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Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On March 10, 2022, for Topic I, the committee will meet in open session to hear an overview of the research programs in the Gene Transfer and Immunogenicity Branch (GTIB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Research (CBER). After the Topic I open session, the meeting will be closed to the public for committee deliberations.
Meeting Materials
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.
Materials for this meeting will be available at the Cellular, Tissue, and Gene Therapies Advisory Committee meeting main page.
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.
Public Participation Information
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.
- On March 10, 2022, oral presentations from the public will be scheduled between approximately 11:40 a.m. and 12:40 p.m. Eastern Time for Topic I.
Those individuals interested in making 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.-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 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.
Webcast Information
CBER plans to provide a free of charge, live webcast of the Cellular, Tissue, and Gene Therapies Advisory Committee meeting. If there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible.
The online web conference meeting will be available at the following links:
