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Notice

Secretary's Advisory Committee on Human Research Protections

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Information about this document as published in the Federal Register.

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AGENCY:

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

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 fourth meeting. The meeting will be open to the public.

DATES:

The meeting will be held on Monday, October 4, 2004, from 8:30 a.m. to 5 p.m., and on Tuesday, October 5, 2004, from 8:30 a.m. to 5 p.m.

ADDRESSES:

The Raddison Hotel Old Town Alexandria, 900 North Fairfax Street; Alexandria, VA 22314.

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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.

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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 October 4, 2004, SACHRP will receive and discuss preliminary reports from its two subcommittees, the Subpart C Working Group (HHS regulations and policies for research involving prisoners) and the Subpart D Working Group (HHS regulations and policies for research involving children). The subcommittees were established by SACHRP at its meeting held on July 22, 2003, to provide assistance in addressing issues related to the specified topics. The Committee also will receive an update from OHRP staff on Subpart B issues.

On October 5, 2004, SACHRP will assemble three panels of experts to discuss the following issues: (1) The application of Subpart A in the current research environment; (2) the relationship between public health surveillance activities and research, the relationship between quality assurance/quality improvement activities, and research as defined in the HHS regulations for the protection of human subjects at 45 CFR 46.102(d); (3) and issues related to central IRBs.

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 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 material distributed to SACHRP members for this scheduled meeting should submit materials to the Executive Director, SACHRP, prior to the close of business on September 29, 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.

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Dated: September 14, 2004.

Bernard A. Schwetz,

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

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[FR Doc. 04-21072 Filed 9-17-04; 8:45 am]

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