[Federal Register Volume 75, Number 211 (Tuesday, November 2, 2010)]
[Notices]
[Pages 67378-67379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27539]
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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]
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