Notice2023-13833
Meeting of the Secretary's Advisory Committee on Human Research Protections
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 29, 2023
Issuing agencies
Health and Human Services Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 124 (Thursday, June 29, 2023)</title>
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[Federal Register Volume 88, Number 124 (Thursday, June 29, 2023)]
[Notices]
[Pages 42086-42087]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html">http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html</a>.
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
<a href="https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html">https://www.hhs.gov/ohrp/sachrp-committee/meetings/index.html</a>.
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: <a href="/cdn-cgi/l/email-protection#461507050e1416062e2e3568212930"><span class="__cf_email__" data-cfemail="c99a888a819b9989a1a1bae7aea6bf">[email protected]</span></a>.
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 <a href="http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html">http://www.dhhs.gov/ohrp/sachrp-committee/meetings/index.html</a>. 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
<a href="/cdn-cgi/l/email-protection#6a392b2922383a2a020219440d051c"><span class="__cf_email__" data-cfemail="c192808289939181a9a9b2efa6aeb7">[email protected]</span></a> 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
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