[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9067-9069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03387]



[[Page 9067]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0132]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food and Drug 
Administration's Study of How Consumers Use Flavors To Make Inferences 
About Electronic Nicotine Delivery System Product Qualities and 
Intentions To Use (Phase 2)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing that a proposed collection of information has been submitted 
to the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by March 21, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The title of this 
information collection is ``Food and Drug Administration's Study of How 
Consumers Use Flavors to Make Inferences About Electronic Nicotine 
Delivery System Product Qualities and Intentions to Use (Phase 2).'' 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
<a href="/cdn-cgi/l/email-protection#643436253710050202240200054a0c0c174a030b12"><span class="__cf_email__" data-cfemail="95c5c7d4c6e1f4f3f3d5f3f1f4bbfdfde6bbf2fae3">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.
    Food and Drug Administration's Study of How Consumers Use Flavors 
to Make Inferences About Electronic Nicotine Delivery System (ENDS) 
Product Qualities and Intentions to Use (Phase 2)

OMB Control Number 0910--NEW

    ENDS, also called electronic cigarettes, e-cigarettes, and 
vaporizers, are deemed tobacco products and fall under FDA's regulatory 
scope. FDA has the authority under the Family Smoking Prevention and 
Tobacco Control Act (Pub. L. 111-31, H.R. 1256) to regulate and 
restrict the marketing of tobacco products. However, given the recency 
of ENDS products to the market, limited research exists to inform the 
regulation of certain aspects of their marketing. Research to 
understand ``marketing influences on youth experimentation, initiation, 
use and cessation of tobacco products'' is a regulatory priority for 
the FDA Center for Tobacco Products (CTP).\1\
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    \1\ https://www.fda.gov/tobacco-products/research/research-priorities.
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    Flavors are a unique and important aspect of ENDS. ENDS use a 
liquid (``e-liquid'' or ``e-juice'') that can span a diverse range of 
flavors, from tobacco flavor, menthol, mint, fruit flavors, non-fruit 
sweet flavors (e.g., cr[egrave]me brulee, gummi bears), spices (e.g., 
cinnamon, vanilla), alcohol (e.g., strawberry daiquiri, bourbon, Irish 
cream), and ``concept flavors.'' Flavors are a regulatory area of 
interest, and FDA has issued an advance notice of proposed rulemaking 
(Docket No. FDA-2017-N-6565) ``to obtain information related to the 
role that flavors play in tobacco products,'' with a specific interest 
in how flavors may spur youth product initiation.
    This study of ``How Consumers Make Inferences About ENDS'' is 
voluntary research. The primary goal of the study is to understand 
whether flavor-related imagery, descriptors, and flavor name modifiers 
affect product appeal, curiosity about the product, interest in using 
the product, and product perceptions among youth and young adults. The 
project will examine three features identified in the research team's 
prior work: The use of flavor-related imagery, the use of flavor 
descriptors (e.g., ``cool,'' ``fresh''), and the use of flavor name 
modifiers (e.g., Cherry Crush).
    The study will collect data from two groups of consumers: 2,500 
youth (aged 13 to 17 years old) and 2,500 young adults (aged 18 to 24 
years old). The sample will be stratified by ENDS and cigarette use, so 
that 625 participants in each age group will be (a) noncigarette and 
non-ENDS users (N=625), (b) cigarette users only (N=625), (c) ENDS 
users only (N=625), and (d) dual ENDS and cigarette users (N=625). 
Participants will participate in a repeated measure experiment in which 
they will be asked to view five ads and report their liking of the ad, 
curiosity about using the product (an important precursor to use), and 
interest in using the product. Participants will also report additional 
perceptions of product qualities. This study is not meant to inform or 
guide other public health agencies' policies and messaging regarding 
the role of flavors in ENDS. This study will contribute to scientific 
knowledge regarding the use of flavors in ENDS marketing. Thus, other 
agencies may learn about the findings from our study through 
manuscripts published in peer-reviewed journals, for example, but this 
study is not intended to specifically influence their policies and 
messaging.
    Study Overview: In this study, youth noncigarette and non-ENDS 
users, current cigarette smokers, ENDS only users, and dual users of 
ENDS and cigarettes, as well as young adult noncigarette and non-ENDS 
users, current cigarette smokers, ENDS only users, and dual users of 
ENDS and cigarettes will be recruited from two existing internet online 
panels and screened for inclusion into the study. Youth will also be 
recruited through their parent panelists (parents who are members of 
the existing online panel) and screened for inclusion into the study.
    All recruited participants must complete a double opt-in procedure, 
and parents of youth panelists must consent for their child to be on 
the online panel. For this study, youth will provide assent and young 
adults will provide consent to participate in the surveys. Per 
institutional review board approval, parental consent was waived given 
that this study is minimal risk, documentation of parental consent 
would create an identifier, and verification of parental consent is 
difficult and could potentially bias the sample towards participants 
who have parents readily available and able to consent. The survey 
platform can detect and prevent duplicate responses by scanning for 
duplicate cookies and internet protocol (IP) addresses.
    Participants who meet the inclusion criteria will be randomized to 
view five ads across five conditions to report their liking of the ad, 
curiosity about using the product (an important precursor to use), and 
interest in using the product. The order of ad presentation will be 
randomized. These procedures will minimize order effects as well as the 
likelihood of a demand characteristic in which a participant guesses 
the purpose of the experiment and intentionally or unintentionally 
alters their response. Participants will receive a small

[[Page 9068]]

incentive as a token of appreciation in exchange for their survey 
participation.
    Study outcomes include comparisons to assess the extent to which 
presence or absence of a flavor-representing image, name modifier, or 
descriptor will be associated with increased or decreased (a) product 
appeal, (b) curiosity about the product, (c) interest in using the 
product, and (d) increased positive product perceptions compared to a 
control condition ad (without or with flavor features).
    In the Federal Register of March 3, 2021 (86 FR 12468), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received nine comments, four of which 
were PRA-related.
    (Comment 1) One commenter supports FDA's proposed collection of 
information and stated that research on the advertising of flavored e-
cigarettes and its impact on the perceptions of nonusers, e-cigarette 
users, cigarette smokers, and dual users is important. The commenter 
also noted that the proposed study length is acceptable and comprises 
typical burden for respondents in this type of research.
    (Response) FDA agrees with this comment and believes the study will 
contribute to our understanding of how consumers interpret flavor 
features on product labeling to make inferences about ENDS product 
qualities and intentions to use. We also believe the study's burden 
estimate aligns with previous research studies of this kind.
    (Comment 2) One commenter stated that FDA should research the role 
of flavored noncombustible tobacco products in converting adult smokers 
from cigarettes.
    (Response) This study focuses on the appeal of the selected 
advertising tactics on youth and young adults. Expanding the sample to 
include older adults (or all adults) is beyond the scope of the study.
    (Comment 3) FDA received a comment suggesting the Agency consider 
separating underage individuals from those who are of legal age to 
purchase tobacco products.
    (Response) The aim of this study centers around appeal of the 
selected advertising tactics on youth and young adults. The selection 
of the advertising tactics to be studied was grounded in research 
conducted when the Federal legal age to purchase tobacco was 18 years 
of age. Thus, we intend to sample youth aged 13-17 and young adults 
aged 18-24. However, as resources allow, we will plan to conduct 
supplementary analyses to account for the new Federal legal age (e.g., 
under 21 years vs. 21+ years).
    (Comment 4) FDA received a comment suggesting the Agency expand the 
sample to include tobacco users aged 25 and older.
    (Response) This study focuses on appeal of the selected advertising 
tactics on youth and young adults. Expanding the sample to include 
older adults is beyond the scope of the study.
    (Comment 5) FDA received a comment suggesting the Agency include a 
range of flavor name modifiers.
    (Response) The flavor name modifiers used in the study were 
selected based on careful review of prior research analyzing the 
tactics that ENDS companies use to advertise flavor. Our assessment is 
that the selected name modifiers are consistent with that research.
    (Comment 6) One commenter stated that using generalized data to 
support premarket determinations for specific products on specific 
applications is scientifically inappropriate. The commenter stated that 
the public should have the opportunity to provide comment on any 
proposed regulations. Additionally, the commenter stated any proposed 
de facto category-wide restriction on the manufacture, marketing, and 
distribution of tobacco products should undergo the appropriate notice 
and comment rulemaking procedures.
    (Response) The primary goal of the study is to understand whether 
flavor-related imagery, descriptors, and flavor name modifiers affect 
product appeal, curiosity about the product, interest in using the 
product, and product perceptions among youth and young adults. This 
study will not produce product-specific data; thus, it would not form 
the sole basis for any premarket determinations, but the results could 
be taken into consideration more broadly as part of premarket review. 
Additionally, this study might inform FDA's thinking regarding possible 
rulemaking but it will not provide sole support for any rulemaking. 
FDA's consideration of any future rulemaking would follow the 
appropriate notice and comment rulemaking procedures, which would 
include an explanation of the scientific basis for the proposed rule. 
The scientific basis would consider all relevant science, not just the 
results of this one study. Lastly, this study does not indicate FDA's 
intent to propose such a rule. The intent is to advance scientific 
knowledge broadly regarding the use of flavors in ENDS marketing.
    (Comment 7) FDA received a comment expressing concern about 
exposing youth to ENDS advertisements.
    (Response) Our study protocol includes measures to minimize risk of 
youth exposure to ENDS advertisements. Before participating in the 
study, participants are informed that they will be shown five ENDS 
advertisements. All participants are free to stop participation at any 
time and for any reason. At the end of the survey, participants will 
view a ``debrief'' screen containing information about the risks of 
ENDS and references to FDA and others' ENDS education and prevention 
campaigns.
    The Johns Hopkins Bloomberg School of Public Health's Institutional 
Review Board reviewed and approved this study. We amended our 
recruitment process to further address this concern. We will also 
recruit youth aged 13-17 through their parent panelists (parents who 
are members of an existing online panel). Recruitment emails will be 
sent to parent panelists inviting them to have their child aged 13-17 
participate in the study. Parents who are interested in having their 
child participate can have their child click the survey link in the 
recruitment email. This means that youth will be recruited to 
participate through two ways. First, we will recruit current youth 
panel members. Second, we will recruit youth through their parent 
panelists (parents who are members of the existing online panel).
    (Comment 8) FDA received a comment expressing that the study does 
not provide data that would inform ``conclusions regarding the role of 
flavors in youth attractiveness'' and that the study does not 
distinguish between characterizing and noncharacterizing flavors.
    (Response) The objective of this study is to examine the effect of 
flavor advertising tactics on consumer product perceptions and 
intentions to use, not the effect of actual flavors and flavor use. 
Therefore, this comment is out of scope for the proposed study.
    (Comment 9) FDA received a comment inquiring about whether ``the 
survey will representatively sample/oversample for certain 
subpopulations--with a particular lens on race/ethnicity and other 
priority populations.''
    (Response) The current sample was designed with a primary focus of 
sampling adequate numbers of youth and young adults across a variety of 
cigarette and ENDS use statuses (noncigarette and non-ENDS users; 
cigarette users only; ENDS users only; dual ENDS and cigarette users), 
and we are not able to do additional oversampling given that some of 
these groups are of low frequency in the

[[Page 9069]]

general population. However, we will be able to identify how our sample 
compares to national data, and our data will be weighted to be 
proportionally reflective of the U.S. population by race/ethnicity.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
     Participant subgroup          Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
                                        No. to read the survey invitation
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Youth (aged 13-17)............         125,000               1         125,000  0.016 (1 minute)           2,084
Young adults (aged 18-24).....         125,000               1         125,000  0.016 (1 minute)           2,084
                               ---------------------------------------------------------------------------------
    Total.....................         250,000  ..............  ..............  ................           4,168
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                                    No. to complete the consent and screener
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Youth (aged 13-17)............           3,750               1           3,750  0.116 (7                     438
                                                                                 minutes).
Young adults (aged 18-24).....           3,750               1           3,750  0.116 (7                     438
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
    Total.....................           7,500  ..............  ..............  ................             876
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                                           No. to complete main study
----------------------------------------------------------------------------------------------------------------
Youth (aged 13-17)............           2,500               1           2,500  0.333 (20                    834
                                                                                 minutes).
Young adults (aged 18-24).....           2,500               1           2,500  0.333 (20                    834
                                                                                 minutes).
                               ---------------------------------------------------------------------------------
        Total.................           5,000  ..............  ..............  ................           1,668
                               =================================================================================
Total.........................  ..............  ..............  ..............  ................           6,712
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA's burden estimate is based on prior experience with research 
that is similar to this proposed study (OMB control number 0910-0848). 
Applying assumptions from previous experience in conducting similar 
studies, approximately 250,000 respondents from an internet panel will 
be recruited via an email invitation, which is estimated to take 1 
minute to read and respond. An estimated 7,500 (3,750 youth and 3,750 
young adults) respondents will provide assent and consent and be 
screened to yield the desired sample size of 5,000 total (2,500 youth 
and 2,500 young adults) participants. The consent/screening process is 
estimated to take an average of 7 minutes per respondent. Participants 
that qualify for the study will be automatically directed to begin the 
online survey, which is estimated to take an average of 20 minutes per 
respondent.
    The total estimated burden for the data collection is 6,712 hours.

    Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03387 Filed 2-16-22; 8:45 am]
BILLING CODE 4164-01-P


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