Heidi Alexander: “I ask unanimous consent to have printed in the Record the commitment letter for the Animal Generic Drug User Fee…”

“I ask unanimous consent to have printed in the Record the commitment letter for the Animal Generic Drug User Fee Agreements of 2018. There being no objection, the material was ordered to be printed in the Record, as follows: Animal Generic Drug User Fee Amendments of 2018 agdufa reauthorization performance goals and procedures for fy's 2019 thru 2023 The goals and procedures of the Food and Drug Administration (FDA or the Agency) as agreed to under the ``Animal Generic Drug User Fee Amendments of 2018'' are summarized as follows: application/submission goals Beginning October 1, 2018, all applications and submissions under the Federal Food, Drug, and Cosmetic Act (FD&C Act) section 512(b) must be created using the eSubmitter tool and submitted to the Agency through the FDA Center for Veterinary Medicine (CVM) Electronic Submission System (ESS). 1. Original Abbreviated New Animal Drug Applications (ANADAs) and Reactivations Review and act on 90 percent of original ANADAs within 240 days after the submission date. An application is incomplete if it would require additional data or information to enable the Agency to complete a comprehensive review of the application and reach a decision on the issue(s) presented in the application. If the Agency determines that the deficiencies are not substantial, the Agency will review and act on 90 percent of reactivated applications within 120 days after the reactivated ANADA submission date.…”