Notice2024-12111
Agency Information Collection Request; 60-Day Public Comment Request
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 3, 2024
Issuing agencies
Health and Human Services Department
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Full Text
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<title>Federal Register, Volume 89 Issue 107 (Monday, June 3, 2024)</title>
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[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47578-47579]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-12111]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0260]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
ACTION: Notice.
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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before August 2,
2024.
ADDRESSES: Submit your comments to <a href="/cdn-cgi/l/email-protection#bfecd7dacdcddacbcbda91f9cad1d1ffd7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="386b505d4a4a5d4c4c5d167e4d56567850504b165f574e">[email protected]</span></a> or by calling
(202) 264-0041 and <a href="/cdn-cgi/l/email-protection#efbfbdaeafa7a7bcc1a8a0b9"><span class="__cf_email__" data-cfemail="1d4d4f5c5d55554e335a524b">[email protected]</span></a>.
FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting
information, please include the document identifier 0990-0260-60D and
project title for reference, to Sherrette A. Funn, email:
<a href="/cdn-cgi/l/email-protection#b0e3d8d5c2c2d5c4c4d59ef6c5dedef0d8d8c39ed7dfc6"><span class="__cf_email__" data-cfemail="1e4d767b6c6c7b6a6a7b30586b70705e76766d30797168">[email protected]</span></a>, <a href="/cdn-cgi/l/email-protection#affffdeeefe7e7fc81e8e0f9"><span class="__cf_email__" data-cfemail="a9f9fbe8e9e1e1fa87eee6ff">[email protected]</span></a> or call (202) 264-0041 the Reports
Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and
[[Page 47579]]
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Title of the Collection: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation.
Type of Collection: 3-year extension of a currently approved
collection.
OMB No. 0990-0260
Abstract: The Office of the Assistant Secretary for Health, Office
for Human Research Protections is requesting a three-year extension of
the Protection of Human Subjects: Assurance of Compliance with Federal
Policy/IRB Review/IRB Recordkeeping/Informed Consent/Consent
Documentation, OMB No. 0990-0260.
Information reported to the Federal departments and agencies under
the Common Rule with respect to a satisfactory assurance is used to
ensure that an institution engaged in non-exempt research involving
human subjects conducted or supported by a Common Rule department or
agency has (1) established adequate administrative policies and
procedures for protecting the rights and welfare of human subjects in
research, and (2) accepts that responsibility. Other reporting
requirements are used to: assess whether the institution is following
the established procedures; ensure that Federal funds are not expended
for unapproved human subjects research; and, determine if the approved
status of an awarded grant, contract, or cooperative agreement should
be reviewed, with the ultimate goal of maintaining or increasing human
subject protections.
Likely Respondents: institutions and institutional review boards.
Annualized Burden Hour Tables
Table 1--Estimated Annual IRB Recordkeeping Burden
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Number of Average
Common rule provision Number of responses per Total annual burden per Total hours
respondents respondent responses response
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.115 [Pre-2018 and 2018 6,000 16 96,000 12 1,152,000
Requirement]--Preparation and
documentation of IRB activities
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Total....................... .............. .............. 96,000 .............. 1,152,000
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Table 2--Estimated Annual Third-Party Disclosure Burden
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Number of
Number of disclosures Total annual Average
respondents per disclosures burden per Total hours
respondent disclosure
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.109(d) [Pre-2018 and 2018 6,000 25 150,000 0.5 75,000
Requirements]--Written
notification of................
IRB approval or disapproval of
research.......................
.116(a) and (b) (Pre-2018 6,000 25 150,000 0.5 75,000
Requirements)/.116 (b), (c) and
(d) [2018 Requirements]--
Elements of informed consent
and broad consent..............
.116(h)--[2018 Requirements]-- 425 5 2,125 0.5 1,063
Posting clinical trial consent
form...........................
.117(a) [Pre-2018 and 2018 6,000 20 120,000 0.5 60,000
Requirements]--Documentation of
informed consent...............
.117(c)(2) [Pre-2018 and 2018 6,000 5 30,000 .5 15,000
Requirements]--Written
statement about the research
when informed consent
documentation is waived........
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Total....................... .............. .............. 452,125 .............. 308,563
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-12111 Filed 5-31-24; 8:45 am]
BILLING CODE 4150-36-P
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