Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke, 30721-30724 [2019-13758]
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Federal Register / Vol. 84, No. 124 / Thursday, June 27, 2019 / Notices
before, manufacturers who submit
510(k)s and receive marketing clearance
will continue to be exempt from the
Electronic Product Radiation Control
reporting requirements in 21 CFR
1002.12, for diagnostic ultrasound
devices, as described in the notice to
industry entitled ‘‘Exemption from
Reporting under 21 CFR 1002’’ dated
February 24, 1986.1
FDA considered comments received
on the draft guidance that appeared in
the Federal Register of October 2, 2017
(82 FR 45856). FDA revised the
guidance as appropriate in response to
the comments.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on information for
manufacturers seeking marketing
clearance of diagnostic ultrasound
systems and transducers. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/medical-devices/
device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This
guidance document is also available at
IV. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following:
OMB control
No.
21 CFR part or guidance
Topic
807, subpart E ............................................................................
801 ..............................................................................................
820 ..............................................................................................
Premarket Notification ................................................................
Medical Device Labeling Regulations ........................................
Current Good Manufacturing Practice (CGMP); Quality System
(QS) Regulation.
Reporting and Recordkeeping for Electronic Products—General Requirements.
Premarket Approval of Medical Devices ....................................
De Novo Classification Process (Evaluation of Automatic
Class III Designation).
Q-submissions ............................................................................
1002 and 1010 ...........................................................................
814, subpart A–E ........................................................................
513(f)(2) FD&C Act .....................................................................
‘‘Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug
Administration Staff’’.
Dated: June 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13687 Filed 6–26–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0075]
jspears on DSK30JT082PROD with NOTICES
https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 560 to
identify the guidance you are
requesting.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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: Fax written comments on the
collection of information by July 29,
2019.
SUMMARY:
HHS.
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Experimental Study on Measuring
Consumer Comprehension of Displays
of Harmful and Potentially Harmful
1 Available at https://www.fda.gov/downloads/
Radiation-EmittingProducts/RadiationEmitting
ProductsandProcedures/MedicalImaging/
UCM509874.pdf.
ADDRESSES:
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Experimental
Study on Measuring Consumer
Comprehension of Displays of Harmful
and Potentially Harmful Constituents
in Tobacco Products and Tobacco
Smoke
AGENCY:
Food and Drug Administration,
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0910–0120
0910–0485
0910–0073
0910–0025
0910–0231
0910–0844
0910–0756
Constituents in Tobacco Products and
Tobacco Smoke.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Experimental Study on Measuring
Consumer Comprehension of Displays
of Harmful and Potentially Harmful
Constituents in Tobacco Products and
Tobacco Smoke OMB Control Number
0910–NEW
SUPPLEMENTARY INFORMATION:
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I. Background
On June 22, 2009, the Family
Smoking Prevention and Tobacco
Control Act (Pub. L. 111–31) (Tobacco
Control Act) was signed into law. This
law amended the Federal Food, Drug,
and Cosmetic Act (FD&C Act) and
granted FDA the authority to regulate
the manufacture, marketing, and
distribution of cigarettes, cigarette
tobacco, roll-your-own tobacco, and
smokeless tobacco products to protect
the public health and to reduce tobacco
use by minors. The Tobacco Control Act
also gave FDA the authority to issue
regulations deeming other products that
meet the statutory definition of a
tobacco product to be subject to chapter
IX of the FD&C Act (section 901(b) of
the FD&C Act (21 U.S.C. 387a(b))).
In accordance with that authority, on
May 10, 2016 (81 FR 28974), FDA
issued a final rule deeming all products
that meet the statutory definition of
tobacco product, except accessories of
newly deemed tobacco products, to be
subject to FDA’s tobacco product
authority. The deemed products include
electronic nicotine delivery systems,
cigars, waterpipe (hookah), pipe
tobacco, nicotine gels, dissolvables that
were not already subject to the FD&C
Act, and other tobacco products that
may be developed in the future.
Among other requirements, section
904(e) of the FD&C Act (21 U.S.C.
387d(e)) requires FDA to establish, and
periodically revise as appropriate, a list
of harmful and potentially harmful
constituents (HPHCs), including smoke
constituents, to health in each tobacco
product by brand and by quantity in
each brand and subbrand. Section
904(d)(1) of the FD&C Act further
requires that this list be published in a
format that is understandable and not
misleading to a lay person (the Section
904(d) list).
FDA has undertaken a rigorous
science-based research approach to
ensure that the Section 904(d) list is not
misleading to lay persons. As part of
this research, FDA is seeking to conduct
an experimental/quantitative study
(4,500 online surveys), consisting of
adult and youth (aged 13 to17)
participants to evaluate the best way to
convey information about HPHCs in
tobacco products and tobacco smoke, by
brand and by quantity in each brand
and subbrand, in a format that is
understandable and not misleading to a
lay person. Participants will view
sample formats and complete an online
survey that will include questions
regarding their understanding of the
HPHC information presented to them.
The purpose of the research is to gain
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insight on consumer comprehension of,
and preferences regarding, HPHC
presentations that will inform the
Agency’s efforts in connection with
publishing the Section 904(d) list.
In the Federal Register of February
11, 2019 (84 FR 3188), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. FDA received comments
from six individuals or organizations,
three of which were PRA related.
(Comment) One comment
recommended that FDA make the study
design, sample formats, and all study
measures available for public comment.
(Response) FDA notes that the study
protocol, list formats, and the survey
questionnaire are available for review
upon request and are described in detail
as part of the overall information
collection request submitted to OMB for
review.
(Comment) One comment suggested
that FDA add a control group that does
not view a sample format to our study
design.
(Response) FDA considered the utility
of adding a no-exposure control group
to this study. However, FDA determined
that this is not in line with the study
aims. The aims of the study are derived
from section 904(e) of the FD&C Act
which requires FDA to publish a list of
HPHCs in each brand and sub-brand of
tobacco product, in a way that people
find understandable and not misleading.
Therefore, the proposed study will test
different formats of HPHC lists to meet
this statutory requirement. A condition
in which people do not see a list of
HPHCs in a tobacco product does not
approximate real-life conditions.
(Comment) One comment suggested
that FDA should clarify whether the
HPHC sample formats will include
smokeless brands since items in the
draft survey are exclusive to cigarettes.
The comment also noted that FDA
should clarify whether smokeless
tobacco and exclusive cigarette users
will only view HPHC lists in their
respective categories.
(Response) HPHC sample formats will
not include smokeless brands because
HPHC lists for cigarettes are the focus of
the proposed study. All participants
will view HPHC lists for cigarettes only
to allow for a parsimonious and focused
design that is adequately powered to
detect effects.
(Comment) One comment suggested
that FDA should use validated survey
measures, establish the validity of other
metrics prior to use, and consider using
validated risk perception metrics.
(Response) FDA agrees that validated
items should be used whenever
possible. FDA engaged in a multistep
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process to select validated survey items
for this study. First, FDA conducted a
literature review and used available
validated survey measures, including
measures from past HPHC research (Ref.
1). However, for some outcomes (e.g.,
knowledge about the tested format),
validated measures do not exist because
questions are specific to the stimuli.
Second, FDA conducted qualitative
research to inform our measures. Based
on insights uncovered during this
research, we created and modified
survey items. Third, FDA conducted
cognitive testing to refine the measures.
It should be noted that there are many
ways to measure these constructs,
including harm perceptions. The harm
perceptions items that FDA used are
based on a systematic review that
identified the most commonly measured
tobacco-related health consequences in
the literature (Ref. 2).
(Comment) One comment suggested
that FDA should get end-user input into
the development and refinement of the
survey items. The comment suggested
that survey items should be subject to
cognitive testing, with individuals
representing end users until the point of
saturation is reached.
(Response) FDA agrees that it is
important to test a survey before
collecting responses. As part of the
research program, FDA conducted 54
indepth interviews, ‘‘Consumer
Comprehension of Displays of Harmful
and Potentially Harmful Constituents
(HPHCs) in Tobacco Products’’ (OMB
control number 0910–0796), as a first
step to develop items. Based on the
findings from that study and a literature
review to uncover validated measures,
FDA developed a draft survey. Next,
FDA cognitively tested the draft survey
and stimuli and refined each by
reducing redundant content and editing
any confusing items. FDA reached
saturation in both qualitative studies.
(Comment) One comment suggested
that including a midpoint on some of
the scales (e.g. ‘‘neutral’’ and ‘‘neither
agree nor disagree’’) may be difficult for
some respondents to understand. The
comment suggested that FDA
incorporate a ‘‘don’t know’’ response
option for some items including the
HPHC general knowledge questions.
(Response) The inclusion of a ‘‘don’t
know’’ response on the knowledge items
was made in order to best match the
source of those items (Refs. 1 and 3).
That is, FDA included a ‘‘don’t know’’
option when the source item did so.
Although it is true that individuals
interpret middle options like ‘‘neutral’’
in different ways, these personal
interpretations should be randomly
distributed across condition and thus
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not affect the comparisons among the
stimuli (Ref. 4).
(Comment) One comment
recommended that FDA ask several of
the post-test items (e.g., items 33, 34, 38)
during the pre-test so that we can obtain
a baseline estimate of misperceptions
and determine whether there was any
change in respondents’ incorrect beliefs
following exposure to the stimulus.
(Response) The primary purpose of
this study is to test formats to see if they
are understandable and not misleading.
This can be achieved by comparing
post-test measures of understanding and
misleading across conditions and does
not require a pre-test. We note that
participants may have baseline
misperceptions that are not accounted
for in this design; however, since we are
collecting data from a representative
sample of people, we can account for
these differences during the analysis.
Further, as these items are part of a
validated scale if FDA selects only a few
items to ask in the pre-test, this may
lead to data that is not reliable or valid.
As these items are part of a larger scale
that has been used and tested in
previous research, only selecting a few
questions may alter how participants
respond to these and other questions in
the survey. Also, these items have not
been tested to be used alone.
(Comment) One comment suggested
that FDA add an attention check and
measures of believability, truthfulness,
or skepticism to provide additional
context for the study results.
(Response) The knowledge items in
the survey are inherently an attention
check because the participant can use
the information in the stimulus to
answer questions. Adding an attention
check will not provide any additional
benefit. Adding additional measures
about believability, truthfulness, or
skepticism are outside of the scope and
purpose of this study.
(Comment) One comment suggested
that FDA oversample vulnerable
populations including youth,
minorities, and those with low levels of
education in our survey. An additional
comment commended FDA for
including youth aged 13 to 17 in this
study as it is critically important
because most tobacco consumers begin
using tobacco before the age of 18.
Further, including youth in the sample
underscores FDA’s recognition that it is
possible to survey youth about the
comprehension of information about
tobacco without violating ethical
standards.
(Response) FDA agrees, we have
established quotas in the recruitment to
ensure that the sample is comprised of
at least 20 percent of low socioeconomic
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participants (income of less than
$25,000 year) and at least 20 percent of
adults without a high school diploma or
GED. These proportions are not
exclusive because low education and
low socioeconomic status are strongly
correlated. Further, the study sample
will include approximately 1,500
adolescent tobacco users and
adolescents at risk for using tobacco
(ages 13 to 17).
(Comment) One comment suggested
that FDA collect demographic
information pertaining to race/ethnicity,
age, and education level.
(Response) FDA agrees, we already
plan to collect this demographic
information as part of the screening
procedures.
(Comment) One comment suggested
that FDA ask participants where they
would look for information about
tobacco constituents.
(Response) FDA appreciates the
suggestion. As previously mentioned in
our comment responses FDA conducted
54 indepth interviews where this was
assessed. There is also an item on the
survey that asks, ‘‘Where would you
most like to see information on
chemicals in cigarettes and cigarette
smoke?’’ The response options are ‘‘on
cigarette packs,’’ ‘‘in stores,’’ and
‘‘online.’’ Between this item and the
indepth interviews FDA conducted, this
will provide FDA with adequate
information on where participants
would look for information about
tobacco constituents.
(Comment) One comment suggested
that FDA add ‘‘to the best of your
knowledge’’ at the beginning of
questions 6 through 10.
(Response) FDA does not believe this
is necessary as these questions include
a ‘‘don’t know’’ response option.
Further, these questions were used in
previous research (Ref. 1).
(Comment) There were a few
comments about the ‘‘understanding’’
section of the survey. One comment
suggested that FDA add nicotine,
acetone, and carbon monoxide to this
section. Another comment suggested
that FDA expand the ‘‘Understanding’’
section to include a section on
addiction. The comment suggested that
the section list specific constituents and
ask participants if they cause addiction.
One comment suggested that FDA
modify the question that asks, ‘‘does
smoking cause addiction’’ and change it
to ‘‘does smoking cigarettes cause
addiction.’’
(Response) FDA appreciates these
suggestions. FDA declines to add
additional items or modify items in the
‘‘understanding’’ section as it is
consistent with prior research. Further,
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30723
these items were part of cognitive
testing and did not cause confusion.
Prior research deliberately selected two
chemicals that would be familiar to
respondents (ammonia and lead) and
three that would be unfamiliar (1aminonaphthalene, acrylonitrile, and
isoprene) (Ref. 1). Further, even though
there is not a specific question about the
link between certain chemicals and
addiction, FDA assesses participants’
understanding of whether smoking
causes addiction in items 11 to 24.
(Comment) There were two comments
that asked FDA to add additional items
measuring participants behavior. One
comment suggested that FDA should
add additional questions so that the
survey could also determine how likely
someone is to not only switch brands,
but also whether they are likely to quit
or switch to a different product. Another
comment suggested that FDA add
questions to the post-test to measure the
behavioral impacts of these formats
including cessation intentions.
(Response) Although measuring these
behavioral intentions and outcomes are
interesting, these questions are outside
the scope of this study. The focus of this
study is to assess whether displays of
HPHC information are understandable
and not misleading per the statutory
requirement.
(Comment) FDA received two
comments that supported the collection
of this information. One comment urged
FDA to move forward promptly with
this study.
(Response) FDA appreciates this
comment and intend to move forward
with the study promptly. We note that
data collection will occur within 2
months following OMB approval.
(Comment) One comment noted that
FDA was required to publish a list of
constituents in a format that is
understandable and not misleading to a
lay person by June 2012. However, no
such list has been published. The
comment also noted that it is important
for FDA to ensure that information is
disclosed in a way that is not
misleading.
(Response) FDA agrees that the
proposed study is important to help
FDA fulfill its statutory requirement.
FDA has undertaken an extensive
program of research to ensure that we
not only publish a list of constituents in
a manner that is understandable and not
misleading, but also avoid any
unintended consequences of such a list.
(Comment) One comment noted that
FDA should make it clear that
characterizations of information on the
list by tobacco product manufacturers in
advertising or promotional material are
subject to the requirements of the
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provisions of section 911 of the Tobacco
Control Act (21 U.S.C. 387k) regarding
modified risk claims.
(Response) Thank you for this
suggestion. However, this comment is
outside the scope of the present study
as it is about the implementation of the
public displays of HPHCs and not about
testing the display.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent
Total annual
responses
Average
burden per
response
Total hours
Youth Screener ....................................................................
Youth Survey .......................................................................
1,800
1,500
1
1
1,800
1,500
0.05
0.33
90
500
Total Youth Hours .........................................................
........................
........................
........................
........................
590
Adult Screener .....................................................................
Adult Survey .........................................................................
3,400
3,000
1
1
3,400
3,000
0.05
0.33
170
1,000
Total Adult Hours ..........................................................
........................
........................
........................
........................
1,170
Total Burden Hours ......................................................
........................
........................
........................
........................
1,760
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
For this study, potential participants
will be recruited by a market research
firm that maintains an internet panel,
and information will be collected
through self-administered, online
screening tests and surveys of youth
aged 13 to17 and adults aged 18 and
older. Approximately 5,200 respondents
(1,800 youth and 3,400 adults) will be
requested to complete a screening test to
determine eligibility for participation in
the study, estimated to take
approximately 3 minutes (0.05 hour) per
screening test, for a total of 260 hours
for screening activities. Respondents
who qualify for the study will be
directed to the survey. Approximately
4,500 participants (1,500 youth and
3,000 adults) will complete the survey,
estimated to take 20 minutes (0.33 hour)
per survey, for a total of 1,500 hours for
completion of both adult and adolescent
samples. The length of time to complete
the screening test and survey are based
on the research firm’s experience that
panel members answer approximately
2.5 questions per minute. This data
collection will take place one time in
2019. Thus, the total estimated burden
is estimated to be 1,760 hours.
II. References
jspears on DSK30JT082PROD with NOTICES
Number of
responses per
respondent
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852 and are available for viewing by
interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also
are available electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
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Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff.
1. Byron, M.J., A.J. Lazard, E. Peters, et al.
(2018). ‘‘Effective Formats for
Communicating Risks from Cigarette Smoke
Chemicals.’’ Tobacco Regulatory Science,
4(2), 16–29. doi:10.18001/TRS.4.2.2.
* 2. O’Brien, E.K., A. Persoskie, and J. Tam
(2019). ‘‘Multi-Item Measures of Tobacco
Health Perceptions: A Review,’’ American
Journal of Health Behavior, 43(2), 266–278.
doi:10.5993/AJHB.43.2.4.
3. Brewer, N.T., J.C. Morgan, S.A, Baig, et
al. (2017). ‘‘Public Understanding of Cigarette
Smoke Constituents: Three US Surveys.’’
Tobacco Control, 26(5), 592–599.
* 4. Nadler, J.T., R. Weston, and E.C.
Voyles (2015). ‘‘Stuck in the Middle: The Use
and Interpretation of Mid-Points in Items on
Questionnaires,’’ The Journal of General
Psychology, 142(2), 71–89.
Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–13758 Filed 6–26–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–3516]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Disease
Awareness and Prescription Drug
Promotion on Television
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00035
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The Food and Drug
Administration (FDA) 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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by July 29,
2019.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Disease Awareness and
Prescription Drug Promotion on
Television.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
ADDRESSES:
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. For copies of the
questionnaire contact: Office of
Prescription Drug Promotion (OPDP)
Research Team, DTCresearch@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 84, Number 124 (Thursday, June 27, 2019)]
[Notices]
[Pages 30721-30724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13758]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-0075]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study on
Measuring Consumer Comprehension of Displays of Harmful and Potentially
Harmful Constituents in Tobacco Products and Tobacco Smoke
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA 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: Fax written comments on the collection of information by July
29, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Experimental Study on Measuring Consumer Comprehension of
Displays of Harmful and Potentially Harmful Constituents in Tobacco
Products and Tobacco Smoke.'' Also include the FDA docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Experimental Study on Measuring Consumer Comprehension of Displays
of Harmful and Potentially Harmful Constituents in Tobacco Products and
Tobacco Smoke OMB Control Number 0910-NEW
[[Page 30722]]
I. Background
On June 22, 2009, the Family Smoking Prevention and Tobacco Control
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. This
law amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
granted FDA the authority to regulate the manufacture, marketing, and
distribution of cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco products to protect the public health and to
reduce tobacco use by minors. The Tobacco Control Act also gave FDA the
authority to issue regulations deeming other products that meet the
statutory definition of a tobacco product to be subject to chapter IX
of the FD&C Act (section 901(b) of the FD&C Act (21 U.S.C. 387a(b))).
In accordance with that authority, on May 10, 2016 (81 FR 28974),
FDA issued a final rule deeming all products that meet the statutory
definition of tobacco product, except accessories of newly deemed
tobacco products, to be subject to FDA's tobacco product authority. The
deemed products include electronic nicotine delivery systems, cigars,
waterpipe (hookah), pipe tobacco, nicotine gels, dissolvables that were
not already subject to the FD&C Act, and other tobacco products that
may be developed in the future.
Among other requirements, section 904(e) of the FD&C Act (21 U.S.C.
387d(e)) requires FDA to establish, and periodically revise as
appropriate, a list of harmful and potentially harmful constituents
(HPHCs), including smoke constituents, to health in each tobacco
product by brand and by quantity in each brand and subbrand. Section
904(d)(1) of the FD&C Act further requires that this list be published
in a format that is understandable and not misleading to a lay person
(the Section 904(d) list).
FDA has undertaken a rigorous science-based research approach to
ensure that the Section 904(d) list is not misleading to lay persons.
As part of this research, FDA is seeking to conduct an experimental/
quantitative study (4,500 online surveys), consisting of adult and
youth (aged 13 to17) participants to evaluate the best way to convey
information about HPHCs in tobacco products and tobacco smoke, by brand
and by quantity in each brand and subbrand, in a format that is
understandable and not misleading to a lay person. Participants will
view sample formats and complete an online survey that will include
questions regarding their understanding of the HPHC information
presented to them. The purpose of the research is to gain insight on
consumer comprehension of, and preferences regarding, HPHC
presentations that will inform the Agency's efforts in connection with
publishing the Section 904(d) list.
In the Federal Register of February 11, 2019 (84 FR 3188), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received comments from six individuals
or organizations, three of which were PRA related.
(Comment) One comment recommended that FDA make the study design,
sample formats, and all study measures available for public comment.
(Response) FDA notes that the study protocol, list formats, and the
survey questionnaire are available for review upon request and are
described in detail as part of the overall information collection
request submitted to OMB for review.
(Comment) One comment suggested that FDA add a control group that
does not view a sample format to our study design.
(Response) FDA considered the utility of adding a no-exposure
control group to this study. However, FDA determined that this is not
in line with the study aims. The aims of the study are derived from
section 904(e) of the FD&C Act which requires FDA to publish a list of
HPHCs in each brand and sub-brand of tobacco product, in a way that
people find understandable and not misleading. Therefore, the proposed
study will test different formats of HPHC lists to meet this statutory
requirement. A condition in which people do not see a list of HPHCs in
a tobacco product does not approximate real-life conditions.
(Comment) One comment suggested that FDA should clarify whether the
HPHC sample formats will include smokeless brands since items in the
draft survey are exclusive to cigarettes. The comment also noted that
FDA should clarify whether smokeless tobacco and exclusive cigarette
users will only view HPHC lists in their respective categories.
(Response) HPHC sample formats will not include smokeless brands
because HPHC lists for cigarettes are the focus of the proposed study.
All participants will view HPHC lists for cigarettes only to allow for
a parsimonious and focused design that is adequately powered to detect
effects.
(Comment) One comment suggested that FDA should use validated
survey measures, establish the validity of other metrics prior to use,
and consider using validated risk perception metrics.
(Response) FDA agrees that validated items should be used whenever
possible. FDA engaged in a multistep process to select validated survey
items for this study. First, FDA conducted a literature review and used
available validated survey measures, including measures from past HPHC
research (Ref. 1). However, for some outcomes (e.g., knowledge about
the tested format), validated measures do not exist because questions
are specific to the stimuli. Second, FDA conducted qualitative research
to inform our measures. Based on insights uncovered during this
research, we created and modified survey items. Third, FDA conducted
cognitive testing to refine the measures. It should be noted that there
are many ways to measure these constructs, including harm perceptions.
The harm perceptions items that FDA used are based on a systematic
review that identified the most commonly measured tobacco-related
health consequences in the literature (Ref. 2).
(Comment) One comment suggested that FDA should get end-user input
into the development and refinement of the survey items. The comment
suggested that survey items should be subject to cognitive testing,
with individuals representing end users until the point of saturation
is reached.
(Response) FDA agrees that it is important to test a survey before
collecting responses. As part of the research program, FDA conducted 54
indepth interviews, ``Consumer Comprehension of Displays of Harmful and
Potentially Harmful Constituents (HPHCs) in Tobacco Products'' (OMB
control number 0910-0796), as a first step to develop items. Based on
the findings from that study and a literature review to uncover
validated measures, FDA developed a draft survey. Next, FDA cognitively
tested the draft survey and stimuli and refined each by reducing
redundant content and editing any confusing items. FDA reached
saturation in both qualitative studies.
(Comment) One comment suggested that including a midpoint on some
of the scales (e.g. ``neutral'' and ``neither agree nor disagree'') may
be difficult for some respondents to understand. The comment suggested
that FDA incorporate a ``don't know'' response option for some items
including the HPHC general knowledge questions.
(Response) The inclusion of a ``don't know'' response on the
knowledge items was made in order to best match the source of those
items (Refs. 1 and 3). That is, FDA included a ``don't know'' option
when the source item did so. Although it is true that individuals
interpret middle options like ``neutral'' in different ways, these
personal interpretations should be randomly distributed across
condition and thus
[[Page 30723]]
not affect the comparisons among the stimuli (Ref. 4).
(Comment) One comment recommended that FDA ask several of the post-
test items (e.g., items 33, 34, 38) during the pre-test so that we can
obtain a baseline estimate of misperceptions and determine whether
there was any change in respondents' incorrect beliefs following
exposure to the stimulus.
(Response) The primary purpose of this study is to test formats to
see if they are understandable and not misleading. This can be achieved
by comparing post-test measures of understanding and misleading across
conditions and does not require a pre-test. We note that participants
may have baseline misperceptions that are not accounted for in this
design; however, since we are collecting data from a representative
sample of people, we can account for these differences during the
analysis. Further, as these items are part of a validated scale if FDA
selects only a few items to ask in the pre-test, this may lead to data
that is not reliable or valid. As these items are part of a larger
scale that has been used and tested in previous research, only
selecting a few questions may alter how participants respond to these
and other questions in the survey. Also, these items have not been
tested to be used alone.
(Comment) One comment suggested that FDA add an attention check and
measures of believability, truthfulness, or skepticism to provide
additional context for the study results.
(Response) The knowledge items in the survey are inherently an
attention check because the participant can use the information in the
stimulus to answer questions. Adding an attention check will not
provide any additional benefit. Adding additional measures about
believability, truthfulness, or skepticism are outside of the scope and
purpose of this study.
(Comment) One comment suggested that FDA oversample vulnerable
populations including youth, minorities, and those with low levels of
education in our survey. An additional comment commended FDA for
including youth aged 13 to 17 in this study as it is critically
important because most tobacco consumers begin using tobacco before the
age of 18. Further, including youth in the sample underscores FDA's
recognition that it is possible to survey youth about the comprehension
of information about tobacco without violating ethical standards.
(Response) FDA agrees, we have established quotas in the
recruitment to ensure that the sample is comprised of at least 20
percent of low socioeconomic participants (income of less than $25,000
year) and at least 20 percent of adults without a high school diploma
or GED. These proportions are not exclusive because low education and
low socioeconomic status are strongly correlated. Further, the study
sample will include approximately 1,500 adolescent tobacco users and
adolescents at risk for using tobacco (ages 13 to 17).
(Comment) One comment suggested that FDA collect demographic
information pertaining to race/ethnicity, age, and education level.
(Response) FDA agrees, we already plan to collect this demographic
information as part of the screening procedures.
(Comment) One comment suggested that FDA ask participants where
they would look for information about tobacco constituents.
(Response) FDA appreciates the suggestion. As previously mentioned
in our comment responses FDA conducted 54 indepth interviews where this
was assessed. There is also an item on the survey that asks, ``Where
would you most like to see information on chemicals in cigarettes and
cigarette smoke?'' The response options are ``on cigarette packs,''
``in stores,'' and ``online.'' Between this item and the indepth
interviews FDA conducted, this will provide FDA with adequate
information on where participants would look for information about
tobacco constituents.
(Comment) One comment suggested that FDA add ``to the best of your
knowledge'' at the beginning of questions 6 through 10.
(Response) FDA does not believe this is necessary as these
questions include a ``don't know'' response option. Further, these
questions were used in previous research (Ref. 1).
(Comment) There were a few comments about the ``understanding''
section of the survey. One comment suggested that FDA add nicotine,
acetone, and carbon monoxide to this section. Another comment suggested
that FDA expand the ``Understanding'' section to include a section on
addiction. The comment suggested that the section list specific
constituents and ask participants if they cause addiction. One comment
suggested that FDA modify the question that asks, ``does smoking cause
addiction'' and change it to ``does smoking cigarettes cause
addiction.''
(Response) FDA appreciates these suggestions. FDA declines to add
additional items or modify items in the ``understanding'' section as it
is consistent with prior research. Further, these items were part of
cognitive testing and did not cause confusion. Prior research
deliberately selected two chemicals that would be familiar to
respondents (ammonia and lead) and three that would be unfamiliar (1-
aminonaphthalene, acrylonitrile, and isoprene) (Ref. 1). Further, even
though there is not a specific question about the link between certain
chemicals and addiction, FDA assesses participants' understanding of
whether smoking causes addiction in items 11 to 24.
(Comment) There were two comments that asked FDA to add additional
items measuring participants behavior. One comment suggested that FDA
should add additional questions so that the survey could also determine
how likely someone is to not only switch brands, but also whether they
are likely to quit or switch to a different product. Another comment
suggested that FDA add questions to the post-test to measure the
behavioral impacts of these formats including cessation intentions.
(Response) Although measuring these behavioral intentions and
outcomes are interesting, these questions are outside the scope of this
study. The focus of this study is to assess whether displays of HPHC
information are understandable and not misleading per the statutory
requirement.
(Comment) FDA received two comments that supported the collection
of this information. One comment urged FDA to move forward promptly
with this study.
(Response) FDA appreciates this comment and intend to move forward
with the study promptly. We note that data collection will occur within
2 months following OMB approval.
(Comment) One comment noted that FDA was required to publish a list
of constituents in a format that is understandable and not misleading
to a lay person by June 2012. However, no such list has been published.
The comment also noted that it is important for FDA to ensure that
information is disclosed in a way that is not misleading.
(Response) FDA agrees that the proposed study is important to help
FDA fulfill its statutory requirement. FDA has undertaken an extensive
program of research to ensure that we not only publish a list of
constituents in a manner that is understandable and not misleading, but
also avoid any unintended consequences of such a list.
(Comment) One comment noted that FDA should make it clear that
characterizations of information on the list by tobacco product
manufacturers in advertising or promotional material are subject to the
requirements of the
[[Page 30724]]
provisions of section 911 of the Tobacco Control Act (21 U.S.C. 387k)
regarding modified risk claims.
(Response) Thank you for this suggestion. However, this comment is
outside the scope of the present study as it is about the
implementation of the public displays of HPHCs and not about testing
the display.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Youth Screener.................. 1,800 1 1,800 0.05 90
Youth Survey.................... 1,500 1 1,500 0.33 500
-------------------------------------------------------------------------------
Total Youth Hours........... .............. .............. .............. .............. 590
----------------------------------------------------------------------------------------------------------------
Adult Screener.................. 3,400 1 3,400 0.05 170
Adult Survey.................... 3,000 1 3,000 0.33 1,000
-------------------------------------------------------------------------------
Total Adult Hours........... .............. .............. .............. .............. 1,170
-------------------------------------------------------------------------------
Total Burden Hours.......... .............. .............. .............. .............. 1,760
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
For this study, potential participants will be recruited by a
market research firm that maintains an internet panel, and information
will be collected through self-administered, online screening tests and
surveys of youth aged 13 to17 and adults aged 18 and older.
Approximately 5,200 respondents (1,800 youth and 3,400 adults) will be
requested to complete a screening test to determine eligibility for
participation in the study, estimated to take approximately 3 minutes
(0.05 hour) per screening test, for a total of 260 hours for screening
activities. Respondents who qualify for the study will be directed to
the survey. Approximately 4,500 participants (1,500 youth and 3,000
adults) will complete the survey, estimated to take 20 minutes (0.33
hour) per survey, for a total of 1,500 hours for completion of both
adult and adolescent samples. The length of time to complete the
screening test and survey are based on the research firm's experience
that panel members answer approximately 2.5 questions per minute. This
data collection will take place one time in 2019. Thus, the total
estimated burden is estimated to be 1,760 hours.
II. References
The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 and
are available for viewing by interested persons between 9 a.m. and 4
p.m., Monday through Friday; they also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff.
1. Byron, M.J., A.J. Lazard, E. Peters, et al. (2018).
``Effective Formats for Communicating Risks from Cigarette Smoke
Chemicals.'' Tobacco Regulatory Science, 4(2), 16-29. doi:10.18001/
TRS.4.2.2.
* 2. O'Brien, E.K., A. Persoskie, and J. Tam (2019). ``Multi-
Item Measures of Tobacco Health Perceptions: A Review,'' American
Journal of Health Behavior, 43(2), 266-278. doi:10.5993/AJHB.43.2.4.
3. Brewer, N.T., J.C. Morgan, S.A, Baig, et al. (2017). ``Public
Understanding of Cigarette Smoke Constituents: Three US Surveys.''
Tobacco Control, 26(5), 592-599.
* 4. Nadler, J.T., R. Weston, and E.C. Voyles (2015). ``Stuck in
the Middle: The Use and Interpretation of Mid-Points in Items on
Questionnaires,'' The Journal of General Psychology, 142(2), 71-89.
Dated: June 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13758 Filed 6-26-19; 8:45 am]
BILLING CODE 4164-01-P
