Agency Information Collection Activities: Proposed Collection; Comment Request, 73891-73892 [2014-29172]
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Federal Register / Vol. 79, No. 239 / Friday, December 12, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers CMS–10341, CMS–R–
246 and CMS–10531]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid 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 a 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.
SUMMARY:
Comments must be received by
February 10, 2015.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number (OCN). 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 https://
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–
mstockstill on DSK4VPTVN1PROD with NOTICES
DATES:
VerDate Sep<11>2014
16:57 Dec 11, 2014
Jkt 235001
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
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
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–10341 Affordable Care Act
Information and Collection
Requirements for Section 1115
Demonstration Projects
CMS–R–246 Medicare Advantage,
Medicare Part D, and Medicare FeeFor-Service Consumer Assessment
of Healthcare Providers and
Systems (CAHPS) Survey
CMS–10531 Transcatheter Mitral Valve
Repair (TMVR) National Coverage
Decision (NCD)
Under the Paperwork Reduction Act
(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: Extension of a currently
PO 00000
Frm 00013
Fmt 4703
Sfmt 4703
73891
approved collection; Title of
Information Collection: Affordable Care
Act Information and Collection
Requirements for Section 1115
Demonstration Projects; Use: This
collection is necessary to ensure that
states comply with regulatory and
statutory requirements related to the
development, implementation and
evaluation of demonstration projects.
States seeking waiver authority under
Section 1115 are required to meet
certain requirements for public notice,
the evaluation of demonstration
projects, and reports to the Secretary on
the implementation of approved
demonstrations. Form Number: CMS–
10341 (OMB control number 0938–
1162); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
37; Total Annual Responses: 130; Total
Annual Hours: 13,910. (For policy
questions regarding this collection
contact Lane Terwilliger at 410–786–
2059).
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Advantage, Medicare Part D, and
Medicare Fee-For-Service Consumer
Assessment of Healthcare Providers and
Systems (CAHPS) Survey; Use: The
primary purpose of the Medicare
consumer assessment of healthcare
providers and systems (CAHPS) surveys
is to provide information to Medicare
beneficiaries to help them make more
informed choices among health and
prescription drug plans available to
them. The surveys also provides data to
help CMS and others monitor the
quality and performance of Medicare
health and prescription drug plans and
identify areas to improve the quality of
care and services provided to enrollees
of these plans. Form Number: CMS–R–
246 (OMB control number: 0938–0732;
Frequency: Yearly; Affected Public:
Individuals and households; Number of
Respondents: 799,650; Total Annual
Responses: 799,650; Total Annual
Hours: 277,740 (For policy questions
regarding this collection contact Sarah
Gaillot at 410–786–4637).
3. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Transcatheter
Mitral Valve Repair (TMVR) National
Coverage Decision (NCD); Use: The data
collection is required by the Centers for
Medicare and Medicaid Services (CMS)
National Coverage Determination (NCD)
entitled, ‘‘Transcatheter Mitral Valve
Repair (TMVR)’’. The TMVR device is
only covered when specific conditions
are met including that the heart team
E:\FR\FM\12DEN1.SGM
12DEN1
73892
Federal Register / Vol. 79, No. 239 / Friday, December 12, 2014 / Notices
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.
We find 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 TMVR. The
TVT Registry will support a national
surveillance system to monitor the
safety and efficacy of the TMVR
technologies for the treatment of mitral
regurgitation (MR). The data will also
include the variables on the eight item
Kansas City Cardiomyopathy
Questionnaire (KCCQ–10) to assess
heath 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 pursuant
to 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
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 to
determine if TMVR 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 mitral regurgitation. For
purposes of the TMVR 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–10531(OMB
Control Number: 0938–NEW);
Frequency: Annually; Affected Public:
Business or other for-profits; Number of
Respondents: 4,000; Total Annual
Responses: 16,000 Total Annual Hours:
5,600. (For policy questions regarding
this collection contact Roya Lotfi at
410–786–4072.)
Dated: December 9, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–29172 Filed 12–11–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Adoption and Foster Care
Analysis Reporting System for title IV–
B and title IV–E, AFCARS.
OMB No.: 0970–0422.
Description: The Adoption and Foster
Care Analysis and Reporting System
(AFCARS) is mandated by 42 U.S.C.
679. The regulation at 45 CFR part 1355
sets forth the requirements of the statute
for the collection of uniform, reliable
information on children who are under
the responsibility of the State or Tribal
title IV–B/IV–E agency for placement,
care, and adoption. Effective October 1,
2009, section 479B(b) of the Act
authorizes direct Federal funding of
Indian Tribes, Tribal organizations, and
Tribal consortia that choose to operate
a foster care, adoption assistance and, at
Tribal option, a kinship guardianship
assistance program under title IV–E of
the Act. The Federal regulations at 45
CFR 1355.40 were amended as part of
an Interim Final Rule published January
6, 2012 to apply the same regulatory
requirements for data collection and
reporting to a Tribal title IV–E agency as
are applied to a State title IV–E agency.
The data collected will inform State/
Tribal/Federal policy decisions,
program management, and responses to
Congressional and Departmental
inquiries. Specifically, the data are used
for short/long-term budget projections,
trend analysis, child and family service
reviews, and to target areas for
improved technical assistance. The data
will provide information about foster
care placements, adoptive parents,
length of time in care, delays in
termination of parental rights and
placement for adoption.
Respondents: Title IV–E State and
Tribal Child Welfare Agencies
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
AFCARS ..........................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
Instrument
72
2
1786
257,184
Estimated Total Annual Burden
Hours: 257,184.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
VerDate Sep<11>2014
16:57 Dec 11, 2014
Jkt 235001
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
PO 00000
Frm 00014
Fmt 4703
Sfmt 4703
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 79, Number 239 (Friday, December 12, 2014)]
[Notices]
[Pages 73891-73892]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29172]
[[Page 73891]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers CMS-10341, CMS-R-246 and CMS-10531]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid 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 a
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 February 10, 2015.
ADDRESSES: When commenting, please reference the document identifier or
OMB control number (OCN). 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
https://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 https://www.cms.hhs.gov/PaperworkReductionActof1995.
2. Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov.
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-10341 Affordable Care Act Information and Collection Requirements
for Section 1115 Demonstration Projects
CMS-R-246 Medicare Advantage, Medicare Part D, and Medicare Fee-For-
Service Consumer Assessment of Healthcare Providers and Systems (CAHPS)
Survey
CMS-10531 Transcatheter Mitral Valve Repair (TMVR) National Coverage
Decision (NCD)
Under the Paperwork Reduction Act (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: Extension of a currently
approved collection; Title of Information Collection: Affordable Care
Act Information and Collection Requirements for Section 1115
Demonstration Projects; Use: This collection is necessary to ensure
that states comply with regulatory and statutory requirements related
to the development, implementation and evaluation of demonstration
projects. States seeking waiver authority under Section 1115 are
required to meet certain requirements for public notice, the evaluation
of demonstration projects, and reports to the Secretary on the
implementation of approved demonstrations. Form Number: CMS-10341 (OMB
control number 0938-1162); Frequency: Yearly; Affected Public: State,
Local, or Tribal Governments; Number of Respondents: 37; Total Annual
Responses: 130; Total Annual Hours: 13,910. (For policy questions
regarding this collection contact Lane Terwilliger at 410-786-2059).
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare
Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer
Assessment of Healthcare Providers and Systems (CAHPS) Survey; Use: The
primary purpose of the Medicare consumer assessment of healthcare
providers and systems (CAHPS) surveys is to provide information to
Medicare beneficiaries to help them make more informed choices among
health and prescription drug plans available to them. The surveys also
provides data to help CMS and others monitor the quality and
performance of Medicare health and prescription drug plans and identify
areas to improve the quality of care and services provided to enrollees
of these plans. Form Number: CMS-R-246 (OMB control number: 0938-0732;
Frequency: Yearly; Affected Public: Individuals and households; Number
of Respondents: 799,650; Total Annual Responses: 799,650; Total Annual
Hours: 277,740 (For policy questions regarding this collection contact
Sarah Gaillot at 410-786-4637).
3. Type of Information Collection Request: New collection (Request
for a new OMB control number); Title of Information Collection:
Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision
(NCD); Use: The data collection is required by the Centers for Medicare
and Medicaid Services (CMS) National Coverage Determination (NCD)
entitled, ``Transcatheter Mitral Valve Repair (TMVR)''. The TMVR device
is only covered when specific conditions are met including that the
heart team
[[Page 73892]]
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.
We find 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 TMVR. The TVT Registry will
support a national surveillance system to monitor the safety and
efficacy of the TMVR technologies for the treatment of mitral
regurgitation (MR). The data will also include the variables on the
eight item Kansas City Cardiomyopathy Questionnaire (KCCQ-10) to assess
heath 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 pursuant
to 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
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 to
determine if TMVR 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 mitral
regurgitation. For purposes of the TMVR 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-10531(OMB Control Number: 0938-NEW);
Frequency: Annually; Affected Public: Business or other for-profits;
Number of Respondents: 4,000; Total Annual Responses: 16,000 Total
Annual Hours: 5,600. (For policy questions regarding this collection
contact Roya Lotfi at 410-786-4072.)
Dated: December 9, 2014.
Martique Jones,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2014-29172 Filed 12-11-14; 8:45 am]
BILLING CODE 4120-01-P