We are giving notice that the Secretary of Veterans Affairs intends to renew the
Department of Veterans Affairs (VA) Cooperative Studies Scientific Evaluation Committee (CSSEC) for a
2-year period. The Secretary has determined that the Committee is necessary and in the public
interest.

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.

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 No. 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.

The point of contact is Jeffrey Moragne, Committee Management Office, Department of Veterans Affairs, Advisory Committee Management Office (00AC), 811 Vermont Avenue, 4th floor, NW, Washington, DC 20420; telephone (202) 714-1578; or email at Jeffrey.Moragne@va.gov.

Please see the Federal Register notice for additional information.