§379j–73 Reauthorization; reporting requirements

Summary

Prepare and send an annual report within 120 calendar days after each fiscal year ends to the House Energy and Commerce Committee and the Senate HELP Committee about how the FDA is doing on the OTC monograph goals and what it plans to do next. Starting with fiscal year 2026, that report must also show counts of certain types of OTC monograph order requests (Tier 1, Tier 2, specified safety, and generally recognized as safe and effective) for which proposed and final orders were issued in the prior year, average processing times overall and by submission type, postmarket safety work (like collecting adverse event reports, using better analysis and IT systems and outside databases, and actions under section 379aa), which OTC facilities and contract manufacturers were first registered under sections 360(c) or 360(i) and which paid assessed facility fees, how evidence and testing standards under section 355h(r) are being used for topical nonprescription drugs and how many active ingredient requests were reviewed under section 355h(b), and progress on nonclinical alternatives to animal testing for sunscreen ingredients. The report must not disclose information the law bars from release (for example, under sections 331(j), 1905 of title 18, or FOIA exemption 552(b)(4)). The Secretary must also file, within the same 120-day period, a report on how the fee authority was carried out and how the FDA used the fees, and post both reports on the FDA website. For planning the first five fiscal years after fiscal year 2030 and reauthorization, the Secretary must consult with Congress, experts, health professionals, patient and consumer groups, and industry; negotiate with industry; publish recommendations in the Federal Register; allow 30 calendar days for public written comments; hold a public meeting; revise the recommendations as needed; and send the revised recommendations, a summary of comments, and any changes to Congress by January 15, 2030. The FDA must post detailed written minutes of all negotiation meetings on its website within 30 days that show proposals, major disagreements, and how they were resolved.