Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Campaign Outcomes Evaluation Study: Cohort 3, 7983-7985 [2023-02501]
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Federal Register / Vol. 88, No. 25 / Tuesday, February 7, 2023 / Notices
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.
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.
SUMMARY:
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.
ADDRESSES:
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, PRAStaff@fda.hhs.gov.
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
ddrumheller on DSK120RN23PROD with NOTICES
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
VerDate Sep<11>2014
18:52 Feb 06, 2023
Jkt 259001
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 selfreported 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
Æ Health and addiction risk
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7983
perceptions
Æ Perceived loss of control or threat
to freedom expected from tobacco
use
Æ Anticipated guilt, shame, and regret
from tobacco use
Æ Tobacco use susceptibility
Æ Intention or willingness to use
tobacco
Æ 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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07FEN1
7984
Federal Register / Vol. 88, No. 25 / Tuesday, February 7, 2023 / Notices
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
Number of
respondents
Respondent/Activity
Average
burden per
response
Total annual
responses
Total hours
Parent Recruitment Study Materials—Main: Baseline & Follow-up 2
Replenishment.
Parent Screener—Main: Baseline & Follow-up 2 Replenishment ...........
Household Roster—Main: Baseline & Follow-up 2 Replenishment ........
CATI Screener—Main: Baseline & Follow-up 2 Replenishment .............
Parent Permission—Main: Baseline & Follow-up 1,2,3 ...........................
Youth Assent—Main: Baseline & Follow-up 1,2,3 ...................................
Youth Survey—Main: Baseline & Follow-up 1,2,3 ...................................
Youth Screener—Supplemental ...............................................................
Youth Assent—Supplemental: Baseline & Follow-up 1,2,3 .....................
Youth Survey—Supplemental: Baseline & Follow-up 1,2,3 ....................
545,000
1
545,000
0.17 (10 minutes) .......
92,650
272,500
5,500
2,000
21,600
21,600
21,600
5,000
4,428
4,428
1
1
1
1
1
1
1
1
1
272,500
5,500
2,000
21,600
21,600
21,600
5,000
4,428
4,428
0.08
0.08
0.08
0.08
0.08
0.50
0.08
0.08
0.50
(5 minutes) .........
(5 minutes) .........
(5 minutes) .........
(5 minutes) .........
(5 minutes) .........
(30 minutes) .......
(5 minutes) .........
(5 minutes) .........
(30 minutes) .......
21,800
440
160
1,728
1,728
10,800
400
354
2,214
Total ..................................................................................................
........................
........................
........................
.....................................
132,274
1 There
ddrumheller on DSK120RN23PROD with NOTICES
Number of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Main Data Collection
Baseline
Follow-Up 2
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 computerassisted 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.
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.
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
VerDate Sep<11>2014
18:52 Feb 06, 2023
Jkt 259001
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.
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Federal Register / Vol. 88, No. 25 / Tuesday, February 7, 2023 / Notices
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.
ddrumheller on DSK120RN23PROD with NOTICES
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 selfadministered 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
VerDate Sep<11>2014
18:52 Feb 06, 2023
Jkt 259001
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0008]
Advisory Committee; Cellular, Tissue,
and Gene Therapies Advisory
Committee; Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Cellular, Tissue, and
Gene Therapies Advisory Committee by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Cellular, Tissue,
and Gene Therapies Advisory
Committee for an additional 2 years
beyond the charter expiration date. The
new charter will be in effect until the
October 28, 2024, expiration date.
DATES: Authority for the Cellular,
Tissue, and Gene Therapies Advisory
Committee will expire on October 28,
2024, unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Christina Vert, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
1244, Silver Spring, MD 20993–0002,
240–402–8054, Christina.Vert@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Cellular, Tissue, and
Gene Therapies Advisory Committee
(the Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
SUMMARY:
PO 00000
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7985
to the Commissioner. The Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data relating to the safety,
effectiveness, and appropriate use of
human cells, human tissues, gene
transfer therapies, and
xenotransplantation products which are
intended for transplantation,
implantation, infusion, and transfer in
the prevention and treatment of a broad
spectrum of human diseases and in the
reconstruction, repair, or replacement of
tissues for various conditions. The
Committee also considers the quality
and relevance of FDA’s research
program that provides scientific support
for the regulation of these products, and
makes appropriate recommendations to
the Commissioner.
The Committee shall consist of a core
of 13 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of cellular
therapies, tissue transplantation, gene
transfer therapies and
xenotransplantation (biostatistics,
bioethics, hematology/oncology, human
tissues and transplantation,
reproductive medicine, general
medicine, and various medical
specialties, including surgery and
oncology, immunology, virology,
molecular biology, cell biology,
developmental biology, tumor biology,
biochemistry, rDNA technology, nuclear
medicine, gene therapy, infectious
diseases, and cellular kinetics).
Members will be invited to serve for
overlapping terms of up to 4 years. NonFederal members of this committee will
serve as Special Government
Employees, representatives, or ExOfficio members. Federal members will
serve as Regular Government Employees
or Ex-Officios. The core of voting
members may include one technically
qualified member, selected by the
Commissioner or designee, who is
identified with consumer interests and
is recommended by either a consortium
of consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one non-voting representative
member who is identified with industry
interests. There may also be an alternate
industry representative.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
E:\FR\FM\07FEN1.SGM
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]]>Agencies
[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]
[[Page 7983]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Respondent/Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 7985]]
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
