§379j–22 Reauthorization; reporting requirements

Summary

Starting with fiscal year 2024, in every year when fees are collected under this part, the Secretary must, within 120 days after the fiscal year ends, send two reports to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. One report must describe progress on the goals in the Animal Generic Drug User Fee Amendments of 2023 for speeding up development and review of generic new animal drugs, including abbreviated and supplemental applications and investigational submissions. The other report must explain how the fee authority was used that year and how the Food and Drug Administration spent the fees. Both reports must be posted on the FDA’s website. When making recommendations for the review process and for reauthorizing this part for the first five fiscal years after fiscal year 2028, the Secretary must talk with the two congressional committees, scientific and academic experts, veterinary professionals, patient and consumer groups, and the regulated industry. Before negotiating with the industry, the Secretary must ask the public for input in the Federal Register, hold a public meeting, allow 30 days for written comments, and post those comments online. During negotiations, the Secretary must meet with advocacy groups at least every four months. After negotiations, the Secretary must publish recommendations, allow 30 days for comment, hold a public meeting, revise the recommendations as needed, and send the final recommendations and a summary of public views to Congress by January 15, 2028. Minutes of all meetings with industry must be posted on the FDA website before the recommendations go to Congress and must summarize major proposals and disagreements and how they were resolved.