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  4. Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement - 05/08/2020 - 05/08/2020
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Advisory Committee Meeting

Event Title
Cellular, Tissue and Gene Therapies Advisory Committee May 8, 2020 Meeting Announcement
May 8, 2020

Scheduled

Date:
May 8, 2020
Time:
1:00 PM - 4:55 PM ET

UPDATED INFORMATION (as of 4/30/2020):

Please note that due to the impact of the COVID-19 public health emergency, to ensure the safety of all participants, the format of the May 8, 2020 meeting of the Cellular, Tissue and Gene Therapies Advisory Committee has been now changed.

As previously announced Official FR Notice, it was scheduled as a combination teleconference where members participate by teleconference and the Public and FDA staff participate in person on the FDA, White Oak Campus, Great Room Conference Center, Silver Spring, MD; It is now changed to an entirely (100%) virtual meeting through Adobe Connect where all meeting participants join via teleconference. The meeting will no longer be webcast from the Great Room. However, the meeting presentations will be heard, viewed, captioned and recorded through Adobe Connect. The open sessions of the meeting including the Open Public Hearing (OPH) of the meeting can be accessed through the Adobe Connect link: https://collaboration.fda.gov/ctgtac050820/

While CBER is working to make the Adobe Connect teleconference run as smoothly as possible, there may be instances where there may be interruptions to the teleconference; staff will work to re-establish the connection as soon as possible.
If you have any questions, please contact Christina Vert, MS, Designated Federal Officer, via e-mail (christina.vert@fda.hhs.gov) or phone (240-402-8054) or Joanne Lipkind, MS, Committee Management Specialist, via e-mail (joanne.lipkind@fda.hhs.gov) or phone (240-402-8106).

Agenda
On May 8, 2020, the committee will meet by teleconference. In open session, the committee will hear an overview and updates of research programs in the Tumor Vaccines and Biotechnology Branch (TVBB) and Cellular and Tissue Therapy Branch (CTTB), Division of Cellular and Gene Therapies (DCGT), Office of Tissues and Advanced Therapies (OTAT), CBER, FDA.

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.

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 May 1, 2020.
  • On May 8, 2020, oral presentations from the public will be scheduled between approximately 2:40 p.m. to 3:40 p.m.

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 April 23, 2020. 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 April 24, 2020.

Closed Committee Deliberations
On May 8, 2020 from 3:55 p.m. to 4:55 p.m., 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 investigator's research will, along with other information, be used in making personnel and staffing decisions regarding individual scientists. We believe that public discussion of these recommendations on individual scientists would constitute an unwarranted invasion of personal privacy.

For those unable to attend in person, the meeting will also be available via webcast.

Webcast Information
CBER plans to provide a free of charge, live webcast of the Cellular, Tissue and Gene Therapies Advisory Committee meeting. While CBER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The link for the webcast (both days) is available for both days at:  https://collaboration.fda.gov/ctgtac050820/.

Contact Information

  • Christina Vert, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, by e-mail: Christina.Vert@fda.hhs.gov or by phone 240-402-8054 or
  • Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6270, Silver Spring, MD  20993-0002, by e-mail: Joanne.Lipkind@fda.hhs.gov; or by phone 240-402-8106
  • 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.

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.

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 physical disabilities or special needs.

If you require special accommodations due to a disability, please contact Christina Vert at least 7 days in advance of the meeting.

Information regarding ground transportation, airport information, lodging, driving directions; visitor parking and security can be accessed at the Public Meetings at White Oak main page.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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).

Official FR Notice

Recorded Webcast
https://collaboration.fda.gov/p97zq9yv66l1/


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).