Office for Human Research Protections Incident Report Form

Forms and Documents

Document Name	Status
Form 0990-0477 Incident Report Form	Modified
Form 0990-0477 Incident Report Form	Modified
Form 0990-0477 Incident Report Form	Modified
Incident Report Form Instructions_June 2024.docx Supplementary Document	2024-07-11
Incident Report Form_June 2024.docx Supplementary Document	2024-07-11
Supporting Statement_ Incident Report Form 30-Day Reinstatement PRA_June 2024.docx Supporting Statement A	2024-07-11
42 U.S.C. Section 289.docx Supplementary Document	2024-04-19
45 CFR 46 2018 Requirements.docx Supplementary Document	2024-04-19
45 CFR part 46 Regulations_Pre-2018 Requirements.pdf Supplementary Document	2024-04-19

IC Document Collections

IC ID	Document Title	Status
245427	Incident Report Form	Modified
245426	Incident Report Form	Modified
245425	Incident Report Form	Modified

ICR Details

OMB Control No: 0990-0477	ICR Reference No: 202404-0990-008
Status: Received in OIRA	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	Date Submitted to OIRA: 07/24/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	1,100	0
Time Burden (Hours)	551	0
Cost Burden (Dollars)	0	0

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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.

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Authorizing Statute(s): US Code: 42 USC 289 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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ICR Summary of Burden

	Total Request	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.

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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

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Common Form ICR:  No

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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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