Federal Register #FDA-2025-N-1600

FDA Seeks Public Comment on Youth Tobacco Campaign Outcomes Evaluation Study

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is seeking public comment on its proposed information collection for The Real Cost Campaign Outcomes Evaluation Study: Cohort 3. - Government Buyer: - Food and Drug Administration (FDA), Center for Tobacco Products - Department of Health and Human Services - Purpose and Scope: - Longitudinal evaluation of FDA's tobacco education campaigns targeting U.S. youth aged 11-17 - Study measures exposure, awareness, and behavioral outcomes related to tobacco use - Involves baseline and up to eight follow-up surveys, with data collection every 6-9 months - Estimated 14,053 youth participants per survey wave - Recruitment through mail and supplemental social media outreach - Data Collection and Requirements: - Collects demographic data (race, ethnicity, sexual orientation, biological sex) - Excludes gender identity questions to comply with current executive orders - Focuses on campaign effectiveness, demographic reach, and behavioral change - No OEMs or commercial vendors are specified, as this is a government-led research initiative - Place of performance and contracting office is FDA's Office of Operations at Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852

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 the evaluation of The Real Cost Campaign Outcomes Evaluation Study: Cohort 3, which assesses the impact of FDA's tobacco education campaigns on youth tobacco use behaviors and related outcomes. The study involves longitudinal data collection through surveys of youth aged 11-17, including baseline and multiple follow-up waves, to measure exposure, awareness, and impact of the campaigns. Comments on this information collection are requested by June 12, 2026.

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