Agency Information Collection Activities: Proposed Collection; Comment Request
| Published date | 02 July 2021 |
| Citation | 86 FR 35300 |
| Record Number | 2021-14162 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 86 Issue 125 (Friday, July 2, 2021)
[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
