[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]
BILLING CODE 4164-01-P