|NCTR||January 29, 2014|
January 30, 2014
|8:45 a.m. - 5:30 p.m.|
8:00 a.m. - 2:00 p.m.
NCTR SAB Conference Room B-12,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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 January 29, 2014, from 8:45 a.m. to 5:30 p.m. and on January 30, 2014, from 8 a.m. to 2 p.m.
Location: NCTR SAB Conference Room B-12, 3900 NCTR Rd., Jefferson, AR 72079.
Contact Person: 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), to find out further information regarding FDA advisory committee information. 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.htm1 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 January 29, 2014, 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 be presented with an overview of the Division of Microbiology Subcommittee and the Subcommittee Site Visit Report. Following the public session, the SAB will hear an update from each of NCTR's research Division's the Office of Science Coordination, followed by a report from the National Toxicology Program of the National Institutes of Environmental Health Sciences on current and future collaboration.
On January 30, 2014, the Arkansas Bioinformatics Consortium will present concepts and ideas on defining and meeting NCTR and FDA's scientific computing needs and discuss how it can partner with FDA to foster the development of collaborative efforts in this area. To facilitate the discussion representatives from each of the product centers will discuss their bioinformatic needs, how those needs are being addressed and areas of possible collaboration.
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.htm2. Scroll down to the appropriate advisory committee meeting link.
Procedure: On January 29, 2014, from 8:45 a.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 January 21, 2014. 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 January 13, 2014. 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 January 14, 2014.
Closed Committee Deliberations: On January 30, 2014, from 11 a.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.htm3 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: December 17, 2013
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.