View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0990-0477
ICR Reference No:
202404-0990-008
Status:
Active
Previous ICR Reference No:
202009-0990-002
Agency/Subagency:
HHS/HHSDM
Agency Tracking No:
Title:
Office for Human Research Protections Incident Report Form
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/06/2024
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/24/2024
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2027
36 Months From Approved
Responses
1,100
0
0
Time Burden (Hours)
551
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The U.S. Department of Health and Human Services (HHS)’ Office for Human Research Protections (OHRP) is requesting reinstatement of OMB No. 0990-0477, the OHRP Incident Report Form, with changes, for a three-year period. Reinstatement will be necessary because the current collection is approved by OMB through May 31, 2024, and a request for OMB to extend its approval has gone beyond the required time span for submission to OMB prior to that expiration date. This reinstatement information collection request includes 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 inclusion of these data elements did not affect the burden estimate. 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. Respondents for this information collection are organizations and institutions conducting or reviewing HHS conducted or supported human subjects research in compliance with the HHS Federal Policy for the Protection of Human Subjects (the Common Rule), which is codified for HHS at 45 CFR part 46, subpart A.
Authorizing Statute(s):
US Code:
42 USC 289
Name of Law: Public Health Service Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
89 FR 31759
04/25/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 58167
07/17/2024
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Incident Report
0990-0477
Incident Report
Incident Report
0990-0477
Incident Report
Incident Report
0990-0477
Incident Report
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
1,100
0
0
-100
0
1,200
Annual Time Burden (Hours)
551
0
0
-49
0
600
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The program changes are due to agency adjustments.
Annual Cost to Federal Government:
$256,563
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Sherette Funn-Coleman
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
07/24/2024
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