[Federal Register: October 7, 2005 (Volume 70, Number 194)]
[Page 58712-58713]
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 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 
    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]