[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Page 18657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08017]


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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 the Assistant Secretary for Health.

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 Thursday, May 25, from 8:30 a.m. 
until 5:00 p.m., and Friday, May 26 from 8:30 a.m. until 4:30 p.m. 
Please note: this meeting was originally scheduled to be held March 15-
16, but was postponed due to a predicted snow storm.

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].

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 be open to the public at 8:30 a.m., on 
Thursday, May 25, 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 consideration 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 Thursday meeting will adjourn at approximately 5:00 p.m.
    The Friday, May 26, 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. May 26, 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 the designated SACHRP point 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: April 17, 2017.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2017-08017 Filed 4-19-17; 8:45 am]
 BILLING CODE 4150-36-P