View Information Collection Request (ICR) Package

OMB Control No: 0935-0238	ICR Reference No: 201906-0935-002
Status: Historical Active	Previous ICR Reference No: 201707-0935-003
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: The AHRQ Safety Program for Improving Antibiotic Use
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: 08/30/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2022	36 Months From Approved	09/30/2020
Responses	63,211	0	56,372
Time Burden (Hours)	27,064	0	22,442
Cost Burden (Dollars)	0	0	0

Abstract: The Agency for Healthcare Research and Quality (AHRQ) requests to revise and extend the currently approved AHRQ Safety Program for Improving Antibiotic Use. The AHRQ Safety Program for Improving Antibiotic Use aims to help facilities implement antibiotic stewardship programs and to reduce unnecessary antibiotic prescribing. The Safety Program has already been implemented in a pilot of integrated delivery systems and a national cohort of 400 acute care hospitals, and is currently being implemented in a national cohort of 500 long-term care facilities. The AHRQ Safety Program for Improving Antibiotic Use was last approved by OMB on September 25, 2017 and will expire on September 30, 2020. The request for extension is to allow for completion of activities and data collection in the AHRQ Safety Program, which are scheduled to occur through March 30, 2021. The OMB control number for the AHRQ Safety Program for Improving Antibiotic Use is 0935-0238. All of the supporting documents for the current AHRQ Safety Program for Improving Antibiotic Use can be downloaded from OMB’s website at https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201707-0935-003 The 2017 AHRQ Safety Program for Improving Antibiotic Use OMB clearance included one response for the Structural Assessment and the Medical Office Survey on Patient Safety Culture (MOSOPS) but did not include electronic health record (EHR) data or a second response for the Structural Assessment or MOSOPS. This was because our OMB clearance expiration date fell in the middle of the planned 4th cohort, set in ambulatory care settings, so the second Structural Assessment and MOSOPS were not within the timeframe, and EHR data collection would have been incomplete. In addition, we were not certain that the ambulatory care practices would be able to access EHR data, however based on the experience of the pilot cohort, we believe that many ambulatory practices can access this data, and that these practices are more likely to feasibly participate in the AHRQ Safety Program. The revision also updates the estimated annual burden accordingly, and includes changes to the data collection forms which will be used for the ambulatory care cohort based on lessons learned during the pilot cohort. Antibiotics can have serious adverse effects including Clostridium difficile infections (CDI), organ dysfunction, allergic reactions, and the development of antibiotic resistance on both a patient level and population level. This project will assist acute care, long-term care and ambulatory care settings across the United States in adopting and implementing antibiotic stewardship programs, which are coordinated efforts to improve the use of antibiotics by promoting the selection of the optimal antibiotic regimen, dose, route of administration, and duration of therapy. More specifically, this project has the following goals: • Identify best practices in the delivery of antibiotic stewardship in the acute care, long-term care and ambulatory care settings • Adapt the Comprehensive Unit-Based Safety Program (CUSP) model to enhance antibiotic stewardship efforts in the health care settings • Assess the adoption of CUSP for antibiotic stewardship and evaluate the effectiveness of the intervention in the participating health care systems • Develop a bundle of technical and adaptive interventions and associated tools and educational materials designed to support enhanced antibiotic stewardship efforts • Provide technical assistance and training to health care organizations nationwide, using a phased approach, to implement effective antibiotic stewardship programs and interventions • Improve communication and teamwork between health care workers surrounding antibiotic decision-making • Improve communication between health care workers and patients/families surrounding antibiotic decision-making

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:
	84 FR 12251	04/01/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 27123	06/11/2019
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	63,211	56,372	6,839
Annual Time Burden (Hours)	27,064	22,442	4,622
Annual Cost Burden (Dollars)	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 revision to the current clearance adds the monthly HER data collection and endline data collection activities for the ambulatory care cohort, which are scheduled to begin in December 2019 and end in January 2021. The estimated annual burden has been adjusted accordingly.

Annual Cost to Federal Government: $1,887,609

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. 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? Uncollected

Agency Contact: Erwin Brown 301 427-1652 erwin.brown@ahrq.hhs.gov

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