- March 10, 2022
- 10:00 AM - 1:30 PM ET
Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.
The online web conference meeting will be available at the following:
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.
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.
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:
- Christina Vert, by e-mail: firstname.lastname@example.org
- Tonica Burke, by e-mail: email@example.com
- FDA Advisory Committee Information Line:
1-800-741-8138 (301-443-0572 in the Washington, DC area)
Please call the Information Line for up-to-date information on this meeting.
- For press inquiries, please contact the Office of Media Affairs at firstname.lastname@example.org or 301-796-4540.
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 the Cellular, Tissue, and Gene Therapies Advisory Committee’s meeting main page or call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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).
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 the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.
Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.
Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings 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).