[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]


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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.

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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\
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                                                                Number of
        Type of respondent/activity             Number of     responses per   Total annual           Average burden  per response           Total hours
                                               respondents     respondent       responses
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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
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    Total..................................  ..............  ..............  ..............  ...........................................          31,500
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\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