This PDF is the current document as it appeared on Public Inspection on 09/17/2012 at 08:45 am.
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 23, 2012, from 8:45 a.m. to 5 p.m. and on October 24, 2012, from 8 a.m. to 12 p.m.
Location: NCTR SAB Conference Room B-12, 3900 NCTR Rd., Jefferson, AR 72079.
Contact Person For More Information: Margaret Miller, 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). 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 at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Agenda: On October 23, 2012, the NCTR Director will welcome the participants and provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will then briefly review an update of research activities of the Division of Neurotoxicology. The SAB will be presented with the NanoCore Subcommittee report, and will provide a response to that report. The SAB will review and update of the research activities of the Division of Genetic and Molecular Toxicology.
Following the public session, the SAB will hear an update from the Office of Science Coordination, followed by a report from the National Toxicology Program on current and future collaboration.
The Center for Biological Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, Center for Tobacco Products, and the Center for Food Safety and Applied Nutrition will each briefly discuss their center-specific research strategic needs.
On October 24, 2012, the Director of the Center for Food Safety and Applied Nutrition will update the SAB on their research needs, and discuss opportunities for collaboration to help address these needs.
The SAB will discuss an overview of research activities from the NCTR Division of Bioinformatics and Computational Biology and the Division of Systems Biology. The SAB will also receive and update from the subcommittee on Immunotoxicology.
Following an open discussion of all the information presented, the open session of the meeting will close so that SAB members can discuss personnel issues at NCTR.
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 meeting link.
Procedure: On October 23, 2012, from 8:45 a.m. to 12 p.m. and from 2 p.m. to 5 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 16, 2012. Oral presentations from the public will be scheduled between approximately 12 p.m. to 2 p.m. Those individuals interested in making 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 9, 2012. 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 10, 2012.
Closed Committee Deliberations: On October 24, 2012, from 12 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 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 12, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-22918 Filed 9-17-12; 8:45 am]
BILLING CODE 4160-01-P