[Federal Register Volume 91, Number 85 (Monday, May 4, 2026)]
[Notices]
[Pages 23995-23996]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-08604]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-3070]
Agency Information Collection Activities; Proposed Collection;
Comment Request; National Youth Tobacco Survey
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) 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 notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the National Youth Tobacco Survey.
DATES: Submit either electronic or written comments on the collection
of information by July 6, 2026.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 6, 2026. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 6, 2026. 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-2026-N-3070 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; National Youth Tobacco Survey.''
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.
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: Amber Barrett, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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, including
each proposed extension of an existing 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
[[Page 23996]]
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.
National Youth Tobacco Survey 2027-2029
OMB Control Number 0910-0932--Revision
This information collection supports the development and
implementation of the National Youth Tobacco Survey (NYTS), which is a
key component of FDA's youth tobacco surveillance. By providing
national estimates of youth tobacco use, the NYTS directly contributes
to FDA's ability to effectively regulate tobacco use and prevent youth
access to tobacco products in the United States. FDA's Center for
Tobacco Products (CTP) was created to carry out the authorities granted
under the Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) to educate the public about the dangers
of tobacco use and to serve as a public health resource for tobacco and
health information. CTP's tobacco surveillance research, including the
NYTS, directly contributes to advancing the goals of Executive Order
14212: Establishing the President's Make America Healthy Again
Commission, including the Make Our Children Healthy Again assessment,
in three ways. First, the NYTS helps FDA CTP evaluate the effect of
policies and regulations on efforts to reduce tobacco use, the leading
cause of chronic disease and mortality in the United States. Second,
the NYTS protects the health of children by influencing policies,
regulatory action, public education campaigns, and compliance and
enforcement efforts designed to decrease the likelihood of youth
tobacco initiation and reduce youth tobacco use. Third, the NYTS
gathers information about youth tobacco use by means of rigorous
scientific methods.
The NYTS has been conducted since 1999 and serves as the gold-
standard source of nationally representative estimates of youth tobacco
use in the United States. In 2025, after 14 years of study support and
collaboration, FDA took over leadership of the survey from the Centers
for Disease Control and Prevention (CDC) (previous OMB Control No.
0920-0621). The NYTS is an integral part of FDA CTP's aim to reduce
chronic disease and protect the health of children.
The survey will be conducted among a nationally representative
sample of students attending public and private schools in grades 6-12.
The survey will be digital, web-based, anonymous, self-administered,
and will be taken on school or personal computers, tablets, or mobile
devices. Information supporting the NYTS also will be collected from
state-, district-, and school-level administrators and teachers.
Information collected through the NYTS will be used to identify trends
in youth tobacco use over time, and to inform the development of public
education campaigns, policies and rules, and compliance and enforcement
programs for tobacco products.
The survey will examine the following topics: use of e-cigarettes,
cigarettes, cigars, smokeless tobacco (chewing tobacco, snuff, dip),
hookahs, pipes, snus, nicotine pouches, other oral nicotine products,
bidis, heated tobacco products, and roll-your-own cigarettes; knowledge
and attitudes; media and advertising; access to tobacco products and
enforcement of restrictions on access; secondhand smoke and e-cigarette
aerosol exposure, and cessation.
FDA estimates the burden of this collection of information as
follows:
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Number of
Type of respondent Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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State administrators......................... 42 1 42 0.5 (30 minutes)......................... 21
District administrators...................... 384 1 384 0.5 (30 minutes)......................... 192
School administrators........................ 555 1 555 0.5 (30 minutes)......................... 278
Teachers..................................... 1,388 1 1,388 0.25 (15 minutes)........................ 347
Parents/guardians............................ 3,500 1 3,500 0.17 (10 minutes)........................ 595
Students (questionnaire)..................... 29,575 1 29,575 0.75 (45 minutes)........................ 22,181
Students (cognitive testing screeners)....... 300 1 300 0.08 (5 minutes)......................... 24
Students (cognitive interviews).............. 70 1 70 1........................................ 70
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Total.................................... .............. .............. .............. ......................................... 23,708
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimated burden for the information collection reflects an
overall increase of 1,108 hours and a corresponding increase of 4,313
responses. For 2027-2029, there are no changes to the frequency of data
collection for the survey instrument. The burden per response is
approximately the same for state and district administrators, school
administrators, and teachers. We added burden estimates for parents who
complete active consent forms (i.e., forms that must be returned in
order for their child to participate) to account for states' increased
reliance on this type of consent. The total number of students sampled
increased slightly between 2024-2026 and 2027-2029, increasing the
burden slightly. This change is to accommodate declining response rates
for school-based studies, in other words, the need to sample a greater
number of students to get the same number of survey responses. The
burden for cognitive interviews is roughly equivalent.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08604 Filed 5-1-26; 8:45 am]
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