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), 12468-12470 [2021-04372]
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12468
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
regulations enable a common
understanding of the regulatory process
by describing requirements to be
followed by drug manufacturers,
applicants, and FDA. Under part 211 (21
CFR part 211; see 21 CFR 211.94(e)(1)),
specific requirements for medical gas
containers and closures are also found
in the regulations. Finally, the
information collection also supports
regulations codified under parts 610 and
680 (21 CFR parts 610 and 680), which
reference certain CGMP regulations in
part 211 (see §§ 610.12(g), 610.13(a)(2),
610.18(d), 680.2(f), and 680.3(f)).
These regulations set forth
information collection requirements that
allow FDA to meet its public health
protection responsibilities. Products
that fail to comply with CGMP
requirements may be rendered
adulterated under section 501(a)(2)(B) of
the FD&C Act. To demonstrate that their
products comply with the requirements
of section 501(a)(2)(B), API
manufacturers must maintain CGMP
records; therefore, we have counted
them among respondents who incur
burden for the information collection. In
the table below, we have included an
additional 1,260 respondents to reflect
API manufacturers not included in our
previous submission for renewal.
To assist respondents with the
information collection requirements for
medical gases, we developed a draft
guidance for industry entitled ‘‘Current
Good Manufacturing Practice for
Medical Gases.’’ This guidance, when
finalized will discuss our
recommendations regarding compliance
with applicable requirements found in
the regulations as they apply to these
products. The guidance is available for
download from our internet site at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/current-goodmanufacturing-practice-medical-gases.
We believe the recommendations, if
followed, will help respondents focus
their information collection activities
most efficiently with regard to
demonstrating regulatory compliance.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN—APIS, FINISHED PHARMACEUTICALS, AND MEDICAL GASES 1 2
Section 501(a)(2)(B) of the FD&C
Act; parts 210 and 211
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per recordkeeping
Total hours
CGMP API Manufacturers ................
CGMP Finished Pharmaceuticals
Manufacturers (excludes medical
gases).
CGMP Medical Gases Manufacturers.
1,260
3,270
256
299
322,560
977,730
0.82 (49.2 minutes) ..........................
0.64 (38 minutes) .............................
264,499
625,747
2,284
280
639,520
0.62 (37 minutes) .............................
396,502
Total ...........................................
........................
........................
1,939,810
...........................................................
1,286,748
1 There
are no capital or operating and maintenance costs associated with the information collection.
and burden per activity have been averaged and rounded.
2 Records
Our estimated burden for the
information collection reflects an
overall decrease of 29,073 hours and
1,762 records annually for CGMP for
finished pharmaceutical manufacturers,
excluding those manufacturers of
medical gases. Our estimated burden for
the information collection also reflects
an overall decrease of 486 hours and
1,574 records annually for medical gas
manufacturers. Our inclusion of API
manufacturers in this collection
represents an addition of 264,499 hours
and 322,560 records prepared.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 25, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
AGENCY:
[FR Doc. 2021–04380 Filed 3–2–21; 8:45 am]
SUMMARY:
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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)
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
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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:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
E:\FR\FM\03MRN1.SGM
03MRN1
Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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.
• 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:
• 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.
• 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.
• 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
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17:29 Mar 02, 2021
Jkt 253001
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-201509-18/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, PRAStaff@fda.hhs.gov.
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
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12469
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
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 (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
1 https://www.fda.gov/tobacco-products/research/
research-priorities.
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Federal Register / Vol. 86, No. 40 / Wednesday, March 3, 2021 / Notices
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 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. 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
Number of
respondents
Participant subgroup
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
Number to read the survey invitation
Youth (aged 13–17) .................................................
Young adults (aged 18–24) .....................................
Total ..................................................................
125,000
125,000
250,000
1
1
........................
125,000
125,000
........................
0.016 (1 minute) ........
0.016 (1 minute) ........
....................................
2,084
2,084
4,168
0.116 (7 minutes) ......
0.116 (7 minutes) ......
....................................
438
438
876
Number to complete the consent and screener
Youth (aged 13–17) .................................................
Young adults (aged 18–24) .....................................
Total ..................................................................
3,750
3,750
7,500
1
1
........................
3,750
3,750
........................
Number to complete main study
Youth (aged 13–17) .................................................
Young adults (aged 18–24) .....................................
Total ..................................................................
2,500
2,500
5,000
1
1
........................
2,500
2,500
........................
0.333 (20 minutes) ....
0.333 (20 minutes) ....
....................................
834
834
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)
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Jkt 253001
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.
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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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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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.
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:
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.
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.
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,
[email protected].
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\
---------------------------------------------------------------------------
\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 (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
