06-1046. Establishment of Human Studies Review Board

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice; Establishment of Advisory Committee.

SUMMARY:

As required by section 9(a)(2) of the Federal Advisory Committee Act, the United States Environmental Protection Agency (EPA or Agency) is giving notice that it is establishing the Human Studies Review Board (HSRB). The purpose of this Board is to provide advice and recommendations to EPA on issues related to the scientific and ethical review of human subjects research. EPA has determined that this advisory committee is in the public interest and will assist the Agency in performing its duties as directed in the 2006 EPA Appropriations Act. Further, the Agency included the establishment of such a Board in a final rule for protection of subjects in human research. The Agency is publishing, in a separate Federal Register notice, the final rule that strengthens the protections for subjects in human research, including a provision addressing the establishment and operation of the HSRB. In addition, in a report requested by the Agency, the National Academy of Sciences recommended that EPA establish such a Board. See: “Department of Interior, Environment, and Related Agencies Appropriations Act, 2006,” Public Law 109-54; and “Intentional Human Dosing Studies for EPA Regulatory Purposes,” Washington, DC: National Academy Press. 2004. Balanced membership will be driven by a number of considerations characterized by: inclusion of the necessary areas of technical expertise, different scientific perspectives within each technical discipline, and the collective breadth of experience needed to address the Agency's charge. Copies of the Committee Charter will be filed with the appropriate congressional committees and the Library of Congress.

FOR FUTHER INFORMATION CONTACT:

Paul I. Lewis, Office of the Science Advisor, Mail Code 8105R, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: [phone]; fax number [phone]; e-mail: [e-mail].

Dated: January 25, 2006.

William H. Farland,

Chief Scientist, Office of the Science Advisor.