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Protection of human subjects--Department of Energy. Proposed rule.

Executive Order 12044 sets forth a program of regulatory reform to be followed by all executive departments. One element of that program is periodic review of existing regulations. The Department of Energy is committed to review all of its existing regulations within five years, on schedule set forth in the Federal Register for May 8, 1980, 45 FR 30448. As part of that commitment, the Department has reexmained the regulations contained in 10 CFR Part 745. These regulations deal with the protection of human subjects in research activities supported by the Department. In this notice, we are proposing regulations that will supersede the existing requirements. These proposed regulations are intended substantially to duplicate the policies and procedures proposed by the Department of Health and Human Services on August 14, 1979 (44 FR 47688). The primary responsibility for adequate review and approval to protect human subjects of research activities sponsored by the Department of Energy is placed on the institution that receives, or is accountable to the Department, for the funds awarded.