Notice2021-19686
Blood 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 13, 2021
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 Blood 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 174 (Monday, September 13, 2021)</title>
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[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Notices]
[Pages 50885-50886]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19686]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0008]
Blood 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 Agency) announces a
forthcoming public advisory committee meeting of the Blood 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 November 4, 2021, from 9:30 a.m. to
5:20 p.m. Eastern Time.
ADDRESSES: Please note that due to the impact of the 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/2Xz4YzkwNDs">https://youtu.be/2Xz4YzkwNDs</a>.
FOR FURTHER INFORMATION CONTACT: Christina Vert or Joanne Lipkind,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver
Spring, MD 20993-0002, 240-402-8054, <a href="/cdn-cgi/l/email-protection#63200b110a10170a0d024d35061117230507024d0b0b104d040c15"><span class="__cf_email__" data-cfemail="71321903180205181f105f27140305311715105f1919025f161e07">[email protected]</span></a>, or
240-402-8106, <a href="/cdn-cgi/l/email-protection#a0eacfc1cecec58eecc9d0cbc9cec4e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="cc86a3ada2a2a9e280a5bca7a5a2a88caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a>, respectively, 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 November
4, 2021, for Topic I, the committee will meet in open session to hear
an overview of the research programs of the Plasma Derivatives Branch,
Division of Plasma Protein Therapeutics, Office of Tissues and Advanced
Therapies, Center for Biologics Evaluation and Research (CBER). For
Topic II, the committee will meet in open session to hear an overview
of the research programs of the Laboratory of Cellular Hematology,
Division of Blood Components and Devices, Office of Blood Research and
Review (OBRR), CBER. For Topic III, the committee will meet in open
session to hear an overview of the research programs of the Laboratory
of Emerging Pathogens, Division of Emerging & Transfusion Transmitted
Diseases, OBRR, CBER. After the open sessions, the meeting will be
closed to the public for committee deliberations.
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
[[Page 50886]]
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 November 4, 2021, the meeting is open to the public,
from 9:30 a.m. to 11:30 a.m. for Topic I; 12:50 p.m. to 2:10 p.m. for
Topic II; and 3:10 p.m. to 4:30 p.m. for Topic III. Interested persons
may present data, information, or views, orally or in writing, on
issues pending before the committee. Written submissions may be
submitted to the contact person on or before October 28, 2021. Oral
presentations from the public will be scheduled between approximately
11:10 a.m. and 11:30 a.m. for Topic I; 1:50 p.m. and 2:10 p.m. for
Topic II; and 4:10 p.m. and 4:30 p.m. for Topic III. 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 20, 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 October 21, 2021.
Closed Committee Deliberations: On November 4, 2021, from 11:30
a.m. to 12:20 p.m. for Topic I; 2:10 p.m. to 3 p.m. for Topic II; and
4:30 p.m. to 5:20 p.m. for Topic III, 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#a7c1c3c6c8cac6e7c1c3c689cfcfd489c0c8d1"><span class="__cf_email__" data-cfemail="325456535d5f53725456531c5a5a411c555d44">[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 Christina Vert (<a href="/cdn-cgi/l/email-protection#4406140507042220256a2c2c376a232b32"><span class="__cf_email__" data-cfemail="5d1f0d1c1e1d3b393c7335352e733a322b">[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 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19686 Filed 9-10-21; 8:45 am]
BILLING CODE 4164-01-P
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