[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Pages 67525-67526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27118]



Food and Drug Administration

[Docket No. FDA-2008-N-0578]

Pediatric Ethics Subcommittee; 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 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]a@fda.hhs.gov 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 
    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 
    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: November 5, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-27118 Filed 11-13-08; 8:45 am]