[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1097-1099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-00221]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0987]


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the collection of qualitative data on 
tobacco products and communications.

DATES: Either electronic or written comments on the collection of 
information must be submitted by March 11, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 11, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such

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as a manufacturing process. Please note that if you include your name, 
contact information, or other information that identifies you in the 
body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-N-0987 for ``Generic Clearance for the Collection of 
Qualitative Data on Tobacco Products and Communications.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Generic Clearance for the Collection of Qualitative Data on Tobacco 
Products and Communications

OMB Control Number 0910-0796--Extension

    This information collection supports Food and Drug Administration 
(FDA, us, or we) 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, indepth 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,

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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 indepth 
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. FDA estimates the burden of this collection of information as 
follows:

                                                     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 Indepth Interviews.....           4,500               1           4,500  1.........................................           4,500
Indepth 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: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-00221 Filed 1-8-24; 8:45 am]
BILLING CODE 4164-01-P