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 3, 2015, from
12:30 p.m. to 5 p.m., and November 4, 2015, from 8 a.m. to 5 p.m.
Location: NCTR SAB, 3900 NCTR Rd., Conference rm. B-12, Jefferson,
AR 72079. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
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 3, 2015, the SAB Chair will welcome the
participants, and the NCTR Director will 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 Biochemistry
Subcommittee and the Subcommittee Site Visit Report. Representatives
from the Office of the Chief Scientist and Office of Medical Products
and Tobacco will discuss research needs and opportunities for
collaborations with NCTR.
On November 4, 2015, the Center for Drug Evaluation and Research,
Center for Devices and Radiological Health, Center for Biologics
Evaluation and Research, Center for Tobacco Products, Center for
Veterinary Medicine, and Office of Regulatory Affairs will each briefly
discuss their Center-specific research strategic needs. Following the
public session, the SAB will hear an update from each of NCTR's
Following an open discussion of all the information presented, the
open session of the meeting will close so the SAB members can discuss
personnel issues at NCTR at the end of each day.
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: On November 3, 2015, from 12:30 p.m. to 5 p.m., and
November 4, 2015, from 8 a.m. to 4:15 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 27,
2015. Oral presentations from the public will be scheduled between
approximately 11:45 a.m. and 12:45 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 19, 2015. 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 20, 2015.
Closed Committee Deliberations: On November 4, 2015, from 4:15 p.m.
to 5 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 discussions 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.