Notice2026-09448
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
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Published
May 13, 2026
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 91 Issue 92 (Wednesday, May 13, 2026)</title>
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[Federal Register Volume 91, Number 92 (Wednesday, May 13, 2026)]
[Notices]
[Pages 27062-27065]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09448]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1600]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; The Real Cost
Campaign Outcomes Evaluation Study: Cohort 3
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 June 12, 2026.
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 OMB control number for
this information collection is 0910-0915. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#feaeacbfad8a9f9898be989a9fd096968dd0999188"><span class="__cf_email__" data-cfemail="90c0c2d1c3e4f1f6f6d0f6f4f1bef8f8e3bef7ffe6">[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.
The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
OMB Control Number 0910-0915--Revision
This information collection supports the development and
implementation of FDA public education campaigns related to tobacco
use. FDA's Center for Tobacco Products (CTP) was created to carry out
the authorities granted under the Family Smoking Prevention and Tobacco
Control Act (Tobacco Control Act) (Pub. L. 111-31) to educate the
public about the dangers of tobacco use and to serve as a public health
resource for tobacco and health information. CTP's tobacco education
mission directly contributes to advancing the goals of Executive Order
14212: Establishing the President's Make America Healthy Again
Commission, including the Make Our Children Health Again assessment, in
three ways. First, CTP works to reduce tobacco use, the leading cause
of chronic disease and mortality in the United States. Second, CTP
protects the health of children; public education campaigns and other
CTP efforts decrease the likelihood that youth initiate or escalate
tobacco use. Third, CTP uses gold-standard science to develop,
implement, and evaluate its programs.
FDA launched ``The Real Cost'' educational campaigns in February
2014, seeking to reduce tobacco use among at-risk youth in the United
States who are open to using or have already experimented with
cigarettes or electronic nicotine delivery systems (ENDS). As with CTP
as a whole, FDA's ``The Real Cost'' Youth Cigarette and E-Cigarette
Prevention Campaigns aim to reduce chronic disease and protect the
health of children. ``The Real Cost'' campaigns use evidence-based
messaging distributed through multiple channels, including paid media
advertising, to highlight the negative health consequences of tobacco
use to U.S. youth. The Real Cost Campaign Outcomes Evaluation Study,
also known as the Evaluation of FDA's Public Education Campaign on Teen
Tobacco (ExPECTT) study, uses gold-standard science to measure
exposure, awareness, and impact of ``The Real Cost'' campaigns among
youth in the United States.
The first ExPECTT study (Cohort 1) assessed the campaign's impact
on outcome variables of interest from November 2013 to November 2016.
The second ExPECTT study (Cohort 2; OMB Control No. 0910-0753) assessed
the campaign's impact on outcome variables of interest from June 2018
to August 2022. The third ExPECTT study (Cohort 3; OMB Control No.
0910-0915) has been assessing the campaign's impact on outcome
variables of interest starting in February 2023. To continue assessing
the impact of ``The Real Cost'' campaigns, FDA intends to extend
implementation of the ExPECTT Cohort 3 study. The study consists of
multiple waves of data collection, including a baseline survey and up
to eight continuing follow-up (FU) surveys, conducted approximately 6-9
months apart. The online surveys are conducted with youth ages 11-17 at
baseline (for mail-based recruitment).
The purpose of FDA's ExPECTT Cohort 3 study is to provide credible
evidence that changes in key outcomes can be attributed to exposure to
the campaign. Using gold-standard science, FDA can determine the
strength of the attribution and rule out alternative explanations for
observed changes in key outcomes. In the ExPECTT study, FDA has been
measuring variation in both potential campaign exposure (e.g., market-
level delivery) and self-reported campaign exposure to media
advertising and how those exposures relate to key outcomes.
The goal of ExPECTT Cohort 3 is to determine whether future waves
of ``The Real Cost'' public education campaigns will continue to
influence the following key outcomes: \1\
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\1\ MacMonegle, A., Zarndt, A.N., Wang, Y., Bennett, M., Malo,
V., Pitzer, L., . . . & Duke, J. (2025). The Impact of ``The Real
Cost'' on E-cigarette Initiation among US Youth. American Journal of
Preventive Medicine.
<bullet> Awareness of campaign messages
<bullet> Tobacco use behaviors (such as initiation, escalation,
cessation)
<bullet> Specific beliefs targeted by messages (message-targeted
beliefs)
<bullet> Psychosocial predictors or precursors of tobacco use behavior
[cir] Health and addiction risk perceptions
[cir] Perceived loss of control or threat to freedom expected from
tobacco use
[cir] Anticipated guilt, shame, and regret from tobacco use
[cir] Perceptions of prevalence, approval, and popularity of tobacco
use
[cir] Pro-health changes in normative beliefs about tobacco product use
[cir] Tobacco use susceptibility
[cir] Intention or willingness to use tobacco
[cir] Intention to quit and/or reduce daily consumption
In support of the provisions of the Tobacco Control Act (Pub. L.
111-31) that require FDA to protect the public health and to reduce
tobacco use by
[[Page 27063]]
minors, FDA requested and received OMB approval to collect information
to evaluate CTP's public education campaign ``The Real Cost'' through
the Evaluation Study: Cohort 3 under the OMB control number 0910-0915.
This notice requests an extension of the currently approved data
collection.
In the Federal Register of July 14, 2025 (90 FR 31229), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One PRA-related comment was received.
(Comment) The commenter strongly supported FDA's proposed ``Real
Cost'' Campaign Outcomes Evaluation Study (Cohort 3), emphasizing the
campaign's proven effectiveness and urges continued funding of the
campaigns and evaluation studies. The comment highlights that ``'The
Real Cost'' Youth E-Cigarette Prevention Campaign has been
``instrumental in reversing the trajectory of youth vaping, driving
rates down from a peak of 5.4 million in 2019 to about 1.6 million
today'' and that ``The Real Cost'' Youth Cigarette Prevention Campaign
demonstrated exceptional cost-effectiveness by generating ``$180 in
savings for every dollar of the nearly $250 million invested in its
first two years.'' The commenter recommends that the proposed
information collection reaches communities historically targeted by the
tobacco industry. Finally, the commenter advocated for inclusion of
questions related to gender in the information collection.
(FDA Response) FDA appreciates the comment in response to the 60-
day notice. FDA agrees with the commenter that continued campaign
evaluation is ``crucial to maintaining the ongoing success of `The Real
Cost''' campaigns through rigorous gold standard research, and that
this information collection has strong practical utility. Specifically,
the proposed information collection will continue to assess the
campaign's impact on reducing chronic disease among youth through
decreased tobacco initiation and identify opportunities to enhance
program effectiveness and adapt to changing public health challenges.
The proposed information collection is designed to collect high-quality
data with a longitudinal cohort design that will follow youth
participants over time to assess changes in tobacco-relevant outcomes
due to campaign exposure. The data collected has strong practical
utility and will provide essential insights for campaign optimization
by identifying messages that are most effective in preventing and
reducing youth tobacco use and while providing vital campaign
evaluation data to ensure FDA is advancing public health goals in
protecting children from the harmful effects of tobacco use.
The goal of the current information collection is to assess the
reach and impact of ``The Real Cost'' Youth E-Cigarette and Cigarette
Prevention campaigns for the general population of youth (aged 12-17)
in the United States who are at risk of tobacco use. This information
collection focuses on all U.S. youth (ages 12-17) because, as the
commenter states, the tobacco industry has historically targeted young
people in their marketing strategies (U.S. DHHS, 2012), and most adult
tobacco users begin using during this critical age range (U.S. DHHS,
2014).
FDA's approach to this evaluation study is conducted in full
compliance with all applicable Executive Orders and current
Administration priorities regarding federal research and data
collection activities. Preventing tobacco initiation among U.S. youth
is essential to combat the chronic disease caused by tobacco use. The
focus of this proposed information collection is the general population
U.S. youth. While examining specific racial, ethnic, or demographic
subgroups is not a primary aim of the study, FDA is able to assess
campaign reach and impact for various population segments among the
youth sample. The study collects demographic data that can support
examination of campaign effectiveness among different groups of youth
who may be at varying levels of risk for tobacco initiation and use.
For example, the survey collects data on participant race and ethnicity
items in compliance of Office of Management and Budget's Statistical
Policy Directive No. 15: Standards for Maintaining, Collecting, and
Presenting Federal Data on Race and Ethnicity.
Additionally, the commenter requests for the inclusion of survey
items to assess gender in the information collection, which would not
be in compliance with Executive Order 14168 ``Defending Women from
Gender Ideology Extremism and Restoring Biological Truth to the Federal
Government.'' FDA does not assess or examine gender or gender identity
in this study. To be in compliance with Executive Order 14168
``Defending Women from Gender Ideology Extremism and Restoring
Biological Truth to the Federal Government,'' we are unable to assess
or examine gender or gender identity in this study. We include one item
on sexual orientation: ``Which of the following best represents how you
think of yourself?'' (Response options: Straight or heterosexual,
Bisexual, Gay or lesbian). We also include one item on sex: ``Are you
female or male?'' (Response options: Male, Female). The inclusion of
these two items enables us to examine differences in exposure and
responses to campaign messages among demographic groups in a manner
that is compliant with Executive Orders.
FDA estimates the burden of this collection of information during
the extension period as follows.
Table 1--Estimated Annual Reporting Burden \1\ \3\
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Number of Total
Respondent/activity Number of responses per annual Average burden per Total hours
respondents respondent responses response
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Household Recruitment Study 305,000 1 305,000 0.05 (9 mins).......... 15,250
Materials--Mail: Baseline
Recruitment & Follow-up
Replenishments.
Household Screener--Mail: 65,000 1 65,000 0.08 (5 mins).......... 5,200
Baseline Recruitment &
Follow-up Replenishments.
Household Roster--Mail: 7,661 1 7,661 0.08 (5 mins).......... 613
Baseline Recruitment &
Follow-up Replenishments.
Parent Permission at 12,245 1 12,245 0.08 (5 mins).......... 980
Recruitment-Mail: Baseline
Recruitment & Follow-up
Replenishments.
Invitation Emails-Mail: 9,738 1 9,738 0.02 (1 min)........... 195
Baseline Recruitment &
Follow-up Replenishments.
Eligibility Letter/Emails- 280 1 280 0.03 (2 mins).......... 8
Mail: Baseline Recruitment &
Follow-up Replenishments.
Email/Text Reminder-Mail: 9,738 1 9,738 0.03 (2 mins).......... 292
Baseline Recruitment &
Follow-up Replenishments.
Invitations and Study 57,729 1 57,729 0.17 (10 mins)......... 9,814
Materials: Follow-up waves.
Youth Assent: Baseline and 44,768 1 44,768 0.08 (5 mins).......... 3,581
Follow-up waves.
Parent Permission at 7,336 1 7,336 0.08 (5 mins).......... 587
Recontact: Follow-up waves.
Youth Survey: Baseline and 44,768 1 44,768 0.50 (30 mins)......... 22,384
Follow-up waves.
[[Page 27064]]
Youth Incentive Thank You 44,768 1 44,768 0.02 (1 min)........... 895
Letter: Baseline and Follow-
up waves.
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Total.................... .............. .............. ........... ....................... 59,799
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* We received a waiver of parental permission from IRB for youth 14+, so not all respondents require parental
permission at recontact.
\1\ Note that all values in the table are rounded to the nearest hundredths place (for the Average Burden per
Response column) or to the nearest whole number (for all other columns); therefore, sums may not equal the
exact totals due to rounding.
\2\ Note that values in the table are not annualized. These values reflect the full burden hours required for
the study.
\3\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Four waves of data collection (a baseline survey and 3 follow-up
surveys) are scheduled to be conducted prior to the start of the
extension period. The extension period includes up to 5 additional
follow-up surveys with sample replenishment at 2 of those waves of data
collection. We detail below the recruitment activities and data
collection materials for the full range of the study, including data
collections prior to the extension period and during the extension
period.
Data Collection Recruitment
Baseline Recruitment
This study includes a baseline survey and up to eight continuing
follow-up surveys, conducted approximately 6-9 months apart. There are
two ways that we recruited initial participants to the study at
baseline, which took place in 2023: mail-based recruitment (the primary
mode of recruitment) and supplemental social media-based recruitment.
The recruitment sample for the mail-based data collection included
youth ages 11-17. We mailed 326,709 recruitment/study material packages
to households at baseline (3 minutes per response) and received 64,314
completed screeners (5 minutes per response) by adults within those
households. For the 8,207 households identified as eligible for the
study during the screening process (i.e., the presence of one or more
youth ages 11 to 17), we asked the adult completing the screener to
list all eligible youth in their households for study selection, a
process called rostering (5 minutes per response). We randomly selected
up to 2 eligible youth per household. We asked parents to provide
permission for each eligible youth to participate in the study (5
minutes). If more than one youth was selected, parental permission was
required for each child. In some cases, the adult taking the screener
was not the parent of the eligible youth(s). We then reached out by
email and/or with a letter to notify the parent of their child(ren)s'
eligibility (2 minutes) and a request parental permission (N = 300).
All youth with parental permission (n = 10,431) were sent an invitation
email to participate in the study (1 minute). We also sent reminder
emails and texts out to eligible youth during data collection who had
not yet completed the survey (2 minutes).
In addition to the primary mail-based data collection at baseline
in 2023, we recruited an additional sample using a social media-based
recruitment from a subpopulation of respondents at increased risk for
initiating use of cigarettes and ENDS products. This supplemental data
collection consisted of online self-administered surveys of
participants recruited through social media advertisements. The
recruitment sample for this data collection was youth ages 14 to 20 who
met the subpopulation criteria. At baseline, 13,888 respondents were
invited to take the screener through social media ads (1 minute). We
screened 9,444 respondents (5 minutes per screener response) and
identified 1,501 eligible respondents. This is a longitudinal study, so
participants from the social media sample will be retained in the
sample because they were members of the original study cohort.
Follow-Up (Replenishment) Recruitment
We estimate that we will lose approximately 15 percent of the
original baseline sample at each follow-up wave. Replenishing the
sample will ensure we maintain an adequate longitudinal sample at each
study wave and continue to have representation from younger respondents
in our aging sample. We will replenish the sample up to 4 times during
the study period. We will send out recruitment/study material packages
to an additional 450,000 households in total (3 minutes per response)
over the course of the study period. We expect to receive an estimated
95,000 completed screeners (5 minutes per response). For households
identified as eligible for the study during the replenishment screening
process (i.e., the presence of 1 or more youth ages 11 to 17), we will
ask the parent/guardian to list all eligible youth in their households
for study selection, a process called rostering (5 minutes per
response). We will randomly select up to 2 eligible youth per
household. We will ask parents to provide permission for each eligible
youth to participate in the study (5 minutes). If more than one youth
is selected, parental permission will be required for each child. In
some cases, where the adult taking the screener is not the parent of
the eligible youth(s), we will reach out by email and/or letter with a
notice of eligibility (2 minutes) and a request to provide parental
permission. All youth with parental permission will be sent an
invitation email to participate in the study (1 minute). We will also
send reminder emails and texts out to eligible youth during data
collection who have not yet completed the survey (2 minutes). We will
not use social media to recruit any respondents for the replenishment
samples.
Youth Survey Materials
Baseline
For the main data collection at baseline in 2023, we collected data
from 5,354 youth respondents recruited by mail. For the supplemental
social media data collection at baseline in 2023, we collected data
from 1,501 youth respondents. These 6,855 youth respondents provided
baseline assent (5 minutes per response) and completed the survey (30
minutes per response). Following completion of the study, we mailed an
incentive letter (1 minute). For the 5,354 youth respondents recruited
for the main data collection, we asked the parent/guardian to provide
permission (5 minutes per response) for the youth to participate in the
study. We received a waiver of parental permission for youth 14+ and
did not require parental permission for respondents from the social
media data collection.
Follow-Up Waves
As this is a longitudinal data collection, participants who
complete the baseline survey or any follow-up replenishment survey will
be recontacted for each subsequent follow-
[[Page 27065]]
up wave. We will send invitations and study materials to sample
respondents for up to eight follow-up waves (10 minutes per
respondent). Including youth recruited in the replenishment, this will
be up to 14,053 youth at each wave. At each of the eight follow-up
waves, respondents are estimated to provide assent (5 minutes per
respondent) and complete the survey (30 minutes per respondent). Where
required, we will ask the parent/guardian to provide permission (5
minutes per respondent) for the youth to participate in the study. For
youth who complete the survey, we will also mail an incentive letter (1
minute per respondent).
To align with Executive Order 14168, Defending Women From Gender
Ideology Extremism and Restoring Biological Truth to the Federal
Government, we are revising this information collection to remove
questions relating to gender. Since publication of the 60-day notice,
the burden estimates have been updated. Overall, the estimated burden
reflects a decrease of 455 burden hours and an increase of 507,886
responses.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09448 Filed 5-12-26; 8:45 am]
BILLING CODE 4164-01-P
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