Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 70167-70168 [2020-24435]

Download as PDF Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices estimates from previous rounds of the program (specifically Round 2 Recompete and Round 1 2017) and without reference to changes in burden. Form Number: CMS–10744 (OMB control number: 0938–New); Frequency: Occasionally (varies by form); Affected Public: Private Sector, Business or other for-profits; Number of Respondents: 2,984; Total Annual Responses: 271,597; Total Annual Hours: 31,121. (For policy questions regarding this collection contact Julia Howard at 410– 786–8645.) Dated: October 30, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2020–24442 Filed 11–3–20; 8:45 am] BILLING CODE 4120–01–P 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) Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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. khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:16 Nov 03, 2020 Jkt 253001 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 https:// 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-andGuidance/Legislation/ PaperworkReductionActof1995/PRAListing. ADDRESSES: FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786–4669. 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. SUPPLEMENTARY INFORMATION: 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 70167 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 Conditionlevel 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 E:\FR\FM\04NON1.SGM 04NON1 70168 Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices collection contact Sarah Bennett at 410– 786–3354.) DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 30, 2020. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs. Centers for Medicare & Medicaid Services [CMS–9126–N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—July Through September 2020 [FR Doc. 2020–24435 Filed 11–3–20; 8:45 am] BILLING CODE 4120–01–P Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This quarterly notice lists CMS manual instructions, substantive SUMMARY: It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice. FOR FURTHER INFORMATION CONTACT: Addenda Contact I. CMS Manual Instructions .............................................................................................................. II. Regulation Documents Published in the FEDERAL REGISTER ....................................................... III. CMS Rulings ................................................................................................................................ IV. Medicare National Coverage Determinations ............................................................................. V. FDA-Approved Category B IDEs ................................................................................................. VI. Collections of Information ........................................................................................................... VII. Medicare—Approved Carotid Stent Facilities ............................................................................ VIII. American College of Cardiology-National Cardiovascular Data Registry Sites ....................... IX. Medicare’s Active Coverage-Related Guidance Documents ...................................................... X. One-time Notices Regarding National Coverage Provisions ....................................................... XI. National Oncologic Positron Emission Tomography Registry Sites ........................................... XII. Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities ....................... XIII. Medicare-Approved Lung Volume Reduction Surgery Facilities .............................................. XIV. Medicare-Approved Bariatric Surgery Facilities ....................................................................... XV. Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials ............................... All Other Information ......................................................................................................................... Ismael Torres ..................... Terri Plumb ......................... Tiffany Lafferty ................... Wanda Belle, MPA ............. John Manlove ..................... William Parham .................. Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ JoAnna Baldwin, MS .......... JoAnna Baldwin, MS .......... David Dolan, MBA .............. David Dolan, MBA .............. Sarah Fulton, MHS ............ Sarah Fulton, MHS ............ David Dolan, MBA .............. Annette Brewer .................. SUPPLEMENTARY INFORMATION: I. Background khammond on DSKJM1Z7X2PROD with NOTICES and interpretive regulations, and other Federal Register notices that were published from July through September 2020, relating to the Medicare and Medicaid programs and other programs administered by CMS. The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue VerDate Sep<11>2014 18:16 Nov 03, 2020 Jkt 253001 Phone No. (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) (410) 786–1864 786–4481 786–7548 786–7491 786–6877 786–4669 786–2749 786–2749 786–7205 786–7205 786–3365 786–3365 786–2749 786–2749 786–3365 786–6580 various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently. Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register. websites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the website. These listservs avoid the need to check the website, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a website proves to be difficult, the contact person listed can provide information. II. Format for the Quarterly Issuance Notices III. How To Use the Notice This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS website or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the website list provides more timely access for beneficiaries, providers, and suppliers. We also believe the website offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and ‘‘real time’’ accessibility. In addition, many of the PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at https:// www.cms.gov/manuals. The Administrator of the Centers for Medicare & Medicaid Services (CMS), Seema Verma, having reviewed and approved this document, authorizes Trenesha Fultz-Mimms, who is the Federal Register Liaison, to electronically sign this document for E:\FR\FM\04NON1.SGM 04NON1

Agencies

[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.

-----------------------------------------------------------------------

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 
https://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
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