Notice2023-02499
Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal
Primary source
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Published
February 7, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Cellular, Tissue, and Gene Therapies Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the October 28, 2024, expiration date.
Full Text
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<title>Federal Register, Volume 88 Issue 25 (Tuesday, February 7, 2023)</title>
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[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7985-7986]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02499]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0008]
Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory
Committee; Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of Federal advisory committee.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cellular, Tissue, and Gene Therapies Advisory Committee
by the Commissioner of Food and Drugs (the Commissioner). The
Commissioner has determined that it is in the public interest to renew
the Cellular, Tissue, and Gene Therapies Advisory Committee for an
additional 2 years beyond the charter expiration date. The new charter
will be in effect until the October 28, 2024, expiration date.
DATES: Authority for the Cellular, Tissue, and Gene Therapies Advisory
Committee will expire on October 28, 2024, unless the Commissioner
formally determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Christina Vert, Division of Scientific
Advisors and Consultants, 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,
<a href="/cdn-cgi/l/email-protection#f2b19a809b81869b9c93dca4978086b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="72311a001b01061b1c135c24170006321416135c1a1a015c151d04">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Cellular, Tissue,
and Gene Therapies Advisory Committee (the Committee). The Committee is
a discretionary Federal advisory committee established to provide
advice to the Commissioner. The Committee advises the Commissioner or
designee in discharging responsibilities as they relate to helping to
ensure safe and effective drugs for human use and, as required, any
other product for which FDA has regulatory responsibility.
The Committee reviews and evaluates available data relating to the
safety, effectiveness, and appropriate use of human cells, human
tissues, gene transfer therapies, and xenotransplantation products
which are intended for transplantation, implantation, infusion, and
transfer in the prevention and treatment of a broad spectrum of human
diseases and in the reconstruction, repair, or replacement of tissues
for various conditions. The Committee also considers the quality and
relevance of FDA's research program that provides scientific support
for the regulation of these products, and makes appropriate
recommendations to the Commissioner.
The Committee shall consist of a core of 13 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of cellular therapies, tissue transplantation, gene transfer
therapies and xenotransplantation (biostatistics, bioethics,
hematology/oncology, human tissues and transplantation, reproductive
medicine, general medicine, and various medical specialties, including
surgery and oncology, immunology, virology, molecular biology, cell
biology, developmental biology, tumor biology, biochemistry, rDNA
technology, nuclear medicine, gene therapy, infectious diseases, and
cellular kinetics). Members will be invited to serve for overlapping
terms of up to 4 years. Non-Federal members of this committee will
serve as Special Government Employees, representatives, or Ex-Officio
members. Federal members will serve as Regular Government Employees or
Ex-Officios. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting representative member who is identified with industry
interests. There may also be an alternate industry representative.
The Commissioner or designee shall have the authority to select
members of other scientific and technical FDA advisory committees
(normally not to
[[Page 7986]]
exceed 10 members) to serve temporarily as voting members and to
designate consultants to serve temporarily as voting members when: (1)
expertise is required that is not available among current voting
standing members of the Committee (when additional voting members are
added to the Committee to provide needed expertise, a quorum will be
based on the combined total of regular and added members) or (2) to
comprise a quorum when, because of unforeseen circumstances, a quorum
is or will be lacking. Because of the size of the Committee and the
variety in the types of issues that it will consider, FDA may, in
connection with a particular committee meeting, specify a quorum that
is less than a majority of the current voting members. The Agency's
regulations (21 CFR 14.22(d)) authorize a committee charter to specify
quorum requirements.
If functioning as a medical device panel, an additional non-voting
representative member of consumer interests and an additional non-
voting representative member of industry interests will be included in
addition to the voting members.
Further information regarding the most recent charter and other
information can be found at <a href="https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/cellular-tissue-and-gene-therapies-advisory-committee">https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/cellular-tissue-and-gene-therapies-advisory-committee</a> or by contacting the Designated Federal Officer (see
FOR FURTHER INFORMATION CONTACT). In light of the fact that no change
has been made to the committee name or description of duties, no
amendment will be made to 21 CFR 14.100.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at <a href="http://www.fda.gov/AdvisoryCommittees/default.htm">http://www.fda.gov/AdvisoryCommittees/default.htm</a>.
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02499 Filed 2-6-23; 8:45 am]
BILLING CODE 4164-01-P
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