[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24994-24996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08684]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by May 25, 2023.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The title of this 
information collection is ``Food and Drug Administration's Study of 
Assessing Physiological, Neural and Self-Reported Response to Tobacco 
Education Messages.'' Also include the FDA docket number found in 
brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Food and Drug Administration's Study of 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 (https://www.fda.gov/tobacco-products/public-health-education-campaigns/real-cost-campaign) 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 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

[[Page 24995]]

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).
    In the Federal Register of November 22, 2022 (87 FR 71335), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received that was not PRA 
related.
    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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                                               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
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  ..............  ..............  ..............  .............................................             150
                                          --------------------------------------------------------------------------------------------------------------
        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

[[Page 24996]]

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: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08684 Filed 4-24-23; 8:45 am]
BILLING CODE 4164-01-P