§387v Reporting on Tobacco Regulation Activities

Summary

The Secretary of Health and Human Services must prepare and send an annual report, no later than 180 days after the end of each fiscal year starting with fiscal year 2022 when fees are collected under section 387s. The report must go to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. Each report must show totals for fee collections, amounts obligated and unobligated carryover, and how the Center for Tobacco Products spent money on things like compliance and enforcement, public education, research, communications, leadership/management, and overhead. It must list counts of applications by product class and review pathway under sections 387e, 387j, and 387k and their statuses (for example submitted, pending, accepted, refused to file, withdrawn, denied, authorized, given deficiency or environmental letters, or sent to the advisory committee). The report must also list guidance and rule documents and whether deadlines were met; public meetings and their titles; pre‑submission meeting requests, meetings held, and median wait time for decisions for section 387j; full‑time equivalent staff paid by these fees and their FDA locations; inspections and investigations at registrant establishments under section 387e; and totals for compliance and enforcement actions (including warning letters, civil money penalties, no‑sale orders, seizures, injunctions, and criminal prosecutions). The FDA must post the reports on its website. If exact figures are not available, the FDA must give its best estimates, explain why the exact number is missing, give a date to fix its accounting, and say how it will align systems across the agency when the Center for Tobacco Products provides an estimate but another fee program reports exact data.