Agency Information Collection Activities: Proposed Collection; Comment Request, 6631-6634 [E9-2680]
Download as PDF
<![CDATA[
6631
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
At each of the five sites, up to 100
pharmacy staff members will be
sampled, with an expected response rate
of 75 percent, yielding 75 respondents
per site.
Estimated Annual Respondent Burden
Exhibit 1 show the estimated
annualized burden hours for the
respondents’ time to participate in this
evaluation. The on-site interviews will
require about 1 hour to complete for a
total of 30 burden hours. The preinterview questionnaire is expected to
take 15 minutes to complete for a total
of 9 burden hours. The phannacy staff
survey will take about 30 minutes to
complete for a total of 188 burden
hours. The total burden hours for all
data collections is estimated to be 227
hours.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents’ time to participate in
this project. The cost burden is
estimated to be $10,800.
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
site
Number of
sites
Form name
Hours per
response
Total burden
hours
On-Site Interviews ...........................................................................................
Pre-Interview Questionnaire for Demonstration Project Leaders .............
Pre-Interview Questionnaire for All Interview Participants .......................
Survey of Pharmacy Staff ................................................................................
5
5
5
5
6
1
6
75
1.00
15/60
15/60
30/60
30
1
8
188
Total ...................................................................................................
20
........................
........................
227
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
sites
Form name
Total burden
hours
Average hourly wage rate*
Total cost
burden
On-Site Interviews ...........................................................................................
Pre-Interview Questionnaire for Demonstration Project Leaders .............
Pre-Interview Questionnaire for All Interview Participants .......................
Survey of Pharmacy Staff ................................................................................
5
5
5
5
30
1
8
188
$47.58
47.58
47.58
47.58
$1,427
48
380
8,945
Total ...................................................................................................
20
227
........................
$10,800
*Based on the national average wage for pharmacists (29–1051), National Compensation Survey: Occupational wages in the United States
May 2007, U.S. Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal
Government
The estimated total cost to the Federal
government for this one year evaluation
is $208,874. Exhibit 3 shows a
breakdown of the costs.
EXHIBIT 3—ESTIMATED ANNUAL COSTS
TO THE FEDERAL GOVERNMENT
Component
Total
Developing the interview guide
and survey instrument ..............
Preparing OMB clearance submission ......................................
Site visits to each demonstration
Analyzing the data from each
demonstration site .....................
Preparing a final report .................
erowe on PROD1PC63 with NOTICES
Total ...............................
$33,905
6,704
73,368
54,835
40,062
208,874
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 health care research and health
care information dissemination
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
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: February 2, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–2679 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–90–M
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
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:
‘‘Reducing Waste and Inefficiency
through Process Redesign: Lean/Toyota
Production System (TPS)
Implementation.’’ In accordance with
the Paperwork Reduction Act of 1995,
44 U.S.C. 3506(c)(2)(A), AHRQ invites
the public to comment on this proposed
information collection.
This proposed information collection
was previously published in the Federal
Register on November 21, 2008 and
allowed 60 days for public comment. No
comments were received. The purpose
E:\FR\FM\10FEN1.SGM
10FEN1
6632
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
erowe on PROD1PC63 with NOTICES
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by March 12, 2009.
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
‘‘Reducing Waste and Inefficiency
through Process Redesign: Lean/Toyota
Production System (TPS)
Implementation’’
AHRQ proposes to investigate the
contribution of Lean/TPS to reducing
waste in health care delivery systems.
Lean/TPS is a process-redesign
methodology adopted from Toyota
Production Systems. The goal of Lean/
TPS is to empower front-line staff to
apply continuous quality improvement
methods to reduce waste and enhance
value in workflows and operations
(Spear, S., Fixing healthcare from the
inside, today. Harvard Business Rev.,
2005 83(9), 78–91).
AHRQ is interested in assessing and
disseminating promising techniques and
methodologies for redesigning health
care processes to reduce waste and
enhance efficiency. Using a purposive
sample of health care organizations and
projects, AHRQ will describe and assess
the ways in which Lean/TPS has been
implemented and the related challenges
and solutions experienced. The sampled
organizations will vary in community
and market characteristics, type of
service (e.g., inpatient/outpatient), and
delivery system characteristics (e.g.,
relationship between physicians and
hospitals, ownership). AHRQ plans to
disseminate the lessons learned from
this project on the implementation of
Lean/TPS to health care delivery
systems. AHRQ will work with a
contractor to complete this work,
including all activities mentioned
above. This project is being performed
pursuant to AHRQ’s statutory authority
to conduct and support research on
healthcare and on healthcare delivery
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
systems, including activities with
respect to: The quality, effectiveness,
efficiency, appropriateness and value of
health care services; quality
measurement and improvement; and
health care costs, productivity,
organization, and market forces. 42
U.S.C. 299a(a)(1), (2), and (6).
Method of Collection
Four or five research locations (i.e.,
hospitals or other heath settings) will be
selected to create nine case study
reports. Four of the studies will employ
a retrospective analytics perspective,
while five will employ a prospective
analytics perspective, including one
study focused on the construction of a
hospital. For the other eight case
studies, the department will be unit of
analysis for the case study. At each
research location, implementation of
Lean/TPS in two departments will be
studied: One department with an
essentially linear process (clinical
laboratory, radiology, or ED) and one
department with an essentially nonlinear process (cardiology, GI, or med/
surg unit). A linear department is one in
which the process is essentially uniform
and predictable for most or all services
delivered. A non-linear department is
one in which the process is much less
uniform and predictable.
Qualitative data will be collected
directly from the departments selected
for this study. The collection will be
accomplished using interviews
(telephone and in-person), collection of
documentation, and digital diaries for
the five prospective case studies. The
‘‘digital diary’’ is a data collection
method using a diary entry guide and a
digital recorder to describe key aspects
of the implementation process. The
number of digital diary submissions will
depend on the number and duration of
the Lean/TPS projects within in each
department. The in-person interviews
will be conducted through a multi-day
visit to each site. Only the in-person
interviews and collection of
documentation methods will be
employed for the retrospective case
studies.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours. The table
includes burden for both the
retrospective and prospective case
studies in separate sections. As this
project will collect data from
establishments, we have defined each
establishment as the medical or
administrative department that is
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
implementing the Lean/TPS project to
be studied.
In Exhibit 1, the total burden hours in
each row (Column F) is calculated as the
product of the values in the other
colunms (Columns B–E). Thus, for each
of the 5 prospective case studies, we
will conduct in-person interviews with
15 administrative and clinical
personnel. Each person will be
interviewed twice during the 36 week
data collection period. The estimated
time per response is 1.0 hour for a total
of 150 burden hours for in-person
interviews. Using the same calculation
approach, we project 23 burden hours
for telephone interviews, 53 burden
hours for digital diaries, and 20 burden
hours for assembling documents for a
subtotal of 246 burden hours for the 5
prospective case studies. For each
retrospective case study, we have
defined establishment as the department
from which we will collect data. A total
of 15 in-person interviews will be
conducted with the administrative and
clinical personnel during a site visit.
The estimated time per response is 1.0
hour. For all 4 retrospective case
studies, we estimate a total of 60 burden
hours. Similar to the prospective case
studies, administrative staff from each
site will be asked to provide training
materials, reports on Lean/TPS
implementation, and/or any other
documentation or existing data from
previous or current Lean/TPS projects
implemented and will take 4 hours. The
total estimated burden for the
retrospective case studies is 76 hours.
The total burden hours for all 9 case
studies is 322 hours.
Exhibit 2 shows the estimated
annualized cost burden for the
respondents’ time to provide the
requested data. The hourly rate of
$35.07 is an average of the
administrative personnel hourly wage of
$14.53 and the clinical personnel hourly
wage of $62.52 for physicians and
$28.15 for registered nurses. The
average hourly wage of administrative
and clinical personnel is used to
estimate the cost of in-person
interviews, telephone interviews, and
digital diaries, because all kinds of staff
may be asked to participate in these
three activities. The average hourly
wage for administrative personnel—
$14.53—is used to estimate the cost of
assembling documentation, because
administrative support staff will
perform this task. The total estimated
cost burden is about $10,554.
E:\FR\FM\10FEN1.SGM
10FEN1
6633
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Data collection
Number of
establishments
Number of respondents per
establishment
Number of
responses per
respondent
Hours per
response
Total burden
hours
A
B
C
D
E
F
Prospective Case Studies & Hospital Case Study
In-person interviews .........................................
Telephone interviews .......................................
Digital Diaries ...................................................
Collection of documentation ............................
Prospective Subtotal .................................
5
5
5
5
20
15
3
2
1
n/a
2
3
32
1
n/a
1
30/60
10/60
4
n/a
150
23
53
20
246
Retrospective Case Studies
In-person interviews .........................................
Collection of documentation ............................
Retrospective Subtotal ..............................
4
4
8
15
1
n/a
1
1
n/a
1
4
n/a
60
60
76
Grand Total ........................................
28
n/a
n/a
n/a
322
EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
establishments
Data collection
Total burden
hours
Average
hourly wage
rate*
Total cost burden
Prospective, Retrospective, & Hospital Case Studies
In-person interviews .........................................................................
Telephone interviews .......................................................................
Digital Diaries ...................................................................................
Collection of documentation ............................................................
Total ..........................................................................................
9
5
5
9
28
210
23
53
36
322
$35.07
35.07
35.07
14.53
n/a
$7,365
807
1,859
523
10,554
*Based upon the average hourly wages of administrative support personnel, physicians, and registered nurses, National Compensation Survey:
Occupational Wages in the United States 2005, U.S. Department of Labor, Bureau of Labor Statistics.
Estimated Annual Costs to the Federal
Government
The total cost to the Federal
Government for this project is $494,999,
with an average annual cost of $247,500.
This figure includes the cost of data
collection, data analysis, reporting, and
contract oversight by the government.
Exhibit 3 shows the individual cost
components.
EXHIBIT 3—ESTIMATED COST
Cost component
Total cost
Annualized cost
Project Development .......................................................................................................................................
Data Collection Activities .................................................................................................................................
Data Processing and Analysis .........................................................................................................................
Publication of Results ......................................................................................................................................
Project Management ........................................................................................................................................
Overhead .........................................................................................................................................................
Government Oversight .....................................................................................................................................
$19,885
231,339
62,621
67,087
21,349
77,532
15,186
$9,942
115,670
31,310
33,544
10,675
38,766
7,593
Total ..........................................................................................................................................................
494,999
247,500
erowe on PROD1PC63 with NOTICES
Request for Comments
In accordance with the above-cited
Paperwork Reduction Act legislation,
comments on AHRQs 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’s health care research and health
care information dissemination
functions, including whether the
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
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
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\10FEN1.SGM
10FEN1
6634
Federal Register / Vol. 74, No. 26 / Tuesday, February 10, 2009 / Notices
Dated: February 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention (CDC).
[FR Doc. E9–2805 Filed 2–9–09; 8:45 am]
Dated: February 2, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9–2680 Filed 2–9–09; 8:45 am]
BILLING CODE 4160–90–M
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Centers for Disease Control and
Prevention
Advisory Committee to the Director,
Centers for Disease Control and
Prevention (ACD, CDC)
erowe on PROD1PC63 with NOTICES
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of the
aforementioned committee:
Time and Date: 3 p.m.–4:30 p.m., February
24, 2009.
Place: The teleconference call will
originate at the CDC. For details on accessing
the teleconference is located in the
supplementary information.
Status: Open to the public, teleconference
access limited only by availability of
telephone ports.
Purpose: The committee will provide
advice to the CDC Director on strategic and
other broad issues facing CDC.
Matters to be Discussed: The Advisory
Committee to the Director will discuss and
decide on recommendations from its Ethics
Subcommittee, National Biosurveillance
Advisory Subcommittee, and Budget
Workgroup. The Ethics Subcommittee will
make recommendations on using travel
restrictions for individuals with infectious
illnesses. The Ethics Subcommittee will also
discuss a draft charge that clearly articulates
the ethical foundation for focusing on health
protection activities and examining the social
determinants of health. The National
Biosurveillance Advisory Subcommittee will
seek approval on recommendations for
latitude to share specific points with key
members of the new administration. The
Budget Workgroup will provide
recommendations around principles for
change, in terms of the budget and the budget
structure and process for the CDC.
Agenda items are subject to change as
priorities dictate.
Supplementary Information: This
conference call is scheduled to begin at 3
p.m. Eastern Standard Time. To participate
in the teleconference, please dial 1 (888)
323–9787 and enter conference code
4735949.
Contact Person for More Information: Brad
Perkins, M.D., M.B.A., Executive Officer,
ACD, CDC, 1600 Clifton Road, NE., M/S D–
14, Atlanta, Georgia 30333. Telephone: (404)
639–7000.
The Director, Management Analysis and
Services office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities for
both the CDC and the Agency for Toxic
Substances and Disease Registry.
VerDate Nov<24>2008
14:17 Feb 09, 2009
Jkt 217001
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Assessing the
Accuracy of Self-Report of HIV Testing
Behavior, Program Announcement
Number (PA) 09–002
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting.
Time and Date: 8 a.m.–5 p.m., March 20,
2009 (Closed).
Place: Sheraton Gateway Hotel, Atlanta
Airport, 1900 Sullivan Road, Atlanta, GA
30337, Telephone (770) 997–1100.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c)(4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters to be Discussed: The meeting will
include the review, discussion, and
evaluation of ‘‘Assessing the Accuracy of
Self-Report of HIV Testing Behavior, Program
Announcement Number (PA) 09–002.’’
Contact Person for More Information:
Gregory Anderson, M.P.H., M.S., Scientific
Review Administrator, Strategic Science and
Program Unit, Office of the Director,
Coordinating Center for Infectious Diseases,
CDC, 1600 Clifton Road, Mailstop E–60,
Atlanta, GA 30333, Telephone: (404) 498–
2275.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: February 3, 2009.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E9–2803 Filed 2–9–09; 8:45 am]
Frm 00066
Fmt 4703
Food and Drug Administration
[Docket No. FDA–2008–D–0339]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry on Updating Labeling for
Susceptibility Test Information in
Systemic Antibacterial Drug Products
and Antimicrobial Susceptibility
Testing Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by March 12,
2009.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–6974, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Guidance for Industry on
Updating Labeling for Susceptibility
Test Information in Systemic
Antibacterial Drug Products and
Antimicrobial Susceptibility Testing
Devices.’’ Also include the FDA docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance for Industry on Updating
Labeling for Susceptibility Test
Information in Systemic Antibacterial
Drug Products and Antimicrobial
Susceptibility Testing Devices
In the Federal Register of June 12,
2008 (73 FR 33438), FDA announced the
availability of a draft guidance for
BILLING CODE 4163–18–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
E:\FR\FM\10FEN1.SGM
10FEN1
]]>Agencies
[Federal Register Volume 74, Number 26 (Tuesday, February 10, 2009)]
[Notices]
[Pages 6631-6634]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2680]
-----------------------------------------------------------------------
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: ``Reducing Waste and Inefficiency through Process Redesign:
Lean/Toyota Production System (TPS) Implementation.'' In accordance
with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ
invites the public to comment on this proposed information collection.
This proposed information collection was previously published in
the Federal Register on November 21, 2008 and allowed 60 days for
public comment. No comments were received. The purpose
[[Page 6632]]
of this notice is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by March 12, 2009.
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
``Reducing Waste and Inefficiency through Process Redesign: Lean/
Toyota Production System (TPS) Implementation''
AHRQ proposes to investigate the contribution of Lean/TPS to
reducing waste in health care delivery systems. Lean/TPS is a process-
redesign methodology adopted from Toyota Production Systems. The goal
of Lean/TPS is to empower front-line staff to apply continuous quality
improvement methods to reduce waste and enhance value in workflows and
operations (Spear, S., Fixing healthcare from the inside, today.
Harvard Business Rev., 2005 83(9), 78-91).
AHRQ is interested in assessing and disseminating promising
techniques and methodologies for redesigning health care processes to
reduce waste and enhance efficiency. Using a purposive sample of health
care organizations and projects, AHRQ will describe and assess the ways
in which Lean/TPS has been implemented and the related challenges and
solutions experienced. The sampled organizations will vary in community
and market characteristics, type of service (e.g., inpatient/
outpatient), and delivery system characteristics (e.g., relationship
between physicians and hospitals, ownership). AHRQ plans to disseminate
the lessons learned from this project on the implementation of Lean/TPS
to health care delivery systems. AHRQ will work with a contractor to
complete this work, including all activities mentioned above. This
project is being performed pursuant to AHRQ's statutory authority to
conduct and support research on healthcare and on healthcare delivery
systems, including activities with respect to: The quality,
effectiveness, efficiency, appropriateness and value of health care
services; quality measurement and improvement; and health care costs,
productivity, organization, and market forces. 42 U.S.C. 299a(a)(1),
(2), and (6).
Method of Collection
Four or five research locations (i.e., hospitals or other heath
settings) will be selected to create nine case study reports. Four of
the studies will employ a retrospective analytics perspective, while
five will employ a prospective analytics perspective, including one
study focused on the construction of a hospital. For the other eight
case studies, the department will be unit of analysis for the case
study. At each research location, implementation of Lean/TPS in two
departments will be studied: One department with an essentially linear
process (clinical laboratory, radiology, or ED) and one department with
an essentially non-linear process (cardiology, GI, or med/surg unit). A
linear department is one in which the process is essentially uniform
and predictable for most or all services delivered. A non-linear
department is one in which the process is much less uniform and
predictable.
Qualitative data will be collected directly from the departments
selected for this study. The collection will be accomplished using
interviews (telephone and in-person), collection of documentation, and
digital diaries for the five prospective case studies. The ``digital
diary'' is a data collection method using a diary entry guide and a
digital recorder to describe key aspects of the implementation process.
The number of digital diary submissions will depend on the number and
duration of the Lean/TPS projects within in each department. The in-
person interviews will be conducted through a multi-day visit to each
site. Only the in-person interviews and collection of documentation
methods will be employed for the retrospective case studies.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours. The table
includes burden for both the retrospective and prospective case studies
in separate sections. As this project will collect data from
establishments, we have defined each establishment as the medical or
administrative department that is implementing the Lean/TPS project to
be studied.
In Exhibit 1, the total burden hours in each row (Column F) is
calculated as the product of the values in the other colunms (Columns
B-E). Thus, for each of the 5 prospective case studies, we will conduct
in-person interviews with 15 administrative and clinical personnel.
Each person will be interviewed twice during the 36 week data
collection period. The estimated time per response is 1.0 hour for a
total of 150 burden hours for in-person interviews. Using the same
calculation approach, we project 23 burden hours for telephone
interviews, 53 burden hours for digital diaries, and 20 burden hours
for assembling documents for a subtotal of 246 burden hours for the 5
prospective case studies. For each retrospective case study, we have
defined establishment as the department from which we will collect
data. A total of 15 in-person interviews will be conducted with the
administrative and clinical personnel during a site visit. The
estimated time per response is 1.0 hour. For all 4 retrospective case
studies, we estimate a total of 60 burden hours. Similar to the
prospective case studies, administrative staff from each site will be
asked to provide training materials, reports on Lean/TPS
implementation, and/or any other documentation or existing data from
previous or current Lean/TPS projects implemented and will take 4
hours. The total estimated burden for the retrospective case studies is
76 hours. The total burden hours for all 9 case studies is 322 hours.
Exhibit 2 shows the estimated annualized cost burden for the
respondents' time to provide the requested data. The hourly rate of
$35.07 is an average of the administrative personnel hourly wage of
$14.53 and the clinical personnel hourly wage of $62.52 for physicians
and $28.15 for registered nurses. The average hourly wage of
administrative and clinical personnel is used to estimate the cost of
in-person interviews, telephone interviews, and digital diaries,
because all kinds of staff may be asked to participate in these three
activities. The average hourly wage for administrative personnel--
$14.53--is used to estimate the cost of assembling documentation,
because administrative support staff will perform this task. The total
estimated cost burden is about $10,554.
[[Page 6633]]
Exhibit 1--Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Number of
Data collection Number of respondents per responses per Hours per Total burden
establishments establishment respondent response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
A B C D E F
--------------------------------------------------------------------------------------------------------------------------------------------------------
Prospective Case Studies & Hospital Case Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-person interviews.......................................... 5 15 2 1 150
Telephone interviews.......................................... 5 3 3 30/60 23
Digital Diaries............................................... 5 2 32 10/60 53
Collection of documentation................................... 5 1 1 4 20
Prospective Subtotal...................................... 20 n/a n/a n/a 246
--------------------------------------------------------------------------------------------------------------------------------------------------------
Retrospective Case Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
In-person interviews.......................................... 4 15 1 1 60
Collection of documentation................................... 4 1 1 4 60
Retrospective Subtotal.................................... 8 n/a n/a n/a 76
-----------------------------------------------------------------------------------------
Grand Total........................................... 28 n/a n/a n/a 322
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Data collection establishments hours wage rate* burden
----------------------------------------------------------------------------------------------------------------
Prospective, Retrospective, & Hospital Case Studies
----------------------------------------------------------------------------------------------------------------
In-person interviews.................... 9 210 $35.07 $7,365
Telephone interviews.................... 5 23 35.07 807
Digital Diaries......................... 5 53 35.07 1,859
Collection of documentation............. 9 36 14.53 523
Total............................... 28 322 n/a 10,554
----------------------------------------------------------------------------------------------------------------
*Based upon the average hourly wages of administrative support personnel, physicians, and registered nurses,
National Compensation Survey: Occupational Wages in the United States 2005, U.S. Department of Labor, Bureau
of Labor Statistics.
Estimated Annual Costs to the Federal Government
The total cost to the Federal Government for this project is
$494,999, with an average annual cost of $247,500. This figure includes
the cost of data collection, data analysis, reporting, and contract
oversight by the government. Exhibit 3 shows the individual cost
components.
Exhibit 3--Estimated Cost
------------------------------------------------------------------------
Cost component Total cost Annualized cost
------------------------------------------------------------------------
Project Development................. $19,885 $9,942
Data Collection Activities.......... 231,339 115,670
Data Processing and Analysis........ 62,621 31,310
Publication of Results.............. 67,087 33,544
Project Management.................. 21,349 10,675
Overhead............................ 77,532 38,766
Government Oversight................ 15,186 7,593
-----------------------------------
Total........................... 494,999 247,500
------------------------------------------------------------------------
Request for Comments
In accordance with the above-cited Paperwork Reduction Act
legislation, comments on AHRQs 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's health care research and health care 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.
[[Page 6634]]
Dated: February 2, 2009.
Carolyn M. Clancy,
Director.
[FR Doc. E9-2680 Filed 2-9-09; 8:45 am]
BILLING CODE 4160-90-M
