[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Pages 67524-67525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27117]



Food and Drug Administration

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

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 (DHHS), when that research is also regulated by the FDA.
    Date and Time: The meeting will be held on Tuesday, December 9, 
2008, from 3:30 p.m. to 6 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 Advisory Committee will 
hear and discuss the recommendation of the Pediatric Ethics 
Subcommittee from its meeting on December 9, 2008, regarding a referral 
by an Institutional Review Board of a clinical investigation that 
involves both an FDA-regulated product and research involving children 
as subjects that is conducted or supported by DHHS.
    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 

[[Page 67525]]

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 
December 2, 2008. Oral presentations from the public will be scheduled 
between approximately 4 p.m. and 5 p.m. on December 9, 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 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 submitted 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 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.gov, or 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. E8-27117 Filed 11-13-08; 8:45 am]