[Federal Register Volume 73, Number 76 (Friday, April 18, 2008)]
[Page 21145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8352]

[[Page 21145]]



Food and Drug Administration

Pediatric Ethics Subcommittee of the 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 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 
    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 
    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 
    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]