§379j–62 Authority to Assess and Use Outsourcing Facility Fees

Summary

Starting in fiscal year 2015, the Secretary must charge every outsourcing facility an annual establishment fee and must charge a reinspection fee each time the facility is reinspected. The Secretary sets the fees each year using the rules below and must publish the fee amounts in the Federal Register at least 60 days before the year starts. The basic fee numbers are $15,000 for the annual establishment fee and $15,000 for each reinspection, both adjusted each year for inflation. The inflation change is calculated from recent FDA pay changes and the Consumer Price Index, weighted between personnel and other costs, and compounded year to year. Small businesses with gross annual sales of $1,000,000 or less for the 12 months ending April 1 of the prior year pay one‑third of the base $15,000 amount if they apply in writing by April 30 of that prior year in the format the Secretary requires. The Secretary also sets a small business adjustment so total fees collected match what would have been collected if no one got the small business discount, and must credit any overestimate to the next year. An establishment fee is due when a facility submits its annual registration. Reinspection fees are collected after a reinspection in the manner and on the timeline the Secretary announces. If fees are not paid, a facility is not considered registered for that year, its drugs are treated as misbranded until fees are paid, and unpaid fees not paid within 30 calendar days become a government claim collectible under federal law. All fees collected must be used only to pay the costs of overseeing outsourcing facilities. Fee money must add to, not replace, other federal funding for these activities. Fees are collected and spent only as allowed by appropriations acts and may remain available until spent. The Secretary may transfer needed sums from FDA accounts to pay oversight costs. Within 120 calendar days after each fiscal year, the Secretary must report to Congress on fees collected, who paid them, hiring and staff placement, how fee funds were used for inspections, and the number of inspections and reinspections. For fiscal year 2014 and later years, Congress may appropriate an amount equal to the total fees assessed.