§379j–13 Reauthorization; Reporting Requirements

Summary

Starting in fiscal year 2024, the Secretary must prepare and send two reports no later than 120 days after the end of each fiscal year when fees are collected. The first report must explain how the FDA is doing on the goals from the Animal Drug User Fee Amendments of 2023 to speed animal drug development and reviews, list future plans, give review times for abbreviated new animal drug applications, and describe steps the FDA has taken to keep those review times from getting longer because of the fee program. The second report must explain how the fee authority was used and how the FDA spent the fees that year. Both reports must go to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce, and must be posted on the FDA website. When making recommendations to Congress about goals and reauthorizing the fee program for the five fiscal years after fiscal year 2028, the Secretary must consult with the two Congressional committees, scientists, veterinarians, patient and consumer groups, and the regulated industry. Before negotiating with industry, the Secretary must ask the public for input in the Federal Register, hold a public meeting, allow 30 days for written comments after the meeting, and post those comments online. During negotiations, the Secretary must meet with veterinary, patient, and consumer groups at least once every four months. After negotiations, the Secretary must present and publish recommendations, allow 30 days for public comments, hold a public meeting, revise recommendations as needed, and send the revised recommendations plus a summary of views and changes to Congress by January 15, 2028. The Secretary must also post minutes of all negotiation meetings on the FDA website, showing major proposals, disagreements, and how they were resolved.