§379j–22 Reauthorization; Reporting Requirements

Summary

The Secretary must send two reports to the Senate Committee on Health, Education, Labor, and Pensions and the House Committee on Energy and Commerce within 120 days after the end of each fiscal year when fees are collected, starting with fiscal year 2024. One report must explain FDA’s progress on the goals in the 2023 Animal Generic Drug User Fee letters for speeding up development and review of generic new animal drugs and related submissions. The other must show how the fee authority was used and how the FDA spent the fees that year. Both reports must be posted on the FDA website. For reauthorization and planning for the first five fiscal years after fiscal year 2028, the Secretary must talk with the two congressional committees, experts, veterinarians, patient and consumer groups, and industry. Before negotiating with industry, the Secretary must ask for public input in the Federal Register, hold a public meeting, give 30 days for written comments, and post those comments on the FDA website. During negotiations, the Secretary must meet with veterinary, patient, and consumer groups at least once every four months. After negotiations, the Secretary must give revised recommendations to Congress, publish them in the Federal Register, allow 30 days for public comment, hold a public meeting, revise the recommendations as needed, and send the final recommendations plus a summary of public views and changes to Congress by January 15, 2028. The Secretary must also post minutes of all negotiation meetings on the FDA website that summarize major proposals, disagreements, and how they were resolved.