[Federal Register Volume 76, Number 40 (Tuesday, March 1, 2011)]
[Notices]
[Page 11248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-4473]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Secretary's Advisory Committee on Human Research Protections; 
Notice of Meeting

AGENCY: Department of Health and Human Services, Office of the 
Secretary, Office of the Assistant Secretary for Health, Office for 
Human Research Protections.

ACTION: Notice.

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SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby 
given that the Secretary's Advisory Committee on Human Research 
Protections (SACHRP) will hold its twenty-fourth meeting. The meeting 
will be open to the public. Information about SACHRP and the meeting 
agenda will be posted on the SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

DATES: The meeting will be held on Tuesday, March 8, 2011 from 8:30 
a.m. until 5 p.m. and Wednesday, March 9, 2011 from 8:30 a.m. until 5 
p.m.

ADDRESSES: U.S. Department of Health and Human Services, 200 
Independence Avenue, SW., Hubert H. Humphrey Building, Room 800, 
Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT: Jerry Menikoff, M.D., J.D., Director, 
Office for Human Research Protections, or Julia Gorey, J.D., Executive 
Director, SACHRP; U.S. Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, Maryland 20852; 240-453-6900, 
fax: 240-453-6909; e-mail address: <a href="/cdn-cgi/l/email-protection#f6bc839a9f97d8b19984938fb69e9e85d8919980"><span class="__cf_email__" data-cfemail="4f053a23262e6108203d2a360f27273c61282039">[email protected]</span></a>.

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 8, 2011, SACHRP will hear a panel presentation on the work 
of the Federal Demonstration Partnership, followed by discussion. This 
will be followed by the report of the Subpart A Subcommittee (SAS), 
focusing on improvements to the informed consent process. SAS 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 2006 meeting. The afternoon will close with a panel 
presentation on the reporting and return of individual research 
results, including issues associated with the Clinical Laboratory 
Improvement Amendments.
    On March 9, 2011, the morning will open with a panel discussion on 
the reporting and return of aggregate research results, including a 
report on the status of ClinicalTrials.gov. The Subcommittee on 
Harmonization (SOH) will end the meeting with a report on their work to 
date. The SOH was established by SACHRP at its July 2009 meeting, and 
is charged with identifying and prioritizing areas in which regulations 
and/or guidelines for human subjects research adopted by various 
agencies or offices within HHS would benefit from harmonization, 
consistency, clarity, simplification and/or coordination. Public 
comment will be heard on both days. 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 on March 4, 2011.
    An unforeseen administrative matter delayed this notice being 
submitted to the Federal Register for publication.

    Dated: February 23, 2011.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2011-4473 Filed 2-28-11; 8:45 am]
BILLING CODE 4150-36-P


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