Generic Clearance SS A_0820 2021 Final

U.S. Food and Drug Administration
Generic Clearance for the Collection of Quantitative Data on Tobacco Products and
Communications
OMB Control No. 0910-0810
Supporting Statement Part A: Justification
1. Circumstances Making the Collection of Information Necessary
In order to conduct educational and public information programs relating to tobacco use as
authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
393(d)(2)(D)), FDA’s Center for Tobacco Products will conduct research and use a variety of
media to inform and educate the public, tobacco retailers, and health professionals about the
health risks of tobacco use, how to quit using tobacco products, and FDA’s role in regulating
tobacco.
To ensure that these educational and public information programs have the highest potential to
be received, understood, and accepted by those for whom they are intended, the Center for
Tobacco Products will conduct research and develop health messages relating to the control and
prevention of disease. In conducting such research, FDA will use quantitative methods (i.e.,
surveys, experimental studies) for studies about tobacco products. These studies may be used to
collect information related to foundational research informing message development or the
formative pretesting of tobacco communication messages and other materials directed at
consumers. This type of research involves: (1) assessing audience knowledge, attitudes,
behaviors, and other characteristics for the purpose of determining the need for and developing
health messages, communication strategies, and public information programs; (2) pretesting
these health messages, strategies, and program components while they are in developmental form
to assess audience comprehension, reactions, and perceptions; and (3) adding to the regulatory
science knowledge base. Quantitative studies play an important role in exploring areas of
research and gathering information because they can be used to summarize a population of
interest on key variables or reveal systematic relationships between variables.
Foundational research to inform message development and the formative pretesting of messages
are a staple of best practices in communications research. Obtaining voluntary feedback from
intended audiences during the development of messages and materials is crucial for the success
of every communication program. The purpose of obtaining information from formative
pretesting is that it allows FDA to improve materials and strategies while revisions are still
affordable and possible. Formative pretesting can also avoid potentially expensive and
dangerous unintended outcomes caused by audiences’ interpreting messages in a way that was
not intended by the drafters. By maximizing the effectiveness of messages and strategies for
reaching targeted audiences, the frequency with which tobacco communication messages need to
be modified should be greatly reduced.
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The voluntary information collected will serve the primary purpose of providing FDA
information about various measures of ad performance including message comprehension,
perceived effectiveness, emotional responses and knowledge, attitudes, and behaviors change to
assess the ability of messages, advertisements, and materials to reach and successfully
communicate with their intended audiences. Quantitative testing messages and other materials
with a sample of the target audience will allow FDA to refine messages, advertisements, and
materials directed at consumers while the materials are still in the developmental stage.
In addition, quantitative information is needed by FDA to track changes in response to policy
and regulatory actions and to expand the tobacco regulatory science base by providing
information on changing behaviors, knowledge and attitudes about tobacco products, including
post-marketing surveillance of tobacco products.
FDA requests Office of Management and Budget (OMB) approval for an extension of this
generic clearance to collect quantitative information related to the testing and development of
tobacco communication messages and other materials directed at consumers and to assess
knowledge and perceptions about tobacco-related topics with specific target audiences. FDA
conducts research relating to tobacco products under its statutory authority in section
1103(d)(2)(C) of the FD&C Act, to conduct research “relating to foods, drugs, cosmetics,
devices, and tobacco products in carrying out the act.” To coordinate efforts, FDA proposes that
this generic clearance continue to cover all information collection activities aimed to better
understand knowledge and perceptions about tobacco-related topics, to add to the regulatory
science base, and to test and develop communication messages by the Center for Tobacco
Products. FDA intends to utilize best practices for effective health communication research set
forth by other DHHS agencies such as the National Cancer Institute. 1
FDA will submit individual collections under this generic clearance to OMB. Before submission
to OMB, individual collections will undergo review by FDA’s Institutional Review Board (IRB)
senior leadership in the Center for Tobacco Products, and Paperwork Reduction Act (PRA)
specialists. FDA will prepare a report during the OMB collection renewal summarizing the
number of hours used, as well as the nature and results of the activities completed under this
clearance.
2. Purpose and Use of the Information
FDA plans to use the data collected under this generic clearance to better understand consumers’
responses to tobacco related topics and concepts. Data may also be collected to better
understand consumers’ behavior, knowledge and attitudes about tobacco products, including
testing of tobacco communication and post-marketing surveillance of tobacco products. Data
collected under this generic will inform the regulatory science base and the development of
FDA’s public education campaigns and other materials directed at consumers. The data will not
be directly used for the purposes of making policy or regulatory decisions.
National Cancer Institute (NCI). Making Health Communications Work: A planner’s guide, Pink Book. Pub. No.
T068. Washington, DC: U.S. Department of Health and Human Services (HHS), August 2004.
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Screening for inclusion in any specific collection will ensure that participants included represent
the group needed for the specific collection. Screening may focus on age, tobacco use status, or
other demographic and/or behavioral factors of individuals to ensure that the intended study
population is included in the collection. For example, if testing public education materials
targeted towards youth age 13-17 who are current cigarette smokers, then screening would
ensure that youth age 13-17 who are current cigarette smokers are included in the collection, but
a 24-year-old never smoker (for whom the public education materials are not intended) would
not be included.
The information collected will add to the regulatory science knowledge base and may help FDA
understand gaps in knowledge and attitudes about tobacco products, as well as behaviors and
behavioral intentions for tobacco use. This information can help to inform communication
directed at consumers. Further, quantitative research can give FDA information about the
perceived effectiveness and reactions to messages, advertisements, and materials in reaching and
successfully communicating with consumers.
FDA will only submit a collection for approval under this generic clearance if it meets the
following conditions:
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•
•
•

The collections are voluntary;
The collections are low burden for respondents (based on considerations of total burden
hours, total number of respondents, or burden hours per respondent) and are low cost for
both the respondents and the Federal Government;
The collections are noncontroversial;
Personal identifiable information (PII) is collected only to the extent necessary 2 and is
not retained; and
Information gathered will not be used for substantially informing influential policy
decisions. 3

If these conditions are not met, FDA will submit an information collection request to OMB for
approval through the normal PRA process.
To obtain approval for a collection that meets the conditions of this generic clearance, an
abbreviated supporting statement will be submitted to OMB along with supporting
documentation (e.g., a copy of the study instrument, experimental stimuli). Before submission to

For example, collections that collect PII in order to provide remuneration for participants of focus groups and
cognitive laboratory studies will be submitted under this request. All privacy act requirements will be met.
3
As defined in OMB and agency Information Quality Guidelines, “influential” means that “an agency can
reasonably determine that dissemination of the information will have or does have a clear and substantial impact on
important public policies or important private sector decisions.”
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OMB, individual collections will undergo review by FDA’s IRB, senior leadership in the Center
for Tobacco Products, and PRA specialists.
3. Use of Information Technology and Burden Reduction
As computer technology has continued to improve and become more widespread, opportunities
to implement web-based data collection via the internet have increased. Thus, wherever
possible, FDA will make use of web-based data collection methods when collecting quantitative
data. Using computer-assisted information technology to transmit data collection instruments
and/or collect responses will continue to reduce the burden on respondents. For example,
respondents can access and respond to data collection requests at a time and place that is
convenient to them, eliminating the need to travel for survey administration.
Web-based data collections, including those using experimental designs, are an especially
convenient option for eliciting feedback on visual stimuli. With web-based surveys, respondents
complete an online survey and then submit the data electronically over the internet. Closedended questions (e.g., multiple-choice items, Likert scales) will be employed whenever possible.
With 99 percent of 18-to-29-year old’s indicating in of 2021 that they use the internet, 4 webbased surveys offer an especially useful way to solicit responses from young adults and
adolescents and to assess the relative efficacy of alternative message presentations.
Approximately 90 percent of respondents will respond to this collection of information
electronically.
4. Efforts to Identify Duplication and Use of Similar Information
As each new research study is developed, FDA will review existing literature and databases,
including pretesting reports on existing messages and materials. FDA will also consult with
outside experts to evaluate available information on similar messages with comparable
audiences. FDA will work with other HHS agencies responsible for communicating about
tobacco use with the general public.
However, because communications to consumers on the use of tobacco will be diverse and vary
by target audience, new data collection instruments generally will be prepared for each
quantitative study.
Therefore, each set of data collected by FDA is unique. Coordination with other agencies ensures
that duplicative data is not being gathered. Further, no similar data are gathered or maintained
by FDA or are available from other sources known to FDA.

Internet/Broadband Fact Sheet. Pew Research Center, April 7, 2021 https://www.pewresearch.org/internet/factsheet/internet-broadband/, accessed on July 22, 2021
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5. Impact on Small Businesses or Other Small Entities
Small businesses, or other small entities, may be involved in efforts related to collections of
information approved under this clearance. However, FDA will minimize the effect and burden
on them by sampling appropriately
6. Consequence of Collecting the Information Less Frequently
FDA is using a variety of media messages and materials to inform and educate the public about
the risks of tobacco use. Communicating effectively about the risks of using tobacco products
involves conveying complex concepts. Continued quantitative research is also needed to assess
the continued relevance of such messages given dynamic social and environmental factors and
the changing education and information needs of the public. Without quantitative testing and
data collections, FDA cannot fully ensure that tobacco messages and materials directed at
consumers are serving their intended purpose. As a result, the FDA could spend a large amount
of money on communications that are ineffective in achieving the intended purpose of reducing
tobacco-associated costs to people’s lives and to the government. Further, quantitative research
is often necessary to track changes in response to policy and regulatory actions.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
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. However, some studies submitted under this generic may use panels that may yield
nationally representative results. When probability samples are employed (such as through an
online panel), representative estimates to the national population will not be made.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside
Agency
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for public comment on the
proposed collection of information in the FEDERAL REGISTER of March 5, 2021 (86 FR
12952). FDA received one comment that was PRA-related.
Comment: The comment suggested specific types of messages that FDA should test and the
implement in public health campaigns.
Response: FDA appreciates the comment. The content and focus on studies submitted through
this generic clearance will depend on agency priorities and needs, which are not yet determined
at this time.

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9. Explanation of Any Payment or Gift to Respondents
It is standard practice in commercial market research to offer recruited respondents some form of
remuneration for the time they spend engaged in a personal interview activity. Instances for
offering a small incentive will be determined on a case-by-case basis (depending on the
information collection design). Small amounts of money may be offered as an incentive for
participation in in-person interviews. FDA will provide a rationale in the justification memo for
any studies that propose to offer incentives for participation.
10. Assurance of Confidentiality Provided to Respondents
In developing this study, CTP consulted the agency Privacy Officer to identify potential risks to
the privacy of participants and other individuals whose information may be handled by or 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 CTP satisfy all in accordance with law and policy. FDA submitted a
Privacy Impact Assessment to the privacy office that has been approved by the Department of
Health and Human Services (PIA Unique Identifier: P-9008729-198376).
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.
PII Collection
For respondent enrollment, PII will be collected on an as needed basis during the
enrollment/screening process. Mailing address and/or e-mail addresses may be collected for
contacting the respondent regarding enrollment details (e.g. directions, schedule). PII will be
collected during the screening process to assess study eligibility. PII collected as part of the
respondent enrollment will not be maintained or linked to other study information. Contractors
and subcontractors that collect data on behalf of CTP are contractually prohibited from passing
along any PII, and at the most FDA receive ID numbers. For these collections, FDA does not
have any systems to maintain or retrieve PII.
For data quality management, PII in the form of audio recordings (biometric identifiers) may be
used as a means of quality control and/or data assurance. Permission (active consent) for this
type of PII is obtained from all respondents. Respondents must agree to have study activities
audio recorded. Audio files are used to produce a transcript for developing a report and then
destroyed. Audio recordings, including any transcripts made from the audio recordings, will not
be linked to any other PII or transmitted.
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For study implementation, PII in the form of e-mail and IP addresses and/or zip codes may be
collected on an as needed basis for study implementation. This type of PII may be checked
against respondent data to avoid duplicates and reduce fraudulent activity. If multiple e-mails
have the same IP address, researchers will review the data, retain the first recorded response, and
remove duplicates from the final analytical dataset. Researchers may also contact respondents to
convey follow-up information about the study or if there is an issue with incentive delivery. PII
collected as part of the study implementation will not be included in the dataset used for analysis
or maintained. There will be no secondary uses, PII will only be used to for primary study
purposes.
FDA has minimized the risk of unnecessary access, disclosure, use or proliferation PII about
respondents. FDA and other parties involved in the study collect and maintain study records
containing PII only as long as required. For many studies that information is not retained once
the study is completed (e.g., email addresses needed to re-contact participants for the follow-up
session of a study. PII is always removed before any data is sent to FDA. That PII may be is
linked to data by a code, only when necessary, or more commonly fully disassociated from the
data.
Notice and Transparency
Neither FDA nor direct contractors, including 3rd parties share PII gathered via this collection
with any other individuals or entities.
All PII subjects are provided notice regarding the collection and use of the information they
submit. A panel provider may collect IP addresses when participants register for the panel, but
FDA does not receive IP addresses. FDA and its contractors will notify participants if IP
addresses are recorded. FDA sponsorship when appropriate (in some cases, FDA sponsorship
will not be made known to respondents prior to data collection out of concern for the potential
introduction of bias to study results. In such cases, FDA sponsorship will be made known after
the data are collected.); and that participation is voluntary at all times.
Individual Participation and Control
While anonymity of respondents generally cannot be assured unless there is a statutory
requirement associated with the information collection, information provided by respondents will
be kept private and anonymous, to the extent allowable by law. This will be communicated to
respondents by means of introductory letters, explanatory texts on the cover pages of
questionnaires, scripts read prior to focus groups, telephone interviews, and consent forms.
Respondents also will be advised of the following: the nature of the activity; the purpose and use
of the data collected; FDA sponsorship (when appropriate); and the fact that participation is
voluntary at all times. Because responses are voluntary, respondents will be assured that there
will be no penalties if they decide not to respond, either to the information collection or to any
particular questions.
Data Security
Contractors are required to maintain appropriate administrative, technical and physical
safeguards to ensure the security and confidentiality of records. User roles and responsibilities
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will determine the type and content data and information necessary for job function (both PII and
non-PII). Role-based access will determine and control who will access to PII on an as needed
basis.
Access to the system is restricted on the business need to ensure minimum extent necessary.
Only personnel from a contractor conducting the information collection will have access to focus
group or interview data. All project staff from a contractor conducting the information collection
must take required measures to ensure the privacy and anonymity of data. PII will be limited to
information that may be required in the process of respondent enrollment. PII will be accessible
to contractors on an as needed basis and will not be linked to interview data. All PII will be
destroyed following data collection at the completion of the study.
Neither FDA employees nor any Federal employee of any other agency will have access to this
information.
All electronic and hard copy data will be maintained securely throughout the information
collection and data processing phases. While under review, electronic data will be stored in
locked files on secured computers and hard copy data will be maintained in secure building
facilities in locked filing cabinets. As a further guarantee of privacy and anonymity, all
presentation of data in reports will be in aggregate form, with no links to individuals. Reports
will be used only for research purposes and for the development of communication messages.
Interviews are typically considered exempt from the “Regulations for the Protection of Human
Subjects” in accordance with 45 CFR 46.101(b)(3).
Before data are collected, FDA researchers will obtain either an exemption or approval for the
research from FDA’s Institutional Review Board (IRB) or an external accredited IRB.
Minors (or children) are persons who have not attained the legal age for consent to treatments or
procedures described in the study are covered under the applicable law of the jurisdiction in
which the research will be conducted. Where FDA’s IRB determines that minors are capable of
giving an assent, the IRB will determine whether adequate provisions are made for soliciting
assent. Generally, assent to the research requires securing the signature of a minor in a separate
assent form, in addition to the consent form the parent or legal guardian signs. An assent
document should contain an explanation of the study, a description of what is required of the
subject (e.g., what the child will experience (in what setting the interview or focus group will
take place, whether the child's parents will be with him or her, etc.)), an explanation of any risks
or mental anguish associated with the study topic, and an explanation of the benefits to the child
or others.
Administrative safeguards include user training; system documentation that advises on proper
use; implementation of Need to Know and Minimum Necessary principles when awarding
access, and others. Technical Safeguards include use of multi-factor access authentication,
firewalls, and network monitoring and intrusion detection tools. Physical controls include that all
system servers are located at facilities protected by guards, locked facility doors, and climate
controls. Other appropriate controls have been selected from the National Institute of Standards
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and Technology’s (NIST’s) Special Publication 800-53, as determined using Federal Information
Processing Standard (FIPS) 199.
11. Justification for Sensitive Questions
Some studies require the inclusion of people who match selected characteristics of the target
audience that FDA is trying to reach. Efforts to match characteristics may require asking a
question about race/ethnicity, income, education and/or health status on the initial screening
questionnaire used for recruiting. Potential participants are informed that this is being done to
make sure that FDA speaks with the kinds of people for whom its messages are intended. Again,
respondents are assured that the information is voluntary and will be treated as private and
anonymous. All information on race/ethnicity will comply fully with the standards of OMB
Statistical Policy Directive No. 15, October 1997 (https://www.whitehouse.gov/wpcontent/uploads/2017/11/Revisions-to-the-Standards-for-the-Classification-of-Federal-Data-onRace-and-Ethnicity-October30-1997.pdf).
Because these data collections may be concerned with the prevention of premature mortality
from heart disease and oral and respiratory cancers, some projects may involve asking questions
about (or discussing) how one perceives his/her own personal risk for serious illness. Fears of
heart disease and cancer and experiences with both may also be covered. Graphic displays of
negative health outcomes (e.g., cancerous lung tissue, gum disease and tooth loss) may also be
presented as stimuli to assess the ability of such displays to encourage current tobacco users to
quit or prevent non-tobacco users from initiating use. This information is needed to gain a better
understanding of the target audience so that the messages, strategies, and materials designed will
be appropriate and sensitive. Questions of this nature, while not as personal as those about
sexual behavior or religious beliefs, still require some sensitivity in how they are worded and
approached. In face-to-face data collections, questions of this kind are generally asked later in
the interview or group discussion, when respondents are more comfortable with the interview
situation and are more at ease with the interviewer/moderator. As noted in section A.10.,
participants are informed prior to actual participation about the nature of the activity and the
voluntary nature of their participation. The interviewer/moderator makes it clear that they do not
have to respond to any question that makes them uncomfortable.
FDA tobacco communications may also be concerned with discouraging tobacco use by
adolescents before they start. FDA acknowledges the sensitivity of questions about the purchase
and use of tobacco, which is illegal for minors in some states.
Raw data from data collections that may include sensitive information (for example, screening
questionnaires) are not retained once the data have been extracted and aggregated. The
information never becomes part of a system of records containing permanent identifiers that can
be used for retrieval.
12. Estimates of Annualized Burden Hours and Costs
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Table 1 provides an estimate of anticipated burden levels that may be incurred during a 3-year
period.
Table 1. -- Estimated Annual Reporting Burden
Number of
Respondents

No. of
Responses per
Respondent

Total
Annual
Responses

Screener

485,580

1

SelfAdministered
Surveys

133,728

1

Survey Type

Average
Burden per
Response

Total
Hours

485,580

0.083
(5 minutes)

40,465

133,728

0.33
(20 minutes)

44,576

Total

85,041

12b. Annualized Cost Burden Estimate

The general public will complete the majority of data collections. The mean average hourly
compensation for this group is $27.07. 5 The estimated annualized annual cost for the general
public in this information collection for 85,041 hours of reporting time is $2,302,059.87. The
number of respondents and length of response was determined based on FDA prior experience
with communications testing and an estimate of the communication needs of the Center for
Tobacco Products. The actual numbers will vary depending upon the topic of interest.

Screener
Self-Administered Surveys
Total

Total Burden
Hours
40,465
44,576

Average Rate

Total Respondent Cost

$27.07
$27.07

$1,095,387.55
$1,206,672.32
$2,302,059.87

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no capital, start-up, operating, or maintenance costs associated with this information
collection.
14. Annualized Cost to the Federal Government

5

U.S. Bureau of Labor Statistics, http://www.bls.gov/oes/current/oes_nat.htm, May 2020.

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Costs will also include contractor expenses for designing and conducting information collection
activities, specifically, drawing samples, training interviewers, collecting and analyzing
information, and reporting findings. Contractor expenses may vary from $20,000-$250,000
depending on the size of the study. Therefore, in a given year, it is anticipated that
approximately $500,000 in contractor expenses will be expended to fund at least two large scale
study and eight smaller scale studies.
In addition, government staff costs may be incurred for monitoring by the government Project
Officer and Senior Analyst, projected to be about 25 percent of an FTE’s time per year (522
hours). Given an FDA personnel cost of $48.35 per hour, an estimated $25,238.70 would be
spent annually on government staff salaries.
The total estimated annual cost to the government for this collection of information is
$525,238.70 (which is equal to the total of contractor expenses ($500,000) plus FDA government
staff salary cost ($25,238.70)).
15. Explanation for Program Changes or Adjustments
The burden for this information collection is proposed to increase by 60,000 hours from the
current inventory. The burden increase is result of an increase in the number of new quantitative
studies that are anticipated underneath this information collection during the next three years.
16. Plans for Tabulation and Publication and Project Time Schedule
The process for conducting quantitative research includes the following steps: first, the
objectives are discussed, next the analytic questions to be addressed are determine, then the
procedures, instruments and data analysis plan are developed. The analyses conducted for each
quantitative research study will be determined by the objectives, the data being collected, and the
characteristics of the participants. Specifics of the analyses cannot be determined until the
survey instrument is developed.
Techniques include primarily quantitative analyses using descriptive statistics. Descriptive
statistics — including percentages, cross tabulations, and averages — will be calculated and
presented, along with demographic descriptions of study respondents. Information collected
from study participants will be subjected to subgroup analyses to uncover potential differences
among key groups (defined by gender, age, race/ethnicity, etc.). Inferential statistical analyses
may also be conducted using cross-tabulation procedures with categorical variables (e.g., chisquare) and between-group procedures with continuous variables (e.g., ANOVA and t-tests).
Parametric statistical tests will be used in the case of sufficient sample sizes, normal
distributions, and continuous or interval data; nonparametric procedures will be used otherwise.
All the analyses will be done in the context of understanding the limitations of the data with
respect to their not representing population parameters.

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While the primary purpose of quantitative research is to provide information to FDA, FDA may
make the results available to a variety of health program planners at Government agencies,
voluntary organizations, health professional organizations, and medical institutions. In addition,
FDA may present the findings of its work at professional association meetings, including those
of the American Public Health Association. Some results may be published in professional
journals such as the Journal of Public Policy and Marketing and Tobacco Control. In any
findings presented at professional association meetings or in professional journals, FDA will
state the limitations of the data by recognizing the qualitative and non-representative nature of its
pretests.
Specific timelines associated with the individual quantitative research projects are not known at
this time. While data collection period varies somewhat depending on the complexity of the
design and number of respondents required, the typical study will require approximately 12
weeks from initial design to preparation of the report of findings. A schedule for a typical data
collection is shown below:

Activity
Finalize materials
Finalize design
Collection of data
Analysis of data
Report

Project Time Schedule

Time Schedule
1 week after OMB approval
3 weeks after OMB approval
5 weeks after OMB approval
10 weeks after OMB approval
12 weeks after OMB approval

17. Reason(s) Display of OMB Expiration Date is Inappropriate
We are not requesting an exemption to this requirement. The OMB expiration date will be
displayed.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
These information collection activities involve no exception to the Certification for Paperwork
Reduction Act Submissions.

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