[Federal Register Volume 89, Number 118 (Tuesday, June 18, 2024)]
[Notices]
[Pages 51534-51536]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 0910-0796. 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, 
[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 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:
     Educating youth about the risks of tobacco product use.
     Educating people who use tobacco products about the 
benefits of cessation.
     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:
     ``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.
     ``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.
     ``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.
     ``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