CLIA Proficiency Testing (PT) (CMS-10690)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CMS-10690 Supporting Statement Part A final 7-11-22.docx	Supporting Statement A	Uploaded 2022-07-11	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
234841	PT Program Reapproval		Unchanged
234840	Submission of PT Data by Laboratories		Removed
234838	Clarification for Reporting of Microbiology Organism Indentification		Modified

ICR Details

OMB Control No: 0938-1357	ICR Reference No: 202206-0938-003
Status: Historical Active	Previous ICR Reference No: 201902-0938-003
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: CLIA Proficiency Testing (PT) (CMS-10690)
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: 12/16/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/11/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2025	36 Months From Approved
Responses	350	0	0
Time Burden (Hours)	431	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: A. Clarification for Reporting of Microbiology Organism Identification. This information is necessary to ensure that laboratories are reporting proficiency testing (PT) results for microbiology organism identification to the highest level that they report results on patient specimens. The laboratories will provide this information to the PT programs as well as CMS. B. PT Program Reapproval. This information may be needed by CMS should we require a PT program to reapply for approval using the process for initial applications if widespread or systemic problems are encountered during the reapproval process.

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Authorizing Statute(s): PL: Pub.L. 112 - 202 353 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AT55	Final or interim final rulemaking	87 FR 41194	07/11/2022

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

IC Title	Form No.	Form Name
Clarification for Reporting of Microbiology Organism Indentification
PT Program Reapproval
Submission of PT Data by Laboratories

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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	350	0	0	350	0	0
Annual Time Burden (Hours)	431	0	0	431	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: The burden hours decreased from 593 to 431. The burden cost decreased from $36,577 to $21,673. This is due to not finalizing a proposed provision requiring the submission of PT data by laboratories to limit the participants’ online submission of PT data to one submission or that a method be provided to track changes made to electronically reported results. Feedback from commenters indicated that this would be a significant burden, and CMS agreed.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

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? No

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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: 07/11/2022

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