Office for Human Research Protections Incident Report Form

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Supporting Doc IRPT PRA_0990_OMB_New Collection.pdf	Supporting Statement A	Uploaded 2020-12-30	Repair queued
Incident Report Form with Instructions .pdf	Supplementary Document	Uploaded 2020-09-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
245427	Incident Report	Other-form	New
245426	Incident Report	Other-form	New
245425	Incident Report	Other-form	New

ICR Details

OMB Control No: 0990-0477	ICR Reference No: 202009-0990-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Office for Human Research Protections Incident Report Form
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/04/2021
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/26/2021
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2024	36 Months From Approved
Responses	1,200	0	0
Time Burden (Hours)	600	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: OHRP in the Office of the Assistant Secretary for Health of HHS is requesting approval from the Office of Management and Budget of OHRP’s Incident Report Form. This form will facilitate prompt reporting of specific human subject protection incidents to OHRP by organizations and institutions conducting or reviewing human subjects research, and will provide a simplified standardized format for the reports. The information collected on the form will help OHRP to ensure the safety of human research subjects involved in non-exempt HHS-conducted or –supported research and to ensure that the research is conducted in accordance with the HHS Protection of Human Subjects regulations at 45 CFR part 46. This is a new information collection request.

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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:
	85 FR 59537	09/22/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 6657	01/22/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Incident Report
Incident Report
Incident Report

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ICR Summary of Burden

table that charts list 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	1,200	0	0	1,200	0	0
Annual Time Burden (Hours)	600	0	0	600	0	0
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: No

Burden Reduction Due to:

Short Statement: New Collection

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Annual Cost to Federal Government: $97,221

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: 01/26/2021

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