Notice2024-27483
Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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
November 25, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) 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.
Full Text
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<title>Federal Register, Volume 89 Issue 227 (Monday, November 25, 2024)</title>
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[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92943-92944]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-27483]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0180]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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 December 26, 2024.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0810. 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,
<a href="/cdn-cgi/l/email-protection#154547544661747373557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="aafaf8ebf9decbcccceacccecb84c2c2d984cdc5dc">[email protected]</span></a>.
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.
Generic Clearance for the Collection of Quantitative Data on Tobacco
Products and Communications
OMB Control Number 0910-0810--Extension
This information collection supports FDA 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, FDA's Center for Tobacco
Products (CTP) conducts research and uses a variety of media to inform
and
[[Page 92944]]
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, 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 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.
In the Federal Register of June 21, 2024 (89 FR 52055), 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\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondents responses per response
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Screener...................... 1,360,000 1 1,360,000 0.083 (5 113,334
minutes).
Self-Administered Surveys..... 204,000 1 204,000 0.33 (20 68,000
minutes).
Informed Consent/Assent....... 204,000 1 204,000 0.033 (2 6,800
minutes).
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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: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-27483 Filed 11-22-24; 8:45 am]
BILLING CODE 4164-01-P
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