Agency Information Collection Activities: Proposed Collection; Comment Request, 28255-28257 [2010-11993]
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Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices
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:
‘‘Eisenberg Center Voluntary Customer
Survey Generic Clearance for the
Agency for Healthcare Research and
Quality.’’ In accordance with the
Paperwork Reduction Act, 44 U.S.C.
3501–3520, AHRQ invites the public to
comment on this proposed information
collection.
DATES: Comments on this notice must be
received by July 19, 2010.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.
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
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Eisenberg Center Voluntary Customer
Survey Generic Clearance for the
Agency for Healthcare Research and
Quality
The Agency for Healthcare Research
and Quality (AHRQ) requests that the
Office of Management and Budget
(OMB) renew, under the Paperwork
Reduction Act of 1995, AHRQ’s Generic
Clearance to collect information from
users of work products and services
initiated by the John M. Eisenberg
Clinical Decisions and Communications
Science Center (Eisenberg Center).
AHRQ is the lead agency charged
with supporting research designed to
improve the quality of healthcare,
reduce its cost, improve patient safety,
decrease medical errors, and broaden
access to essential services. See 42
U.S.C. 299. AHRQ’s Eisenberg Center is
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an innovative effort aimed at improving
communication of findings to a variety
of audiences (‘‘customers’’), including
consumers, clinicians, and health care
policy makers. The Eisenberg Center
compiles research results into a variety
of useful formats for customer
stakeholders. The Eisenberg Center also
conducts its own program of research
into effective communication of
research findings in order to improve
the usability and rapid incorporation of
findings into medical practice. The
Eisenberg Center is one of three
components of AHRQ’s Effective Health
Care Program, see 42 U.S.C. 299b–7. For
the period 2005 until September 2008,
the Eisenberg Center was operated
through a contractual arrangement with
the Oregon Health and Science
University (OHSU), Department of
Medicine, located in Portland, Oregon.
In September 2008, the contract for
operation of the Eisenberg Center was
awarded to Baylor College of Medicine
(BCM), located in Houston Texas.
The collections proposed under this
clearance include activities to assist in
the development of materials to be
disseminated through the Eisenberg
Center and to provide feedback to
AHRQ on the extent to which these
products meet customer needs. These
materials include Summary Guides that
summarize and translate the findings of
comparative effectiveness reviews (CER)
and research reports for purposes of
summarizing research findings for
various decision-making audiences,
such as consumers, clinicians, or
policymakers. The guides are designed
to help these decision makers use
research evidence to maximize the
benefits of health care, minimize harm,
and optimize the use of health care
resources. In addition, each year of the
project the Eisenberg Center will
develop one computerized, interactive
decision aid for those clinical problems
identified from selected CERs. The
intent is for the decision aid to increase
the patient/consumer’s knowledge of
the health condition, options, and risk/
benefits, lead to greater assurance in
making a decision, increase the
congruence between values and choices,
and ethance involvement in the
decision making process. Information
collections conducted under this
generic clearance are not required by
regulation and will not be used to
regulate or sanction customers. Surveys
will be entirely voluntary, and
information provided by respondents
will be combined and summarized so
that no individually identifiable
information will be released. The
Eisenberg Center will produce from 17
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28255
to a maximum of 33 Summary Guides
per audience (i.e., clinician,
policymaker, consumer) per year,
depending on the information needed
for each product with each audience.
In accordance with OMB guidelines
for generic clearances for voluntary
customer surveys and Executive Order
12862, AHRQ has established an
independent review process to assure
the development, implementation, and
analysis of high quality customer
surveys within AHRQ. Specifically,
AHRQ understands that each activity
conducted must be submitted to OMB
with a supporting statement and
accompanying instruments. Information
collection may not proceed until
approved by OMB.
Method of Collection
Information collections conducted
under this clearance will be collected
via the following methods:
• Focus Groups. Focus groups may
include clinical professionals, patients
or other health care consumers, or
health policy makers. They will be used
to provide input regarding the needs for
products and for the development of
Decision Aids and Summary Guides.
Focus groups may also be used to test
draft products to determine if intended
information and messages are being
delivered through products that are
produced and disseminated through the
Eisenberg Center.
• In-person or Telephone Interviews.
Interviews will be conducted with
individuals from one or more of the
three groups identified above. The
purpose of these interviews is to (1) to
provide input regarding the
development of Decision Aids and
Summary Guides, (2) to determine if
intended information and messages are
being delivered effectively through
products that are produced and
disseminated through the Eisenberg
Center, and (3) to engage the subject in
cognitive testing to (a) determine if
changes in topical knowledge levels can
be identified following exposure to
Eisenberg Center informational or
instructional products, and (b) identify
strengths and weaknesses in products
and services for purposes of making
improvements that are practical and
feasible.
• Customer Satisfaction Survey for
the Decision Aids. Baseline survey data
will be collected on both clinician and
patient characteristics, characteristics of
the health care condition, and selected
outcome measures such as knowledge
and decisional self-efficacy. Following
delivery of the decision aid, a user
survey will be completed to explore
subjects’ impressions of the tool,
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Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices
including ease of use, clarity of
presentation, length, balance of
information, rating of interactive
features, and overall satisfaction. Both
clinicians and patients/consumers will
be surveyed. For patients, the customer
satisfaction survey will include
decisional outcome measures (e.g.,
decisional conflict, desire for
involvement in decision-making),
measures of attitudes and self-efficacy,
and indicators of choice intention or
actual choice made. If the aid is
evaluated within a clinical context,
measures of physician-patient
interaction will also be considered.
Additionally, clinicians may be
interviewed about the impact of the aid
on clinical flow.
• Customer Satisfaction Surveys for
the Summary Guides. These surveys
will be offered to health care
professionals, consumers, and policy
makers that use the online Summary
Guides. Respondents will report via
Likert-type or numerical response scales
how specific informational or
educational products or materials
influenced health care or clinical
practice behaviors.
• Follow-up CME Surveys. Continuing
Medical Education (CME) credit will be
offered to physicians who wish to
participate in online activities
developed around the Summary Guides
for clinicians. Three months after
completing the educational activity,
physicians will be asked to complete a
follow-up survey to assess realized
changes in clinical practice, barriers to
making change, and self-assessed
impacts on patient care.
• Solicited Topic Nominations.
Visitors to the Web site will have the
opportunity to provide information
about suggested topics that might be
addressed through the research and
dissemination efforts of the EHC
program.
• Web site Registration. Visitors to the
Web site will be able to register personal
contact information (e.g., name, e-mail
address) if wishing to receive updated
information and materials as they
become available.
• Glossary Feedback Survey. Visitors
to the Web site who access the health
care glossary will be asked to suggest
missing terms and provide additional
comments on definitions or usage
sentences, if desired.
This information will be used to
develop, improve and/or maintain high
quality products and services to lay and
health professional publics.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden for the respondents
time to participate in this research.
These estimates assume a maximum of
33 Summary Guides per year and
separate Guides for clinicians, policy
makers and consumers and are thus
slight overestimates.
Focus groups will be used for needs
assessment and will be conducted with
clinicians and consumers for
development of the Summary Guides,
and additionally with policymakers for
those Guides in which policy
recommendations are applicable. Focus
groups will be conducted with no more
than 1,056 persons per year and will last
about 11⁄2 hours.
Once the Summary Guides are
developed they will be subjected to inperson or telephone interviews for
purposes of usability and product
testing with clinicians, policy makers
and consumers. In-person telephone
interviews will be conducted twice with
about 1,386 persons annually and will
take about 66 minutes on average. Two
rounds of interviews will be conducted
with all consumer representatives
during product development, with a
second round of interviews conducted
occasionally with clinicians and policy
makers, as needed.
Number of
respondents
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Type of data collection
Customer satisfaction surveys for the
Summary Guides will be conducted
with approximately 6,600
representatives from the audience to be
targeted by the Summary Guides
annually (i.e., clinician, policymaker or
consumer) and will take 5 minutes to
complete.
Customer satisfaction surveys will
also be administered to approximately
50 clinicians and 500 patients in
evaluating the Decision Aid. These
surveys will take about 10 minutes to
complete, and will be administered
before and after implementation of the
Decision Aid in the study populations.
Clinicians that have completed CME
accrediting requirements and are
requesting CME credit will be asked to
complete the follow-up CME Survey
three months following completion of
the online activity. This data collection
will be completed with about 1,320
clinicians annually and will require 5
minutes to complete.
Approximately 2,500 solicited topic
nomination forms will be completed
annually by healthcare professional and
consumer visitors to the Web site and
will require about 5 minutes to
complete. Web site Registration will be
completed by all persons wanting to
stay up-to-date with the latest
information from the Eisenberg Center,
about 6,000 annually, and requires
about 5 minutes to complete. The
Glossary Feedback Survey will be
completed by about 200 persons
annually that access the glossary and
takes 5 minutes to complete. The total
burden hours are estimated to be 6,203.
Exhibit 2 shows the estimated
annualized cost burden associated with
the respondents time to participate in
this research. The cost burden is
estimated to be $290,227 annually.
Exhibit 1. Estimated Annualized
Burden Hours
Number of
responses per
respondent
Hours per
response
Total burden
hours
Focus Groups ..........................................................................................
In-person/Telephone Interviews ..............................................................
Customer Satisfaction Surveys for the Decision Aid ...............................
Customer Satisfaction Surveys for the Summary Guides .......................
Follow-up CME Surveys ..........................................................................
Solicited Topic Nominations ....................................................................
Web site Registration ..............................................................................
Glossary Feedback Survey .....................................................................
1,056
1,386
550
6,600
1,320
2,500
6,000
200
1
2
2
1
1
1
1
1
1.5
1.1
10/60
5/60
5/60
5/60
5/60
5/60
1,584
3,050
184
550
110
208
500
17
Total ..................................................................................................
19,612
(1)
(1)
6,203
1 Not
applicable.
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Federal Register / Vol. 75, No. 97 / Thursday, May 20, 2010 / Notices
Exhibit 2. Estimated Annualized Cost
Burden
Number of
respondents
Type of data collection
Total burden
hours
Average hourly
wage rate *
Total cost
burden
Focus Groups ..........................................................................................
In-person/Telephone Interviews ..............................................................
Customer Satisfaction Surveys for the Decision Aid ...............................
Customer Satisfaction Surveys for the Summary Guides .......................
Follow-up CME Surveys ..........................................................................
Solicited Topic Nominations ....................................................................
Web site Registration ..............................................................................
Glossary Feedback Survey .....................................................................
1,056
1,386
550
6,600
1,320
2,500
6,000
200
1,584
3,050
184
550
110
208
500
17
$48.98
46.82
25.53
39.55
77.64
48.07
48.07
48.07
$77,584
142,801
4,698
21,753
8,540
9,999
24,035
817
Total ..................................................................................................
19,612
6,203
(1)
290,227
1 Not
applicable.
* Based upon the mean and weighted mean wages for clinicians (29–1062 family and general practitioners), policy makers (11–0000 management occupations, 11–3041 compensation & benefits managers, 13–1072 compensation, benefits & job analysis specialists, 11–9111 medical
and health service managers, 13–2053 insurance underwriters and 15–2011 actuaries) and consumers (00–0000 all occupations). Focus groups
include 528 clinicians ($77.64/hr) and 528 consumers ($20.32/hr); in-person/telephone interviews includes 528 clinicians, 330 policy makers
($39.91/hr) and 528 consumers; customer satisfaction surveys for the decision aid includes 50 clinicians and 500 consumers; customer satisfaction surveys for the summary guides includes 1,650 clinicians, 1,650 policy makers and 3,300 consumers; follow-up CME surveys includes 1,320
clinicians; solicited topic nominations include 1,125 clinicians, 250 policy makers and 1,125 consumers; Web site registration includes 2,700 clinicians, 600 policy makers and 2,700 consumers; glossary feedback survey includes 90 clinicians, 20 policy makers and 90 consumers, National
Compensation Survey: Occupational wages in the United States May 2008, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’
Estimated Annual Costs to the Federal
Government
The maximum cost to the Federal
Government is estimated to be
$1,439,003 annually. Exhibit 3 shows
the total and annualized cost by the
major cost components.
Exhibit 3. Estimated Total and
Annualized Cost
Cost component
Total
cost
Project Development .......................................................................................................................................................
Data Collection Activities .................................................................................................................................................
Data Processing and Analysis .........................................................................................................................................
Project Management ........................................................................................................................................................
Overhead .........................................................................................................................................................................
$1,019,970
735,405
1,889,505
557,380
114,750
$339,990
245,135
629,835
185,793
38,250
Total ..........................................................................................................................................................................
4,317,010
1,439,003
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
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
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request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Dated: May 10, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–11993 Filed 5–19–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–D–0226]
Draft Guidance for Industry, Third
Parties and Food and Drug
Administration Staff; Medical Device
ISO 13485:2003 Voluntary Audit Report
Submission Program; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Notice.
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Annualized
cost
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Medical Device ISO
13485:2003 Voluntary Audit Report
Submission Program.’’ This draft
guidance is intended to provide
information on the implementation of a
section of the Food and Drug
Administration Amendments Act of
2007 (FDAAA), which amends a section
of the Federal Food, Drug, and Cosmetic
Act (the act). This guidance document
describes how FDA’s Center for Devices
and Radiological Health (CDRH) and
Center for Biologics Evaluation and
Research (CBER) are implementing this
provision of the law. This draft
guidance is not final nor is it in effect
at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
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Agencies
[Federal Register Volume 75, Number 97 (Thursday, May 20, 2010)]
[Notices]
[Pages 28255-28257]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11993]
[[Page 28255]]
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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: ``Eisenberg Center Voluntary Customer Survey Generic Clearance
for the Agency for Healthcare Research and Quality.'' In accordance
with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the
public to comment on this proposed information collection.
DATES: Comments on this notice must be received by July 19, 2010.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
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
Eisenberg Center Voluntary Customer Survey Generic Clearance for the
Agency for Healthcare Research and Quality
The Agency for Healthcare Research and Quality (AHRQ) requests that
the Office of Management and Budget (OMB) renew, under the Paperwork
Reduction Act of 1995, AHRQ's Generic Clearance to collect information
from users of work products and services initiated by the John M.
Eisenberg Clinical Decisions and Communications Science Center
(Eisenberg Center).
AHRQ is the lead agency charged with supporting research designed
to improve the quality of healthcare, reduce its cost, improve patient
safety, decrease medical errors, and broaden access to essential
services. See 42 U.S.C. 299. AHRQ's Eisenberg Center is an innovative
effort aimed at improving communication of findings to a variety of
audiences (``customers''), including consumers, clinicians, and health
care policy makers. The Eisenberg Center compiles research results into
a variety of useful formats for customer stakeholders. The Eisenberg
Center also conducts its own program of research into effective
communication of research findings in order to improve the usability
and rapid incorporation of findings into medical practice. The
Eisenberg Center is one of three components of AHRQ's Effective Health
Care Program, see 42 U.S.C. 299b-7. For the period 2005 until September
2008, the Eisenberg Center was operated through a contractual
arrangement with the Oregon Health and Science University (OHSU),
Department of Medicine, located in Portland, Oregon. In September 2008,
the contract for operation of the Eisenberg Center was awarded to
Baylor College of Medicine (BCM), located in Houston Texas.
The collections proposed under this clearance include activities to
assist in the development of materials to be disseminated through the
Eisenberg Center and to provide feedback to AHRQ on the extent to which
these products meet customer needs. These materials include Summary
Guides that summarize and translate the findings of comparative
effectiveness reviews (CER) and research reports for purposes of
summarizing research findings for various decision-making audiences,
such as consumers, clinicians, or policymakers. The guides are designed
to help these decision makers use research evidence to maximize the
benefits of health care, minimize harm, and optimize the use of health
care resources. In addition, each year of the project the Eisenberg
Center will develop one computerized, interactive decision aid for
those clinical problems identified from selected CERs. The intent is
for the decision aid to increase the patient/consumer's knowledge of
the health condition, options, and risk/benefits, lead to greater
assurance in making a decision, increase the congruence between values
and choices, and ethance involvement in the decision making process.
Information collections conducted under this generic clearance are not
required by regulation and will not be used to regulate or sanction
customers. Surveys will be entirely voluntary, and information provided
by respondents will be combined and summarized so that no individually
identifiable information will be released. The Eisenberg Center will
produce from 17 to a maximum of 33 Summary Guides per audience (i.e.,
clinician, policymaker, consumer) per year, depending on the
information needed for each product with each audience.
In accordance with OMB guidelines for generic clearances for
voluntary customer surveys and Executive Order 12862, AHRQ has
established an independent review process to assure the development,
implementation, and analysis of high quality customer surveys within
AHRQ. Specifically, AHRQ understands that each activity conducted must
be submitted to OMB with a supporting statement and accompanying
instruments. Information collection may not proceed until approved by
OMB.
Method of Collection
Information collections conducted under this clearance will be
collected via the following methods:
Focus Groups. Focus groups may include clinical
professionals, patients or other health care consumers, or health
policy makers. They will be used to provide input regarding the needs
for products and for the development of Decision Aids and Summary
Guides. Focus groups may also be used to test draft products to
determine if intended information and messages are being delivered
through products that are produced and disseminated through the
Eisenberg Center.
In-person or Telephone Interviews. Interviews will be
conducted with individuals from one or more of the three groups
identified above. The purpose of these interviews is to (1) to provide
input regarding the development of Decision Aids and Summary Guides,
(2) to determine if intended information and messages are being
delivered effectively through products that are produced and
disseminated through the Eisenberg Center, and (3) to engage the
subject in cognitive testing to (a) determine if changes in topical
knowledge levels can be identified following exposure to Eisenberg
Center informational or instructional products, and (b) identify
strengths and weaknesses in products and services for purposes of
making improvements that are practical and feasible.
Customer Satisfaction Survey for the Decision Aids.
Baseline survey data will be collected on both clinician and patient
characteristics, characteristics of the health care condition, and
selected outcome measures such as knowledge and decisional self-
efficacy. Following delivery of the decision aid, a user survey will be
completed to explore subjects' impressions of the tool,
[[Page 28256]]
including ease of use, clarity of presentation, length, balance of
information, rating of interactive features, and overall satisfaction.
Both clinicians and patients/consumers will be surveyed. For patients,
the customer satisfaction survey will include decisional outcome
measures (e.g., decisional conflict, desire for involvement in
decision-making), measures of attitudes and self-efficacy, and
indicators of choice intention or actual choice made. If the aid is
evaluated within a clinical context, measures of physician-patient
interaction will also be considered. Additionally, clinicians may be
interviewed about the impact of the aid on clinical flow.
Customer Satisfaction Surveys for the Summary Guides.
These surveys will be offered to health care professionals, consumers,
and policy makers that use the online Summary Guides. Respondents will
report via Likert-type or numerical response scales how specific
informational or educational products or materials influenced health
care or clinical practice behaviors.
Follow-up CME Surveys. Continuing Medical Education (CME)
credit will be offered to physicians who wish to participate in online
activities developed around the Summary Guides for clinicians. Three
months after completing the educational activity, physicians will be
asked to complete a follow-up survey to assess realized changes in
clinical practice, barriers to making change, and self-assessed impacts
on patient care.
Solicited Topic Nominations. Visitors to the Web site will
have the opportunity to provide information about suggested topics that
might be addressed through the research and dissemination efforts of
the EHC program.
Web site Registration. Visitors to the Web site will be
able to register personal contact information (e.g., name, e-mail
address) if wishing to receive updated information and materials as
they become available.
Glossary Feedback Survey. Visitors to the Web site who
access the health care glossary will be asked to suggest missing terms
and provide additional comments on definitions or usage sentences, if
desired.
This information will be used to develop, improve and/or maintain
high quality products and services to lay and health professional
publics.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden for the respondents
time to participate in this research. These estimates assume a maximum
of 33 Summary Guides per year and separate Guides for clinicians,
policy makers and consumers and are thus slight overestimates.
Focus groups will be used for needs assessment and will be
conducted with clinicians and consumers for development of the Summary
Guides, and additionally with policymakers for those Guides in which
policy recommendations are applicable. Focus groups will be conducted
with no more than 1,056 persons per year and will last about 1\1/2\
hours.
Once the Summary Guides are developed they will be subjected to in-
person or telephone interviews for purposes of usability and product
testing with clinicians, policy makers and consumers. In-person
telephone interviews will be conducted twice with about 1,386 persons
annually and will take about 66 minutes on average. Two rounds of
interviews will be conducted with all consumer representatives during
product development, with a second round of interviews conducted
occasionally with clinicians and policy makers, as needed.
Customer satisfaction surveys for the Summary Guides will be
conducted with approximately 6,600 representatives from the audience to
be targeted by the Summary Guides annually (i.e., clinician,
policymaker or consumer) and will take 5 minutes to complete.
Customer satisfaction surveys will also be administered to
approximately 50 clinicians and 500 patients in evaluating the Decision
Aid. These surveys will take about 10 minutes to complete, and will be
administered before and after implementation of the Decision Aid in the
study populations.
Clinicians that have completed CME accrediting requirements and are
requesting CME credit will be asked to complete the follow-up CME
Survey three months following completion of the online activity. This
data collection will be completed with about 1,320 clinicians annually
and will require 5 minutes to complete.
Approximately 2,500 solicited topic nomination forms will be
completed annually by healthcare professional and consumer visitors to
the Web site and will require about 5 minutes to complete. Web site
Registration will be completed by all persons wanting to stay up-to-
date with the latest information from the Eisenberg Center, about 6,000
annually, and requires about 5 minutes to complete. The Glossary
Feedback Survey will be completed by about 200 persons annually that
access the glossary and takes 5 minutes to complete. The total burden
hours are estimated to be 6,203.
Exhibit 2 shows the estimated annualized cost burden associated
with the respondents time to participate in this research. The cost
burden is estimated to be $290,227 annually.
Exhibit 1. Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Type of data collection Number of responses per Hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Focus Groups................................ 1,056 1 1.5 1,584
In-person/Telephone Interviews.............. 1,386 2 1.1 3,050
Customer Satisfaction Surveys for the 550 2 10/60 184
Decision Aid...............................
Customer Satisfaction Surveys for the 6,600 1 5/60 550
Summary Guides.............................
Follow-up CME Surveys....................... 1,320 1 5/60 110
Solicited Topic Nominations................. 2,500 1 5/60 208
Web site Registration....................... 6,000 1 5/60 500
Glossary Feedback Survey.................... 200 1 5/60 17
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Total................................... 19,612 (\1\) (\1\) 6,203
----------------------------------------------------------------------------------------------------------------
\1\ Not applicable.
[[Page 28257]]
Exhibit 2. Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
Number of Total burden Average hourly Total cost
Type of data collection respondents hours wage rate * burden
----------------------------------------------------------------------------------------------------------------
Focus Groups................................ 1,056 1,584 $48.98 $77,584
In-person/Telephone Interviews.............. 1,386 3,050 46.82 142,801
Customer Satisfaction Surveys for the 550 184 25.53 4,698
Decision Aid...............................
Customer Satisfaction Surveys for the 6,600 550 39.55 21,753
Summary Guides.............................
Follow-up CME Surveys....................... 1,320 110 77.64 8,540
Solicited Topic Nominations................. 2,500 208 48.07 9,999
Web site Registration....................... 6,000 500 48.07 24,035
Glossary Feedback Survey.................... 200 17 48.07 817
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Total................................... 19,612 6,203 (\1\) 290,227
----------------------------------------------------------------------------------------------------------------
\1\ Not applicable.
* Based upon the mean and weighted mean wages for clinicians (29-1062 family and general practitioners), policy
makers (11-0000 management occupations, 11-3041 compensation & benefits managers, 13-1072 compensation,
benefits & job analysis specialists, 11-9111 medical and health service managers, 13-2053 insurance
underwriters and 15-2011 actuaries) and consumers (00-0000 all occupations). Focus groups include 528
clinicians ($77.64/hr) and 528 consumers ($20.32/hr); in-person/telephone interviews includes 528 clinicians,
330 policy makers ($39.91/hr) and 528 consumers; customer satisfaction surveys for the decision aid includes
50 clinicians and 500 consumers; customer satisfaction surveys for the summary guides includes 1,650
clinicians, 1,650 policy makers and 3,300 consumers; follow-up CME surveys includes 1,320 clinicians;
solicited topic nominations include 1,125 clinicians, 250 policy makers and 1,125 consumers; Web site
registration includes 2,700 clinicians, 600 policy makers and 2,700 consumers; glossary feedback survey
includes 90 clinicians, 20 policy makers and 90 consumers, National Compensation Survey: Occupational wages in
the United States May 2008, ``U.S. Department of Labor, Bureau of Labor Statistics.''
Estimated Annual Costs to the Federal Government
The maximum cost to the Federal Government is estimated to be
$1,439,003 annually. Exhibit 3 shows the total and annualized cost by
the major cost components.
Exhibit 3. Estimated Total and Annualized Cost
------------------------------------------------------------------------
Annualized
Cost component Total cost cost
------------------------------------------------------------------------
Project Development........................... $1,019,970 $339,990
Data Collection Activities.................... 735,405 245,135
Data Processing and Analysis.................. 1,889,505 629,835
Project Management............................ 557,380 185,793
Overhead...................................... 114,750 38,250
-------------------------
Total..................................... 4,317,010 1,439,003
------------------------------------------------------------------------
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 comments will become a matter of
public record.
Dated: May 10, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-11993 Filed 5-19-10; 8:45 am]
BILLING CODE 4160-90-M