Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Study of Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages

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Published

November 22, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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 youth and young adults process tobacco education messaging and to identify effective tobacco prevention and education message strategies.

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<title>Federal Register, Volume 87 Issue 224 (Tuesday, November 22, 2022)</title>
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[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Pages 71335-71338]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25406]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2657]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Food and Drug Administration's Study of Assessing
Physiological, Neural and Self-Reported Response to Tobacco Education
Messages

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on FDA's investigation of how youth and young adults
process tobacco education messaging and to identify effective tobacco
prevention and education message strategies.

DATES: Either electronic or written comments on the collection of
information must be submitted by January 23, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 23, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.

Electronic Submissions

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

[[Page 71336]]

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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-N-2657 for ``Food and Drug Administration's Study of Assessing
Physiological, Neural and Self-Reported Response to Tobacco Education
Messages.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#0e5e5c4f5d7a6f68684e686a6f2066667d20696178"><span class="__cf_email__" data-cfemail="134341524067727575537577723d7b7b603d747c65">[email&#160;protected]</span></a>.

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

Food and Drug Administration's Study of Assessing Physiological, Neural
and Self-Reported Response to Tobacco Education Messages

OMB Control Number 0910-NEW

On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act granted FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products; to
inform the public on health-related issues; and to protect public
health by reducing tobacco use and by preventing death and disease
caused by tobacco use.
FDA's Center for Tobacco Products (CTP) was created to carry out
the authorities granted under the Tobacco Control Act, to educate the
public about the dangers of tobacco use and serve as a public health
resource for tobacco and health information. Through CTP, FDA
researches, develops, and distributes information about tobacco and
health to the public, professionals, various branches of government,
and other interested groups nationwide using a wide array of formats
and media channels. FDA's ``The Real Cost'' campaign (<a href="https://www.fda.gov/tobacco-products/public-health-education-campaigns/real-cost-campaign">https://www.fda.gov/tobacco-products/public-health-education-campaigns/real-cost-campaign</a>) uses evidence-based paid media advertising to highlight
the negative health consequences of tobacco use. To develop the
appropriate messaging to inform the public, it is important for FDA to
conduct research to assess youth and young adults' perceptions of
tobacco use prevention messaging.
The study of ``Assessing Physiological, Neural and Self-Reported
Response to Tobacco Education Messages'' is voluntary research.
Information obtained through this study will primarily be used to
assess the performance of ads developed to reduce tobacco initiation
and use among at-risk youth and young adults as part of CTP's ``The
Real Cost'' campaign. Traditionally, message testing research employs
self-reported measures of perceived effectiveness (e.g., an
individual's perception that the ad would make one less likely to use
tobacco), but research indicates that while these self-reported
measures are useful, they may be imperfect proxies for real world
knowledge, attitude, and behavior change. This imprecision

[[Page 71337]]

could lead message developers to select less than optimal messages or
cost-ineffective strategies for widespread dissemination.
Physiological and neural responses to tobacco education messages
offer an innovative and useful supplement to traditional self-report
measures. Indicators such as heart rate variability, galvanic skin
response, and facial electromyography can assess arousal and affective
response to messages, while tools such as eye tracking and neuroimaging
can measure attention and levels of activation in key areas in the
brain associated with message processing and message acceptance.
Research indicates that these techniques can be more effective than
self-report measures at predicting ``real world'' tobacco education
message effectiveness.
There is a need for research that implements these techniques to
identify the most effective tobacco prevention and education message
strategies. Additionally, there is a need to triangulate data collected
through physiological and neuroimaging-based approaches with self-
reported measures to better understand how self-reported measures can
be implemented in order to accurately predict knowledge, attitude, and
behavior change.
This study will recruit participants from the Baltimore, Maryland
area to participate in an in-person study visit at Johns Hopkins
University Bloomberg School of Public Health. Inclusion and exclusion
criteria are based on the target populations for ``The Real Cost''
campaign. Specifically, the study will collect data from two groups: 50
youth (aged 13-17) and 50 young adults (aged 18-24 years old).
Participants will be stratified by electronic nicotine delivery systems
and cigarette use, so that approximately half of each sample will be:
(1) at risk for initiating a tobacco product (i.e., think they might
try one in the near future or would try one if a friend offered it to
them) or (2) tobacco experimenter (have had at least 1 but less than
100 cigarettes in their lifetime; have had at least 1 puff of an e-
cigarette). Individuals who respond that they have never used tobacco
products and respond ``definitely not'' to all questions assessing
openness to tobacco use will be excluded from participation.
Additionally, those who have established tobacco use patterns will be
excluded from participation. Both groups are outside the target
demographic for ``The Real Cost'' campaign.
The study will use community-based recruiting, using methods such
as flyers posted at locations frequented by young adults, teenagers,
and their parents (e.g., local Baltimore City colleges, markets, and
other relevant venues), social media, and word-of-mouth. Flyers will be
posted with permission and advertise the study as assessing perceptions
of tobacco education messages using monitors placed on the head, face,
and fingers; special glasses; and a survey. Participants will be
directed to complete an online screening survey before scheduling their
study visit.
For youth participants, eligible participants will provide contact
information for their parent/guardian. The study team will then contact
the parent and receive parental permission and schedule a study visit.
At the study visit, study personnel will confirm that 13-15-year-olds
are accompanied by someone 18 or older, and then the youth will provide
assent. For young adult participants, after completing the screener,
eligible participants will provide their contact information. The study
team will then contact the participant and schedule a study visit. At
the study visit, young adult participants will provide informed consent
prior to beginning study participation.
After the consenting/assenting process, participants will complete
one study visit (90 minutes long) in which they will view four FDA
tobacco education and prevention ads. First, participants will complete
a survey and be fitted with neuroimaging and psychophysiological
equipment. Second, participants will be fitted for a functional near-
infrared spectroscopy (fNIRS) headband (the headband can be adjusted
based on head circumference) and then have the fNIRS headband and
electrodes for physiological data collection, and eye-tracking glasses
placed on them. They will then complete a series of computer tasks to
ensure placement of the fNIRS headband and fill out part one of the
survey on demographic characteristics, tobacco use behaviors, and
social influence related to tobacco use. Next, they will view tobacco
education messages, and complete part two of the survey providing self-
reported response data (e.g., how much they liked the ad) after each
message. Participants will conclude the survey by completing the third
part of the survey assessing psychosocial variables. Participants will
receive a small incentive as a token of appreciation in exchange for
their survey participation. Additionally, for youth (ages 13-15)
participants, the adult who accompanies the youth will receive a token
of appreciation in exchange for costs of accompanying the youth to the
study site (e.g., parking, gas, and potential loss of income/childcare
needed for youth to participate).
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 \1\
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Number to take the eligibility screener
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Youth (aged 13-17)....................... 150 1 150 0.083 (5 minutes)............................ 13
Young adults (aged 18-24)................ 150 1 150 0.083 (5 minutes)............................ 13
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Total................................ .............. .............. .............. ............................................. 26
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Number to obtain parental permission process (for parents of youth only) and schedule site visit
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Parents of youth participants............ 75 1 75 0.167 (10 minutes)........................... 13
Young adults (aged 18-24)................ 50 1 50 0.083 (5 minutes)............................ 4
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Total................................ .............. .............. .............. ............................................. 17
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[[Page 71338]]

Number to complete consent (5 min) and main study (85 min)
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Youth (aged 13-17)....................... 50 1 50 1.5.......................................... 75
Young adults (aged 18-24)................ 50 1 50 1.5.......................................... 75
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Total................................ .............. .............. .............. ............................................. 150
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Total............................ .............. .............. .............. ............................................. 193
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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. Applying assumptions from
previous experience in conducting similar studies, approximately 150
youth and 150 young adults would take the eligibility screener, which
is estimated to take 5 minutes to read and respond. An estimated 75
parents of youth participants will provide parental permission and
schedule a site visit (10 minutes total); and an estimated 50 young
adults will schedule a site visit (5 minutes). Finally, approximately
50 youth and 50 young adults will complete an in-person study visit
that consists of the consent/assent (5 minutes) and complete the main
study (85 minutes) to yield the desired sample size of 100 total. The
total estimated burden for the data collection is 193 hours. Table 1
details these estimates.

Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25406 Filed 11-21-22; 8:45 am]
BILLING CODE 4164-01-P

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