Agency Information Collection Activities: Proposed Collection; Comment Request, 24955-24957 [2012-10007]
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Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
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2012, the Board of Directors of the
Federal Deposit Insurance Corporation
met in closed session to consider
matters related to the Corporation’s
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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.
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Chairman Martin J. Gruenberg, that
Corporation business required its
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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
tkelley on DSK3SPTVN1PROD with NOTICES
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:
VerDate Mar<15>2010
17:51 Apr 25, 2012
Jkt 226001
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.
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
24955
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:
E:\FR\FM\26APN1.SGM
26APN1
24956
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.
tkelley on DSK3SPTVN1PROD with NOTICES
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 .................................................................................................................................................................
VerDate Mar<15>2010
17:51 Apr 25, 2012
Jkt 226001
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
E:\FR\FM\26APN1.SGM
26APN1
$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
24957
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Notices
TABLE 3—COST TO THE FEDERAL GOVERNMENT—Continued
Cost component
Total cost
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.
Proposed Project
[FR Doc. 2012–10007 Filed 4–25–12; 8:45 am]
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
tkelley on DSK3SPTVN1PROD with NOTICES
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:
Jkt 226001
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
PO 00000
Frm 00033
Fmt 4703
Sfmt 4703
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
E:\FR\FM\26APN1.SGM
26APN1
Agencies
[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Notices]
[Pages 24955-24957]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10007]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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: ``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.
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:
[[Page 24956]]
(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 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 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.
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
Data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
In-person interviews............................ 160 1 1 160
Collection of documentation..................... 8 1 2 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 Total burden Average hourly Total cost
Data collection respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
In-person interviews............................ 160 160 $56.23 $8,997
Collection of documentation..................... 8 16 15.30 245
---------------------------------------------------------------
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.
Table 3--Cost to the Federal Government
------------------------------------------------------------------------
Annualized
Cost component Total cost cost
------------------------------------------------------------------------
Project Development..................... $49,161 $16,377
Data Collection Activities.............. 123,478 41,159
Data Processing and Analysis............ 109,433 36,478
Publication of Results.................. 81,836 27,279
Project Management...................... 18,438 6,146
Overhead................................ 117,531 39,177
[[Page 24957]]
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.
[FR Doc. 2012-10007 Filed 4-25-12; 8:45 am]
BILLING CODE 4160-90-M