Reduction of Clostridium difficile Infections in a Regional Collaborative of Inpatient Healthcare Settings through Implementation of Antimicrobial Stewardship

Forms and Documents

Document Name	Status
Form Form #3 ASP Questionnaire Form and Instruction	New
Form Form #2 Focus groups at control sites Form and Instruction	New
Form Form #1 Focus groups at intervention sites Form and Instruction	New
Supporting Statement Part B -- Reduction of Clostridium difficile Infections in a Regional Collaborative -- 6-16-2010.doc Supporting Statement B	2010-09-30
Attachment A -- Healthcare Research and Quality Act of 1999.pdf Supplementary Document	2010-09-30
Attachment F -- Federal Register Notice.pdf Supplementary Document	2010-09-30
Supporting Statement Part A -- Reduction of Clostridium difficile Infections in a Regional Collaborative -- 8-10-2010.doc Supporting Statement A	2010-09-30

IC Document Collections

IC ID	Document Title	Status
194862	ASP Questionnaire Form and Instruction	New
194861	Focus groups at control sites Form and Instruction	New
194860	Focus groups at intervention sites Form and Instruction	New

ICR Details

OMB Control No: 0935-0172	ICR Reference No: 201010-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Reduction of Clostridium difficile Infections in a Regional Collaborative of Inpatient Healthcare Settings through Implementation of Antimicrobial Stewardship
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 without change	Conclusion Date: 12/20/2010
	Date Received in OIRA: 10/15/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2012	24 Months From Approved
Responses	1,606	0	0
Time Burden (Hours)	239	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths among the 2.1 million people who acquired infections while hospitalized in 2000, and HAI rates have risen relentlessly since then. Alarmingly, 70% of HAIs are due to bacteria that are resistant to commonly used antibiotics (Huang 2007). This project is designed to evaluate the implementation of a program to reduce Clostridium difficile Infection (CDI) in acute care facilities via Antimicrobial Stewardship Programs (ASPs). Working with an already existing collaborative network of acute care facilities in New York that currently collect and report mandatory data on CDI rates and practice strict environmental controls, this project will go beyond environmental strategies in order to attempt to reduce rates of CDI. ASPs seek to promote the appropriate use of antimicrobials via several methods including selecting the appropriate dose, duration and route of administration of antibiotics. Using antibiotics appropriately can potentially improve efficacy, reduce costs, and keep drug-related adverse events to a minimum. The project is a partnership with Boston University School of Public Health (BUSPH), Montefiore Medical Center (MMC), and Greater New York Hospital Association (GNYHA).

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Authorizing Statute(s): US Code: 42 USC 299 Name of Law: Healthcare Research and Quality Act of 1999
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 43169	07/23/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 60461	09/30/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Focus groups at intervention sites	Form #1	Focus Group Guide- Intervention Sites
Focus groups at control sites	Form #2	Focus Group Guide-Control Sites
ASP Questionnaire	Form #3, Form #4	ASP Questionnaire - intervention sites ,   ASP Questionnaire - control sites

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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	1,606	0	0	1,606	0	0
Annual Time Burden (Hours)	239	0	0	239	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 new information collection request.

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Annual Cost to Federal Government: $499,998

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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

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Common Form ICR:  No

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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: 10/15/2010

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