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pdfU.S. Food and Drug Administration
NATIONAL PANEL OF TOBACCO CONSUMER STUDIES
SUPPORTING STATEMENT PART A
OMB Control No. 0910-0815
TABLE OF CONTENTS
Section
Page
A. Justification ......................................................................................................................... 1
A.1
Circumstances Making the Collection of Information Necessary............................ 1
A.2
Purposes and Use of the Information Collection...................................................... 2
A.2.1
A.2.2
A.2.3
Overview of the Design ............................................................................2
Purpose of the Panel .................................................................................5
Information Elements and Data Sources ..................................................6
A.3
Use of Improved Information Technology and Burden Reduction ........................ 11
A.4
Efforts to Identify Duplication and Use of Similar Information ............................ 12
A.5
Impact on Small Businesses or Other Small Entities ............................................. 13
A.6
Consequences of Collecting the Information Less Frequently .............................. 13
A.7
Special Circumstances Relating to the Guidelines of 5 CFR1320.5 ...................... 13
A.8
Comments in Response to the Federal Register Notice and Efforts to
Consult Outside the Agency ................................................................................... 14
A.8.1
A.8.2
A.9
Federal Register Announcements and Comments ..................................14
Consultation Within the Research Community ......................................14
Explanation of Any Payment or Gift to Respondents ............................................ 15
A.10 Assurance of Privacy Provided to Respondents ..................................................... 17
A.10.1
A.10.2
A.10.3
A.10.4
A.10.5
Procedures for Protecting Data Collected from Participants ..................18
Privacy Procedures for In-Person Data Collection .................................23
Additional Privacy Concerns Associated with On-line Data
Collection ................................................................................................24
Privacy Procedures for Mail Survey Participants ...................................25
Privacy Concerns for Participants Using Loaned Tablet
Computers ...............................................................................................26
A.11 Justification for Sensitive Questions ...................................................................... 27
A.12 Estimates of Annualized Burden Hours and Costs ................................................ 27
A.12.1
A.12.2
Annualized Hour Burden Estimate .........................................................27
Annualized Cost Burden Estimate ..........................................................29
A.13 Estimates of Other Total Annual Cost Burden to Respondents or
Recordkeepers ........................................................................................................ 29
A.14 Annualized Cost to the Federal Government ......................................................... 29
A.15 Explanation for Program Changes or Adjustments ................................................ 29
ii
A.16 Plans for Tabulation and Publication and Project Time Schedule ......................... 30
A.16.1
A.16.2
Study Schedule .......................................................................................30
Analysis, Publication and Reporting Plans .............................................30
A.17 Reason(s) Display of OMB Expiration Date Is Inappropriate ............................... 32
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions ............... 32
References ............................................................................................................................... 32
Appendix A. Demographic Profile of Established Panel........................................................ 36
Appendix B. Demographic Profile of Study A Respondents ................................................. 38
EXHIBITS
Number
Page
Exhibit A.2-1. Study Design ......................................................................................................... 10
Exhibit A.2-2. Survey Flow, by Study Condition......................................................................... 10
Exhibit A.9-1. Incentive Type and Amount.................................................................................. 17
Exhibit A.12-1. Estimated Annual Reporting Burden .................................................................. 28
Exhibit A.12-2. Estimated Annualized Response Burden for Panel Members ............................ 29
Exhibit A.16-1. Panel Project Schedule ........................................................................................ 31
LIST OF ATTACHMENTS
1.
2.
3.
4.
5.
6.
Questionnaires: English-Language Versions ................................................................... 1-1
Questionnaires: Spanish-Language Versions .................................................................. 2-1
Respondent Materials: English-Language Versions ........................................................ 3-1
Respondent Materials: Spanish-Language Versions ....................................................... 4-1
Summary of the Sample Design for the Panel ................................................................. 5-1
Incentives ......................................................................................................................... 6-1
iii
A.
JUSTIFICATION
On June 22, 2009, the Tobacco Control Act (Pub. L.111–31) was signed into law. The
Tobacco Control Act granted the U.S. Food and Drug Administration (FDA) authority to
regulate the manufacture, marketing, and distribution of tobacco products to protect the public
health generally and to reduce tobacco use by minors. Section 201 of the Tobacco Control Act,
which amends Section 4 of the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1333),
requires FDA to issue “regulations that require color graphics depicting the negative health
consequences of smoking to accompany the label statements specified in subsection (a)(1).”
FDA also can assert authority over other tobacco products and require similar label statements.
In June 2016, the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products
(CTP) obtained clearance to establish a panel to conduct experimental and observational studies
with a national sample of tobacco users designed to collect information from tobacco users from
across the sociodemographic spectrum in order to assess consumers’ responses to tobacco
marketing warning statements, product labels, and other communications about tobacco
products. The FDA CTP is seeking an extension for ongoing maintenance and replenishment of
the national panel as well as the implementation of three experimental and observational studies.
A.1
Circumstances Making the Collection of Information Necessary
In June 2016, the U. S. Food and Drug Administration’s (FDA) Center for Tobacco
Products (CTP) obtained clearance to establish a high-quality, national panel of about 4,000
tobacco users who agree to participate in up to 8 studies over a 3-year period to assess
consumers’ responses to tobacco marketing warning statements, product labels, and other
communications about tobacco products CTP established the panel due to limitations with
existing Web-based panels, including panel conditioning, lack of generalizability of study
findings, and panel samples that are not designed to represent the sociodemographic spectrum of
tobacco users. As a result, FDA established a primarily Web-based panel of tobacco users
through in-person probability-based recruitment of eligible adults and limited the number of
times individuals participate in tobacco-related studies to reduce the likelihood of bias in data
collections. The collection of experimental and observational studies conducted with the panel
are referred to as the National Panel of Tobacco Consumer Studies (TCS).
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The currently approved information collection request obtained in June 2016 focused on
the study design and data collection processes to recruit and maintain a national panel of about
4,000 tobacco users. The first of the TCS panel studies, Study A “Brands and Purchasing
Behaviors,” was included in the currently approved information collection request. The FDA
CTP is seeking an extension for ongoing maintenance and replenishment of the TCS panel.
Approval for Study B “Coupons and Free Samples” and Study C “Consumer Perceptions of
Product Standards” is also included in this extension request. Data from these studies will be
used to inform FDA’s regulatory authority over tobacco products. Data collection activities
under the extension information collection request include panel recruitment and maintenance,
mail and in-person household screening, in-person recruitment of tobacco users, enrollment of
selected household members, and administration of a baseline survey, following all required
informed consent procedures for panel members. Panel members, who are asked to participate in
up to 8 experimental and observational studies over the 3-year panel commitment period 1, will
be invited to participate in the two observational and experimental studies. Approval for the
remainder of the studies will be sought in future requests.
A.2
Purposes and Use of the Information Collection
A.2.1 Overview of the Design
The panel is designed to establish a primarily Web-based panel of about 4,000 adult
tobacco users, aged 18 and older, in housing units and in non-institutionalized group quarters in
the 50 states and the District of Columbia. The sample is designed to allow in-depth analysis of
subgroups of interest and to the extent possible, provide insight into tobacco users more
generally.
For this panel, the young adult population (aged 18-25) are oversampled, while tobacco
users ages 26 and older are undersampled. This will allow us to achieve the target sample sizes in
four domains formed by age group (18-25, 26+) and social economic status (SES) (low SES,
non-low SES) and to conduct more in-depth study of these groups of tobacco users. The primary
reason to oversample young adults is because they are at a point in their life when their tobacco
use habits are not fully established and they may respond differently to tobacco regulation than
1
Near the end of their 3-year panel commitment period, panel members will be asked to continue their participation
in the TCS for up to 3 years through a web/mail re-consent process.
2
older, more established smokers. To better understand this population, we are oversampling 1825 year-olds because the sample size of young adult smokers we would get for the panel would
be relatively small otherwise. In addition to this oversample, smokeless tobacco users identified
during screening are assigned higher probabilities of selection than other tobacco users.
Supporting Statement Part B (Section B.1) details the panel sample design. Exhibit B.1-1
provides the sample sizes achieved in each of the sample domains of interest during panel
establishment Panel recruitment and enrollment efforts during panel establishment, described
below, also pertain to ongoing panel maintenance and replenishment.
Panel members were enrolled through in-person, probability-based screening of sampled
households and recruitment of selected eligible adult household members. The panel
methodology, including the panel recruitment, incentive, and maintenance protocols, were
informed by focus group discussions and consultation with experts in Web survey methodology
and Web panels during the study design phase. For panel establishment, in-person panel
recruitment was competed in two field data collection phases. The initial implementation phase,
conducted between August and October 2016, served as a small pilot test of the panel protocols
and systems. Seventeen panel members were enrolled during this phase. The national
implementation phase, conducted between January 2017 and August 2017, yielded an additional
3,876 enrollments, for a total of 3,893 panel members.
To minimize the potential for coverage and nonresponse bias, we implemented a
multimodal design to maximize Web participation yet provide a means of participation for
individuals who were unwilling or unable to do so online. Across both phases of panel
recruitment, we enrolled 3,342 panel members (86%) to participate via Web mode using
personal devices. We also offered selected adults the option to participate via mail mode or
online using a study-provided tablet computer. The 546 panel members (14%) enrolled as mail
mode participants were generally older, less educated adults, who did not use or were
uncomfortable with computers and who did not regularly access the Internet. We offered the loan
of the study-provided tablet computer to maximize the number of panel members who could
participate in the planned studies online. We expected the tablet offer to encourage Web mode
enrollment by individuals who did not have a readily available or reliable means of participating
online but who would otherwise be capable Web participants. During panel recruitment,
3
however, we found very few eligible adults who were interested in the tablet loan offer, and only
5 panel members (0.1%) opted to participate via Web mode using study-provided tablets.
Following the initial and national implementation phases, four panel members were
disenrolled, including two who passed away and two who were determined to be
physically/mentally incapacitated and unable to continue participation. At their enrollment into
the panel, the remaining 3,889 panel members represented a diverse group of tobacco users from
across the sociodemographic spectrum, including 882 (22.7%) adults aged 18 to 25 and 3,007
(77.3%) adults aged 26 or older. These panel members also reflected a broad spectrum of
tobacco use, including 2,160 (55.5%) cigarette-only users, 303 (7.8%) cigar-only users, 428
(11%) smokeless tobacco-only users, and 998 (25.7%) poly users of cigarettes, cigars, or
smokeless tobacco products. The demographic profile of the established panel is presented in
Appendix A.
It is important to note that the sample selection is independent of the mode of data
collection. That is, we first draw a random sample from all addresses on our address-based
sample frame. In the process of recruitment we identify those who are either unable or unwilling
to participate in an online panel and provide them with the option of an alternative mode to avoid
biasing the panel. Section B.3.2 provides additional details about the procedures for nonresponse
bias assessment and the strategy used to weight results to address differences in mode of survey
administration, oversampling of young adults, and adjust for deviations from the original design
due to factors such as variable nonresponse.
A total of 3,889 panel members were invited to participate in the first TCS panel study
(Study A “Brands and Purchasing Behaviors), including 3,344 (86%) web mode participants and
545 (14%) mail mode participants. Five of the 3,344 web mode participants enrolled using the
loan of a study-provided tablet computer so they could participate in the panel studies online.
Of the 3,889 panel members invited to participate in Study A, a total of 1,626 elected to
do so. Respondents included 292 (18.0%) adults aged 18 to 25 and 1334 (82%) adults aged 26 or
older. Study A respondents also reflected a broad spectrum of tobacco use, including 959
(59.0%) cigarette-only users, 133 (8.2%) cigar-only users, 181 (11.1%) smokeless tobacco-only
users, and 353 (21.7%) poly users of cigarettes, cigars, or smokeless tobacco products. The
demographic profile of Study A respondents is presented in Appendix B.
4
Attrition from the sample is expected, and the sample design provides for in-person panel
replenishment, as needed, using the same sampling and data collection design described above,
to replace panel members who choose to end their involvement in the panel.
A.2.2 Purpose of the Panel
The overall purpose of the data collection is to collect information from a national sample
of tobacco users to provide data that may be used to develop and support FDA’s policies related
to tobacco products, including their labels, labeling, and advertising. Data are collected from the
panel primarily through the use of randomized experimental designs. In the future FDA may
submit ICRs under a separate clearance mechanism that use other methods, such as surveys,
interviews, or online group discussions. As discussed in Section A.1, existing panels of tobacco
users are not appropriate for this purpose for one or more reasons. The project establishes and
maintains a panel of tobacco users who are asked to participate in up to 8 experimental and
observational studies over a 3-year period. Oversampling of young adults (18-25) is another key
feature of this study. Smoking initiation has increased among young adults (Lanz, 2003), and this
age group has the highest smoking prevalence rate in the United States (Schiller, Lucas, &
Peregoy, 2012). As a result, information about how proposed regulations might impact them is
essential to continued decreases in tobacco use among Americans. Another key feature of this
study is the oversampling of adults who use smokeless tobacco products and the inclusion of
panelists who use cigars.
A nationally representative sample is not necessary for conducting the experiments;
rather the need is for a sample that is sufficiently varied with respect to the major
sociodemographic characteristics of tobacco users. Although we use probability methods to
recruit the panel of tobacco users, the final panel may not be able to produce results that are
representative for the population of tobacco users in the U.S. Of particular concern are the
complex relationships among tobacco use, age, income, race/ethnicity, education, and geography
(both location and urban/rural). As such, whenever the results are presented, CTP will clearly
describe the sociodemographic and geographic characteristics of the sample that responded to a
given survey, explicitly characterizing potential limitations in generalizability. It is likely that,
for at least some studies, we may be limited to describing the results as sufficiently varied to
reflect the general characteristics of smokers in the U.S. Such a description should be sufficient
5
for documenting the trends and patterns of interest to CTP in the context of this information
collection. Consistent with obligations under HHS’ and OMB’s Information Quality Guidelines,
CTP will assess the quality of the information generated for each regulatory or policy purpose
under consideration.
A.2.3 Information Elements and Data Sources
The data elements in the initial set of surveys used for establishing the panel was driven
primarily by the need for quality baseline data to benchmark future experimental and
observational studies and to accurately characterize the tobacco use of panel members. The
surveys also took into account the methodological and administrative factors relevant to
collecting data in a cost effective manner that does not burden respondents unduly, and that
adequately deals with the requirements of a diverse multicultural population of interest. Relevant
factors taken into account included the overall length and complexity of each survey and the
presentation of individual questions, response sets, and respondent instructions in both Web and
paper self-administration environments (e.g., minimizing use of grids or other complex question
formats). All surveys were also translated into Spanish.
Instrument Development Process
Four questionnaires—a mail screening questionnaire, field screening questionnaire,
enrollment questionnaire, and baseline questionnaire—were developed to support screening and
recruitment of the panel and collection and maintenance of participant contact information,
demographic data, and other background information pertinent to panel management and
analysis. The questionnaires were drafted using existing survey items from the National Health
Interview Survey (NHIS) and the Tobacco Use Supplement in the Current Population Survey
(TUS-CPS) as the source for items on tobacco use. Use of previously tested and fielded survey
items mitigates the need for extensive pretesting of the questionnaires. In addition, an
interviewer observation questionnaire was developed. Study A was included in the currently
approved information collection request in order to engage panel members in their first
substantive study within the first few months of their panel enrollment. Studies B and C are
included in this extension request. The panel instruments, including Studies B and C
questionnaires, are described in detail in the sections that follow. Further details are provided in
Section B.2.3.
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Baseline Questionnaire
The baseline survey collects a detailed history of the panel member’s use of cigarettes,
cigars or little cigars, and smokeless tobacco products. Panel members are asked how frequently
they use each tobacco product and whether they intend to quit within the next 30 days. They are
also asked questions to assess their level of addiction to nicotine, their general health status, and
use of other tobacco products, including electronic cigarettes, pipes, and water pipes.
At the conclusion of the baseline survey, and upon leaving the panel member’s home, the
interviewer completes a brief interviewer observation questionnaire on his/her tablet computer to
document perceptions about the panel member recruitment process, comfort level with the Web
baseline survey and computers in general, and his/her likelihood of remaining in the panel. This
information, coupled with the baseline survey items on comfort with the computer, is used to
identify panel members at greater risk of attrition or who may need increased levels of technical
support while in the panel. These panelists receive more targeted or more frequent support while
in the panel, and in particular during the initial weeks and months following enrollment. The
interviewer observation questionnaire is also used to capture information collected by
interviewers during their post-enrollment follow-up call to those panelists using a loaned tablet.
Experimental and Observational Studies
Periodic self-administered Web (or mail) surveys will be the mechanism for collecting
experimental and observational data desired by FDA. As noted above, up to 8 studies will be
conducted with TCS panel members during the initial 3-year panel period. The first TCS panel
study, Study A “Brands and Purchasing Behaviors,” was included in the currently approved
information collection request in order to engage panel members in their first substantive study
within the first few months of their panel enrollment. Studies B and C are included in this
extension request. The remaining studies will be handled in separate clearance requests. To
minimize burden, each of these studies will require no more than 20 minutes for panel members
to complete.
The first panel study, Study A, was an observational study offered to all TCS panelists
focused on purchasing behavior, tobacco brands, and use of coupons and price promotions for
tobacco products. The goal of this study was to collect information about participants’ tobacco
product brand loyalty and more accurate measures of their tobacco product consumption. It was
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important to quantify the brand loyalty of panel participants in order to examine how it affects
panelist choices in planned experimental studies. Study A was completed in June 2018, and
therefore will be mentioned minimally in this extension.
Study B: Study B will be an observational study offered to all panelists that will provide
a more in-depth examination of tobacco product promotions, namely free samples and coupons,
after the ban on distribution of free samples of tobacco products (with the exception of certain
smokeless tobacco exemptions) that went into effect when FDA finalized the “Deeming Rule”
on August 8, 2016 (published May 10, 2016 (81 FR 28973)) that extended FDA’s regulatory
authority to all tobacco products. This extended the free samples ban to all types of tobacco
products except smokeless tobacco, which remained exempted from this rule. The free samples
ban went into effect immediately.
A common industry marketing practice is to offer price promotions in the form of
coupons that are directly sent to consumers that allow them to reduce the costs of their tobacco
products. This legal marketing practice offers the tobacco industry opportunities to introduce
new products to current or potential tobacco users, and also retain current tobacco users with
discounts on their usual products. While CTP does not have authority to regulate the prices/taxes
associated with tobacco products, CTP does have the authority to regulate industry marketing
practices.
Study Design: Study B will explore whether tobacco users report receiving free samples
of prohibited tobacco products. This will help CTP understand the occurrence of free sample
distribution despite the ban on distribution of free samples of tobacco products (with the
exception of certain smokeless tobacco exemptions). It will also explore the frequency of receipt
and use of smokeless tobacco free samples among tobacco users as well as, if feasible, the
associations between receipt and product liking, health perceptions, and quit intentions. This will
help CTP better understand the current impact of smokeless tobacco free sample receipt on
tobacco users. In addition, this study will explore the intentions, motivations, and behaviors of
regular tobacco users who seek and/or receive coupons (as part of industry marketing) to reduce
the costs of tobacco products. This study will also explore coupon use among tobacco users and
its associated impact, including product experimentation, subsequent product liking, and
associated health perceptions and quit intentions; and the receipt of samples that are close to free.
8
This information will help CTP understand manufacturers’ price-related marketing strategies and
target populations. Specifically, this study will examine prevalence of free sample and coupon
receipt for tobacco products, where and how consumers are receiving free samples and coupons,
and how free sample and coupon receipt may be associated with tobacco product perceptions,
use intentions, and behavior. The questionnaire includes items from national surveys including
the NHIS, PATH Study, and CPS-TUS.
Study C: FDA was granted authority to regulate the manufacture, distribution, and
marketing of tobacco products to protect public health. Some of the Agency’s responsibilities
include setting product standards that would regulate the levels of certain harmful and potential
harmful constituents (HPHCs). To understand the potential impact of a product standard, we
should first determine whether consumers are aware of potential tobacco regulations. Second, we
should better understand how product standards may influence perceptions and intentions to use
tobacco, both constructs that have been shown to predict future tobacco use (Ajzen, 1991).
Study Design: Study C will be an experimental study examining how a hypothetical
tobacco product standard may impact consumers’ perceptions, attitudes, and intentions to use
tobacco. Specifically, this study will use an experimental design where treatment group
participants are exposed to a stimulus that describes a hypothetical product standard that reduces
‘a chemical’ in cigarettes or smokeless tobacco and then respond to questions about perceptions
and intentions. Comparison group participants will respond to questions about perceptions and
intentions before stimulus exposure. The survey will assess whether consumers are aware of
potential tobacco regulations and product standards; consumers’ perceptions of FDA’s
credibility; consumers’ knowledge and awareness of HPHCs in tobacco products; consumers’
harm perceptions of HPHCs; consumers’ attitudes about tobacco product standards; how
consumer attitudes toward tobacco product standards are related to perceptions, tobacco use, and
intentions; and how a hypothetical product standard may change tobacco product perceptions and
use intentions. The questionnaire includes items from the Health Information National Trends
Survey and peer-reviewed literature. This design enables a comparison of outcomes between the
treatment group (i.e., those exposed to the product standard statement in the middle of the survey
instrument), and the comparison group (i.e., those exposed to the product standard statement
later in the survey instrument).
9
We will randomly assign respondents to one of 8 conditions with variation in timing of
exposure to the stimulus, product type described in the stimulus, and health outcome described in
the stimulus. Exhibit A.2-1 illustrates the study design.
Exhibit A.2-1. Study Design
Timing of
Exposure to
Stimulus
Treatment (T):
stimulus shown
before assessment of
perceptions and
intentions
Comparison (C):
stimulus shown after
assessment of
perceptions and
intentions
Product Type
Described in
Stimulus
Health Outcome Described in Stimulus
Cancer (a)
Heart Attack and
Stroke (b)
Cigarettes (1)
T_A1
T_B1
Dip (2)
T_A2
T_B2
Cigarettes (1)
C_A1
C_B1
Dip (2)
C_A2
C_B2
Survey flow will vary for Treatment and Comparison groups. Exhibit A.2-2 illustrates
the survey flow for each group. In Section X (Stimuli Exposure), respondents will be shown a
statement with piped text that varies according to product type and health outcome.
Exhibit A.2-2. Survey Flow, by Study Condition
Treatment (T)
Section A: Awareness of FDA Authority
Comparison (C)
Section A: Awareness of FDA Authority
Section B: FDA Credibility
Section B: FDA Credibility
Section C: Current Tobacco Use
Section C: Current Tobacco Use
Section D: HPHC Knowledge And Awareness
Section F: HPHC Knowledge And Awareness
Section E: Demographics
Section E: Demographics
Section X: Stimuli Exposure
Section G: Future Tobacco Behavior Intentions
Section F: Attitudes About Product Standard
Section H: Product Harm Perceptions
Section G: Future Tobacco Behavior Intentions
Section J: HPHC Harm Perceptions
Section H: Product Harm Perceptions
Section X: Stimuli Exposure
Section J: HPHC Harm Perceptions
Section F: Attitudes About Product Standard
10
A.3
Use of Improved Information Technology and Burden Reduction
The panel instruments, including the field screener, enrollment survey, baseline survey,
and experimental and observation study instruments, are programmed for computer-assisted data
collection. Computer-assisted interviewing (CAI) technology affords well-known improvements
and efficiencies in the collection of survey data. The technology permits more complex routings
compared to a paper-and-pencil mode of data collection. It allows for on-screen cueing of
respondents, delivery of media images, and consistency checks during self-administration or by
the field interviewer, and produces quality backend data that saves costs associated with datacleaning and data analysis.
The contractor uses its mobile field system (via interviewer tablet computers) to conduct
all counting and listing and field screening operations. This includes identification of dwelling
units that were not part of the sampling frame using Check for Housing Units Missed (CHUM)
protocols. The mobile field system is also used for the administration of the enrollment survey
and interviewer observation survey that are deployed on the interviewer’s tablet computer. This
system enables the ready creation of instruments for deployment and the easy output of
codebooks and data at the backend. Use of mobile technology enhances the quality of data, for
example allowing behind-the-scenes GPS capture to verify sampled addresses, while improving
the efficiency of the doorstep screening operation. Survey data on the tablet are encrypted and
both the tablet and the mobile field system are password protected. An integrated field
management system supports field staff data transmissions, time reporting, and assignment of
cases.
The contractor’s Hatteras Web authoring system is used for the panel member’s baseline
and Study A instruments. Like the mobile field system, the Hatteras survey engine supports all
aspects of survey deployment, data output, and codebook generation. A Hatteras Web page can
display a wide array of fonts, colors, and images, including videos with superior resolution. Use
of both systems reduces user burden and creates efficiencies, both for project staff and panel
members. Hatteras is also used to support the collection of panel member survey data in
alternative modes, including entry of completed mail questionnaires. Additionally, any in-person
or telephone data collection undertaken as part of nonresponse follow-up efforts for Study A or
11
subsequent experimental and observational studies can also be supported by the mobile field
system and/or Hatteras.
Access to the panel member Web surveys is controlled through a project Web portal
hosted by the contractor. A two-tiered security approach is used for accessing the surveys and
transmitting the data. An ID and password is required for a panel member to enter a Web survey;
Secure Socket Layer (SSL) certification ensures that only encrypted data flow over the Internet.
A control system is the central component of all the activities that take place with the
panel. Data maintained in the control system database provides a record of the panel operations,
including sampling, screening and recruiting, data collection, panel member communications
(mailings, e-mailings, text messaging, automated telephone prompting), panel member tracing,
fulfillment operations (incentive and questionnaire mailings, mail survey receipt and data entry),
helpdesk operations, and data processing. This centralized repository of information creates
efficiencies in the generation of reports on sample disposition, data quality monitoring and the
flow of information between the contractor, self-administered interviews, and field operations.
A.4
Efforts to Identify Duplication and Use of Similar Information
Three commercial Web-based panels include smokers, but none of these panels meet the
rigorous requirements needed to inform FDA’s regulatory authority over tobacco products. For
example, Harris Interactive includes smokers, but there is limited participation by disadvantaged
populations that may be of interest to FDA. Many tobacco control investigators use the GfK
Knowledge Networks panel for survey research, as it is built from an address-based sample and
includes many difficult to reach populations such as young adults, cell-phone only households,
and ethnic/racial minorities. However, there are significant concerns that the smokers in this
panel may be biased by conditioning effects because they participate in a relatively high number
of tobacco-related studies. These effects may be particularly pronounced among the small
number of disadvantaged populations due to the gap in smoking-related information about them
which places them in high demand for surveys. Of particulate note, however, is that in our own
experience we have found that these commercial panels cannot easily recruit the number of cigar
smokers or smokeless tobacco users that the planned studies may require.
12
Existing longitudinal surveillance studies of tobacco users, such as FDA’s Population
Assessment of Tobacco and Health (PATH), are not appropriate for the planned experimental or
observational studies. PATH is intended to understand the natural history of tobacco use uptake,
cessation, and relapse and associated health consequence without conducting experiments that
may influence their behavior. Therefore, subjecting PATH participants to experiments may
influence their behavior and then the PATH study would not be able to claim that it is a
representative picture of tobacco use and health for the U.S.
The survey items in the panel instruments are standard measures used to characterize
participant demographics, smoking status, and level of addiction to tobacco products. These
items are included in many national surveillance systems to monitor trends in tobacco use.
However, their inclusion in the panel questionnaires is nonduplicative of these surveys; rather,
they are included to identify tobacco users to be recruited to the panel and to measure potential
covariates that may be needed to account for nonresponse in future studies.
A.5
Impact on Small Businesses or Other Small Entities
There is no impact on small business or other entities. No small businesses are involved
in this study.
A.6
Consequences of Collecting the Information Less Frequently
By design, the panel has been established to support up to 8 experimental and
observational studies of adult tobacco users over a 3-year period to assess consumers’ responses
to tobacco marketing, warning statements, product labels, and other communications about
tobacco products. Given the length of commitment, it is critical to the overall success of the
panel, especially in minimizing attrition, to maintain frequent contact with panelists to ensure
their continued interest and participation, address technical or other issues they may have, and to
maintain accurate locator information that will facilitate longitudinal contact and tracking of
movers. Thus, other contacts, involving other forms of communication with panel members are
planned for this purpose.
A.7
Special Circumstances Relating to the Guidelines of 5 CFR1320.5
None.
13
A.8
Comments in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
A.8.1 Federal Register Announcements and Comments
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment
in the FEDERAL REGISTER of 10/23/2018 (83 FR 53485). FDA received ten comments,
however only one was PRA related. Within those submissions, FDA received one comment
which the agency has addressed.
(Comment) One commenter supports FDA’s establishment of a tobacco user panel,
adding that high-quality research is critical to successful implementation of many provisions of
tobacco policy. The commenter further stated that the research panel can provide the FDA with
critical information on how adult tobacco users respond to tobacco marketing, product labels,
warning statements and other communications about tobacco products. The commenter also
noted the ability to have its own panel of tobacco users will allow the FDA to gather more
reliable information in a more efficient manner.
(Response) FDA agrees with this comment and believes the panel will be a valuable tool
for conducting new observational and experimental studies.
A.8.2 Consultation Within the Research Community
To inform the design of the panel recruitment and retention strategies, the contractor
engaged the services of a Web survey panel expert in the research community. The consultant
participated in discussions with the contractor to review focus group findings (Focus groups
conducted under OMB Control No. 0910-0497) and provide feedback on strategies for recruiting
and engaging panel members long-term. This included guidance on 1) the feasibility of providing
tablet computers to panelists as part of a study incentive protocol rather than a loan, and potential
challenges with this approach; 2) panelist use of personal computing devices to complete Web
surveys; 3) cash-based incentive options both at enrollment and throughout the panel period; 4)
the need for Internet service provision by the study to enroll some panelists; 5) length of the
panel commitment period; and 6) panel maintenance strategies, including short surveys and other
forms of contact with the panel. The consultant also provided feedback on the most significant
challenges in Web-enabling survey respondents and keeping them engaged long-term, and the
14
need for alternative survey modes for panel members who will not participate online in order to
minimize coverage and nonresponse bias.
Consultant contact information is provided below.
Scott Crawford
Founder, Chief Executive Officer
A.9
Survey Sciences Group, LLC
950 Victors Way, Suite 50
Ann Arbor, Michigan 48108
Ph. 734-527-2150
Explanation of Any Payment or Gift to Respondents
The multi-year longitudinal design with multiple surveys can pose a burden to
respondents, while the self-administered modes of data collection and relatively sensitive topic
limit the ability to motivate sample members and encourage participation. Along with other
features of the study, these factors create a substantial risk of nonresponse and attrition bias in
estimates of tobacco use (e.g., Seltzer, Bosse and Garvey, 1974; Vestbo and Rasmussen, 1992;
Cunradi et al., 2005), if left unaddressed. A comprehensive incentive strategy was implemented
to recruit and maintain the 4,000-member panel, given the length of the panel commitment, the
need for panelists to have frequent yet easy access to the Web survey application, and the
planned frequency of contacts (up to 8 experimental and observational studies) during their time
in the panel.
Two key concerns in longitudinal panel maintenance are panel attrition and panel
conditioning. To combat panel attrition and increase the likelihood of participation at each
survey request during the life of the panel, panel members are offered incentives contingent on
survey completion (Baker et al., 2010). Furthermore, minimum burden through limited number
of survey requests can ensure panel retainment and at the same time minimize panel
conditioning, associated with repeated measurement on the same topic and frequency of the
survey request. However, the limited number of survey requests can also induce nonresponse due
to lack of engagement. Given the significant investment made during the recruitment stage and
the high cost of replacing panel members (due to in-person recruitment and screening), we have
developed a sound incentive strategy to keep recruited panelists engaged throughout the life of
the panel.
15
We conducted a review of the existing longitudinal surveys in terms of panel
maintenance strategies, and specifically, incentives (see Attachment 6). The incentive protocol,
based on findings in the survey literature, focus groups (OMB Control No. 0910-0497), and
discussions with survey researchers outside of the study team, includes the following:
•
to minimize the initial screening cost, we mail a paper screener to all sampled
households to determine if there is an eligible tobacco user in the household. A $2
prepaid incentive is enclosed with this initial mailing to maximize response rates and
reduce the number of households requiring a more expensive in-person screening
visit. 2 This approach is consistent with other large federal surveys (e.g., National
Household Education Survey, U.S. Department of Education (as part of the transition
from a telephone to a mail mode of administration); The National Survey of Early
Care and Education, Administration for Children and Families) that have
experimented with a mail screener that includes a small prepaid incentive (typically,
$2 or $5) and have reported on their effectiveness in increasing screener response
rates.
•
provision of a one-time $35 enrollment incentive, paid by the interviewer upon the
panelists’ completion of both the enrollment and baseline surveys. The goal of this
incentive is to engage the potential panelist, provide a token of appreciation for
his/her participation in the enrollment and baseline surveys (an estimated interview
burden of 20 minutes, plus interviewer training on website login) and serve as a proof
that future promised incentives are paid upon survey completion.
•
a $15 promised incentive, payable upon completion of each experimental and
observational study. The goal of this incentive is to maximize participation in each
study. Each study instrument is expected to take approximately 20 minutes to
complete, on average.
We believe the existing incentive strategy, summarized in Exhibit A.9-1, is reasonable
for recruiting, maintaining, and replenishing a 4,000 member panel of tobacco users for the 3year period, maintaining their interest and active participation long-term, thereby minimizing
attrition, and achieving the necessary response rates to support the planned analyses for each of
the 8 experimental and observational studies. Additional documentation in support of the
incentive strategy is provided in Attachment 6.
2
The design provides for screening all nonresponding households in a face-to-face mode and selecting a 10%
random sample of those who report ineligibility to be screened by an interviewer during a face-to-face visit.
16
Exhibit A.9-1. Incentive Type and Amount
Type of Incentive
Participant
Amount/Value
Mail screener incentive
All sample members
$2 one time
Enrollment incentive
All panel members
$35 one time
Experimental and observational
study cash or digital gift card
incentive
All panel members
$15/study;
Up to $120 total, covering 8 studies
Over the 3-year panel period, panel members have the opportunity to receive a maximum
of $155 in incentives if they enroll and complete all planned studies (8).
A.10
Assurance of Privacy Provided to Respondents
The contractor’s Institutional Review Board (IRB) has reviewed and approved the panel
protocols and consent forms (see Attachments 3-25, 3-26, 3-55, 4-25, 4-26, and 4-55). The IRB’s
primary concern is protecting respondents’ rights, one of which is maintaining the privacy of
respondent information to the fullest extent of the law and in accordance with 45 CFR 46.103(f).
The IRB will review any amendments to the study protocol before the requested changes are
implemented, and conduct annual continuing reviews.
This data collection is not covered by the Privacy Act and does not require a SORN
because the federal government will never have access to any personally identifiable information
received during the establishment and implementation of the panel. Instead, the government will
only receive de-identified datasets. All personally identifiable information is handled by the
contractor that establishes and maintains the panel. The contractor assigns a unique 8-digit
identification number to each sample member and the contractor uses this number to maintain
linkages between the survey data files and control system files that the contractor maintains. The
contractor removes the following sensitive data to produce the datasets to be delivered to the
government: a) names, addresses, telephone numbers, and email addresses for panel members, b)
names of all household members, and c) names, addresses, telephone numbers, and email
addresses of contact persons.
All data collection activities are conducted in full compliance with FDA regulations to
maintain the privacy of data obtained from respondents and to protect the rights and welfare of
17
human research subjects as contained in their regulations. Respondents receive information about
privacy protections as part of the informed consent process.
A.10.1 Procedures for Protecting Data Collected from Participants
PRIVACY ANALYSIS & DESIGN
In developing this study, FDA-CTP consulted the agency Privacy Officer to identify
potential risks to the privacy of survey participants and panel members whose information may
be handled on behalf of FDA in the performance of this study. FDA designed the study to
minimize privacy risks in keeping with the Fair Information Practice Principles (FIPPs) and
applying controls selected from the National Institute of Standards and Technology (NIST),
Special Publication 800-53, Security and Privacy Controls for Federal Information Systems and
Organizations. CTP also identified privacy compliance requirements and coordinated with
FDA’s Privacy Officer to ensure responsible offices in the CTP satisfy all in accordance with
law and policy.
PII Collection
As part of this study, CTP’s contractor, acting on behalf of FDA, collects and maintains
personally identifiable information (PII) about potential survey participants, household screening
respondents, enrollment survey respondents, and enrolled panel members. The PII about
potential survey respondents consists of the addresses selected via address-based sampling for
household screening in 80 primary sampling units (PSUs) across the nation. The PII about
household screening respondents consists of respondent and household member names and
address of households, and is collected directly from the adult household screening respondent.
The PII about enrollment survey respondents consists of name, address, telephone numbers,
email addresses, and contact person information for the eligible adult selected for the panel, and
is collected directly from the enrollment survey respondent. Updated contact information (name,
address, telephone numbers, email addresses, and contact person information) may be provided
directly by the panel member or updated through panel tracing and/or nonresponse prompting
activities. An estimated 74,165 household screening respondents and 9,000 3 enrollment/baseline
3
Includes 4,000 respondents from the initial/national implementation phase and an additional 5,000 from annual
replenishment efforts (1,400 for each of 3 years, plus an additional 800 respondents should attrition be greater than
expected.)
18
survey respondents are expected to provide PII. FDA does not receive PII data. All PII data is
handled by the contractor that establishes and maintains the panel.
Privacy Act Applicability
The information collection is not subject to the Privacy Act of 1974. Hence, no Privacy
Act Statement is required to be displayed on the form, website, mobile application or other point
at which information is collected.
Data Minimization
The PII collected or used for this study is limited to the minimum necessary to achieve
the authorized purpose and produce a valid study. The purpose of the TCS is to assess
consumers’ responses to tobacco marketing, warning statements, product labels, and other
communications about tobacco products to inform FDA’s regulatory authority over tobacco
products. The study is authorized under the Tobacco Control Act (Pub. L.111–31). The PII is
necessary to screen sampled households, select eligible adult tobacco users for the panel, achieve
the desired sample sizes across age and SES domains, and maintain contact with panel members
for the experimentational and observational studies.
FDA has minimized the risk of unnecessary access, disclosure, use or proliferation of PII
about respondents. All PII subjects are provided notice regarding the collection and use of the
information they submit. FDA does not receive IP addresses. FDA and its contractors will notify
participants if IP addresses are recorded. FDA’s contractor will maintain study records
containing PII only as long as required to maintain and replenish the TCS panel and conduct the
planned experimental and observational studies. PII will be deleted and/or securely shredded at
the conclusion of all panel activities. Sample and panel member names, addresses, telephone
numbers, and email addresses will not be included on any data file delivered to FDA by the
contractor. All open-ended survey text responses included on the files will be reviewed by the
contractor for the presence of PII. If found, PII will be masked in the text string by replacing it
with generic terminology, such as “[NAME]”. All contractor personnel involved in the project
will sign Commitment to Protect Non-Public Information agreement forms, and access to PII
will be limited to authorized project staff involved in data processing, data delivery, and panel
data collection and panel maintenance activities. Contractors and subcontractors that collect data
on behalf of CTP never pass along any PII, and at the most we receive ID numbers. For these
19
collections, we don’t have any systems where we maintain or retrieve PII. In most if not all our
contracts we even specify that contractors cannot send FDA any PII.
FDA’s contractor only shares collected PII for (1) the secure printing of some respondent
materials (e.g., personalized letters, mailing envelopes), (2) database tracing of panel members
who may have moved, (3) fulfillment activities, (4) telephone verification interviews, tracing,
and prompting, and (5) field screening, recruitment, tracing, and prompting. The contractor’s
print vendor, who does not access the panel systems, works in accordance with a detailed Data
Security Plan governing submission of print jobs via their secure web portal, which uses SSL
encryption and automated deletion of files following order receipt. Printing is done in a
controlled access environment. PII shared for printing purposes is limited to sample and panel
member names and addresses and contact person information. The contractor only uses tracing
vendors with whom it has executed Data Use Agreements (DUAs). The primary purpose of the
DUA is to protect PII when it is determined that the existing contact information is incorrect and
needs to be updated through tracing. PII shared for tracing purposes is limited to the names,
addresses, and telephone numbers of panel members whose contact information needs to be
updated to facilitate ongoing study activities. The contractor also uses three subcontractors to
provide staff recruiting, human resources, and payroll services for fulfillment staff, telephone
interviewers, and field interviewers who support panel data collection activities. PII may be
shared with these staff to prepare study mailings, receipt and process mail survey forms, conduct
telephone verification interviews, or conduct telephone or field tracing, prompting, or data
collection activities. All fulfillment and interviewing staff are required to sign confidentiality
agreements when hired. They are also trained on project-specific protocols for the protection of
physical and electronic PII and are required to sign Commitment to Protect Non-Public
Information agreement forms. The contractor’s Research Operations Center, which houses its
Call Center, tracing, and fulfillment operations, is a controlled access facility. The Center
complies with the confidentiality and data security guidelines set forth by the National Institute
of Standards and Technology (NIST) in Recommended Security Controls for Federal
Information Systems and Organizations, and can accommodate both low- and moderate-risk
projects, as defined by NIST’s Federal Information Processing Standards Publication 199,
Standards for Security Categorization of Federal Information and Information Systems.
Notice and Transparency
20
All PII subjects are provided notice regarding the collection and use of the information
they submit. This is communicated through the survey descriptions that are read to or by the
participant at the beginning of each survey, the informed consent statements/forms associated
with the study, the TCS study brochure provided to panel members, and in the Frequently Asked
Questions pages of the study website. The panel data collection forms, website pages, and other
study materials are clearly branded as FDA-sponsored products.
The privacy compliance documentation materials such as Privacy Impact Assessments
are typically posted on HHS.gov and linked on FDA.gov to provide further notice and
transparency regarding this collection.
FDA and its contractor identified certain privacy risks entailed in this study. Study
participants have control over the information they submit and may choose to submit PII about
other individuals who have not been provided notice or an opportunity to object or consent. To
mitigate this risk, panel enrollment questionnaires and documents limit the amount of collected
PII to that information needed for household eligibility screening and panel member contact
during planned studies and panel maintenance activities. The use of open-ended text fields to
gather information is also avoided when possible. Access to the contact information section of
the study website, as well as the online experimental and observational studies launched through
the study website, requires the entry of panel member unique login credentials.
Individual Participation and Control
Participation in all TCS surveys is voluntary and respondents can skip any question they
do not want to answer. Household screening respondents are read an informed consent statement
as part of the questionnaire introduction and verbally consent to participate in the interview.
Enrollment survey respondents are read and required to sign a written informed consent form as
part of their panel enrollment process; the enrollment process includes completing both the
enrollment and baseline survey components. Panel members who agree to participate using a
study-provided tablet also sign an equipment agreement form acknowledging their use of the
loaned device while participating in the panel and the steps to be taken by the contractor to clean
and restore the device to factory settings upon its return. Panel members who respond to the
experimental and observational studies are provided an informed consent statement as part of
their web and mail survey questionnaires. Web participants to the studies indicate their
21
agreement to complete the online surveys by answering a yes/no consent question at the
beginning of the online survey. Mail participants to the studies indicate their agreement to
participate by completing and returning the paper survey form to the contractor. Subjects can
refuse to participate in any study and can opt out of the panel entirely. Panel members will be
disenrolled from the panel at their request. Near the end of their 3-year panel commitment
period, panel members may be invited to continue their participation in the TCS for up to 3 years
through a web/mail re-consent process. Web re-consent would involve reading the re-consent
script and actively consenting (answering “yes” or “no”) to continue participation in the panel.
Mail re-consent would involve signing and returning the re-consent form to the contractor. As
part of their panel enrollment consent, and the re-consent process (if implemented), panel
members will be informed that a Certificate of Confidentiality exists for this research. Panel
members will also be informed that TCS researchers may use, share, or release their deidentified
panel data for similar research in the future without obtaining additional informed consent.
Data Security
A detailed description of the steps to protect the privacy of information collected inperson, online, by mail, and through the use of study-provided tablets are summarized in
Sections A.10.2 to A.10.5, respectively. This includes protections for both electronic and
physical (hardcopy) data, and the use of encryption protocols for electronic information
submitted online or through secure transmissions from contractor field data collection personnel.
The contractor’s Institutional Review Board reviewed and approved all study protocols
and respondent materials, including provisions for protection of private information. The
contractor’s IRB was also consulted on privacy and human subjects protections during the study
design phase. This included reviewing preliminary plans for obtaining informed consent,
collecting data using various modes, protecting the privacy of data to be collected, and
provisions for loaning study-provided tablets to panel members. The contractor’s IRB required
minor modifications to the study consent forms specific to panel participation requirements, and
respondent materials associated with the loan of the study-provided tablets. This included adding
language to the equipment agreement specifying that the contractor would wipe the device clean
and restore it to factory default settings upon return by the panel member, with no attempt made
to access any data that may have been stored locally on the device. The IRB also consulted on
22
the protocols for secure access to the study website by panel members, including the protocol for
establishing a security question at panel enrollment and the 2-step process for resetting
passwords. Copies of all study protocols and respondent materials were also provided to CTP’s
RIHSC.
A.10.2 Privacy Procedures for In-Person Data Collection
The procedures that are used to maintain privacy for the panel in-person data collection
are summarized below:
•
All project staff, including fulfillment personnel, sign a privacy pledge that emphasizes
the importance of nondisclosure and describes their obligations.
•
All field data collectors are trained on privacy procedures and are prepared to describe
them in full detail, if necessary, or to answer any related questions raised by sample
members. Training includes procedures for safeguarding sample member information in
the field, including securing hardcopy case materials and tablet computers in the field,
while traveling, and in respondent homes, and protecting the identity of sample members.
•
Hardcopy documents containing personally identifying information (PII) are stored in
locked files and cabinets. Discarded hard copy material containing PII are securely
shredded.
•
Hardcopy consent forms and case folders for completed field cases are receipted and
securely stored at the contractor’s Research Operations Center (ROC), which uses a
keyless card-controlled entry system for controlled access.
•
Responses to all screening, CHUM, enrollment, and interviewer observation surveys are
entered directly into the Android tablet computing device provided to each field
interviewer. The data entered are encrypted before being written to the local database on
each tablet. In the unlikely event the tablet is stolen or otherwise compromised, the tables
holding the survey data would be unreadable.
•
GPS data collected on the field interviewer’s tablet during the screening and enrollment
process are used for quality control purposes only to verify the interviewer’s location in
relation to the sampled address. These data are not used in analyses of the substantive
data or included on deliverable data files.
•
Both the Android tablet, the contractor’s MOBILE FS system on the tablet, and any field
supervisor laptops used for administrative tasks are password protected with unique user
logins.
•
Field supervisor laptops have whole disk encryption to protect the hard drive. The
associated Checkpoint FDE software is FIPS 140 compliant. File transfers are done
through an FTP site using secure socket layer (SSL) to protect data in transit. The FTP
23
site is specific to the project and requires credentials specific to the project. Data files are
encrypted using FIPS 140 certified libraries prior to sending.
•
All data transferred to the contractor’s servers from field staff Android tablets including
CARI files, media files such as audio, photo and video and survey data are encrypted onthe-fly using AES-256 with a ‘secure random’ public key hashed using SHA-256 and a
private key. These files are transmitted back to the contractor using secure socket layer
(SSL) over HTTPS. A batch process decrypts these files after receipt on the contractor’s
private network where they are stored on secure contractor servers. The survey data are
stored in SQL Server databases on those servers. Only authorized project staff members
are able to access them on the secure network share or databases. Access requires
passwords and the enabling of user access by contractor IT security personnel.
•
Respondents receive information about privacy protections as part of the informed
consent process.
•
A unique 8-digit identification number is assigned to each sample member and used to
maintain linkages between survey data files and control system files.
•
Following receipt from the field, PII is stored only on contractor password protected,
secured servers. Only authorized project members have access to PII for research sample
members.
•
Reports and data files provided to the research community will not include any
individually identifying information.
•
As noted above, all precautions are taken against inadvertent disclosure. Project
directories and files containing data, and files of identifiers and contacting data, are
protected through the use of encryption and passwords.
A.10.3 Additional Privacy Concerns Associated with On-line Data Collection
Panel member privacy concerns regarding use of the Internet for participation will
typically be related to three issues:
•
Disclosure of subjects’ PII by the researchers to others outside the study;
•
Use of electronic information to gather additional PII without the subject’s knowledge or
consent, and;
•
Electronic breach of security allowing access of subjects’ PII to unrelated third parties.
Plans to minimize potential for risk and addressing these three issues are described
below, respectively.
All study consent forms provide participants with advance notice of what data are
collected and the measures that are taken to protect their privacy. These methods include: using
24
approved encryption and other methods to physically and electronically secure data, collecting
only the minimum amount of information necessary to conduct the study, not disclosing this
information to anyone outside the research team, and destroying data as soon as possible after the
study has been completed. The data are collected only for the stated purpose and not used
subsequently for any other purposes.
Panelists access the panel website using their unique 8-digit identification code. They are
required to create a unique password to access their Web surveys, and in the event of a break-off,
to resume surveys at a later date. At their initial log in, panelists are also required to select and
answer one of 5 security questions that is used in the event the panel member requests a
password reset during the course of the panel period. Responses entered through the Web-based
survey are encrypted as the responses are on the panel website with an SSL certificate applied.
Like the mobile instrument survey data, the Web survey data reside on secure contractor servers
on SQL Server databases. Only authorized project staff have access.
The type of Web browser and operating system used by a panel member cannot be used
to identify an individual. Panel member access to the Web survey system requires a unique panel
member identifier and password, as noted above. In addition, the panel member is reassured that
the researchers do not gather any other information aside from the survey answers and electronic
information already described. The Web site does not place session cookies, persistent cookies,
or any other type of tracking or monitoring software on panel members’ computers, tablets, or
smartphones to track or monitor. There is no tracking or monitoring of panel members’ internet
behavior in this information collection.
A.10.4 Privacy Procedures for Mail Survey Participants
The privacy of responses from mail survey participants is treated in the same manner as
Web survey participants.
•
Project staff take all necessary precautions to ensure the secure transport of study
materials to participants and to ensure the secure transport, processing, and storage of
participant data.
•
All study materials, while in possession of the contractor, are assembled, processed, and
stored at the contractor’s ROC, a controlled-access facility equipped to support sensitive,
large-scale mail survey efforts. Access to the building is by keyless card-controlled entry.
25
•
All staff who come in contact with private project materials have signed privacy pledges
and have been trained on all project security procedures.
•
Electronic files containing sensitive data created in the process of preparing printed
materials for mailouts (e.g., mail-merge data files, print files) are deleted by staff as soon
as all associated mailings or printings have been completed.
•
Any printed sensitive materials not used, such as test printouts or batches of materials
with printing problems for which reprinting is required, are securely shredded
immediately.
•
Mailings for mail survey participants are assembled by project staff that have signed
privacy pledges.
•
After participants complete a mail survey, they return the completed form, identified only
by the Case ID, to the contractor in a standard Business Reply Envelope. All returned
mailings and forms received by the contractor are sent directly to the Survey Support
Department (SSD) at the ROC and stored in a secure area at all times. The SSD area is
locked at all times. A supervisor is present at all times when work is being performed in
the SSD area. At SSD, a Document Control Clerk is assigned the responsibility of
processing, filing, and maintaining all project materials. Incoming materials are stored in
a locked file cabinet after processing and then shredded at the end of the project.
•
After receipt by the contractor, completed mail survey forms are scanned using Teleform.
Panel member names are not printed on paper survey forms; instead, forms are labeled
with the panelist’s study ID.
•
Re-consent forms (if implemented) for mail mode panelists are not returned to the
contractor with completed survey forms.
•
Completed mail survey forms are security shredded at the end of the project, following
data delivery to FDA.
A.10.5 Privacy Concerns for Participants Using Loaned Tablet Computers
The privacy of responses from panel members using the loaned tablet computer is treated
in the same manner as Web survey participants. In addition:
•
The Web-enabled tablet computer loaned to a subset of panel members is provided as
a tool for accessing the panel website to participate in panel surveys online. No
survey data are collected or stored locally on the device. Additionally, the device is
not used to track the panel member’s location or to collect data from the device about
non-study usage.
•
Panel members receive detailed written instructions by mail for the packaging and
return of loaned tablets to the contractor when their panel participation ends. This
includes shipping boxes and overnight postage-paid shipping labels.
26
•
A.11
Upon return, loaned devices are inventoried and receipted, wiped clean of any data
that might have been stored on them, and restored to their factory settings. Panel
members are reassured that no attempts are made to gather any other information
from the device aside from the survey answers and electronic information already
described.
Justification for Sensitive Questions
The panel field screener and enrollment surveys contain items about current employment
status and basic demographic information including age, gender, birth month and year,
race/ethnicity, educational attainment, and marital status. Federal regulations governing the
administration of these questions, which might be viewed as sensitive due to personal or private
information, require (a) clear documentation of the need for such information as it relates to the
primary purpose of the study, (b) provisions to respondents that clearly inform them of the
voluntary nature of participation in the study, and (c) assurances that responses may be used only
for statistical purposes, except as required by law (20 U.S.C. § 9573).
The collection of data related to current employment status and basic demographic
information is essential for subsequent analyses, which includes examination of demographic
characteristics of survey nonrespondents and panel members who leave the study over time.
These data are used to accurately characterize and/or subset panel members for inclusion in the
experimental and observational studies, and for descriptive and other analyses described in
Section A.16.
Respondents are advised of the voluntary nature of participation and their right to refuse
to answer any question during the informed consent process.
A.12
Estimates of Annualized Burden Hours and Costs
A.12.1 Annualized Hour Burden Estimate
Exhibit A.12-1 contains the estimated interview times for each member of the panel.
Burden was estimated using data from timed-readings of each instrument, including the mail and
field screeners, enrollment survey, baseline survey, and Study B and C questionnaires. To
compute the total estimated annual cost, the total burden hours were multiplied by the average
hourly wage for each adult participant, according to the Bureau of Labor Statistics, Current
Employment Statistics Survey, 2011. Estimates are presented in Exhibit A.12-2.
27
Exhibit A.12-1. Estimated Annual Reporting Burden
Activity/Respondent
Study B
Number Of
Avg. Burden
Responses
Number Of
Total Annual Hours Per
Per
Respondents Respondent* Responses+ Response** Total Hours+
4,000
Study C
.33
1,320
.33
436
.33
1,320
.33
436
Panel Replenishment
Household Screening
Respondent1
38,280
.33
12,632
.13
1,642
Panel Replenishment
Enrollment Survey2
5,000
.33
1,650
.25
413
.33
1,650
.25
413
Panel Replenishment
Baseline Survey2
TOTAL
51,280
3,340
* Assumes respondents will participate once over a 3-year period, or .33 responses annually.
** Reflects estimated average burden hours per response from currently approved clearance request. The actual
average hours per response from panel establishment are: .15 for household screening, .30 for enrollment survey,
and .10 for baseline survey.
+ Amounts are rounded to the nearest whole number.
1
Includes both mail and field screening. Of the total screening respondents, we expect 25% will respond only in the
mail screening (household deemed ineligible), 65% will respond only in the field screening (mail screening
nonrespondents), and the remaining 10% will respond in both the mail screening and the field screening. The latter
includes eligible households from the mail screening that are subsequently field-screened to sample the panel
member, and the 10% quality control sample of households whose mail screening ineligibility is verified through inperson screening. Assumes an estimated 11,385 household screening respondents during yearly panel replenishment
and allows for an additional 1,375 household screening respondents during each replenishment should annual
attrition rates be higher than expected (38,280 total).
2
Assumes 1,400 additional panel members will be recruited annually (4,200 total) as part of the panel replenishment
effort. Allows for an additional 800 panel replenishment enrollment and baseline survey respondents should annual
attrition rates be higher than expected (5,000 total).Replenishment panel members replace original panel members
and become part of the 4,000-member panel that receives experimental/observational and panel maintenance
surveys.
28
A.12.2 Annualized Cost Burden Estimate
Exhibit A.12-2. Estimated Annualized Response Burden for Panel Members
Avg. Annual
Burden
Hours+
Hourly
Wage Rate
Study B
436
$22.88
$9,975.68
Study C
436
$22.88
$9,975.68
1,642
$22.88
$37,568.96
413
$22.88
$9,449.44
413
$22.88
$9,449.44
3,340
$22.88
76,419.20
Activity/Respondent
Panel Replenishment Household Screening
Respondent1
Panel Replenishment Enrollment Survey3
3
Panel Replenishment Baseline Survey
TOTAL
Total
Respondent
Costs
+ Amounts are rounded to the nearest whole number.
A.13
Estimates of Other Total Annual Cost Burden to Respondents or Recordkeepers
There are no capital or operating and maintenance costs associated with this collection.
There are no direct monetary costs to individual participants other than their time to participate
in the study.
A.14
Annualized Cost to the Federal Government
The estimated annual cost to the government for each year of the panel maintenance
contract is $3,265,966.80. This figure is based on a total cost to the Federal government for
maintaining and replenishing the panel under the terms of the 3-year, $9,797,900.40 contract to
RTI International and their subcontractors. These costs include design and implementation of the
panel replenishment samples over the 3-year period, screening and recruitment of additional
panel members annually as part of the panel replenishment effort, tracing and prompting of study
nonrespondents, data processing and analysis, and preparation of reports and data files. Panel
member incentive costs associated with panel replenishment are included in this estimate.
A.15
Explanation for Program Changes or Adjustments
FDA is requesting an extension on the currently approved information collection request
for remaining planned studies, panel maintenance and replenishment activities and non-
29
substantive changes to update the estimated burden for an additional year of panel replenishment.
The average annual burden hours will decrease by 1,095 hours, from 4,435 to 3,340 hours.
A.16
Plans for Tabulation and Publication and Project Time Schedule
A.16.1 Study Schedule
Exhibit A.16-1 provides a schedule of the major activities for the panel project. A 3-year
extension of the currently approved information collection is requested given the long-term
nature of the Panel and the plan to enroll replenishment panel members for a 3-year period.
A.16.2 Analysis, Publication and Reporting Plans
The key findings of the TCS panel experimental and observational studies will be
summarized in presentations and/or written reports and disseminated to target audiences within
the public health community (including researchers and policymakers) within approximately one
year after the completion of data collection. As described in Section A.2.3, Study A focused on
purchasing behavior, tobacco brands, and the use of coupons and price promotions for tobacco
products. Data collection for Study A was completed in June 2018, and data analysis was
completed in September 2018. The analysis and reporting of the key findings of Study A consists
of descriptive and bivariate analyses to describe participants’ tobacco product brand preferences
by demographic characteristics and to identify factors associated with brand loyalty for tobacco
products.
In Study B, the focus of this evaluation study, and the analysis, will be on describing the
receipt and use of free samples of tobacco products after the prohibition of free samples of
tobacco products (with the adults-only exception for smokeless tobacco) that became effective
with the Deeming Rule. The intervention or “independent variable” is the free sample prohibition
itself. Therefore, descriptive and bivariate analyses will be used to assess the prevalence of
coupon and free sample receipt and use as well as details surrounding the receipt and use
context, e.g. demographics, product type/brands, locations, etc. Further analyses using inferential
statistical methods, as feasible and appropriate, may explore the relationships of free samples and
coupons receipt with use behaviors, quit intentions, and harm perceptions. For the qualitative
questions, we will assess the quality of the responses utilizing a team of at least two coders to
independently code each response and come to agreements where there is disagreement on
responses.
30
In Study C, bivariate and multivariate analyses will examine the association between
stimulus exposure to the hypothetical product standard and tobacco product use intentions and
tobacco product harm perceptions. Sub-group analyses will be conducted with exclusive
cigarette, smokeless tobacco, and cigars, as well as among respondents with any dual use. A subgroup analysis among respondents whose dual use includes the product they were exposed to in
the stimuli will also be considered.
When communicating or publishing research outcomes associated with this clearance,
CTP will present: a) the unweighted distribution of sociodemographic and geographic
characteristics of the sample that responded to a given survey, and b) study results based on both
weighted and unweighted data. CTP will assess the quality of the information generated by
collections conducted under this clearance for each regulatory or policy purpose under
consideration.
Analysis, Publication and Reporting Plans for each subsequent observational or
experimental study will be described in the information collection request for that study.
Exhibit A.16-1. Panel Project Schedule
Time frame
Activity
Start date
End date
Select address sample for panel implementation
June 2016
July 2016
Recruit and train field staff for panel implementation
August 2016
January 2017
Conduct field enumeration activities in selected areas
November 2016
December 2016
Recruit and enroll initial cohort of panel members
September 2016
August 2017
Conduct nonresponse follow-up and troubleshooting (flow
basis)
October 2016
End of Panel
Provide reports of panel recruitment and maintenance
activities (flow basis, during active recruiting phases)
October 2016
End of Panel
Conduct Study A, first experimental or observational study
April 2018
June 2018
Conduct panel replenishment (as needed)
April 2018
End of Panel
Conduct analysis and reporting of Study A findings
July 2018
September 2018
Conduct Studies B and C and reporting of findings
March 2020
September 2020
31
A.17
Reason(s) Display of OMB Expiration Date Is Inappropriate
The OMB number and expiration date is displayed on the survey website where
questionnaires are launched, all mail survey instruments, and on the consent forms.
A.18
Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
REFERENCES
Ajzen, I. 1991. The theory of planned behavior. Organizational Behavior and Human Decision
Processes, 50(2), pp.179-211.
Armstrong, J. Scott. 1975. Monetary Incentives in Mail Surveys. Public Opinion Quarterly, 39,
pp. 111–116.
Baker, R., Blumberg, S., Brick, M., Couper, M., Courtright, M., Dennis, J. M., Dillman, D.,
Frankel, M., Garland, P., Groves, R., Kennedy, C., Krosnick, J. and Lavrakas, P. 2010.
AAPOR Report on Online Panels. Public Opinion Quarterly, 74 (4), pp.711–781.
Baumgartner, Robert and Pamela Rathbun (1997). Prepaid monetary incentives and mail survey
response rates. Paper presented at AAPOR, Norfolk, VA
Bethlehem, J. (2002). Weighting Nonresponse Adjustments Based on Auxiliary Information. In
Survey Nonresponse. R.M. Groves, D.A. Dillman, J.L. Eltinge, & R.J.A. Little, eds. pp.
275-278. New York: John Wiley and Sons.
Biemer, P. P., & Lyberg, L. (2003). Introduction to Survey Quality. Hoboken, NJ: Wiley.
Biner, P. M. and Kidd, H. J., 1994. The Interactive Effects of Monetary Incentive Justification
and Questionnaire Length on Mail Survey Response Rates. Psychology and Marketing
11:483–492.
Clark, S. M. and Mack, S.P. 2009. SIPP 2008 Incentive Analysis. Paper Presented at the Federal
Committee on Statistical Methodology Research Conference, Washington, D.C.
Creighton, K., King, K. and Martin, E. 2007. The Use of Monetary Incentives in Census Bureau
Longitudinal Surveys. Survey Methodology Research Report Series N2007-2.
Washington, DC: U.S. Census Bureau.
Cunradi, C. B., Moore, R., Killoran, M., and Ames, G. 2005. Survey Nonresponse Bias among
Young Adults: The Role of Alcohol, Tobacco, and Drugs. Subst Use Misuse 40(2): 171–
85.
32
DeBell, M., Krosnick, J. and A. Lupia 2010. Methodology Report and User’s Guide for the
2008-2009 ANES Panel Study. Palo Alto, CA and Ann Arbor, MI: Stanford University
and the University of Michigan.
Dillman, D. A. 2000. Mail and Internet Surveys: The Tailored Design Method, 2nd edition. New
York: Wiley.
Dillman, D. A., 2007. Mail and Internet Surveys: The Tailored Design Method, 2nd edition. 2007
Update with New Internet, Visual and Mixed-mode Guide. New York: Wiley.
Folsom, R. E., & Singh, A. C. (2000). The generalized exponential model for sampling weight
calibration for extreme values, nonresponse, and poststratification. In Proceedings of the
American Statistical Association, Survey Research Methods Section, pp. 598-603.
Alexandria, VA: American Statistical Association.
Fox, R.J., Crask, M.R., and Kim, J. 1988. Mail Survey Response Rate: A Meta-analysis of
Selected Techniques for Inducing Response. Public Opinion Quarterly, 52, 467–491.
Groves, R. M., Singer, E., and Corning, A. 2000. Leverage-Saliency Theory of Survey
Participation - Description and an Illustration. Public Opinion Quarterly 64(3): 299–308.
Groves, R., & Peytcheva E. (2008). The impact of nonresponse rates on nonresponse bias: A
meta-analysis. Public Opinion Quarterly, 72(2), 167-189.
Heberlein, T. A. and Baumgartner, R. 1978. Factors Affecting Response Rates to Mailed
Questionnaires: A Quantitative Analysis of the Published Literature. American
Sociological Review 3:447-62.
Heberlein, T. A. and Baumgartner, R. 1978. Factors Affecting Response Rates to Mailed
Questionnaires: A Quantitative Analysis of the Published Literature. American
Sociological Review 3:447-62.
Iannacchione, V. G. (2011). The changing role of address-based sampling in survey research.
Public Opinion Quarterly, 75(3), 556–575.
James, T. L. 1997. Results of Wave 1 Incentive Experiment in the 1996 Survey of Income and
Program Participation. Proceedings of the Survey Research Methods Section of the
American Statistical Association, pp.834–839.
Kish, L. (1965). Survey Sampling. New York: John Wiley and Sons.
Lanz, P. M. 2003. Smoking on the Rise among Young Adults: Implications for Research and
Policy. Tobacco Control 12 (Suppl I): i60-i70.
Lengacher, J., Sullivan, C., Couper, M. P and R. Groves. 1995. Once Reluctant, Always
Reluctant? Effects pf Differential Incentives on Later Survey Participation in a
Longitudinal Survey. Proceedings of the American Statistical Association, Survey
Research Methods Section, p.1029–1034.
33
Levine, S. and Gordon, G. 1958. Maximizing Returns on Mail Questionnaires. Public Opinion
Quarterly, 22:568-75.
Lin, I. F., & Schaeffer, N. (1995). Using survey participants to estimate the impact of
nonparticipation. Public Opinion Quarterly, 59, 236-258.
Linsky, A. 1975. Stimulating Responses to Mailed Questionnaires: A Review. Public Opinion
Quarterly, 39, pp. 82–101.
Mack, S., Huggins, V., Keathley, D. and Sundukchi, M. 1998. Do Monetary Incentives Improve
Response Rates in the Survey of Income and Program Participation? Proceedings of the
American Statistical Association, Survey Research Methods Section, 529–534.
McMichael, J., Ridenhour, J., & Shook-Sa, B. 2008. A robust procedure to supplement the
coverage of address-based sampling frames for household surveys. Proceedings of the
American Statistical Association, Section on Survey Research Methods, 4329–4335.
Peytcheva, E., & Groves, R. M. (2009). Using variation in response rates of demographic
subgroups as evidence of nonresponse bias in survey estimates. Journal of Official
Statistics, 25(2), 193–201.
Poynter, R. and P. Comley. 2003. Beyong Online Panels. Proceedings of the ESOMAR
Technovate Conference. Amsterdam: ESOMAR.
Rodgers, W. 2002. Size of Incentive Effects in a Longitudinal Study. Proceedings of the
American Association for Public Research 2002: Strengthening Our Community Section on Survey Research Methods.
RTI, 2010, SUDAAN Release 10.
Schiller, J. S., Lucas, J. W., Peregoy, J.A. 2012. Summary health statistics for U.S. adults:
National Health Interview Survey, 2011. National Center for Health Statistics. Vital
Health Stat 10(256).
Seltzer, C. C., R. Bosse and A. J. Garvey 1974. Mail Survey Response by Smoking Status.
American Journal of Epidemiology 100(6): 453–457.
Singer, E., Van Hoewyk, J. and Maher, M. P. 1998. Does the Payment of Incentives Create
Expectation Effects? Public Opinion Quarterly, 62: 152–64.
TUS-CPS, 2010-2011. Public Use Dataset updated May 2011;
http://thedataweb.rm.census.gov/ftp/cps_ftp.html#cpssupps.
U.S. Census Bureau 2013. Computer and Internet Use in the United States. U.S. Census Bureau
publication P20-569. http://www.census.gov/prod/2013pubs/p20-569.pdf
34
Vestbo, J. and Rasmussen, F. V. 1992. Baseline Characteristics Are Not Sufficient Indicators of
Non-Response Bias Follow up Studies. Journal of Epidemiology and Community Health
46(6): 617–619.
Yu, J. and H. Cooper, 1983. A Quantitative Review of Research Design Effects on Response
Rates to Questionnaires. Journal of Marketing Research 20: 36-44.
Zickuhr, K. 2013. Who’s not Online and Why. Washington, DC: Pew Research
Center; http://www.pewinternet.org/2013/09/25/whos-not-online-and-why/
35
APPENDIX A. DEMOGRAPHIC PROFILE OF ESTABLISHED PANEL
Characteristica
N
Percentage
3,893
100.0%
18–25
883
22.7%
26–34
724
18.6%
35–49
1,002
25.7%
50–74
1,200
30.8%
84
2.2%
2,682
68.9%
Black or African American
790
20.3%
American Indian/Alaska Native
81
2.1%
Asian
34
0.9%
Native Hawaiian, Other Pacific Islander
6
0,2%
More than one race selected
156
4.0%
Missing
144
3.7%
453
11.6%
3.428
88.1%
12
0.3%
Male
2,341
60.1%
Female
1,551
39.8%
Missing
1
0.0%
644
16.5%
1,524
39.1%
Some college/voc tech
856
22.0%
2-year college degree
4-year college degree
420
448
10.8%
11.5%
1
0.0%
Total Enrolled in Panelb
Age
75 or older
Race
White
Ethnicity
Hispanic or Latino
Not Hispanic or Latino
Missing
Gender
Education
Less than high school
High school/GED
Missing
(continued)
36
APPENDIX A. DEMOGRAPHIC PROFILE OF ESTABLISHED PANEL (CONTINUED)
Characteristica
N
Percentage
1,727
44.4%
$30,000 to $49,999
901
23.1%
$50,000 to $74,999
$75,000 to $99,999
486
269
12.5%
6.9%
$100,000 to $124,999
141
3.6%
$125,000 to $149,999
52
1.3%
$150,000 or more
$30,000 or more (if other not available)
97
144
2.5%
3.7%
Missing
76
2.0%
2,163
303
55.5%
7.8%
Smokeless tobacco only
428
11.0%
Two of the three tobacco products
852
21.9%
All three tobacco products
147
3.8%
Cigarettes
3,088
79.3%
Cigars
1,127
28.9%
Smokeless tobacco
Poly use of cigarettes, cigars, and or smokeless
824
999
21.2%
25.7%
E-cigarettes
544
14.0%
Pipe
188
4.8%
Water pipe or hookah
306
7.9%
Other tobacco products
159
4.1%
3,342
85.8%
546
14.0%
5
0.1%
English
3,789
97.3%
Spanish
104
2.7%
Household Income
Less than $30,000
Tobacco Use for Enrollment
c
Cigarettes only
Cigars only
d
Current Tobacco Use
Panel Participation Mode
Web, using personal device
Mail mode
Web, using study-provided tablet
Enrollment Language
a
b
c
d
Missing includes Don’t Know, Refused, and Not Available categories.
Includes one panel member from the national implementation phase who passed away after enrollment.
Indicates current use of the tobacco products that determined panel eligibility.
Count of panel members who reported using these products at enrollment. Does not sum to number of panel
members because of poly use.
37
APPENDIX B. DEMOGRAPHIC PROFILE OF STUDY A RESPONDENTS
Characteristica
N
Percentage
1,626
100.0%
18–25
292
18.0%
26–34
275
16.9%
35–49
430
26.4%
50–74
591
36.3%
75 or older
38
2.3%
1,159
71.3%
Black or African American
295
18.1%
American Indian/Alaska Native
32
2.0%
Asian
12
0.7%
Native Hawaiian, Other Pacific Islander
2
0.1%
More than one race selected
61
3.8%
Missing
65
4.0%
161
9.9%
1,464
90.0%
1
0.1%
Male
877
53.9%
Female
748
46.0%
Missing
1
0.1%
Less than high school
197
12.1%
High school/GED
589
36.2%
Some college/voc tech
402
24.7%
2-year college degree
4-year college degree
190
248
11.7%
15.3%
0
0.0%
Total Study A Respondents
Age
Race
White
Ethnicity
Hispanic or Latino
Not Hispanic or Latino
Missing
Gender
Education
Missing
(continued)
38
APPENDIX B. DEMOGRAPHIC PROFILE OF STUDY A RESPONDENTS
(CONTINUED)
Characteristica
N
Percentage
Less than $30,000
699
43.0%
$30,000 to $49,999
356
21.9%
$50,000 to $74,999
216
13.3%
$75,000 to $99,999
132
8.1%
$100,000 to $124,999
$125,000 to $149,999
69
28
4.2%
1.7%
$150,000 or more
44
2.7%
$30,000 or more (if other not available)
53
3.3%
29
1.8%
Cigarettes only
959
59.0%
Cigars only
Smokeless tobacco only
133
181
8.2%
11.1%
Two of the three tobacco products
297
18.3%
All three tobacco products
56
3.4%
1,312
80.7%
309
19.0%
5
0.3%
English
1,606
98.8%
Spanish
20
1.2%
Household Income
Missing
Tobacco Use for Enrollmentb
Panel Participation Mode
Web, using personal device
Mail mode
Web, using study-provided tablet
Enrollment Language
a
b
Missing includes Don’t Know, Refused, and Not Available categories.
Indicates current use of the tobacco products that determined panel eligibility.
39
| File Type | application/pdf |
| File Title | FDA Internal Review |
| Author | Radway, Anne |
| File Modified | 2020-04-22 |
| File Created | 2020-04-22 |