[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7985-7986]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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, 
[email protected].

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 https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/cellular-tissue-and-gene-therapies-advisory-committee 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 http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02499 Filed 2-6-23; 8:45 am]
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