Title 21, Food and DrugsRelease 119-73not60

§360fff–2 Eligibility Determinations; Data Submission; Filing

Title 21 › Chapter 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter V— DRUGS AND DEVICES › Part I— Nonprescription Sunscreen and Other Active Ingredients › § 360fff–2

Last updated Apr 5, 2026|Official source

Summary

The Secretary must decide within 60 calendar days after getting a request whether that request can move forward for review. The request must be for a nonprescription sunscreen active ingredient (or combination) that is not already listed in 21 CFR part 352 and that has been used to a material extent and for a material time under the conditions claimed, and the sponsor must include the information required by 21 CFR 330.14. The Secretary must tell the sponsor the decision and post it publicly, with redactions for information protected under 5 U.S.C. 552(b), 18 U.S.C. 1905, or 21 U.S.C. 331(j). The sponsor must mark any parts they think are confidential when they submit the request. While the Secretary is deciding eligibility, the request stays confidential. If the request is eligible, the FDA posts that fact online, invites comments, and gives at least 45 calendar days for people to send data and other information. Within 60 calendar days after the sponsor sends their data, the Secretary must decide if the submission is complete. If complete, the Secretary will notify the sponsor and file the request. If not, the Secretary will refuse to file, explain why, and make that public. The sponsor can ask for a meeting within 30 days and send more information. The Secretary must hold the meeting within 30 days. After the meeting the Secretary may file the request within 60 days, the sponsor may send more data, or the sponsor can choose within 120 days to have the Secretary file the request over protest, in which case the Secretary must file within 30 days and notify the sponsor. Any additional submissions must be reconsidered within 60 days. After the confidentiality period ends, submitted data become public with the same redactions described above.

Full Legal Text

Title 21, §360fff–2

Food and Drugs, Source: USLM XML via OLRC

(a)(1)Not later than 60 calendar days after the date of receipt of a request under section 360fff–1 of this title, the Secretary shall—

(A)determine, in accordance with paragraph (2), whether the request is eligible for further review under subsection (b) and section 360fff–3 of this title;

(B)notify the sponsor of the determination of the Secretary; and

(C)make such determination publicly available in accordance with paragraph (3) and subsection (b)(1).

(2)(A)To be eligible for review under subsection (b) and section 360fff–3 of this title, a request shall be for a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof, that—

(i)is not included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen; and

(ii)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.

(B)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).

(3)(A)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.

(B)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).

(C)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).

(b)(1)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.

(2)Not later than 60 calendar days after the submission of data and other information described in paragraph (1) by the sponsor, the Secretary shall determine whether the data and other information submitted by the sponsor under this section are sufficiently complete, including being formatted in a manner that enables the Secretary to determine the completeness of such data and information, to enable the Secretary to conduct a substantive review under section 360fff–3 of this title with respect to such request. Not later than 60 calendar days after the submission of data and other information described in paragraph (1) by the sponsor, if the Secretary determines—

(A)that such data and other information are sufficiently complete, the Secretary shall—

(i)issue a written notification to the sponsor of the determination to file such request, and make such notification publicly available; and

(ii)file such request made under section 360fff–1 of this title; or

(B)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.

(3)(A)If the Secretary refuses to file a request made under section 360fff–1 of this title, the sponsor may—

(i)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

(ii)submit additional data or other information.

(B)(i)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.

(ii)Following any meeting held under clause (i)—

(I)the Secretary may file the request within 60 calendar days;

(II)the sponsor may submit additional data or other information; or

(III)if the sponsor elects, within 120 calendar days, to have the Secretary file the request (with or without amendments to correct any purported deficiencies to the request)—

(aa)the Secretary shall file the request over protest, not later than 30 calendar days after the sponsor makes such election;

(bb)at the time of filing, the Secretary shall provide written notification of such filing to the sponsor; and

(cc)the Secretary shall make such notification publicly available.

(iii)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).

(C)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).

(4)(A)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.

(B)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).

Reference

Citations & Metadata

Citation

21 U.S.C. § 360fff–2

Title 21, Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60