§387v Reporting on Tobacco Regulation Activities

Summary

The Secretary of Health and Human Services must prepare and send an annual report starting for fiscal year 2022 and for each later year when fees are collected under section 387s. The report is due no later than 180 days after the fiscal year ends. It must go to the House Committees on Energy and Commerce and on Appropriations, and to the Senate Committees on Health, Education, Labor, and Pensions and on Appropriations. The Secretary must also post the report on the FDA website. Each report must say, for the prior fiscal year, the total user fees collected, the total fees obligated, any unobligated carryover, and how the Center for Tobacco Products spent fees across its main activities (such as compliance and enforcement, public education, research, communications, management and admin, and related overhead). It must give counts of tobacco product applications by product class and review pathway and by outcome (for example submitted, pending, accepted, refused to file, withdrawn, denied, authorized for marketing, sent deficiency or environmental requests, or sent to the Tobacco Products Scientific Advisory Committee). The report must list the number and titles of guidance documents and regulations and whether deadlines were met; the number and titles of public meetings about application reviews; counts of pre-submission meeting requests, meetings held, and the median time to grant or deny requests; the number of full-time equivalent employees paid from these fees and where they work in FDA; the number of domestic and foreign inspections and investigations at registered establishments; and the total number of compliance and enforcement actions (including warning letters, civil money penalties, no-tobacco-sale orders, seizures, injunctions, and criminal prosecutions). If exact numbers are not available, the report may use best estimates but must explain why exact figures are missing and give a date when the FDA will fix its accounting. If other fee programs report exact figures but the Center for Tobacco Products gives an estimate, the report must explain how FDA will align systems and apply lessons so future reports are accurate.