Notice2023-02501
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
February 7, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 88 Issue 25 (Tuesday, February 7, 2023)</title>
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[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7983-7985]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-02501]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0862]
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 or we) 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 March 9, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``The Real Cost Campaign Outcomes Evaluation
Study: Cohort 3.'' Also include the FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#a3f3f1e2f0d7c2c5c5e3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="92c2c0d3c1e6f3f4f4d2f4f6f3bcfafae1bcf5fde4">[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--NEW
This information collection supports the development and
implementation of FDA's public education campaign related to tobacco
use. To reduce the public health burden of tobacco use in the United
States and educate the public--especially young people--about the
dangers of tobacco use, the FDA Center for Tobacco Products (CTP) is
developing and implementing multiple public education campaigns.
FDA launched ``The Real Cost'' in February 2014, seeking to reduce
tobacco use among at-risk youth ages 12-17 in the United States who are
open to smoking cigarettes and/or using electronic nicotine delivery
systems (ENDS) products, or have already experimented with cigarettes
and/or ENDS products. Complementary evaluation studies, including the
``Evaluation of FDA's Public Education Campaign on Teen Tobacco
(ExPECTT),'' were designed and implemented to measure awareness of and
exposure to ``The Real Cost'' paid media campaign among youth ages 12-
17 in targeted areas of the United States.
The first cohort (ExPECTT: Cohort 1) assessed the campaign's impact
on outcome variables of interest from November 2013 to November 2016.
The second cohort (ExPECTT: Cohort 2) has been assessing the campaign's
impact on outcome variables of interest from June 2018 and will run
through August 2022. To continue assessing the impact of ``The Real
Cost'' campaign, FDA will implement The Real Cost Campaign Outcomes
Evaluation Study: Cohort 3. The study will consist of four waves of
data collection, including the baseline survey and three follow-up (FU)
surveys. Online surveys with youth ages 11-20 will be conducted at
baseline.
Online surveys of youth will be conducted in the United States to
measure the effectiveness of FDA's ``The Real Cost'' campaign. The
purpose of FDA's The Real Cost Campaign Outcomes Evaluation Study:
Cohort 3 is to evaluate whether changes in key outcomes can be
attributed to exposure to the campaign. The strength of the attribution
is determined by the ability of the evaluation approach to rule out
alternative explanations for observed changes in key outcomes. To
improve attribution, we intend to measure self-reported campaign
exposure to media advertising, which among many things, will enable FDA
to assess its relationship with market-level delivery.
The goal of The Real Cost Campaign Outcomes Evaluation Study:
Cohort 3 is to determine whether future waves of ``The Real Cost''
public education campaign will influence key outcomes including:
<bullet> Awareness of campaign messages (self-reported exposure)
<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] 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 minors, FDA requests OMB approval to collect information
to evaluate CTP's public education campaign ``The Real Cost'' through
the Evaluation Study: Cohort 3.
In the Federal Register of July 26, 2022 (87 FR 44409), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One PRA related comment was received.
(Comment) The commentor does not support this data collection and
expressed concerns with collecting data from those who identify as
LGBTQ+. The rational for not collecting these data is because those who
identify as LGBTQ+ are at risk for privacy and security concerns by
asking them to report their sexual orientation or gender
identification. The commentor believes this type of questioning is
invasive and may expose LGBTQ+ members to further bias and
discrimination. Further, the commentor believes that FDA's proposal to
target LGBTQ+ youth aged 11-17 is concerning as youth can be
particularly vulnerable to exploitation for two reasons: (1) their
minds are still developing, and (2) ``function creep'' occurs when data
is collected for one reason and can then be utilized for other, non-
intended purposes.
(Response) FDA appreciates the comment in response to the 60-day
notice. We provide more information below about why this is an
important opportunity to support LGBTQ+ youth populations and how FDA
is proposing to carry out this collection of information in a manner
that minimizes risks, while building credible and useful evidence about
LGBTQ+ youth populations. This data will be used to inform tobacco
public education campaigns that aim to reduce tobacco use disparities,
including among LGBTQ+ populations. Recent data from the 2021 National
Youth Tobacco Survey demonstrates that teens who are sexual or gender
minorities have higher rates of cigarette and e-cigarette use compared
to heterosexual teens. For
[[Page 7984]]
example, 6 percent of heterosexual teens reported ever experimenting
with cigarettes, compared to 10.9 percent of gay or lesbian teens, 15.6
percent of bisexual male teens, 14 percent of bisexual female teens,
and 11.2 percent of teens who are transgender. Furthermore, 17.9
percent of heterosexual teens reported ever using e-cigarettes,
compared to 27.3 percent of bisexual male teens, 29.6 percent of
bisexual female teens, and 30.7 percent of teens who are transgender.
This is credible evidence as to why LGBTQ+ youth are priority
populations when it comes to minimizing health disparities.
The cited negative impact raised by the commentor, in which data
collected are misused to the detriment of LGBTQ+ youth, is mitigated by
the extensive, specific, and efficacious measures and practices put in
place by FDA and its contractors to secure data privacy and avoid
individual harm. This is not a broad data collection effort but rather
data collection limited in nature solely for the purpose of collecting
data to answer a circumscribed set of questions that will support FDA's
mission of protecting and promoting public health which includes LGBTQ+
youth populations. To address the privacy concerns mentioned in the
comment, FDA has included a document in the docket which details the
privacy protections for this study.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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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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Parent Recruitment Study Materials--Main: 545,000 1 545,000 0.17 (10 minutes)........................ 92,650
Baseline & Follow-up 2 Replenishment.
Parent Screener--Main: Baseline & Follow-up 2 272,500 1 272,500 0.08 (5 minutes)......................... 21,800
Replenishment.
Household Roster--Main: Baseline & Follow-up 5,500 1 5,500 0.08 (5 minutes)......................... 440
2 Replenishment.
CATI Screener--Main: Baseline & Follow-up 2 2,000 1 2,000 0.08 (5 minutes)......................... 160
Replenishment.
Parent Permission--Main: Baseline & Follow-up 21,600 1 21,600 0.08 (5 minutes)......................... 1,728
1,2,3.
Youth Assent--Main: Baseline & Follow-up 21,600 1 21,600 0.08 (5 minutes)......................... 1,728
1,2,3.
Youth Survey--Main: Baseline & Follow-up 21,600 1 21,600 0.50 (30 minutes)........................ 10,800
1,2,3.
Youth Screener--Supplemental................. 5,000 1 5,000 0.08 (5 minutes)......................... 400
Youth Assent--Supplemental: Baseline & Follow- 4,428 1 4,428 0.08 (5 minutes)......................... 354
up 1,2,3.
Youth Survey--Supplemental: Baseline & Follow- 4,428 1 4,428 0.50 (30 minutes)........................ 2,214
up 1,2,3.
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Total.................................... .............. .............. .............. ......................................... 132,274
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Main Data Collection
The main data collection will include a baseline survey and three
FU surveys. The recruitment sample for the main data collection is
youth ages 11-17. We intend to replenish the longitudinal sample at FU2
to obtain 6,000 youth respondents to maintain at least 4,800
respondents at each wave. We expect the screening process to yield a
100:1 ratio of eligible responding households. We estimate that we will
mail 400,000 recruitment/study material packages (10 minutes per
response) in order to receive at least 200,000 completed screeners (5
minutes per response) by adults within households. Households
completing the screener by mail will be contacted to complete a
computer-assisted telephone interview (CATI) where an interviewer will
determine eligibility and obtain parental permission (5 minutes per
response). For households identified as eligible for the study during
the 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 estimate from the 200,000 completed
screeners, we will recruit 6,000 eligible youth from the 4,000 eligible
households.
Baseline
At baseline, we plan to collect data from approximately 6,000 youth
respondents from the 4,000 eligible households identified through
screening. More than one eligible youth per household may be recruited
for the study. These 6,000 youth respondents are estimated to provide
baseline assent (5 minutes per response) and complete the survey (30
minutes per response). For these youth respondents, we will ask the
parent/guardian to provide permission (5 minutes per response) for the
youth to participate in the study. We estimate that we will lose
approximately 20 percent of the original baseline sample at each FU
wave.
Follow-Up 1
We estimate that we will retain 80 percent of the sample from
baseline and collect data from 4,800 respondents (5 minutes per
response) at FU1. These 4,800 youth respondents are estimated to
provide assent (5 minutes per response) for FU1 and complete the survey
(30 minutes per response). For these youth respondents, we will ask the
parent/guardian to provide permission (5 minutes per response) for the
youth to participate in the study. We do not intend to replenish the
sample at FU1.
Follow-Up 2
We estimate that we will retain 80 percent of the sample from FU1
resulting in 3,840 respondents at FU2. To replenish the longitudinal
sample at FU2, we will send additional ``baseline'' screeners to new
households. We intend to send recruitment/study material packages to an
additional 145,000 households (10 minutes per response) to receive an
estimated 72,500 completed screeners (5 minutes per response). For
households identified as eligible for the study during the 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). Households completing the screener by mail will be contacted
to complete a CATI where an interviewer will determine eligibility and
obtain parental permission (5 minutes per response). From these
completed screeners, we estimate that we will obtain data from an
additional 2,160 youth within approximately 1,500 households.
Replenishing the sample will allow us to obtain 6,000 youth respondents
at FU2 (3,840 from the original sample, and 2,160 from the
replenishment sample) and maintain a minimum study sample of 4,800
respondent at all study waves. These 6,000 youth respondents are
estimated
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to provide assent (5 minutes per response) for FU2 and complete the
survey (30 minutes per response). For these youth respondents, we will
ask the parent/guardian to provide permission (5 minutes per response)
for the youth to participate in the study.
Follow-Up 3
We estimate that we will retain 80 percent of the sample from FU2
and collect data from 4,800 respondents at FU3. We do not intend to
replenish the sample at FU3. These 4,800 youth respondents are
estimated to provide assent (5 minutes per response) for FU2 and
complete the survey (30 minutes per response). For these youth
respondents, we will ask the parent/guardian to provide permission (5
minutes per response) for the youth to participate in the study.
Supplemental Data Collection
In addition to the main data collection, we intend to collect data
from subpopulations shown to be at higher risk of initiating use of
cigarettes and ENDS products, such as youth who identify as LGBTQ+ and
youth who have a mental health disorder. Data collection will consist
of online self-administered surveys of participants recruited through
social media advertisements. The recruitment sample for this data
collection will be youth ages 14 to 20 who meet the subpopulation
criteria. We intend to collect data at baseline from 1,500 respondents.
We anticipate that we will need to screen 5,000 respondents (5 minutes
per response) to obtain a baseline sample of 1,500 respondents who meet
the subpopulation criteria. At baseline, we plan to collect data from
approximately 1,500 respondents identified as eligible through
screening. These 1,500 youth respondents are estimated to provide
assent (5 minutes per response) and complete the survey (30 minutes per
response). We estimate that we will lose approximately 20 percent of
the original baseline sample at each FU wave; therefore, estimating
1,200 respondents at FU1, 960 respondents at FU2, and 768 respondents
at FU3. For the FU samples, youth will provide assent (5 minutes per
response) and complete the survey (30 minutes per response).
We made several minor edits from the 60-day Federal Register notice
to the 30-day Federal Register notice. These edits consisted of (a)
minor revisions for clarity (e.g., indicating that self-report exposure
is a measures of awareness rather than a unique outcome); (b) removing
text alluding to using multiple methods to understand the campaign
impact (because the proposed study is just one method); and (c)
removing bullets on two outcomes related to perceived norms of tobacco
use, as the ads that will be on air at the time of data collection are
not attempting to change those particular outcomes so they are not
relevant to assess in the study.
Dated: February 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02501 Filed 2-6-23; 8:45 am]
BILLING CODE 4164-01-P
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