[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57742-57743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23413]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4657]


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 to the 
National Center for Toxicological Research. The general function of the 
committee is to provide advice and recommendations to the Agency on 
research being conducted at the National Center for Toxicological 
Research. At least one portion of the meeting will be closed to the 
public.

DATES: The meeting will be held on December 3, 2019 from 8 a.m. to 5:55 
p.m., and on December 4, 2018 from 8 a.m. to 11:30 a.m.

ADDRESSES: Heifer Village, 1 World Ave., 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 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 INFORMATON: Agenda: On December 3, 2019, the Science 
Advisory Board 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 Science Advisory Board 
will be presented with an overview of the Science Advisory Board 
Subcommittee Site Visit Report and a response to this review. 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, the Center for Tobacco 
Products and the Office of Regulatory Affairs will each briefly discuss 
their specific research strategic needs and potential areas of 
collaboration.
    On December 4, 2019, there will be updates from the NCTR Research 
Divisions and a public comment session. Following an open discussion

[[Page 57743]]

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 the 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 3, 2019, from 8 a.m. to 5:55 p.m., and 
December 4, 2019, from 8 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 26, 
2019. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on December 3, 2019. 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 18, 2019. 
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, 2019.
    Closed Committee Deliberations: On December 4, 2019, 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 14 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 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23413 Filed 10-25-19; 8:45 am]
 BILLING CODE 4164-01-P


