Notice2024-13386
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Qualitative 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 18, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, us, or we) 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 118 (Tuesday, June 18, 2024)</title>
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[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51534-51536]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-13386]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0987]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
the Collection of Qualitative 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, us, or we) 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 July 18, 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 0910-0796. 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#e9b9bba8ba9d888f8fa98f8d88c781819ac78e869f"><span class="__cf_email__" data-cfemail="154547544661747373557371743b7d7d663b727a63">[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 Qualitative Data on Tobacco
Products and Communications
OMB Control Number 0910-0796--Extension
This information collection supports FDA's 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.
In conducting studies relating to the regulation and communications
related to tobacco products, FDA will need to employ formative
qualitative research including but not limited to focus groups,
usability and/or psychometric testing, in-depth interviews (IDIs),
cognitive interviews and asynchronous qualitative discussions (e.g.,
online journaling or web-based discussion boards), naturalistic
observation and ethnographic studies to assess knowledge and
perceptions about tobacco-related topics with specific target
audiences. The information collected will serve four major purposes.
First, foundational research will provide critical knowledge and
insights about intended audiences. FDA must first understand people's
knowledge of, perceptions of, and reactions to tobacco related topics
prior to developing survey/research questions as well as stimuli for
experimental studies. Second, formative research will provide
information about people's responses, thoughts, and feelings regarding
potential creative messaging, or stimuli. Third, by collecting
communications usability information, FDA will be able to serve and
respond to the ever-changing demands of consumers of tobacco products.
Additionally, we will be able to determine the best way to communicate
with intended audiences around tobacco prevention and cessation.
Fourth, cognitive testing will allow FDA to assess consumer
understanding of survey/research questions and study stimuli. Focus
groups and/or IDIs with a sample of the intended audience will allow
FDA to refine the survey/research questions and study stimuli while
they are still in the developmental stage. FDA will collect, and
interpret information gathered through this generic clearance to: (1)
better understand characteristics of the intended audience--its
perceptions, knowledge, attitudes, beliefs, and behaviors--and use
these in the development of appropriate survey/research questions,
study stimuli, or communications; (2) more efficiently and effectively
design survey/research questions and study stimuli; and (3) more
efficiently and effectively design experimental studies.
FDA is requesting approval of an extension of this generic
clearance for collecting information using qualitative methods (e.g.,
interviews, focus groups, asynchronous discussion boards, etc.) for
studies involving all tobacco products regulated by FDA. This
information will be used to explore concepts of interest and assist in
the development of quantitative study proposals, complementing other
important research efforts in the Agency. This information may also be
used to help identify and develop communication messages, which may be
used in education campaigns. Qualitative research plays an important
role in gathering information because it allows for an in-depth
understanding of
[[Page 51535]]
individuals' attitudes, beliefs, motivations, and feelings. Qualitative
research serves the narrowly defined need for direct and informal
public opinion on a specific topic.
The number of respondents to be included in each new study may
vary, depending on the nature of the study (e.g., foundational,
formative, etc.), approach (synchronous vs. asynchronous, or virtual
vs. in person) and the intended audience. Table 1 provides examples of
the types of studies that may be administered and estimated burden
levels during the 3-year period. Time to read, view, or listen to the
message being tested is built into the ``Average Burden per Response''
figures.
In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice
for public comment on the proposed collection of information in the
Federal Register of January 9, 2024 (89 FR 1097). FDA received two PRA
related comments.
(Comment) The comment expressed that the Paperwork Reduction Act
was written to reduce burden on the public, but the overuse of surveys
is encouraged generically, making it even easier to collect information
with no need based. The comment stated further that ``This seems to be
counterintuitive to the purpose of the PRA and exactly what the Act was
supposed to be protecting us from, another survey we do not have time
or resources to complete buy you would like to give us with no specific
goal. Overuse.''
(Response) FDA disagrees with the comment suggesting that the
generic information collection process enables the overuse of surveys
and undermines the Paperwork Reduction Act. In response to this
comment, FDA has updated Supporting Statement Part A to clarify the
necessity of the information collected under this generic clearance for
the proper performance of FDA CTP's function and the practical utility
of collecting such information. The information collected will support
FDA CTP's function by advancing CTP's Strategic Plan and its specific
goals: ``Goal 1: Develop, Advance, and Communicate Comprehensive and
Impactful Tobacco Regulations and Guidance'' and ``Goal 4: Enhance
Knowledge and Understanding of the Risks Associated with Tobacco
Product Use.'' The practical utility of the collected data is evidenced
by its role in facilitating the development of clear and accessible CTP
public statements and communications, such as web content, press
releases, fact sheets, and retailer resources. Furthermore, the utility
is demonstrated by CTP achieving the following objectives with specific
audiences:
<bullet> Educating youth about the risks of tobacco product use.
<bullet> Educating people who use tobacco products about the
benefits of cessation.
<bullet> Educating adults who smoke about the relative risks of
tobacco products.
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.
(Comment) The comment expressed the lack of specificity regarding
FDA's public education goals. Specifically, the comment notes that FDA
vaguely states it will collect qualitative data to ``explore concepts
of interest and assist in the development of quantitative research
proposals'' and ``help identify and develop communication messages,
which may be used in education campaigns.'' The comment stated further
that they encourage ``FDA to prioritize educating adults, particularly
adult smokers and physicians and medical staff who advise adult smokers
about tobacco harm reduction. [. . .], FDA's public education campaigns
should aim to improve understanding among adult smokers where there
currently exists significant uncertainty and confusion about materially
important issues that are detrimental to public-health efforts. These
important issues include ``educating the adult public, particularly
adult smokers, about the continuum of risk, and where alternatives to
combustible cigarettes fall on that continuum,'' and ``correcting
misunderstandings about the absence of any direct causal link between
nicotine and tobacco-related diseases.''
(Response) FDA disagrees with the comment suggesting that an
overarching purpose or plan for communications, information goals, or
target audiences was not provided. In response to this comment, FDA has
updated Supporting Statement Part A to clarify that the information
collected under this generic clearance is necessary for the proper
performance of FDA CTP's function and will be of practical utility in
advancing CTP's Strategic Plan and its specific goals. The information
collected under this generic clearance will advance CTP's objectives to
educate people who use tobacco products about the benefits of cessation
and to educate adults who smoke about the relative risks of tobacco
products. The following generic information collections were recently
approved under 0910-0796. FDA has summarized how they address specific
objectives such as educating adults about tobacco products' relative
risks:
<bullet> ``Consumer Perceptions of Cessation and Harm'': Focus
group study with established cigarette smokers ages 25 and up. The
objective is to learn about consumer perceptions (and misconceptions)
regarding nicotine and tobacco products.
<bullet> ``Consumer Perceptions of Modified and Reduced Risk
(MoRR)'': Focus group study with current and established cigarette
smokers ages 21 and older. The objective is to gain information to
inform health communication materials dedicated to modified risk
products and/or the continuum of risk. This may help reduce
misperceptions and lack of awareness.
<bullet> ``Menthol User Audience Research'': In-depth interviews
conducted with adult menthol smokers ages 21 and older. The objective
is to examine demographic, sociocultural, psychographic, and behavioral
characteristics of adult menthol cigarette users; to identify segments
that are most likely to adopt less harmful behaviors in response to
targeted messaging; and to identify communication strategies to support
menthol smokers in adopting less harmful behaviors.
<bullet> ``Qualitative Study of Product Category Comparison
Statements--modified risk tobacco product (MRTPs) and harmful and
potentially harmful constituents (HPHCs)'': Focus group study with
adult current and former cigarette smokers ages 18 and older. The
objective is to understand participants' knowledge, attitudes, beliefs,
and perceptions about different tobacco products. This includes a
stimulus-driven discussion of HPHC information and MRTP claims.
FDA estimates the burden of this collection of information as
follows:
[[Page 51536]]
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Type of interview Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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In-Person Individual In-depth Interviews.... 4,500 1 4,500 1......................................... 4,500
In-depth Interview Screener................. 22,500 1 22,500 0.083 (5 minutes)......................... 1,875
Focus Group Screener........................ 56,000 1 56,000 0.25 (15 minutes)......................... 14,000
Focus Group Discussion...................... 252,000 1 252,000 1.5....................................... 378,000
Discussion Board Screener................... 8,000 1 8,000 0.083 (5 minutes)......................... 667
Discussion Board Participation.............. 100 1 100 1.5....................................... 150
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Total................................... .............. .............. .............. .......................................... 399,192
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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 384,258 hours and a corresponding increase of
314,926 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 qualitative 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). As a result, we have adjusted our
burden estimate and revised the number of respondents to the
information collection.
Dated: June 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-13386 Filed 6-17-24; 8:45 am]
BILLING CODE 4164-01-P
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