[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Pages 8850-8851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03366]



Food and Drug Administration

[Docket No. FDA-2022-N-0008]

Cellular, Tissue and Gene Therapies Advisory Committee; Notice of 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 

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: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. The online web conference meeting will be available at 
the following link on the day of the meeting: https://youtu.be/silb2C_Ro8I.

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, [email protected], 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 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 joining 
the meeting.

    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 
https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. 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 
[email protected] 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 [email protected] (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 https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm 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]