[Federal Register Volume 74, Number 93 (Friday, May 15, 2009)]
[Notices]
[Pages 22941-22942]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-11317]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]


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 Tuesday, June 23, 2009, 
from 8:30 a.m. to 5 p.m.
    Location: Hilton Washington DC/Rockville Executive Meeting Center, 
Plaza Ballroom, 1750 Rockville Pike, Rockville, MD 20852.
    Contact Person: Carlos Pe[ntilde]a, Office of Science and Health 
Coordination, Office of the Commissioner (HF-33), Food and Drug 
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08), 
Rockville, MD 20857, 301-827-3340, or by e-mail: 
carlos.pe[ntilde][email protected] 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: On June 23, 2009, the Pediatric Advisory Committee will 
review and discuss reports by the agency, as mandated by the Best 
Pharmaceuticals for Children Act and the Pediatric Research Equity Act, 
for ALVESCO (ciclesonide), ANDROGEL (testosterone), ASMANEX (mometasone 
furoate), COMBIGAN (brimonidine/timolol), DEPAKOTE (divalproex sodium), 
DERMA-SMOOTHE F/S (fluocinolone acetate), DIOVAN (valsartan), HEPSERA 
(adefovir dipivoxil), INSPRA (eplerenone), MOXATAG (amoxicillin), 
OMNARIS (ciclesonide), and ZOMETA (zoledronic acid).
    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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2009 and 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 June 
9, 2009. 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 June 1, 2009. 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 June 2, 
2009.
    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 Carlos Pe[ntilde]a 
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/oc/advisory/default.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).


[[Page 22942]]


    Dated: May 8, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-11317 Filed 5-14-09; 8:45 am]
BILLING CODE 4160-01-S