Document ID: FDA-2012-N-0001-0045
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee Meeting
Posted Date: 2012-04-02T04:00Z

[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Page 19673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7765]

[[Page 19673]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-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 May 7, 2012, from 8 a.m. 
to 5:30 p.m. and May 8, 2012, from 8:30 a.m. to 11:30 a.m.
    Location: Hilton Rockville Executive Meeting Center, 1750 Rockville 
Pike, Rockville, MD 20852.
    Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics, 
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), 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: On May 7, 2012, 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 Differin Lotion (adapalene), Dulera Inhalation Aerosol (mometasone 
furoate and formotorol fumarate), MultiHance Injection (gadobenate 
dimeglumine), Nasonex (mometasone furoate monohydrate), Natazia 
(estradiol valerate and estradiol valerate/dienogest), Omnaris Nasal 
Spray (ciclesonide), Protonix (pantoprazole), Tamiflu (oseltamivir 
phosphate), Taxotere (docetaxel) and Viread (tenofovir disoproxil 
fumarate). The committee will also receive an Informational Update on 
FDA's KidNet pilot study.
    On May 8, 2012, the Pediatric Advisory Committee will meet 
regarding the pediatric-focused safety reviews, as mandated by the 
Pediatric Research Equity Act, for Gardasil Human Papillomavirus 
Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant, Isopto Carpine 
(pilocarpine hydrochloride), Menveo Meningococcal (Group A,C,Y, and W-
135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Zylet 
(loteprednol etabonate and tobramycin) and Zymaxid (gatifloxacin).
    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 
April 30, 2012. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12:30 p.m. on May 7, 2012. 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 20, 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 April 23, 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: March 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-7765 Filed 3-30-12; 8:45 am]
BILLING CODE 4160-01-P