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:
201104-0935-004
Status:
Historical Active
Previous ICR Reference No:
201011-0935-003
Agency/Subagency:
HHS/AHRQ
Agency Tracking No:
Title:
Patient Safety Organization Certification Forms and Patient Safety Confidentiality Complaint Form
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
06/02/2011
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/12/2011
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2012
6 Months From Approved
08/31/2011
Responses
278
0
183
Time Burden (Hours)
101
0
77
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. The Guidance addresses questions that have arisen regarding the obligations of PSOs where they or the organization of which they are a part are legally obligated under the FDCA and its implementing regulations to report certain information to the FDA and to provide FDA with access to its records, including access during an inspection of its facilities. This Guidance applies to all entities that seek to be or are PSOs or component PSOs that have mandatory FDA-reporting obligations under the FDCA and its implementing regulations or are organizationally related to such FDA-regulated reporting entities. In order to meet the requirements of the Guidance, AHRQ is requesting approval of supplemental attestations regarding FDA reporting obligations of PSOs form. This form is for entities to certify that they meet the obligations that an entity must meet to be listed and that a PSO must meet to remain listed when the entity or PSO is an FDA-regulated reporting entity or is organizationally related to an FDA-regulated reporting entity. This form will be used for less than one year and will be incorporated into the existing PSO forms with the submission on the renewal clearance later in the year.
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
02/21/2008
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
74 FR 4748
01/27/2009
30-day Notice:
Federal Register Citation:
Citation Date:
76 FR 10905
02/28/2011
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 #6
Certification for Continued Listing Form
Disclosure Form - Revised
Form #5
Disclosure Statement Form
Information Form - Revised
Form #3
Information Form
Patient Safety Confidentiality Complaint Form
Form #1
Patient Safety Confidentiality Complaint Form
Patient Safety Organization Certification for Initial Listing Form
Form #4
Patient Safety Organization Certification for Initial Listing Form
Two Bona Fide Contracts Requirement Form
Form #2
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
278
183
0
95
0
0
Annual Time Burden (Hours)
101
77
0
24
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:
Addition of a new form to the PSO Forms. The addition of the Attestation Form will add 24 burden hours annually to the existing data 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]?
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:
04/12/2011
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