§387v Reporting on tobacco regulation activities

Summary

The Secretary of Health and Human Services must make and send an annual report for fiscal year 2022 and for every 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 report must also be posted on the Food and Drug Administration website. Each report must show key numbers from the previous year. That includes total user fee money collected, how much was spent, and any unused balance carried over. It must say how the Center for Tobacco Products used the money for things like enforcement, public education, scientific work, communications, management, and overhead. The report must list counts of tobacco product applications by product class and by review route under sections 387e, 387j, and 387k and give their status (for example submitted, pending, accepted, refused to file, withdrawn, denied, authorized, given a deficiency or information request, or sent to the Tobacco Products Scientific Advisory Committee). It must list draft and final guidance and rules and whether they met deadlines, public meeting titles and counts, pre-submission meeting requests and waits (including median wait time), number of full-time staff paid from these fees and where they work in FDA, inspections at U.S. and foreign registered establishments, and the total number of enforcement actions (for example warning letters, fines, no-sale orders, seizures, injunctions, and criminal cases). If FDA cannot give exact numbers it may give its best estimates, but it must explain why, give a date it will fix its accounting, and say how it will use lessons from other fee programs to improve accuracy.