
[Federal Register: October 28, 2009 (Volume 74, Number 207)]
[Notices]               
[Page 55564-55565]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc09-70]                         

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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]

BILLING CODE 4160-01-S
