Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications, 92943-92944 [2024-27483]
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Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
Portal Discharge Tab, presented as an
appendix to the form.
Æ Add ‘‘Concurrent Planning:
Additional Potential Sponsors’’ segment
to Family Reunification Section with
the following fields (which will autopopulate from the Sponsor Assessment
(Form S–5, currently approved under
this information collection):
D Potential Sponsor Name.
D Relationship to Child.
D Sponsor Category.
Æ Split the ‘‘Know Your Rights
Presentation and Legal Screening’’ into
two distinct fields to capture the
completion date for each more
accurately, acknowledging that they
D Back-up Case Manager
Organization.
D Assigned on (MM/DD/YYYY).
Æ Adjust the burden estimate to
account for an increase in the number
of care provider facilities and number of
children placed in ORR care, as well as
the addition of the above listed new
segments and fields. The annual number
of respondents increased from 216 to
300, the annual number of responses per
respondent increased from 278 to 327,
and the average burden hours per
response increased from 0.08 hours to
0.25 hours.
Respondents: ORR grantee and
contractor staff.
Annual Burden Estimates:
typically are not completed on the same
day.
Æ Add ‘‘Back-Up Case Manager’’
segment to Case Manager Information
Section to designate an alternative Case
Manager who may take actions on
behalf of the primary Case Manager
when they are unavailable. The
corresponding fields mirror those for
primary case manager and will either be
system-generated or auto-populate with
user account data already entered the
system. The fields include:
D Back-up Case Manager Name.
D Back-up Case Manager Email
Address.
D Back-up Case Manager Phone
Number.
ANNUAL BURDEN ESTIMATE FOR RESPONDENTS
Annual
number of
respondents
Form
Average
burden hours
per response
Annual total
burden hours
Foster Care Travel Req. Form (S–14) ............................................................
Admission (S–18) ............................................................................................
UC Authorized/Restricted Call List and Call Log (S–20) ................................
Case Manager Call Log and Case Notes (S–23) ...........................................
UC Case Status (S–27) ...................................................................................
138
300
300
300
300
178
327
15,711
8,183
327
0.25
0.33
0.08
0.08
0.25
6,141
32,373
377,064
196,392
24,525
Estimated Annual Burden Hours Total .....................................................
........................
........................
........................
636,495
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 6 U.S.C. 279; 8 U.S.C.
1232.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–27505 Filed 11–22–24; 8:45 am]
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Number of
responses per
respondent
VerDate Sep<11>2014
18:29 Nov 22, 2024
Jkt 265001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–0180]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Quantitative Data
on Tobacco Products and
Communications
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 December
26, 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
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0810. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Generic Clearance for the Collection of
Quantitative Data on Tobacco Products
and Communications
OMB Control Number 0910–0810—
Extension
This information collection supports
FDA 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. Under this
umbrella, FDA’s Center for Tobacco
Products (CTP) conducts research and
uses a variety of media to inform and
E:\FR\FM\25NON1.SGM
25NON1
92944
Federal Register / Vol. 89, No. 227 / Monday, November 25, 2024 / Notices
educate stakeholders (e.g., the public,
tobacco retailers, and health
professionals) about the risks of tobacco
use, how to quit using tobacco products,
and FDA’s role in regulating tobacco.
To ensure that these educational and
public information programs have the
highest potential to be received,
understood, and accepted by those for
whom they are intended, CTP conducts
research to understand and identify and
develop health messages relating to the
control and prevention of disease. In
conducting such research, FDA uses
quantitative methods for studies about
tobacco products, including but not
limited to surveys, experimental
studies, quasi-experimental studies, and
the collection and analysis of digital
metrics. These studies are used to
collect information related to
foundational research informing
message development; formative
pretesting of tobacco communication
messages and other materials directed at
consumers; understanding the impact of
tobacco public education materials in
the digital environment; awareness of
and receptivity to tobacco public
education materials; and developing
and testing survey measures to inform
future research.
This type of research may involve: (1)
assessing audience knowledge,
attitudes, intentions, behaviors, and
other characteristics for the purpose of
determining the need for and
developing health messages,
communication strategies,
dissemination strategies, and public
information programs; (2) testing health
messages, strategies, and program
components while they are in
developmental form to assess audience
comprehension, reactions, and
perceptions, as well as after they have
been disseminated to consumers; and
(3) adding to the tobacco control, public
health communication, and regulatory
science knowledge base. Quantitative
studies play an important role in
exploring areas of research and
gathering information because they can
be used to summarize a population of
interest on key variables or reveal
systematic relationships between
variables.
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.
The voluntary information collected
serves the primary purpose of providing
FDA information about various
measures of ad performance including,
but not limited to, message
comprehension, perceived effectiveness,
emotional responses and knowledge,
attitudes, and behavioral intentions to
assess the ability of messages,
advertisements, and materials to reach
and successfully communicate with
their intended audiences. Additionally,
this information collection provides
FDA with insights into how to best
measure public education message
performance. Quantitative testing of
messages and other materials with a
sample of the target audience allows
FDA to refine and assess messages,
advertisements, and materials directed
at consumers.
In addition, quantitative information
is collected under this umbrella by FDA
to track changes in response to policy
and regulatory actions and to expand
the tobacco regulatory science base by
providing information on changing
behaviors, knowledge and attitudes
about tobacco products, including postmarketing surveillance of tobacco
products. In addition, quantitative
information is collected by FDA to track
changes in response to policy and
regulatory actions and to expand the
tobacco regulatory science base by
providing information on changing
behaviors, knowledge, and attitudes
about tobacco products, including
postmarketing surveillance of tobacco
products.
In the Federal Register of June 21,
2024 (89 FR 52055), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total annual
responses
Average burden per response
Total hours
Screener ............................................
Self-Administered Surveys ................
Informed Consent/Assent .................
1,360,000
204,000
204,000
1
1
1
1,360,000
204,000
204,000
0.083 (5 minutes) .............................
0.33 (20 minutes) .............................
0.033 (2 minutes) .............................
113,334
68,000
6,800
Total ...........................................
1,768,000
........................
........................
...........................................................
188,134
1 There
khammond on DSK9W7S144PROD with NOTICES
Number of
responses per
respondents
Number of
respondents
Activity
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 96,269 hours and a
corresponding increase of 1,106,692
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 quantitative 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
VerDate Sep<11>2014
18:29 Nov 22, 2024
Jkt 265001
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) to
support activities and initiatives that
will enable the public to receive
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
evidence-based, timely, and clear health
communication and education. As a
result, we have adjusted our burden
estimate and revised the number of
respondents to the information
collection.
Dated: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024–27483 Filed 11–22–24; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 89, Number 227 (Monday, November 25, 2024)]
[Notices]
[Pages 92943-92944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27483]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-0180]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Generic Clearance for
the Collection of Quantitative Data on Tobacco Products and
Communications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 December 26, 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 0910-0810. 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 Quantitative Data on Tobacco
Products and Communications
OMB Control Number 0910-0810--Extension
This information collection supports FDA 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. Under this umbrella, FDA's Center for Tobacco
Products (CTP) conducts research and uses a variety of media to inform
and
[[Page 92944]]
educate stakeholders (e.g., the public, tobacco retailers, and health
professionals) about the risks of tobacco use, how to quit using
tobacco products, and FDA's role in regulating tobacco.
To ensure that these educational and public information programs
have the highest potential to be received, understood, and accepted by
those for whom they are intended, CTP conducts research to understand
and identify and develop health messages relating to the control and
prevention of disease. In conducting such research, FDA uses
quantitative methods for studies about tobacco products, including but
not limited to surveys, experimental studies, quasi-experimental
studies, and the collection and analysis of digital metrics. These
studies are used to collect information related to foundational
research informing message development; formative pretesting of tobacco
communication messages and other materials directed at consumers;
understanding the impact of tobacco public education materials in the
digital environment; awareness of and receptivity to tobacco public
education materials; and developing and testing survey measures to
inform future research.
This type of research may involve: (1) assessing audience
knowledge, attitudes, intentions, behaviors, and other characteristics
for the purpose of determining the need for and developing health
messages, communication strategies, dissemination strategies, and
public information programs; (2) testing health messages, strategies,
and program components while they are in developmental form to assess
audience comprehension, reactions, and perceptions, as well as after
they have been disseminated to consumers; and (3) adding to the tobacco
control, public health communication, and regulatory science knowledge
base. Quantitative studies play an important role in exploring areas of
research and gathering information because they can be used to
summarize a population of interest on key variables or reveal
systematic relationships between variables.
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.
The voluntary information collected serves the primary purpose of
providing FDA information about various measures of ad performance
including, but not limited to, message comprehension, perceived
effectiveness, emotional responses and knowledge, attitudes, and
behavioral intentions to assess the ability of messages,
advertisements, and materials to reach and successfully communicate
with their intended audiences. Additionally, this information
collection provides FDA with insights into how to best measure public
education message performance. Quantitative testing of messages and
other materials with a sample of the target audience allows FDA to
refine and assess messages, advertisements, and materials directed at
consumers.
In addition, quantitative information is collected under this
umbrella by FDA to track changes in response to policy and regulatory
actions and to expand the tobacco regulatory science base by providing
information on changing behaviors, knowledge and attitudes about
tobacco products, including post-marketing surveillance of tobacco
products. In addition, quantitative information is collected by FDA to
track changes in response to policy and regulatory actions and to
expand the tobacco regulatory science base by providing information on
changing behaviors, knowledge, and attitudes about tobacco products,
including postmarketing surveillance of tobacco products.
In the Federal Register of June 21, 2024 (89 FR 52055), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondents responses per response
----------------------------------------------------------------------------------------------------------------
Screener...................... 1,360,000 1 1,360,000 0.083 (5 113,334
minutes).
Self-Administered Surveys..... 204,000 1 204,000 0.33 (20 68,000
minutes).
Informed Consent/Assent....... 204,000 1 204,000 0.033 (2 6,800
minutes).
---------------------------------------------------------------------------------
Total..................... 1,768,000 .............. .............. ................ 188,134
----------------------------------------------------------------------------------------------------------------
\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 96,269 hours and a corresponding increase of
1,106,692 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 quantitative 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) to support activities and initiatives that will
enable the public to receive evidence-based, timely, and clear health
communication and education. As a result, we have adjusted our burden
estimate and revised the number of respondents to the information
collection.
Dated: November 19, 2024.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2024-27483 Filed 11-22-24; 8:45 am]
BILLING CODE 4164-01-P
