[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44409-44412]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0862]


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, Agency, or we) 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 a 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

[[Page 44410]]

solicits comments on a proposed information collection titled ``The 
Real Cost Campaign Outcomes Evaluation Study: Cohort 3.''

DATES: Submit either electronic or written comments on the collection 
of information by September 26, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before September 26, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of September 26, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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 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-0862 for ``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 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.

The Real Cost Campaign Outcomes Evaluation Study: Cohort 3

OMB Control Number 0910--NEW

    This information collection supports the development and 
implementation of FDA public education campaigns 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

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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 followup (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 provide credible evidence that 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. 
Attributing effects to a campaign require using multiple, complementary 
methods that build a case that exposure to the campaign leads to 
changes in key outcomes. For a national campaign evaluation, FDA can 
improve attribution by carefully assessing potential confounders. To 
improve attribution, we intend to measure variation in both potential 
campaign exposure (e.g., market-level delivery) and self-reported 
campaign exposure to media advertising.
    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 any of the following key 
outcomes:

 Awareness of campaign messages
 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] 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. 
11-31) 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.
    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    Total hours
                                    respondents     respondent       responses     per response
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Parent Recruitment Study                 545,000               1         545,000  0.17 (10 mins)          92,650
 Materials--Main: Baseline &
 Followup 2 Replenishment.......
Parent Screener--Main: Baseline          272,500               1         272,500   0.08 (5 mins)          21,800
 & Followup 2 Replenishment.....
Household Roster--Main: Baseline           5,500               1           5,500   0.08 (5 mins)             440
 & Followup 2 Replenishment.....
CATI Screener--Main: Baseline &            2,000               1           2,000   0.08 (5 mins)             160
 Followup 2 Replenishment.......
Parent Permission--Main:                  21,600               1          21,600   0.08 (5 mins)           1,728
 Baseline & Followup 1,2,3......
Youth Assent--Main: Baseline &            21,600               1          21,600   0.08 (5 mins)           1,728
 Followup 1,2,3.................
Youth Survey--Main: Baseline &            21,600               1          21,600  0.50 (30 mins)          10,800
 Followup 1,2,3.................
Youth Screener--Supplemental....           5,000               1           5,000   0.08 (5 mins)             400
Youth Assent--Supplemental:                4,428               1           4,428   0.08 (5 mins)             355
 Baseline & Followup 1,2,3......
Youth Survey--Supplemental:                4,428               1           4,428  0.50 (30 mins)           2,214
 Baseline & Followup 1,2,3......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         132,275
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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 one 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

[[Page 44412]]

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.

Followup 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.

Followup 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 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.

Followup 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).

    Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15954 Filed 7-25-22; 8:45 am]
BILLING CODE 4164-01-P


