Reduction of Infections Caused by KPC producing organisms Through Application of Recently Developed CDC/HICPAC Recommendations

Forms and Documents

Document Name	Status
Form Form #5 Post-intervention focus groups with managers Form and Instruction	New
Form Form #4 Post-intervention focus groups with clinical staff Form and Instruction	New
Form Form #3 Clinical staff survey Form and Instruction	New
Form Form #2 Pre-intervention focus groups with managers Form and Instruction	New
Form Form #1 Pre-intervention focus groups with clinical staff Form and Instruction	New
Supporting Statement Part B -- Reductions of Infections Caused by KPC - 9-21-2010-1.doc Supporting Statement B	2010-09-22
Attachment I -- 30 Day FR Notice.pdf Supplementary Document	2010-06-04
Attachment B -- Infection prevention and control guidance.docx Supplementary Document	2010-06-04
Attachment A -- Healthcare Research and Quality Act of 1999.pdf Supplementary Document	2010-06-04
Attachment E -- Cover letter for employee survey.docx Supplementary Document	2010-06-04
Supporting Statement Part A -- Reductions of Infections Caused by KPC - 02 26 2010.doc Supporting Statement A	2010-06-04

IC Document Collections

IC ID	Document Title	Status
193419	Post-intervention focus groups with managers Form and Instruction	New
193418	Post-intervention focus groups with clinical staff Form and Instruction	New
193417	Clinical staff survey Form and Instruction	New
193416	Pre-intervention focus groups with managers Form and Instruction	New
193415	Pre-intervention focus groups with clinical staff Form and Instruction	New

ICR Details

OMB Control No: 0935-0167	ICR Reference No: 201006-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Reduction of Infections Caused by KPC producing organisms Through Application of Recently Developed CDC/HICPAC Recommendations
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: 09/27/2010
	Date Received in OIRA: 06/28/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2013	24 Months From Approved
Responses	90	0	0
Time Burden (Hours)	68	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. On March 20, 2009, the Centers for Disease Control (CDC) and the Healthcare Infections Control Practices Advisory Committee (HICPAC) developed infection control (IC) guidance for Klebsiella pneumonia carbapenemase-producing (KPC) isolates, as they have been rapidly emerging as a significant challenge in healthcare settings (see Attachment B). The danger of these bacteria is that they are resistant to carbapenem (a class of beta-lactam antibiotics with a broad spectrum of antibacterial activity) and cannot be treated by the most commonly prescribed antibiotics. Limited treatment options mean that infections caused by carbapenem resistant bacteria result in substantial mortality and morbidity.

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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 16132	03/31/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 31445	06/03/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Pre-intervention focus groups with clinical staff	Form #1	Pre-intervention focus group guide with clinical staff
Pre-intervention focus groups with managers	Form #2	Pre-intervention focus group guide with managers
Clinical staff survey	Form #3	Placeholder for clinical staff questionnaire
Post-intervention focus groups with clinical staff	Form #4	Placeholder for post-intervention focus group guide with clinical staff
Post-intervention focus groups with managers	Form #5	Placeholder for post-intervention focus group guide with managers

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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	90	0	0	90	0	0
Annual Time Burden (Hours)	68	0	0	68	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: $250,001

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]? Uncollected

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: 06/28/2010

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