Committee’s Official Designation
The Committee shall be known as the Advisory Committee on Organ Transplantation (ACOT or “the Committee”).
Authority:
ACOT is authorized by 42 U.S.C. 217a; Section 222 of the Public Health Service Act, as amended. The Committee is governed by provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. 10), as amended.
Objectives and Scope of Activities:
As provided under 42 CFR § 121.12, ACOT shall provide advice and recommendations to the Secretary of Health and Human Services (Secretary) on proposed Organ Procurement and Transplantation Network (OPTN) policies and such other matters as the Secretary determines.
Description of Duties:
ACOT shall provide advice and recommendations to the Secretary, acting through the Administrator of the Health Resources and Services Administration (HRSA), on proposed or implemented OPTN policies (including those related to organ donation, procurement, allocation, transplantation, patient safety, and data collection, among other policy topics), and on such other matters that the Secretary determines.
Agency or Official to Whom the Committee Reports:
ACOT provides advice and recommendations to the Secretary, acting through the HRSA Administrator.
Support:
Management and support services are provided by the Health Systems Bureau of HRSA.
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 $166,426. Estimated staff support is .95 full-time equivalency at an estimated annual cost of $193,673.
Designated Federal Officer (DFO):
A full-time federal employee, appointed in accordance with agency procedure, will serve as the Designated Federal Official (DFO) (or designee) and ensure that all procedures are within applicable statutory, regulatory, and Department of Health and Human Services (HHS) General Administration Manual directives. The DFO (or designee) approves and prepares all meeting agendas, calls and attends all Committee or subcommittee meetings, adjourns any meeting when the DFO (or designee) determines adjournment to be in the public interest, and chairs meetings when directed to do so by the HRSA Administrator.
Estimated Number and Frequency of Meetings:
ACOT meets up to three times per year. Notice of all meetings shall be given to the public. Meetings shall be open to the public except as determined otherwise by the Secretary or designee in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act of 1972 (5 U.S.C. 10). Meetings shall be conducted, and records of the proceedings kept, as required by applicable laws and departmental regulations.
Duration:
Continuing.
Termination:
Unless renewed by appropriate action prior to its expiration, ACOT will terminate 2 years from the date the charter is filed.
Membership and Designation:
ACOT consists of up to 11 members, who are Special Government Employees (SGEs) appointed by the Secretary for a term of up to 3 years, as well as up to six federal ex-officio, non-voting members. Members shall be selected by the Secretary from individuals involved in organ procurement, organ transplantation (including, but not limited to, transplant candidates, recipients, living organ donors, and families of deceased organ donors), bioethics, and other medical specialties involved in the identification and referral of donors. Ex-officio members may include representatives from HRSA, the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, and the Food and Drug Administration. From the Secretary’s approved SGEs, a Committee Chair shall be selected by the HRSA Administrator. Concurrent service on ACOT and the OPTN Board of Directors is prohibited. To the extent practicable, committee SGEs should represent the diversity of those served by the OPTN.
Subcommittees:
Standing and ad hoc subcommittees, composed of members of the parent committee, may be established with the approval of the DFO to perform specific functions within the Committee’s jurisdiction. Subcommittees must report back to the parent Committee and do not provide advice or work products directly to HHS or HRSA. HHS’ Committee Management Officer will be notified upon the establishment of each subcommittee and will be provided information on the subcommittee’s name, membership, function, and estimated frequency of meetings.
Recordkeeping:
Records of ACOT, formally and informally established subcommittees, or other subgroups of the Committee, shall be handled in accordance with General Records Schedule 6.2, or other approved agency records disposition schedule. These records shall be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
Filing Date:
August 31, 2024
Approved: August 9, 2024