
[Federal Register Volume 76, Number 242 (Friday, December 16, 2011)]
[Notices]
[Page 78284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32205]


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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.
    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, January 30, 2012 
from 8 a.m. to 4 p.m. and on Tuesday, January 31, 2012 from 9 a.m. to 
12 noon.
    Location: Hilton Gaithersburg Hotel, 620 Perry Pkwy., Gaithersburg, 
MD 20877. The hotel's phone number is (301) 977-8900.
    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, (301) 796-
8524, email: Walter.Ellenberg@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-(800) 741-8138 ((301) 443-0572 in the Washington, 
DC area), and follow the prompts to the desired center or product 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: 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 Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria 
CRM197 Protein), Cervarix (Human Papillomavirus Bivalent (Types 16 and 
18) vaccine, recombinant, Focalin XR (dexmethylphenidate), Daytrana 
(methylphenidate), Seroquel (quetiapine), Pancreaze (pancrelipase), 
Zenpep (pancrelipase), Creon (pancrelipase), Xerese cream 5%/1% 
(acyclovir and hydrocortisone), Xolair (omalizumab), Benicar 
(olmesartan medoxomil), Atacand (candesartan cilexetil), Mirena 
(levonorgestrel--releasing intrauterine system), Plan B One Step 
(levonorgestrel), and Flomax (tamsulosin).
    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 
January 24, 2012. 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 January 16, 2012. 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 January 17, 2012.
    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: December 6, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-32205 Filed 12-15-11; 8:45 am]
BILLING CODE 4160-01-P


