SUPPLEMENTARY INFORMATION:

Pursuant to the Federal Advisory Committee ACT, the Secretary of Veterans Affairs intends to renew the Cooperative Studies Scientific Evaluation Committee (CSSEC or Committee) for two (2) years from the filing date of the charter's renewal. The purpose of the Committee is to review proposed and ongoing cooperative studies and multi-site clinical research activities (including clinical trials, epidemiological studies, and related efforts) and advises VA on scientific merit, feasibility, the adequacy of the plan of investigation, related activities and requested resources, technical details including the involvement of human subjects, and mission relevance. The Committee further evaluates and discusses written materials supplied by the proponents of each project as part of its review.

Also in pursuant to 41 CFR § 102-3.65, the Department of Veterans Affairs provides this written notice determination stating that the CSSEC is in the public interest and found to be in accordance with the Federal Advisory Community Act (FACA), the FACA 2025 Final Rule, and current to the U.S. General Services Administration, Committee Management Secretariat guidance. The following factors below provide an overview of the Committee's operations and public interest intent.

Annual Budget—The overall operating costs for the Committee is $35,000. All members receive travel expenses and a per diem allowance in accordance with the Federal Travel Regulation for any travel made in connection with their duties as members of the Committee. The expected costs are broken into:

(i) Federal personnel (based on full-time equivalent (FTE) usage basis) is 0.1 with other Federal internal costs being $14,850.

(ii) Proposed payments to Non-Federal Members is $2,500. Payments to Federal Members are $7,250 and to consultants is $900. The Committee is composed of up to 12 members who may be Regular Government Employees or Special Government Employees.

(iii) Reimbursable costs equate to travel reimbursement for Non-Federal Members is $2,500, for Federal Members is $4,500 and for Federal Staff is $2,500.

This Committee does not have any dollar value of grants expected for the fiscal year.

Membership Selection—The Committee is composed of members having experience and expertise in major medical specialties and disciplines, including biostatistics and epidemiology, and selected based on professional expertise and achievement in clinical research. Committee membership represents and considers the required technical skills in VA positions or other Federal positions, along with diverse geographical backgrounds and Veterans of different eras and branches to the extent possible. The Cooperative Studies Program (CSP) staff also submits recommendations to the VA Chief Research and Development Officer (CRADO) for nominees to be considered for appointments at CSSEC.

Existing Federal Advisory Committees—The following list of 27 VA advisory committees includes 18 that are statute (with an asterisk *) and 9 non-statutory committees.

(1) VA National Academic Affiliations Council

(* 2) Advisory Committee on Cemeteries and Memorials

(3) Cooperative Studies Scientific Evaluation Committee

(* 4) Advisory Committee on Disability Compensation

(* 5) Veterans' Advisory Committee on Education

(* 6) Veterans' Advisory Committee on Environmental Hazards (Administratively Inactive)

(* 7) Advisory Committee on Former Prisoners of War

(* 8) Geriatrics and Gerontology Advisory Committee

(* 9) Research Advisory Committee on Gulf War Veterans' Illnesses

(10) Health Systems Research Service Merit Review Board

(* 11) Advisory Committee on Homeless Veterans

(12) Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board

(* 13) Advisory Committee on Minority Veterans

(14) National Research Advisory Council

(* 15) Advisory Committee on U.S. Outlying Areas and Freely Associated States

(* 16) Advisory Committee on Prosthetics and Special Disabilities Programs

(* 17) Advisory Committee on the Readjustment of Veterans

(* 18) Veterans' Advisory Committee on Rehabilitation

(19) Rehabilitation Research and Development Service Scientific Merit Review Board

(20) Veterans' Rural Health Advisory Committee

(* 21) Special Medical Advisory Group

(* 22) Advisory Committee on Structural Safety of Department of Veterans Affairs Facilities ( printed page 13405)

(* 23) Advisory Committee on Tribal and Indian Affairs

(24) Veterans' Family, Caregiver, and Survivor Advisory Committee

(* 25) Veterans and Community Oversight and Engagement Board

(26) Department of Veterans Affairs Voluntary Service National Advisory Committee

(* 27) Advisory Committee on Women Veterans

Justification—There is no other committee (in the Federal Government or elsewhere) which is specifically selected based on its multi-disciplinary makeup directly related to cooperative clinical research among the VA patient population and qualified to review the scientific merit of submissions for related multi-center clinical studies and research activities.

Summary of Previous Committee Accomplishments—Since FY 2003, the CSSEC has made 177 recommendations to VA on the scientific merit of proposals for multi-center clinical studies and research activities. In doing so, the Committee has advanced landmarks, definitive clinical trials and observational studies in cardiovascular disease, infectious disease, surgery, gastroenterology, mental health, oncology, and endocrinology improving the health and well-being of Veterans and the nation.

Why Committee is Essential—Peer review of research proposals by the external subject matter experts on this committee is a critical element of the VA's Research program. VA research is a statutory mandate under 38 U.S. Code § 7303, Public Law 117-328. VA Research priorities are further mandated by the Hannon Act (traumatic brain injury), the PACT Act (military toxic exposures and Gulf War Illness), the CARA act (Pain and opioid treatment), the Cleland Dole Act (Precision Oncology), and the MISSION and Elizabeth Dole Acts (community care). The CSSEC provides expert advice on VA cooperative studies, which includes multi-site clinical trials and other large multi-site clinical research activities, and policies related to conducting and managing these efforts. Such advice is to ensure that new and ongoing clinical trials/research sponsored by VA meets the highest standards of scientific merit, mission relevance, and quality, and is conducted safely, efficiently, and economically. There is no other mechanism for VA to get this expert advice.

In conclusion, this Notice of Intent states that this renewing committee is in the public interest, essential to the conduct of agency business and that the information provided is not available through any other advisory committee or source within the Federal Government.