21 U.S.C. § 360fff: Eligibility determinations; data submission; filing

determine, in accordance with paragraph (2), whether the request is eligible for further review under subsection (b) and section 360fff–3 of this title ; notify the sponsor of the determination of the Secretary; and make such determination publicly available in accordance with paragraph (3) and subsection (b)(1). is not included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen; and has been used to a material extent and for a material time under such conditions, as described in section 321(p)(2) of this title . A sponsor shall include in a request under section 360fff–1 of this title the information required under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations) to meet the standard described in subparagraph (A)(ii). If a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is determined under paragraph (1)(A) to be eligible for further review, the Secretary shall make the request publicly available, with redactions for information that is treated as confidential under section 552(b) of title 5 , section 1905 of title 18 , or section 331(j) of this title . At the time that a request is made under section 360fff–1 of this title , the sponsor of such request shall identify any information that such sponsor considers to be confidential information described in subparagraph (A). The information contained in a request under section 360fff–1 of this title shall remain confidential during the Secretary’s consideration under this section of whether the request is eligible for further review consistent with section 330.14 of title 21, Code of Federal Regulations (or any successor regulations). In the case of a request under section 360fff–1 of this title that is determined to be eligible under subsection (a) for further review under this section and section 360fff–3 of this title , the Secretary shall, in notifying the public under subsection (a)(1)(C) of such eligibility determination, post the eligibility determination on the Internet website of the Food and Drug Administration, invite the sponsor of such request and any other interested party to submit comments, and provide a period of not less than 45 calendar days for comments in support of or otherwise relating to a GRASE determination, including published and unpublished data and other information related to the safety and efficacy of such request. issue a written notification to the sponsor of the determination to file such request, and make such notification publicly available; and file such request made under section 360fff–1 of this title ; or that such data and other information are not sufficiently complete, the Secretary shall issue a written notification to the sponsor of the determination to refuse to file the request, which shall include the reasons for the refusal, including why such data and other information are not sufficiently complete, and make such notification publicly available. within 30 calendar days of receipt of written notification of such refusal, request, in writing, a meeting with the Secretary regarding the filing determination; and submit additional data or other information. If a sponsor seeks a meeting under subparagraph (A)(i), the Secretary shall convene the meeting within 30 calendar days of the request for such meeting. the Secretary may file the request within 60 calendar days; the sponsor may submit additional data or other information; or the Secretary shall file the request over protest, not later than 30 calendar days after the sponsor makes such election; at the time of filing, the Secretary shall provide written notification of such filing to the sponsor; and the Secretary shall make such notification publicly available. The Secretary shall not require the sponsor to resubmit a copy of the request for purposes of filing a request filed over protest, as described in clause (ii)(III). Within 60 calendar days of any submission of additional data or other information under subparagraph (A)(ii) or (B)(ii)(II), the Secretary shall reconsider the previous determination made under paragraph (2) with respect to the applicable request and make a new determination in accordance with paragraph (2). After the period of confidentiality described in subsection (a)(3)(C), the Secretary shall make data and other information submitted in connection with a request under section 360fff–1 of this title publicly available, with redactions for information that is treated as confidential under section 552(b) of title 5 , section 1905 of title 18 , or section 331(j) of this title . A person submitting information under this section shall identify at the time of such submission the portions of such information that the person considers to be confidential information described in subparagraph (A).