View Information Collection Request (ICR) Package
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Brief and OIRA conclusion
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Burden
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Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
201107-0935-001
Status:
Historical Active
Previous ICR Reference No:
201104-0935-004
Agency/Subagency:
HHS/AHRQ
Agency Tracking No:
Title:
Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
10/31/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/11/2011
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2014
36 Months From Approved
06/30/2012
Responses
919
0
278
Time Burden (Hours)
75,764
0
101
Cost Burden (Dollars)
0
0
0
Abstract:
The Patient Safety and Quality Improvement Act of 2005 was enacted to provide an incentive for health care providers to work to improve patient safety. In order to implement the act, HHS issued the Patient Safety and Quality Improvement Final Rule which establishes a framework by which providers may voluntarily report information to PSOs. In addition, the Patient Safety Rule outlines the requirements that entities must meet to become PSOs and the process by which the Secretary will review and accept certifications and list PSOs. In December 2010, HHS issued Guidance Regarding Patient Safety Organizations' Reporting Obligations and the Patient Safety and Quality Improvement Act of 2005. On June 2nd, 2011 OMB approved Supplemental Attestations Regarding FDA Reporting Obligations Of PSOs, a new form to comply with this new Guidance. With this submission the Attestation Form has been incorporated into the other existing PSO forms.
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:
0919-AA01
Final or interim final rulemaking
73 FR 70732
11/21/2008
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
76 FR 21744
04/18/2011
30-day Notice:
Federal Register Citation:
Citation Date:
76 FR 37115
06/24/2011
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Attestation Form
Form #7
Attestation Form
Certification for Continued Listing Form
Form #2
PSO Certification for Continued Listing Form
Common Formats
Form #7
Common Formats Complete Set of Forms
Disclosure Form - Revised
Form #4
PSO Disclosure Statement Form
Information Form - Revised
Form #5
PSO Information Form
Patient Safety Confidentiality Complaint Form
Form #6
Patient Safety Confidentiality Complaint Form
Patient Safety Organization Certification for Initial Listing Form
Form #1
Patient Safety Organization Certification for Initial Listing Form
Two Bona Fide Contracts Requirement Form
Form #3
PSO Two Bona Fide Contracts Requirement Form
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
919
278
0
605
36
0
Annual Time Burden (Hours)
75,764
101
0
74,959
704
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The burden estimates have changed for all of the PSO forms, except for the Patient Safety Confidentiality Complaint form, and the Common Formats. The burden estimates in the previous submission, which was a new collection, were developed prior to the full implementation of the PSO program. The new estimates were revised to reflect input on the forms and Common Formats received from PSOs, healthcare organizations, and providers at the AHRQ annual meetings, PSO annual meetings, and technical assistance calls with PSOs.
Annual Cost to Federal Government:
$2,037,390
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
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?
Uncollected
Agency Contact:
Doris Lefkowitz 3014271477
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:
07/11/2011
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