§379j–13 Reauthorization; Reporting Requirements

Summary

The Secretary must send two reports each year starting with fiscal year 2024, no later than 120 days after the end of any fiscal year when fees were collected. One report must explain how the FDA did that year at meeting the goals in the letters mentioned in section 101(b) of the Animal Drug User Fee Amendments of 2023 to speed up animal drug development and the review of new, supplemental, and investigational animal drug submissions. It must also say the FDA’s plans to meet those goals, give review times for abbreviated new animal drug applications, and describe steps to keep those review times from getting longer because of the user fee program. The other report must describe how the fee authority was used that year and how the FDA spent the fees. Both reports must be sent to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and they must be posted on the FDA website. Before asking Congress to reauthorize this fee program for the first five fiscal years after fiscal year 2028, the Secretary must consult with the two Congressional committees, scientific and academic experts, veterinarians, patient and consumer advocates, and the regulated industry. The Secretary must first ask for public input in the Federal Register, hold a public meeting, allow 30 days after the meeting for written comments, and post those comments on the FDA website. During talks with industry, the Secretary must meet at least every 4 months with veterinary, patient, and consumer groups. After talks, the Secretary must publish recommendations in the Federal Register, allow 30 days for comment, hold a public meeting, revise the recommendations as needed, and send the revised recommendations plus a summary of views and changes to Congress by January 15, 2028. Minutes of all negotiation meetings must be posted on the FDA website before the recommendations go to Congress and must summarize major proposals, disagreements, and how they were resolved.