[Federal Register Volume 76, Number 181 (Monday, September 19, 2011)]
[Pages 58006-58007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23863]



Meeting of the Secretary's Advisory Committee on Human Research 

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, Department of Health and Human Services.

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-sixth meeting. The meeting will be open to the public. 
Information about SACHRP and the meeting agenda will be posted on the 
SACHRP Web site at: http://www.dhhs.gov/ohrp/sachrp/mtgings/index.html.

DATES: The meeting will be held on Tuesday, October 4, 2011 from 8:30 
a.m. until 5 p.m. and Wednesday, October 5, 2011 from 8:30 a.m. until 5 

ADDRESSES: U.S. Department of Health and Human Services, 200 
Independence Avenue SW., Hubert H. Humphrey Building, Room 800, 
Washington, DC 20201.

FOR FUTHER 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: Julia.Gorey@hhs.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.
    Both days of this meeting will be devoted to SACHRP discussion of 
the recent Advance Notice of Proposed Rulemaking (ANPRM), Human 
Subjects Research Protections: Enhancing Protections for Research 
Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 
published in the July 26 Federal Register. The meeting will open 
October 4 with remarks from SACHRP Chair Dr. Barbara Bierer and OHRP 
Director Dr. Jerry Menikoff, followed by presentation of joint 
recommendations on the ANPRM from the Subpart A Subcommittee (SAS) and 
the Subcommittee on Harmonization (SOH).
    SAS is charged with developing recommendations for consideration by 
SACHRP regarding the application of subpart A of 45 CFR part 46 in the 
current research environment; this

[[Page 58007]]

subcommittee was established by SACHRP in October 2006. 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.
    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 September 30, 2011.

    Dated: September 13, 2011.
Jerry Menikoff,
Director, Office for Human Research Protections, Executive Secretary, 
Secretary's Advisory Committee on Human Research Protections.
[FR Doc. 2011-23863 Filed 9-16-11; 8:45 am]