Federal Register #FDA-2026-N-6540

FDA Requests Public Comment on Tobacco Product Violations Reporting Form Information Collection

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking public comment on its proposed extension of the Potential Tobacco Product Violations Reporting Form (Form FDA 3779) information collection. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - No OEMs or vendors are involved, as this is not a procurement or product solicitation. - Purpose: - Collect public reports of potential violations of federal tobacco laws, including sales to minors, flavored cigarette sales, and illegal marketing. - Gather information to support enforcement of the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act. - Key Details: - Estimated 3,000 respondents annually, each submitting two reports (total 6,000 responses). - Reports can be submitted online, by email, postal mail, or phone. - No products or services are being purchased or contracted. - Unique Requirements: - Focused on public feedback regarding the necessity, accuracy, and burden of the information collection process. - No technical or product-specific requirements, as this is an information collection request only.

Description

The Food and Drug Administration (FDA) is seeking public comment on the proposed collection of information related to the Potential Tobacco Product Violations Reporting Form. This form is used to collect information from the public regarding potential violations of the Federal Food, Drug, and Cosmetic Act as amended by the Tobacco Control Act, including sales to underage purchasers, flavored cigarette sales, illegal marketing, and other tobacco product violations. The FDA accepts reports via online submission, email, postal mail, or phone. Comments on this information collection must be submitted by August 24, 2026.

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