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Notice

Meeting of the Secretary's Advisory Committee on Human Research Protections

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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, (5 U.S.C. Appendix 2), notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its ninth meeting. The meeting will be open to the public.

DATES:

The meeting will be held on Tuesday, November 1, 2005, from 8:30 a.m. to 5 p.m. and on Wednesday, November 2, 2005, from 8:30 a.m. until 4:30 p.m..

ADDRESSES:

The Radisson Hotel Old Town Alexandria, 901 North Fairfax Street, Alexandria, Virginia 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; (240) 453-6900; fax: (240) 453-6909; e-mail 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 November 1, 2005, SACHRP will receive and discuss preliminary reports from its two subcommittees: the Subpart A Subcommittee which is developing recommendations regarding the application of subpart A of 45 CFR part 46 in the current research environment, and the Subcommittee on Research Involving Children which is developing recommendations regarding the Department of Health and Human Services (HHS) regulations and policies for research involving children. The subcommittees were established by SACHRP at its October 4-5, 2004, meeting and at its inaugural meeting on July 22, 2003, respectively. In addition, the Committee will receive a report on progress to date from the Federal Adverse Event Task Force.

On November 2, 2005, the Committee will receive presentations on several topics including an update from the Institute of Medicine concerning work on a report on research involving prisoners; an update on the joint reviews of research involving children that have been conducted by the Food and Drug Administration (FDA) and OHRP under the provisions of FDA regulations at 21 CFR 50.54 and HHS regulations at 45 CFR 46.407; and a series of presentations from ex-officio members to identify future priorities for consideration by the Committee.

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, October 26, 2005. 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: October 7, 2005.

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. 05-20589 Filed 10-13-05; 8:45 am]

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