04-14330. Secretary's Advisory Committee on Human Research Protections

AGENCY:

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

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 fourth 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, July 26, 2004, from 8:30 a.m. to 5 p.m. EDT, and Tuesday, July 27, 2004 from 8:30 a.m. to 5 p.m.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Bernard Schwetz, D.V.M., Ph.D., 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 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, 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 July 26, 2004, SACHRP will receive and discuss preliminary reports from its two subcommittees that were established to address issues related to HHS regulations and policies for research involving prisoners and HHS regulations and policies for research involving children. On July 27, 2004, SACHRP will hold follow-up discussions on issues involving the HIPAA Privacy Rule and hear a presentation on issues involving Subpart B of 45 CFR part 46. In addition, SACHRP will address the formation of a new subcommittee to address an area of human subject protections. The Committee also will host a panel of experts in the fields of behavioral and social sciences to discuss issues affecting the clinical research enterprise. The Committee 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 to gain entry into the building where the meeting is scheduled to be held. 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 July 26 and 27, 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 meeting should submit materials to the Executive Director, SACHRP (contact information listed above) prior to close of business July 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: June 17, 2004.

Bernard A. Schwetz,

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