[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19627-19628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07622]


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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 June 14, 2021.

ADDRESSES: Submit your comments to [email protected] or by calling 
(202) 795-7714.

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 Funn, email: 
[email protected], or call 202-795-7714 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 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.

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 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.......................  ..............  ..............          96,000  ..............       1,152,000
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[[Page 19628]]


                             Table 3--Estimated Annual Third-Party Disclosure Burden
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                                                    Number of                         Average
                                    Number of    disclosures per   Total annual     burden per      Total hours
                                   respondents      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                           100                3             300             0.5             150
 Requirements]--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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Sherrrette A. Funn,
Paperwork Reduction Act Reports Clearance Office, Office of the 
Secretary.
[FR Doc. 2021-07622 Filed 4-13-21; 8:45 am]
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