Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics- American Society for Microbiology

Forms and Documents

Document Name	Status
Form 0920-1096 Clostridium difficile Laboratory Practice Survey Form and Instruction	New
CDI - Baseline Form and Instruction	Removed
UT - Baseline Form and Instruction	Unchanged
BSI - Baseline Form and Instruction	Unchanged
BCC - Post Form and Instruction	Unchanged
BCC - Baseline Form and Instruction	Unchanged
0920-1096 - 2018 C difficile ASM LPG Survey Change Request_08132018.docx Justification for No Material/Nonsubstantive Change	2018-08-15
ASM SSB 08102015_clean.docx Supporting Statement B	2015-08-11
ASM SSA 08102015_clean.docx Supporting Statement A	2015-08-11
Appendix MM4 Pilot test C diff questions Responses.docx Supplementary Document	2015-08-04
Appendix MM3 Pilot test UT questions Responses.docx Supplementary Document	2015-08-04
Appendix MM2 Pilot test BSI questions Responses.docx Supplementary Document	2015-08-04
Appendix MM1 Pilot test BCC questions V3 Responses.docx Supplementary Document	2015-08-04
Appendix L4 CMIU- C diff 03162015.pdf Supplementary Document	2015-08-04
Appendix L3 CMIU- UT 03162015.pdf Supplementary Document	2015-08-04
Appendix L2 BSI CMIU 05072015.pdf Supplementary Document	2015-08-04
Appendix L1 CMIU BCC 05072015.pdf Supplementary Document	2015-08-04
Appendix K5 C diff Promo DivCNet Reminder 03162015.pdf Supplementary Document	2015-08-04
Appendix K4 UT DivC Reminder 05062015.pdf Supplementary Document	2015-08-04
Appendix K3 BSI Promo DivCNet Reminder 03162015.pdf Supplementary Document	2015-08-04
Appendix K2 BCC post-Promo DivCNet Reminder V3.pdf Supplementary Document	2015-08-04
Appendix K1 BCC pre-Promo DivCNet Reminder V3.pdf Supplementary Document	2015-08-04
Appendix J5 C diff DivC 03162015.pdf Supplementary Document	2015-08-04
Appendix J4 UT DivC 03162015.pdf Supplementary Document	2015-08-04
Appendix J3 BSI DivC 03162015.pdf Supplementary Document	2015-08-04
Appendix J2 BCC post-Promo DivCNet V3.pdf Supplementary Document	2015-08-04
Appendix J1 BCC pre-Promo DivCNet V4.pdf Supplementary Document	2015-08-04
Appendix I5 C diff Promo CMN Reminder 03162015.pdf Supplementary Document	2015-08-04
Appendix I4 UT Promo CMN Reminder 03162015.pdf Supplementary Document	2015-08-04
Appendix I3 BSI Promo CMN Reminder 03162015.pdf Supplementary Document	2015-08-04
Appendix I2 BCC post Promo CMN REMINDER V3.pdf Supplementary Document	2015-08-04
Appendix I1 BCC pre Promo CMN REMINDER V3.pdf Supplementary Document	2015-08-04
Appendix H5 C diff CMN 03162015.pdf Supplementary Document	2015-08-04
Appendix H4 UT CMN 03162015.pdf Supplementary Document	2015-08-04
Appendix H3 BSI CMN 03162015.pdf Supplementary Document	2015-08-04
Appendix H2 BCC post-CMN V3.pdf Supplementary Document	2015-08-04
Appendix H1 BCC pre-CMN V3.pdf Supplementary Document	2015-08-04
Appendix G4 C difficile Promo MICROBE 03202015.pdf Supplementary Document	2015-08-04
Appendix G3 UT Promo Microbe2 03202015.pdf Supplementary Document	2015-08-04
Appendix G2 BSI Promo Microbe 03202015.pdf Supplementary Document	2015-08-04
Appendix G1 BCC Promo Microbe 05112015.pdf Supplementary Document	2015-08-04
Appendix E5 Sentinel Labs survey introduction letter draft CDI 03202015.docx Supplementary Document	2015-08-04
Appendix E4 Sentinel Labs survey introduction letter draft 2 UT 03202015.docx Supplementary Document	2015-08-04
Appendix E3 Sentinel Labs survey introduction letter draft 2 BSI 03192015.docx Supplementary Document	2015-08-04
Appendix E2 Sentinel Labs survey introduction letter BCC post- 02022015 (2) V2.docx Supplementary Document	2015-08-04
Appendix E1 Sentinel Labs survey introduction letter BCC pre- 04022015 V2.docx Supplementary Document	2015-08-04
Appendix F5 Sentinel Labs survey Reminder CDI 04022015 V2.docx Supplementary Document	2015-08-04
Appendix F4 Sentinel Labs survey Reminder 2 UT 04022015 V2.docx Supplementary Document	2015-08-04
Appendix F3 Sentinel Labs survey Reminder BSI 04022015 V2.docx Supplementary Document	2015-08-04
Appendix F2 Sentinel Labs survey Reminder BCC post- 04022015 V2.docx Supplementary Document	2015-08-04
Appendix F1 Sentinel Labs survey Reminder BCC pre- 04022015 V2.docx Supplementary Document	2015-08-04
Appendix D5 LRN cover letter for survey reminder CDI 04022015 V2.docx Supplementary Document	2015-08-04
Appendix D4 LRN cover letter for survey Reminder UT 04022015 V2.docx Supplementary Document	2015-08-04
Appendix D3 LRN cover letter for survey Reminder BSI 04022015 V2.docx Supplementary Document	2015-08-04
Appendix D2 LRN cover letter for survey Reminder BCC post-survey 04022015 V2.docx Supplementary Document	2015-08-04
Appendix D1 LRN cover letter for survey Reminder BCC pre-survey 04022015 V2.docx Supplementary Document	2015-08-04
Appendix B ASM LPG NEW_Published 60-Day FRN.pdf Supplementary Document	2015-07-23
Appendix A Authorization legislation 42USC241.pdf Supplementary Document	2015-07-23

IC Document Collections

IC ID	Document Title	Status
232669	Clostridium difficile Laboratory Practice Survey Form and Instruction	New
217836	LRN Lab Director Cover Letter - CDI Baseline REMINDER Instruction	Unchanged
217835	LRN Lab Director Cover Letter - UT Baseline REMINDER Instruction	Unchanged
217834	LRN Lab Director Cover Letter - BSI Baseline REMINDER Instruction	Unchanged
217833	LRN Lab Director Cover Letter - BCC Post REMINDER Instruction	Unchanged
217832	LRN Lab Director Cover Letter - BCC Baseline REMINDER Instruction	Unchanged
217831	LRN Lab Director Cover Letter - CDI Baseline Instruction	Unchanged
217830	LRN Lab Director Cover Letter - UT Baseline Instruction	Unchanged
217829	LRN Lab Director Cover Letter - BSI Baseline Instruction	Unchanged
217828	LRN Lab Director Cover Letter - BCC Post Instruction	Unchanged
217827	LRN Lab Director Cover Letter - BCC Baseline Instruction	Unchanged
217765	CDI - Baseline Form and Instruction	Removed
217764	UT - Baseline Form and Instruction	Unchanged
217763	BSI - Baseline Form and Instruction	Unchanged
217762	BCC - Post Form and Instruction	Unchanged
217760	BCC - Baseline Form and Instruction	Unchanged

ICR Details

OMB Control No: 0920-1096	ICR Reference No: 201808-0920-008
Status: Historical Active	Previous ICR Reference No: 201507-0920-012
Agency/Subagency: HHS/CDC	Agency Tracking No: 18AWG
Title: Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics- American Society for Microbiology
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/17/2018
	Date Received in OIRA: 08/16/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	01/31/2019	01/31/2019
Responses	40,305	0	40,305
Time Burden (Hours)	17,276	0	17,276
Cost Burden (Dollars)	0	0	0

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Abstract: The CDC is funding three 5-yr cooperative agreement projects designed to encourage partners to increase the effectiveness of laboratory practice guidelines (LPGs) to address important diseases and/or public health threats by defining and using metrics to inform better LPG creation, revision, dissemination, promotion, uptake, and impact. The project will explore how these processes and their impediments and facilitators differ among various intended users of LPGs. Through this demonstration project, CDC seeks to understand how to customize LPG creation and promotion to better serve these intended users. This information collection request only concerns the American Society for Microbiology arm of the project, and will address issues concerning reducing blood culture contamination (BCC), rapid diagnosis of blood stream infections (BSI), proper collection and transport of urine (UT), and microbiological practices to improve the diagnosis and management of patients with Clostridium difficile (C. difficile) infection (CDI). Non-substantive changes are being requested for the C. difficile lab practice survey.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Services Act
  

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:
	79 FR 65967	11/06/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 46585	08/05/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 15

IC Title	Form No.	Form Name
BSI - Baseline	NA	Bloodstream Infections Laboratory Practice Survey
UT - Baseline	NA	Urine Collection, Storage and Preservation Laboratory Practice Survey
BCC - Baseline	NA	Effectiveness of Practices to Reduce Blood Culture Contamination: BCC - Pre
LRN Lab Director Cover Letter - BCC Post
LRN Lab Director Cover Letter - CDI Baseline
LRN Lab Director Cover Letter - BSI Baseline REMINDER
LRN Lab Director Cover Letter - UT Baseline REMINDER
LRN Lab Director Cover Letter - CDI Baseline REMINDER
LRN Lab Director Cover Letter - BCC Baseline
CDI - Baseline	NA	Clostridium difficile (C. difficile) Laboratory Practice Survey
LRN Lab Director Cover Letter - BSI Baseline
LRN Lab Director Cover Letter - UT Baseline
LRN Lab Director Cover Letter - BCC Baseline REMINDER
LRN Lab Director Cover Letter - BCC Post REMINDER
BCC - Post	NA	Effectiveness of Practices to Reduce Blood Culture Contamination: BCC - Post
Clostridium difficile Laboratory Practice Survey	0920-1096	Clostridium difficile (C. difficile) Laboratory Practice Survey

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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	40,305	40,305	0	0	0	0
Annual Time Burden (Hours)	17,276	17,276	0	0	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: Replaced a current instrument with non-substantive changes to questions.

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Annual Cost to Federal Government: $45,958

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.     No

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

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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: 08/16/2018

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