35300 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 

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. 

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: lll, 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/PRAListing.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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10769] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 


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