03-26436. Research and Development Cooperative Studies Evaluation Committee; Notice of Meeting

The Department of Veterans Affairs (VA) gives notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Research and Development Cooperative Studies Evaluation Committee will be held at the Crystal Gateway Marriott Hotel, 1700 Jefferson Davis Highway, Arlington, VA 22202, on December 16 and 17, 2003. The sessions will be held on December 16 from 8 a.m. to 3:45 p.m. and December 17 from 7:30 a.m. to 2 p.m.

The Committee advises the Chief Research and Development Officer through the Director of the Cooperative Studies Program on the relevance and feasibility of the studies, the adequacy of the protocols, and the scientific validity and propriety of technical details, including protection of human subjects.

On December 16, the Committee will review the following studies submitted: Efficacy of GM-CSF to Reduce Incidence and Duration of Mucositis Associated with Concomitant Chemoradiation Therapy in Head and Neck Cancer Patients; Integrating Practice Guidelines for Smoking Cessation into Mental Health Care for Post-Traumatic Stress Disorder; Risperidone Treatment for Refractory Combat-Related Post-Traumatic Stress Disorder; and A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial of DL-Alpha-tocopherol for the Treatment of Functional Decline in Outpatients with Alzheimer's Disease on Donepezil. On December 17, the Committee will review the study submitted on S-Adenosylmethionine Improves Survival in Alcoholic Cirrhosis.

The meeting will be open to the public December 16 from 8 a.m. to 8:30 a.m. to discuss the general status of the program. Those who plan to attend should contact Mrs. Karen Hood, Staff Assistant, Department of Veterans Affairs, Washington, DC, at [phone]. The meeting will be closed December 16 from 8:30 a.m. to 3:45 p.m. and December 17 from 7:30 a.m. to 2 p.m. That portion of the meeting involves committee business that falls within the scope of provisions set forth in section 10(d) of Public Law 92-463, as amended by sections 5(c) of Public Law 94-409, and 5 U.S.C. 552b(c)(6). During the closed session of the meeting, discussions and recommendations will deal with qualifications of personnel conducting the studies, staff and consultant critiques of research proposals, and similar documents, and the medical records of patients who are study subjects, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Dated: October 14, 2003.

By Direction of the Secretary.

E. Philip Riggin,

Committee Management Officer.