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:
200810-0935-001
Status:
Historical Active
Previous ICR Reference No:
200804-0935-003
Agency/Subagency:
HHS/AHRQ
Agency Tracking No:
Title:
Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
10/02/2008
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/06/2008
Retrieve Notice of Action (NOA)
Date Received in OIRA:
10/02/2008
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2009
6 Months From Approved
Responses
183
0
0
Time Burden (Hours)
77
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The Patient Safety and Quality Improvement Act of 2005 (hereafter the Patient Safety Act, see Attachment A-2), signed into law on July 29, 2005, 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. When specific statutory requirements are met by organizations seeking to offer expert analytic services regarding patient safety, the information collected and the analyses and deliberations regarding the information, receive Federal confidentiality and privilege protections under this legislation. The Secretary of the Department of Health and Human Services delegated authority to the Director of the Office for Civil Rights (OCR) to enforce the confidentiality protections of the patient safety legislation and delegated authority to the Director of the Agency for Healthcare Research and Quality (AHRQ) to implement and administer the rest of the statute's provisions (Federal Register, Vol. 71, No. 95, May 17, 2006, p. 28701-2).
Emergency Justfication:
AHQR is requesting an emergency review of this collection because it has been decided that listing of PSOs should take place during the period between now and the effective date of the final rule (i.e., interim period). An Interim Guidance document, reviewed and approved by OMB, will provide guidance during this interim period to entities seeking listing and entities that are listed as PSOs during this interim period. These forms have been revised to reflect only the statutory requirements and the provisions of the proposed rule that the Interim Guidance document notes are binding.
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 8112
02/12/2008
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
Disclosure Form
Form #3
Disclosure Form
Disclosure Form - Revised
Form #3
Disclosure Form 10/2/2008
Information Form
Form #5
Information Form
Information Form - Revised
Form #5
Information Form 10/2/2008
Patient Safety Confidentiality Complaint Form
Form #6
Patient Safety Confidentiality Complaint Form
Patient Safety Confidentiality Complaint Form - Revised
Form #6
Patient Safety Confidentiality Complaint Form 10/2/2008
Patient Safety Organization Certification Form
Form #1
Patient Safety Organization Certification Form
Patient Safety Organization Certification Form - Revised
Form #1
Patient Safety Organization Certification Form 10/2/2008
Recertification Form
Form #2
Recertification Form
Recertification Form - Revised
Form #2
Recertification Form 10/2/2008
Two-Contract Requirement Form
Form #4
Two-Contract Requirement Form
Two-Contract Requirement Form - Revised
Form #4
Two-Contract Requirement Form 10/2/2008
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
183
0
0
183
0
0
Annual Time Burden (Hours)
77
0
0
77
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:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection
Annual Cost to Federal Government:
$7,500
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
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:
10/02/2008
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