[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Page 30876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13932]


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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 Secretary, Office of the Assistant Secretary for 
Health, 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 Tuesday, July 25, 2017, from 8:30 
a.m. until 5:00 p.m., and Wednesday, July 26, 2017, from 8:30 a.m. 
until 2:30 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].

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 
Tuesday, July 25, 2017, followed by opening remarks from Dr. Jerry 
Menikoff, Director, Office for Human Research Protections and Dr. 
Stephen Rosenfeld, SACHRP Chair. (https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/html/2017-01058.htm).
    The SOH will present their recommendations regarding the new Common 
Rule's compliance dates and transition provisions, as well as for the 
interpretation and implementation of the broad consent provision, 
followed by the SAS discussing their report on the interpretation of 
the new exemption involving benign behavioral interventions. The 
Tuesday, July 25, meeting will adjourn at approximately 5:00 p.m.
    The Wednesday, July 26, meeting will begin at 8:30 a.m. with 
discussion of recommendations from the SAS regarding the new Common 
Rule's expedited review requirements.
    The meeting will adjourn at approximately 2:30 p.m., July 26, 2017. 
Time for public comment sessions will be allotted both days. On-site 
registration is required for participation in the live public comment 
session. Note that public comment must be relevant to issues currently 
being addressed by the SACHRP. Individuals submitting 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.
    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.

    Dated: June 27, 2017.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2017-13932 Filed 6-30-17; 8:45 am]
 BILLING CODE 4150-36-P