03-29298. Meeting of the Secretary's Advisory Committee on Human Research Protections

AGENCY:

Office of the Secretary, HHS.

ACTION:

Notice of meeting.

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 second meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP). The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the contact person listed below.

DATES:

The meeting will be held on Thursday, December 11 and Friday, December 12, 2003, and will convene each day from approximately 8:30 a.m. until 5 p.m. EST.

ADDRESSES:

The Sheraton Four Points Hotel, 1201 K Street, NW., Washington, DC, 20005.

FOR FURTHER INFORMATION CONTACT:

Bernard Schwetz, D.V.M., Ph.D., Acting Executive Secretary, SACHRP, Department of Health and Human Services (HHS), Office of Public Health and Science (OPHS), 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852, [phone], fax: [phone], e-mail address: [e-mail] or Catherine Slatinshek, Executive Director, SACHRP, HHS, OPHS, 1101 Wootton 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, HHS established SACHRP to provide expert advice and recommendations to the Secretary of HHS and the Assistant Secretary for Health on issues and topics pertaining to or associated with the protection of human research subjects.

On December 11, SACHRP will receive and discuss preliminary reports from its three subcommittees that were created by SACHRP at its July 22, 2003 meeting to address issues related to the following three topics areas: Department of Health and Human Services (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 December 12, SACHRP will hold panel discussions related to human subjects research in international settings and adverse event reporting requirements under HHS and Food and Drug Administration regulations. The committee will also discuss future tasks for 2004.

Members of the public will have the opportunity to provide comments at the meeting on December 11 and 12, 2003. 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 should submit materials to the Acting Executive Secretary of SACHRP (contact information listed above) prior to close of business December 2, 2003.

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: November 18, 2003.

Bernard A. Schwetz,

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