Notice2025-13047
Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
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Published
July 14, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the extension of the currently approved collection "The Real Cost Campaign Outcomes Evaluation Study: Cohort 3."
Full Text
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<title>Federal Register, Volume 90 Issue 132 (Monday, July 14, 2025)</title>
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[Federal Register Volume 90, Number 132 (Monday, July 14, 2025)]
[Notices]
[Pages 31229-31232]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13047]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No.FDA-2025-N-1600]
Agency Information Collection Activities; Proposed Collection;
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 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, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the extension of the currently approved
collection ``The Real Cost Campaign Outcomes Evaluation Study: Cohort
3.''
DATES: Either electronic or written comments on the collection of
information must be submitted by September 12, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 12, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
[[Page 31230]]
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2025-N-1600 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; The Real Cost Campaign Outcomes
Evaluation Study: Cohort 3.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Amber Sanford, 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#025250435176636464426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="16464457456277707056707277387e7e6538717960">[email protected]</span></a>.
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, including
each proposed extension of an existing 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.
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
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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
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden 1 2
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Number of
Respondent/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Household Recruitment Study Materials--Mail: 776,719 1 776,719 0.05 (3 min)............................... 38,836
Baseline Recruitment & Follow-up
Replenishments.
Household Screener--Mail: Baseline Recruitment 159,314 1 159,314 0.08 (5 min)............................... 13,756
& Follow-up Replenishments.
Household Roster--Mail: Baseline Recruitment & 19,511 1 19,511 0.08 (5 min)............................... 1,561
Follow-up Replenishments.
Parent Permission at Recruitment--Mail: 31,183 1 31,183 0.08 (5 min)............................... 2,495
Baseline Recruitment & Follow-up
Replenishments.
Invitation Emails-Mail: Baseline Recruitment & 24,798 1 24,798 0.02 (1 min)............................... 496
Follow-up Replenishments.
Eligibility Letter/Emails--Mail: Baseline 713 1 713 0.03 (2 min)............................... 21
Recruitment & Follow-up Replenishments.
Email/Text Reminder--Mail: Baseline Recruitment 24,798 1 24,798 0.03 (2 min)............................... 744
& Follow-up Replenishments.
Recruitment Study Materials--Social Media: 13,888 1 13,888 0.02 (1 min)............................... 278
Baseline Recruitment only.
Youth Screener--Social Media: Baseline 9,444 1 9,444 0.08 (5 min)............................... 756
Recruitment only.
Invitations and Study Materials: Follow-up 80,494 1 80,494 0.17 (10 min).............................. 13,684
waves.
Youth Assent: Baseline and Follow-up waves..... 70,798 1 70,798 0.08 (5 min)............................... 5,664
Parent Permission at Recontact: Follow-up waves 10,630 1 10,630 0.08 (5 min)............................... 850
*.
Youth Survey: Baseline and Follow-up waves..... 70,798 1 70,798 0.50 (30 min).............................. 35,399
Youth Incentive Thank You Letter: Baseline and 70,798 1 70,798 0.02 (1 min)............................... 1,416
Follow-up waves.
Total...................................... ............ .............. .............. ........................................... 115,956
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* We have received a waiver of parental permission from IRB for youth 14+, so not all respondents require parental permission.
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ 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 totals exactly due to rounding.
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
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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 FU 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-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. Our estimated burden for the information
collection reflects an overall decrease of 557 hours and an increase of
507,886 responses. We are proposing up to 3 additional follow-up waves
of data collections, including up to 2 additional replenishment
samples. In addition, we updated the estimated burden per response
based on past data collections for the baseline and first follow-up
wave.
Dated: July 8, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-13047 Filed 7-11-25; 8:45 am]
BILLING CODE 4164-01-P
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