Secretary's Advisory Committee on Human Research Protections

AGENCY:

Office of the Secretary, Department of Health and Human Services.

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 that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its fifth meeting. The meeting will be open to the public.

DATES:

The meeting will be held on Monday, January 31, 2005 from 8:30 a.m. to 5 p.m. and Tuesday, February 1, 2005 from 8:30 a.m. to 5 p.m.

ADDRESSES:

The Radisson Hotel Old Town Alexandria, 901 North Fairfax Street, Alexandria, VA 22314.

FOR FURTHER INFORMATION CONTACT:

Bernard Schwetz, D.V.M., Ph.D., Director, Office for Human Research Protections (OHRP), or Catherine Slatinshek, Executive Director, Secretary's Advisory Committee on Human Research Protections, Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852; (301) 496-7005; fax: (301) 496-0527; email address: sachrp@osophs.dhhs.gov.

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 January 31, 2005, SACHRP will receive and discuss reports from its three subcommittees, the Subpart C subcommittee (HHS regulations and policies for research involving prisoners); the Subcommittee on Research Involving Children; and the newly formed Subpart A Subcommittee. The first two subcommittees were established by SACHRP at its meeting held on July 22, 2003, and the Subpart A Subcommittee was established at the SACHRP's fourth meeting on October 5, 2004, to provide assistance in addressing issues related to the specified topics.

On February 1, 2005, SACHRP will hear presentations from experts on the following topics: Adverse Events reporting and Compliance Oversight Issues.

Public attendance at the meeting is limited to space available. Individuals who plan to attend the meeting and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the designated contact persons. Members of the public will have the opportunity to provide comments on both days of the meeting. Public comment will be limited to five minutes per speaker. Any members of the public who wish to have printed materials distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business on January 14, 2005.

Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at http://www.dhhs.gov/ohrp/sachrp/index.html.