[Federal Register Volume 69, Number 33 (Thursday, February 19, 2004)]
[Notices]
[Pages 7749-7750]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 04-3603]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Secretary's Advisory Committee on Human Research Protections

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

ACTION:  Notice of meeting.

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    Authority: 42 U.S.C. 217a, section 222 of the Public Health 
Services (PHS) Act, as amended. The Committee is governed by the 
provisions of Public Law 92-463, as amended (5 U.S.C. appendix 2), 
which sets forth standards for the formation and use of advisory 
committees.

SUMMARY: Pursuant to section 10(A) of the Federal Advisory Committee 
Act, as amended (5 U.S.C. appendix 2), notice is hereby given of the 
third meeting of the Secretary's Advisory Committee on Human Research 
Protections (SACHRP). The meeting will be open to the public.

DATES: The meeting will be held on Monday, March 29, 2004, from 8:30 
a.m. to 4:30 p.m. e.s.t., and Tuesday, March 30, 2004, from 8:30 a.m. 
to 4:30 p.m. e.s.t.

ADDRESSES: Holiday Inn Hotel and Suites, The Commonwealth Center, 625 
First Street, Alexandria, VA 22314.

FOR FURTHER INFORMATION CONTACT: Bernard Schwetz, D.V.M., Ph.D., Acting 
Director, Office for Human Research Protections, Department of Health 
and Human Services, 1101 Wootton Parkway, Suite 200, Rockville, 
Maryland 20852, (301) 496-7005, fax: (301) 402-0527, e-mail address: 
sachrp@osophs.dhhs.gov or Catherine Slatinshek, Executive Director, 
SACHRP Office for Human Research Protections, 1101 Wooton Parkway, 
Suite 200; Rockville, Maryland 20852, (301) 496-7005, fax: (301) 496-
0527, e-mail address: sachrp@osophs.dhhs.gov.

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 29, SACHRP will receive and discuss preliminary reports 
from its three subcommittees. The three subcommittees were created by 
SACHRP at its meeting held on July 22, 2003, to address issues related 
to the following three topic areas: HHS regulations and policies for 
research involving prisoners, HHS regulations and policies for research 
involving children, and the accreditation of human research protection 
programs by non-federal accrediting bodies. On March 30, SACHRP will 
hold follow-up discussions on adverse events reporting issues under HHS 
and FDA regulations. This topic was discussed at the Committee meeting 
held on December 11-12, 2003. In addition, discussions will be held to 
review human subjects research in international settings. These will be 
followed by panel discussions related to HIPAA regulations, and will

[[Page 7750]]

conclude with a presentation on litigation issues affecting the 
clinical research enterprise. The Committee also will discuss future 
tasks for the remainder of the year.
    Public attendance at the meeting is limited to space available. 
Individuals must provide a photo ID for entry into the meeting. 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the designated contact person. Members of the public will have 
the opportunity to provide comments at the meeting on March 29 and 30, 
2004. Public comment will be limited to five minutes per speaker. Any 
members of the public who wish to have printed material distributed to 
SACHRP members for this scheduled meeting should submit materials to 
the Executive Director, SACHRP (contact information listed above) prior 
to close of business March 16, 2004.
    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: February 12, 2004.
Bernard A. Schwetz
Acting Director, Office for Human Research Protections, and Acting 
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 04-3603 Filed 2-18-04; 8:45 am]
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