[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Page 8732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04406]


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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, Department of 
Health and Human Services, Office of the Secretary.

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 Wednesday, March 27, 2019, from 8:30 
a.m. until 4:00 p.m., and Thursday, March 28, 2019, from 8:30 a.m. 
until 3:00 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, 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 
Wednesday, March 27, 2019, followed by opening remarks from Dr. Jerry 
Menikoff, Director of OHRP and Dr. Stephen Rosenfeld, SACHRP Chair.
    The SAS subcommittee will present their revised recommendation on 
Subject Payment: Ethical and Regulatory Considerations. This will be 
followed by a discussion of implementation issues experienced to date 
regarding the newly effective revised Common Rule. The afternoon will 
conclude with a discussion of questions newly posed to SACHRP regarding 
Deceased Donor 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. 
The meeting is scheduled to end at approximately 4:00 p.m.
    The meeting will begin at 8:30 a.m. on Thursday, March 28th. The 
SAS subcommittee will present and discuss draft recommendations 
regarding charging subjects to participate in clinical trials. 
Additional time is reserved for emerging topics and continuing the 
previous day's discussions. The meeting will adjourn at approximately 
3:00 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 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: February 26, 2019.
Julia G. Gorey, J.D.,
Executive Director, Secretary's Advisory Committee on Human Research 
Protections.
[FR Doc. 2019-04406 Filed 3-8-19; 8:45 am]
 BILLING CODE 4150-36-P