21 U.S.C. § 379j–73 — Reauthorization; reporting requirements

(a) Performance report. (1) Within 120 days after the end of each fiscal year in which fees are collected under this subpart, the Secretary must send a report to the House Energy and Commerce Committee and the Senate Health, Education, Labor, and Pensions Committee. The report covers the FDA's progress toward the goals described in the letters referenced in section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments, and the FDA's future plans for meeting those goals. (2) Starting with fiscal year 2026, this report must also include: (A) progress and future plans, including — (i) the number of Tier 1 order requests that got a proposed order, and the number that got a final order, last fiscal year; (ii) the same two counts for Tier 2 order requests; (iii) the same two counts for specified safety order requests; (iv) the same two counts for generally-recognized-as-safe-and-effective finalization order requests; (v) the average processing time for order requests, overall and broken down by submission type; and (vi) postmarket safety work on OTC monograph drugs, including collecting, developing, and reviewing safety information such as adverse event reports; building better analytical tools and data-collection systems (including information technology and access to outside databases) to catch safety problems; and the activities described in section 379aa. (B) information on facility registration and fee payment, including — (i) which OTC monograph drug and contract manufacturing organization facilities registered for the first time that year under section 360(c) or 360(i); and (ii) for each facility charged a facility fee that year under section 379j–72(a), whether it paid the fee. (C) the status of applying evidence and testing standards under section 355h(r) to nonprescription drugs applied to the skin, including how those standards are used and how many active-ingredient requests for such drugs were reviewed under the standards in section 355h(b). (D) the FDA's progress in letting companies use non-animal testing alternatives when evaluating sunscreen active ingredients. (3) Confidentiality. Nothing in paragraph (2) allows disclosing information that is otherwise protected from disclosure under section 331(j), under 18 U.S.C. § 1905, or under 5 U.S.C. § 552(b)(4). (b) Fiscal report. Within that same 120-day window after each fee-collecting fiscal year, the Secretary must send Congress a separate report describing how the fee authority was used that year, and how the FDA spent the fees it collected. (c) Public availability. The Secretary must post both the performance report and the fiscal report on the FDA's website. (d) Reauthorization. (1) Consultation. While developing recommended goals and plans for OTC monograph drug work covering the first five fiscal years after fiscal year 2030, and recommendations for renewing this subpart for those years, the Secretary must consult with: (A) the House Energy and Commerce Committee; (B) the Senate Health, Education, Labor, and Pensions Committee; (C) scientific and academic experts; (D) health care professionals; (E) patient and consumer advocacy groups; and (F) the regulated industry. (2) Public review of recommendations. After negotiating with the regulated industry, the Secretary must: (A) present the recommendations to the congressional committees listed above; (B) publish the recommendations in the Federal Register; (C) give the public 30 days to submit written comments; (D) hold a public meeting where people can share their views; and (E) revise the recommendations as needed after considering those comments and views. (3) Transmittal of recommendations. By January 15, 2030, the Secretary must send Congress the revised recommendations, a summary of the public comments and views received, and any changes made because of them. (4) Minutes of negotiation meetings. (A) The Secretary must post detailed written minutes of every negotiation meeting between the FDA and the regulated industry on FDA's website within 30 days after each meeting. (B) Those minutes must describe, in detail, every substantive proposal any party made during negotiations, plus any significant disagreements and how they were resolved.