[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Page 57569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22918]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Science Advisory Board to the National Center for Toxicological
Research; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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]
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