[Federal Register Volume 85, Number 214 (Wednesday, November 4, 2020)]
[Notices]
[Pages 70167-70168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10757]


Emergency Clearance: Public Information Collection Requirements 
Submitted to the Office of Management and Budget (OMB)

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: On March 13, 2020, the President declared a national emergency 
in response to the public health emergency (PHE) caused by the SARS-
CoV-2 virus, otherwise known as COVID-19. The CARES Act was published 
in response to the PHE that requires ``every laboratory that performs 
or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose 
a possible case of COVID-19 shall report the results from each such 
test.'' 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. Consistent with the 
CARES Act laboratory reporting requirements, CMS made modifications to 
the CLIA regulations to meet the SARS-CoV-2 test result reporting 
provisions related to the Secretary's Public Health Emergency 
declaration with respect to COVID-19.

DATES: Comments must be received by November 19, 2020.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted within 15 days in any one of the 
following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the PRA, Federal agencies are required 
to publish notice in the Federal Register concerning each proposed ICR. 
Interested persons are invited to send comments regarding our burden 
estimates or any other aspect of this ICR including the necessity and 
utility of the proposed ICR for the proper performance of the agency's 
functions, the accuracy of the estimated burden, ways to enhance the 
quality, utility, and clarity of the information to be collected and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

Contents

    This notice sets out a summary of the use and burden associated 
with the following ICR. More detailed information can be found in the 
collection's supporting statement and associated materials (see 
ADDRESSES).

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

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public: submit reports, keep records, or provide information to a 
third party. To comply with this requirement, CMS is publishing this 
notice that summarizes the following proposed collection(s) of 
information for public comment:

Information Collection

    1. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: CLIA 
Collection of Information Requirements Related to SARS-CoV-2 Test 
Results Reporting; Use: In order to be in compliance with the new CLIA 
mandatory SARS-CoV-2 test results reporting requirements, laboratories 
will need to develop a mechanism to track, collect, and report test 
results as well as update policies and procedures. In addition, 
Accreditation Organizations (AOs) and Exempt States (ESs) will need to 
update laboratory standards to reflect the reporting requirements and 
update policies and procedures related to reporting laboratories that 
do not report test results as required.
    The CDC has an information collection request (OMB Control Number 
0920-1299) in order to collect laboratory data related to the COVID-19 
Pandemic Response. The CMS package (ICR) is for laboratory 
implementation and CMS monitoring of compliance with the CMS-3401-IFC 
CLIA-certified laboratory reporting requirements.
    The information collected by the Centers for Medicare and Medicaid 
Services (CMS) or its designee, such as a CMS agent or CMS approved 
laboratory accreditation organization, when conducting inspections will 
be used to determine a laboratory's compliance with the CLIA SARS-CoV-2 
test result reporting requirements. During an on-site survey, the 
Condition-level laboratory requirement at 42 CFR 493.41 and 493.1100(a) 
are assessed for compliance. The information is used by CMS in 
determining appropriate Civil Money Penalties (CMPs) when laboratories 
fail to report as required. Form Number: CMS-10757 (OMB control number: 
0938-NEW); Frequency: Daily; Affected Public: Private Sector Not-for-
profit institutions and State, Local and Tribal Governments; Number of 
Respondents: 77,033; Total Annual Responses: 308,114; Total Annual 
Hours: 1,386,873 (For policy questions regarding this

[[Page 70168]]

collection contact Sarah Bennett at 410-786-3354.)

    Dated: October 30, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-24435 Filed 11-3-20; 8:45 am]
BILLING CODE 4120-01-P