Document ID: FDA-2010-N-0001-0012
Agency: fda
Document Type: Notice
Title: Meetings: Pediatric Advisory Committee
Posted Date: 2010-02-18T05:00Z

[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]               
[Page 7281-7282]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18fe10-42]                         

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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 Monday, March 22, 2010, 
from 8 a.m. to 6 p.m.
    Location: Bethesda Marriott Hotel, 5151 Pooks Hill Rd., Bethesda, 
MD., 20814.
    Contact Person: Doreen Kezer, Office of the Commissioner, Food and 
Drug Administration, 5600 Fishers Lane (HF-33), rm. 14-65, Rockville, 
MD 20857, 301-827-1249, e-mail: Doreen.Kezer@fda.hhs.gov, 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: Anthelios 40, Cardiolite (technetium Tc-99), Nasacort AQ 
(triamcinolone), Viramune

[[Page 7282]]

(nevirapine), Valtrex (valacyclovir), Zmax (azithromycin), Rotarix 
(rotavirus vaccine, live, oral), Kinrix (Diphtheria and Tetanus Toxoids 
and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine), 
Pentacel [Diphtheria and Tetanus Toxoids and Acellular Pertussis 
Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus 
Toxoid Conjugate) Vaccine], and Daptacel (Diphtheria and Tetanus 
Toxoids and Acellular Pertussis Vaccine Adsorbed vaccine). The 
committee will also receive an update on Topical Calcineurin 
Inhibitors: Elidel (pimecrolimus) and Protopic (tacrolimus). Also, the 
committee will receive a brief followup on the FDA Early Communication 
about reports of liver-related adverse events in patients taking 
orlistat (marketed as Alli and Xenical).
    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 
March 8, 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 
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 February 28, 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 March 1, 
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 Doreen Kezer, 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: February 4, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-3024 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S