[Federal Register Volume 84, Number 138 (Thursday, July 18, 2019)]
[Notices]
[Pages 34403-34404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15289]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, July 30, 2019, from 9 a.m. 
until 4:45 p.m., and Wednesday, July 31, 2019, from 9 a.m. until 3:30 
p.m.

ADDRESSES: National Institutes of Health, Vaccine Research Center Rooms 
1201/1203, 40 Convent Drive, Bethesda, Maryland 20892.

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 or 
coordination.
    The SACHRP meeting will open to the public at 9 a.m., on Tuesday, 
July 30, 2019, followed by opening remarks from Dr. Jerry Menikoff, 
Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair. New SACHRP 
members will be welcomed and introduced.
    The SOH subcommittee will present its recommendations on End User 
Licensing Agreements and Terms of Service, and Charging Subjects to 
Participate in Clinical Trials. This will be followed by a discussion 
of site monitoring under single IRB review, with a review of possible 
recommendations, and finally a discussion of guidance for institutions 
affected by the end of the voluntary check-the-box option to extend a 
federalwide assurance to all research regardless of funding.
    Wednesday will begin with a discussion of questions newly posed to 
SACHRP regarding Deceased Organ Intervention Research (DDIR), with a 
particular focus on recipient informed consent. There will be a panel 
presentations from leading experts in the field of DDIR, followed by 
SACHRP discussion. This will be followed by a discussion of ethical and 
regulatory issues surrounding reconsent of subjects for human subjects 
research. The meeting is scheduled to end at approximately 3:30 p.m.
    Time will be allotted for public comment on 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

[[Page 34404]]

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: July 3, 2019.
Julia G. Gorey,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2019-15289 Filed 7-17-19; 8:45 am]
BILLING CODE 4150-28-P