[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21381-21382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9150]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
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 21382]]
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 Monday, May 16, 2011,
from 8 a.m. to 3 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel's telephone number is 301-
589-5200.
Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics,
Office of the Commissioner, Food and Drug Administration, Bldg. 32, rm.
5154, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
0885, e-mail: [email protected], or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area). 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 May 16, 2011, the Pediatric Advisory Committee will meet
to discuss pediatric-focused safety reviews, as mandated by the Best
Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric
Research Equity Act (Pub. L. 110-85) for Bepreve (bepotastine
besliate), Besivance (besifloxacin hydrochloride), Cetraxal
(ciprofloxacin hydrochloride), Patanase Spray (olopatadine
hydrochloride), Astepro Spray (azelastine hydrocholoride), Crestor
(rosuvastatin calcium), Welchol (colesevelam hydrochloride), Intuniv
(guanfacine), Lexapro (escitalopram oxalate), Actonel (risedronate),
Hiberix [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)],
and Valcyte (valganciclovir). The committee will also receive further
followup on Topical Calcineurin Inhibitors: Elidel (pimecrolimus) and
Protopic (tacrolimus).
The Pediatric Advisory Committee will hear and discuss the
recommendation of the Pediatric Ethics Subcommittee from its meeting on
May 11, 2011, regarding the Institutional Review Board process for
clinical investigations that involve both an FDA regulated product and
research involving children as subjects that is conducted or supported
by HHS. The announcement of the May 11, 2011, Pediatric Ethics
Subcommittee of the Pediatric Advisory Committee meeting can be found
elsewhere in this issue of the Federal Register.
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 May
2, 2011. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
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 April 25, 2011. 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 April 26, 2011.
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: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9150 Filed 4-14-11; 8:45 am]
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