Notice2022-03387
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)
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Published
February 17, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
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<title>Federal Register, Volume 87 Issue 33 (Thursday, February 17, 2022)</title>
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[Federal Register Volume 87, Number 33 (Thursday, February 17, 2022)]
[Notices]
[Pages 9067-9069]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-03387]
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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\ <a href="https://www.fda.gov/tobacco-products/research/research-priorities">https://www.fda.gov/tobacco-products/research/research-priorities</a>.
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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
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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\
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Number of
Participant subgroup Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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
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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).
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Total..................... 7,500 .............. .............. ................ 876
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No. to complete main study
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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).
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Total................. 5,000 .............. .............. ................ 1,668
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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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