Notice2024-00221
Agency Information Collection Activities; Proposed Collection; 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
January 9, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 6 (Tuesday, January 9, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 6 (Tuesday, January 9, 2024)]
[Notices]
[Pages 1097-1099]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-00221]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
[[Page 1098]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#e0b0b2a1b394818686a0868481ce888893ce878f96"><span class="__cf_email__" data-cfemail="f7a7a5b6a483969191b7919396d99f9f84d9909881">[email protected]</span></a>.
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,
[[Page 1099]]
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of Interview Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------------------------
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: 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on January 9, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.