[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30226-30227]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0001]


Science Board to the Food and Drug Administration 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 Board to 
the Food and Drug Administration. The Science Board provides advice to 
the Commissioner of Food and Drugs and other appropriate officials on 
specific, complex scientific and technical issues important to FDA and 
its mission, including emerging issues within the scientific community. 
Additionally, the Science Board provides advice to the Agency on 
keeping pace with technical and scientific developments, including in 
regulatory science, input into the Agency's research agenda, and on 
upgrading its scientific and research facilities and training 
opportunities. It will also provide, where requested, expert review of 
Agency-sponsored intramural and extramural scientific research 
programs. The meeting will be open to the public.

DATES: The meeting will be held virtually on June 14, 2022, from 9 a.m. 
to 4 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.

FOR FURTHER INFORMATION CONTACT: Rakesh Raghuwanshi, Office of the 
Chief Scientist, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 1, Rm. 3309, Silver Spring, MD 20993, 301-796-4769, 
<a href="/cdn-cgi/l/email-protection#7624171d13051e582417111e03011718051e1f36101217581e1e0558111900"><span class="__cf_email__" data-cfemail="8ddfece6e8fee5a3dfeceae5f8faece3fee5e4cdebe9eca3e5e5fea3eae2fb">[email protected]</span></a>, 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

[[Page 30227]]

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: The meeting presentations will be heard, viewed, captioned, 
and recorded through an online teleconferencing platform. The Science 
Board to the Food and Drug Administration will consider challenges in 
evaluating the safety of dietary supplement and food ingredients with 
predicted pharmacological activity, utilizing cannabinoids as a case 
study. The Science Board to the Food and Drug Administration will also 
hear about the Agency's enhanced efforts to spur the development, 
qualification, and adoption of new alternative methods for regulatory 
use that can replace, reduce, and refine animal testing and have the 
potential to provide both more timely and more predictive information 
to accelerate product development and enhance emergency preparedness. 
The Science Board to the Food and Drug Administration will also hear 
about the Agency's enhanced efforts to ensure optimal organization, 
infrastructure, and expertise for data science efforts in alignment 
with its regulatory scope and evidence-based decision making, in 
support of FDA's public health priorities.
    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 on FDA's website at 
the time of the advisory committee meeting. Background material and the 
link to the online teleconference meeting room will be available at 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll 
down to the appropriate advisory committee meeting link. The meeting 
will include slide presentations with audio components to allow the 
presentation of materials in a manner that most closely resembles an 
in-person advisory committee meeting.
    Procedure: 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 June 
7, 2022. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 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 June 1, 2022. 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 June 7, 2022.
    For press inquiries, please contact the Office of Media Affairs at 
<a href="/cdn-cgi/l/email-protection#610705000e0c00210705004f0909124f060e17"><span class="__cf_email__" data-cfemail="e38587828c8e82a3858782cd8b8b90cd848c95">[email protected]</span></a> or 301-796-4540.
    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 Rakesh Raghuwanshi (see FOR FURTHER INFORMATION CONTACT) 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: May 13, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-10697 Filed 5-17-22; 8:45 am]
BILLING CODE 4164-01-P


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