[Federal Register: March 19, 2007 (Volume 72, Number 52)]
[Page 12806-12807]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Pediatric Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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. The committee 
also advises and makes recommendations to the Secretary of Health and 
Human Services under 21 CFR 50.54 and 45 CFR 46.407 on research 
involving children as subjects that is conducted or supported by the 
Department of Health and Human Services, when that research is also 
regulated by FDA.
    Date and Time: The meeting will be held on April 11, 2007, from 4 
p.m. to 6 p.m.
    Location: Advisory Committee Conference Room, rm. 1066, 5630 
Fishers Lane, Rockville, MD.
    Contact Person: Carlos Pena, 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, e-mail: Carlos.Pena@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.
    Agenda: The Pediatric Advisory Committee will hear and discuss 
reports by the agency, as mandated in section 17 of the Best 
Pharmaceuticals for Children Act, on adverse event reports for 
fluvastatin (LESCOL) and octreotide (SANDOSTATIN). The committee will 
also receive updates to adverse event reports for orlistat (XENICAL) 
and oxybutynin (DITROPAN) which were requested by the Pediatric 
Advisory Committee when the reports were first presented.
    FDA intends to make background material available to the public no 
later than 1 business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 

[[Page 12807]]

submissions may be made to the contact person on or before March 28, 
2007. Oral presentations from the public will be scheduled between 
approximately 4 p.m. to 5 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 by March 20, 2007. 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 pubic hearing session. The contact person will 
notify interested person regarding their request to speak by March 21, 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 notify Carlos Pena at least 
7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 8, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-4877 Filed 3-16-07; 8:45 am]