[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Notices]
[Pages 12110-12111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03895]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Secretary's Advisory Committee on Human Research 
Protections

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

ACTION: Notice.

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SUMMARY: Pursuant to Section 10(a) of the Federal Advisory Committee 
Act, 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: http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

DATES: The meeting will be held on Wednesday, March 15, 2017, from 8:30 
a.m. until 5:00 p.m. and Thursday, March 16, 2017, from 8:30 a.m. until 
4:30 p.m.

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

FOR FURTHER INFORMATION CONTACT: Julia Gorey, J.D., Executive Director, 
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].

[[Page 12111]]


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 Subpart A Subcommittee (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 environment.
    The Subcommittee on Harmonization (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 SACHRP meeting will open to the public at 8:30 a.m., 
on Wednesday, March 15, 2017, followed by opening remarks from Dr. 
Jerry Menikoff, Director of OHRP and Executive Secretary of SACHRP, and 
Dr. Stephen Rosenfeld, SACHRP Chair. Dr. Menikoff will then lead a 
discussion focusing on selected sections of the new Common Rule, which 
was published January 19, 2017, with an effective date of January 19, 
2018 (see https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm).
    The SOH will present their recommendations for considerations of 
the new Common Rule's compliance dates and transition provisions, as 
well as for the interpretation and implementation of the new broad 
consent provision. The SAS will discuss their report on the 
interpretation of the new exemption involving benign behavioral 
interventions.
    The Wednesday meeting will adjourn at approximately 5:00 p.m.
    The Thursday, March 16, meeting will begin at 8:30 a.m. with 
recommendations from the SOH on the FDA Draft Guidance ``Use of Real-
World Evidence to Support Regulatory Decision-Making for Medical 
Devices,'' issued July 27, 2016. SOH will also present recommendations 
on the return of incidental findings to research subjects. The SAS will 
present recommendations surrounding the new Common Rule's expedited 
review requirements.
    The meeting will adjourn at 4:30 p.m. March 16, 2017. Time for 
public comment sessions will be allotted both days. Note that public 
comment must be relevant to issues being addressed by the SACHRP.
    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. On-
site registration is required for participation in the live public 
comment session. 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.

    Dated: February 23, 2017.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2017-03895 Filed 2-27-17; 8:45 am]
 BILLING CODE 4150-36-P