Document ID: FDA-2008-N-0038-0054
Agency: fda
Document Type: Notice
Title: Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting
Posted Date: 2008-07-25T04:00Z

[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]

BILLING CODE 4160-01-S