Attachment K -- 30 Day FR Notice

Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, HHS.
ACTION: Notice.
AGENCY:

This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) approve the proposed
information collection project:
‘‘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.
This proposed information collection
was previously published in the Federal
Register on May 20th 2010 and allowed
60 days for public comment. One
comment was 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 September 24, 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 [email protected]
(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:
SUMMARY:

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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).

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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 enhance involvement in the
decision making process. Information
collections conducted under this
generic clearance are not required by
regulation and will not be used to

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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

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Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices

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,
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, email
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 total
burden for the respondents’ time to
participate in this research. These
estimates assume a maximum of 99
Summary Guides over 3 years 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 3,168 persons over 3 years 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-personltelephone
interviews will be conducted twice with
about 4,158 persons over 3 years and
will take about 66 minutes on average.
As depicted in Attachment B, 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 19,800
representatives from the audience to be
targeted by the Summary Guides over 3
years (i.e., clinician, policymaker or
consumer) and will take 5 minutes to
complete.
Customer satisfaction surveys will
also be administered to approximately
150 clinicians and 1,500 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 3,960
clinicians over 3 years and will require
5 minutes to complete.
Approximately 7,500 solicited topic
nomination forms will be completed
over 3 years 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 18,000 over 3 years, and requires
about 5 minutes to complete. The
Glossary Feedback Survey will be
completed by about 600 persons that
access the glossary over a 3-year period
and takes 5 minutes to complete. The
total burden hours are estimated to be
18,605 over 3-years.
Exhibit 2 shows the estimated total
cost burden associated with the
respondents’ time to participate in this
research. The cost burden is estimated
to be $865,829 annually.

EXHIBIT 1—ESTIMATED TOTAL BURDEN HOURS OVER 3 YEARS
Number of
respondents

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Type of data collection

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 .............................................................................

3,168
4,158
1,650
19,800
3,960
7,500
18,000
600

1
2
2
1
1
1
1
1

1.5
1.1
10/60
5/60
5/60
5/60
5/60
5/60

4,752
9,148
550
1,650
330
625
1,500
50

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

58,836

na

na

18,605

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Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices
EXHIBIT 2—ESTIMATED TOTAL COST BURDEN OVER 3 YEARS
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 .............................................................................

3,168
4,158
1,650
19,800
3,960
7,500
18,000
600

4,752
9,148
550
1,650
330
625
1,500
50

$46.71
53.17
24.50
46.71
73.86
19.56
19.56
19.56

$221,966
486,399
13,475
77,072
24,374
12,225
29,340
978

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

58,836

18,605

na

865,829

* 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 include 528 clinicians, 330 policy makers
($39.91/hr) and 528 consumers; customer satisfaction surveys for the decision aid include 50 clinicians and 500 consumers; customer satisfaction surveys for the summary guides include 1,650 clinicians, 1,650 policy makers and 3,300 consumers; follow-up CME surveys include 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

Annualized
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

Request for Comments

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Total cost

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: August 9, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010–20913 Filed 8–24–10; 8:45 am]
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request; NCCAM Office of
Communications and Public Liaison
Communications Program Planning
and Evaluation Research
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the

SUMMARY:

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National Center for Complementary and
Alternative Medicine (NCCAM), at the
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: NCCAM
Office of Communications and Public
Liaison Communications Program
Planning and Evaluation Research. Type
of Information Collection Request:
Extension.
Need and Use of Information
Collection: To carry out NCCAM’s
legislative mandate to educate and
disseminate information about
complementary and alternative
medicine (CAM) to a wide variety of
audiences and organizations, the
NCCAM Office of Communications and
Public Liaison (OCPL) requests
clearance to carry out formative research
of a variety of print and online
materials, outreach activities, and
messages to maximize their impact and
usefulness.

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