[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Pages 17609-17610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06930]


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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) announces a forthcoming 
virtual 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 virtually on May 11, 2021, from 8 a.m. 
to 5:55 p.m., Central Standard Time, and on May 12, 2021 from 8 a.m. to 
11:30 a.m., Central Standard 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/advisory-committees/about-advisory-committees/common-questions-and-answers-about-fda-advisory-committee-meetings. 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/advisory-committees and scroll 
down to the appropriate advisory committee meeting link, or call the 
advisory committee information line to learn about possible 
modifications before joining the meeting.

SUPPLEMENTARY INFORMATION: 
    Agenda: On May 11, 2021, 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 May 12, 2021, 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 https://collaboration.fda.gov/nctr1000/, and the recording plus transcript will 
be posted on FDA's website after the meeting. Background material is 
available at https://www.fda.gov/advisory-committees/advisory-committee-calendar. Scroll down to the appropriate advisory committee 
meeting link.
    Procedure: On May 11, 2021, from 8 a.m. to 5:55 p.m., Central 
Standard Time, and May 12, 2021, from 8 a.m. to 11:30 a.m., Central 
Standard 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 (see FOR FURTHER INFORMATION CONTACT) on or before 
May 4, 2021. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Central Standard 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 
April 26, 2021. 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 April 27, 2021.
    Closed Committee Deliberations: On May 12, 2021, from 11:30 a.m. to 
12 p.m., Central Standard 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

[[Page 17610]]

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 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings 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: March 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06930 Filed 4-2-21; 8:45 am]
BILLING CODE 4164-01-P


