[Federal Register: July 25, 2008 (Volume 73, Number 144)]
[Notices]
[Page 43453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jy08-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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: The Board advises the Director,
NCTR, in establishing, implementing and evaluating the research
programs that assist the Commissioner of Food and Drugs in fulfilling
his responsibilities. The Board provides an extra-agency review in
ensuring that the research programs at NCTR are scientifically sound
and pertinent.
Date and Time: The meeting will be held on August 12, 2008, from
8:30 a.m. to 4:30 p.m. and on August 13, 2008, from 8 a.m. to 1 p.m.
Location: August 12, 2008, NCTR SAB Conference Room B-12, 3900 NCTR
Dr., Jefferson, AR 72079. August 13, 2008, University of Arkansas for
Medical Sciences, Stevens Spine Center, Hamlin Board Room, 501 Jack
Stevens Dr., Little Rock, AR 72205.
Contact Person: Margaret Miller, Designated Federal Official,
National Center for Toxicological Research (HFT-10), Food and Drug
Administration, 5600 Fishers Lane, rm. 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 August 12, 2008, the SAB will hear presentations from
the NCTR Divisions that will update them on ongoing research
activities. The SAB will be presented with the responses to two
evaluations, one of the Division of Microbiology and one of the
Division of Biochemical Toxicology. The evaluation of the Division of
Microbiology was the product of an on-site review visit conducted of
the Division in August 2007. The evaluation of the Division of
Biochemical Toxicology was the product of an on-site review in April
2008. The responses will address the issues raised and recommendations
made by the site visit teams. On August 13, 2008, the NCTR Director
will provide a Center-wide update on scientific endeavors and will
discuss the NCTR realignment and strategic focus.
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
link.
Procedure: On August 12, 2008, from 8:30 a.m. to 4:30 p.m., and
August 13, 2008, from 8 a.m. to 10:30 a.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 August 5,
2008. Oral presentations from the public will be scheduled on August
12, 2008, 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 August 1, 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 August 4, 2008.
Closed Committee Deliberations: On August 13, 2008, from
approximately 11 a.m. to 1 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 issues related to
personnel progress and promotion.
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 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: July 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17136 Filed 7-24-08; 8:45 am]
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