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 November 6, 2014, from
8:15 a.m. to 4:15 p.m. and on November 7, 2014, from 8 a.m. to 2 p.m.
Location: NCTR SAB, 3900 NCTR Rd., Conference Room B-12, Jefferson,
Contact Person: Donna Mendrick, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm. 2208, Silver Spring, MD 20993-0002,
301-796-8892, 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 November 6, 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 Divisions, the Office
of Science Coordination, followed by an update on NCTR's Global
On November 7, 2014, the Office of the Chief Scientist will update
the SAB on their research needs, and discuss opportunities for
collaboration to help address these needs, followed by a report from
the National Toxicology Program of the National Institutes of
Environmental Health Sciences on current and future collaboration.
The Center for Biological Evaluation and Research, the Center for
Drug Evaluation and Research, the Center for Devices and Radiological
Health, the Center for Veterinary Medicine, the Center for Tobacco
Products, the Office of Regulatory Affairs, and the Center for Food
Safety and Applied Nutrition will each briefly discuss their Center-
specific research strategic needs.
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
Procedure: 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 30, 2014. Oral presentations from the public will be scheduled
between approximately 12 noon to 1 p.m. on November 6, 2014. 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 22, 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 October 23,
Closed Committee Deliberations: On November 7, 2014, from 12 noon
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
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 Donna Mendrick 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).