[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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