§379j–13 Reauthorization; reporting requirements

Summary

Starting in fiscal year 2024, not later than 120 days after the end of any year when fees are collected under this subpart, the Secretary must send two reports to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce. One report must describe FDA’s progress on the goals named in the letters in section 101(b) of the Animal Drug User Fee Amendments of 2023, including efforts to speed animal drug development and the review of new, supplemental, and investigational animal drug submissions, plans for meeting those goals, review times for abbreviated new animal drug applications, and the steps FDA has taken to keep those review times from increasing because of the user fee program. The second report must explain how the fee authority was used and how the collected fees were spent that year. Both reports must be posted on FDA’s website. For planning the review process and reauthorization 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 industry. Before starting negotiations with industry, the Secretary must publish a notice in the Federal Register asking for public input, hold a public meeting, allow 30 days after that meeting for written comments, and post those comments on FDA’s website. During negotiations, the Secretary must meet with veterinary, patient, and consumer groups at least once every four months. After negotiations, the Secretary must present recommendations to the same Congressional committees, publish them in the Federal Register, allow 30 days for public written comments, hold a public meeting for views, revise recommendations as needed, and send the revised recommendations and a summary of comments and changes to Congress by January 15, 2028. Before sending the recommendations to Congress, the Secretary must post on FDA’s website minutes of all negotiation meetings that summarize key proposals, major disagreements, and how those disagreements were resolved.