectively, will provide a brief summary of the meetings.
    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 
November 29, 2010. 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

[[Page 67379]]

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 November 18, 2010. 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 November 
19, 2010.
    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 Walter Ellenberg 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 27, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27539 Filed 11-1-10; 8:45 am]
BILLING CODE 4160-01-P