[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Pages 51897-51898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20057]


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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 or Agency) 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 October 18, 2021.

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: Rachel Showalter, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, 
[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

    In order to conduct educational and public information programs 
relating to tobacco use as authorized by section 1003(d)(2)(D) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA's 
Center for Tobacco Products will conduct research and use a variety of 
media to inform and educate the public, tobacco retailers, and health 
professionals about the health 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, the Center for Tobacco Products will 
conduct research and develop health messages relating to the control 
and prevention of disease. In conducting such research, FDA will use 
quantitative methods (i.e., surveys, experimental studies) for studies 
about tobacco products. These studies may be used to collect 
information related to foundational research informing message 
development or the formative pretesting of tobacco communication 
messages and other materials directed at consumers. This type of 
research involves: (1) Assessing audience knowledge, attitudes, 
behaviors, and other characteristics for the purpose of determining the 
need for and developing health messages, communication strategies, and 
public information programs; (2) pretesting these health messages, 
strategies, and program components while they are in developmental form 
to assess audience

[[Page 51898]]

comprehension, reactions, and perceptions; and (3) adding to the 
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.
    Foundational research to inform message development and the 
formative pretesting of messages are a staple of best practices in 
communications research. Obtaining voluntary feedback from intended 
audiences during the development of messages and materials is crucial 
for the success of every communication program. The purpose of 
obtaining information from formative pretesting is that it allows FDA 
to improve materials and strategies while revisions are still 
affordable and possible. Formative pretesting can also avoid 
potentially expensive and dangerous unintended outcomes caused by 
audiences interpreting messages in a way that was not intended by the 
drafters. By maximizing the effectiveness of messages and strategies 
for reaching targeted audiences, the frequency with which tobacco 
communication messages need to be modified should be greatly reduced.
    The voluntary information collected will serve the primary purpose 
of providing FDA information about various measures of ad performance 
including message comprehension, perceived effectiveness, emotional 
responses and knowledge, attitudes, and behavior change to assess the 
ability of messages, advertisements, and materials to reach and 
successfully communicate with their intended audiences. Quantitative 
testing messages and other materials with a sample of the target 
audience will allow FDA to refine messages, advertisements, and 
materials directed at consumers while the materials are still in the 
developmental stage.
    In addition, quantitative information is needed 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 March 5, 2021 (86 FR 12952), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. One PRA related comment was received.
    (Comment) The comment suggested specific types of messages that FDA 
should test and then implement in public health campaigns.
    (Response) FDA appreciates the comment. The content and focus on 
studies submitted through this generic clearance will depend on Agency 
priorities and needs, which are not yet determined at this time.
    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     respondent       responses      per response
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Screener......................         485,580               1         485,580  0.083 (5                  40,465
                                                                                 minutes).
Self-Administered Surveys.....         133,728               1         133,728  0.33 (20                  44,576
                                                                                 minutes).
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    Total.....................  ..............  ..............  ..............  ................          85,041
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Number of respondents to be included in each new survey will vary, 
depending on the nature of the material or message being tested and the 
target audience. Table 1 provides examples of the types of activities 
that may be administered and estimated burden levels during the 3-year 
period. Time to read, review, or complete the activity is built into 
the ``Average Burden per Response'' figures. Our estimated burden for 
the information collection reflects an overall increase of 60,000 hours 
and a corresponding increase of 461,808 responses. We attribute the 
adjustment to an increase in the number of new quantitative studies 
that are anticipated underneath this information collection during the 
next 3 years (proposed extension).

    Dated: September 10, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20057 Filed 9-16-21; 8:45 am]
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