[Federal Register Volume 86, Number 69 (Tuesday, April 13, 2021)]
[Notices]
[Page 19269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07559]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10757]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection 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.

DATES: Comments must be received by June 14, 2021.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted 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: CMS-P-0015A, 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.html.

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

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each 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. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Extension of a currently 
approved information collection; 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 493.41and 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: 
0938-1391); 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 collection 
contact Sarah Bennett at 410-786-3354.)

    Dated: April 8, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-07559 Filed 4-12-21; 8:45 am]
BILLING CODE 4120-01-P