FDA-TRACK: Animal Drug User Fee Act Performance - INAD H Submissions Submitted at Division Level
Animal Drug Applications and Supplements
Other Performance Goals
On September 30, 2023, the fourth reauthorization of the Animal Drug User Fee Act (ADUFA), referred to as ADUFA V, was signed into law. ADUFA V amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional five years (FY 2024 through FY 2028). ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provides FDA with resources to improve its review of applications for new animal drugs, with the result that safe and effective new products will be more readily available.
Per the ADUFA V goals letter, beginning in FY 2024, FDA will report quarterly in FDA‐TRACK the number of H submissions submitted to each review division in the Office of New Animal Drug Evaluation. H submissions have a 100-day review clock and are submitted under Investigation New Animal Drug files in support of a meeting request, in support of a protocol, or to reach agreement on the raw data to submit in a Target Animal Safety data submission.
Note: Current Fiscal Year represents performance year-to-date. (10/1/2023 - 6/30/2024)
| Division Code | Code Description |
|---|---|
| DABCT | Division of Animal Biotechnology and Cellular Therapies |
| DBISM | Division of Business Information Science and Management |
| DCAD | Division of Companion Animal Drugs |
| DFAD | Division of Food Animal Drugs |
| DHFS | Division of Human Food Safety |
| DMT | Division of Manufacturing Technologies |
| DSS | Division of Scientific Support |
Download INAD H Submissions Submitted at Division Level Dataset
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.