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), 9067-9069 [2022-03387]
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Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices
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.
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, PRAStaff@
fda.hhs.gov.
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)
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:23 Feb 16, 2022
Jkt 256001
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
Flavors are a unique and important
aspect of ENDS. ENDS use a liquid (‘‘eliquid’’ or ‘‘e-juice’’) that can span a
diverse range of flavors, from tobacco
flavor, menthol, mint, fruit flavors, nonfruit sweet flavors (e.g., cre`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
1 https://www.fda.gov/tobacco-products/research/
research-priorities.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
9067
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 peerreviewed 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
E:\FR\FM\17FEN1.SGM
17FEN1
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9068
Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices
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 PRArelated.
(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
VerDate Sep<11>2014
17:23 Feb 16, 2022
Jkt 256001
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 flavorrelated 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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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
E:\FR\FM\17FEN1.SGM
17FEN1
Federal Register / Vol. 87, No. 33 / Thursday, February 17, 2022 / Notices
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.
9069
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Participant subgroup
Total annual
responses
Average burden per response
Total hours
No. to read the survey invitation
Youth (aged 13–17) ..........................
Young adults (aged 18–24) ..............
125,000
125,000
1
1
125,000
125,000
0.016 (1 minute) ...............................
0.016 (1 minute) ...............................
2,084
2,084
Total ...........................................
250,000
........................
........................
...........................................................
4,168
No. to complete the consent and screener
Youth (aged 13–17) ..........................
Young adults (aged 18–24) ..............
3,750
3,750
1
1
3,750
3,750
0.116 (7 minutes) .............................
0.116 (7 minutes) .............................
438
438
Total ...........................................
7,500
........................
........................
...........................................................
876
No. to complete main study
Youth (aged 13–17) ..........................
Young adults (aged 18–24) ..............
2,500
2,500
1
1
2,500
2,500
0.333 (20 minutes) ...........................
0.333 (20 minutes) ...........................
834
834
Total ....................................
5,000
........................
........................
...........................................................
1,668
Total ..................................................
........................
........................
........................
...........................................................
6,712
lotter on DSK11XQN23PROD with NOTICES1
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 10, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2022–03387 Filed 2–16–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
17:23 Feb 16, 2022
Jkt 256001
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
Section 2112(b)(2) of the Public Health
Service (PHS) Act, as amended. While
the Secretary of HHS is named as the
respondent in all proceedings brought
by the filing of petitions for
compensation under the Program, the
United States Court of Federal Claims is
charged by statute with responsibility
for considering and acting upon the
petitions.
SUMMARY:
For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
SUPPLEMENTARY INFORMATION:
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
[email protected].
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\
---------------------------------------------------------------------------
\1\ https://www.fda.gov/tobacco-products/research/research-priorities.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
No. to complete the consent and screener
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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
