[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42086-42087]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-13833]


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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 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, the full meeting agenda, and 
instructions for linking to public access 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, July 19, 2023 from 11:00 
a.m. until 5:00 p.m., and Thursday, July 20, 2023, from 11:00 a.m. 
until 5:00 p.m. (times are tentative and subject to change). The 
confirmed times and agenda will be posted on the SACHRP website as this 
information becomes available.

ADDRESSES: This meeting will be held via webcast. Members of the public 
may also attend the meeting via webcast. Instructions for attending via 
webcast will be posted at least one week prior to the meeting at 
https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html.

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 11:00 a.m., on 
Wednesday, July 19, 2023, followed by opening remarks from Julie 
Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP 
Chair. The meeting will begin with a discussion of IRB effectiveness, 
topic #4 of the recently published GAO report #GAO-23-104721, 
Institutional Review Boards: Actions Needed to Improve Federal 
Oversight and Examine Effectiveness. This will be followed by 
commentary on the FDA draft guidance, Decentralized Clinical Trials for 
Drugs, Biological Products, and Devices, in addition to discussion of 
recommendations that address the ethical conduct of decentralized 
clinical trials in human subjects research more broadly.
    Discussion of both topics will continue on July 20, in addition to 
commentary on the recently released

[[Page 42087]]

draft HHS guidance, Frequently Asked Questions: Limited Institutional 
Review Board Review and Related Exemptions. Other topics may be added; 
for the full and updated meeting agenda, see http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html. The meeting will adjourn by 5:00 
p.m. July 20, 2023.
    Time will be allotted for public comment on both days of the 
meeting. The public may submit written public comment in advance to 
[email protected] no later than midnight July 12, 2023, ET. Written 
comments will be shared with SACHRP members and may be read aloud 
during the meeting. Public comment must be relevant to topics being 
addressed by the SACHRP.

    Dated: June 12, 2023.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2023-13833 Filed 6-28-23; 8:45 am]
BILLING CODE 4150-36-P