[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]
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