Notice2023-04324
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
March 2, 2023
Issuing agencies
Health and Human Services Department
Abstract
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, 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 41 (Thursday, March 2, 2023)</title>
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<body><pre>[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13131-13132]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-04324]
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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, 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, March 22, 2023 from 11:00
a.m. until 5:00 p.m., and Thursday, March 23, 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#673426242f3537270f0f1449000811"><span class="__cf_email__" data-cfemail="326173717a6062725a5a411c555d44">[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.
[[Page 13132]]
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, March 22, 2023, followed by opening remarks from Julie
Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP
Chair. The meeting will begin with an overview of the recently
published GAO report #GAO-23-104721, Institutional Review Boards:
Actions Needed to Improve Federal Oversight and Examine Effectiveness,
followed by a panel of expert speakers addressing the topic of defining
stakeholders and evaluating HRPP/IRB quality and effectiveness. SACHRP
will subsequently discuss recommendations related to the report's
recommendation #4.
A second agenda topic will be introduced and discussed at SACHRP in
the afternoon, the FDA draft guidance on Ethical Considerations for
Clinical Investigations of Medical Products Involving Children Guidance
for Industry, Sponsors, and IRBs.
Discussion of both topics will continue on March 23rd. 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. March 23, 2022.
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#b7e4f6f4ffe5e7f7dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="6a392b2922383a2a020219440d051c">[email protected]</span></a> no later than midnight March 20th, 2023, ET. Written
comments will be shared with SACHRP members and may read aloud during
the meeting. Comments which are read aloud are limited to three minutes
each. Public comment must be relevant to topics being addressed by the
SACHRP.
Dated: February 23, 2023.
Julia G. Gorey,
Executive Director, SACHRP, Office for Human Research Protections.
[FR Doc. 2023-04324 Filed 3-1-23; 8:45 am]
BILLING CODE 4150-36-P
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