[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Notices]
[Pages 67525-67526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27118]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0578]
Pediatric Ethics Subcommittee; 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 Tuesday, December 9,
2008, from 9 a.m. to 3 p.m.
Location: The Legacy Hotel & Meeting Centre, 1775 Rockville Pike,
Rockville, MD 20852.
Contact Person: Carlos Pe[ntilde]a, 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, or by 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 hot line/phone line to learn
about possible modifications before coming to the meeting.
Agenda: On December 9, 2008, the Pediatric Ethics Subcommittee
(subcommittee) of the Pediatric Advisory Committee will meet to discuss
a referral by an Institutional Review Board (IRB) of a clinical
investigation that involves both an FDA regulated product and research
involving children as subjects that is conducted or supported by DHHS.
The clinical investigation is entitled ``Children's Oncology Group
Protocol ASCT0631: A Phase III Randomized Trial of Granulocyte Colony
Stimulating Factor (G-CSF) Stimulated Bone Marrow vs. Conventional Bone
Marrow as a Stem Cell Source in Matched Sibling Donor
Transplantation.'' Because the clinical investigation would be
regulated by FDA, and conducted or supported by the DHHS, both FDA and
the Office for Human Research Protections, DHHS, will participate in
the meeting.
After presentation of an overview of the IRB referral process,
background information on the use of G-CSF stimulated bone marrow in
stem cell transplantation, an overview of the protocol and the
referring IRB's deliberations on the protocol, and a summary of public
comments received concerning whether the protocol should proceed, the
subcommittee will discuss the proposed protocol and develop a
recommendation regarding whether the protocol should proceed. The
subcommittee's recommendation will then be presented to the FDA
Pediatric Advisory Committee on December 9, 2008; the announcement of
the December 9, 2008, Pediatric Advisory Committee meeting can be found
elsewhere in this issue of the Federal Register.
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 subcommittee.
Written submissions may be made to the contact person on or before
December 2, 2008. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on December 9, 2008. Those
desiring to make formal oral presentations should notify the contact
[[Page 67526]]
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 November 24, 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. The contact person will notify interested
persons regarding their request to speak by November 25, 2008.
Electronic comments should be submited to http://www.regulations.gov. Select Docket No. FDA-2008-N-0578 entitled ``G-CSF
Stimulated Bone Marrow IRB Referral'' and follow the prompts to submit
your statement. Written comments should be submitted to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Please submit comments by
4:30 p.m. on December 2, 2008. Received comments may be viewed at
http://www.regulations.govor may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
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: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-27118 Filed 11-13-08; 8:45 am]
BILLING CODE 4160-01-S