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:
0935-0269
ICR Reference No:
202506-0935-002
Status:
Active
Previous ICR Reference No:
Agency/Subagency:
HHS/AHRQ
Agency Tracking No:
Title:
The AHRQ Safety Program for Healthcare Associated Infection Prevention
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:
08/08/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/23/2025
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2028
36 Months From Approved
Responses
3,800
0
0
Time Burden (Hours)
2,469
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
Healthcare-associated infections (HAIs) are a major cause of illness in the U.S., affecting one out of every 31 hospital inpatients (3% of all hospitalized patients) daily and resulting in as many as 700,000 infections per year. Some of the most predominant HAIs include catheter-associated urinary tract infections (CAUTI), central line-associated blood stream infections (CLABSI), and ventilator-associated pneumonia and ventilator-associated adverse events (VAP/VAE). The current estimate for CAUTI incidence in hospitalized patients is approximately 27,000 cases annually and 30,000 CLABSI cases annually,1 VAEs affect between 5-40% of patients requiring mechanical ventilator support for more than two days. VAE is considered the deadliest HAI, with all-cause mortality rates associated with VAE as high as 50% and a direct attributable mortality rate of 9%. To help hospitals reduce HAIs AHRQ created the Comprehensive Unit-based Safety Program (CUSP). CUSP is designed to engage clinical teams to make healthcare safer by combining improved teamwork, clinical best practices, and the science of safety. The CUSP approach improves safety culture at the unit level, enables harm prevention, and engages providers who are on the front lines while integrating technical and adaptive/cultural approaches to making sustainable change. The Core CUSP toolkit provides teams with training resources and tools to apply the CUSP method and build their capacity to address safety issues. The AHRQ Safety Program for HAI Prevention Program will assess what components of the updated toolkits are routinely used and helpful and what components need additional updating and refinement. Current AHRQ HAI Prevention Toolkits provide a wealth of valuable information but also require revision to incorporate new evidence-based practices and remove those no longer supported by scientific evidence. Revised Toolkits based on lessons learned from the implementation of this program will enhance their utility to healthcare workers and support the adoption of the AHRQ Safety Program for HAI prevention practices.
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 91753
11/20/2024
30-day Notice:
Federal Register Citation:
Citation Date:
90 FR 21305
05/19/2025
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
CUSP Device Rounds
3, 3, 3
CLABSI Monthly Device Rounds Checklist
,
CAUTI Monthly Device Rounds Checklist
,
VAP VAE Monthly Device Rounds Checklist
Clinical Outcomes Data
5
Clinical Outcomes Data Template
Gap Analysis
4, 4, 4
CLABSI Gap Analysis
,
CAUTI Gap Analysis
,
VAP VAE Gap Analysis
HSOPS
2
HSOPS
Semi-Structured Interview Guide
1
Semi-Structured Interview Guide
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
3,800
0
0
3,800
0
0
Annual Time Burden (Hours)
2,469
0
0
2,469
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:
This is a request for a new ICR.
Annual Cost to Federal Government:
$1,416,853
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
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.
Yes
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:
Amie Park 301 427-1662 amie.park@ahrq.hhs.gov
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:
06/23/2025