Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics- Clinical and Laboratory Standards Institute

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CDC/CLSI POC Fingerstick Glucose Testing Survey (FGS 1-3)	Form and Instruction	New	Available
SSA New_Improving the Impact of LPGs_CLSI_052615Lubinedits_06122015_clean.docx	Supporting Statement A	Uploaded 2015-06-23	Available
Appendix L POCT3Surv23_042415.pdf	Supplementary Document	Uploaded 2015-06-18	Available
Appendix K POCT2Surv23_042415.pdf	Supplementary Document	Uploaded 2015-06-18	Available
Appendix J POCT1Surv23_042415.pdf	Supplementary Document	Uploaded 2015-06-18	Available
Appendix I POCT3Surv1_042415.pdf	Supplementary Document	Uploaded 2015-06-18	Available
Appendix H POCT2Surv1_042415.pdf	Supplementary Document	Uploaded 2015-06-18	Available
Appendix G POCT1Surv1_042415.pdf	Supplementary Document	Uploaded 2015-06-18	Available
Appendix F CSELS survey emails with logocleared_survey 2and3final45-26-15.docx	Supplementary Document	Uploaded 2015-06-18	Available
Appendix E CSELS survey emails with logocleared_survey 1final4OMB 5-26-15.docx	Supplementary Document	Uploaded 2015-06-18	Available
Appendix B CLSI LPG NEW_Published 60 Day FRN.pdf	Supplementary Document	Uploaded 2015-06-18	Available
Appendix A Authorization legislation 42USC241.pdf	Supplementary Document	Uploaded 2015-06-18	Available
SSB CLSI 12-2-14_dhlkclean 052615ILedits_061115ILJune12_clean.docx	Supporting Statement B	Uploaded 2015-06-18	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
217102	CDC/CLSI POC Fingerstick Glucose Testing Survey (FGS 1-3)	Form and Instruction	New

ICR Details

OMB Control No: 0920-1088	ICR Reference No: 201506-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15GE
Title: Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics- Clinical and Laboratory Standards Institute
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: 11/24/2015
	Date Received in OIRA: 06/25/2015
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2018	36 Months From Approved
Responses	74,070	0	0
Time Burden (Hours)	18,518	0	0
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. The CLSI project will address 2 fingerstick glucose testing LPGs.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health and Welfare 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 73588	12/11/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 35360	06/19/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
CDC/CLSI POC Fingerstick Glucose Testing Survey (FGS 1-3)	None, None	CDC/CLSI Point-of-Care Fingerstick Glucose Testing Survey (FGS1) ,   CDC/CLSI Point-of-Care Fingerstick Glucose Testing Survey (FGS2,3)

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ICR Summary of Burden

table that charts list 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	74,070	0	0	74,070	0	0
Annual Time Burden (Hours)	18,518	0	0	18,518	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: Submission of 0920-15GE is a New ICR.

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Annual Cost to Federal Government: $43,276

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: 06/25/2015

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