Attachment H -- Federal Register Notice

Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices
For Further Information Contact:
Renee Chapman, Contact
Representative; or Theresa Kingsberry,
Legal Assistant; Federal Trade
Commission, Premerger Notification
Office,Bureau of Competition, Room H–
303, Washington, DC 20580, (202) 326–
3100.
By Direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2012–3310 Filed 2–14–12; 8:45 am]
BILLING CODE 6750–01–M

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: ‘‘Use of
Deliberative Methods to Enhance Public
Engagement in the Agency for
Healthcare Research and Quality’s
(AHRQ’s) Effective Healthcare (EHC)
Program and Comparative Effectiveness
Research (CER) Enterprise.’’ 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 December 1st, 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 March 16, 2012.
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

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SUMMARY:

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Clearance Officer, (301) 427–1477, or by
email at [email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
Use of Deliberative Methods To Enhance
Public Engagement in the Agency for
Healthcare Research and Quality’s
(AHRQ’s) Effective Healthcare (EHC)
Program and Comparative Effectiveness
Research (CER) Enterprise
With this project, AHRQ seeks
evidence on the feasibility and
usefulness of public deliberation as an
approach to obtaining public input on
questions related to the conduct and use
of comparative effectiveness research
(CER). Although stakeholder
engagement has been central to the
Effective Healthcare (EHC) program to
date, public input has not traditionally
been used to inform and guide broad
strategies related to the use of evidence
to inform decisions. This study would
provide a research base to address this
gap. This project closely ties to AHRQ’s
efforts to improve the rigor of methods,
as it will generate methodological
evidence through a randomized
controlled experiment comparing five
distinct methods of public deliberation
to find the most effective approaches for
involving the general public, including
members of AHRQ’s priority
populations, in questions related to the
research enterprise.
Public deliberation is a strategy for
engaging lay people in informing
decisions when these decisions require
consideration of values and ethics in
addition to scientific evidence. It
includes three core elements:
(1) Convening a group of people
(either in person or via online
technologies to connect people in
remote locations),
(2) Educating the participants on the
relevant issue(s) through dissemination
of educational materials and/or the use
of content experts, and
(3) Having the participants engage in
a reason-based discussion, or
deliberation, on all sides of the issue(s).
AHRQ wishes to study the
effectiveness of public deliberation,
because it offers the opportunity to
obtain public input on complex topics
in an environment that encourages
participants to educate themselves
about the topic and discuss it in a
thoughtful, respectful manner.
Information about the topic is
intentionally neutral and respectful of
the full range of underlying values and
experience with health care issues in
the population. This approach is
designed to improve upon the
sometimes superficial or ‘‘top of mind’’

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responses that are often provided by
public opinion surveys. AHRQ views
public deliberation as a potential source
of higher quality public input on issues
fundamental to the Agency’s mission,
such as the best and most effective ways
to use comparative effectiveness
research, than has heretofore been
available.
Several distinct deliberative methods
have been developed and used
previously. They share the three core
elements of public deliberation, but
differ on key features of implementation
such as duration, whether they take
place in-person or online, and the use
of content experts. Although there is
considerable theoretical and case study
literature endorsing the value of public
deliberation, there has been little
empirical research about its
effectiveness and even less about the
comparative merits of different
deliberative methods (Community
Forum Deliberative Methods Literature
Review, 2010).
The objectives of this study are to:
1. Obtain informed and deliberated
input from lay people on important
questions underlying AHRQ’s research
program; and
2. Expand the evidence base for the
use of public deliberation methods for
exploring issues relevant to health care
research by comparing the outcomes of
five distinct deliberative methods to a
control condition and to each other.
This study is being conducted by
AHRQ through its contractor, the
American Institutes of Research (AIR),
pursuant to AHRQ’s statutory authority
to (1) promote health care quality
improvement by conducting and
supporting both research that develops
and presents scientific evidence
regarding all aspects of health care and
the synthesis and dissemination of
available scientific evidence for use by
policymakers, among others, and (2)
conduct and support research, provide
technical assistance, and disseminate
information on healthcare and on
systems for the delivery of such care.
See 42 U.S.C. 299(b)(1)(A), (D), (F), and
(G); 42 U.S.C. 299(b)(2); 42 U.S.C.
299a(a)(1)–(4).
Method of Collection
To achieve the objectives of this study
the following activities and data
collections will be implemented:
(1) Participant recruitment—A short
screening questionnaire, including a
brief overview of the study, will be used
to recruit persons for the study.
(2) Educational Materials—
Educational materials are designed to
inform participants about the topics that
are being deliberated and will be

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provided to all 1,685 participants
recruited before the implementation of
any of the methods, but after the
administration of the Knowledge and
Attitudes Pre-test Survey (described
below). Additional content provided
during the deliberative method sessions
includes an overview of the study and
the background materials needed by
participants to competently deliberate
the issues. For two methods (ODP and
IDP; see below) educational materials to
be used during the sessions will be sent
to participants before the sessions (but
after administration of the pre-test).
(3) Deliberative Discussion Groups
and Control Group—The purpose of the
discussion groups is to obtain informed
and deliberated input from lay people
on an important set of issues underlying
health care research. Participants will be
randomly assigned to one of the five
deliberative methods or a control
condition. The five methods were
selected because they have been
previously implemented and vary on
key features that may affect the
scalability and effectiveness of the
methods, including: duration (from two
hours to three days), mode of
implementation (online versus in
person), role of content experts, and
time between sessions allowing
participants to seek additional
information on the issues and
communicate informally with other
participants. The subject of the
deliberations is the use of research
evidence in healthcare decision-making.
This deliberative topic encompasses
several themes or ‘‘variations’’ that will
be elaborated in the deliberations:
1. Use of evidence to encourage better
healthcare: Is evidence useful (or, what
kind of evidence is useful) to a
physician and a patient who are
considering a test or treatment that has
been found to be ineffective, less
effective than another, riskier than
another, or for which effectiveness has
not been demonstrated?
2. Use of evidence to encourage better
value: Is evidence useful (or, what kind
of evidence is useful) to a physician and
a patient who are considering a test or
treatment that is effective even though
an equally effective but less expensive
alternative is available?.
3. Decision-making when evidence
shows more complex trade-offs: Is
evidence useful (or, what kind of
evidence is useful) in treatment
decisions that involve the balancing of
effectiveness, risk, and value?
The issues involved in each variation
will be discussed in the context of
specific comparative effectiveness
research (CER) examples. These
‘‘vignettes’’ illustrate the issues and

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elicit participants’ input on the issues
and the values employed by participants
in the deliberations.
(4) Knowledge and Attitudes Pre-test
Survey — This survey will measure
knowledge of and attitudes about the
health issues discussed in the
deliberations. It will be administered to
deliberation participants and controls
before educational materials are sent or
the methods are implemented.
As described, study participants will
be provided with educational materials
related to the deliberative topic. In order
to assess whether or not participants
were sufficiently informed on the topics
addressed in the materials, the
Knowledge and Attitudes Survey
contains items assessing knowledge of
medical research and medical evidence,
of comparative effectiveness research,
and of healthcare costs. The attitudinal
questions refer to the use of medical
evidence in healthcare decision making.
They include attitudes about health care
decision-making when research findings
can provide no support for, or conflict
with patient and doctor preferences for
particular treatments.
The questionnaire will also gather
demographic and other information
necessary to characterize the study
sample, test the success of the
randomization, and define population
subgroups for which variation in
outcomes will be examined. The
demographic variables also will be used
to control for participant and group
characteristics that may influence the
outcomes. Even though the design
involves randomization, and these
characteristics should be balanced
across groups, including them in the
statistical models guards against
inadequate results from randomization.
The variables to be measured in the
Knowledge and Attitudes Pre-test
Survey include:
• Sociodemographic characteristics:
gender, age, marital status, education,
employment status, household income,
race/ethnicity, priority population,
languages spoken (in addition to
English).
• General health status.
• Recent experience with the
healthcare system (e.g., seeing a
healthcare provider more than three
times for the same condition in the last
12 months).
• Health insurance coverage.
• Health information-seeking
behavior (e.g., the extent to which
people seek healthcare information or
rely on their doctors to provide
information).
(5) Knowledge and Attitudes Post-test
Survey—This survey will measure
knowledge of and attitudes about the

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issues discussed in the deliberations
after the deliberations take place. It will
be administered to deliberation
participants and controls within one
week following conclusion of the
deliberative methods and will include
the same knowledge and attitude
questions as the pre-test questionnaire.
(6) Deliberative Experience Survey—
As described above, the five deliberative
methods being tested vary in terms of
duration, mode, use of educational
materials, and time between deliberative
sessions. A one-time survey will be
administered to participants in the
deliberative methods after
implementation of the experimental
conditions to compare deliberative
methods to each other. Levels of
discourse quality and implementation
quality achieved will be assessed. Using
multi-item scales, the survey will
measure the following:
Discourse Quality
• Equal participation in the
discussions
• Respect for others’ opinions and
tolerance of differing perspectives
• Appreciation of perspectives other
than their own
• Reasoned justification of ideas:
sharing the reasoning or rationale for
positions, opinions, beliefs, or
preferences
Implementation Quality
• Quality of group facilitation
• Quality of the educational materials
provided
• Quality of the experts
• Transparency of the process and
use of the results
• Participants’ perceived value of
method
• Participants’ view of the influence
the results will have on programs
In sum, information collection in this
study will entail qualitative transcript
review and quantitative surveys. This
information will be used to describe and
summarize the input obtained from the
participants in the deliberative groups
concerning the use of evidence,
presenting the findings in reports for
AHRQ and the public.
The information from the surveys also
will be used to expand the evidence
base for public deliberation. The
experiment is designed to: (1) Compare
the effectiveness of the five deliberative
methods to the control condition and to
each other, (2) compare the quality of
the discourse achieved by the
deliberative methods to each other, (3)
assess the quality of implementation of
the five methods, and (4) test for
variation in effectiveness and discourse
quality by features of the deliberations

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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices
and for population subgroups defined
by sociodemographic characteristics of
the participants.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated
annualized burden associated with the
respondents’ time to participate in this
research. The total annualized burden
hours are estimated to be 11,647 hours.
The burden estimate comprises the
following activities:
Participant Recruitment—The
screening questionnaire and recruitment
letter and materials will be sent to 1,685
participants. We estimate that it will
take 15 minutes to complete the
questionnaire and review the
recruitment letter and materials.
Educational materials—Educational
materials will be provided to all 1,685
participants recruited before the
implementation of any of the methods.

We estimate that it will take up to 1
hour to review the materials.
Short Citizens’ Deliberation (SCD):
This method will be tested with 192
participants (12 groups). Participants
will attend a single, 2-hour in-person
meeting.
Online Deliberative Polling® (ODP):
This method will be tested with 288
participants (24 groups) and will consist
of 4 online sessions over the course of
4 weeks; in total, this method will take
about 5 hours per person.
In-Person Deliberative Polling® (IDP):
This method will be tested with 288
participants (16 groups); participants
will attend a single in-person meeting,
lasting a full day.
Citizens’ Panel (CP): This method will
be tested with 96 participants (4
groups); participants will attend a 3-day,
in-person meeting.
Interrupted Deliberation (ID): This
method will be tested with 192

participants (12 groups). Participants
will attend 2 in-person meetings, lasting
3 hours each, a week apart. Between
meetings, participants will be asked to
access an online platform. In total, this
method will take about 6 hours per
person.
Knowledge and Attitudes Pre-test
Survey: This survey will be
administered to 1,685 participants and
will take an estimated 30 minutes to
complete.
Knowledge and Attitudes Post-test
Survey: This survey will be
administered to 1,685 participants and
will take an estimated 20 minutes to
complete.
Deliberative Experience Survey: This
survey will be administered to 1,056
deliberative methods participants at the
conclusion of the deliberative method. It
will take about 15 minutes to complete.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name/Deliberative method

Number of
responses per
respondent

Hours per
response

Total burden
hours

Recruitment and Consent Materials ................................................................
Short Citizens’ Deliberation (SCD) ..................................................................
Online Deliberative Polling® (ODP) ................................................................
In-Person Deliberative Polling® (IDP) .............................................................
Citizens’ Panel .................................................................................................
Interrupted Deliberation (ID) ............................................................................
Educational Materials ......................................................................................
Knowledge and Attitudes Pretest Survey ........................................................
Knowledge and Attitudes Post-test Survey .....................................................
Deliberative Experience Survey .......................................................................

1,685
192
288
288
96
192
1,685
1,685
1,685
1,056

1
1
1
1
1
1
1
1
1
1

15/60
2
5
9
24
6
1
30/60
20/60
15/60

421
384
1,440
2,592
2,304
1,152
1,685
843
562
264

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

8852

N/A

N/A

11,647

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name/deliberative method

Total burden
hours

Average
hourly wage
rate

Total cost
burden

Recruitment and Consent Materials ................................................................
Short Citizens’ Deliberation (SCD) ..................................................................
Online Deliberative Polling® (ODP) ................................................................
In-Person Deliberative Polling® (IDP) .............................................................
Citizens’ Panel .................................................................................................
Interrupted Deliberation (ID) ............................................................................
Educational Materials ......................................................................................
Knowledge and Attitudes Pretest Survey ........................................................
Knowledge and Attitudes Post-test Survey .....................................................
Deliberative Experience Survey .......................................................................

1,685
192
288
288
96
192
1,685
1,685
1,685
1,056

421
384
1,440
2,592
2,304
1,152
1,685
843
562
264

$21.35
21.35
21.35
21.35
21.35
21.35
21.35
21.35
21.35
21.35

$8,988
8,198
30,744
55,339
49,190
24,595
35,975
17,998
11,999
5,636

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

8852

N/A

N/A

$248,662

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* Based upon the mean of the wages for 00–000 All Occupations ($21.35), May 2010 National Occupational Employment and Wage Estimates.
United States, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ http://www.bls.gov/oes/current/oes_nat.htm#00–0000

Estimated Annual Costs to the Federal
Government
Exhibit 3 below breaks down the costs
related to this study. These are the costs

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associated with the portion of the
contract awarded to AIR to conduct the
experiment. Since the implementation
and evaluation periods will span 24

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months, the costs have been annualized
by taking the total cost and dividing by
2.

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Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices
EXHIBIT 3—ESTIMATED ANNUALIZED COST TO THE FEDERAL GOVERNMENT
Cost component

Annualized
cost

Project Management ................................................................................................................................................
Technical Expert Panel ............................................................................................................................................
Technology Tools ....................................................................................................................................................
Develop Educational Materials ................................................................................................................................
Evaluation Plan ........................................................................................................................................................
Implement Methods .................................................................................................................................................
Conceptual Framework ............................................................................................................................................
Data Processing and Analysis .................................................................................................................................
Reporting .................................................................................................................................................................
Overhead .................................................................................................................................................................

$60,106
117,793
177,580
368,624
214,566
1,624,169
50,195
566,846
135,693
1,281,340

$30,053
58,896
88,790
184,312
107,283
812,085
25,098
283,423
67,847
640,670

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

$4,596,914

$2,298,457

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
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 3, 2012.
Carolyn M. Clancy,
Director.
BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–12–12DO]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for

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opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Kimberly Lane, CDC
Reports Clearance Officer, 1600 Clifton
Road, MS–D74, Atlanta, GA 30333 or
send an email to [email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection 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
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
CDC National Healthy Worksite
Program (NHWP)—New—National
Center for Chronic Disease Prevention
and Health Promotion (NCCDPHP),
Centers for Disease Control and
Prevention (CDC).

[FR Doc. 2012–3309 Filed 2–14–12; 8:45 am]

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Total cost

Background and Brief Description
In the United States, chronic diseases
such as cancer, heart disease, and
diabetes are among the leading causes of
death and disability. Although chronic
diseases are among the most common
and costly health problems, they are
also among the most preventable.
Adopting healthy behaviors, such as
eating nutritious foods, being physically
active, and avoiding tobacco use, can

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prevent the devastating effects of these
diseases and lead to reduced rates of
obesity, cancer, heart disease, stroke,
and diabetes.
Increasing health care costs, and
decreases in employee productivity due
to health-related factors, are leading
American businesses to examine
strategies to improve health and contain
health care costs. Employers are
recognizing the role they can play in
creating a healthy work environment
and providing their employees with
opportunities to make healthy lifestyle
choices. They increasingly look to CDC
and other public health experts for
guidance and solutions to combat the
effects of chronic diseases on their
employees and businesses.
To support these efforts, the Centers
for Disease Control and Prevention
(CDC) is establishing the National
Healthy Worksite Program (NHWP), a
comprehensive workplace health
promotion program to address physical
activity, nutrition, and tobacco use in
the workplace. Participating worksites
will create high quality workplace
health programs by implementing
programs, policies, and environmental
supports that assist employees in
adopting healthy behaviors. The NHWP
is authorized by the Public Health
Service Act and funded through the
Prevention and Public Health Fund of
the Patient Protection and Affordable
Care Act (ACA).
CDC-funded NHWP support will be
provided over a two-year period to an
initial group of 100 worksites drawn
from seven communities. The worksites
will represent small, medium and large
employers in a variety of industry
sectors. The largest employers will be
required to make an in-kind
contribution to supplement the support
provided through the NHWP. Support to
be provided for worksites participating
in the NHWP will include
organizational assessment, guidance on
strategies for supporting a culture of

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