[Federal Register Volume 74, Number 207 (Wednesday, October 28, 2009)]
[Notices]
[Pages 55564-55565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25941]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Science Advisory Board to the National Center for Toxicological
Research 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). At least one
portion of the meeting will be closed to the public.
Name of Committee: Science Advisory Board (SAB) to the National
Center for Toxicological Research (NCTR).
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 17, 2009, from
8:15 a.m. to 5 p.m. and on November 18, 2009, from 8:15 a.m. to 2 p.m.
Location: NCTR SAB Conference Room B-12, 3900 NCTR Dr., Jefferson,
AR 72079.
Contact Person: Margaret Miller, Designated Federal Official (DFO),
National Center for Toxicological Research (HFT-10), Food and Drug
Administration, 5600 Fishers Lane, Room 9C-05, Rockville, MD 20857,
301-827-6693, or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area), code 301-451-2559.
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 November 17, 2009, the NCTR Director will provide a
Center-wide update on scientific endeavors and discuss prioritization,
alignment, and the strategic focus of NCTR. The SAB will be presented
with responses to the evaluations of the Division of Systems Toxicology
and the Division of Genetic and Reproductive Toxicology. The
evaluations were the product of an on-site review of the Division of
Systems Toxicology in February 2009 and the Division of Genetic and
Reproductive Toxicology in July 2009, and will address the issues
raised and recommendations made by the site visit teams. On November
18, 2009, the SAB will be presented with the Division of Personalized
Nutrition and Medicine site visit report. This report is the product of
a site review of the Division of Personalized Nutrition and Medicine in
August 2009 and will address the issues and recommendations made by the
site visit teams.
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/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Procedure: On November 17, 2009, from 8:15 a.m. to 5 p.m., and
November 18, 2009, from 8:15 a.m. to 1 p.m., the meeting is open to the
public. 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 November 16,
2009. Oral presentations from the public will be scheduled November 17,
2009, between approximately 12:30 p.m. to 1:30 p.m. 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 12, 2009. 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 13, 2009.
Closed Committee Deliberations: On November 18, 2009, from
approximately 1 p.m. to 2 p.m., the meeting will be closed to permit
discussion where disclosure would constitute a clearly unwarranted
invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the
meeting will be closed to permit discussion of information
[[Page 55565]]
concerning individuals associated with the research programs at NCTR.
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 Margaret Miller
(Contact Person) 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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: October 23, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25941 Filed 10-27-09; 8:45 am]
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