§379j–22 Reauthorization; Reporting Requirements

Summary

The Secretary must, starting in fiscal year 2024, send two yearly reports within 120 days after a fiscal year ends when fees were collected. One report must say how the FDA is doing on the goals named in the letters under section 201(b) of the Animal Generic Drug User Fee Amendments of 2023 for speeding up development and review of generic new animal drugs (this covers abbreviated, supplemental, and investigational submissions). The other 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 Health, Education, Labor, and Pensions Committee and the House Energy and Commerce Committee and be posted on the FDA website. When making recommendations to Congress about goals and plans for reviewing abbreviated applications for the first five fiscal years after fiscal year 2028 and about reauthorizing the fee program, the Secretary must consult with the two congressional committees, scientific and academic experts, veterinarians, patient and consumer advocates, and the regulated industry. Before negotiating with industry, the Secretary must ask for public input in the Federal Register, hold a public meeting, allow 30 days after that meeting for written comments, and post those comments online. During industry talks, the Secretary must meet with advocacy groups at least once every four months. After negotiations, the Secretary must publish and send the recommendations to Congress, allow 30 days for public comment, hold a meeting for public views, revise the recommendations as needed, and submit the final recommendations, a summary of comments, and any changes to Congress by January 15, 2028. Minutes of all negotiation meetings and summaries of major proposals and disputes must be posted on the FDA website before the recommendations go to Congress.