
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48870-48871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20051]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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.

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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).

[[Page 48871]]

    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 
research divisions.
    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 
link.
    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 
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 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).

    Dated: August 10, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-20051 Filed 8-13-15; 8:45 am]
 BILLING CODE 4164-01-P


