Agency Information Collection Activities: Proposed Collection; Comment Request, 35300 [2021-14162]

Download as PDF 35300 Federal Register / Vol. 86, No. 125 / Friday, July 2, 2021 / Notices 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10531] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: 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. lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:12 Jul 01, 2021 Jkt 253001 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. 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 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 Centers for Medicare & Medicaid Services, Health and Human Services (HHS). ACTION: Notice. AGENCY: The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS’ intention to collect SUMMARY: E:\FR\FM\02JYN1.SGM 02JYN1

Agencies

[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.

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

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