§360fff–2 Eligibility determinations; data submission; filing

Summary

The Secretary must decide within 60 calendar days after getting a request whether a nonprescription sunscreen active ingredient (or combo) can move forward for full review. To be eligible, the ingredient must not already be in the FDA’s nonprescription sunscreen rules (21 CFR part 352) and must have been used “to a material extent and for a material time” as the law defines. The sponsor must include the data required by FDA rule 21 CFR 330.14. The Secretary must tell the sponsor the decision and publish the decision publicly, but the request stays confidential while the Secretary checks eligibility. The sponsor must say which parts are confidential when filing. If found eligible, the Secretary posts the decision on the FDA website, asks for public comments, and gives at least 45 calendar days for people to submit data and opinions. After the sponsor sends its data, the Secretary has 60 calendar days to say whether the submission is complete and in the right format. If complete, the Secretary will notify the sponsor and file the request; if not, the Secretary will explain why and refuse to file. A sponsor who is refused can ask for a meeting within 30 calendar days and send more data. The Secretary must hold the meeting within 30 calendar days. After the meeting the Secretary may file the request, the sponsor may send more data, or the sponsor can ask, within 120 calendar days, that the Secretary file the request over the sponsor’s protest; if the sponsor asks that, the Secretary must file within 30 calendar days and publish notice. Any added data must be rechecked within 60 calendar days. After the confidentiality period ends, submitted data will be made public with usual redactions for confidential information.