Meeting the Statutory Conditions for User Fees in FY 2010
MDUFMA imposes three statutory conditions that FDA must satisfy before it can collect and spend user fees. FDA’s calculations show that FDA met these conditions in FY 2010, as summarized below.
The first condition is a funding condition that affects FDA’s fee collections in FY 2010. MDUFMA, as amended, specifies a minimum amount that must be appropriated for the Device and Radiological Health line of FDA’s appropriation, exclusive of user fees, for each year. For FY 2010, that minimum amount is $250,722,000 (rounded to the nearest whole thousand dollars). In FY 2010, the final appropriation for the Device and Radiological Health line of FDA’s appropriation, exclusive of user fees, was $315,377,000. Therefore, FDA met the first condition.
The second condition is that the amount of user fees collected by FDA in each fiscal year must be specifically stated in the Appropriations Acts. The President signed the FY 2010 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriation Act, Public Law 111-80, on October 21, 2009. It states that the amount collectable from medical device user fees is $57,014,000. Therefore, FDA met the second condition.
The third condition is that user fees may only be retained and spent in years when FDA also spends a specified minimum level of appropriated funds, exclusive of user fees, for the review of medical device applications. The minimum level is the appropriations that FDA spent on the process for the review of medical device applications in FY 2002, multiplied by an adjustment factor. That adjusted minimum level for FY 2010 is $145,852,218. FDA obligated $235,520,440 from appropriations, exclusive of user fees, in FY 2010 on the process for the review of device applications as defined in MDUFMA. Because FDA spent more than the specified minimum level, FDA met the third condition.
MDUFMA also contains a provision that FDA obligations for medical device establishment inspections must be equal to or greater than the amount spent in FY 2002, increased by five percent each fiscal year. If this condition is not met for two consecutive years, FDA is not allowed to use accredited third parties to conduct certain medical device establishment inspections in the future years. Because spending on medical device establishment inspections exceeded the specified minimum level for each of the most recent two fiscal years, FDA may continue to permit accredited third parties to conduct certain medical device establishment inspections in future years.
Additional details on the calculations that show that FDA satisfied these statutory conditions are provided in Appendix A.