[Federal Register Volume 86, Number 172 (Thursday, September 9, 2021)]
[Notices]
[Pages 50540-50541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: https://youtu.be/OHRWDuihDns.

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 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. 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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 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: 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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