Notice2024-18447
Agency Information Collection Request; 30-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
August 19, 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 160 (Monday, August 19, 2024)</title>
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[Federal Register Volume 89, Number 160 (Monday, August 19, 2024)]
[Notices]
[Pages 67095-67096]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-18447]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-0260]
Agency Information Collection Request; 30-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 September 18,
2024.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, <a href="/cdn-cgi/l/email-protection#90c3f8f5e2e2f5e4e4f5bed6e5fefed0f8f8e3bef7ffe6"><span class="__cf_email__" data-cfemail="84d7ece1f6f6e1f0f0e1aac2f1eaeac4ececf7aae3ebf2">[email protected]</span></a>
or (202) 264-0041, or <a href="/cdn-cgi/l/email-protection#a6f6f4e7e6eeeef588e1e9f0"><span class="__cf_email__" data-cfemail="04545645444c4c572a434b52">[email protected]</span></a>. When submitting comments or
requesting information, please include the document identifier 0990-
0260-30D and project title for reference.
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 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: 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
[[Page 67096]]
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
Common rule provision Number of responses per Total annual Average burden Total hours
respondents respondent responses per 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 burden Total hours
respondents per respondent disclosures per 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 .............. 226,063
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2024-18447 Filed 8-16-24; 8:45 am]
BILLING CODE 4150-36-P
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