[Federal Register Volume 89, Number 63 (Monday, April 1, 2024)]
[Notices]
[Page 22413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0263]


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 May 31, 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 0990-0263-60D 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 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 
Identification/IRB Certification/Declaration of Exemption Form.
    Type of Collection: Renewal, three-year extension with non-
substantive changes for the Protection of Human Subjects: Assurance 
Identification/IRB Certification/Declaration of Exemption Form OMB No. 
0990-0263 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 is requesting a three-year 
extension with non-substantive changes of the Protection of Human 
Subjects: Assurance Identification/IRB Certification/Declaration of 
Exemption Form, OMB No. 0990-0263.
    The information collected on the form is to provide a simplified 
method for institutions engaged in research conducted or supported by 
the Department of Health and Human Services (HHS) to satisfy the 
requirements of HHS regulations for the protection of human subjects at 
45 CFR 46.103 for assurance identification and institutional review 
board (IRB) certification and declare exemption status. Non-substantive 
changes include adding instructions that, if additional assurances 
apply, those details can be indicated in the ``Comments'' section and 
clarifying that the form element for IRB expiration date does not apply 
to all projects.
    Likely Respondents: Institutions engaged in research involving 
human subjects where the research is supported by HHS. Institutional 
use of the form is also relied upon by other Federal departments and 
agencies that have codified or follow the Federal Policy for the 
Protection of Human Subjects (Common Rule), which is codified for HHS 
at 45 CFR part 46, subpart A.

                                          Annualized Burden Hour Table
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                                                                  Number of
                  Form name                      Number of      responses per      Hours per     Response burden
                                                respondents       respondent        response          hours
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Protection of Human Subjects: Assurance               13,000                2              0.5           13,000
 Identification/IRB Certification/
 Declaration of Exemption...................
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2024-06803 Filed 3-29-24; 8:45 am]
BILLING CODE 4150-36-P