Notice2021-19436
Allergenic Products 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
September 9, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) announces a forthcoming public advisory committee meeting of the Allergenic Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference. At least one portion of the meeting will be closed to the public.
Full Text
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<title>Federal Register, Volume 86 Issue 172 (Thursday, September 9, 2021)</title>
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[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50540-50541]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19436]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Allergenic Products 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 the Agency) announces
a forthcoming public advisory committee meeting of the Allergenic
Products Advisory Committee. The general function of the committee is
to provide advice and recommendations to the Agency on FDA's regulatory
issues. Members will participate via teleconference. At least one
portion of the meeting will be closed to the public.
DATES: The meeting will be held on October 28, 2021, from 9:30 a.m. to
1:20 p.m. EST.
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. The online
web conference meeting will be available at the following link on the
day of the meeting: <a href="https://youtu.be/OHRWDuihDns">https://youtu.be/OHRWDuihDns</a>.
FOR FURTHER INFORMATION CONTACT: Kathleen Hayes or Monique Hill, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave. Bldg. 71, Rm. 6306, Silver Spring, MD 20993-
0002, via email at <a href="/cdn-cgi/l/email-protection#a4e7e6e1f6f2f6e6f4e5e7e4c2c0c58accccd78ac3cbd2"><span class="__cf_email__" data-cfemail="c08382859296928290818380a6a4a1eea8a8b3eea7afb6">[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 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. On October
28, 2021, the committee will meet in open session to hear an overview
of the research programs in the Laboratory of Immunobiochemistry (LIB),
Division of Bacterial, Parasitic and Allergenic Products (DBPAP),
Office of Vaccines Research and Review (OVRR), Center for Biologics
Evaluation and Research (CBER).
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 <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.
Procedure: On October 28, 2021, from 9:30 a.m. to 12:20 p.m., 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 October 13, 2021. Oral presentations from the public will be
scheduled between approximately 11:20 a.m. to 12:20 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
October 13, 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
[[Page 50541]]
person will notify interested persons regarding their request to speak
by October 14, 2021.
Closed Committee Deliberations: On October 28, 2021, from 12:20
p.m.to 1:20 p.m., 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)). The recommendations of the advisory
committee regarding the progress of the individual investigator's
research programs, along with other information, will be discussed
during this session. We believe that public discussion of these
recommendations on individual scientists would constitute an
unwarranted invasion of personal privacy.
For press inquiries, please contact the Office of Media Affairs at
<a href="/cdn-cgi/l/email-protection#791f1d18161418391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="c4a2a0a5aba9a584a2a0a5eaacacb7eaa3abb2">[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 Kathleen Hayes (<a href="/cdn-cgi/l/email-protection#e4a7a6a1b6b2b6a6b4a5a7a4828085ca8c8c97ca838b92"><span class="__cf_email__" data-cfemail="d59697908783879785949695b3b1b4fbbdbda6fbb2baa3">[email protected]</span></a>) 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/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings">https://www.fda.gov/advisory-committees/about-advisory-committees/public-conduct-during-fda-advisory-committee-meetings</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: September 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19436 Filed 9-8-21; 8:45 am]
BILLING CODE 4164-01-P
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