Notice2022-03366
Cellular, Tissue and Gene Therapies 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
February 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. 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 32 (Wednesday, February 16, 2022)</title>
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[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8850-8851]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03366]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0008]
Cellular, Tissue and Gene Therapies Advisory Committee; Notice of
Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Cellular, Tissue, and Gene
Therapies Advisory Committee. The general function of the committee is
to provide advice and recommendations to the Agency on FDA's regulatory
issues. At least one portion of the meeting will be closed to the
public.
DATES: The meeting will be held virtually on March 10, 2022, from 10
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/silb2C_Ro8I">https://youtu.be/silb2C_Ro8I</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#fb988f9c8f9a98bb9d9f9ad5939388d59c948d"><span class="__cf_email__" data-cfemail="ef8c9b889b8e8caf898b8ec187879cc1888099">[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 March 10,
[[Page 8851]]
2022, for Topic I, the committee will meet in open session to hear an
overview of the research programs in the Gene Transfer and
Immunogencity Branch, Division of Cellular and Gene Therapies, Office
of Tissues and Advanced Therapies, Center for Biologics Research. After
the Topic I 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 March 10, 2022, from 10 a.m. to 12:40 p.m. Eastern
Time, the meeting is open to the public for Topic I. 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 March 3, 2022. Oral presentations from
the public will be scheduled between approximately 11:40 a.m. and 12:40
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 February 23, 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 February
24, 2022.
Closed Committee Deliberations: On March 10, 2022, from 12:40 p.m.
to 1:30 p.m. Eastern Time for Topic I, 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#9afcfefbf5f7fbdafcfefbb4f2f2e9b4fdf5ec"><span class="__cf_email__" data-cfemail="b4d2d0d5dbd9d5f4d2d0d59adcdcc79ad3dbc2">[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#c1a2b5a6b5a0a281a7a5a0efa9a9b2efa6aeb7"><span class="__cf_email__" data-cfemail="690a1d0e1d080a290f0d084701011a470e061f">[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: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03366 Filed 2-15-22; 8:45 am]
BILLING CODE 4164-01-P
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