[Federal Register Volume 83, Number 37 (Friday, February 23, 2018)]
[Notices]
[Pages 8090-8091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03768]


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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

[[Page 8091]]

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 website at: http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html.

DATES: The meeting will be held on Tuesday, March 13, 2018, from 8:30 
a.m. until 5:00 p.m., and Wednesday, March 14, 2018, from 8:30 a.m. 
until 4:00 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 (HHS), 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, March 13, 2018, followed by opening remarks from Dr. Jerry 
Menikoff, Director of the Office for Human Research Protections and Dr. 
Stephen Rosenfeld, SACHRP Chair.
    The SAS and SOH subcommittees will present their recommendations 
regarding the description of ``key information,'' as required by the 
revised Common Rule's Sec.  46.116(a)(5)(i). This will be followed by a 
discussion of SOH recommendations on the research use of repositories 
and registries under various consent models, under both the current and 
the revised Common Rule. The Tuesday, March 13, meeting will adjourn at 
approximately 5:00 p.m.
    The Wednesday, March 14, meeting will begin at 8:30 a.m. The SOH 
will present and discuss recommendations on the European Union's 
General Data Protection Regulation and its impact on U.S. human 
subjects research. Modifications to the previous day's work will be 
discussed and finalized. The meeting will adjourn at approximately 4:00 
p.m.
    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 the designated SACHRP point of contact at the address/phone 
number listed above at least one week prior to the meeting.

    Dated: February 16, 2018.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2018-03768 Filed 2-22-18; 8:45 am]
 BILLING CODE 4150-36-P