[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46497-46498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21440]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-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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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Science Advisory Board (SAB) 
to the National Center for Toxicological Research (NCTR). The general 
function of the committee is to provide advice and recommendations to 
the Agency on FDA's regulatory issues. At least one portion of the 
meeting will be closed to the public.

DATES: The meeting will be held on November 6, 2017, from 8 a.m. to 5 
p.m., and on November 7, 2017, from 8 a.m. to 11:20 a.m.

ADDRESSES: Heifer Village, One World Avenue, Little Rock, AR 72202. 
Answers to commonly asked questions including information regarding 
special accommodations due to a disability, visitor parking, and 
transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm and https://www.heifer.org/what-you-can-do/experience-heifer/heifer-village/index.html.

FOR FURTHER INFORMATION CONTACT: Donna Mendrick, National Center for 
Toxicological Research, 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 https://

[[Page 46498]]

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.

SUPPLEMENTARY INFORMATION: 
    Agenda: On November 6, 2017, 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 Systems 
Biology Subcommittee and the Subcommittee Site Visit Report and a 
response to this review. There will be updates from the NCTR Research 
Divisions and a public comment session.
    On November 7, 2017, the Center for Biologics and Evaluation and 
Research, Center for Drug Evaluation and Research, Center for Devices 
and Radiological Health, Center for Tobacco Products, Center for 
Veterinary Medicine, and the Office of Regulatory Affairs will each 
briefly discuss their center-specific research strategic needs and 
potential areas of collaboration.
    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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On November 6, 2017, from 8 a.m. to 5 p.m., and November 
7, 2017, from 8 a.m. to 11:20 a.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 30, 2017. Oral 
presentations from the public will be scheduled on November 6, 2017, 
between approximately 1:15 p.m. to 2:15 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 23, 2017. 
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 30, 2017.
    Closed Committee Deliberations: On November 6, 2017, from 5 p.m. to 
5:30 p.m., and November 7, 2017, from 11:20 a.m. to 12 noon, 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 
disabilities. If you require 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 https://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 29, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21440 Filed 10-4-17; 8:45 am]
BILLING CODE 4164-01-P