Document ID: FDA-2022-N-0863-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Monthly Monitoring Study
Posted Date: 2022-07-26T04:00Z

[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44405-44407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15955]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0863]

Agency Information Collection Activities; Proposed Collection; 
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 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 a notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on a proposed information collection entitled 
``Monthly Monitoring Study.''

DATES: Either electronic or written comments on the collection of 
information must be submitted by September 26, 2022.

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 September 26, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is 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 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-2022-N-0863 for the ``Monthly Monitoring Study'' 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.

[[Page 44406]]

    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 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.

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 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 12-17 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 the 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 tobacco use by minors, FDA requests OMB approval to collect 
data for the Monthly Monitoring Study.
    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.............................          27,000               1          27,000  0.04167 (2.5 minutes)......................           1,125
Youth Assent...............................          13,500               1          13,500  0.04167 (2.5 minutes)......................             563
Youth Online Survey........................          13,500               1          13,500  0.3333 (20 minutes)........................           4,500
Young Adult Screener.......................          27,000               1          27,000  0.04167 (2.5 minutes)......................           1,125
Young Adult Consent........................          13,500               1          13,500  0.04167 (2.5 minutes)......................             563

[[Page 44407]]

 
Young Adult Online Survey..................          13,500               1          13,500  0.3333 (20 minutes)........................           4,500
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    Total..................................  ..............  ..............  ..............  ...........................................          12,376
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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 2 to 1 ratio of eligible participants. We will need to screen 
approximately 54,000 potential participants (27,000 youth and 27,000 
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 15-17, and young adults ages 18-24, 
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 27,000 youth 
and young adults (13,500 youth and 13,500 young adults) over the course 
of the study period. Respondents will be allowed to complete an 
additional, cross-sectional survey after 6 months.

    Dated: July 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15955 Filed 7-25-22; 8:45 am]
BILLING CODE 4164-01-P