Notice2022-22612
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
October 18, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) 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 related to blood and products derived from blood. At least one portion of the meeting will be closed to the public.
Full Text
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<title>Federal Register, Volume 87 Issue 200 (Tuesday, October 18, 2022)</title>
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[Federal Register Volume 87, Number 200 (Tuesday, October 18, 2022)]
[Notices]
[Page 63077]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-22612]
[[Page 63077]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-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, Agency, or we)
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 related to blood and products derived from blood. At least one
portion of the meeting will be closed to the public.
DATES: The meeting will be held virtually on December 8, 2022, from
9:30 a.m. to 1:30 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. 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>. The online web conference meeting will be available at
the following link on the day of the meeting: <a href="https://youtu.be/AQhF3AM_ssg">https://youtu.be/AQhF3AM_ssg</a>.
FOR FURTHER INFORMATION CONTACT: Christina Vert or Tonica Burke, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 1244, Silver Spring, MD 20993-
0002, 240-402-8054, <a href="/cdn-cgi/l/email-protection#f8bbbabdaabaa8b9bbb89e9c99d690908bd69f978e"><span class="__cf_email__" data-cfemail="541716110616041517143230357a3c3c277a333b22">[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 FDA'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 joining
the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On December
8, 2022, the committee will meet in open session to hear an overview of
the research programs of the Laboratory of Emerging Pathogens and the
Laboratory of Molecular Virology, Division of Emerging and Transfusion
Transmitted Diseases, Office of Blood Research and Review, Center for
Biologics Evaluation and Research. After the open session, 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 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: On December 8, 2022, from 9:30 a.m. to 12:35 p.m.
Eastern Time, 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 December 1, 2022. Oral presentations from
the public will be scheduled between approximately 11:35 a.m. and 12:35
p.m. Eastern Time. 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 November 17, 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 November
18, 2022.
Closed Committee Deliberations: On December 8, 2022, from 12:35
p.m. to 1:30 p.m. Eastern Time, 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
investigators' 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#37515356585a5677515356195f5f4419505841"><span class="__cf_email__" data-cfemail="ee888a8f81838fae888a8fc086869dc0898198">[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 at <a href="/cdn-cgi/l/email-protection#befdfcfbecfceefffdfed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="98dbdaddcadac8d9dbd8fefcf9b6f0f0ebb6fff7ee">[email protected]</span></a> (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: October 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-22612 Filed 10-17-22; 8:45 am]
BILLING CODE 4164-01-P
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