Notice2023-08684
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
Primary source
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Published
April 25, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 79 (Tuesday, April 25, 2023)</title>
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[Federal Register Volume 88, Number 79 (Tuesday, April 25, 2023)]
[Notices]
[Pages 24994-24996]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#015153405275606767416765602f6969722f666e77"><span class="__cf_email__" data-cfemail="06565447557267606046606267286e6e7528616970">[email protected]</span></a>.
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 (<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 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
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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
[[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
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