[Federal Register: October 7, 2005 (Volume 70, Number 194)]
[Notices]
[Page 58712-58713]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc05-64]
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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 45 CFR 46.407 on research involving children as
subjects that is conducted or supported by the Department of Health and
Human Services (HHS), when that research is also regulated by FDA.
Date and Time: The meeting will be held on Wednesday, November 16,
2005, from 8 a.m. to 6 p.m., and Thursday, November 17, 2005, from 8
a.m. to 5 p.m.
Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy.,
Gaithersburg, MD.
Contact Person: Jan N. Johannessen, Office of Science and Health
Coordination of the Office of the Commissioner (HF-33), Food and Drug
Administration, 5600 Fishers Lane, (for express delivery, rm. 14C-06)
Rockville, MD 20857, 301-827-6687, or by e-mail: jjohannessen@fda.gov
or FDA Advisory 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: On Wednesday, November 16, 2005, the committee will hear
and discuss the recommendation of the Pediatric Ethics Subcommittee
from its meeting on November 15, 2005, regarding a referral by an
Institution Review Board of a proposed clinical investigation involving
children as subjects that is regulated by FDA and is conducted or
supported by the Department of Health and Human Services. The committee
will also discuss pediatric obesity and clinical trial designs for the
evaluation of devices intended to treat pediatric obesity.
On Thursday, November 17, 2005, the committee will continue its
discussion of clinical trial designs for, and ethical issues related
to, the evaluation of devices intended to treat pediatric obesity.
The background material will become available no later than the day
before the meeting and will be posted under the Pediatric Advisory
Committee (PAC) Docket site 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 2005 and scroll down to Pediatric
Advisory Committee meetings.)
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 by November 4,
2005. Oral presentations from the public will be scheduled on
Wednesday, November 16, 2005 between approximately 1:30 p.m. and 2:30
p.m. and Thursday, November 17, 2005, between approximately 9:15 a.m.
and 10:15 a.m. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person by November 4, 2005, 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.
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 Jan Johannessen 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).
[[Page 58713]]
Dated: October 3, 2005.
Jason D. Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-20303 Filed 10-5-05; 11:25 am]
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