Skip to Content

Notice

Science Advisory Board to the National Center for Toxicological Research Notice of Meeting

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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 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 Start Printed Page 55565concerning 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).

Start Signature

Dated: October 23, 2009.

David Horowitz,

Assistant Commissioner for Policy.

End Signature End Preamble

[FR Doc. E9-25941 Filed 10-27-09; 8:45 am]

BILLING CODE 4160-01-S