21 U.S.C. § 360fff–4 — Guidance; other provisions

(a) Guidance. (1)(A) Within 1 year of November 26, 2014, the FDA had to issue draft guidance on following this part's sunscreen rules, covering: the format and content sponsors should use for requests; the data needed to prove an ingredient is GRASE and not misbranded; how a sponsor withdraws a request; and how the FDA will apply the Advisory Committee limits in section 360fff–3(c), including handling the total number of requests. (B) The FDA had to finalize that guidance within 2 years of November 26, 2014. (C) The Paperwork Reduction Act does not apply to information collected for this guidance. (2) Sponsors could start submitting requests as soon as November 26, 2014, whether or not the final guidance was ready yet, and the FDA had to review and act on those submissions regardless. (b) Rules of construction. (1) This part doesn't change how sunscreens already being sold as of November 26, 2014 are marketed, except as this part specifically says. (2) This part doesn't limit the FDA's usual power to block unsafe, ineffective, or misbranded sunscreens, or to restrict how they're marketed — except as this part specifically provides, including under section 360fff–3(e). (3) Except as section 360fff–6 provides, this part doesn't affect the FDA's authority over any drug other than nonprescription sunscreen. (4) This part doesn't affect the marketing of drugs already approved under section 355 or under the Public Health Service Act. (c) Timelines. The review deadlines set out in section 360fff–3(a), paragraphs (1), (2), (5), and (6), stop applying to any new request submitted more than 6 years after November 26, 2014.