[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12468-12470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on FDA's investigation of how consumers use flavors 
to make inferences about Electronic Nicotine Delivery System (ENDS) 
product qualities and intentions to use.

DATES: Submit either electronic or written comments on the collection 
of information by May 3, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 3, 2021. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://

[[Page 12469]]

www.regulations.gov will be posted to the docket unchanged. Because 
your comment will be made public, you are solely responsible for 
ensuring that your comment does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your comments, 
that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0132 for ``Food and Drug Administration's Investigation of 
How Consumers Use Flavors to Make Inferences About Electronic Nicotine 
Delivery System (ENDS) Product Qualities and Intentions to Use (Phase 
2).'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
<a href="/cdn-cgi/l/email-protection#3c6c6e7d6f485d5a5a7c5a585d1254544f125b534a"><span class="__cf_email__" data-cfemail="421210031136232424022426236c2a2a316c252d34">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (e.g., ``Heliomilk'', ``Sungrazer''). 
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

[[Page 12470]]

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) non-cigarette 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. Findings from this study will inform 
FDA rulemaking regarding the marketing and presence of flavor features 
in ENDS and be used to guide other public health agencies' policies and 
messaging regarding the role of flavors in ENDS.
    Study Overview: In this study, youth non-cigarette and non-ENDS 
users, current cigarette smokers, ENDS only users, and dual users of 
ENDS and cigarettes, as well as young adult non-cigarette 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. All recruited 
participants must complete a double opt-in procedure, and parents of 
youth participants must consent for their child to be on the panel. 
Youth will provide assent and young adults will provide consent to 
participate in the surveys. Per institutional review board approval, 
parental consent has been waived and will not be required for youth to 
participate in this study. The survey platform can detect and prevent 
duplicate responses by scanning for duplicate cookies and internet 
protocol (IP) addresses. Participants will receive a small incentive as 
a token of appreciation in exchange for their survey participation.
    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.
    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).
    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 per response           Total hours
                                                respondents     respondent       responses
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                                                          Number 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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                                                       Number to complete the consent and screener
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Youth (aged 13-17)..........................           3,750               1           3,750  0.116 (7 minutes).........................             438
Young adults (aged 18-24)...................           3,750               1           3,750  0.116 (7 minutes).........................             438
    Total...................................           7,500  ..............  ..............  ..........................................             876
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                                                              Number to complete main study
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Youth (aged 13-17)..........................           2,500               1           2,500  0.333 (20 minutes)........................             834
Young adults (aged 18-24)...................           2,500               1           2,500  0.333 (20 minutes)........................             834
    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 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04372 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P


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