Federal Register #FDA-2025-N-6076

FDA Request for Public Comment on Information Collection for Required Warnings on Cigarette Packages and Advertisements

This opportunity is a request for public comment from the Food and Drug Administration (FDA) regarding information collection for required health warnings on cigarette packages and advertisements. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Office of Management and Budget (OMB) involved in review and clearance - Scope: - Supports regulations mandating color graphics and textual warnings about smoking health risks - Manufacturers, distributors, and retailers must submit compliance plans for warning display and rotation - Activities include reporting and recordkeeping, not procurement of products or services - Requirements: - Compliance with the Family Smoking Prevention and Tobacco Control Act and Federal Cigarette Labeling and Advertising Act - No collection of consumer data - No OEMs or vendors specified - Notable Details: - Strictly regulatory information gathering; not a procurement or award - Public comments are invited on the information collection process - Place of Performance: - FDA office at Three White Flint North, North Bethesda, MD

Description

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This collection supports FDA regulations requiring cigarette packages and advertisements to display color graphics and textual warnings about the negative health consequences of smoking. The submission includes plans from manufacturers, distributors, and retailers on how they will comply with these warning display and rotation requirements. Public comments on this information collection are invited until June 22, 2026.

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