Agency Information Collection Revision 60-Day Public Comment Request
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...
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.
When submitting comments or requesting information, please include the document identifier 0990-0477-60D and project title for reference, to Sherrette A. Funn, email:
Sherrette.Funn@hhs.gov, PRA@HHS.GOV
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
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
( printed page 31760)
Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance Officer, Office of the Secretary.
45 CFR part 46