COMMITTEE’S OFFICIAL DESIGNATION
Cellular, Tissue, and Gene Therapies Advisory Committee
AUTHORITY
The Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee) is established under 15 U.S.C. 1451 et seq.; 21 U.S.C. 321, 341, 342, 343, 343-1, 344, 345, 346, 348, 349, 350, 350a, 351, 352, 353(f), 355, 355h, 360b, 360c-j, 371, 375, 376, 378, 379e, 381, 393, 394, 881(b); 42 U.S.C. 217a, 241, 242, 242a, 262, 264; 21 CFR Part 14; and is governed by the Federal Advisory Committee Act, as amended (5 U.S.C. 1001 et seq).
OBJECTIVES AND SCOPE OF ACTIVITIES
The Committee advises the Commissioner of Food and Drugs 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 the Food and Drug Administration (FDA) has regulatory responsibility.
DESCRIPTION OF DUTIES
The Committee reviews and evaluates 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 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 of Food and Drugs.
AGENCY OR OFFICIAL TO WHOM THE COMMITTEE REPORTS
The Committee provides advice to the Commissioner of Food and Drugs.
SUPPORT
Management and support services shall be provided by the Center for Biologics Evaluation and Research.
ESTIMATED ANNUAL OPERATING COSTS AND STAFF YEARS
The estimated annual cost for operating the Committee, including compensation and travel expenses for members but excluding staff support, is $195,050. The estimated person years of staff support required is 2.5, at an estimated annual cost of $445,910.
DESIGNATED FEDERAL OFFICER
FDA will select a full-time or permanent part-time Federal employee to serve as the Designated Federal Officer (DFO) to attend each Committee meeting and ensure that all procedures are within applicable statutory, regulatory, and HHS General Administration Manual directives. The DFO will approve and prepare all meeting agendas, call all the Committee and subcommittee meetings, adjourn any meeting when the DFO determines adjournment to be in the public interest, and chair meetings when directed to do so by the official to whom the Committee reports. The DFO shall be present at all meetings of the full committee and subcommittees.
ESTIMATED NUMBER AND FREQUENCY OF MEETINGS
Meetings shall be held approximately two to three times a year. Meetings shall be open to the public except as determined otherwise by the Commissioner or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act. Notice of all meetings shall be given to the public.
DURATION
Continuing
TERMINATION
Unless renewed by appropriate action, the Cellular, Tissue, and Gene Therapies Advisory Committee will terminate two years from the date the charter is filed.
MEMBERSHIP AND DESIGNATION
The Committee shall consist of a core of thirteen 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 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. Members will be invited to serve for overlapping terms of up to four years. 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. 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 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.
SUBCOMMITTEE
Temporary subcommittees consisting of two or more Committee members may be established by the Commissioner or designee as needed to address specific issues within their respective areas of expertise.
Subcommittees make preliminary recommendations to the full Committee regarding specific issues for subsequent action by the full Committee. The Department Committee Management Officer shall be notified upon establishment of each subcommittee, and shall be provided information on its name, membership, function, and estimated frequency of meetings. Subcommittees must report back to the parent committee and must not provide advice or work products directly to the agency.
RECORDKEEPING
Meetings of the Committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws, and Departmental policies. Committee and subcommittee records will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records, or other approved Agency records disposition schedule. These records will be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
FILING DATE
October 28, 2024
APPROVED:
September 12, 2024
Date
/S/
Emily Helms Williams
Director, Advisory Committee Oversight and Management Staff
