§379d–4 Reporting requirements

Summary

Require the Secretary of Health and Human Services to send yearly reports to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. From fiscal year 2013 through fiscal year 2017, the Secretary must, within 120 days after the end of each fiscal year when fees are collected under subpart 7 of part C, report about all applications for approval of generic drugs under section 355(j), related amendments, and prior-approval supplements filed in the prior fiscal year. The report must say how many met the goals set in the Secretary’s letters recorded in the Congressional Record, the average total time to decision (including FDA review days and days the sponsor spent answering a complete response letter), how many were pending more than 10 months as of July 9, 2012, and how many of those had final regulatory action in the prior year. Starting with fiscal year 2014, the Secretary must, within 120 days after each fiscal year when fees are collected under subpart 8 of part C, report to the same committees the number of applications filed under section 262(k) of title 42 and the percentage approved. The report must also explain how the FDA runs the biological product review program so that user fees collected under subpart 2 of part C are not used to review a section 262(k) application.