Supporting Statement Part A

U.S. Food and Drug Administration
Formative Research Support: Outcomes and Awareness Measurement Research
OMB Control Number 0910-0810
SUPPORTING STATEMENT A
A. Justification
1. Circumstances Making the Collection of Information Necessary
FDA’s Center for Tobacco Products (CTP) is interested in developing reliable and valid
measures of media campaign awareness and targeted outcomes to inform the evaluation of
CTP’s Real Cost media campaign. In this study, we will conduct two waves of an online survey
among 2,400 youth ages 13-17 to: 1) examine the extent to which the distribution and accuracy
of self-reported awareness varies across different awareness assessment approaches; and 2)
develop comprehensive and valid, multi-item scales to measure outcomes such as addiction
perceptions, expectations of feeling anxious after using tobacco, and other key predictors of
tobacco use that campaign messages aim to change.
2. Purpose and Use of the Information Collection
The Food and Drug Administration’s (FDA’s) Center for Tobacco Products (CTP) has
contracted with RTI to conduct an online survey of 2,400 youth participants (ages 13-17). The
objectives of this task are to 1) to examine the extent to which the distribution and accuracy of
self-reported awareness varies across different awareness assessment approaches; and 2) develop
comprehensive, valid, multi-item scales to measure outcomes such as addiction perceptions,
expectations of feeling anxious after using tobacco, and other key predictors of tobacco use that
campaign messages aim to change.
To achieve these objectives, we will conduct an online survey with the following
components: 1) a cross-sectional message exposure study to examine variation in and sensitivity
of different awareness assessment approaches; 2) a longitudinal message exposure study to
assess variation in accuracy of different awareness assessment approaches; and 3) creation and
evaluation of comprehensive, multi-item scales assessing outcomes targeted by the campaign.
Findings from this study can be used to inform the evaluation of FDA’s Real Cost anti-tobacco
campaign.
Health communication campaign evaluations have employed a wide variety of approaches
for assessing media campaign awareness, but little is known about how self-reported awareness
varies across these approaches, and which approaches are most accurate and sensitive to
variation in campaign exposure. Effective anti-tobacco media campaign evaluation also requires
valid and reliable measurement of predictors of tobacco use (e.g., addiction perceptions) that are
targeted by the campaign (in this case, the Real Cost campaign). The proposed research will
provide valuable insights to inform the ongoing evaluation of the Real Cost media campaign. To
the extent that we are able to validate brief awareness measures, research findings may also lead
to reduced respondent burden in future studies.
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3. Use of Improved Information Technology and Burden Reduction
Because this is a web-based study, 100% of the respondents will submit the information
in an electronic format. Web-based surveys reduce respondent burden, minimize possible
administration errors, and expedite the timeliness of data processing. Furthermore, web-based
surveys are less intrusive and less costly compared with face-to-face interviews and mail and
telephone surveys. Because there is no interviewer present, participant responses to a web-based
survey are less prone to social desirability bias.
4. Efforts to Identify Duplication and Use of Similar Information
There is no duplicative collection of this information. No comparable data have been
collected by any other entities. We carefully reviewed the literature and existing data sets to
determine whether any of them are sufficiently similar or could be modified to address FDA’s
needs. We concluded that the existing literature and existing data sources do not include the
measures needed by FDA.
5. Impact on Small Businesses or Other Small Entities
No small businesses will be involved in this collection of information.
6. Consequences of Collecting the Information Less Frequently
The collection of information will provide important data needed for FDA to evaluate
ongoing media campaigns, particularly among youth. Failure to collect these data could reduce
effectiveness of the FDA’s messaging, and therefore reduce the benefit of the messages for youth
in the United States.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
This information collection fully complies with 5 CFR 1320.5(d)(2). No special
circumstances are associated with this information collection that would be inconsistent with the
regulation.
8. Comments in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency
The following individuals inside the agency have been consulted on the design of the study,
instrument development, or intra-agency coordination of information collection efforts:
Emily Sanders
Office of Health Communication & Education
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
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Phone: 240-402-4269
E-mail: [email protected]
Matthew Walker
Office of Health Communication & Education
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: 240-402-3824
E-mail: [email protected]
Erin O’Brien
Office of Health Communication & Education
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 240-402-4047
E-mail: [email protected]
Lindsay Pitzer
Office of Health Communication & Education
Center for Tobacco Products
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 240-620-9526
E-mail: [email protected]
FDA collaborates with other federal government agencies that sponsor or endorse health
communication projects, such as the Centers for Disease Control and Prevention, Office on
Smoking and Health (CDC/OSH), the Substance Abuse and Mental Health Services
Administration (SAMHSA) and the National Institutes of Health National Cancer Institute
(NIH/NCI). These affiliations serve as information channels, help prevent redundancy, and
promote use of consistent measures of effectiveness. Coordination activities include:
•
•
•
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Review of proposed messages for advertisements;
Review of questionnaires for testing purposes;
Sharing data; and
Standardizing survey tools where at all possible.

The following individuals outside of the agency have been consulted on questionnaire
development:

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Matt Eggers
RTI International
3040 Cornwallis Road
Research Triangle Park, NC 27709
Phone: 919-541-6683
E-mail: [email protected]
Jessica Pepper
RTI International
3040 Cornwallis Road
Research Triangle Park, NC 27709
Phone: 919-316-3180
E-mail: [email protected]
Jim Nonnemaker
RTI International
3040 Cornwallis Road
Research Triangle Park, NC 27709
Phone: 919-541-6683
E-mail: [email protected]
9. Explanation of Any Payment or Gift to Respondents
For parents recruited from the Lightspeed panel for the online survey, Lightspeed will
provide nonmonetary “LifePoints” valued at approximately $1.00-1.25 to parents of youth who
complete each survey. LifePoints are a routine part of Lightspeed’s panel maintenance strategy
and can be accrued and traded for material items with Lightspeed partner vendors (e.g.,
Amazon.com, Starbucks) or for cash. Lightspeed also partners with other survey panel vendors.
For parents who are recruited from partner survey vendors, the partner company will provide
equivalent reward points in the form typically used by that company with its panelists.
Lightspeed will provide the unique, alphanumeric survey IDs of individuals who should be given
reward points to the partner company.
Upon youths’ completion of the online survey, Lightspeed will post Lifepoints to the
parents’ accounts within a few hours. Lightspeed requests that the timing of the reward points for
parents recruited through partner companies is similar.
In general, empirical studies show that incentives can increase response rates in crosssectional surveys and reduce attrition in longitudinal surveys within some respondent
populations. 1 Although the vast majority of published research on this topic is based on mail,
1

Singer E & Ye C. (2013). The use and effects of incentives in surveys. The Annals of the American Academy of
Political and Social Science. 645(1), 112-141; LeClere F et al. (2012). Household early bird incentives: leveraging
family influence to improve household response rates. In American Statistical Association Joint Statistical Meetings,
Section on Survey Research; Cantor D et al. (2003). Comparing promised and pre-paid incentives for an extended
interview on a random digit dial survey. In Presentation for the Annual Meeting of the American Association for

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telephone, or in-person surveys, there are now several studies on the effects of incentives within
the context of a web-based survey. For example, a 2006 meta-analysis of 32 studies indicates
that incentives increase the odds that potential respondents will begin a web survey, and a second
meta-analysis of 26 studies shows that incentives increase the odds of completing a web survey
once respondents have begun it. 2
10. Assurance of Confidentiality Provided to Respondents
Concern for privacy and protection of respondents’ rights will play a central role in the study
implementation, storage and handling of data, and data analysis and reporting. The Institutional
Review Board (IRB) of RTI International, the research organization contracted to manage data
collection has reviewed and approved the protocols for the survey. FDA’s Research Involving
Human Subjects Committee (RIHSC) conducted a courtesy review before submission to RTI
IRB; RIHSC determined that FDA is not engaged in the research. The primary concern of IRB is
protecting respondents’ rights, one of which is maintaining the privacy of respondent
information. OMB Control Number 0910-0810 is covered underneath a Privacy Impact
Assessment that has been approved by the Department of Health and Human Services (PIA
Unique Identifier: P-9008729-198376).
Privacy for survey respondents will be ensured in a number of ways:
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Each respondent will be known to FDA and RTI only by a unique alphanumeric ID
variable provided by Lightspeed. That ID variable is specific to the study. Although
Lightspeed and any partner survey vendors maintain databases of names and e-mail
addresses of potential participants as part of their normal operations, neither FDA nor
RTI will receive or request this information from Lightspeed.

•

The online survey requests date of birth, which is considered PII. Lightspeed will
remove the DOB variable from the dataset that is provided to RTI and only provide
data on a derived age variable. The survey datafile that will be shared with FDA will
not contain any PII.

•

Lightspeed will invite youth of adult panel participants to complete the survey via an
initial generic communication to their parent through the Lightspeed panelist portal. If
affirmative permission is provided online, parents will be asked to allow their child to
complete the screener and survey in private, so they cannot see the responses. Youth
participants will also be informed that their answers will not be shared with their
parents.

•

Respondents cannot back up in the survey to view previous responses. For example,
if a youth were to exit the survey, the parent could not view previously entered
responses. During survey testing, the test links will include the ability to back up, but

Public Opinion Research, Nashville, TN; Singer E. (2002). The use of incentives to reduce nonresponse in
household surveys. In Survey Nonresponse, eds. Groves RM et al. 163-78. New York, NY: Wiley; Singer E et al.
(1998). Does the payment of incentives create expectation effects? Public Opin Q. 62, 152-64.
2

Göritz AS. (2006). Incentives in web studies: methodological issues and a review. Int J Internet Science. 1(1), 5870.

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this will not be possible in the actual survey that participants complete. RTI will
confirm this with Lightspeed after testing and before survey launch.
•

Parents and youth respondents access the survey through a unique link provided by
Lightspeed. The link cannot be shared for others to use because it is unique.

•

The online survey is self-administered, and respondents will participate on a
voluntary basis. Questions in the screener are required for determining eligibility;
however, respondents can exit the survey by closing the browser if they do not wish
to answer these. All other questions are optional. The voluntary nature of the
information collection is described in the online parental permission and assent forms
to which participants provide online affirmative agreement.

•

Lightspeed will not use the data it collects through the screener or survey to update
panelists’ profiles. Because Lightspeed will not share the data it collects from the
screener or survey with the companies they partner with for recruitment, it will not be
possible for the partners to use this data to update profiles of their own panel
members.

•

When data collection is complete, the deidentified data file will be transmitted from
RTI to FDA via a website with an SSL certificate applied. The data file, which
contains no PII, will be stored by RTI and FDA on a restricted-access folder on a
shared network drive, and only authorized project members will have access. RTI will
store data for 5 years before deletion.

This study is funded by the FDA, a Department of Health and Human Services supported
agency, and is covered by a Certificate of Confidentiality (CoC). Section 2012 of the 21st
Century Cures Act includes significant amendments, to the previous statutory authority for such
protections, to enhance privacy protections for individuals who are the subjects of federally
funded research, under subsection 301(d) of the Public Health Service Act (42 U.S.C. 241).
Specifically, the amended authority requires the FDA to issue a CoC to investigators or
institutions engaged in research funded by the Federal government to protect the privacy of
individuals who are subjects of this research. We will notify participants in the assent form (and
parental permission form) of the protections that the Certificate provides.
11. Justification for Sensitive Questions
Most questions asked will not be of a sensitive nature. However, it will be necessary to
ask some questions that may be considered of a sensitive nature in order to assess specific health
behaviors, such as tobacco use and marijuana/cannabis use. Asking such questions is critical to
the objectives to this information collection.
Some questions about tobacco use are potentially sensitive because tobacco use among
adolescents under age 18 is illegal in a few states, and sales to individuals under age 21 are
illegal nationwide. One question assessing ever having vaped marijuana/cannabis may also be
sensitive because youth possession of marijuana/cannabis is illegal in the U.S. These questions
are essential to the objectives of this information collection. Questions concerning tobacco use
and demographic information, such as race and ethnicity, could be considered sensitive but not
highly sensitive. To address any concerns about inadvertent disclosure of sensitive information,
respondents will be fully informed of the applicable privacy safeguards. The assent form will
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apprise respondents that the topic of tobacco use will be covered during the survey. This study
includes a number of procedures and methodological characteristics that will minimize potential
negative reactions to these types of questions, including the following:
•

Respondents will be informed that they do not need participate and that if they choose to
participate, they do not need answer any question on the survey (aside from required
screening questions) that makes them feel uncomfortable or that they simply do not wish
to answer.

•

The web survey is entirely self-administered to maximize respondent privacy without the
need to verbalize responses.

•

Participants will be provided with a specific toll-free phone number for the RTI Office of
Research Protection and the RTI Principal Investigator to contact in case they have a
question or concern about the sensitive issue.

12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
Information will be collected through a self-administered, online screener and two survey
waves of youth (ages 13-17), with a target of 2,400 completes at each wave. Approximately
11,667 parents will review a Wave 1 generic invitation/permission form estimated to take
approximately 2 minutes per response, for a total of 389 hours. After receiving parental consent
to participate in the study, approximately 9,600 youth will complete an assent form and screener
to determine eligibility for participation in the study, estimated to take approximately 2 and 3
minutes per response, respectively, for a total of 800 hours for assent and screening activities.
We estimate that 2,400 respondents will complete the Wave 1 survey at an average of 20 minutes
per response, for a total of 800 hours. We estimate that up to 2,400 parents will review a Wave 2
permission form at an average of 2 minutes per response, for a total of 80 hours. Up to 2,400
respondents will complete a Wave 2 assent form and survey at an average of 2 and 15 minutes
per response, respectively, for a total of 680 hours. This data collection will take place in 2022.
Thus, the annualized response burden is estimated at 2,749 hours. Table 1 provides details about
how this estimate was calculated.
Table 1. Estimated Annual Reporting Burden
No. of
Respondents

No. of
Responses
per
Respondent

Total
Annual
Responses

Parent—Wave 1
Generic invitation,
Permission

11,667

1

11,667

Youth—Wave 1
Assent

9,600

1

9,600

Type of
Respondent

7

Average
Burden per
Response
(Hours)
0.03
(2 minutes)

0.03
(2 minutes)

Total
Hours
389
320

Youth—Wave 1
Screener

9,600

1

9,600

Youth—Wave 1
Survey

2,400

1

2,400

Parent—Wave 2
Permission

2,400

1

2,400

Youth—Wave 2
Assent

2,400

1

2,400

Youth—Wave 2
Survey

2,400

1

2,400

0.05

480

(3 minutes)

0.33

800

(20 minutes)

0.03

80

(2 minutes)

0.03

80

(2 minutes)

0.25

600

(15 minutes)

Total Burden Hours

2,749

12b. Annualized Cost Burden Estimate
To estimate the annualized cost burden, the mean hourly wage of $7.25 was used for
youth and $22.33 was used for parents. The youth price represents the minimum wage, and the
parental costs represent the Department of Labor estimated mean for state, local, and private
industry earnings. There are no direct costs to respondents associated with participation in this
information collection. Thus, assuming an average hourly wage of $7.25 and $22.33 (youth and
parent), the estimated one-year annualized cost to participants will be $27,003. The estimated
value of respondents’ time for participating in the information collection is summarized in Table
2.
Table 2. Estimated Annualized Cost
Type of Respondent

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

469

$22.33

$10,473

Youth (13–17)

2,280

$7.25

$16,530

Total

2,749

Parent

$27,003

13. Estimates of Other Total Annual Costs to Respondents and/or
Recordkeepers/Capital Costs
No capital, start-up, operating, or maintenance costs are associated with this information
collection.

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14. Annualized Cost to the Federal Government
The total estimated cost to the Federal Government for this study is $97,327.20 as shown
in Table 3. Contractor costs attributable to this information collection are $65,961. This includes
costs to program the survey, draw the sample, and collect the data. Other contractor activities
outside this data collection estimate include coordination with FDA to develop the instrument
and deliver the final data set and reporting deliverables.
Table 3. Itemized Cost to the Federal Government
Time
Commitment

Average Annual
Salary

Total

GS-13

20%

$121,065

$24,213.00

GS-14

5%

$143,064

$7,153.20

Government Personnel

Total Salary Costs

$31.366.20

Contractor Costs

$65,961.00

Total

$97,327.20

15. Explanation for Program Changes or Adjustments
This is a new data collection.
16. Plans for Tabulation and Publication and Project Time Schedule
The project schedule is shown in Table 4. Future development and research activities are
dependent on the timely completion of the present study.
Table 4. Project Schedule
Activity

Approximate Date

Data Collection

April 2022

Draft Reporting Deliverables

June 2022

Final Reporting Deliverables

July 2022

17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA is not requesting an exemption for display of the OMB expiration date and is also
not seeking OMB approval to exclude the expiration date for this information collection. The
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OMB approval and expiration date will be displayed on the relevant materials associated with the
study.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.

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