Notice2022-10697
Science Board to the Food and Drug Administration Advisory Committee; Notice of Meeting
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 96 (Wednesday, May 18, 2022)</title>
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[Federal Register Volume 87, Number 96 (Wednesday, May 18, 2022)]
[Notices]
[Pages 30226-30227]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm</a>.
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
<a href="https://www.fda.gov/AdvisoryCommittees/default.htm">https://www.fda.gov/AdvisoryCommittees/default.htm</a> 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
<a href="https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm">https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm</a>. 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 <a href="https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm">https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm</a> 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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