4164-01-P
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.
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 [INSERT DATE 30 DAYS AFTER DATE OF PUBLICATION IN THE
FEDERAL REGISTER].
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, PRAStaff@fda.hhs.gov.
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 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:

Type of Interview
In-Person Individual
In-depth Interviews
In-depth Interview
Screener
Focus Group Screener

Table 1. --Estimated Annual Reporting Burden1
No. of
No. of Responses
Total Annual
Respondents
per Respondent
Responses
4,500

4,500

22,500

22,500

56,000

56,000

Average Burden
per Response
1
0.083
(5 minutes)

0.25
(15 minutes)

Total
Hours
4,500
1,875
14,000

Focus Group
1.5
252,000
1
252,000
378,000
Discussion
Discussion Board
0.083
8,000
1
8,000
667
(5 minutes)
Screener
Discussion Board
1.5
100
1
100
150
Participation
Total
399,192
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: 6/17/2024 8:45 am; Publication Date: 6/18/2024]