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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 [www.gpo.gov]
[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 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 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, 
[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.

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).
                               ---------------------------------------------------------------------------------
    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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