21 U.S.C. § 360fff–6 — Non-sunscreen time and extent applications

(a) Pending time and extent applications. (1)(A) If, before November 26, 2014, someone filed an application under 21 C.F.R. § 330.14 asking the FDA whether a non-sunscreen ingredient is GRASE, and the FDA found it eligible for the over-the-counter drug review process, the sponsor can ask the FDA for a framework — a set of timelines — for reviewing it. (B) That request must be made within 180 calendar days of November 26, 2014, and must say which of four review processes the sponsor prefers: (i) the pending-request process from section 360fff–3(b), but with its own custom timelines; (ii) the older Part 330 process; (iii) an initial filing decision under section 360fff–2(b) followed by the section 360fff–3(b) pending-request process, again with custom timelines; or (iv) an initial filing decision under section 360fff–2(b) followed by the Part 330 process. (C) If the sponsor doesn't ask within those 180 days, the FDA reviews the application under whatever timelines are eventually finalized under subsection (b). (2) Within 1 year of November 26, 2014, the FDA must give each requesting sponsor a written framework spelling out timelines, in days, for each of the four options above. Those timelines must account for the factors in paragraph (5), and can't be shorter than the pending-request timelines in sections 360fff–2(b) and 360fff–3(b). (3)(A) Within 60 calendar days of getting that framework, the sponsor can choose one of the four review options; the FDA then reviews the application that way, using the framework's timelines, and confirms the choice in writing by the time it sends the report required under paragraph (4). If the sponsor doesn't choose, the FDA uses whatever timelines are finalized under subsection (b). (B) The FDA can later switch to a different one of the four options mid-review, but only if it proposes the switch in writing and the sponsor agrees in writing. (C) If the sponsor picked option (i) or (iii), the FDA can fold the resulting final order into a broader regulation covering similar drugs in the same category — including through direct final rulemaking — and the individual order stops applying once that regulation takes effect. (4) Within 18 months of November 26, 2014, the FDA must report, in writing, to two Congressional committees about the status of all these pending applications, including each one's review timelines, accounting for the factors in paragraph (5). (5) The timelines the FDA sets under this subsection can vary based on how complex or long each application is, but must: reflect FDA's public health priorities, including the benefit of adding more drugs to the over-the-counter system; account for the FDA's available resources; and be reasonable given both of those things. (b) New time and extent applications. (1) Within 18 months of November 26, 2014, the FDA must propose regulations setting review timelines for GRASE applications — for non-sunscreen ingredients — filed after November 26, 2014, or covered by subsection (a). These regulations must ensure timely review of both the initial eligibility decision and the safety/effectiveness review, including reasonable day-based timelines for applications of different complexity, and measurable ways to track whether those timelines are met. (2) These timelines can vary by application complexity, but must reflect FDA's public health priorities, account for its resources, and be reasonable — the same three factors as in subsection (a)(5). (3) To create these regulations, the FDA must publish a proposed rule with the draft regulation, allow at least 60 calendar days for public comment, and publish the final regulation at least 30 calendar days before it takes effect. (4) The FDA can only issue regulations under this section following that exact process — nothing else authorizes it to do so. (5) The FDA must finalize these regulations within 27 months of November 26, 2014.