Notice2024-13644
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 21, 2024
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 notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection titled Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications.
Full Text
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<title>Federal Register, Volume 89 Issue 120 (Friday, June 21, 2024)</title>
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[Federal Register Volume 89, Number 120 (Friday, June 21, 2024)]
[Notices]
[Pages 52055-52057]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13644]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0180]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Generic Clearance for the Collection of Quantitative
Data on Tobacco Products and Communications
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. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection titled Generic
Clearance for the Collection of Quantitative Data on Tobacco Products
and Communications.
DATES: Either electronic or written comments on the collection of
information must be submitted by August 20, 2024.
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 August 20, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received 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
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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-2018-N-0180 for ``Generic Clearance for the Collection of
Quantitative Data on Tobacco Products and Communications.'' 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#85d5d7c4d6f1e4e3e3c5e3e1e4abededf6abe2eaf3"><span class="__cf_email__" data-cfemail="47171506143326212107212326692f2f3469202831">[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, including
each proposed extension of an existing 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.
Generic Clearance for the Collection of Quantitative Data on Tobacco
Products and Communications
OMB Control Number 0910-0810--Extension
This information collection supports Food and Drug Administration
(FDA, us or we) programs. Under section 1003(d)(2)(D) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is
authorized to conduct educational and public information programs.
Under this umbrella generic FDA's Center for Tobacco Products (CTP)
conducts research and uses a variety of media to inform and educate
stakeholders (e.g., the public, tobacco retailers, and health
professionals) about the risks of tobacco use, how to quit using
tobacco products, and FDA's role in regulating tobacco.
To ensure that these educational and public information programs
have the highest potential to be received, understood, and accepted by
those for whom they are intended, CTP conducts research to understand
and identify and develop health messages relating to the control and
prevention of disease. In conducting such research, FDA uses
quantitative methods for studies about tobacco products, including but
not limited to surveys, experimental studies, quasi-experimental
studies and the collection and analysis of digital metrics. These
studies are used to collect information related to foundational
research informing message development; formative pretesting of tobacco
communication messages and other materials directed at consumers;
understanding the impact of tobacco public education materials in the
digital environment; awareness of and receptivity to tobacco public
education materials; and developing and testing survey measures to
inform future research. This type of research may involve: (1)
assessing audience knowledge, attitudes, intentions, behaviors, and
other characteristics for the purpose of determining the need for and
developing health messages, communication strategies,
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dissemination strategies, and public information programs; (2) testing
health messages, strategies, and program components while they are in
developmental form to assess audience comprehension, reactions, and
perceptions, as well as after they have been disseminated to consumers;
and (3) adding to the tobacco control, public health communication, and
regulatory science knowledge base. Quantitative studies play an
important role in exploring areas of research and gathering information
because they can be used to summarize a population of interest on key
variables or reveal systematic relationships between variables.
This foundational research has helped FDA to understand audiences
and inform message development and the testing of messages in
communicating the risks of tobacco use, how to quit using tobacco
products, and FDA's role in regulating tobacco. Obtaining this
information has allowed FDA to improve messages, materials and
implementation strategies while revisions are still affordable and
possible.
The voluntary information collected serves the primary purpose of
providing FDA information about various measures of ad performance
including, but not limited to, message comprehension, perceived
effectiveness, emotional responses and knowledge, attitudes, and
behavioral intentions to assess the ability of messages,
advertisements, and materials to reach and successfully communicate
with their intended audiences. Additionally, this information
collection provides FDA with insights into how to best measure public
education message performance. Quantitative testing of messages and
other materials with a sample of the target audience allows FDA to
refine and assess messages, advertisements, and materials directed at
consumers.
In addition, quantitative information is collected under this
umbrella generic by FDA to track changes in response to policy and
regulatory actions and to expand the tobacco regulatory science base by
providing information on changing behaviors, knowledge and attitudes
about tobacco products, including post-marketing surveillance of
tobacco products. In addition, quantitative information is collected by
FDA to track changes in response to policy and regulatory actions and
to expand the tobacco regulatory science base by providing information
on changing behaviors, knowledge, and attitudes about tobacco products,
including postmarketing surveillance of tobacco products.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Screener................................... 1,360,000 1 1,360,000 0.083 (5 minutes).......................... 113,334
Self-Administered Surveys.................. 204,000 1 204,000 0.33 (20 minutes).......................... 68,000
Informed Consent/Assent.................... 204,000 1 204,000 .033 (2 minutes)........................... 6,800
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Total.................................. 1,768,000 .............. .............. ........................................... 188,134
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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 of 96,269 hours and a corresponding increase of
1,106,692 responses. We attribute this adjustment to the number of
study responses used during the current approval and now estimated for
the next 3 years. A greater number of quantitative studies will be
conducted over the next 3 years due to the need to develop new creative
messages and content. Recent years have seen a dramatic change in
media. With the shift to digital media, FDA must adapt to communicate
effectively in a digital environment. As digital tobacco use
prevention/interventions are still in their infancy, we must better
understand the types of digital channels available. To impact public
health outcomes, we need to understand how to reach our intended
audience. New foundational studies are needed (including those on
digital metrics, measurement, and implementation) to support activities
and initiatives that will enable the public to receive evidence-based,
timely, and clear health communication and education. As a result, we
have adjusted our burden estimate and revised the number of respondents
to the information collection.
Dated: June 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13644 Filed 6-20-24; 8:45 am]
BILLING CODE 4164-01-P
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