Notice2022-15954
Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 26, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 solicits comments on a proposed information collection titled "The Real Cost Campaign Outcomes Evaluation Study: Cohort 3."
Full Text
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<title>Federal Register, Volume 87 Issue 142 (Tuesday, July 26, 2022)</title>
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[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44409-44412]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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:
<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-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 <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: 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#752527342601141313351311145b1d1d065b121a03"><span class="__cf_email__" data-cfemail="96c6c4d7c5e2f7f0f0d6f0f2f7b8fefee5b8f1f9e0">[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 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
[[Page 44411]]
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:
<bullet> Awareness of campaign messages
<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.
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......
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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
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