Advisory Committee; Cellular, Tissue, and Gene Therapies Advisory Committee; Renewal

Issuing agencies

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, 2028, expiration date.

Full Text

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<title>Federal Register, Volume 91 Issue 197 (Wednesday, October 14, 2026)</title>
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[Federal Register Volume 91, Number 197 (Wednesday, October 14, 2026)]
[Notices]
[Pages 65223-65225]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20989]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-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, 2028, expiration date.

DATES: Authority for the Cellular, Tissue, and Gene Therapies Advisory 
Committee will expire on October 28, 2026, unless the Commissioner 
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Advisory Committee Oversight and 
Management Staff, Office of the Chief Scientist, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 3215, Silver 
Spring, MD 20993-0002, (301) 796-8220, <a href="/cdn-cgi/l/email-protection#f2b3b1bdbfa1a187909f9b81819b9d9c81b2949693dc9a9a81dc959d84"><span class="__cf_email__" data-cfemail="fabbb9b5b7a9a98f989793898993959489ba9c9e9bd4929289d49d958c">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65, 21 CFR 
14.40(b), 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 and biologic products for human use and, as required, any other 
product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene 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 and makes appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of at least six voting 
members including the Chair. Subject to legal and regulatory 
requirements, members and the Chair are selected by and serve at the 
discretion of the Commissioner or designee. Each member, including the 
Chair, will be selected from among authorities knowledgeable in the 
fields of cellular therapies, tissue transplantation, gene therapies, 
and xenotransplantation. These may include 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, 
cellular kinetics, and related specialties.
    Members may be invited to serve for terms of up to four years, or 
for less time in the discretion of the Commissioner or designee. Non-
Federal members of this committee will serve as Special Government 
Employees or representatives. Federal members will serve as Regular 
Government Employees or Ex-Officios.
    In addition to the voting members, the Commissioner or designee may 
identify consumer and/or industry representatives to join the Committee 
(or serve as alternate representatives) as non-voting representative 
member(s), via a process consistent with legal and regulatory 
requirements. Individuals currently employed at FDA-regulated 
companies, such as pharmaceutical and medical device manufacturers, 
shall not be selected to serve as members of the Committee unless this 
Committee is expected to address issues for which inclusion of an 
industry representative is required by statute. If this Committee 
includes an industry representative, the Commissioner or designee will 
determine whether to invite them to participate in meetings on a case-
by-case basis, according to applicable legal and regulatory 
requirements.
    The Commissioner or designee shall have the authority to select 
members of other scientific and technical FDA advisory committees to 
serve temporarily as voting members and to designate Special Government 
Employees 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.
    A quorum for the Committee is a majority of the current voting 
members present at the time, provided that FDA may specify a quorum 
that is less than a majority of the current voting members because of 
the size of the Committee and the variety in the types

[[Page 65224]]

of issues that it will consider, or other reason determined appropriate 
in accordance with legal and regulatory requirements. 21 CFR 14.22(d).
    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.
    Members appointed to an advisory committee serve for the duration 
of the committee, or until their terms expire, they resign, or they are 
removed from membership by the Commissioner or designee. Committee 
members' terms may be ended prior to their date of expiration, for 
reasons determined to be good cause. Good cause includes excessive 
absenteeism from committee meetings, a demonstrated bias that 
interferes with the ability to render objective advice, failure to 
abide by established procedures, or violation of other applicable rules 
and regulations.
    Further information regarding the most recent charter and other 
information can be found at <a href="https://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/charter-cellular-tissue-and-gene-therapies-advisory-committee">https://www.fda.gov/advisory-committees/cellular-tissue-and-gene-therapies-advisory-committee/charter-cellular-tissue-and-gene-therapies-advisory-committee</a> or by contacting the 
Advisory Committee Oversight and Management Staff (see FOR FURTHER 
INFORMATION CONTACT). Because the committee's name and description of 
duties remain unchanged, 21 CFR 14.100 will not be amended.
    Renewal Requirements and Justification: The Commissioner has 
determined that renewal of the Cellular, Tissue, and Gene Therapies 
Advisory Committee is in the public interest. This determination is 
based on the Committee's essential role in providing independent expert 
advice on the safety, effectiveness, and appropriate use of human 
cells, human tissues, gene 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 continued need for specialized expertise in 
this therapeutic area, and the Committee's demonstrated value in 
supporting FDA's regulatory mission. The following information supports 
this determination in accordance with applicable legal and regulatory 
requirements.

Public Interest Determination

    Pursuant to 41 CFR 102-3.60(a), to establish, renew, reestablish, 
or merge a discretionary (agency discretion) advisory committee, an 
agency must first consult with the General Services Administration's 
Committee Management Secretariat (the Secretariat) and, as part of the 
consultation, provide a written public interest determination approved 
by the head of the agency to the Secretariat with a copy to the Office 
of Management and Budget. In addition, pursuant to 41 CFR 102-3.35, an 
agency shall follow the same consultation process and document in 
writing the same determination of need before creating a subcommittee 
under a discretionary committee that is not made up entirely of members 
of a parent advisory committee.
    Information on the following factors for the committee is provided 
to the Secretariat to demonstrate that renewing the committee is in the 
public interest:
    1. Annual budget: The overall budget for this committee is $99,231.
    a. Federal personnel on a full-time equivalent (FTE) basis: The 
estimated person years of Federal staff support is 0.30 at an estimated 
annual cost of $46,028.
    b. Other Federal internal costs: The anticipated total value in USD 
of other internal costs, such as cost associated with IT supplies for 
meeting is $19,690.
    c. Proposed payments to members: The estimated annual payments to 
members is $2,520.
    d. Proposed number of members: The anticipated number of members is 
six.
    e. Reimbursable costs: The estimated annual reimbursable costs, 
including travel and related expenses for members is $4,000.
    2. If applicable, the total dollar value of grants expected to be 
recommended during the fiscal year: N/A.
    3. Criteria for selecting members to ensure the committee has the 
necessary expertise and fairly balanced membership.
    Ensuring Necessary Expertise: Members must have background, 
education, and experience commensurate with the committee's function of 
advising FDA on the available data relating to the safety, 
effectiveness, and appropriate use of human cells, human tissues, gene 
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. Scientific and technical competence is critical. Nominees 
should be acknowledged experts with demonstrated skills in critical 
evaluation of data and effective communication.
    As outlined in the committee charter, the membership should include 
authorities knowledgeable in the fields of cellular therapies, tissue 
transplantation, gene therapies, and xenotransplantation. These may 
include 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, cellular kinetics, and related specialties, as 
well as needed consumer and industry representation. FDA also follows 
the requirements in section 505(n)(3) of the Federal Food, Drug, and 
Cosmetic Act regarding membership of drug product advisory committees. 
(21 U.S.C. 355(n)(3)).
    Ensuring Fair Balance: Appointments are made without 
discrimination. The committee is reviewed in totality for balance, 
characterized by inclusion of necessary knowledge, insight, and 
scientific perspective from the relevant community or expertise area. 
Nominations are sought from all geographic locations within the United 
States and its territories, and from diverse sources including 
professional and scientific societies, academia, government agencies, 
industry and trade associations, consumer and patient organizations, 
and current Agency staff.
    4. List of all other Federal advisory committees of the agency:

    <bullet> Anesthetic and Analgesic Drug Products Advisory Committee
    <bullet> Antimicrobial Drugs Advisory Committee
    <bullet> Blood Products Advisory Committee
    <bullet> Cardiovascular and Renal Drugs Advisory Committee
    <bullet> Dermatologic and Ophthalmic Drugs Advisory Committee
    <bullet> Device Good Manufacturing Practice Advisory Committee
    <bullet> Digital Health Advisory Committee
    <bullet> Drug Safety and Risk Management Advisory Committee
    <bullet> Endocrinologic and Metabolic Drugs Advisory Committee
    <bullet> Genetic and Metabolic Disease Advisory Committee
    <bullet> Medical Devices Advisory Committee
    <bullet> National Mammography Quality Assurance Advisory Committee 
(Administratively Inactive)
    <bullet> Nonprescription Drugs Advisory Committee

[[Page 65225]]

    <bullet> Obstetrics, Reproductive and Urologic Drugs Advisory 
Committee
    <bullet> Oncologic Drugs Advisory Committee
    <bullet> Pediatric Advisory Committee
    <bullet> Peripheral and Central Nervous System Advisory Committee
    <bullet> Pharmacy Compounding Advisory Committee
    <bullet> Psychopharmacologic Drugs Advisory Committee
    <bullet> Pulmonary-Allergy Drugs Advisory Committee
    <bullet> Risk Communication Advisory Committee (Administratively 
Inactive)
    <bullet> Science Board to the Food and Drug Administration
    <bullet> Technical Electronic Product Radiation Safety Standards 
Committee
    <bullet> Tobacco Products Scientific Advisory Committee
    <bullet> Vaccines and Related Biological Products Advisory 
Committee

    5. Justification that the information or advice provided by the 
Federal advisory committee or subcommittee is not available from 
another Federal advisory committee, another Federal Government source, 
or any other more cost-effective and less burdensome source.
    The Cellular Tissue and Gene Therapies Advisory Committee provides 
independent expert advice to FDA on the available data relating to the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene 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 topics considered by the Cellular, Tissue, and Gene Therapies 
Advisory Committee require specialized expertise in the fields of 
cellular therapies, tissue transplantation, gene therapies, and 
xenotransplantation. These may include 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, and related specialties. Potential topics that may 
need committee input include products related to the topics outlined in 
Section (6) below. These and other issues cannot be appropriately 
addressed by another standing committee without diminishing the depth 
and relevance of the expert input provided to the Agency.
    6. If the consultation is a committee renewal, a summary of the 
previous accomplishments of the committee and the reasons it needs to 
continue.
    Summary of Previous Accomplishments: On July 30, 2026, the 
Committee met to discuss and make recommendations on Biologics License 
Application (BLA) 125827, from Replimune, Inc. for vusolimogene 
oderparepvec. The proposed indication (use) is in combination with 
nivolumab for the treatment of adult patients with advanced melanoma 
who have previously received an anti-PD-1 containing regimen.
    On July 29, 2026, the Committee met to discuss and make 
recommendations on Biologics License Application (BLA) 125842 from 
Capricor, Inc. for deramiocel (human allogeneic cardiosphere-derived 
cells) the treatment of cardiomyopathy in Duchenne muscular dystrophy 
(DMD).
    On November 21, 2024, the Committee met to discuss and make 
recommendations on supplemental biologics license application (sBLA) 
125586/546 from Astra Zeneca for Andexxa (coagulation factor Xa 
(recombinant), inactivated -zhzo), for patients treated with 
rivaroxaban or apixaban when reversal of anticoagulation is needed due 
to life-threatening or uncontrolled bleeding.
    7. Explanation of why the committee/subcommittee is essential to 
the conduct of agency business.
    Reasons for Continuation: The Committee plays a critical role in 
enabling FDA to meet the requirements of section 505(n)(1) and (s)(1) 
of the Federal Food, Drug, and Cosmetic Act by providing expert 
scientific advice and recommendations. Without the Cellular, Tissue, 
and Gene Therapies Advisory Committee, FDA's ability to obtain external 
input on issues related to human cells, human tissues, gene 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 would be significantly limited.
    In conclusion, this public interest determination documents that 
renewing the committee is in the public interest, essential to the 
conduct of agency business, and that the information to be obtained is 
not already available through another advisory committee or source 
within the Federal Government.
    This notice is issued under the Federal Advisory Committee Act as 
amended (5 U.S.C. 1001 et seq.). 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>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-20989 Filed 10-13-26; 8:45 am]
BILLING CODE 4164-01-P


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