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, 51534-51536 [2024-13386]
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51534
Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section; activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
100.2(d); notification ............................................................
1
1
1
10
10
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate. The
estimated reporting burden for
§ 100.2(d) is minimal because
enforcement notifications are seldom
used by States. During the last 3 years,
we have not received any new
enforcement notifications; therefore, we
estimate that one or fewer notifications
will be submitted annually. Although
we have not received any new
enforcement notifications in the last 3
years, these information collection
provisions should be extended to
provide for the potential future need of
a State government to submit
enforcement notifications informing us
when it intends to take enforcement
action under the FD&C Act against a
particular food located in the State.
Dated: June 13, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–13388 Filed 6–17–24; 8:45 am]
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications
BILLING CODE 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.
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.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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17:57 Jun 17, 2024
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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.
ADDRESSES:
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
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\18JNN1.SGM
18JNN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
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 3year 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
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17:57 Jun 17, 2024
Jkt 262001
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
PO 00000
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Fmt 4703
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51535
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 stimulusdriven discussion of HPHC information
and MRTP claims.
FDA estimates the burden of this
collection of information as follows:
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51536
Federal Register / Vol. 89, No. 118 / Tuesday, June 18, 2024 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of interview
Total annual
responses
Average burden
per response
Total
hours
In-Person Individual In-depth Interviews .................
In-depth Interview Screener .....................................
Focus Group Screener ............................................
Focus Group Discussion ..........................................
Discussion Board Screener .....................................
Discussion Board Participation ................................
4,500
22,500
56,000
252,000
8,000
100
1
1
1
1
1
1
4,500
22,500
56,000
252,000
8,000
100
1 ................................
0.083 (5 minutes) ......
0.25 (15 minutes) ......
1.5 .............................
0.083 (5 minutes) ......
1.5 .............................
4,500
1,875
14,000
378,000
667
150
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 6–17–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
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17:57 Jun 17, 2024
Jkt 262001
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Social and Community Influences
Across the Lifecourse.
Date: July 10, 2024.
Time: 10:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Elia E. Ortenberg, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3108,
Bethesda, MD 20892, 301–827–7189,
femiaee@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–23–
318: Mobile Health: Technology and
Outcomes in Low and Middle Income
Countries Panel A (R21/R33—Clinical Trial
Optional).
Date: July 11–12, 2024.
Time: 9:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Maria De Jesus Diaz Perez,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1000G,
Bethesda, MD 20892, (301) 496–4227,
diazperezm2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neuroimmune and Neuroinflammation
involved in Neurodegenerative Disorders.
Date: July 11–12, 2024.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Mariam Zaka, Ph.D.,
Scientific Review Officer, Center for
PO 00000
Frm 00045
Fmt 4703
Sfmt 9990
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1009J,
Bethesda, MD 20892, (301) 435–1042,
zakam2@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Clinical Informatics and Data Analytics.
Date: July 11–12, 2024.
Time: 9:30 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jessica Bellinger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3158,
Bethesda, MD 20892, (301) 827–4446,
bellingerjd@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Thrombosis and Blood Cells.
Date: July 12, 2024.
Time: 1:00 p.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Bukhtiar H. Shah, DVM,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4120,
MSC 7802, Bethesda, MD 20892, (301) 806–
7314, shahb@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 13, 2024.
Victoria E. Townsend,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–13359 Filed 6–17–24; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\18JNN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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
