[Federal Register Volume 70, Number 198 (Friday, October 14, 2005)]
[Page 60091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-20589]



Meeting of the Secretary's Advisory Committee on Human Research 

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

ACTION: Notice.


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.

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]