Notice2021-20057
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
September 17, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 178 (Friday, September 17, 2021)</title>
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[Federal Register Volume 86, Number 178 (Friday, September 17, 2021)]
[Notices]
[Pages 51897-51898]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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: 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,
<a href="/cdn-cgi/l/email-protection#e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="356567746641545353755351541b5d5d461b525a43">[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
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]
BILLING CODE 4164-01-P
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