[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84349-84350]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28561]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-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, 2022, expiration date.

DATES: Authority for the Cellular, Tissue and Gene Therapies Advisory 
Committee will expire on October 28, 2022, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of 
Scientific Advisors and Consultants, Center for Biologics Evaluation 
and Research, Food and Drug Administration, 10993 New Hampshire Ave., 
Bldg. 71, Rm. 6306, Silver Spring, MD 20993-0002, 240-402-8006, 
[email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by 
the Department of Health and Human Services pursuant to 45 CFR part 11 
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,

[[Page 84350]]

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, which 
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. Almost all non-Federal members of this 
Committee serve as Special Government Employees. 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 member who is 
identified with industry interests.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees 
(normally not to 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, a non-voting 
representative of consumer interests and a non-voting representative 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/cellular-tissue-and-gene-therapies-advisory-committee/charter-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: December 18, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28561 Filed 12-23-20; 8:45 am]
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