The Department of Veterans Affairs gives notice under Public Law 92-463 (Federal Advisory Committee Act) as amended, by section 5(c) of Public Law 94-409, that a meeting of the Research and Development Cooperative Studies Evaluation Committee will be held at The River Inn, 924 Twenty-Fifth Street, NW., Washington, DC 20037, on May 9-10, 2001. The session is scheduled to begin at 7:30 a.m. and end at 5 p.m. A total of six studies and three sub-studies will be reviewed. One study, including its two sub-studies, “Testosterone Treatment to Prevent Fractures in Aging Hypogonadal Men” is a resubmission. Three studies are undergoing mid-term reviews: “18-F-Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Imaging in the Management of Patients with Solitary Pulmonary Nodules,” “Genetic Tissues Banking in VA Clinical Research: A Cooperative Studies Program Demonstration Project,” and “The Coronary Artery Revascularization Prophylasix Trial (CARP).” The two new studies and one new sub-study submitted for review are: “Veterans Affairs Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysm,” “Total Myocardial Revascularization On and Off Cardiopulmonary Bypass: A Prospective Randomized Study,” and a sub-study “Homocysteinemia in Kidney and End Stage Renal Disease—DNA Bank.”
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.
The meeting will be open to the public from 7:30 a.m. to 8 a.m. to discuss the general status of the program. Those who plan to attend should contact Ms. Denise Shorter, Coordinator, Department of Veterans Affairs, Washington, DC at (202) 273-8265.
The meeting will be closed from 8 a.m. to 5 p.m. This portion of the meeting involves consideration of specific proposals in accordance with 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 disclosures of which would constitute a clearly unwarranted invasion of personal privacy.Start Signature
Dated: April 27, 2001.
By Direction of the Secretary.
Robert W. Schultz,
Acting Assistant Secretary for Human Resources and Administration.
[FR Doc. 01-11032 Filed 5-1-01; 8:45 am]
BILLING CODE 8320-01-M