Research Complaint Form

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Research Complaint Form_ Revised July 2023_Clean.docx	Supplementary Document	Uploaded 2023-09-01	Repair queued
Research Complaint Form .pdf	Supplementary Document	Uploaded 2022-12-06	Repair queued
Research Complaint Form .pdf	Supplementary Document	Uploaded 2022-12-06	Repair queued
Supporting Statement_11.02.2022(002)_Revised July 2023_Tracking Changes.docx	Supporting Statement A	Uploaded 2023-09-01	Repair queued
Supporting Statement _11.02.2022.pdf	Supporting Statement A	Uploaded 2022-12-06	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
257259	Research Complaint Form		New
257258	Research Complaint Form		New
257244	Research Complaint Form		New

ICR Details

OMB Control No: 0990-0490	ICR Reference No: 202212-0990-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/HHSDM	Agency Tracking No:
Title: Research Complaint 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: 09/13/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/04/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2026	36 Months From Approved
Responses	1,600	0	0
Time Burden (Hours)	800	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Office of the Assistant Secretary for Health, Office for Human Research Protections (OHRP) is requesting a new approval from the Office of Management and Budget of OHRP’s Research Complaint Form. This form will provide a simplified standardized format for submitting to OHRP allegations of noncompliance involving human subject research projects conducted or supported by HHS. The information collected will help OHRP ensure the rights of human subjects involved in such research and that assured institutions are complying with the HHS Protection of Human Subjects regulations.

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Authorizing Statute(s): US Code: 42 USC Section 289 Name of Law: PHSA
  

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:
	87 FR 76206	12/13/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 25666	04/27/2023
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
Research Complaint Form
Research Complaint Form
Research Complaint Form

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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	1,600	0	0	1,600	0	0
Annual Time Burden (Hours)	800	0	0	800	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 ICR

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Annual Cost to Federal Government: $117,645

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: 05/04/2023

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