2010-23843. 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 : To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time : The meeting will be held on October 19, 2010, from 8:15 a.m. to 5:30 p.m. and on October 20, 2010, from 8:30 a.m. to 1 p.m.

Location : National Center for Toxicological Research, 3900 NCTR Dr., Jefferson, AR 72079, Conference Room B-12.

Contact Person : Margaret Miller, NCTR, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 2208, Silver Spring, MD, 20993-0002, 301-796-8890, 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 October 19, 2010, 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 updates from each of the NCTR divisions on their individual accomplishments and future research plans based on the major items identified in the last subcommittee review. The report of the subcommittee review of the Division of Neurotoxicology will be presented for discussion and adoption by the full Board. On October 20, 2010, the SAB will be presented with and discuss the NCTR Strategic Focus and future direction, and the need for research and potential collaborations. A discussion will be conducted on the organization of the SAB, site visits and SAB assignments.

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 October 19, 2010, from 8:15 a.m. to 5:30 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 October 18, 2010. Oral presentations from the public will be scheduled between approximately 12 p.m. to 1 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 October 8, 2010. 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 October 11, 2010.

Closed Committee Deliberations : On October 20, 2010, from 12 p.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 information 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 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: September 17, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.