E8-17136. Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.