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###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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 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:                         *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,                         *ctgtac@fda.hhs.gov,*                         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.                    

# SUPPLEMENTARY INFORMATION:

*Agenda:*                     The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On March 10,                           ( print 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                     *fdaoma@fda.hhs.gov*                     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                     *ctgtac@fda.hhs.gov*                     (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]

BILLING CODE 4164-01-P