Document ID: FDA-2010-D-0281-0017
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee; Notice of Meeting
Posted Date: 2011-04-15T04:00Z

[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21381-21382]
From the Federal Register Online via the Government Printing 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: Walter.Ellenberg@fda.hhs.gov, 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]
BILLING CODE 4160-01-P