Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 8871 

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: 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: ‘‘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 

OIRA_submission@omb.eop.gov 

(attention: AHRQ’s desk officer). 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

email at doris.lefkowitz@AHRQ.hhs.gov. 

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’’ 

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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8872 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 

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 

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 

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 8873 

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

Form name/Deliberative method Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

Recruitment and Consent Materials ................................................................ 1,685 1 15/60 421 

Short Citizens’ Deliberation (SCD) .................................................................. 192 1 2 384 

Online Deliberative Polling® (ODP) ................................................................ 288 1 5 1,440 

In-Person Deliberative Polling® (IDP) ............................................................. 288 1 9 2,592 

Citizens’ Panel ................................................................................................. 96 1 24 2,304 

Interrupted Deliberation (ID) ............................................................................ 192 1 6 1,152 

Educational Materials ...................................................................................... 1,685 1 1 1,685 

Knowledge and Attitudes Pretest Survey ........................................................ 1,685 1 30/60 843 

Knowledge and Attitudes Post-test Survey ..................................................... 1,685 1 20/60 562 

Deliberative Experience Survey ....................................................................... 1,056 1 15/60 264 

Total .......................................................................................................... 8852 N/A N/A 11,647 

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Form name/deliberative method Number of 

respondents 

Total burden 

hours 

Average 

hourly wage 

rate 

Total cost 

burden 

Recruitment and Consent Materials ................................................................ 1,685 421 $21.35 $8,988 

Short Citizens’ Deliberation (SCD) .................................................................. 192 384 21.35 8,198 

Online Deliberative Polling® (ODP) ................................................................ 288 1,440 21.35 30,744 

In-Person Deliberative Polling® (IDP) ............................................................. 288 2,592 21.35 55,339 

Citizens’ Panel ................................................................................................. 96 2,304 21.35 49,190 

Interrupted Deliberation (ID) ............................................................................ 192 1,152 21.35 24,595

Educational Materials ...................................................................................... 1,685 1,685 21.35 35,975 

Knowledge and Attitudes Pretest Survey ........................................................ 1,685 843 21.35 17,998 

Knowledge and Attitudes Post-test Survey ..................................................... 1,685 562 21.35 11,999 

Deliberative Experience Survey ....................................................................... 1,056 264 21.35 5,636 

Total .......................................................................................................... 8852 N/A N/A $248,662 

*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 

associated with the portion of the 

contract awarded to AIR to conduct the 

experiment. Since the implementation 

and evaluation periods will span 24 

months, the costs have been annualized 

by taking the total cost and dividing by 

2. 


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8874 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 

EXHIBIT 3—ESTIMATED ANNUALIZED COST TO THE FEDERAL GOVERNMENT

Cost component Total cost Annualized 

cost 

Project Management ................................................................................................................................................ $60,106 $30,053 

Technical Expert Panel ............................................................................................................................................ 117,793 58,896 

Technology Tools .................................................................................................................................................... 177,580 88,790 

Develop Educational Materials ................................................................................................................................ 368,624 184,312 

Evaluation Plan ........................................................................................................................................................ 214,566 107,283 

Implement Methods ................................................................................................................................................. 1,624,169 812,085 

Conceptual Framework ............................................................................................................................................ 50,195 25,098 

Data Processing and Analysis ................................................................................................................................. 566,846 283,423 

Reporting ................................................................................................................................................................. 135,693 67,847 

Overhead ................................................................................................................................................................. 1,281,340 640,670 

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. 

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

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 

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 omb@cdc.gov. 

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). 

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 

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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