I am pleased to present to Congress the Food and Drug Administration’s (FDA or the Agency) Fiscal Year (FY) 2016 Performance Report to Congress for the Animal Drug User Fee Act (ADUFA). On June 13, 2013, the second reauthorization of ADUFA was signed into law. This reauthorization of ADUFA for another 5-year period (FY 2014 through FY 2018) is referred to as ADUFA III. This report marks the third year of ADUFA III.
This report details FDA’s preliminary performance for FY 2016, and finalizes performance results for FY 2015. It is my pleasure to report that FDA exceeded all performance goals for FY 2015. The Agency also met review-time goals for all FY 2016 cohort submissions reviewed or due for review by September 30, 2016. With some reviews still pending, FDA has the potential to exceed all performance goals for FY 2016.
FDA is committed to improving the efficiency, quality, and predictability of the new animal drug review process. We are dedicated to exploring new approaches and technologies that offer high-quality, cost-effective improvements in the Agency’s review of new animal drug applications and submissions. Under the leadership of the President and in collaboration with Congress and industry, FDA looks forward to the continued success and significant improvements in the animal drug review process made achievable by ADUFA.
Robert M. Califf, M.D.
Commissioner of Food and Drugs