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, 71335-71338 [2022-25406]
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Chief Scientist, Food and Drug
Administration, 10903 New Hampshire
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MD 20993, 301–796–4769,
rakesh.raghuwanshi@fda.hhs.gov, or
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DATES:
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Notice of this meeting is given under
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Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–25405 Filed 11–21–22; 8:45 am]
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71335
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 SelfReported Response to Tobacco
Education Messages
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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
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Federal Register / Vol. 87, No. 224 / Tuesday, November 22, 2022 / Notices
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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
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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-201509-18/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, PRAStaff@fda.hhs.gov.
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
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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/tobaccoproducts/public-health-educationcampaigns/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
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Federal Register / Vol. 87, No. 224 / Tuesday, November 22, 2022 / Notices
could lead message developers to select
less than optimal messages or costineffective 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 ecigarette). 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.
71337
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
Number of
respondents
Participant subgroup
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 1
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Number to take the eligibility screener
Youth (aged 13–17) ........................................
Young adults (aged 18–24) ............................
150
150
1
1
150
150
0.083 (5 minutes) ...............
0.083 (5 minutes) ...............
13
13
Total .........................................................
........................
........................
........................
.............................................
26
Number to obtain parental permission process (for parents of youth only) and schedule site visit
Parents of youth participants ..........................
Young adults (aged 18–24) ............................
75
50
1
1
75
50
0.167 (10 minutes) .............
0.083 (5 minutes) ...............
13
4
Total .........................................................
........................
........................
........................
.............................................
17
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Federal Register / Vol. 87, No. 224 / Tuesday, November 22, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Participant subgroup
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours 1
Number to complete consent (5 min) and main study (85 min)
Youth (aged 13–17) ........................................
Young adults (aged 18–24) ............................
50
50
1
1
50
50
1.5 ......................................
1.5 ......................................
75
75
Total .........................................................
........................
........................
........................
.............................................
150
Total ..................................................
........................
........................
........................
.............................................
193
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the Advisory
Committee on Infant and Maternal
Mortality
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
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AGENCY:
HRSA is seeking nominations
of qualified candidates for consideration
for appointment as members of the
Advisory Committee on Infant and
Maternal Mortality (ACIMM or
Committee). ACIMM advises the
Secretary of HHS (Secretary) on
SUMMARY:
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department activities, partnerships,
policies, and programs directed at
reducing infant mortality, maternal
mortality and severe maternal
morbidity, and improving the health
status of infants and women before,
during, and after pregnancy. HRSA is
seeking nominations of qualified
candidates to fill open positions on the
ACIMM.
DATES: Written nominations for
membership on the ACIMM must be
received on or before January 23, 2023.
ADDRESSES: Nomination packages must
be submitted electronically as email
attachments to Vanessa Lee, MPH, the
ACIMM’s Designated Federal Official,
at: SACIM@hrsa.gov.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Designated Federal
Official, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
Room 18N84, Rockville, Maryland
20857; 301–443–0543; or SACIM@
hrsa.gov. A copy of the ACIMM charter
and list of the current membership may
be obtained by accessing the ACIMM
website at https://www.hrsa.gov/
advisory-committees/infant-mortality/
index.html.
SUPPLEMENTARY INFORMATION: The
ACIMM was established in 1991 and
advises the Secretary on department
activities, partnerships, policies, and
programs directed at reducing infant
mortality, maternal mortality and severe
maternal morbidity, and improving the
health status of infants and women
before, during, and after pregnancy. The
Committee provides advice on how to
coordinate federal, state, local, tribal,
and territorial governmental efforts
designed to improve infant mortality,
related adverse birth outcomes, and
maternal health, as well as influence
similar efforts in the private and
voluntary sectors. The Committee
provides guidance and
recommendations on the policies,
programs, and resources required to
address the disparities and inequities in
infant mortality, related adverse birth
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outcomes and maternal health
outcomes, including maternal mortality
and severe maternal morbidity. With its
focus on underlying causes of the
disparities and inequities seen in birth
outcomes for women and infants, the
Committee advises the Secretary on the
health, social, economic, and
environmental factors contributing to
the inequities and proposes structural,
policy, and/or systems level changes.
The ACIMM shall meet approximately
four times per year, or at the discretion
of the Designated Federal Officer in
consultation with the Chair.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on the ACIMM to fill open
positions. The Secretary appoints
ACIMM members with the expertise
needed to fulfill the duties of the
Advisory Committee. Information about
SGE membership on the ACIMM is set
forth in the ACIMM charter. Nominees
sought are medical, technical, or
scientific professionals with special
expertise in the field of maternal and
child health, in particular infant and/or
maternal mortality and related health
disparities; members of the public
having special expertise about or
concern with infant and/or maternal
mortality; and/or representatives from
such public health constituencies,
consumers, and medical professional
societies. Interested applicants may selfnominate or be nominated by another
individual or organization.
ACIMM consists of up to 21 members
appointed by the Secretary for a term of
up to 4 years. Individuals selected for
appointment to the Committee will be
invited to serve for up to 4 years.
Members appointed as SGEs receive a
stipend and reimbursement for per diem
and travel expenses incurred for
attending ACIMM meetings and/or
conducting other business on behalf of
the ACIMM, as authorized by 5 U.S.C.
5703 for persons employed
intermittently in government service.
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Participant subgroup Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to take the eligibility screener
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------
Total................................ .............. .............. .............. ............................................. 26
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number to obtain parental permission process (for parents of youth only) and schedule site visit
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------
Total................................ .............. .............. .............. ............................................. 17
--------------------------------------------------------------------------------------------------------------------------------------------------------
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Number to complete consent (5 min) and main study (85 min)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
