[Federal Register Volume 81, Number 81 (Wednesday, April 27, 2016)]
[Pages 24826-24827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09818]



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, May 18, 2016, from 8:30 
a.m. until 5:00 p.m. and Thursday, May 19, 2016, from 8:30 a.m. until 
4:30 p.m.

ADDRESSES: Fishers Lane Conference Center, Terrace Level, 5635 Fishers 
Lane, Rockville, Maryland 20852.

Secretary, SACHRP; U.S. Department of Health and Human Services, 1101 
Wootton Parkway, Suite 200, Rockville, Maryland 20852; telephone: 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., on Wednesday, May 
18, followed by opening remarks from Dr. Jerry Menikoff, Director, 
Office for Human Research Protections (OHRP), and Dr. Jeffrey Botkin, 
SACHRP Chair. OHRP staff will begin the meeting by presenting a summary 
of public

[[Page 24827]]

comment received on the Notice of Proposed Rulemaking on Federal Policy 
for the Protection of Human Subjects. The Subpart A Subcommittee (SAS) 
will then present their draft work products, including considerations 
for single IRB review and minimal risk informed consent models. On 
Thursday, May 19, the Subcommittee on Harmonization (SOH) will present 
revisions to their recommendations on clustered randomized trials, the 
return of individual research results, and benchmarking.
    SAS was established by SACHRP in October 2006 and is charged with 
developing recommendations for consideration by SACHRP regarding the 
application of subpart A of 45 CFR part 46 in the current research 
    SOH was established by SACHRP at its July 2009 meeting and 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 meeting will adjourn at 4:30 p.m. May 19, 2016. Time for public 
comment sessions will be allotted both days.
    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 one of the designated SACHRP points of contact at the address/
phone number listed above at least one week prior to the meeting. 
Registration is required for participation in the on-site public 
comment session; individuals may register on the day of the meeting. 
Individuals who would like to submit written statements as public 
comment should email or fax their comments to SACHRP at [email protected] 
at least five business days prior to the meeting. Note that public 
comment should be relevant to agenda topics.

    Dated: April 21, 2016.
Julia Gorey,
Executive Secretary, Secretary's Advisory Committee on Human Research 
Protections, Office for Human Research Protections.
[FR Doc. 2016-09818 Filed 4-26-16; 8:45 am]