[Federal Register Volume 88, Number 25 (Tuesday, February 7, 2023)]
[Notices]
[Pages 7983-7985]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.reginfo.gov/public/do/PRAMain. 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, 
[email protected].

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:

 Awareness of campaign messages (self-reported exposure)
 Specific beliefs targeted by messages (message-targeted 
beliefs)
 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

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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.
                                              ----------------------------------------------------------------------------------------------------------
    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


