Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Monthly Implementation Assessment, 15875-15876 [2024-04526]
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Federal Register / Vol. 89, No. 44 / Tuesday, March 5, 2024 / Notices
The Real Cost Monthly Implementation
Assessment
Affected Public: State Governments;
Number of Respondents: 19; Total
Annual Responses: 399; Total Annual
Hours: 5,549. (For policy questions
regarding this collection contact Lina
Rashid at 301–492–4193.)
William N. Parham, III
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–04591 Filed 3–4–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0894]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; The Real Cost
Monthly Implementation Assessment
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 April 4,
2024.
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 Monthly Implementation
Assessment.’’ 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, 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.
lotter on DSK11XQN23PROD with NOTICES1
ADDRESSES:
VerDate Sep<11>2014
16:50 Mar 04, 2024
Jkt 262001
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 teens ages 12–
17 in the United States who are open to
smoking cigarettes and/or using
electronic nicotine delivery systems
(ENDS) products, or who have already
experimented with cigarettes and/or
ENDS products. Complementary
evaluation studies, including the
‘‘Evaluation of FDA’s Public Education
Campaign on Teen Tobacco,’’ were
implemented to measure awareness of
‘‘The Real Cost’’ paid media campaign
among teens ages 12–17 in the United
States, and to understand how
awareness is related to change in key
outcomes.
Although outcome evaluation studies
of ‘‘The Real Cost’’ have and continue
to assess the impact of awareness on
outcomes, no studies have sought to
assess the implementation of ‘‘The Real
Cost.’’ As FDA continues to increase the
presence of ‘‘The Real Cost’’ on digital
channels (e.g., Hulu, YouTube,
Instagram), the need for an
implementation evaluation has become
clear as these messages are received by
the target audience on digital channels
differently compared to how the
messages are received on broadcast
channels. Before the migration of
campaign ads to digital channels, ads
from ‘‘The Real Cost’’ were primarily
aired on broadcast TV. In the broadcast
space, for people to avoid receiving the
message, they needed to be proactive
(e.g., finding the remote to change the
channel or leaving the room). In the
digital space, however, people need to
be proactive to watch the full message,
like stopping scrolling on social media
or watching the full ad on YouTube.
Assessment of this information is
integral to understanding self-reported
ad awareness levels, as well as how our
audience experiences and processes the
ads as they are airing in a digital setting.
Therefore, we propose a study to help
us understand, in a digital setting, how
teens experience the messages, how
they engage with messages, the extent to
which teens report being exposed to
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
15875
messages, and how teens process the
messages. Data gathered from this
assessment will also provide the
necessary and timely information to
optimize campaign messages, the digital
media buy (i.e., where, how, and when
ads are shown), and creative rotations
(i.e., which ads are shown).
‘‘The Real Cost’’ Monthly
Implementation Assessment (MIA) is a
repeated cross-sectional survey that will
be conducted using web-based surveys
that are self-administered on personal
computers or web enabled mobile
devices to collect rapid data on ‘‘The
Real Cost’’ stimuli. Data from up to
2,000 teens in the United States will be
collected each month for up to 24
months. To be eligible, participants
must be between the ages of 12–20 and
have not taken the MIA survey within
the past 3 months. We will use an Ipsos
Knowledge Panel to collect data on
‘‘The Real Cost’’ stimuli. This design
offers flexibility to assess new stimuli
messages, as they air across various
digital platforms, examine their
performance over time, as well as the
ability to pivot and add new survey
measures as necessary. Monthly data
will also allow us to obtain timely
information on stimuli awareness,
perceived effectiveness, as well as on
teen attention and processing of the
stimuli.
The purpose of FDA’s ‘‘The Real
Cost’’ is to evaluate the following key
components about ‘‘The Real Cost’’
stimuli:
• Awareness of ‘‘The Real Cost’’
stimuli.
• Attention behaviors when seeing
‘‘The Real Cost’’ stimuli.
• Processing of ‘‘The Real Cost’’
stimuli, including:
Æ Engagement with the stimuli.
Æ Main message comprehension.
Æ Acceptance and/or rejection of the
stimuli.
• Perceived effectiveness of ‘‘The
Real Cost’’ stimuli.
• Potential unintended consequences
of viewing ‘‘The Real Cost’’ stimuli.
In addition to the above components,
the survey will ask participants to report
on tobacco use and other psychographic
and demographic items. The time frame
that the survey items will ask about for
stimuli awareness (i.e., past 30 days or
past week) will depend on several
factors, including how long the stimuli
was on air. The survey will take an
average of approximately 25 minutes to
complete per participant. As the survey
items are tested, any irrelevant items
will be cut as necessary. Stimuli
creative for both vaping and cigarette
products will be assessed; therefore, two
similar surveys (one on ENDS-focused
E:\FR\FM\05MRN1.SGM
05MRN1
15876
Federal Register / Vol. 89, No. 44 / Tuesday, March 5, 2024 / Notices
stimuli and one on cigarette-focused
stimuli) will be fielded as appropriate,
but not within the same month.
In support of the provisions of the
Tobacco Control Act that require FDA to
protect the public health and to reduce
tobacco use by minors, FDA requests
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
OMB approval to collect information to
evaluate CTP’s public education
campaign ‘‘The Real Cost’’ through the
MIA.
In the Federal Register of April 27,
2023 (88 FR 25660), FDA published a
60-day notice requesting public
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of respondent/activity
Total
responses
Parent Screener ..........................................................
Parent Permission .......................................................
Invitation Emails (Respondents ages 18–20) .............
Youth Assent ...............................................................
Young Adult Consent ..................................................
Online Survey ..............................................................
Reminder Emails .........................................................
2,338,560
1,753,920
54,096
27,936
20,064
48,000
48,000
1
1
1
1
1
1
1
2,338,560
1,753,920
54,096
27,936
20,064
48,000
48,000
Total ......................................................................
........................
........................
........................
1 There
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Average burden per
response
0.05
0.05
0.02
0.05
0.05
0.42
0.20
Total hours
(3 minutes) .....
(3 minutes) .....
(1 minute) ......
(3 minutes) .....
(3 minutes) .....
(25 minutes) ..
(12 minutes) ..
116,928
87,696
1,082
1,397
1,003
20,160
9,600
................................
237,866
are no capital costs or operating and maintenance costs associated with this collection of information.
Data collection for the MIA will
consist of administering a monthly
survey to participants ages 12–20 over
the course of 2 years (24 months). We
expect the screening process (3 minutes
per response) to yield an approximate
2.3 to 1 ratio of eligible participants. We
will need to screen approximately
97,440 potential parents each month
(resulting in 2,338,560 screeners) over
the study period. Since the eligible age
for data collection is 12 to 20 years old,
we intend to screen parents of eligible
youth and young adults. Parents of the
youth participants determined to be
eligible through the screener will
provide parent permission (3 minutes
per response). We estimate that
1,753,920 of the parents who complete
the screener will provide their
permission for their youth to complete
the online survey (approximately 75
percent of the 2,338,560 screened). In
addition to recruiting respondents
through parents, we will send direct
invitations to young adult panel
members (18 to 20 years old). We
anticipate that 50 percent of young
adults will agree to participate. We will
send 508 direct invitations a month to
young adult panel members (18 to 20
years old). Eligible youth (1,753,920)
will provide their assent (3 minutes per
response) to participate in the online
survey (25 minutes per response).
Participants who are 18 to 20 years old
(19 to 20 years old in Alabama and
Nebraska in accordance with state law)
will provide their consent (3 minutes
per response) to participate in the
online survey. We estimate that
approximately 42 percent of the 48,000
completed surveys will come from
VerDate Sep<11>2014
16:50 Mar 04, 2024
Jkt 262001
young adults aged 18 to 20 (aged 19 to
20 in Alabama and Nebraska).
Over the course of the study period,
we intend to survey approximately
2,000 teens ages 12–20 per month for 24
months. From completed screeners, we
estimate that we will obtain data from
approximately 27,936 youth and 20,064
young adults. This will give us a total
of 48,000 participants for the study. The
survey will be repeated with a new
cross-sectional sample approximately
every month over a period of 24 months;
however, some participants will
complete more than one wave. These
48,000 respondents will receive an
invitation email with a link to take the
survey (4 minutes), 6 reminder emails (3
minutes each), and a thank you email (3
minutes) upon completion of the study
for a total of 25 minutes for respondents
to read and respond to the emails.
Several changes have been made to
this information collection request since
the 60-day notice was published in the
Federal Register. These changes include
(a) editing to clarify that the ad
campaign is intended for ‘‘teens’’ not
just ‘‘youth;’’ (b) removing the focus on
video ads since the campaign may use
other forms of communication to deliver
its message and replacing the term ‘‘ad’’
with ‘‘stimuli;’’ (c) removing the youth
screener from the burden table because
parents determine the eligibility of their
youth aged 12–17 (18–20 in Alabama
and Nebraska in accordance with state
law); (d) removing the young adult
screener from the burden table, which
will not be needed because young adult
panel members (18–20 years old) will
only receive an email invitation to
complete the survey; (e) updating the
burden table to reflect that we will send
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
direct invitations to young adult panel
members (18–20 years old); (f) updating
the permission, assent, and consents
because of updated information on the
expected sample breakdown from the
sample vendor for the distribution of the
sample who are 12–17 years old and 18–
20 years old; and (g) removing the thank
you email since that will not be a part
of the data collection procedures. In
addition to the implementation
evaluation described above, we will also
assess perceptions to proposed stimuli
and potential unintended consequences
in order to inform the development of
future messaging.
Dated: February 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–04526 Filed 3–4–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Request for Information: Nomination
and Evidence-Based Review Process
of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice of request for public
comment.
AGENCY:
At the request of the Advisory
Committee on Heritable Disorders in
Newborns and Children (ACHDNC or
SUMMARY:
E:\FR\FM\05MRN1.SGM
05MRN1
]]>Agencies
[Federal Register Volume 89, Number 44 (Tuesday, March 5, 2024)]
[Notices]
[Pages 15875-15876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04526]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0894]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; The Real Cost Monthly
Implementation Assessment
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 April 4, 2024.
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 Monthly Implementation
Assessment.'' 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 Monthly Implementation Assessment
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 teens ages 12-17 in the United States who are
open to smoking cigarettes and/or using electronic nicotine delivery
systems (ENDS) products, or who have already experimented with
cigarettes and/or ENDS products. Complementary evaluation studies,
including the ``Evaluation of FDA's Public Education Campaign on Teen
Tobacco,'' were implemented to measure awareness of ``The Real Cost''
paid media campaign among teens ages 12-17 in the United States, and to
understand how awareness is related to change in key outcomes.
Although outcome evaluation studies of ``The Real Cost'' have and
continue to assess the impact of awareness on outcomes, no studies have
sought to assess the implementation of ``The Real Cost.'' As FDA
continues to increase the presence of ``The Real Cost'' on digital
channels (e.g., Hulu, YouTube, Instagram), the need for an
implementation evaluation has become clear as these messages are
received by the target audience on digital channels differently
compared to how the messages are received on broadcast channels. Before
the migration of campaign ads to digital channels, ads from ``The Real
Cost'' were primarily aired on broadcast TV. In the broadcast space,
for people to avoid receiving the message, they needed to be proactive
(e.g., finding the remote to change the channel or leaving the room).
In the digital space, however, people need to be proactive to watch the
full message, like stopping scrolling on social media or watching the
full ad on YouTube. Assessment of this information is integral to
understanding self-reported ad awareness levels, as well as how our
audience experiences and processes the ads as they are airing in a
digital setting.
Therefore, we propose a study to help us understand, in a digital
setting, how teens experience the messages, how they engage with
messages, the extent to which teens report being exposed to messages,
and how teens process the messages. Data gathered from this assessment
will also provide the necessary and timely information to optimize
campaign messages, the digital media buy (i.e., where, how, and when
ads are shown), and creative rotations (i.e., which ads are shown).
``The Real Cost'' Monthly Implementation Assessment (MIA) is a
repeated cross-sectional survey that will be conducted using web-based
surveys that are self-administered on personal computers or web enabled
mobile devices to collect rapid data on ``The Real Cost'' stimuli. Data
from up to 2,000 teens in the United States will be collected each
month for up to 24 months. To be eligible, participants must be between
the ages of 12-20 and have not taken the MIA survey within the past 3
months. We will use an Ipsos Knowledge Panel to collect data on ``The
Real Cost'' stimuli. This design offers flexibility to assess new
stimuli messages, as they air across various digital platforms, examine
their performance over time, as well as the ability to pivot and add
new survey measures as necessary. Monthly data will also allow us to
obtain timely information on stimuli awareness, perceived
effectiveness, as well as on teen attention and processing of the
stimuli.
The purpose of FDA's ``The Real Cost'' is to evaluate the following
key components about ``The Real Cost'' stimuli:
Awareness of ``The Real Cost'' stimuli.
Attention behaviors when seeing ``The Real Cost'' stimuli.
Processing of ``The Real Cost'' stimuli, including:
[cir] Engagement with the stimuli.
[cir] Main message comprehension.
[cir] Acceptance and/or rejection of the stimuli.
Perceived effectiveness of ``The Real Cost'' stimuli.
Potential unintended consequences of viewing ``The Real
Cost'' stimuli.
In addition to the above components, the survey will ask
participants to report on tobacco use and other psychographic and
demographic items. The time frame that the survey items will ask about
for stimuli awareness (i.e., past 30 days or past week) will depend on
several factors, including how long the stimuli was on air. The survey
will take an average of approximately 25 minutes to complete per
participant. As the survey items are tested, any irrelevant items will
be cut as necessary. Stimuli creative for both vaping and cigarette
products will be assessed; therefore, two similar surveys (one on ENDS-
focused
[[Page 15876]]
stimuli and one on cigarette-focused stimuli) will be fielded as
appropriate, but not within the same month.
In support of the provisions of the Tobacco Control Act 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 MIA.
In the Federal Register of April 27, 2023 (88 FR 25660), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/activity Number of responses per Total Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Parent Screener.............................. 2,338,560 1 2,338,560 0.05 (3 minutes)......................... 116,928
Parent Permission............................ 1,753,920 1 1,753,920 0.05 (3 minutes)......................... 87,696
Invitation Emails (Respondents ages 18-20)... 54,096 1 54,096 0.02 (1 minute).......................... 1,082
Youth Assent................................. 27,936 1 27,936 0.05 (3 minutes)......................... 1,397
Young Adult Consent.......................... 20,064 1 20,064 0.05 (3 minutes)......................... 1,003
Online Survey................................ 48,000 1 48,000 0.42 (25 minutes)........................ 20,160
Reminder Emails.............................. 48,000 1 48,000 0.20 (12 minutes)........................ 9,600
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 237,866
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Data collection for the MIA will consist of administering a monthly
survey to participants ages 12-20 over the course of 2 years (24
months). We expect the screening process (3 minutes per response) to
yield an approximate 2.3 to 1 ratio of eligible participants. We will
need to screen approximately 97,440 potential parents each month
(resulting in 2,338,560 screeners) over the study period. Since the
eligible age for data collection is 12 to 20 years old, we intend to
screen parents of eligible youth and young adults. Parents of the youth
participants determined to be eligible through the screener will
provide parent permission (3 minutes per response). We estimate that
1,753,920 of the parents who complete the screener will provide their
permission for their youth to complete the online survey (approximately
75 percent of the 2,338,560 screened). In addition to recruiting
respondents through parents, we will send direct invitations to young
adult panel members (18 to 20 years old). We anticipate that 50 percent
of young adults will agree to participate. We will send 508 direct
invitations a month to young adult panel members (18 to 20 years old).
Eligible youth (1,753,920) will provide their assent (3 minutes per
response) to participate in the online survey (25 minutes per
response). Participants who are 18 to 20 years old (19 to 20 years old
in Alabama and Nebraska in accordance with state law) will provide
their consent (3 minutes per response) to participate in the online
survey. We estimate that approximately 42 percent of the 48,000
completed surveys will come from young adults aged 18 to 20 (aged 19 to
20 in Alabama and Nebraska).
Over the course of the study period, we intend to survey
approximately 2,000 teens ages 12-20 per month for 24 months. From
completed screeners, we estimate that we will obtain data from
approximately 27,936 youth and 20,064 young adults. This will give us a
total of 48,000 participants for the study. The survey will be repeated
with a new cross-sectional sample approximately every month over a
period of 24 months; however, some participants will complete more than
one wave. These 48,000 respondents will receive an invitation email
with a link to take the survey (4 minutes), 6 reminder emails (3
minutes each), and a thank you email (3 minutes) upon completion of the
study for a total of 25 minutes for respondents to read and respond to
the emails.
Several changes have been made to this information collection
request since the 60-day notice was published in the Federal Register.
These changes include (a) editing to clarify that the ad campaign is
intended for ``teens'' not just ``youth;'' (b) removing the focus on
video ads since the campaign may use other forms of communication to
deliver its message and replacing the term ``ad'' with ``stimuli;'' (c)
removing the youth screener from the burden table because parents
determine the eligibility of their youth aged 12-17 (18-20 in Alabama
and Nebraska in accordance with state law); (d) removing the young
adult screener from the burden table, which will not be needed because
young adult panel members (18-20 years old) will only receive an email
invitation to complete the survey; (e) updating the burden table to
reflect that we will send direct invitations to young adult panel
members (18-20 years old); (f) updating the permission, assent, and
consents because of updated information on the expected sample
breakdown from the sample vendor for the distribution of the sample who
are 12-17 years old and 18-20 years old; and (g) removing the thank you
email since that will not be a part of the data collection procedures.
In addition to the implementation evaluation described above, we will
also assess perceptions to proposed stimuli and potential unintended
consequences in order to inform the development of future messaging.
Dated: February 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04526 Filed 3-4-24; 8:45 am]
BILLING CODE 4164-01-P
