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

Forms and Documents

Document Name	Status
Form 0920-1067 IHC Focus Group (Pahtologists, Pathology Chairs, Laboratory Directors, Laboratory Managers, Laboratory Supervisors, Histotechnologists) Form and Instruction	New
Form 0920-1067 IHC Focus Group Invitation (Pathologists, Pathology Chairs, Laboratory Chairs, Laboratory Directors, Laboratory Managers, Laboratory Supervisors) Form and Instruction	New
Form 0920-1067 IHC Telsphone Interview (Pathologists, Laboratory Directors, Laboratory Managers) Form and Instruction	New
Form 0920-1067 IHC Telephone Interview- Contacted (Pathologists, Laboratory Directors, Laboratory Managers) Form and Instruction	New
ALA Baseline Survey Form and Instruction	Removed
Survey of Immunohistochemistry (IHC) Validation Practices and Procedures Form and Instruction	Removed
Att. A - Authorizing Legislation.pdf Supplementary Document	2016-04-20
SSB CAP 2016.docx Supporting Statement B	2016-04-20
SSA CAP 2016 .docx Supporting Statement A	2016-04-20

IC Document Collections

IC ID	Document Title	Status
221170	IHC Focus Group (Pahtologists, Pathology Chairs, Laboratory Directors, Laboratory Managers, Laboratory Supervisors, Histotechnologists) Form and Instruction	New
221169	IHC Focus Group Invitation (Pathologists, Pathology Chairs, Laboratory Chairs, Laboratory Directors, Laboratory Managers, Laboratory Supervisors) Form and Instruction	New
221167	IHC Telsphone Interview (Pathologists, Laboratory Directors, Laboratory Managers) Form and Instruction	New
221163	IHC Telephone Interview- Contacted (Pathologists, Laboratory Directors, Laboratory Managers) Form and Instruction	New
215416	ALA Baseline Survey Form and Instruction	Removed
215414	Survey of Immunohistochemistry (IHC) Validation Practices and Procedures Form and Instruction	Removed

ICR Details

OMB Control No: 0920-1067	ICR Reference No: 201604-0920-010
Status: Historical Active	Previous ICR Reference No: 201502-0920-019
Agency/Subagency: HHS/CDC	Agency Tracking No: 15CK
Title: Improving the Impact of Laboratory Practice Guidelines (LPG): A New Paradigm for Metrics - College of American Pathologists
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/07/2016
	Date Received in OIRA: 04/21/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2017	12 Months From Approved	06/30/2016
Responses	385	0	4,435
Time Burden (Hours)	56	0	1,570
Cost Burden (Dollars)	0	0	0

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Abstract: In May 2015, the OMB approved a quantitative questionnaire to capture current immunohistochemistry validation practices of laboratories. The CAP and CDC respectfully ask OMB to approve a revised version of the questionnaire that is strictly focused on the qualitative aspect and which will allow for a fuller exploration of the factors that underlie the adoption or non-adoption reasons and rates of the immunohistochemistry validation laboratory practice guideline by laboratorians. We are submitting a revision request to OMB #0920-1067 for permission to conduct a limited telephone interview and two in-person focus groups, only for the immunohistochemistry validation laboratory practice guideline.

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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:
	80 FR 7318	11/24/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 23297	04/20/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
IHC Focus Group Invitation (Pathologists, Pathology Chairs, Laboratory Chairs, Laboratory Directors, Laboratory Managers, Laboratory Supervisors)	0920-1067	Att E - IHC FocusGroupInvitation
IHC Focus Group (Pahtologists, Pathology Chairs, Laboratory Directors, Laboratory Managers, Laboratory Supervisors, Histotechnologists)	0920-1067	Att D - IHC FocusGroupScript
ALA Baseline Survey	None	ALA Baseline Survey
IHC Telsphone Interview (Pathologists, Laboratory Directors, Laboratory Managers)	0920-1067	Att C1 - IHC Telephone Interview Script
Survey of Immunohistochemistry (IHC) Validation Practices and Procedures	None	Survey of Immunohistochemistry (IHC) Validation Practices and Procedures
IHC Telephone Interview- Contacted (Pathologists, Laboratory Directors, Laboratory Managers)	0920-1067	Att C - IHC Telephone Interview Contacted

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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	385	4,435	0	-4,050	0	0
Annual Time Burden (Hours)	56	1,570	0	-1,514	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This revision includes three types of laboratory professionals who were not included in the original OMB-approved submission: pathology chairs, laboratory supervisors, and histotechnologists. Because the OMB-approved IHC post-survey has been completed, this request for OMB approval of additional data collection (telephone interviews and focus groups) is a reduction of burden.

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Annual Cost to Federal Government: $25,421

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: 04/21/2016

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