[Federal Register Volume 74, Number 28 (Thursday, February 12, 2009)]
[Notices]
[Page 7066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-3015]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


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

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

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

DATES: The meeting will be held on Tuesday, March 3, 2009 from 8:30 
a.m. until 5 p.m. and Wednesday, March 4, 2009 from 8:30 a.m. until 5 
p.m.

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

FOR FURTHER INFORMATION CONTACT:  Jerry Menikoff, J.D., M.D., Director, 
Office for Human Research Protections (OHRP), or Julia Gorey, J.D., 
Executive Director, SACHRP; U.S. Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 200, Rockville, Maryland 20852; 
240-453-8141; 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 3, 2009, SACHRP will receive and discuss a report from an 
internal task force charged with prioritizing SACHRP's existing 
recommendations to OHRP. The Committee will then hear a presentation of 
the recent National Academy of Sciences report entitled ``Health 
Research and the Privacy of Health Information--The HIPAA Privacy 
Rule,'' followed by a presentation of the Association of Academic 
Health Centers' recent survey on the impact of the HIPAA Privacy Rule 
on research. Lastly, SACHRP will hear a report from the Subpart A 
Subcommittee, which 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, 2004 meeting.
    On March 4, 2009, the Committee will receive and discuss a report 
from the Subcommittee on Inclusion of Individuals with Impaired 
Decision-Making in Research. That subcommittee is charged with 
developing recommendations for consideration by SACHRP about whether 
guidance or additional regulations are needed for research involving 
individuals with impaired decision-making capacity. It was formed as a 
result of discussions during the July 31-August 1, 2006 SACHRP meeting. 
The day will conclude with a panel discussion addressing harmonization 
issues associated with the Common Rule and the FDA regulations.
    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 Friday, February 27, 2009. 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: February 6, 2009.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. E9-3015 Filed 2-11-09; 8:45 am]
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