81 FR 14854 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 81, Issue 53 (March 18, 2016)

Page Range		14854-14855
FR Document		2016-06188

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 any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Federal Register, Volume 81 Issue 53 (Friday, March 18, 2016)

[Federal Register Volume 81, Number 53 (Friday, March 18, 2016)]
[Notices]
[Pages 14854-14855]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-06188]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10443]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid 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 any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.

DATES: Comments must be received by May 17, 2016.

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' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: Reports Clearance Office at (410) 786-
1326.

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-10443 Transcatheter Valve Therapy Registry and KCCQ-10

    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.
    1. Type of Information Collection Request: Extension of a 
previously approved collection. Title of Information Collection: 
Transcatheter Valve Therapy Registry and KCCQ-10. Use: The data 
collection is required by the Centers for Medicare and Medicaid 
Services (CMS) National Coverage Determination (NCD) entitled, 
``Transcatheter Aortic Valve Replacement (TAVR)''. The TAVR 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. CMS finds that the Society of Thoracic Surgery/
American College of Cardiology Transcatheter Valve Therapy (STS/ACC 
TVT) Registry, one registry overseen by the National Cardiovascular 
Data Registry, meets the requirements specified in the NCD on TAVR. The 
TVT Registry will support a national surveillance system to monitor the 
safety and efficacy of the TAVR technologies for the treatment of 
aortic stenosis.
    The data will also include the variables on the eight item Kansas 
City Cardiomyopathy Questionnaire (KCCQ-10) to assess health status, 
functioning and quality of life. In the KCCQ, an overall summary score 
can be derived from the physical function, symptoms (frequency and 
severity), social function and quality of life domains. For each 
domain, the validity, reproducibility, responsiveness and 
interpretability have been independently established. Scores are 
transformed to a range of 0-100, in which higher scores reflect better 
health status.
    The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in 
accordance with Section 1142 of the Social Security Act (the Act) that 
describes the authority of the Agency for Healthcare Research and 
Quality (AHRQ). Under section 1142, research may be conducted and 
supported on the

[[Page 14855]]

outcomes, effectiveness, and appropriateness of health care services 
and procedures to identify the manner in which disease, disorders, and 
other health conditions can be prevented, diagnosed, treated, and 
managed clinically. Section 1862(a)(1)(E) of the Act allows Medicare to 
cover under coverage with evidence development (CED) certain items or 
services for which the evidence is not adequate to support coverage 
under section 1862(a)(1)(A) and where additional data gathered in the 
context of a clinical setting would further clarify the impact of these 
items and services on the health of beneficiaries.
    The data collected and analyzed in the TVT Registry will be used by 
CMS to determine if the TAVR 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 aortic stenosis. For purposes of the TAVR NCD, 
the TVT Registry has contracted with the Data Analytic Centers to 
conduct the analyses. In addition, data will be made available for 
research purposes under the terms of a data use agreement that only 
provides de-identified datasets. Form Number: CMS-10443 (OMB control 
number: 0938-1202); Frequency: Annual; Affected Public: Individuals, 
Households and Private Sector; Number of Respondents: 14,871; Total 
Annual Responses: 59,484; Total Annual Hours: 19,184. (For policy 
questions regarding this collection contact Sarah Fulton at 410-786-
2749.)

    Dated: March 15, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2016-06188 Filed 3-17-16; 8:45 am]
BILLING CODE 4120-01-P

Federal Register / Vol. 81, No. 53 / Friday, March 18, 2016 / Notices 14855

outcomes, effectiveness, and DEPARTMENT OF HEALTH AND information has been submitted to the
appropriateness of health care services HUMAN SERVICES Office of Management and Budget
and procedures to identify the manner (OMB) for review and clearance under
in which disease, disorders, and other Centers for Medicare & Medicaid the Paperwork Reduction Act of 1995.
health conditions can be prevented, Services DATES: Fax written comments on the
diagnosed, treated, and managed [CMS–7040–N2] collection of information by April 18,
clinically. Section 1862(a)(1)(E) of the 2016.
Act allows Medicare to cover under Health Insurance MarketplaceSM, ADDRESSES: To ensure that comments on
coverage with evidence development Medicare, Medicaid, and the Children’s the information collection are received,
(CED) certain items or services for Health Insurance Program; OMB recommends that written
which the evidence is not adequate to Cancellation of the March 23, 2016 comments be faxed to the Office of
support coverage under section Advisory Panel on Outreach and Information and Regulatory Affairs,
1862(a)(1)(A) and where additional data Education Meeting OMB, Attn: FDA Desk Officer, FAX:
gathered in the context of a clinical AGENCY: Centers for Medicare & 202–395–7285, or emailed to oira_
setting would further clarify the impact Medicaid Services (CMS), HHS. submission@omb.eop.gov. All
of these items and services on the health comments should be identified with the
ACTION: Cancellation of meeting.
of beneficiaries. OMB control number 0910-New and
SUMMARY: On February 25, 2016, we title ‘‘Quantitative Information in
The data collected and analyzed in
published a Federal Register notice (81 Direct-to-Consumer Television
the TVT Registry will be used by CMS
FR 9483) announcing a new meeting of Advertisements.’’ Also include the FDA
to determine if the TAVR is reasonable
the Advisory Panel on Outreach and docket number found in brackets in the
and necessary (e.g., improves health heading of this document.
outcomes) for Medicare beneficiaries Education (APOE) (the Panel), which
was scheduled for Wednesday, March FOR FURTHER INFORMATION CONTACT: FDA
under Section 1862(a)(1)(A) of the Act.
23, 2016. This notice announces the PRA Staff, Office of Operations, Food
Furthermore, data from the Registry will and Drug Administration, 8455
cancellation of the March 23, 2016
assist the medical device industry and Colesville Rd., COLE–14526, Silver
meeting.
the Food and Drug Administration Spring, MD 20993–0002, PRAStaff@
(FDA) in surveillance of the quality, FOR FURTHER INFORMATION CONTACT:
fda.hhs.gov.
safety and efficacy of new medical Abigail Huffman, Designated Federal
devices to treat aortic stenosis. For Official, Office of Communications, SUPPLEMENTARY INFORMATION: In
CMS, 7500 Security Boulevard, Mail compliance with 44 U.S.C. 3507, FDA
purposes of the TAVR NCD, the TVT
Stop S1–05–06, Baltimore, MD 21244, has submitted the following proposed
Registry has contracted with the Data
410–786–0897, email collection of information to OMB for
Analytic Centers to conduct the
Abigail.Huffman1@cms.hhs.gov. review and clearance.
analyses. In addition, data will be made
Additional information about the APOE Quantitative Information in Direct-to-
available for research purposes under
is available on the Internet at: http:// Consumer Television Advertisements
the terms of a data use agreement that
www.cms.gov/Regulations-and- OMB Control Number 0910—NEW
only provides de-identified datasets. Guidance/Guidance/FACA/APOE.html.
Form Number: CMS–10443 (OMB Press inquiries are handled through the I. Background
control number: 0938–1202); Frequency: CMS Press Office at (202) 690–6145. Section 1701(a)(4) of the Public
Annual; Affected Public: Individuals, Health Service Act (42 U.S.C.
Dated: March 15, 2016.
Households and Private Sector; Number 300u(a)(4)) authorizes FDA to conduct
of Respondents: 14,871; Total Annual Andrew M. Slavitt,
Acting Administrator, Centers for Medicare research relating to health information.
Responses: 59,484; Total Annual Hours: Section 1003(d)(2)(C) of the Federal
& Medicaid Services.
19,184. (For policy questions regarding Food, Drug, and Cosmetic Act (the
[FR Doc. 2016–06206 Filed 3–17–16; 8:45 am]
this collection contact Sarah Fulton at FD&C Act) (21 U.S.C. 393(d)(2)(C))
BILLING CODE 4120–01–P
410–786–2749.) authorizes FDA to conduct research
Dated: March 15, 2016. relating to drugs and other FDA
William N. Parham, III, DEPARTMENT OF HEALTH AND regulated products in carrying out the
HUMAN SERVICES provisions of the FD&C Act.
Director, Paperwork Reduction Staff, Office
A previous FDA study found that
of Strategic Operations and Regulatory
Food and Drug Administration simple quantitative information could
Affairs.
be conveyed in direct-to-consumer
[FR Doc. 2016–06188 Filed 3–17–16; 8:45 am] [Docket No. FDA–2015–N–3543] (DTC) television ads in ways that
BILLING CODE 4120–01–P increased consumer’s knowledge about
Agency Information Collection
the drug (OMB control number 0910–
Activities; Submission for Office of
0663, ‘‘Experimental Study:
Management and Budget Review;
Presentation of Quantitative
Comment Request; Quantitative
Effectiveness Information to Consumers
Information in Direct-to-Consumer
in Direct-to-Consumer (DTC) Television
asabaliauskas on DSK3SPTVN1PROD with NOTICES

Television Advertisements
and Print Advertisements for
AGENCY: Food and Drug Administration, Prescription Drugs’’) (Ref. 1). However,
HHS. this research only tested simple
ACTION: Notice. information (e.g., one clinical trial,
comparison to placebo). Drug
SUMMARY: The Food and Drug information can be much more
Administration (FDA) is announcing complicated (e.g., complicated
that a proposed collection of endpoints, multiple study arms). The

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Document Created: 2018-02-02 15:14:09
Document Modified: 2018-02-02 15:14:09

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments must be received by May 17, 2016.
Contact		Reports Clearance Office at (410) 786- 1326.
FR Citation		81 FR 14854

81 FR 14854 - Agency Information Collection Activities: Proposed Collection; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 81, Issue 53 (March 18, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services