04-3603. Secretary's Advisory Committee on Human Research Protections

AGENCY:

Office of the Secretary, Office of Public Health and Science.

ACTION:

Notice of meeting.

Authority: 42 U.S.C. 217a, section 222 of the Public Health Services (PHS) Act, as amended. The Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. appendix 2), which sets forth standards for the formation and use of advisory committees.

SUMMARY:

Pursuant to section 10(A) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2), notice is hereby given of the third meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP). The meeting will be open to the public.

DATES:

The meeting will be held on Monday, March 29, 2004, from 8:30 a.m. to 4:30 p.m. e.s.t., and Tuesday, March 30, 2004, from 8:30 a.m. to 4:30 p.m. e.s.t.

ADDRESSES:

Holiday Inn Hotel and Suites, The Commonwealth Center, 625 First Street, Alexandria, VA 22314.

FOR FURTHER INFORMATION CONTACT:

Bernard Schwetz, D.V.M., Ph.D., Acting Director, Office for Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852, [phone], fax: [phone], e-mail address: [e-mail] or Catherine Slatinshek, Executive Director, SACHRP Office for Human Research Protections, 1101 Wooton Parkway, Suite 200; Rockville, Maryland 20852, [phone], fax: [phone], e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

Under the authority of 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended, SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.

On March 29, SACHRP will receive and discuss preliminary reports from its three subcommittees. The three subcommittees were created by SACHRP at its meeting held on July 22, 2003, to address issues related to the following three topic areas: HHS regulations and policies for research involving prisoners, HHS regulations and policies for research involving children, and the accreditation of human research protection programs by non-federal accrediting bodies. On March 30, SACHRP will hold follow-up discussions on adverse events reporting issues under HHS and FDA regulations. This topic was discussed at the Committee meeting held on December 11-12, 2003. In addition, discussions will be held to review human subjects research in international settings. These will be followed by panel discussions related to HIPAA regulations, and will conclude with a presentation on litigation issues affecting the clinical research enterprise. The Committee also will discuss future tasks for the remainder of the year.

Public attendance at the meeting is limited to space available. Individuals must provide a photo ID for entry into the meeting. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact person. Members of the public will have the opportunity to provide comments at the meeting on March 29 and 30, 2004. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed material distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP (contact information listed above) prior to close of business March 16, 2004.

Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at: http://ohrp.osophs.dhhs.gov/​sachrp/​sachrp.htm.

Dated: February 12, 2004.

Bernard A. Schwetz

Acting Director, Office for Human Research Protections, and Acting Executive Secretary, Secretary's Advisory Committee on Human Research Protections.