```

[Federal Register Volume 75, Number 33 (Friday, February 19, 2010)]
[Notices]
[Page 7481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3271]

=======================================================================
-----------------------------------------------------------------------

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, Office of Public Health and Science.

ACTION: Notice.

-----------------------------------------------------------------------

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 
twenty-second meeting. The meeting will be open to the public.

DATE: The meeting will be held on Tuesday, March 9, 2010 from 8:30 a.m. 
until 5 p.m. and Wednesday, March 10, 2010 from 8:30 a.m. until 5 p.m.

ADDRESSES: U.S. Department of Health & 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 (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 9, 2010, OHRP staff will provide a summary of public 
comments received on two recent draft guidance documents: Institutional 
Review Board (IRB) Continuing Review of Research and IRB Approval of 
Research with Conditions. Following this presentation, there will be a 
panel that will examine the context for resolution of regulatory 
harmonization issues through the Clinical Trials Transformation 
Initiative and the International Council on Harmonization and Good 
Clinical Practice. After lunch, the day will conclude with a report 
from the Subpart A Subcommittee (SAS) focusing on issues surrounding 
consent for future use of specimens or data. 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.
    On March 10, 2010, co-chairs of the Subcommittee on Harmonization 
(SOH) will discuss the charge, initial steps, and membership of this 
new group. 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. The remainder of March 10 will be devoted to continuing 
the previous day's focus on the work of the Subpart A Subcommittee. 
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 Thursday, March 4, 2010. 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 16, 2010.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2010-3271 Filed 2-18-10; 8:45 am]
BILLING CODE 4150-36-P
```