[Federal Register Volume 88, Number 21 (Wednesday, February 1, 2023)]
[Notices]
[Page 6762]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02095]
[[Page 6762]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0217]
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 (NCTR). At least one portion of the meeting will be closed to
the public.
DATES: The meeting will be held on April 4, 2023, from 9 a.m. to 6:55
p.m. Eastern Time and April 5, 2023, from 9 a.m. to 12:30 p.m. Eastern
Time.
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://fda.zoomgov.com/j/1608491479?pwd=cStKYmZUdDB5RjR1YWZCTW1kcDY2dz09.
Passcode: v0W1q#.
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 April 4, 2023, 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 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 the Office of Regulatory Affairs will
each briefly discuss their specific research strategic needs and
potential areas of collaboration.
On April 5, 2023, 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 Science Advisory Board members can discuss personnel
issues at NCTR.
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 April 4, 2023, from 9 a.m. to 6:55 p.m. Eastern Time
and April 5, 2023, from 9 a.m. to 12:30 p.m. Eastern Time, 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 March 28, 2023. Oral presentations from the public will be
scheduled between approximately 2 p.m. to 3 p.m. Eastern Time. 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
March 20, 2023. 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 March 21, 2023.
Closed Committee Deliberations: On April 5, 2023, from 2 p.m. to 3
p.m. Eastern Time, 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.
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: January 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02095 Filed 1-31-23; 8:45 am]
BILLING CODE 4164-01-P