05-13155. Meeting of the 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 eighth meeting. The meeting will be open to the public.

DATES:

The meeting will be held on Monday, August 1, 2005, from 8:30 a.m. to 5 p.m. and on Tuesday, August 2, 2005, 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 (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; [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 August 1, 2005, SACHRP will discuss preliminary reports from its two subcommittees: the Subpart A Subcommittee, which is evaluating the application of HHS regulations for the protection of human subjects at subpart A of 45 CFR part 46 in the current research environment, and the Subcommittee on Research Involving Children, which is assessing the 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.

On August 2, 2005, the Committee will hear presentations and participate in deliberations with three panels invited to discuss views on patient/subject issues in research. One panel will include representatives from subject/patient advocacy organizations. Another will offer perspectives from individuals representing specific research subject populations, including women, children, and the cognitively impaired. A third panel will be composed of individual research subjects.

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. 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, July 27, 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.

Dated: June 28, 2005.

Bernard A. Schwetz,

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