Document ID: FDA-2020-N-0008-0011
Agency: fda
Document Type: Notice
Title: Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting
Posted Date: 2020-03-16T04:00Z

[Federal Register Volume 85, Number 51 (Monday, March 16, 2020)]
[Notices]
[Page 14951]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05333]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]

Cellular, Tissue, and Gene Therapies Advisory Committee; Notice 
of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming 
public advisory committee meeting of the Cellular, Tissue, and Gene 
Therapies Advisory Committee (CTGTAC). 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 on May 8, 2020, from 1 p.m. to 4:55 
p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. For those 
unable to attend in person, the meeting will also be webcast and will 
be available at the following link: https://collaboration.fda.gov/ctgtac050820/.

FOR FURTHER INFORMATION CONTACT: Christina Vert or Joanne Lipkind, 
Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver 
Spring, MD 20993-0002, 240-402-8054, christina.vert@fda.hhs.gov, or 
240-402-8106, joanne.lipkind@fda.hhs.gov, respectively, 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 the Agency'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 coming to the meeting.

SUPPLEMENTARY INFORMATION: 
    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.
    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. Background material is 
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On May 8, 2020, from 1 p.m. to 3:40 p.m., the meeting is 
open to the public. 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. Oral presentations from the public will be scheduled between 
approximately 2:40 p.m. to 3:40 p.m. 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 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.
    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 Christina Vert (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: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05333 Filed 3-13-20; 8:45 am]
 BILLING CODE 4164-01-P