Animal Drug and Animal Generic Drug User Fee Amendments of 2018

[AI summary unavailable — showing source text] Animal Drug and Animal Generic Drug User Fee Amendments of 2018 TITLE I--FEES RELATING TO ANIMAL DRUGS This bill addresses the authority of the Food and Drug Administration (FDA) to collect new animal drug (brand name animal drug) and generic animal drug user fees. Animal Drug User Fee Amendments of 2018 (Sec. 103) The bill amends the Federal Food, Drug, and Cosmetic Act to reauthorize through FY2023 the authority of the FDA to collect and use brand name animal drug user fees. The FDA must not collect fees for (1) supplemental applications that are submitted solely to add the animal drug application number to the label of the drug, and (2) applications for genetically engineered animals that are intended to produce human medical products. The bill revises the total amount of revenue brand name animal drug user fees can generate. The bill also revises the requirements for calculating adjustments to revenue amounts based on changes in the workload for reviewing brand name animal drug applications. (Sec. 104) The bill extends requirements for the FDA to report to Congress on achieving goals related to the animal drug development and review processes and implementation of the authority…