[Federal Register Volume 89, Number 81 (Thursday, April 25, 2024)]
[Notices]
[Pages 31759-31760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0477]


Agency Information Collection Revision 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 24, 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 0990-0477-60D 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: Incident Report Form.
    Type of Collection: Reinstatement with Change.
    OMB No.: 0990-0477.
    Abstract: The Office of the Assistant Secretary for Health, Office 
for Human Research Protections (OHRP), is requesting reinstatement of 
the OMB No. 0990-0477, Incident Report Form, with two new information 
elements on the Incident Report form: IORG # for Reviewing IRB; and, 
Revising research policies and procedures as a corrective action plan 
category, if it applies. The purpose of the Incident Report form is to 
facilitate organizations or institutions prompt reporting of specific 
human subject protection incidents to OHRP, in a simplified 
standardized format, as required by HHS protection of human subjects 
regulations at 45 CFR part 46.

                                          Annualized Burden Hour Table
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                                                                     Number of
                   Forms name                        Number of     responses per  Average burden   Total burden
                                                    respondents     respondents    per response        hours
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Incident Report.................................              25               1           30/60            12.5
Incident Report.................................              25               3           30/60            37.5
Incident Report.................................             200               5           30/60             500
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............             550
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[[Page 31760]]

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2024-08799 Filed 4-24-24; 8:45 am]
BILLING CODE 4150-36-P