[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Pages 10523-10524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-04091]



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 a 
meeting that will be open to the public. Information about SACHRP and 
the full meeting agenda will be posted on the SACHRP Web site at: 

DATES: The meeting will be held on Wednesday, March 12, 2014 from 8:30 
a.m. until 5:00 p.m. and Thursday, March 13, 2014 from 8:30 a.m. until 
4:30 p.m.

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

(Acting), 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; email 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, through the Assistant Secretary 
for Health, on issues and topics pertaining to or associated with the 
protection of human research subjects.
    The meeting will open to the public at 8:30 a.m., Wednesday March 
12. Following opening remarks from Dr. Jerry Menikoff, OHRP Director, 
and Dr. Jeffrey Botkin, SACHRP Chair, the Subcommittee on Harmonization 
(SOH) will give their report, presenting recommendations on cluster 
randomized trials and informed consent.
    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 afternoon presentation will focus on a discussion of cluster 
randomization, risk assessment, and consent requirements.
    Following opening remarks on the morning of March 13, the Subpart A 
Subcommittee (SAS) will give their report, focusing on recommendations 
for a remodeled concept of engagement in human subjects research. 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 subcommittee was established by SACHRP in 
October 2006.
    Public attendance at the meeting is limited to space available. 
Individuals who plan to attend and need special assistance, such as 
sign language interpretation or other reasonable accommodations, should 
notify the SACHRP at the address/phone listed above at least one week 
prior to the meeting. Members of the public will have the opportunity 
to provide comment during the public comment periods; pre-registration 
is required for participation in the public comment

[[Page 10524]]

session. Individuals who are on-site may pre-register the day of the 
meeting; individuals participating through webcast should pre-register 
by contacting the Executive Director, SACHRP, by COB March 6. 
Individuals who would like to submit written statements should email or 
fax their comments to SACHRP at least five business days prior to the 

    Dated: February 18, 2014.
Ivor Pritchard,
Director (Acting), Office for Human Research Protections, Executive 
Secretary, Secretary's Advisory Committee on Human Research 
[FR Doc. 2014-04091 Filed 2-24-14; 8:45 am]