[Federal Register Volume 73, Number 221 (Friday, November 14, 2008)]
[Notices]
[Pages 67524-67525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-27117]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0578]
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 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][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 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
the
[[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
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. E8-27117 Filed 11-13-08; 8:45 am]
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