[Federal Register Volume 73, Number 48 (Tuesday, March 11, 2008)]
[Notices]
[Pages 13004-13005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4793]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Secretary's Advisory Committee on Human Research Protections

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of Public Health and Science.

ACTION: Notice.

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

DATES: The meeting will be held on Thursday, March 27, 2008 from 8:30 
a.m. until 4:30 p.m. and Friday, March 28, 2008 from 8:30 a.m. until 
4:30 p.m.

ADDRESSES: The Sheraton National Hotel, 900 South Orme Street, 
Arlington, Virginia 22204. Phone: 703-521-1900.

FOR FUTHER INFORMATION CONTACT: Ivor Pritchard, Ph.D., Acting Director, 
Office for Human Research Protections (OHRP), or Kevin Prohaska, D.O., 
M.P.H., Acting Executive Director, SACHRP; U.S. Department of Health 
and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, 
Maryland 20852; 240-453-8231; fax: 240-453-6909; e-mail address: 
[email protected].

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 March 27, 2008 SACHRP will receive and discuss a report from the 
Subcommittee on Inclusion of Individuals with Impaired Decision-Making 
in Research. The Subcommittee on Inclusion of Individuals with Impaired 
Decision-Making 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 
decision-making capacity. This Subcommittee was formed as a result of 
discussions during the July 31-August 1, 2006 SACHRP meeting. In 
addition, an invited panel will discuss common designs associated with 
quality improvement, quality assurance, and

[[Page 13005]]

health services activities, as well as ethical considerations that may 
be relevant to such activities.
    On March 28, 2008 the Committee will receive and discuss reports 
from an ad hoc subcommittee and from the Subpart A Subcommittee. The ad 
hoc subcommittee was established after the October 29-30, 2007 meeting 
of SACHRP to consider recommendations relative to encouraging diversity 
in clinical trials and conducting research in the disaster setting. The 
Subpart A Subcommittee is charged with developing recommendations for 
consideration by SACHRP about the application of Subpart A of 45 CFR 
part 46 in the current research environment. This subcommittee was 
established by SACHRP at its October 4-5, 2006 meeting.
    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 Acting Executive Director, SACHRP, prior to the close 
of business Monday, March 17, 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: March 5, 2008.
Ivor A. Pritchard,
Acting Director, Office for Human Research Protections, Acting 
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections.
 [FR Doc. E8-4793 Filed 3-10-08; 8:45 am]
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