[Federal Register Volume 89, Number 137 (Wednesday, July 17, 2024)]
[Notices]
[Page 58167]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15655]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Document Identifier: OS-0990-0477]


Agency Information Collection Revision 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 reinstatement for public comment.

DATES: Comments on the ICR must be received on or before August 16, 
2024.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain . 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: Sherrette Funn, [email protected] 
or (202) 264-0041, or [email protected]. When submitting comments or 
requesting information, please include the document identifier 0990-
New-30D 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: 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       Average       Total
                      Forms name                          Number of     responses per    burden per     burden
                                                         respondents     respondents      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
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    Total............................................  ..............  ...............  ...........          550
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Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the 
Secretary.
[FR Doc. 2024-15655 Filed 7-16-24; 8:45 am]
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