On the recordOctober 17, 2023
Mr. President, I ask unanimous consent to have printed in the Record at the appropriate place the commitment letters for the Animal Drug User Fee Amendments of 2023 and the Animal Generic Drug User Fee Amendments of 2023. There being no objection, the material was ordered to be printed in the Record, as follows: Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028 The goals and procedures of the Food and Drug Administration (FDA or the Agency) as agreed to under the ``Animal Drug User Fee Amendments of 2023'' 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 new animal drug (INAD) submission which either (1) approves or conditionally approves an animal drug application or approves a supplemental application or notifies a sponsor that an INAD submission is complete or (2) sets forth in detail the specific deficiencies in such animal drug application, supplemental animal drug application, or INAD submission and, where appropriate, the actions necessary to place such an application, supplemental application, or submission in condition for approval.…
Source
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