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:
0935-0143
ICR Reference No:
202512-0935-001
Status:
Active
Previous ICR Reference No:
202410-0935-002
Agency/Subagency:
HHS/AHRQ
Agency Tracking No:
Title:
Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
12/11/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/08/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2028
07/31/2028
07/31/2028
Responses
1,240
0
1,240
Time Burden (Hours)
100,811
0
100,811
Cost Burden (Dollars)
0
0
0
Abstract:
The Patient Safety and Quality Improvement Act of 2005 (hereafter the Patient Safety Act), 42 U.S.C. 299b-21 to 299b-26, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine's 1999 report, To Err is Human: Building a Safer Health System. The goal of the statute is to improve patient safety by providing an incentive for health care providers to work voluntarily with experts in patient safety to reduce risks and hazards to the safety and quality of patient care. The Patient Safety Act signifies the Federal Government's commitment to fostering a culture of patient safety among health care providers; it offers a mechanism for creating an environment in which the causes of risks and hazards to patient safety can be thoroughly and honestly examined and discussed without fear of penalties and liabilities. It provides for the voluntary formation of Patient Safety Organizations (PSOs) that can collect, aggregate, and analyze confidential information reported voluntarily by health care providers. By analyzing substantial amounts of patient safety event information across multiple institutions, PSOs will be able to identify patterns of failures and propose measures to eliminate or reduce patient safety risks and hazards.
Authorizing Statute(s):
US Code:
42 USC 299
Name of Law: Healthcare Research and Quality Act of 1999
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 65629
08/12/2024
30-day Notice:
Federal Register Citation:
Citation Date:
89 FR 83499
10/16/2024
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
Attachment C_Patient Safety Organization Certification for Initial Listing Form
Form 1
PSO Certification for Initial Listing Form
Attachment D_PSO Certification for Continued Listing Form
Form 2
PSO Certification for Continued Listing Form
Attachment E_PSO Two Bona Fide Contracts Requirement Form
Form 3
PSO Two Bona Fide Contracts Requirement Form
Attachment F_PSO Disclosure Statement Form
Form 4
PSO Disclosure Statement
Attachment G_PSO Profile Form
Form 5
PSO profile name
Attachment H_PSO Change of Listing Information
Form 6
PSO Change of Listing Information
Attachment I_OCR Complaint Consent Form
8
OCR Complaint Consent Form
Attachment J_PSO Voluntary Relinquishment Form
Form 7
PSO Request for Voluntary Relinquishment
Attachment K_AHRQ Common Formats
Form 9
AHRQ Common Formats
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
1,240
1,240
0
0
0
0
Annual Time Burden (Hours)
100,811
100,811
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$1,373,675
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:
Margie Shofer 301 427-1696
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:
12/08/2025
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