Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Monthly Monitoring Study, 6261-6262 [2023-01978]
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Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
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[FR Doc. 2023–01975 Filed 1–30–23; 8:45 am]
BILLING CODE 6730–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–0863]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Monthly
Monitoring Study
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:46 Jan 30, 2023
Jkt 259001
collection of information by March 2,
2023.
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 title
of this information collection is
‘‘Monthly Monitoring Study.’’ Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
Monthly Monitoring Study
OMB Control Number 0910–NEW
This information collection supports
the development and implementation of
FDA public education campaigns
related to tobacco use. To reduce the
public health burden of tobacco use in
the United States and educate the
public—especially young people—about
the dangers of tobacco use, FDA’s
Center for Tobacco Products (CTP) is
developing and implementing multiple
public education campaigns.
FDA launched ‘‘The Real Cost’’ in
February 2014, seeking to reduce
tobacco use among at-risk youth ages 12
to 17 years old in the United States who
are open to smoking cigarettes and/or
using electronic nicotine delivery
systems (ENDS) products, or have
already experimented with cigarettes
and/or ENDS products. Given the
rapidly evolving tobacco landscape in
the United States, frequent and nimble
data collection strategies are needed to
keep pace and provide relevant
information to FDA to inform its
tobacco prevention media campaign
development about changes in tobacco
use and emerging products among youth
and young adults.
In an effort to inform specified
recommendations around ‘‘The Real
Cost’’ and FDA’s other public education
programs to reduce tobacco-related
death and disease, more research is
needed to understand the trends in use
and perceptions of novel and emerging
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
6261
tobacco products, as well as awareness
and preferences related to emerging
tobacco products and specific brands
and device types so that FDA can
develop new media campaign messages
that resonate with youth and young
adults. The purpose of the Monthly
Monitoring Study is to collect primary
data from youth and young adults, ages
15 to 24 years old, in the United States
to monitor perceptions and use of
emerging and novel tobacco products
and emerging trends in brand and
device awareness and use.
The study will be conducted using
web-based surveys that are selfadministered on personal computers or
web enabled mobile devices. The study
will use an online survey to collect data
from up to 27,000 youth and young
adults ages 15 to 24 years to monitor
perceptions about and trends in use of
ENDS and other emerging tobacco
products. Participants will be recruited
through social media advertisements. To
achieve the required pace of data
collection, the study will not contact
parents of youth under 18 years old for
parental permission and will obtain a
waiver of parental permission from the
institutional review board. The study
will include questions about marijuana
use to allow the study team to
differentiate between use of current and
emerging tobacco products and
marijuana, which can be used in
tobacco products such as ENDS and
little cigar/cigarillos. The survey will
take approximately 20 minutes to
complete per participant. This survey
will ask participants to provide
feedback on tobacco use and quitting
behavior, as well as brand and device
preferences, tobacco information
sources, peer influence and perceptions,
and marijuana use.
The aim of the Monthly Monitoring
Study is to answer the following
questions:
• What are the trends in brand and
device use for ENDS products and other
emerging tobacco products among youth
and young adults ages 15 to 24 years in
the United States? What are their
perceptions of these products?
• How is respondent tobacco use
affected by environmental factors,
including peer influence and other
external factors such as COVID–19?
• What are the primary sources of
new product information and where are
these products purchased/acquired?
• What are the primary sources of
health information for ENDS and other
emerging tobacco products?
In support of the provisions of the
Family Smoking Prevention and
Tobacco Control Act that require FDA to
protect the public health and to reduce
E:\FR\FM\31JAN1.SGM
31JAN1
6262
Federal Register / Vol. 88, No. 20 / Tuesday, January 31, 2023 / Notices
tobacco use by minors, FDA requests
OMB approval to collect data for the
Monthly Monitoring Study.
In the Federal Register of July 26,
2022 (87 FR 44405), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. One PRA related comment
was received.
(Comment) The commenter stated that
they believed the study should include
children as young as age 10 years.
(Response) The age range for
inclusion of this study (15 to 24 years)
is based on the target audience for CTP/
Office of Health Communication and
Education’s campaigns, which are
adolescents and young adults.
Additionally, we are limited by the
social media mode of data collection
(platforms generally do not allow
children younger than 13 years old to
have accounts) and by the Children’s
Online Privacy Protection Rule, which
does not allow us to contact youth 13
years old and under without parental
permission. Furthermore, lowering the
age range would greatly increase the
time needed to field the survey, as well
as the costs. Given that parental
permission is not feasible for the social
media-based recruitment, we must be
granted a waiver of parental permission
from our institutional review board. Our
institutional review board has not
historically granted a waiver of parental
permission for respondents younger
than 15 years old.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of
respondents
Type of respondent/activity
Total annual
responses
Youth Screener ......................................................
Youth Assent ..........................................................
Youth Online Survey ..............................................
Young Adult Screener ............................................
Young Adult Consent .............................................
Young Adult Online Survey ....................................
135,000
27,000
27,000
135,000
27,000
27,000
1
1
1
1
1
1
135,000
27,000
27,000
135,000
27,000
27,000
Total ................................................................
........................
........................
........................
1 There
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
Average burden
per response
0.04167
0.04167
0.33333
0.04167
0.04167
0.33333
Total hours
(2.5 minutes)
(2.5 minutes)
(20 minutes) ..
(2.5 minutes)
(2.5 minutes)
(20 minutes) ..
5,625
1,125
9,000
5,625
1,125
9,000
.....................................
31,500
are no capital costs or operating and maintenance costs associated with this collection of information.
We expect the screening process (2.5
minutes per response) to yield a 5 to 1
ratio of eligible participants. We will
need to screen approximately 270,000
potential participants (135,000 youth
and 135,000 young adults) over the
study period. Participants determined to
be eligible through the screener will
complete a youth assent or young adult
consent (2.5 minutes per response) and
the online survey (20 minutes per
response).
Over the course of the study period,
we intend to survey approximately
1,500 youth ages 15 to 17 years old, and
young adults ages 18 to 24 years old,
every 1 to 2 months. The survey will be
repeated with a new cross-sectional
sample approximately every month or
every other month over a period of 18
months. We will obtain a final sample
size of 54,000 youth and young adults
(27,000 youth and 27,000 young adults)
over the course of the study period.
Respondents will be allowed to
complete an additional, cross-sectional
survey after 6 months.
We made the following changes
between the 30-day and 60-day
publications: In reviewing recruitment
metrics for two similar CTP studies, we
found an average of 5:1 screening to
survey completion ratio. Therefore, we
adjusted the number of required
screeners and burden hours accordingly.
VerDate Sep<11>2014
16:46 Jan 30, 2023
Jkt 259001
Dated: January 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–01978 Filed 1–30–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0249]
Authorization of Emergency Use of
Two In Vitro Diagnostic Devices in
Response to an Outbreak of Mpox;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of Emergency Use
Authorizations (EUAs) (the
Authorizations) under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) in
response to an outbreak of mpox. FDA
has issued an Authorization for an in
vitro diagnostic device as requested by
Becton, Dickinson & Company (BD) and
DiaCarta, Inc. The Authorizations
contain, among other things, conditions
on the emergency use of the authorized
products. The Authorizations follow the
August 9, 2022, determination by the
Secretary of Health and Human Services
SUMMARY:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
(HHS) that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
and that involves monkeypox virus. On
the basis of such determination, the
Secretary of HHS declared, on
September 7, 2022, that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of infection
with the monkeypox virus, including in
vitro diagnostics that detect and/or
diagnose infection with non-variola
Orthopoxvirus, pursuant to the FD&C
Act, subject to terms of any
authorization issued under that section.
The Authorizations, which include an
explanation of the reasons for issuance,
are reprinted in this document.
DATES: The Authorization issued to BD
for the VIASURE Monkeypox virus Real
Time PCR Reagents for BD MAX System
is effective as of December 23, 2022. The
Authorization issued to DiaCarta, Inc.
for the QuantiVirus MPXV Test Kit is
effective as of January 10, 2023.
ADDRESSES: Submit written requests for
a single copy of the EUAs to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
E:\FR\FM\31JAN1.SGM
31JAN1
]]>Agencies
[Federal Register Volume 88, Number 20 (Tuesday, January 31, 2023)]
[Notices]
[Pages 6261-6262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-01978]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0863]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Monthly Monitoring
Study
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 March 2, 2023.
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 title of this
information collection is ``Monthly Monitoring Study.'' 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.
Monthly Monitoring Study
OMB Control Number 0910-NEW
This information collection supports the development and
implementation of FDA public education campaigns related to tobacco
use. To reduce the public health burden of tobacco use in the United
States and educate the public--especially young people--about the
dangers of tobacco use, FDA's Center for Tobacco Products (CTP) is
developing and implementing multiple public education campaigns.
FDA launched ``The Real Cost'' in February 2014, seeking to reduce
tobacco use among at-risk youth ages 12 to 17 years old in the United
States who are open to smoking cigarettes and/or using electronic
nicotine delivery systems (ENDS) products, or have already experimented
with cigarettes and/or ENDS products. Given the rapidly evolving
tobacco landscape in the United States, frequent and nimble data
collection strategies are needed to keep pace and provide relevant
information to FDA to inform its tobacco prevention media campaign
development about changes in tobacco use and emerging products among
youth and young adults.
In an effort to inform specified recommendations around ``The Real
Cost'' and FDA's other public education programs to reduce tobacco-
related death and disease, more research is needed to understand the
trends in use and perceptions of novel and emerging tobacco products,
as well as awareness and preferences related to emerging tobacco
products and specific brands and device types so that FDA can develop
new media campaign messages that resonate with youth and young adults.
The purpose of the Monthly Monitoring Study is to collect primary data
from youth and young adults, ages 15 to 24 years old, in the United
States to monitor perceptions and use of emerging and novel tobacco
products and emerging trends in brand and device awareness and use.
The study will be conducted using web-based surveys that are self-
administered on personal computers or web enabled mobile devices. The
study will use an online survey to collect data from up to 27,000 youth
and young adults ages 15 to 24 years to monitor perceptions about and
trends in use of ENDS and other emerging tobacco products. Participants
will be recruited through social media advertisements. To achieve the
required pace of data collection, the study will not contact parents of
youth under 18 years old for parental permission and will obtain a
waiver of parental permission from the institutional review board. The
study will include questions about marijuana use to allow the study
team to differentiate between use of current and emerging tobacco
products and marijuana, which can be used in tobacco products such as
ENDS and little cigar/cigarillos. The survey will take approximately 20
minutes to complete per participant. This survey will ask participants
to provide feedback on tobacco use and quitting behavior, as well as
brand and device preferences, tobacco information sources, peer
influence and perceptions, and marijuana use.
The aim of the Monthly Monitoring Study is to answer the following
questions:
What are the trends in brand and device use for ENDS
products and other emerging tobacco products among youth and young
adults ages 15 to 24 years in the United States? What are their
perceptions of these products?
How is respondent tobacco use affected by environmental
factors, including peer influence and other external factors such as
COVID-19?
What are the primary sources of new product information
and where are these products purchased/acquired?
What are the primary sources of health information for
ENDS and other emerging tobacco products?
In support of the provisions of the Family Smoking Prevention and
Tobacco Control Act that require FDA to protect the public health and
to reduce
[[Page 6262]]
tobacco use by minors, FDA requests OMB approval to collect data for
the Monthly Monitoring Study.
In the Federal Register of July 26, 2022 (87 FR 44405), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One PRA related comment was received.
(Comment) The commenter stated that they believed the study should
include children as young as age 10 years.
(Response) The age range for inclusion of this study (15 to 24
years) is based on the target audience for CTP/Office of Health
Communication and Education's campaigns, which are adolescents and
young adults. Additionally, we are limited by the social media mode of
data collection (platforms generally do not allow children younger than
13 years old to have accounts) and by the Children's Online Privacy
Protection Rule, which does not allow us to contact youth 13 years old
and under without parental permission. Furthermore, lowering the age
range would greatly increase the time needed to field the survey, as
well as the costs. Given that parental permission is not feasible for
the social media-based recruitment, we must be granted a waiver of
parental permission from our institutional review board. Our
institutional review board has not historically granted a waiver of
parental permission for respondents younger than 15 years old.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Youth Screener............................. 135,000 1 135,000 0.04167 (2.5 minutes)...................... 5,625
Youth Assent............................... 27,000 1 27,000 0.04167 (2.5 minutes)...................... 1,125
Youth Online Survey........................ 27,000 1 27,000 0.33333 (20 minutes)....................... 9,000
Young Adult Screener....................... 135,000 1 135,000 0.04167 (2.5 minutes)...................... 5,625
Young Adult Consent........................ 27,000 1 27,000 0.04167 (2.5 minutes)...................... 1,125
Young Adult Online Survey.................. 27,000 1 27,000 0.33333 (20 minutes)....................... 9,000
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. ........................................... 31,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We expect the screening process (2.5 minutes per response) to yield
a 5 to 1 ratio of eligible participants. We will need to screen
approximately 270,000 potential participants (135,000 youth and 135,000
young adults) over the study period. Participants determined to be
eligible through the screener will complete a youth assent or young
adult consent (2.5 minutes per response) and the online survey (20
minutes per response).
Over the course of the study period, we intend to survey
approximately 1,500 youth ages 15 to 17 years old, and young adults
ages 18 to 24 years old, every 1 to 2 months. The survey will be
repeated with a new cross-sectional sample approximately every month or
every other month over a period of 18 months. We will obtain a final
sample size of 54,000 youth and young adults (27,000 youth and 27,000
young adults) over the course of the study period. Respondents will be
allowed to complete an additional, cross-sectional survey after 6
months.
We made the following changes between the 30-day and 60-day
publications: In reviewing recruitment metrics for two similar CTP
studies, we found an average of 5:1 screening to survey completion
ratio. Therefore, we adjusted the number of required screeners and
burden hours accordingly.
Dated: January 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-01978 Filed 1-30-23; 8:45 am]
BILLING CODE 4164-01-P
