GenericClearanceSSB_08102021Final

Generic Clearance for the Collection of Quantitative Data on Tobacco Products and
Communications
0910-0810
Supporting Statement Part B
B. STATISTICAL METHODS
1. Respondent Universe and Sampling Methods
The respondent universe for the quantitative testing may include a wide range of consumers,
including current tobacco users, adults and youth, as well as non-users of tobacco products. The
samples will be selected from an appropriate target audience, which could be online panel
members or samples obtained through ads presented via social media (e.g., Facebook,
Instagram), or in-person intercepts (e.g., in malls and schools). Sampled panel members will
receive an email inviting them to participate in the study. Sampled participants recruited via
social media will be invited to participate in the study through ads posted online. Intercept
participants will be invited to participate in the study by trained recruiters. Participants who
choose to participate will complete a screener and, if eligible, receive a questionnaire. Completed
interviews will be monitored to ensure samples are diverse in terms of age, gender, education,
and ethnicity/race. Other sources of samples may also be employed.
Generally, studies under this collection rely on quantitative methods and use convenience
samples rather than probability samples. As a result, the results are not intended to yield results
that are statistically projectable, nationally representative, or precise estimates of population
parameters. When probability samples are employed (such as through an online panel),
representative estimates to the national population will not be made.
2. Procedures for the Collection of Information
For most studies submitted under this generic clearance, FDA will use an online panel or
market research vendor experienced in conducting in-person intercepts. When participants are
recruited through online panels, the vendor will send email invitations to the target audiences
using their market research panel. Each invitation will contain the title, the length of the
participation, amount provided for successful completion of the survey (if any), and instructions
for accessing the secure website. Once a participant enters the secure web site, a brief
introduction will be presented informing the participant of the confidential and voluntary nature
of the survey. Individuals who consent to participate in the survey will be able to access the
survey by clicking on the link to the survey URL.
When participants are recruited through ads on social media or in-person intercepts, participants
will be invited to complete a screener to determine study eligibility. During the screening
process, potential participants will be asked for personal information including their email
address and questions about their tobacco use behavior. This information will be used to
determine eligibility, and to send email invitations to participants. Similar to the process of
using online panels, each invitation will contain the title, the length of the participation, amount

provided for successful completion of the survey (if any), and instructions for accessing the
secure website. Once a participant enters the secure web site, a brief introduction will be
presented informing the participant of the confidential and voluntary nature of the survey.
Individuals who consent to participate in the survey will be able to access the survey by clicking
on the link to the survey URL.
In all cases the questionnaire will be designed to measure responses to the study stimuli and
collect demographic and smoking status information from the participants. Participants may
answer questions before and/or after viewing study stimuli indicating their opinions.
Summary of Protocol
•

Survey screener — confirm eligibility.

•

Pretest measures of behavior, knowledge and attitudes about tobacco products
and/or other key study outcomes identified (if appropriate).

•

Random assignment to view stimulus, such as an image or video or message (if
appropriate).

•

Respondents provide information about behavior, knowledge and attitudes about
tobacco products and/or other key study outcomes identified.

Potential Measures
Key Outcomes (measured post-exposure and/or at 1-week follow-up):
•

Recall (aided and/or unaided)

•

Reactions

•

Beliefs

•

Intentions

•

Knowledge

•

Openness to tobacco use (youth)

Covariates and controls:
Age, gender, race, SES (income and education), personal and family tobacco use history
Analysis Plan (example for experimental studies)
Note: the analysis plan will be developed according to the study protocol, and will be guided by
the study purpose, design, research questions, and hypotheses tested (if appropriate). The
following is an example related to an experimental study design, which would be tailored based
on specific study protocol.
Tests:
1. Tests of treatment effect: comparison of outcomes in treatment group(s) to control
2. Contrasts between treatment groups

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The sample design for each quantitative test will be adequately powered to test the
primary research hypothesis:
•

The key outcomes for the groups viewing a different version of the stimulus will
be significantly different from each other.

Unusual Problems Requiring Specialized Sampling Procedures
No specialized sampling procedures are involved.
Use of Periodic Data Collection Cycles to Reduce Burden
This is a one-time survey data collection effort.
3. Methods to Maximize Response Rates
Experience with online studies suggests that about 15 percent of those who are sent survey
invitations will complete a study. Despite, this low baseline value, FDA will implement several
procedures to increase participation wherever possible. We will conduct cognitive interviews and
pretests to help improve understandability of the questionnaire, to reduce participant burden, and
to enhance interview administration. We will keep the questionnaire at a reasonable length to
minimize break-offs. Tested recruitment and data collection procedures will be used to maximize
cooperation and to achieve the desired response rates.
4. Tests of Procedures or Methods
FDA may conduct cognitive interviews to evaluate and refine the draft questionnaire or study
materials. If the number of cognitive interview respondents exceeds nine members of the public,
the Agency will submit the cognitive interview protocol for review. The cognitive interviews
will help identify areas where the instrument was ambiguous, burdensome, or confusing for
respondents and the survey will be revised accordingly.
Additionally, FDA may conduct a pretest with individuals who are Federal employees to
thoroughly test the programmed questionnaire. At the conclusion of the pretest, all strategies,
algorithms, and programs for sampling, survey administration, and data compilation will be
tested, validated, and readied for launch of the data collection instrument. The instrument will be
revised based on the pretest findings.
5. Individuals Involved in Statistical Consultation and Information Collection
In general, FDA plans to use a contractor for recruiting and survey programming. If needed, the
contractor will also provide an analysis of the data and provide a summary report.

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