Notice2022-15955
Agency Information Collection Activities; Proposed Collection; 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
July 26, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 142 (Tuesday, July 26, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 142 (Tuesday, July 26, 2022)]
[Notices]
[Pages 44405-44407]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15955]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
[[Page 44406]]
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#411113001235202727012725206f2929326f262e37"><span class="__cf_email__" data-cfemail="441416051730252222042220256a2c2c376a232b32">[email protected]</span></a>.
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:
<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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of respondent/activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. ........................................... 12,376
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on July 26, 2022.
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.