21 U.S.C. § 360fff–3 — GRASE determination

(a) Review of new request. (1) For a new request filed under section 360fff–2, the FDA has 300 calendar days from filing to finish its review and issue a "proposed sunscreen order." It may, but doesn't have to, convene the Advisory Committee first. (2) If the FDA misses that 300-day deadline, the sponsor can ask the FDA's Office of the Commissioner to step in; the Commissioner then has 60 calendar days to issue the proposed order. (3) Whichever way it's issued, the proposed order opens a 45-calendar-day public comment period. (4) The sponsor can request a written meeting about a proposed order that either found the ingredient not GRASE, or found the data insufficient, within 30 calendar days of the order; the FDA must hold that meeting within 45 calendar days of the request. (5) After the comment period, the FDA must issue a "final sunscreen order" — within 90 calendar days if the proposed order found the ingredient GRASE or not GRASE, or within 210 calendar days (measured from when the sponsor submits requested extra data) if the proposed order found the data insufficient. If the FDA misses that deadline, the sponsor can again ask the Office of the Commissioner to step in. (6) The Commissioner then has 60 calendar days to issue the final order. (b) Review of pending requests. (1)-(2) Requests that were already pending before this law's sunscreen system started follow this subsection instead of sections 360fff–1 and 360fff–2. (3) A feedback letter the FDA already sent under the old regulation (21 C.F.R. § 330.14(g)) before November 26, 2014 counts as a proposed sunscreen order; it must be posted online, with a Federal Register notice within 45 calendar days of November 26, 2014. (4) For pending requests that never got such a letter, the FDA must finish its review and issue a proposed sunscreen order within 90 calendar days of November 26, 2014. (5) If the FDA misses that deadline, or fails to publish notice of an existing letter, the sponsor can ask the Office of the Commissioner to issue the proposed order within 60 calendar days. (6) Any proposed order (or letter treated as one) gets a 45-calendar-day public comment period. (7) A sponsor can request, in writing, a regular meeting about the proposed order within 30 calendar days of it issuing; the FDA must hold it within 45 calendar days of the request. A sponsor can also request one or more confidential meetings to discuss the data needed to support GRASE status; the FDA must hold those within a reasonable time, though it can refuse extra confidential meetings on the same order if they aren't really necessary or lack enough information to discuss, and it must publish a summary of each confidential meeting that hides trade secrets and confidential business information. (8) The FDA may convene the Advisory Committee to review a pending request at any of these proposed-order stages. (9) After the comment period, the FDA must issue a final sunscreen order — within 90 calendar days if the proposed order found the ingredient GRASE or not GRASE; or, if the data were found insufficient, within 210 calendar days of the sponsor's extra data (if no Advisory Committee meeting was held, with a written reason why not) or within 270 calendar days if the Committee was convened. If the FDA misses that deadline, the sponsor can ask the Office of the Commissioner to step in. (10) The Commissioner then has 60 calendar days to issue the final order. (c) Advisory Committee. The FDA doesn't have to convene the Advisory Committee more than once for the same request, more than twice a year overall for this review process, or review more than 3 requests per Committee meeting. (d) No delegation. The Commissioner's specific duties under subsections (a)(2), (a)(6), (b)(5), and (b)(10) — stepping in when the FDA misses a deadline — cannot be handed off to anyone else. (e) Effect of final sunscreen order. (1) If a final order says an ingredient is GRASE and not misbranded, sunscreens with that ingredient can be sold across state lines under the order's conditions, following all the normal rules for nonprescription drugs, for as long as the order stays in effect. If a final order says an ingredient is not GRASE and is misbranded, sunscreens with that ingredient cannot be sold across state lines under those conditions — unless a separate drug application is approved for it, or the ingredient is later found GRASE through the regular over-the-counter drug process. (2) The FDA can update a final order on its own, by issuing a new proposed order and repeating this section's process, if new information comes in. Any interested person can also petition the FDA to amend a final order; if the FDA grants the petition, it must likewise start over with a new proposed order. While that amendment process is happening, the old final order stays in effect. (3) A final sunscreen order counts as a final order under section 355h. (f) Exclusivity. (1) A final order gives only the sponsor who requested it (or its licensees, assignees, or successors) the right to market a sunscreen with a newly-added ingredient for 18 months, starting when they can first lawfully sell it. (2) This exclusivity covers only changes that add an active sunscreen ingredient not already in a marketed sunscreen. (3) "Already marketed" means sold either under the older sunscreen monograph rules or under a previous final order issued under this section. (4) Each ingredient can get only one 18-month exclusivity period, ever. (5) The sponsor must give the FDA a list of its licensees, assignees, and successors when it first starts selling the drug.