Attachment C -- Federal Register Notice

Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
FEDERAL DEPOSIT INSURANCE
CORPORATION
Sunshine Act Meeting
Pursuant to the provisions of the
‘‘Government in the Sunshine Act’’
(5 U.S.C. 552b), notice is hereby given
that at 2:22 p.m. on Monday, April 23,
2012, the Board of Directors of the
Federal Deposit Insurance Corporation
met in closed session to consider
matters related to the Corporation’s
supervision, corporate, and resolution
activities.
In calling the meeting, the Board
determined, on motion of Director
Thomas M. Hoenig (Appointive),
seconded by Director Richard Cordray
(Director, Consumer Financial
Protection Bureau), concurred in by
Director Thomas J. Curry (Comptroller
of the Currency), Director Jeremiah O.
Norton (Appointive), and Acting
Chairman Martin J. Gruenberg, that
Corporation business required its
consideration of the matters which were
to be the subject of this meeting on less
than seven days’ notice to the public;
that no earlier notice of the meeting was
practicable; that the public interest did
not require consideration of the matters
in a meeting open to public observation;
and that the matters could be
considered in a closed meeting by
authority of subsections (c)(4), (c)(6),
(c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10)
of the ‘‘Government in the Sunshine
Act’’ (5 U.S.C. 552b(c)(4), (c)(6), (c)(8),
(c)(9)(A)(ii), (c)(9)(B), and (c)(10)).
The meeting was held in the Board
Room of the FDIC Building located at
550 17th Street NW., Washington, DC.
Federal Deposit Insurance Corporation.
Dated: April 23, 2012.
Robert E. Feldman,
Executive Secretary.
[FR Doc. 2012–10161 Filed 4–24–12; 11:15 am]
BILLING CODE P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality

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Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and

SUMMARY:

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Budget (OMB) approve the proposed
information collection project: ‘‘System
Redesign for Value in Safety Net
Hospitals and Delivery Systems.’’ In
accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501–3521,
AHRQ invites the public to comment on
this proposed information collection.
This proposed information collection
was previously published in the Federal
Register on February 24th, 2012 and
allowed 60 days for public comment. No
substantive comments were received.
The purpose of this notice is to allow an
additional 30 days for public comment.
DATES: Comments on this notice must be
received by May 29, 2012.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at
OIRA_submission@omb.eop.gov
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
System Redesign for Value in Safety Net
Hospitals and Delivery Systems
This proposed project is a case study
of 8 safety net (SN) hospitals. The goals
of the project are to:
(1) Identify the tools and resources
needed to facilitate system redesign in
SN hospitals and;
(2) Identify any barriers to adoption of
these in SN environments, or any gaps
that exist in the available resources.
These goals are consistent with The
National Strategy for Quality
Improvement in Health Care, published
by the U.S. Department of Health and
Human Services in March 2011, which
articulated a need for progress toward
three goals: (1) Better Care, (2) Healthy
People/Healthy Communities and (3)
Affordable Care. SN hospitals and
systems are critical to achieving all
three. SN hospitals are hospitals and
health systems which provide a
significant portion of their services to
vulnerable, uninsured and Medicare
patients. While all hospitals face
challenges in improving both quality
and operating efficiency, safety net (SN)
hospitals face even greater challenges
due to growing demand for their
services and decreasing funding
opportunities.

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Despite these challenging
environmental factors, some SN
hospitals and health systems have
achieved financial stability and
implemented broad-ranging efforts to
improve the quality of care they deliver.
However, while there have been
successful quality improvement
initiatives for SN providers, most
initiatives aim at specific units within
large organizations. The improvements
introduced into these units have not
often been spread throughout the
organization. Additionally, these
improvements often are hard to sustain.
‘‘System redesign’’ refers to aligned and
synergistic quality improvement efforts
across a hospital or health system
leading to multidimensional changes in
the management or delivery of care or
strategic alignment of system changes
with an organization’s business strategy.
System redesign, if done successfully,
will allow SN providers to improve
their operations, remain afloat
financially, and provide better quality
healthcare to vulnerable and
underserved populations. Resources, as
defined here, may include learning
materials and environments developed
to support, advance, and facilitate
quality improvement efforts (e.g., tools,
guides, webinars, learning
collaboratives, training programs). The
term ‘‘resources’’ should not be
interpreted here to imply financial
support for routine staffing or
operations of Safety Net systems, but
may include quality improvement
grants, fellowships, collaboratives and
trainings.
Many tools, guides, and other learning
environments have been developed to
support the implementation of
individual quality improvement
initiatives. However, the development
of resources to support alignment across
multiple domains of a health system has
been limited. Furthermore, the
applicability of existing resources to SN
environments is unknown.
This study is being conducted by
AHRQ through its contractor, Boston
University, pursuant to AHRQ’s
statutory authority to conduct and
support research on healthcare and on
systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to quality
measurement and improvement. 42
U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goals of this project the
following activities and data collections
will be implemented:

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Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices

(1) In-person interviews will be
conducted during a 2-day site visit with
senior medical center leaders, clinical
managers and staff involved in system
redesign from each of the 8 participating
SN hospitals. These interviews may be
conducted one-on-one or in small
groups, depending upon the
participants’ availability. The purpose
of these interviews is to learn directly
from hospital leadership and staff about
the resources they have used to support
and guide their system redesign efforts
and what, if any, gaps there are in the
resources available to them.
(2) Collection of documentation from
each SN hospital. The documentation to
be collected includes annual reports,
performance dashboards, reports on
specific system redesign and quality
improvement projects and hospital
newsletters. The purpose of this task is
to provide supplementary information

presented as illustrative of the issues
facing SN hospitals engaging in system
redesign—rather than as representing
the quantity or distribution of
conditions and practices within SN
hospitals. All presentations and
publications will state the limitations of
our case-study methodology.

about the hospitals and their quality
improvement and system redesign
efforts. Collection of documentation
from participating hospitals will allow
the research team to collect additional
information that is readily available in
hospital documents, but may not be
known or readily accessible to interview
subjects during their interviews.
The findings and recommendations
developed from this project will be
disseminated through AHRQ networks
and through our partnership with the
National Association of Public Hospitals
and its membership group to ensure that
findings are reaching administrators at
public and SN hospitals directly. In
addition, findings will be published in
peer-reviewed and trade literature so
that they will be available to a wide
range of SN delivery system managers
and clinicians for use in hospitals and
healthcare systems. Findings will be

Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondents’ time to participate in this
data collection. In-person interviews
will be conducted with a total of 160
hospital staff members (20 from each of
the 8 participating SN hospitals) and
will last about 1 hour. The collection of
documentation will require 2 hours
work from 1 staff member at each
hospital. The total burden is estimated
to be 176 hours.

EXHIBIT 1—ANNUALIZED BURDEN HOURS
Number of
respondents

Data collection

Number of
responses per
respondent

Hours per
response

Total burden
hours

In-person interviews .........................................................................................
Collection of documentation ............................................................................

160
8

1
1

1
2

160
16

Total ..........................................................................................................

168

n/a

n/a

176

Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to provide the

requested data. The total cost burden is
estimated to be $9,242 annually.

EXHIBIT 2—ESTIMATED ANNUALIZED BURDEN COST
Number of
respondents

Data collection

Total burden
hours

Average
hourly wage
rate *

Total cost
burden

In-person interviews .........................................................................................
Collection of documentation ............................................................................

160
8

160
16

$56.23
15.30

$8,997
245

Total ..........................................................................................................

168

176

na

9,242

* The hourly rate of $56.23 is an average of the clinical personnel hourly wage of $91.10 for physicians and $32.56 for registered nurses, and
the administrative personnel hourly wage of $45.03 for medical and health services managers. The hourly rate of $15.30 is median hourly rate
for medical administrative support staff. All hourly rates are based on median salary data provided by the U.S. Bureau of Labor Statistics.

Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the estimated total
and annualized cost to the government

for this 3 year project. The total cost is
$499,877 and includes the cost of data
collection, data analysis, reporting, and
government oversight of the contract.
The costs associated with data

collection activities are not all for the
primary data collection of the case
studies but include the review of
existing literature and other available
data sources.

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TABLE 3—COST TO THE FEDERAL GOVERNMENT
Cost component

Total cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Publication of Results ..............................................................................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................

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$49,161
123,478
109,433
81,836
18,438
117,531

Annualized
cost
$16,377
41,159
36,478
27,279
6,146
39,177

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Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
TABLE 3—COST TO THE FEDERAL GOVERNMENT—Continued
Cost component

Annualized
cost

Government Oversight .............................................................................................................................................

13,710

4,570

Total ..................................................................................................................................................................

499,877

166,626

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: April 19, 2012.
Carolyn M. Clancy,
Director.
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘American Recovery and Reinvestment
Act ‘‘Developing a Registry of
Registries’’.’’ In accordance with the

SUMMARY:

VerDate Mar<15>2010

17:51 Apr 25, 2012

Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on February 23, 2012 and
allowed 60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by May 29, 2012.
ADDRESSES: Written comments should
be submitted to: AHRQ’s OMB Desk
Officer by fax at (202) 395–6974
(attention: AHRQ’s desk officer) or by
email at
OIRA_submission@omb.eop.gov
(attention: AHRQ’s desk officer).
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from the AHRQ Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427–1477, or by
email at doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project

[FR Doc. 2012–10007 Filed 4–25–12; 8:45 am]

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Total cost

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American Recovery and Reinvestment
Act ‘‘Developing a Registry of
Registries’’
The Food and Drug Administration
Modernization Act of 1997, Public Law
105–115, provided for the creation of a
Clinical Trials Data Bank, known as
ClinicalTrials.gov. Since its launch in
2000, the ClinicalTrials.gov system has
registered over 90,500 trials. The large
volume of studies currently listed in
ClinicalTrials.gov and the high usage
numbers suggest that the system has
been successful at improving access to
information about clinical studies.
However, while ClinicalTrials.gov
supports the listing of observational
studies, such listing is not required.
Patient registries are a distinct type of
observational study. Patient registries
may be designed for many purposes,
such as to observe the natural history of
disease, examine comparative
effectiveness, or fulfill post-approval
commitments. Patient registries have
specific characteristics that are not

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currently captured on
ClinicalTrials.gov. To date, some
registry sponsors have attempted to
leverage the observational study model
to post patient registry-type records on
ClinicalTrials.gov. However,
stakeholders have noted that the system
does not fully meet their needs.
Patient registries have received
significant attention and funding in
recent years. Similar to controlled
interventional studies, patient registries
represent some burden to patients (e.g.,
time to complete patient reported
outcome measures, risk of loss of
privacy), who often participate
voluntarily in hopes of improving
knowledge about a disease or condition.
Patient registries also represent a
substantial investment of health
research resources. Despite these
factors, registration of patient registries
in ClinicalTrials.gov is not currently
required, presenting the potential for
duplication of efforts and insufficient
dissemination of findings that are not
published in the peer-reviewed
literature. To ensure that resources are
used in the most efficient manner,
registries need to be listed in a manner
similar to that of trials in
ClinicalTrials.gov.
By creating a central point of
collection for information about all
patient registries in the United States,
the Registry of Patient Registries (RoPR)
helps to further AHRQ’s goals by
making information regarding quality,
appropriateness, and effectiveness of
health services (and patient registries in
particular) more readily available and
centralized.
The primary goal of this project is to
engage stakeholders in the design and
development of a RoPR database system
that is compatible with
ClinicalTrials.gov and meets the
following objectives:
(1) Provides a searchable database of
patient registries in the United States (to
promote collaboration, reduce
redundancy, and improve
transparency);
(2) Facilitates the use of common data
fields and definitions in similar health
conditions (to improve opportunities for
sharing, comparing, and linkage);
(3) Provides a public repository of
searchable summary results (including

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