[Federal Register: March 19, 2007 (Volume 72, Number 52)]
[Notices]
[Page 12806-12807]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr07-68]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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. 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
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written
[[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,
2007.
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 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]
BILLING CODE 4160-01-S