[Federal Register Volume 89, Number 107 (Monday, June 3, 2024)]
[Notices]
[Pages 47578-47579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 [email protected] or by calling 
(202) 264-0041 and [email protected].

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: 
[email protected], [email protected] 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