[Federal Register Volume 79, Number 196 (Thursday, October 9, 2014)]
[Pages 61082-61083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-24039]



Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Science Advisory Board to the National Center for Toxicological 
Research Advisory Committee; 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 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, 
AR 72079.
    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

[[Page 61083]]

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).

    Date: September 30, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-24039 Filed 10-8-14; 8:45 am]