Notice2023-01978
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Monthly Monitoring Study
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 31, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 20 (Tuesday, January 31, 2023)</title>
</head>
<body><pre>
[Federal Register Volume 88, Number 20 (Tuesday, January 31, 2023)]
[Notices]
[Pages 6261-6262]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#bceceefdefc8dddadafcdad8dd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="7a2a283b290e1b1c1c3a1c1e1b54121209541d150c">[email protected]</span></a>.
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:
<bullet> 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?
<bullet> How is respondent tobacco use affected by environmental
factors, including peer influence and other external factors such as
COVID-19?
<bullet> What are the primary sources of new product information
and where are these products purchased/acquired?
<bullet> 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
</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 31, 2023.
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.