Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics - College of American Pathologists

Forms and Documents

Document Name	Status
ALA Baseline Survey Form and Instruction	New
Survey of Immunohistochemistry (IHC) Validation Practices and Procedures Form and Instruction	New
Attachment I ALA Pilot Survey Results Summary_011615.pdf Supplementary Document	2015-02-26
Attachment H IHCValidationPilotSurveyQuesResults010514.pdf Supplementary Document	2015-02-26
Attachment G ALA COMMUNICATIONS MATERIALS _FINAL 02 3 15.pdf Supplementary Document	2015-02-26
Attachment F IHC COMMUNICATIONS MATERIALS _FINAL 020315.pdf Supplementary Document	2015-02-26
Attachment E Privacy Act Checklist.docx Supplementary Document	2015-02-26
Attachment B CAP LPG NEW_Published 60-Day FRN.pdf Supplementary Document	2015-02-26
Attachment A Authorizing legislation 42USC241.pdf Supplementary Document	2015-02-26
SSB New CAP 02202015_clean.docx Supporting Statement B	2015-02-26
SSA New CAP 02202015_clean.docx Supporting Statement A	2015-02-26

IC Document Collections

IC ID	Document Title	Status
215416	ALA Baseline Survey Form and Instruction	New
215414	Survey of Immunohistochemistry (IHC) Validation Practices and Procedures Form and Instruction	New

ICR Details

OMB Control No: 0920-1067	ICR Reference No: 201502-0920-019
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 15CK
Title: Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics - College of American Pathologists
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: 05/29/2015
	Date Received in OIRA: 03/06/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	12 Months From Approved
Responses	4,435	0	0
Time Burden (Hours)	1,570	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 CAP project will address immunohistochemistry test validation and an algorithm for diagnosing acute leukemia.

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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 65219	11/03/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 10489	02/26/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
ALA Baseline Survey	None	ALA Baseline Survey
Survey of Immunohistochemistry (IHC) Validation Practices and Procedures	None	Survey of Immunohistochemistry (IHC) Validation Practices and Procedures

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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	4,435	0	0	4,435	0	0
Annual Time Burden (Hours)	1,570	0	0	1,570	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 0920-15CK is a New ICR

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Annual Cost to Federal Government: $26,094

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: 03/06/2015

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