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Food and Drug Administration, HHS.
Notice.
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.
Submit either electronic or written comments on the collection of information by July 6, 2026.
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.
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
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.
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.
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, PRAStaff@fda.hhs.gov.
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 ( printed 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.
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:
| Type of respondent | Number of respondents | Number of responses per respondent | Total annual responses | Average burden per response | Total hours |
|---|---|---|---|---|---|
| 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 |
| Total | 23,708 | ||||
| 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
34 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.