Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications, 1097-1099 [2024-00221]
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Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
Responses: 30; Total Annual Hours:
1,790. (For policy questions regarding
this collection contact: Beverly Boston
at 410–786–4186.)
3. Title of Information Collection:
Behavioral Health Clinic Quality Data
Reporting; Type of Information
Collection Request: Revision of an active
collection of information request; Use:
This Information Collection concerns
the Behavioral Health Clinic Quality
Data Reporting Template (hereinafter
‘‘Reporting Template’’ or ‘‘Template’’),
developed in partnership with the
Substance Abuse and Mental Health
Services Administration (SAMHSA) and
the Assistant Secretary for Planning and
Evaluation (ASPE) (collectively, ‘‘the
Agencies’’). The Reporting Template is
designed to collect quality measure data
and to report at the clinic level. The
Agencies developed the Template to
provide states and clinics with a
streamlined and structured tool to
report quality measures data. The
Reporting Template aims to eliminate
the time required for states or clinics to
develop their own reporting templates
for quality measure data reporting and
minimizes inconsistencies in reporting.
Furthermore, the Reporting Template,
with its accompanying instructions,
support an innovative approach to
improve behavioral health, a key focus
of health care reform. Form Number:
CMS–10398 (#48) (OMB control
number: 0938–1148); Frequency:
Annual; Affected Public: Private Sector
(Businesses or other for profits and Not
for profit institutions) and State, Local,
or Tribal Governments; Number of
Respondents: 429; Total Annual
Responses: 1,009; Total Annual Hours:
6,814. (For policy questions regarding
this collection contact: Beverly Boston
at 410–786–4186.)
Dated: January 4, 2024.
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–00205 Filed 1–8–24; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2020–N–0026]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
16:38 Jan 08, 2024
FOR FURTHER INFORMATION CONTACT:
Myrna Hanna, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), FDA will
award priority review vouchers to
sponsors of approved rare pediatric
disease product applications that meet
certain criteria. FDA has determined
that CASGEVY (exagamglogene
autotemcel), manufactured by Vertex
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
CASGEVY (exagamglogene
autotemcel) is indicated for treatment of
sickle cell disease in patients 12 years
of age and older with recurrent vasoocclusive crises.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/industry/
developing-products-rare-diseasesconditions/rare-pediatric-disease-rpddesignation-and-voucher-programs. For
further information about CASGEVY
(exagamglogene autotemcel), go to the
Center for Biologics Evaluation and
Research’s Approved Cellular and Gene
Therapy Products website at https://
www.fda.gov/vaccines-blood-biologics/
cellular-gene-therapy-products/
approved-cellular-and-gene-therapyproducts.
SUPPLEMENTARY INFORMATION:
Dated: January 4, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–00263 Filed 1–8–24; 8:45 am]
Notice.
VerDate Sep<11>2014
The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act)
authorizes FDA to award priority review
vouchers to sponsors of approved rare
pediatric disease product applications
that meet certain criteria. FDA is
required to publish notice of the award
of the priority review voucher. FDA has
determined that CASGEVY
(exagamglogene autotemcel),
manufactured by Vertex
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
SUMMARY:
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1097
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.
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.
SUMMARY:
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
E:\FR\FM\09JAN1.SGM
09JAN1
1098
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
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
VerDate Sep<11>2014
16:38 Jan 08, 2024
Jkt 262001
‘‘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-201509-18/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, PRAStaff@fda.hhs.gov.
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
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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,
E:\FR\FM\09JAN1.SGM
09JAN1
Federal Register / Vol. 89, No. 6 / Tuesday, January 9, 2024 / Notices
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.
1099
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. FDA estimates the
burden of this collection of information
as follows:
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 Indepth Interviews ...................
Indepth 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
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
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]
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16:38 Jan 08, 2024
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–3168]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Extralabel Drug
Use in Animals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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 February 8,
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
SUMMARY:
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by using the search function. The OMB
control number for this information
collection is 0910–0325. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, 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.
Extralabel Drug Use in Animals—21
CFR Part 530
OMB Control Number 0910–0325—
Extension
This information collection supports
FDA implementation of section 512 of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360b), which
governs new animal drugs. Agency
regulations in 21 CFR part 530 permit
FDA, if we find that there is a
reasonable probability that the
extralabel use of an animal drug may
present a risk to public health, to
establish a safe level for a residue from
E:\FR\FM\09JAN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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 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
[[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 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,
[[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
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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
