21 U.S.C. § 379j–22 — Reauthorization; reporting requirements

(a) Performance reports. Starting with fiscal year 2024, within 120 days after each fiscal year in which fees are collected, the FDA must report to the Senate HELP Committee and House Energy and Commerce Committee on its progress toward the goals in the 2023 Animal Generic Drug User Fee Amendments letters — specifically, speeding up generic new animal drug development and reviewing abbreviated applications, supplemental abbreviated applications, and investigational submissions for generic new animal drugs. (b) Fiscal report. Starting with fiscal year 2024, within 120 days after each fee-collection year, the FDA must also report to the same two committees on how it used its fee authority and the fees collected that year. (c) Public availability. The FDA must post both reports online for the public. (d) Reauthorization. (1) Consultation. In developing goals and plans for the 5 fiscal years after FY2028, and for renewing this fee program, the FDA must consult with the House Energy and Commerce Committee, the Senate HELP Committee, scientific and academic experts, veterinary professionals, patient and consumer advocacy groups, and the regulated industry. (2) Prior public input. Before negotiating with industry on renewal, the FDA must publish a Federal Register notice asking for public input, hold a public meeting on possible goal changes, allow 30 days after the meeting for written public comments, and post those comments online. (3) Periodic consultation. At least once every 4 months during industry negotiations, the FDA must discuss the renewal with veterinary, patient, and consumer advocacy groups and hear their suggestions. (4) Public review of recommendations. After negotiating with industry, the FDA must present its recommendations to the two committees, publish them in the Federal Register, allow 30 days for public written comments, hold a meeting for public views, and revise the recommendations as needed based on that input. (5) Transmittal of recommendations. By January 15, 2028, the FDA must send Congress its revised recommendations, a summary of the comments received, and any changes made in response. (6) Minutes of negotiation meetings. Before presenting its recommendations to Congress, the FDA must post online the minutes of every negotiation meeting it held with industry. Those minutes must summarize any substantive proposal made by either side, plus any major disagreements and how they were resolved.