Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Monthly Implementation Assessment, 25660-25663 [2023-08945]
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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
requests for waivers or reductions of
ADUFA user fees, we developed
guidance for industry (GFI) #170
entitled ‘‘Animal Drug User Fees and
Fee Waivers and Reductions’’ (April
2023), available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/cvm-gfi-170animal-drug-user-fees-and-fee-waiversand-reductions. This document
discusses the types of fees FDA is
authorized to collect under section 740
of the FD&C Act, and how to request
waivers or reductions from these fees.
Further, this guidance also describes
what information FDA recommends be
submitted in support of a request for a
fee waiver or reduction, a request for
reconsideration of denial of a fee waiver
or reduction request, or an appeal of the
denial decision in accordance with 21
CFR 10.75; how to submit such a
request or appeal; and FDA’s process for
reviewing such requests or appeals.
Similarly, we developed guidance for
industry (GFI) #199 entitled ‘‘Animal
Generic Drug User Fees and Fee Waivers
and Reductions’’ (May 2009), available
at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/cvm-gfi-199-animal-genericdrug-user-fees-and-fee-waivers-andreductions. This document discusses
the types of fees FDA is authorized to
collect under section 741(a)(1) of the
FD&C Act, and how to request waivers
or reductions from these fees. Further,
this guidance also describes what
information FDA recommends be
submitted in support of a request for a
fee waiver or reduction, a request for
reconsideration of denial of a fee waiver
or reduction request, or an appeal of the
denial decision in accordance with 21
CFR 10.75; how to submit such a
request or appeal; and FDA’s process for
reviewing such requests or appeals.
We use the information submitted by
respondents to determine whether
requests for waiver or reduction of user
fees, reconsideration requests, or
appeals may be granted.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FD&C Act section; activity
Number of
responses per
respondent
Number of
respondents
FDA form No.
Total annual
responses
Average burden
per response
Total hours
User fee cover sheets, by type
740(a)(1); Animal Drug User Fee
cover sheet.
741(a)(1); Animal Generic Drug
User Fee cover sheet.
FDA 3546 ...........
15
1
15
1 .........................
15
FDA 3728 ...........
22
2
44
.08 (5 minutes) ...
3.5
Waiver and other requests, by type
740(d)(1)(A); significant barrier to
innovation.
740(d)(1)(B); fees exceed cost .......
740(d)(1)(C); free choice feeds ......
740(d)(1)(D); minor use or minor
species.
740(d)(1)(E); small business ..........
741(d)(1); minor use or minor species.
Request for reconsideration of a
decision.
21 CFR 10.75; Appeal of a decision.
N/A .....................
65
1
65
2 .........................
130
N/A .....................
N/A .....................
N/A .....................
8
4
73
3.75
1
1
30
4
73
0.5 (30 minutes)
2 .........................
2 .........................
15
8
146
N/A .....................
N/A .....................
1
2
1
1
1
2
2 .........................
2 .........................
2
4
N/A .....................
1
1
1
2 .........................
2
N/A .....................
1
1
1
2 .........................
2
Total .........................................
............................
........................
........................
........................
............................
327.5
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the
information collection reflects an
overall increase. We attribute this
adjustment to an increase in the number
of submissions we have received since
our last evaluation. The total number of
annual responses is based on the
average number of submissions received
by FDA in fiscal years 2019 to 2021. The
estimated time we attribute to the hours
per response is based on our experience
with the various submissions and
reflects the average burden we attribute
to all respondents.
Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–08946 Filed 4–26–23; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0894]
BILLING CODE 4164–01–P
Agency Information Collection
Activities; Proposed Collection;
Comment Request; The Real Cost
Monthly Implementation Assessment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
SUMMARY:
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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
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 entitled ‘‘The
Real Cost Monthly Implementation
Assessment.’’
Either electronic or written
comments on the collection of
information must be submitted by June
26, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 26, 2023. 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.
DATES:
Electronic Submissions
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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
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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–
2023–N–0894 for ‘‘The Real Cost
Monthly Implementation Assessment.’’
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-201509-18/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.
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25661
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: 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 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 youth ages 12
to 17 in the United States who are open
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Federal Register / Vol. 88, No. 81 / Thursday, April 27, 2023 / Notices
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
(ExPECTT),’’ were implemented to
measure awareness of ‘‘The Real Cost’’
paid media campaign among youth ages
12 to 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 skipping the 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, realworld setting.
Therefore, we propose a study to help
us understand, in a digital setting, how
youth experience the messages, how
they engage with messages, the extent to
which youth report being exposed to
messages, and how youth process the
messages. Studying exposure to ad
messages as it naturally occurs in the
real world can help us understand the
points of connection—or
disconnection—between the results of
copy testing studies (which assess
responses to the ads with forced
exposure to them) and outcome
evaluation findings (which are based on
natural exposure to ads in the real
world). 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 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’’ ads. Data from up to 2,000
youth in the United States will be
collected each month for up to 24
months. To be eligible, youth and young
adults must be between the ages of 12
to 20 and have not taken ‘‘The Real
Cost’’ Monthly Implementation
Assessment survey within the past 3
months. We will use an Ipsos
Knowledge Networks Panel to collect
data on ‘‘The Real Cost’’ ads. This
design offers flexibility to assess new ad
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 ad awareness, perceived
effectiveness, as well as on youth
attention and processing of the ads.
The purpose of FDA’s ‘‘The Real
Cost’’ Monthly Implementation
Assessment is to evaluate the following
key components about ‘‘The Real Cost’’
ads:
• Awareness of ‘‘The Real Cost’’ ads.
• Attention behaviors when seeing
‘‘The Real Cost’’ ads.
• Processing of ‘‘The Real Cost’’ ads,
including:
Æ Engagement with the ads.
Æ Main message comprehension.
Æ Acceptance and/or rejection of the
ads.
• Perceived effectiveness of ‘‘The
Real Cost’’ ads.
• Belief and knowledge tracking of
‘‘The Real Cost’’ ads.
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
ad awareness (i.e., past 30 days or past
week) will depend on several factors,
including how long the ad 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. Ad creative for both
vaping and cigarette products will be
assessed; therefore, two similar surveys
(one on ENDS-focused ads and one on
cigarette-focused ads) 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 Monthly Implementation
Assessment.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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Type of respondent/activity
Number of
responses per
respondent
Average
burden per
response
Total
responses
Parent/Young Adult Screener .......................................
Parent Permission .........................................................
Youth Screener .............................................................
Youth Assent .................................................................
Young Adult Consent ....................................................
Online Survey ................................................................
Invitation Email/Reminder Emails/Thank you Email .....
2,688,000
2,016,000
2,016,000
36,000
12,000
48,000
48,000
1
1
1
1
1
1
1
2,688,000
2,016,000
2,016,000
36,000
12,000
48,000
48,000
Total .......................................................................
........................
........................
........................
1 There
0.05
0.05
0.05
0.05
0.05
0.42
0.42
Total hours
(3 minutes) ...
(3 minutes) ...
(3 minutes) ...
(3 minutes) ...
(3 minutes) ...
(25 minutes)
(25 minutes)
134,400
100,800
100,800
1,800
600
20,160
20,160
..............................
378,720
are no capital costs or operating and maintenance costs associated with this collection of information.
Data collection for the Monthly
Implementation Assessment will consist
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of administering a monthly survey to
participants aged 12 to 20 over the
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course of 2 years (24 months). We
expect the screening process (3 minutes
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per response) to yield an approximate
2.3 to one ratio of eligible participants.
We will need to screen approximately
112,000 potential parents and young
adults each month (resulting in
2,688,000 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, as well as 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
2,016,000 of the parents who complete
the screener will provide their
permission for their youth to complete
the online survey (approximately 75
percent of the 2,688,000 screened).
Eligible youth (2,016,000) will provide
their assent (3 minutes per response) to
participate in the online survey (25
minutes per response). Participants that
are 18 to 20 (19 to 20 in Alabama and
Nebraska in accordance with state law)
will complete the screener for
themselves and provide their consent (3
minutes per response) to participate in
the online survey. We estimate that
approximately 25 percent of the 48,000
completed surveys will come from
young adults aged 18 to 20 (19 to 20 in
Alabama and Nebraska).
Over the course of the study period,
we intend to survey approximately
2,000 youth and young adults ages 12 to
20 per month for 24 months. From these
completed screeners, we estimate that
we will obtain data from 36,000 youth
and 12,000 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), six
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.
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
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[FR Doc. 2023–08945 Filed 4–26–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1466]
Good Manufacturing Practices for
Cosmetic Products Listening Session;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a virtual listening
session entitled ‘‘Good Manufacturing
Practices for Cosmetic Products
Listening Session.’’ The purpose of the
listening session is to consult cosmetics
manufacturers, including smaller
businesses, consumer organizations, and
other experts, to inform Agency efforts
to develop regulations to establish good
manufacturing practices for facilities
that manufacture or process cosmetic
products distributed in the United
States.
SUMMARY:
The virtual listening session will
be held on June 1, 2023, from 10 a.m.
to 1 p.m. Eastern Daylight Time (EDT)
or until after the last public commenter
has spoken, whichever occurs first.
Submit requests to make oral
presentations at the listening session by
6 p.m. EDT, May 18, 2023. Either
electronic or written comments on this
listening session must be submitted to
the docket by July 3, 2023. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: Additional details, such as
registration information, are available at
https://www.fda.gov/cosmetics/
cosmetics-news-events/public-meetinggood-manufacturing-practices-cosmeticproducts-06012023.
FDA is establishing a public docket
for this listening session. You may
submit comments as follows. Please
note that late, untimely filed comments
will not be considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. EDT at the end of July 3,
2023. Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are received on or before that
date.
DATES:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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25663
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–
2023–N–1466 for ‘‘Good Manufacturing
Practices for Cosmetic Products
Listening Session.’’ 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
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]]>Agencies
[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25660-25663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08945]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0894]
Agency Information Collection Activities; Proposed Collection;
Comment Request; The Real Cost Monthly Implementation Assessment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency.
[[Page 25661]]
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 entitled ``The Real Cost Monthly
Implementation Assessment.''
DATES: Either electronic or written comments on the collection of
information must be submitted by June 26, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 26, 2023. 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-2023-N-0894 for ``The Real Cost Monthly Implementation
Assessment.'' 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 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 youth ages 12 to 17 in the United States who
are open
[[Page 25662]]
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
(ExPECTT),'' were implemented to measure awareness of ``The Real Cost''
paid media campaign among youth ages 12 to 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 skipping the
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, real-world setting.
Therefore, we propose a study to help us understand, in a digital
setting, how youth experience the messages, how they engage with
messages, the extent to which youth report being exposed to messages,
and how youth process the messages. Studying exposure to ad messages as
it naturally occurs in the real world can help us understand the points
of connection--or disconnection--between the results of copy testing
studies (which assess responses to the ads with forced exposure to
them) and outcome evaluation findings (which are based on natural
exposure to ads in the real world). 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 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'' ads. Data from up to
2,000 youth in the United States will be collected each month for up to
24 months. To be eligible, youth and young adults must be between the
ages of 12 to 20 and have not taken ``The Real Cost'' Monthly
Implementation Assessment survey within the past 3 months. We will use
an Ipsos Knowledge Networks Panel to collect data on ``The Real Cost''
ads. This design offers flexibility to assess new ad 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 ad awareness, perceived effectiveness, as well as on youth attention
and processing of the ads.
The purpose of FDA's ``The Real Cost'' Monthly Implementation
Assessment is to evaluate the following key components about ``The Real
Cost'' ads:
Awareness of ``The Real Cost'' ads.
Attention behaviors when seeing ``The Real Cost'' ads.
Processing of ``The Real Cost'' ads, including:
[cir] Engagement with the ads.
[cir] Main message comprehension.
[cir] Acceptance and/or rejection of the ads.
Perceived effectiveness of ``The Real Cost'' ads.
Belief and knowledge tracking of ``The Real Cost'' ads.
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 ad awareness (i.e., past 30 days or past week) will depend on
several factors, including how long the ad 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. Ad creative for both vaping and cigarette products
will be assessed; therefore, two similar surveys (one on ENDS-focused
ads and one on cigarette-focused ads) 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 Monthly Implementation Assessment.
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/Young Adult Screener................... 2,688,000 1 2,688,000 0.05 (3 minutes)........................ 134,400
Parent Permission............................. 2,016,000 1 2,016,000 0.05 (3 minutes)........................ 100,800
Youth Screener................................ 2,016,000 1 2,016,000 0.05 (3 minutes)........................ 100,800
Youth Assent.................................. 36,000 1 36,000 0.05 (3 minutes)........................ 1,800
Young Adult Consent........................... 12,000 1 12,000 0.05 (3 minutes)........................ 600
Online Survey................................. 48,000 1 48,000 0.42 (25 minutes)....................... 20,160
Invitation Email/Reminder Emails/Thank you 48,000 1 48,000 0.42 (25 minutes)....................... 20,160
Email.
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 378,720
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Data collection for the Monthly Implementation Assessment will
consist of administering a monthly survey to participants aged 12 to 20
over the course of 2 years (24 months). We expect the screening process
(3 minutes
[[Page 25663]]
per response) to yield an approximate 2.3 to one ratio of eligible
participants. We will need to screen approximately 112,000 potential
parents and young adults each month (resulting in 2,688,000 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, as well
as 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 2,016,000 of the parents who complete
the screener will provide their permission for their youth to complete
the online survey (approximately 75 percent of the 2,688,000 screened).
Eligible youth (2,016,000) will provide their assent (3 minutes per
response) to participate in the online survey (25 minutes per
response). Participants that are 18 to 20 (19 to 20 in Alabama and
Nebraska in accordance with state law) will complete the screener for
themselves and provide their consent (3 minutes per response) to
participate in the online survey. We estimate that approximately 25
percent of the 48,000 completed surveys will come from young adults
aged 18 to 20 (19 to 20 in Alabama and Nebraska).
Over the course of the study period, we intend to survey
approximately 2,000 youth and young adults ages 12 to 20 per month for
24 months. From these completed screeners, we estimate that we will
obtain data from 36,000 youth and 12,000 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), six 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.
Dated: April 20, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08945 Filed 4-26-23; 8:45 am]
BILLING CODE 4164-01-P
