[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Pages 71335-71338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
[email protected].

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

Food and Drug Administration's Study of 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

[[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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                                               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 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


