Notice2023-08945
Agency Information Collection Activities; Proposed Collection; Comment Request; The Real Cost Monthly Implementation Assessment
Primary source
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Published
April 27, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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. 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.''
Full Text
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<title>Federal Register, Volume 88 Issue 81 (Thursday, April 27, 2023)</title>
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[Federal Register Volume 88, Number 81 (Thursday, April 27, 2023)]
[Notices]
[Pages 25660-25663]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-08945]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#742426352700151212341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="7f2f2d3e2c0b1e19193f191b1e5117170c51181009">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
The Real Cost 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:
<bullet> Awareness of ``The Real Cost'' ads.
<bullet> Attention behaviors when seeing ``The Real Cost'' ads.
<bullet> Processing of ``The Real Cost'' ads, including:
[cir] Engagement with the ads.
[cir] Main message comprehension.
[cir] Acceptance and/or rejection of the ads.
<bullet> Perceived effectiveness of ``The Real Cost'' ads.
<bullet> 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\
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Number of
Type of respondent/activity Number of responses per Total Average burden per response Total hours
respondents respondent responses
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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.
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Total..................................... .............. .............. .............. ........................................ 378,720
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\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
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