Agency Information Collection Activities: Proposed Collection; Comment Request, 53202-53203 [2012-21594]
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Federal Register / Vol. 77, No. 170 / Friday, August 31, 2012 / Notices
By order of the Federal Open Market
Committee, August 22, 2012.
William B. English,
Secretary, Federal Open Market Committee.
Wyomissing, Philadelphia, and thereby
indirectly acquire Affinity Bank of
Pennsylvania, Wyomissing,
Philadelphia.
[FR Doc. 2012–21557 Filed 8–30–12; 8:45 am]
Board of Governors of the Federal Reserve
System, August 28, 2012.
Margaret McCloskey Shanks,
Associate Secretary of the Board.
BILLING CODE 6210–01–P
FEDERAL RESERVE SYSTEM
[FR Doc. 2012–21543 Filed 8–30–12; 8:45 am]
EMCDONALD on DSK67QTVN1PROD with NOTICES
Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
BILLING CODE 6210–01–P
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, are available for immediate
inspection at the Federal Reserve Bank
indicated. The applications will also be
available for inspection at the offices of
the Board of Governors. Interested
persons may express their views in
writing on the standards enumerated in
the BHC Act (12 U.S.C. 1842(c)). If the
proposal also involves the acquisition of
a nonbanking company, the review also
includes whether the acquisition of the
nonbanking company complies with the
standards in section 4 of the BHC Act
(12 U.S.C. 1843). Unless otherwise
noted, nonbanking activities will be
conducted throughout the United States.
Unless otherwise noted, comments
regarding each of these applications
must be received at the Reserve Bank
indicated or the offices of the Board of
Governors not later than September 26,
2012.
A. Federal Reserve Bank of New York
(Ivan Hurwitz, Vice President) 33
Liberty Street, New York, New York
10045–0001:
1. RSB Bancorp, MHC and RSB
Bancorp, Inc., both of Roselle, New
Jersey, to become bank holding
companies by acquiring 100 percent of
Roselle Savings Bank, Roselle, New
Jersey.
B. Federal Reserve Bank of
Philadelphia (William Lang, Senior Vice
President) 100 North 6th Street,
Philadelphia, Pennsylvania 19105–
1521:
1. First Priority Financial Corp,
Malvern, Philadelphia, to acquire 100
percent of Affinity Bancorp, Inc.,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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Centers for Medicare & Medicaid
Services
[Document Identifier CMS–10443 and CMS–
10149]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS) is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate 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.
1. Type of Information Collection
Request: New 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/
AGENCY:
PO 00000
Frm 00035
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Sfmt 4703
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 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 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
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
E:\FR\FM\31AUN1.SGM
31AUN1
EMCDONALD on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 170 / Friday, August 31, 2012 / Notices
only provides de-identified datasets.
Form Number: CMS–10443 (OCN: 0938New); Frequency: Annual; Affected
Public: Individuals, Households and
Private Sector; Number of Respondents:
12,000; Total Annual Responses:
24,000; Total Annual Hours: 7,000. (For
policy questions regarding this
collection contact JoAnna Baldwin at
410–786–7205. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: Health
Insurance Reform: Electronic Security
Standards; Use: This information
collection corresponds to existing
regulations establishing standards for
the security of electronic protected
health information to be implemented
by health plans, health care
clearinghouses and certain health care
providers, as required under title II,
subtitle F, sections 261 through 264 of
the Health Insurance Portability and
Accountability Act of 1996 (HIPAA),
Public Law 104–191. The use of the
security standards improves Federal
health programs, private health
programs, and the effectiveness and
efficiency of the health care industry in
general by establishing a level of
protection for certain electronic health
information. This information collection
request does not propose any changes to
this information collection related to
future modifications of the underlying
HIPAA security standards. Form
Number: CMS–10149 (OCN: 0938–
0949); Frequency: Occasionally;
Affected Public: Business or other forprofit, Not-for-profit institutions,
Federal Government, and State, Local or
Tribal Government; Number of
Respondents: 135,560; Total Annual
Responses: 285,560; Total Annual
Hours: 536,743. (For policy questions
regarding this collection contact
William Parham at 410–786–4669. For
all other issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
VerDate Mar<15>2010
15:22 Aug 30, 2012
Jkt 226001
be submitted in one of the following
ways by October 30, 2012:
1. Electronically. You may submit
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) 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: CMS–R–284 (OCN 0938–
0345), Room C4–26–05, 7500 Security
Boulevard, Baltimore, Maryland 21244–
1850.
Dated: August 28, 2012.
Martique Jones,
Director, Regulations Development Group,
Division B, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2012–21594 Filed 8–30–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–359 and CMS–
360]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate 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 function;
(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.
1. Type of Information Collection
Request: Extension without change of a
currently approved collection. Title of
AGENCY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
53203
Information Collection: Comprehensive
Outpatient Rehabilitation Facility
(CORF) Eligibility and Survey Forms.
Use: CMS–359 serves as the application
for facilities wishing to participate in
the Medicare/Medicaid program as
CORFs. The form initiates the process
for obtaining a decision as to whether
the conditions of participation are met.
It also promotes data reduction (key
punching) or introduction to and
retrieval from the Medicare/Medicaid
Automated Certification System,
ASPEN, by the CMS Regional Offices.
Should any question arise regarding the
structure of the organization, this
information is readily available without
going through the process of completing
the form again.
CMS–360 is used by the State survey
agency to record data collected to
determine provider compliance with
individual conditions of participation
and to report it to the federal
government. CMS has the responsibility
and authority for certification decisions
which are based on provider
compliance with the conditions of
participation. The information needed
to make these decisions is available to
CMS only through the information
abstracted from the survey checklists.
The form is primarily a worksheet
designed to facilitate key punching into
ASPEN by the state agency after the
survey is completed. Form Number:
CMS–359 (CORF Eligibility Form) and
CMS–360 (CORF Survey Report Form);
(OCN 0938–0267); Frequency:
Occasionally. Affected Public: Private
Sector (Business or other for-profits).
Number of Respondents: 295. Total
Annual Responses: 42. Total Annual
Hours: 137. (For policy questions
regarding this collection contact Georgia
Johnson at 410–786–6859. For all other
issues call 410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on October 1, 2012. OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–6974, Email: OIRA_
submission@omb.eop.gov.
E:\FR\FM\31AUN1.SGM
31AUN1
]]>Agencies
[Federal Register Volume 77, Number 170 (Friday, August 31, 2012)]
[Notices]
[Pages 53202-53203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21594]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier CMS-10443 and CMS-10149]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS) is publishing the following summary of proposed
collections for public comment. Interested persons are invited to send
comments regarding this burden estimate 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.
1. Type of Information Collection Request: New 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 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 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 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
[[Page 53203]]
only provides de-identified datasets. Form Number: CMS-10443 (OCN:
0938-New); Frequency: Annual; Affected Public: Individuals, Households
and Private Sector; Number of Respondents: 12,000; Total Annual
Responses: 24,000; Total Annual Hours: 7,000. (For policy questions
regarding this collection contact JoAnna Baldwin at 410-786-7205. For
all other issues call 410-786-1326.)
2. Type of Information Collection Request: Reinstatement without
change of a previously approved collection; Title of Information
Collection: Health Insurance Reform: Electronic Security Standards;
Use: This information collection corresponds to existing regulations
establishing standards for the security of electronic protected health
information to be implemented by health plans, health care
clearinghouses and certain health care providers, as required under
title II, subtitle F, sections 261 through 264 of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191.
The use of the security standards improves Federal health programs,
private health programs, and the effectiveness and efficiency of the
health care industry in general by establishing a level of protection
for certain electronic health information. This information collection
request does not propose any changes to this information collection
related to future modifications of the underlying HIPAA security
standards. Form Number: CMS-10149 (OCN: 0938-0949); Frequency:
Occasionally; Affected Public: Business or other for-profit, Not-for-
profit institutions, Federal Government, and State, Local or Tribal
Government; Number of Respondents: 135,560; Total Annual Responses:
285,560; Total Annual Hours: 536,743. (For policy questions regarding
this collection contact William Parham at 410-786-4669. For all other
issues call 410-786-1326.)
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS'
Web site address at https://www.cms.hhs.gov/PaperworkReductionActof1995,
or Email your request, including your address, phone number, OMB
number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call
the Reports Clearance Office on (410) 786-1326.
In commenting on the proposed information collections please
reference the document identifier or OMB control number. To be assured
consideration, comments and recommendations must be submitted in one of
the following ways by October 30, 2012:
1. Electronically. You may submit 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) 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: CMS-R-284 (OCN 0938-
0345), Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland
21244-1850.
Dated: August 28, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-21594 Filed 8-30-12; 8:45 am]
BILLING CODE 4120-01-P
