Notice2021-13211
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
June 24, 2021
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 86 Issue 119 (Thursday, June 24, 2021)</title>
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[Federal Register Volume 86, Number 119 (Thursday, June 24, 2021)]
[Notices]
[Pages 33319-33320]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-13211]
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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 July 26, 2021.
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: <a href="/cdn-cgi/l/email-protection#ca99a2afb8b8afbebeafe48cbfa4a48aa2a2b9e4ada5bc"><span class="__cf_email__" data-cfemail="f5a69d90878790818190dbb3809b9bb59d9d86db929a83">[email protected]</span></a> or (202) 795-
7714. When submitting comments or requesting information, please
include the document identifier 0990-0260 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: Protection of Human Subjects: Assurance of
Compliance with Federal Policy/IRB Review/IRB Recordkeeping/Informed
Consent/Consent Documentation.
Type of Collection: Extension with change.
OMB No. 0990-0260 Office of the Assistant Secretary for Health,
Office for Human Research Protections.
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
[[Page 33320]]
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, institutional review boards and
investigators.
Table 1--Estimated Annual Reporting 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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.103(b)(5), .113 [Pre-2018 5,200 1 5,200 1 5,200
Requirements]/.108(a)(4), .113
[2018 Requirements]--Incident
Reporting, Suspension or
Termination of IRB approval
Reporting......................
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Total....................... .............. .............. 5,200 .............. 5,200
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Table 2--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....................... 6,000 .............. 96,000 .............. 1,152,000
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Table 3--Estimated Annual Third-Party Disclosure Burden
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Number of Average
Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures 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........
.46.116(a) and (b) (Pre-2018 6,000 25 150,000 0.5 75,000
Requirements)/.46.116 (b), (c)
and (d) [2018 Requirements]--
Elements of informed consent
and broad consent..............
.46.116(h)--[2018 Requirements]-- 100 3 300 0.5 150
Posting clinical trial consent
form...........................
.117(a) [Pre-2018 and 2018 6,000 25 150,000 0.5 75,000
Requirements]--Documentation of
informed consent...............
.117(c)(2) [Pre-2018 and 2018 6,000 10 60,000 1 60,000
Requirements]--Written
statement about the research
when informed consent
documentation is waived........
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Total....................... .............. .............. 510,300 .............. 285,150
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2021-13211 Filed 6-23-21; 8:45 am]
BILLING CODE 4150-36-P
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