[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Page 57569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22918]



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.


    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 
    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, 
    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 
    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]