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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health and Human Services Department

NOTICE: NOTICES

ACTION: Meetings:

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: Secretary's Advisory Committee on Human Research Protections; Notice of Meetings

DATES: The meeting will be held on Monday, October 27, 2008 from 8:30 a.m. until 4:30 p.m. and Tuesday, October 28, 2008 from 8:30 a.m. until 4:30 p.m.

DOCUMENT 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 seventeenth meeting. The meeting will be open to the public.

SUMMARY: Secretary's Advisory Committee on Human Research Protections,

SUPPLEMENTAL 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 27, 2008, the morning session will begin with a SACHRP update. Members of OHRP and the Office of the General Counsel will make brief presentations on the status of SACHRP recommendations that have been approved to date, the OHRP guidance and Federal rulemaking process, and the status of OHRP budget and staffing. This will be followed by a period of discussion. In the afternoon, SACHRP will receive a report from the Subpart A Subcommittee. This subcommittee is charged with developing recommendations for consideration by SACHRP regarding the application of Subpart A of 45 CFR part 46 in the current research environment. This subcommittee was established by SACHRP at its October 45, 2006 meeting.

The following day, October 28, 2008, the Subcommittee on Inclusion of Individuals with Impaired DecisionMaking in Research will present and discuss their current report. The Subcommittee on Inclusion of Individuals with Impaired DecisionMaking in Research is charged with developing recommendations for consideration by SACHRP about whether guidance and/or additional regulations are needed for research involving individuals with impaired decisionmaking capacity. This subcommittee was formed as a result of discussions during the July 31 August 1, 2006 SACHRP meeting. The afternoon session will consist of an invited panel of community and consumer representatives who will discuss their reaction and provide feedback on the subcommittee's recommendations.

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 [[Page 60288]]
materials to the Acting Executive Director, SACHRP, prior to the close of business Tuesday, October 14, 2008. Information about SACHRP and the draft meeting agenda will be posted on the SACHRP Web site at: http:// www.hhs.gov/ohrp/sachrp/index.html.

Dated: October 7, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections, Acting Executive Secretary,Secretary's Advisory Committee on Human Research Protections.
[FR Doc. E824169 Filed 10908; 8:45 am]
BILLING CODE 415036P

FOR FURTHER INFORMATION CONTACT Ivor Pritchard, PhD, Acting Director, Office for Human Research Protections (OHRP), or Julia Gorey, JD, Executive Director, Secretary's Advisory Committee on Human Research Protections (SACHRP); U.S. Department of Health and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240453 8141; fax: 2404536909; email address: sachrp@osophs.dhhs.gov.