E6-2560. Secretary's Advisory Committee on Human Research Protections

AGENCY:

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

ACTION:

Notice.

SUMMARY:

Pursuant to Section 10(a) of the Federal Advisory Committee Act, (U.S.C. Appendix 2), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP), will hold its tenth meeting. The meeting will be open to the public.

DATES:

The meeting will be held on Monday, March 13, 2006 from 8:30 a.m. until 5 p.m. and Tuesday, March 14, 2006 from 8:30 a.m. until 4:30 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., PhD, Director, Office for Human Research Protections, 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; [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 13, 2006, SACHRP will receive and discuss preliminary reports from its Subpart A Subcommittee, which is evaluating the provisions of the HHS regulations for the protection of human subjects at Subpart A of 45 CFR part 46 and related OHRP guidance. On March 14, 2006, the Subcommittee on Research Involving Children will present another in a series of reports to the members of the Committee. The subcommittees were established by SACHRP at its October 4-5, 2004 meeting and at its inaugural meeting on July 22, 2003, respectively.

On March 14, 2006, the Committee will host presentations and invite discussions from panelists concerning issues on research ethics training at international sites. Topics discussed will include developing and carrying out educational programs in research ethics in developing countries; federal interactions with industry in studies overseas; how the FDA monitors compliance with regulations and ethical guidelines, and other 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 Wednesday, March 8, 2006. 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 16, 2006.

Bernard A. Schwetz,

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