[Federal Register Volume 83, Number 185 (Monday, September 24, 2018)]
[Notices]
[Pages 48318-48319]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20676]


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

DATES: The meeting will be held on Tuesday, October 16, 2018, from 8:30 
a.m. until 5 p.m., and Wednesday, October 17, 2018, from 8:30 a.m. 
until 4 p.m.

ADDRESSES: 6700B Rockledge Drive, Bethesda, MD 20817.

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

[[Page 48319]]

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, October 16, 2018, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP 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 at Sec.  46.116(a)(5)(i). This will be followed by 
a discussion of recommendations of the interpretation of the revised 
Common Rule's exemptions Sec.  46.104(d)(1) and (2) for HHS funded 
research. Lastly, the committee will continue its July discussions on 
the Office of Inspector General Report, July 7, 2017: ``OHRP Generally 
Conducted Its Compliance Activities Independently, But Changes Would 
Strengthen Its Independence.''
    The Wednesday, October 17, meeting will begin at 8:30 a.m. The SAS 
subcommittee will present and discuss recommendations on the 
interpretation of ``reasonably available'' at Sec.  46.408(b), as well 
as discuss issues surrounding payment of subjects for participation in 
research. Modifications to the previous day's work will be discussed 
and finalized. The meeting will adjourn at approximately 4:00 p.m., 
October 17, 2018.
    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 topics 
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: September 14, 2018.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2018-20676 Filed 9-21-18; 8:45 am]
 BILLING CODE 4150-36-P