§379d–4 Reporting Requirements

Summary

The Secretary of Health and Human Services must, for fiscal years 2013 through 2017 and within 120 days after any fiscal year when fees were collected under subpart 7 of part C, send a report to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. The report must cover all generic drug approval applications under section 355(j), plus their amendments and prior approval supplements filed in the previous fiscal year. It must say how many met the goals the Secretary set in the Congressional Record letters, give the average total time to a decision (including days the FDA spent reviewing and days the sponsor spent answering a complete response letter), list how many had been pending for more than 10 months as of July 9, 2012, and say how many of those got final regulatory action in the previous fiscal year. Starting with fiscal year 2014, and within 120 days after any fiscal year when fees were collected under subpart 8 of part C, the Secretary must send the same two committees a report showing the number of applications filed under section 262(k) of title 42 and the percentage approved. That report must also explain how the FDA manages the biological product review program so that user fees collected under subpart 2 are not used to review applications under section 262(k).