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

“I ask unanimous consent to have printed in the Record the commitment letter for the Animal Drug User Fee Agreements of 2018. There being no objection, the material was ordered to be printed in the Record, as follows: Animal Drug User Fee Amendments of 2018 ADUFA Reauthorization Performance Goals and Procedures--FYs 2019 thru 2023 The goals and procedures of the FDA Center for Veterinary Medicine (CVM) as agreed to under the ``Animal Drug User Fee Amendments of 2018'' are summarized as follows: I. Definitions 1. For the application/submission goals below, the term ``review and act on'' is understood to mean the issuance of a complete action letter after the complete review of an animal drug application, supplemental animal drug application, or investigational animal drug submission which either (1) approves an animal drug application or supplemental application or notifies a sponsor that an investigational animal drug submission is complete or (2) sets forth in detail the specific deficiencies in such animal drug application, supplemental animal drug application, or investigational animal drug submission and, where appropriate, the actions necessary to place such an application, supplemental application, or submission in condition for approval.…”