Agency Information Collection Activities: Proposed Collection; Comment Request, 31445-31447 [2010-13107]
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Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices
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sroberts on DSKD5P82C1PROD with NOTICES
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[FR Doc. 2010–13178 Filed 6–2–10; 8:45 am]
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31445
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:
‘‘Reductions of Infection Caused by
Carbapenem Resistant
Enterobacteriaceae (KPC) Producing
Organisms through the Application of
Recently Developed CDC/HICPAC
Recommendations.’’ In accordance with
the Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on March 31st, 2010 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 July 6, 2010.
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
e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Reductions of Infections Caused by
Carbapenem Resistant
Enterobacteriaceae (KPC) Producing
Organisms Through the Application of
Recently Developed CDC/HICPAC
Recommendations.
Healthcare Acquired Infections (HAIs)
caused almost 100,000 deaths among
the 2.1 million people who acquired
infections while hospitalized in 2000,
and HAI rates have risen relentlessly
E:\FR\FM\03JNN1.SGM
03JNN1
31446
Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices
since then. On March 20, 2009, the
Centers for Disease Control (CDC) and
the Healthcare Infections Control
Practices Advisory Committee (HICPAC)
developed infection control (IC)
guidance for Klebsiella pneumonia
carbapenemase-producing (KPC)
isolates, as they have been rapidly
emerging as a significant challenge in
healthcare settings. The danger of these
bacteria is that they are resistant to
carbapenem (a class of beta-lactam
antibiotics with a broad spectrum of
antibacterial activity) and cannot be
treated by the most commonly
prescribed antibiotics. Limited
treatment options mean that infections
caused by carbapenem-resistant bacteria
result in substantial mortality and
morbidity.
The CDC and HICPAC
recommendations draw on infection
control strategies which have been
applied to these pathogens in other
settings, and other evidence-based
strategies in infection control. There has
been little research, however, on the
implementation of control strategies to
prevent the spread of these KPC
infections. The goal of this project is to
understand how these recommendations
can best be implemented and how
effective these recommendations will be
in practice. This research will advance
private and public efforts to improve
health care quality by improving
measures to control the spread of a
dangerous organism. This research will
also provide data for the development of
an implementation toolkit that hospitals
can use to prevent the spread of
carbapenem resistant bacteria. The
toolkit may include the following types
of resources: General information about
the implementation of evidence-based
clinical practices, resource materials,
and tools and methods that users can
adopt to conduct point prevalence
surveys, protocols and tools that users
can adopt to specify when active KPC
surveillance is needed, and resources
for approaching the problem as a teambased quality-improvement effort. OMB
clearance will be sought for this toolkit
once it is developed.
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
This project will include the following
data collections from the intensive care
unit (ICU) staff within each of three
participating hospitals:
(1) Pre-intervention focus groups will
be conducted separately with managers
and staff. The purpose of these focus
groups is to identify potential problems
in the implementation that can be
addressed through various means (e.g.,
additional education, other changes in
process). Another purpose is to
understand the existing approach to
quality improvement, the connection(s)
between overall approach to quality
improvement and to KPC infection
control practices, current practices at
the hospital of quality reporting and
accountability, and constraints and
obstacles to quality improvement as
seen in their roles. Staff members
identified for the focus groups will be
those with the most first-hand
knowledge of existing quality
improvement efforts, and KPC infection
control practices.
(2) Clinical staff survey. Factors
identified in the pre-intervention focus
groups will be used to inform the
development of a self-administered
survey of staff knowledge of and
attitudes toward KPC surveillance and
infection control procedures.
Respondents will be health care workers
on the units where these new guidelines
have been implemented. Findings from
the survey will be used to assess barriers
perceived by the staff, potential
differences across units, and potential
differences by employee/occupational
group.
(3) Post-intervention focus groups (6
months after implementation of new
KPC IC guidelines) will be conducted
separately with managers and staff. The
purpose of these focus groups is to
identify actual problems experienced in
the initial implementation and possible
measures to address, and to identify
successful practices to include in a
toolkit that hospitals can use to
implement the CDC and HICPAC
recommendations.
In addition to developing a toolkit,
AHRQ plans to disseminate the lessons
learned from this project about how
hospitals can best implement the CDC
guidance for KPC screening and
infection control, in order to inform
efforts to change practice in this area.
Estimated Annual Respondent Burden
The estimated annualized burden
hours for respondents to participate in
this two year research project are
presented in Exhibit 1. Pre-intervention
focus groups with clinical staff will be
conducted with 18 staff members (an
average of 9 per year for 2 years) from
each of the 3 participating hospitals and
will take about 1 hour. Pre-intervention
focus groups with also be conducted
with 2 managers (an average of I per
year for 2 years) from each hospital and
will take about an hour to complete.
The clinical staff survey will be
administered to 20 clinical staff (an
average of 10 per year for years) from
each hospital and will take 15 minutes
to complete.
Finally, respondents from the preintervention focus groups will
participate in post-intervention focus
groups approximately four months after
the initiation of the intervention. They
will not last more than an hour each.
The total annualized burden hours are
estimated to be 68 hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this research. The total annualized cost
burden is estimated to be $3,108.
EXHIBIT 1. ESTIMATED ANNUALIZED BURDEN HOURS
Number of respondents
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Data collection
Number of responses per
respondent
Hours per response
3
3
3
3
3
9
1
10
9
1
1
1
15/60
1
1
Pre-intervention focus groups with clinical staff * ............................................
Pre-intervention focus groups with managers* ................................................
Clinical staff survey ..........................................................................................
Post-intervention focus groups with clinical staff * ...........................................
Post-intervention focus groups with managers* ..............................................
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Total burden
hours
27
3
8
27
3
31447
Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices
EXHIBIT 1. ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of respondents
Data collection
Number of responses per
respondent
Hours per response
15
n/a
n/a
Total ..........................................................................................................
Total burden
hours
68
* Individuals
that cannot attend the focus groups will be interviewed one-on-one. Clinical staff includes IC leaders, QI team members and unit
staff. Managers include the chief nursing officer and chief medical officer.
EXHIBIT 2. ESTIMATED ANNUALIZED COST BURDEN
Number of respondents
Data collection
Total burden
hours
Average hourly wage rate
Total cost burden
Pre-intervention focus groups with clinical staff * ............................................
Pre-intervention focus groups with managers * ...............................................
Clinical staff survey ..........................................................................................
3
3
3
27
3
8
$36.73 *
$138.38 **
$36.73 *
$992
$415
$294
Post-intervention focus groups with clinical staff * ...........................................
Post-intervention focus groups with managers * ..............................................
3
3
27
3
$36.73 *
$138.38 **
$992
$415
Total ..........................................................................................................
15
68
na
$3,108
* Based
upon the mean hourly wage for Registered Nurses in Nassau and Suffolk County, NY as reported by the Bureau of Labor Statistics in
May 2008.
** Based on report of a private survey of HR departments conducted in November 2009 in New York, NY published by https://www.saIary.com; 3
chief nursing officers at $101.14/hr and 3 chief medical officers at $175.61/hour.
Estimated Annual Costs to the Federal
Government
Exhibit 3 shows the annualized and
total cost to the federal government for
this two year research project. Project
development covers steps taken to
revise the research plan and begin
implementation. The total cost is
estimated to be $500,001.
EXHIBIT 3. ANNUALIZED AND TOTAL COST TO THE FEDERAL GOVERNMENT
Annualized
cost
Cost component
Total cost
Project Management ................................................................................................................................................
Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Travel .......................................................................................................................................................................
Overhead .................................................................................................................................................................
$125,526
$54,622
$41,864
$4,000
$23,754
$251,052
$109,244
$83,728
$8,000
$47,507
Total ..................................................................................................................................................................
$250,001
$500,001
sroberts on DSKD5P82C1PROD with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
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
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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
will become a matter of public record.
Dated: May 21, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–13107 Filed 6–2–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Agency Recordkeeping/Reporting
Requirements Under Emergency
Review by the Office of Management
and Budget
Title: State Personal Responsibility
Education Program.
OMB No.: New Collection.
Description: An emergency request is
being made to solicit comments from
the public on paperwork reduction as it
relates to ACYF’s receipt of the
following documents from applicants
and awardees:
• Application for Formula Grant
• Performance Progress Reports
• Year 1 Implementation Plan
• Performance Measure Reporting
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]]>Agencies
[Federal Register Volume 75, Number 106 (Thursday, June 3, 2010)]
[Notices]
[Pages 31445-31447]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13107]
-----------------------------------------------------------------------
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: ``Reductions of Infection Caused by Carbapenem Resistant
Enterobacteriaceae (KPC) Producing Organisms through the Application of
Recently Developed CDC/HICPAC Recommendations.'' In accordance with the
Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public
to comment on this proposed information collection.
This proposed information collection was previously published in
the Federal Register on March 31st, 2010 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 July 6, 2010.
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
e-mail 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 e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Reductions of Infections Caused by Carbapenem Resistant
Enterobacteriaceae (KPC) Producing Organisms Through the Application of
Recently Developed CDC/HICPAC Recommendations.
Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths
among the 2.1 million people who acquired infections while hospitalized
in 2000, and HAI rates have risen relentlessly
[[Page 31446]]
since then. On March 20, 2009, the Centers for Disease Control (CDC)
and the Healthcare Infections Control Practices Advisory Committee
(HICPAC) developed infection control (IC) guidance for Klebsiella
pneumonia carbapenemase-producing (KPC) isolates, as they have been
rapidly emerging as a significant challenge in healthcare settings. The
danger of these bacteria is that they are resistant to carbapenem (a
class of beta-lactam antibiotics with a broad spectrum of antibacterial
activity) and cannot be treated by the most commonly prescribed
antibiotics. Limited treatment options mean that infections caused by
carbapenem-resistant bacteria result in substantial mortality and
morbidity.
The CDC and HICPAC recommendations draw on infection control
strategies which have been applied to these pathogens in other
settings, and other evidence-based strategies in infection control.
There has been little research, however, on the implementation of
control strategies to prevent the spread of these KPC infections. The
goal of this project is to understand how these recommendations can
best be implemented and how effective these recommendations will be in
practice. This research will advance private and public efforts to
improve health care quality by improving measures to control the spread
of a dangerous organism. This research will also provide data for the
development of an implementation toolkit that hospitals can use to
prevent the spread of carbapenem resistant bacteria. The toolkit may
include the following types of resources: General information about the
implementation of evidence-based clinical practices, resource
materials, and tools and methods that users can adopt to conduct point
prevalence surveys, protocols and tools that users can adopt to specify
when active KPC surveillance is needed, and resources for approaching
the problem as a team-based quality-improvement effort. OMB clearance
will be sought for this toolkit once it is developed.
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
This project will include the following data collections from the
intensive care unit (ICU) staff within each of three participating
hospitals:
(1) Pre-intervention focus groups will be conducted separately with
managers and staff. The purpose of these focus groups is to identify
potential problems in the implementation that can be addressed through
various means (e.g., additional education, other changes in process).
Another purpose is to understand the existing approach to quality
improvement, the connection(s) between overall approach to quality
improvement and to KPC infection control practices, current practices
at the hospital of quality reporting and accountability, and
constraints and obstacles to quality improvement as seen in their
roles. Staff members identified for the focus groups will be those with
the most first-hand knowledge of existing quality improvement efforts,
and KPC infection control practices.
(2) Clinical staff survey. Factors identified in the pre-
intervention focus groups will be used to inform the development of a
self-administered survey of staff knowledge of and attitudes toward KPC
surveillance and infection control procedures. Respondents will be
health care workers on the units where these new guidelines have been
implemented. Findings from the survey will be used to assess barriers
perceived by the staff, potential differences across units, and
potential differences by employee/occupational group.
(3) Post-intervention focus groups (6 months after implementation
of new KPC IC guidelines) will be conducted separately with managers
and staff. The purpose of these focus groups is to identify actual
problems experienced in the initial implementation and possible
measures to address, and to identify successful practices to include in
a toolkit that hospitals can use to implement the CDC and HICPAC
recommendations.
In addition to developing a toolkit, AHRQ plans to disseminate the
lessons learned from this project about how hospitals can best
implement the CDC guidance for KPC screening and infection control, in
order to inform efforts to change practice in this area.
Estimated Annual Respondent Burden
The estimated annualized burden hours for respondents to
participate in this two year research project are presented in Exhibit
1. Pre-intervention focus groups with clinical staff will be conducted
with 18 staff members (an average of 9 per year for 2 years) from each
of the 3 participating hospitals and will take about 1 hour. Pre-
intervention focus groups with also be conducted with 2 managers (an
average of I per year for 2 years) from each hospital and will take
about an hour to complete.
The clinical staff survey will be administered to 20 clinical staff
(an average of 10 per year for years) from each hospital and will take
15 minutes to complete.
Finally, respondents from the pre-intervention focus groups will
participate in post-intervention focus groups approximately four months
after the initiation of the intervention. They will not last more than
an hour each. The total annualized burden hours are estimated to be 68
hours.
Exhibit 2 shows the estimated annualized cost burden associated
with the respondents' time to participate in this research. The total
annualized cost burden is estimated to be $3,108.
Exhibit 1. Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Pre-intervention focus groups with clinical 3 9 1 27
staff \*\......................................
Pre-intervention focus groups with managers\*\.. 3 1 1 3
Clinical staff survey........................... 3 10 15/60 8
Post-intervention focus groups with clinical 3 9 1 27
staff \*\......................................
Post-intervention focus groups with managers\*\. 3 1 1 3
---------------------------------------------------------------
[[Page 31447]]
Total....................................... 15 n/a n/a 68
----------------------------------------------------------------------------------------------------------------
\*\ Individuals that cannot attend the focus groups will be interviewed one-on-one. Clinical staff includes IC
leaders, QI team members and unit staff. Managers include the chief nursing officer and chief medical officer.
Exhibit 2. Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Data collection respondents hours wage rate burden
----------------------------------------------------------------------------------------------------------------
Pre-intervention focus groups with clinical 3 27 $36.73 \*\ $992
staff \*\......................................
Pre-intervention focus groups with managers \*\. 3 3 $138.38 \**\ $415
Clinical staff survey........................... 3 8 $36.73 \*\ $294
---------------------------------------------------------------
Post-intervention focus groups with clinical 3 27 $36.73 \*\ $992
staff \*\......................................
Post-intervention focus groups with managers \*\ 3 3 $138.38 \**\ $415
---------------------------------------------------------------
Total....................................... 15 68 na $3,108
----------------------------------------------------------------------------------------------------------------
\*\ Based upon the mean hourly wage for Registered Nurses in Nassau and Suffolk County, NY as reported by the
Bureau of Labor Statistics in May 2008.
\**\ Based on report of a private survey of HR departments conducted in November 2009 in New York, NY published
by https://www.saIary.com; 3 chief nursing officers at $101.14/hr and 3 chief medical officers at $175.61/hour.
Estimated Annual Costs to the Federal Government
Exhibit 3 shows the annualized and total cost to the federal
government for this two year research project. Project development
covers steps taken to revise the research plan and begin
implementation. The total cost is estimated to be $500,001.
Exhibit 3. Annualized and Total Cost to the Federal Government
------------------------------------------------------------------------
Annualized
Cost component cost Total cost
------------------------------------------------------------------------
Project Management...................... $125,526 $251,052
Project Development..................... $54,622 $109,244
Data Collection Activities.............. $41,864 $83,728
Travel.................................. $4,000 $8,000
Overhead................................ $23,754 $47,507
-------------------------------
Total............................... $250,001 $500,001
------------------------------------------------------------------------
Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, 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 will become a matter of public
record.
Dated: May 21, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-13107 Filed 6-2-10; 8:45 am]
BILLING CODE 4160-90-M
