AGENCY:
Office of the Secretary, HHS.
ACTION:
Notice.
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, Sherrette.Funn@hhs.gov or (202) 264-0041, or PRA@HHS.GOV. 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
| Forms name | Number of respondents | Number of responses per respondents | Average burden per response | Total burden hours |
|---|---|---|---|---|
| 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 |
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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