Standardizing Antibiotic Use in Long-term Care Setting

Forms and Documents

Document Name	Status
Form Form #5 Post-implementation semi-structured interview Form and Instruction	New
Form Form #4 Post training semi-structured interview Form and Instruction	New
Form Form #3 Pre-implementation semi-structured interview Form and Instruction	New
Form Form #2 Staff training Form and Instruction	New
Form Form #1 Loeb Criteria COF Form and Instruction	New
Waiver of Consent-TAMU.pdf Supplementary Document	2011-04-12
Waiver of Consent-AIR.pdf Supplementary Document	2011-04-12
IRB Approval-TAMU.pdf Supplementary Document	2011-04-12
IRB Approval-AIR.pdf Supplementary Document	2011-04-12
HIPPA-WAIVER-SAUL-TAMU.pdf Supplementary Document	2011-04-12
Supporting Statement Part B -- Standardizing Antibiotic Use in LTC Settings 4-18-2011.doc Supporting Statement B	2011-04-18
Attachment A -- Healthcare Research and Quality Act of 1999.pdf Supplementary Document	2011-02-03
Attachment J-Consent Form for Interviews.doc Supplementary Document	2011-02-03
Attachment I-Information Sheet.doc Supplementary Document	2011-02-03
Attachment H -- Federal Register Notice.pdf Supplementary Document	2011-02-03
Attachment C-Medical Record Data Abstraction Form.doc Supplementary Document	2011-02-03
Supporting Statement Part A -- Standardizing Antibiotic Use in LTC Settings 4-18-2011.doc Supporting Statement A	2011-04-18

IC Document Collections

IC ID	Document Title	Status
196225	Post-implementation semi-structured interview Form and Instruction	New
196224	Post training semi-structured interview Form and Instruction	New
196223	Pre-implementation semi-structured interview Form and Instruction	New
196222	Staff training Form and Instruction	New
196221	Loeb Criteria COF Form and Instruction	New

ICR Details

OMB Control No: 0935-0177	ICR Reference No: 201102-0935-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/AHRQ	Agency Tracking No:
Title: Standardizing Antibiotic Use in Long-term Care Setting
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: 04/25/2011
	Date Received in OIRA: 02/15/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2012	12 Months From Approved
Responses	1,224	0	0
Time Burden (Hours)	476	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This project seeks to contribute to AHRQ's mission by optimizing antibiotic prescribing practices in nursing homes. Nursing homes serve as one of our most fertile breeding grounds for antibiotic-resistant strains of bacteria. Nursing home residents, with their combination of the effects of normal aging and multiple chronic diseases, have relatively high rates of infection. With high rates of respiratory, urinary, skin, and other infection comes a very high rate of antibiotic use that gives rise to Methicillin-resistant Staphylococcus aureus (MRSA), Vancomycin-resistant Enterococci (VRE), fluoroquinolone-resistant strains of a variety of bacteria, and multi-drug resistant organisms (MDROs). Inappropriate antibiotic prescribing practices by primary care clinicians caring for residents in long-term care (LTC) communities is becoming a major public health concern. Antibiotics are among the most commonly prescribed pharmaceuticals in LTC settings, yet reports indicate that a high proportion of antibiotic prescriptions are inappropriate.

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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 69677	11/15/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 4700	01/26/2011
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Loeb Criteria COF	Form #1	Loeb Criteria Communication and Order Form
Staff training	Form #2	Staff Training Guide
Pre-implementation semi-structured interview	Form #3	Pre-Implementation Semi-Structured Interview Protocol
Post training semi-structured interview	Form #4	Post-Training Semi-Structured interview Protocol
Post-implementation semi-structured interview	Form #5	Post-Implementation Semi-Structured Interview Protocol

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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	1,224	0	0	1,224	0	0
Annual Time Burden (Hours)	476	0	0	476	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: $499,777

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: 02/15/2011

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