Attachment Q -- Federal Register Notice

Attachment Q -- Federal Register Notice.pdf

Evaluation of ARRA Comparative Effectiveness Research Dissemination Contractor Efforts

Attachment Q -- Federal Register Notice

OMB: 0935-0191

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70456

Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices

submissions may be made to the contact
person on or before two days prior to
the workgroup’s meeting date. Oral
comments from the public will be
scheduled at the conclusion of each
workgroup meeting. Time allotted for
each presentation will be limited to
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requesting to comment is greater than
can be reasonably accommodated
during the scheduled open public
session, ONC will take written
comments after the meeting until close
of business on that day.
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public at its advisory committee
meetings. Seating is limited at the
location, and ONC will make every
effort to accommodate persons with
physical disabilities or special needs. If
you require special accommodations
due to a disability, please contact Mary
Jo Deering at least seven (7) days in
advance of the meeting.
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conduct of its advisory committee
meetings. Please visit our Web site at
http://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: November 7, 2011.
Mary Jo Deering,
Office of Policy and Planning, Office of the
National Coordinator for Health Information
Technology.
[FR Doc. 2011–29356 Filed 11–10–11; 8:45 am]
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Decision To Evaluate a Petition To
Designate a Class of Employees From
Brookhaven National Laboratory,
Upton, NY, To Be Included in the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
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AGENCY:

HHS gives notice as required
by 42 CFR 83.12(e) of a decision to
evaluate a petition to designate a class
of employees from Brookhaven National
Laboratory, Upton, New York, to be
included in the Special Exposure Cohort
under the Energy Employees
Occupational Illness Compensation

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John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2011–29312 Filed 11–10–11; 8:45 am]
BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Decision To Evaluate a Petition To
Designate a Class of Employees From
Sandia National Laboratory,
Albuquerque, NM, To Be Included in
the Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Department of Health and
Human Services (HHS).
ACTION: Notice.
AGENCY:

HHS gives notice as required
by 42 CFR 83.12(e) of a decision to
evaluate a petition to designate a class
of employees from Sandia National
Laboratory, Albuquerque, New Mexico,
to be included in the Special Exposure
Cohort Under the Energy Employees
Occupational Illness Compensation
Program Act of 2000. The initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Sandia National Laboratory.
Location: Albuquerque, New Mexico.
Job Titles and/or Job Duties: All
personnel who worked in any area.
Period of Employment: January 1,
1963 through May 21, 2011.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
SUMMARY:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

SUMMARY:

Program Act of 2000. The initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Brookhaven National
Laboratory.
Location: Upton, New York.
Job Titles and/or Job Duties: All
employees of the Department of Energy,
its predecessor agencies, and its
contractors and subcontractors.
Period of Employment: January 1,
1980 through December 31, 1993.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone (877)
222–7570. Information requests can also
be submitted by Email to
[email protected].

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National Institute for Occupational
Safety and Health (NIOSH), 4676
Columbia Parkway, MS C–46,
Cincinnati, OH 45226, Telephone (877)
222–7570. Information requests can also
be submitted by email to
[email protected].
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2011–29322 Filed 11–10–11; 8:45 am]
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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 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:
‘‘Evaluation of ARRA Comparative
Effectiveness Research Dissemination
Contractor Efforts.’’ In accordance with
the Paperwork Reduction Act, 44 U.S.C.
3501–3521, AHRQ invites the public to
comment on this proposed information
collection.
This proposed information collection
was previously published in the Federal
Register on July 27th, 2011 and allowed
60 days for public comment. No
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
DATES: Comments on this notice must be
received by December 14, 2011.
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
email at
doris.lefkowitz@r,AHRQ.hhs.gov.
SUMMARY:

SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 76, No. 219 / Monday, November 14, 2011 / Notices
Proposed Project

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Evaluation of ARRA Comparative
Effectiveness Research Dissemination
Contractor Efforts
Today, both patients and their health
care providers have many options when
deciding on a treatment plan.
Information available to patients and
their health care providers offers great
opportunities for informed decision
making. However, the volume of
information that needs to be reviewed
and synthesized can be daunting. To
complicate matters, studies may offer
conflicting information or have a
conflict of interest (e.g., research
sponsored by pharmaceutical
companies that make drugs). Sorting
through conflicting information requires
a background in research that most
patients do not have, and physicians
have limited time to conduct these
reviews. Having a neutral third party
review research, draw conclusions, and
disseminate findings is necessary to
ensure effective health care delivery and
consumption of quality care.
AHRQ recognizes the need to fill this
gap and has taken a lead role in
developing mechanisms for reviewing
and disseminating Comparative
Effectiveness Research (CER) and
findings to clinicians, health care
decision makers, purchasers/business
decision makers, and consumers
through its Effective Healthcare Program
(EHCP). CER directly compares the
benefits, potential risks, and costs of
two or more health care interventions.
These direct comparisons allow
assessments of how well a health care
treatment or intervention works under
real-world conditions. AHRQ has paid
careful attention not only to how studies
are conducted but also to how results
are communicated to its audiences.
To augment AHRQ’s existing CER
dissemination efforts performed by the
Eisenberg Center and other initiatives,
AHRQ is conducting four one-time
projects to test other ways to
disseminate CER results. These four
related projects will test new
approaches to CER dissemination and
promote awareness of the EHCP.
Collectively, dissemination efforts will
reach AHRQ’s priority audiences of:
Clinical decision makers, health care
system decision makers, purchasers/
business decision makers, public policy
decision makers, and consumers/
patients.
Through these four projects AHRQ
aims to: (1) Educate professional and
consumer audiences about CER;
(2) inform professional and consumer
audiences about AHRQ’s EHCP; (3) and

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inform a wide range of audiences about
new EHCP research findings.
This project will evaluate the
effectiveness of these four new
dissemination efforts. The evaluation
has four main goals:
1. Assess the effectiveness of the four
dissemination strategies in creating
awareness of CER, specific CER topics,
and the EHCP.
2. Assess the effectiveness of the four
dissemination strategies in fostering
knowledge and understanding of CER
finding, specific CER topics, and the
EHCP.
3. Assess the effectiveness of the four
dissemination strategies in promoting
utilization, including use of the EHCP
materials by consumers and by
clinicians in patient care and if usage by
clinicians is increasing across time.
4. Assess the effectiveness of the four
dissemination strategies in supporting
the benefits of using CER, and specific
CER topics, for both patients and health
care providers.
This study is being conducted by
AHRQ through its contractor, IMPAQ
International, LLC and its subcontractor,
Battelle Memorial Institute, pursuant to
AHRQ’s statutory authority to conduct
and support research on healthcare and
on systems for the delivery of such care,
including activities with respect to the
quality, effectiveness, efficiency,
appropriateness and value of healthcare
services and with respect to clinical
practice, including primary care and
practice-oriented research. 42 U.S.C.
299a(a)(1) and (4).
Method of Collection
To achieve project goals the following
data collections will be implemented,
each of which apply to all of the abovestated goals:
1. Clinician Survey—Conduct three
cross-sectional mail surveys with
clinicians to measure awareness,
understanding, use of the EHCP
materials, and benefits of CER.
Collecting survey data at multiple time
points is critical to assess trends in the
outcomes of interest among clinicians
and the impact of ongoing and increased
dissemination contractor activities.
Three data points for the survey will
allow us to test if the proportion of
clinicians aware of CER and the
Effective Healthcare Program is
changing over time and if the rate of
change is changing. The Survey will be
administered at the end of years 1, 3 and
4; the burden for the year 4 data
collection is not included in the
estimates in Exhibits 1 and 2 since it
will be included in a second OMB
clearance package to be submitted after
year 3.

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2. Consumer/Patient Survey—
Conduct two cross-sectional telephone
surveys with consumers/patients to
measure awareness, understanding, use
of the EHCP materials, and benefits of
CER. Collecting survey data at multiple
time points is critical to assess trends in
the outcomes of interest among
consumers/patients and the impact of
ongoing and increased dissemination
contractor activities. Two data points for
the survey will allow us to test if the
proportion of consumers/patients aware
of CER and the Effective Healthcare
Program is changing over time. The
Survey will be administered at the end
of years 1 and 3. A short screener
questionnaire will be used to identify
eligible respondents.
3. Health System Decision Maker
Survey—Conduct one cross-sectional
telephone survey with health care
system decision makers to measure
awareness, understanding, use of the
EHCP materials, and benefits of CER.
The questionnaire and respondent
materials for this data collection are not
included in this submission since it
occurs in year 4 of the project and have
not yet been developed. These materials
will be submitted in another OMB
clearance package in year 3 of this
project. This data collection is
mentioned here in order to provide an
overview of the entire 5 years of the
project; it is not included in the burden
estimates in Exhibits 1 and 2.
4. Clinician Focus Groups—Conduct
six follow-up focus groups with
clinicians after the first and third crosssectional surveys of this audience. The
focus groups will be conducted with
three clinician segments: (1) Those who
report awareness of CER and have selfreported use of CER in their clinical
practice; (2) those who report awareness
of CER and have self-reported non-use
of CER in their clinical practice; and (3)
those who report no awareness of CER.
One moderator guide will be used for
each focus group. By asking the same
questions to each clinician segment,
who will have been targeted by all four
dissemination contractors, differences
among answers are more likely to be
attributed to the segmentation criteria
and eliminate bias through different
questions. Two focus groups will be
conducted for each of the three
segments. The clinician focus groups
will be conducted by telephone. The
focus groups will be administered at the
end of year 2 and during year 5; the
burden for the year 5 data collection is
not included in the estimates in Exhibits
1 and 2 since it will be included in a
second OMB clearance package to be
submitted after year 3.

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5. Consumer/Patients Focus Groups—
Conduct twelve follow-up focus groups
with consumers/patients after the first
cross-sectional survey of this audience,
at the end of year 2 of the project. The
focus groups will be conducted with
three consumer/patient segments: (1)
Those who report awareness of CER and
have self-reported use of CER in medical
decision making; (2) those who report
awareness of CER and have self-reported
non-use of CER in medical decision
making; and (3) those who report no
awareness of CER. Four focus groups
will be conducted for each of the three
segments. A single screening
questionnaire will be used to recruit
participants. The consumer/patient
focus groups will be conducted by
telephone.
6. Health System Decision Maker
Focus Groups—Conduct twelve followup focus groups with health care system
decision makers, after the crosssectional survey of this audience. The
focus groups will be conducted with
three decision maker segments: (1)
Those who reported awareness of CER
and have self-reported use of CER in
business decision making; (2) those who
reported awareness of CER and have
self-reported non-use of CER in business
decision making; and (3) those who
report no awareness of CER. Four focus
groups will be conducted for each of the
three segments. The focus groups will
be conducted by telephone. The
screener, moderator guides, and
respondent materials for this data
collection are not included in this
submission since it occurs in year 5 of
the project and have not yet been
developed. These materials will be
submitted in another OMB clearance
package in year 3 of this project. This
data collection is mentioned here in
order to provide an overview of the
entire 5 years of the project; it is not
included in the burden estimates in
Exhibits 1 and 2.
7. Semi-Structured Interviews—
Conduct semi-structured interviews, in
year 3 of the project, with 20

individuals in each of the following
groups: health care system decision
makers, purchasers, and policymakers
for a total of 60 interviews. In-depth
interviews will be used to determine
how people receive and interpret CERrelated materials and verbal
information, and adopt new behaviors
based on information they receive.
AHRQ will use the survey, focus
group, and in-depth interview data to
assess trends and the effectiveness of
the four complementary and different
dissemination methods to inform
current and future dissemination of the
EHCP. Specific attention will be given
to changes in audience awareness,
understanding, behavior change/use,
and benefits of CER. Collecting data at
multiple times will enable AHRQ to
determine whether increased
dissemination contractors’ activities
over time is associated with any change
in CER awareness, knowledge, use, or
benefit. Finally, collecting data from
five audiences (i.e., clinicians,
consumers/patients, health system
decision makers, purchasers, and policy
makers) will enable AHRQ to assess the
effectiveness of its CER-related
dissemination efforts among its target
populations.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden hours for the
respondent’s time to participate in this
evaluation. The total burden hours are
estimated to be 3,760.
Clinician Surveys: The design for the
clinician survey consists of three cross
sectional waves (only 2 of which are
included in the estimates here, as
explained in section 1), each wave
having 1,926 respondents for a total of
3,852 across the two waves included in
this information collection request. The
survey will take no longer than 20
minutes to complete.
Consumer/Patient Surveys: The
design for the consumer/patient survey
consists of two cross-sectional waves,
each wave having 1,000 respondents for

a total of 2,000 across both waves. The
screener will take no longer than 5
minutes to complete. The survey will
take no longer than 20 minutes to
complete.
Clinician Focus Groups: Six follow-up
focus groups with clinicians will be
conducted by telephone twice; once
after the first and again after the third
cross-sectional surveys of this audience
(only one of which is included in the
estimates here, as explained in section
1). Focus group participants will have
completed the survey and will have
expressed interest in participating in a
telephone focus group. For each of the
two rounds of focus groups, twelve
clinicians will be recruited for each of
six focus groups. Focus groups will last
one hour.
Consumer/Patient Focus Groups:
Twelve follow-up focus groups with
consumer/patients will be conducted by
telephone after the first cross-sectional
survey of this audience. Focus group
participants will have completed the
survey and will have expressed interest
in participating in a telephone focus
group. Eight people will be in each
focus group. The screener will take no
longer than 5 minutes to complete.
Focus group will last approximately 90
minutes.
In-Depth Interviews With Other Key
Audiences: In-depth interviews will be
conducted with up to 20 representatives
in each of three key audiences: (1)
Health care system decision makers, (2)
purchasers, and (3) policy makers.
Respondents located in the metropolitan
Washington, DC/Baltimore area will be
interviewed in person, and respondents
located outside the local area will be
interviewed by telephone. Participant
recruitment should take no longer than
five minutes. The interviews will last
one hour.
The estimated annualized cost burden
associated with the respondent’s time to
participate in this evaluation is shown
in Exhibit 2. The total cost burden is
estimated to be $144,266.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

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Data collection activity
Clinician Survey ...............................................................................................
Consumer/Patient Survey:
Screener ...................................................................................................
Survey .......................................................................................................
Clinician Focus Groups ...................................................................................
Consumer/Patient Focus Groups:
Screener ...................................................................................................
Focus Group .............................................................................................
Semi-structured Interviews with Health System Decision Makers ..................
Semi-structured Interviews with Purchasers ...................................................

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Number of
responses per
respondent

Hours per
response

Total burden
hours

3,852

1

20/60

1,284

2,560
2,000
72

1
1
1

5/60
20/60
60/60

214
667
72

120
96
20
20

1
1
1
1

5/60
90/60
60/60
60/60

10
144
20
20

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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents

Data collection activity

Number of
responses per
respondent

Hours per
response

Total burden
hours

Semi-structured Interviews with Policymakers ................................................

20

1

60/60

20

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

8,760

n/a

n/a

2,451

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Data collection activity

Total burden
hours

Average
hourly wage
rate *

Total cost
burden

Clinician Survey ...............................................................................................
Consumer/Patient Survey:
Screener ...................................................................................................
Survey .......................................................................................................
Clinician Focus Groups ...................................................................................
Consumer/Patient Focus Groups:
Screener ...................................................................................................
Focus Groups ...........................................................................................
Semi-structured Interviews with Health System Decision Makers ..................
Semi-structured Interviews with Purchasers ...................................................
Semi-structured Interviews with Policymakers ................................................

3,852

1,284

$88.46

$113,583

2,560
2,000
72

214
667
72

20.90
20.90
88.46

4,473
13,940
6,369

120
96
20
20
20

10
144
20
20
20

20.90
20.90
43.74
46.59
43.74

209
3,010
875
932
875

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

8,760

2,451

n/a

144,266

* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United States May 2009, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ Hourly wage rates for clinicians were estimated using the mean wage for internists (occupation
code 29–1063). Hourly wage rates for consumers/patients were estimated using the mean wage for all occupations (occupation code 00–0000)
since participants in the consumer groups may have a wide range of jobs and occupations. Hourly wage rates for health system decision makers
and policymakers were estimated using the mean wage for medical and health services managers (occupation code 11–9111). Hourly wage
rates for purchasers were estimated using the mean wage for purchasing managers (occupation code 11–3061). These rates were obtained in
January 2011 at the following Web site: http://www.bls.gov/oes/current/oes_nat.htm#b29-0000.

Estimated Annual Costs to the Federal
Government

over the five years of the project. Exhibit
3 provides a breakdown of these costs.

The total cost to the Government for
this information collection is $2,719,272

EXHIBIT 3—ESTIMATED TOTAL AND ANNUALIZED COST

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Cost component

Total cost

Annualized
cost

Project Development ...............................................................................................................................................
Data Collection Activities .........................................................................................................................................
Data Processing and Analysis, and Reports to AHRQ ...........................................................................................
Project Management ................................................................................................................................................
Overhead .................................................................................................................................................................

$420,055
1,452,290
141,637
291,706
413,584

$84,011
290,458
28,327
58,341
82,717

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

2,719,272

543,854

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ healthcare
research and healthcare information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to

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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.

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Dated: October 31, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011–28981 Filed 11–10–11; 8:45 am]
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