Science Advisory Board to the National Center for Toxicological Research Advisory Committee; Notice of Meeting
| Published date | 17 July 2020 |
| Citation | 85 FR 43587 |
| Record Number | 2020-15524 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 85 Issue 138 (Friday, July 17, 2020)
[Federal Register Volume 85, Number 138 (Friday, July 17, 2020)]
[Notices]
[Pages 43587-43588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15524]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1647]
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 August 18, 2020, from 8 a.m. to 5:55
p.m. (CST), and on August 19, 2020, from 8 a.m. to 11:30 a.m. (CST).
ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. The meeting will be webcast both
days and will be available at the following link: https://collaboration.fda.gov/nctr1000/.
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 August 18, 2020, 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 SAB Subcommittee Site
Visit Report and a response to this review. The Center for Biologics
Evaluation and Research, Center for Drug Evaluation and Research,
Center for Devices and Radiological Health, Center for Food Safety and
Applied Nutrition, Center for Tobacco Products, and Office of
Regulatory Affairs will each briefly discuss their specific research
strategic needs and potential areas of collaboration.
On August 19, 2020, there will be updates from the NCTR Research
Divisions and a public comment session. 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 the 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 August 18, 2020, from 8 a.m. to 5:55 p.m., and on
August 19, 2020, from 8 a.m. to 11:30 a.m. (CST),
[[Page 43588]]
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 August 11, 2020. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 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 August 3, 2020. 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 August 4, 2020.
Closed Committee Deliberations: On August 18, 2020, from 11:30 a.m.
to 12 p.m. (CST), 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 the NCTR.
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: July 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15524 Filed 7-16-20; 8:45 am]
BILLING CODE 4164-01-P
