CLIA Collection of
Information Requirements Related to SARS-CoV-2 Test Results
Reporting (CMS-10757)
New
collection (Request for a new OMB Control Number)
No
Emergency
11/20/2020
11/10/2020
Requested
Previously Approved
6 Months From Approved
308,114
0
1,386,873
0
0
0
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.
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.
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:
(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;
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.
CMS-10757_CLIA PRA Emergency Justification Rev. 1 (CLEAN)_10-14-20.pdf
CMS-10757 Supporting Statement - Part A 10-14-20.docx
CMS-3401-IFC CLIA Information Collection Requirements Related to SARS-CoV-2 Test Results Reporting