[Federal Register Volume 83, Number 211 (Wednesday, October 31, 2018)]
[Notices]
[Pages 54756-54757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[[Docket No. FDA-2018-N-3844]


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 or Agency) 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 research being conducted at the NCTR. 
At least one portion of the meeting will be closed to the public.

DATES: The meeting will be held on December 4, 2018, from 8:00 a.m. to 
5:45 p.m., and on December 5, 2018, from 8:00 a.m. to 11:30 a.m.

ADDRESSES: Heifer Village, 1 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.

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 website at https://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 December 4, 2018, the SAB Chairperson 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 SAB 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 December 5, 2018, there will be a statement given by the FDA 
Chief Scientist. The Center for Biologics and Evaluation and Research, 
Center for Drug Evaluation and Research, Center for Devices and 
Radiological Health, Center for Food Safety and Applied Nutrition, and 
the Center for Tobacco Products 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 website 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 website 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 December 4, 2018, from 8:00 a.m. to 5:45 p.m., and 
December 5, 2018, from 8:00 a.m. to 11:30 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 November 27, 
2018. Oral presentations

[[Page 54757]]

from the public will be scheduled between approximately 1:15 p.m. and 
2:15 p.m. on December 4, 2018. 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 November 19, 2018. 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 November 19, 2018.
    Closed Committee Deliberations: On December 4, 2018, from 5:45 p.m. 
to 6:00 p.m., and December 5, 2018, from 11:30 a.m. to 12:00 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 
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 website 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: October 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23742 Filed 10-30-18; 8:45 am]
 BILLING CODE 4164-01-P


