[Federal Register Volume 73, Number 76 (Friday, April 18, 2008)]
[Notices]
[Page 21145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8352]
[[Page 21145]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Pediatric Ethics Subcommittee of the 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 Ethics Subcommittee of the Pediatric
Advisory Committee.
General Function of the Committee: To provide advice and
recommendations to the Pediatric Advisory Committee on FDA and certain
Department of Health and Human Services (DHHS) regulatory issues.
Date and Time: The meeting will be held on June 9, 2008, from 8:30
a.m. to 5:30 p.m. and June 10, 2008, from 8 a.m. to 1 p.m.
Location: Holiday Inn /Gaithersburg, The Ballroom, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Carlos Pe[ntilde]a, 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.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 hotline/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On June 9, 2008, the Pediatric Ethics Subcommittee of the
Pediatric Advisory Committee will meet to discuss the application of 21
CFR 50.52 (Clinical investigations involving greater than minimal risk
but presenting the prospect of direct benefit to individual subjects)
to FDA-regulated research. The discussion will be illustrated with
hypothetical case examples of research involving HIV vaccines in
adolescents and controlled trials of inhaled corticosteroids in
children with asthma. On June 10, 2008, the Subcommittee will meet to
discuss the application of 21 CFR 50.52 to FDA-regulated research
illustrated with a hypothetical case example of research using stem
cells for treating periventricular white matter injury in children.
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 2008 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 May
20, 2008. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 1:30 p.m. on June 9, 2008, and between
approximately 8 a.m. and 8:30 a.m. on June 10, 2008. 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 May 13, 2008. 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. Persons making oral presentations should arrive early to be
sure that they are present to make their presentation in case the
schedule advances. The contact person will notify interested persons
regarding their request to speak by May 12, 2008.
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).
Dated: April 10, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-8352 Filed 4-17-08; 8:45 am]
BILLING CODE 4160-01-S