CLIA Collection of Information Requirements Related to SARS-CoV-2 Test Results Reporting (CMS-10757)

Forms and Documents

Document Name	Status
CMS-10757_CLIA PRA Emergency Justification Rev. 1 (CLEAN)_10-14-20.pdf Supplementary Document	2020-11-10
CMS-10757 Supporting Statement - Part A 10-14-20.docx Supporting Statement A	2020-11-10

IC Document Collections

IC ID	Document Title	Status
244436	CMS-3401-IFC CLIA Information Collection Requirements Related to SARS-CoV-2 Test Results Reporting	New

ICR Details

OMB Control No:	ICR Reference No: 202011-0938-003
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: CLIA Collection of Information Requirements Related to SARS-CoV-2 Test Results Reporting (CMS-10757)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 11/20/2020
Date Submitted to OIRA: 11/10/2020

	Requested	Previously Approved
Expiration Date	6 Months From Approved
Responses	308,114	0
Time Burden (Hours)	1,386,873	0
Cost Burden (Dollars)	0	0

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Abstract: The September 2, 2020 interim final rule with comment (CMS-3401-IFC) requires laboratories to report SARS-CoV-2 test results in a manner and frequency specified by the Secretary. As a result, CMS has made modifications to the CLIA regulations to require reporting of SARS-CoV-2 test results. Laboratories will be reporting test results to State and local health departments, not CMS. Accreditation Organizations and Exempt States will be reporting laboratories that fail to report test results to CMS for the purposes of enforcement (i.e., imposition of CMPs). CMS will impose CMP on accredited laboratories; Exempt States will impose CMPs on exempt-state laboratories.

Emergency Justfication: The Centers for Medicare & Medicaid Services (CMS) is requesting that a new information collection request associated with the CMS-3401-IFC be processed as an Emergency in accordance with the implementing regulations of the Paperwork Reduction Act of 1995 at 5 CFR 1320.13(a)(2)(i). The CLIA information collection request is related to SARS-CoV-2 Test Results Reporting, which is associated with the COVID-19 Public Health Emergency (PHE). CMS will be unable to assess laboratory compliance with CLIA SARS-CoV-2 CLIA reporting requirements if the normal, non-emergency clearance procedures are followed. Laboratories will need to develop a mechanism to track, collect, and report SARS-CoV-2 test results. CMS’ needs to have the ability to collect the SARS-CoV-2 test result reporting information from laboratories in order to determine compliance. This collection is of utmost importance in order to meet the Administration’s priorities. CMS will not be able to assure a rapid and thorough public health response to the COVID-19 pandemic unless we have complete and comprehensive laboratory testing data that can improve both the response to SARS-CoV-2 and treatment of COVID-19. These data can contribute to understanding disease incidence and trends: initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and identifying supply chain issues for reagents and other material. Laboratory testing data, in conjunction with case reports and other data, also provide vital guidance for mitigation and control activities. We believe that public harm is reasonably likely to result if normal clearance procedures are followed. Specifically, we are requesting emergency approval for information collection requirements (ICRs) related to SARS-Co-V-2 test result reporting requirements (42 CFR 493.41, 42 CFR 493.555 and 42 CFR 493.1100(a)). In accordance with 5 CFR 1320.13(a)(2)(ii), we believe that the unanticipated public health emergency (PHE) justifies the requirements for CLIA-certified laboratories and Accreditation Organizations (AOs) to collect this information.

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Authorizing Statute(s): US Code: 42 USC 1302, 1395 Name of Law: Public Health Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AU33	Final or interim final rulemaking	85 FR 54820	09/02/2020

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 54820	09/02/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 70167	11/04/2020
Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
CMS-3401-IFC CLIA Information Collection Requirements Related to SARS-CoV-2 Test Results Reporting

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ICR Summary of Burden

	Total Request	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	308,114	0	0	308,114	0	0
Annual Time Burden (Hours)	1,386,873	0	0	1,386,873	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: This is a new information collection.

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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? Yes

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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: 11/10/2020

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