[Federal Register Volume 86, Number 125 (Friday, July 2, 2021)]
[Notices]
[Page 35300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-14162]



[[Page 35300]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10531]


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 August 31, 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: ___, 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 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-10531 Transcatheter Valve Therapy (TVT) Registry

    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: Revision of a currently 
approved collection; Title of Information Collection: Transcatheter 
Valve Therapy (TVT) Registry; Use: The data collection is required by 
the Centers for Medicare & Medicaid Services (CMS) National Coverage 
Determination (NCD) entitled, ``Transcatheter Edge-to-Edge Repair 
(TEER) for Mitral Valve Regurgitation'' and was previously entitled 
``Transcatheter Mitral Valve Repair (TMVR)''. Effective January 19, 
2021, CMS updated this NCD to expand coverage to functional mitral 
regurgitation (MR). Previously, coverage was limited to degenerative 
MR. To more precisely define the treatment addressed in this NCD, we 
replaced the term TMVR with TEER. The TEER device is only covered when 
specific conditions are met including that the heart team and hospital 
are submitting data in a prospective, national, audited registry. The 
data includes patient, practitioner and facility level variables that 
predict outcomes such as all-cause mortality and quality of life. In 
order to remove the data collection requirement under this coverage 
with evidence development (CED) NCD or make any other changes to the 
existing policy, we must formally reopen and reconsider the policy. We 
are continuing to review and analyze the data collected since the 
original NCD was effective in 2014 and following the update in 2021.
    The data collected and analyzed in the TVT Registry will be used by 
CMS to determine if TEER is reasonable and necessary (e.g., improves 
health outcomes) for Medicare beneficiaries under Section 1862(a)(1)(A) 
of the ACT. Furthermore, data from the Registry will assist the medical 
device industry and the Food and Drug Administration (FDA) in 
surveillance of the quality, safety and efficacy of new medical devices 
to treat MR. Form Number: CMS-10531 (OMB control number: 0938-1274); 
Frequency: Annually; Affected Public: Private sector (Business or other 
for-profits); Number of Respondents: 8,649; Total Annual Responses: 
34,596; Total Annual Hours: 12,974. (For policy questions regarding 
this collection contact Sarah Fulton at 410-786-2749.)

    Dated: June 28, 2021
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2021-14162 Filed 7-1-21; 8:45 am]
BILLING CODE 4120-01-P