[Federal Register Volume 70, Number 198 (Friday, October 14, 2005)]
[Notices]
[Page 60091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20589]
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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, (5 U.S.C. Appendix 2), notice is hereby given that the Secretary's
Advisory Committee on Human Research Protections (SACHRP) will hold its
ninth meeting. The meeting will be open to the public.
DATES: The meeting will be held on Tuesday, November 1, 2005, from 8:30
a.m. to 5 p.m. and on Wednesday, November 2, 2005, from 8:30 a.m. until
4:30 p.m..
ADDRESSES: The Radisson Hotel Old Town Alexandria, 901 North Fairfax
Street, Alexandria, Virginia 22314.
FOR FURTHER INFORMATION CONTACT: Bernard Schwetz, D.V.M., Ph.D.,
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; (240) 453-6900; 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 November 1, 2005, SACHRP will receive and discuss preliminary
reports from its two subcommittees: the Subpart A Subcommittee which is
developing recommendations regarding the application of subpart A of 45
CFR part 46 in the current research environment, and the Subcommittee
on Research Involving Children which is developing recommendations
regarding the Department of Health and Human Services (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. In addition, the
Committee will receive a report on progress to date from the Federal
Adverse Event Task Force.
On November 2, 2005, the Committee will receive presentations on
several topics including an update from the Institute of Medicine
concerning work on a report on research involving prisoners; an update
on the joint reviews of research involving children that have been
conducted by the Food and Drug Administration (FDA) and OHRP under the
provisions of FDA regulations at 21 CFR 50.54 and HHS regulations at 45
CFR 46.407; and a series of presentations from ex-officio members to
identify future priorities for consideration by the Committee.
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 Wednesday, October 26, 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: October 7, 2005.
Bernard A. Schwetz,
Director, Office for Human Research Protections, Executive Secretary,
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 05-20589 Filed 10-13-05; 8:45 am]
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