---
kind: "section"
citation: "21 U.S.C. § 360fff–2"
title: "21"
title_heading: "Food and Drugs"
number: "360fff–2"
heading: "Eligibility determinations; data submission; filing"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360fff-2"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part I — Nonprescription Sunscreen and Other Active Ingredients"
---

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

- (a) **Eligibility determinations—**
  - (1) **In general—** Not later than 60 calendar days after the date of receipt of a request under [section 360fff–1 of this title](/usc/21/360fff–1.md), the [Secretary](/usc/21/321.md?p=d) shall—
    - (A) determine, in accordance with [paragraph (2)](#a-2), whether the request is eligible for further review under [subsection (b)](#b) and [section 360fff–3 of this title](/usc/21/360fff–3.md);
    - (B) notify the [sponsor](/usc/21/360fff.md?p=8) of the determination of the [Secretary](/usc/21/321.md?p=d); and
    - (C) make such determination publicly available in accordance with [paragraph (3)](#a-3) and [subsection (b)(1)](#b-1).
  - (2) **Criteria for eligibility—**
    - (A) **In general—** To be eligible for review under [subsection (b)](#b) and [section 360fff–3 of this title](/usc/21/360fff–3.md), a request shall be for a [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredient](/usc/21/360fff.md?p=10) or combination of [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredients](/usc/21/360fff.md?p=10), for use under specified conditions, to be prescribed, recommended, or suggested in the [labeling](/usc/21/321.md?p=m) thereof, that—
      - (i) is not included in part [352](/usc/21/352.md) of title 21, Code of Federal Regulations (or any successor regulations) concerning [nonprescription](/usc/21/360fff.md?p=5) [sunscreen](/usc/21/360fff.md?p=9); 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](/usc/21/321.md?p=p-2).
    - (B) **Establishment of time and extent—** A [sponsor](/usc/21/360fff.md?p=8) shall include in a request under [section 360fff–1 of this title](/usc/21/360fff–1.md) 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)](#a-2-A-ii).
  - (3) **Public availability—**
    - (A) **Redactions for confidential information—** If a [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredient](/usc/21/360fff.md?p=10) or combination of [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredients](/usc/21/360fff.md?p=10) is determined under [paragraph (1)(A)](#a-1-A) to be eligible for further review, the [Secretary](/usc/21/321.md?p=d) shall make the request publicly available, with redactions for information that is treated as confidential under [section 552(b) of title 5](/usc/5/552.md?p=b), [section 1905 of title 18](/usc/18/1905.md), or [section 331(j) of this title](/usc/21/331.md?p=j).
    - (B) **Identification of confidential information by sponsor—** At the time that a request is made under [section 360fff–1 of this title](/usc/21/360fff–1.md), the [sponsor](/usc/21/360fff.md?p=8) of such request shall identify any information that such [sponsor](/usc/21/360fff.md?p=8) considers to be confidential information described in [subparagraph (A)](#a-3-A).
    - (C) **Confidentiality during eligibility review—** The information contained in a request under [section 360fff–1 of this title](/usc/21/360fff–1.md) shall remain confidential during the [Secretary](/usc/21/321.md?p=d)’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) **Data submission and filing of requests—**
  - (1) **In general—** In the case of a request under [section 360fff–1 of this title](/usc/21/360fff–1.md) that is determined to be eligible under [subsection (a)](#a) for further review under this section and [section 360fff–3 of this title](/usc/21/360fff–3.md), the [Secretary](/usc/21/321.md?p=d) shall, in notifying the public under [subsection (a)(1)(C)](#a-1-C) of such eligibility determination, post the eligibility determination on the Internet website of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, invite the [sponsor](/usc/21/360fff.md?p=8) 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](/usc/21/360fff.md?p=4), including published and unpublished data and other information related to the safety and efficacy of such request.
  - (2) **Filing determination—** Not later than 60 calendar days after the submission of data and other information described in [paragraph (1)](#b-1) by the [sponsor](/usc/21/360fff.md?p=8), the [Secretary](/usc/21/321.md?p=d) shall determine whether the data and other information submitted by the [sponsor](/usc/21/360fff.md?p=8) under this section are sufficiently complete, including being formatted in a manner that enables the [Secretary](/usc/21/321.md?p=d) to determine the completeness of such data and information, to enable the [Secretary](/usc/21/321.md?p=d) to conduct a substantive review under [section 360fff–3 of this title](/usc/21/360fff–3.md) with respect to such request. Not later than 60 calendar days after the submission of data and other information described in [paragraph (1)](#b-1) by the [sponsor](/usc/21/360fff.md?p=8), if the [Secretary](/usc/21/321.md?p=d) determines—
    - (A) that such data and other information are sufficiently complete, the [Secretary](/usc/21/321.md?p=d) shall—
      - (i) issue a written notification to the [sponsor](/usc/21/360fff.md?p=8) 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](/usc/21/360fff–1.md); or
    - (B) that such data and other information are not sufficiently complete, the [Secretary](/usc/21/321.md?p=d) shall issue a written notification to the [sponsor](/usc/21/360fff.md?p=8) 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) **Refusal to file a request—**
    - (A) **Request for meetings; submission of additional data or other information—** If the [Secretary](/usc/21/321.md?p=d) refuses to file a request made under [section 360fff–1 of this title](/usc/21/360fff–1.md), the [sponsor](/usc/21/360fff.md?p=8) may—
      - (i) within 30 calendar days of receipt of written notification of such refusal, request, in writing, a meeting with the [Secretary](/usc/21/321.md?p=d) regarding the filing determination; and
      - (ii) submit additional data or other information.
    - (B) **Meetings—**
      - (i) **In general—** If a [sponsor](/usc/21/360fff.md?p=8) seeks a meeting under [subparagraph (A)(i)](#b-3-A-i), the [Secretary](/usc/21/321.md?p=d) shall convene the meeting within 30 calendar days of the request for such meeting.
      - (ii) **Actions after meeting—** Following any meeting held under [clause (i)](#b-3-B-i)—
        - (I) the [Secretary](/usc/21/321.md?p=d) may file the request within 60 calendar days;
        - (II) the [sponsor](/usc/21/360fff.md?p=8) may submit additional data or other information; or
        - (III) if the [sponsor](/usc/21/360fff.md?p=8) elects, within 120 calendar days, to have the [Secretary](/usc/21/321.md?p=d) file the request (with or without amendments to correct any purported deficiencies to the request)—
          - (aa) the [Secretary](/usc/21/321.md?p=d) shall file the request over protest, not later than 30 calendar days after the [sponsor](/usc/21/360fff.md?p=8) makes such election;
          - (bb) at the time of filing, the [Secretary](/usc/21/321.md?p=d) shall provide written notification of such filing to the [sponsor](/usc/21/360fff.md?p=8); and
          - (cc) the [Secretary](/usc/21/321.md?p=d) shall make such notification publicly available.
      - (iii) **Requests filed over protest—** The [Secretary](/usc/21/321.md?p=d) shall not require the [sponsor](/usc/21/360fff.md?p=8) to resubmit a copy of the request for purposes of filing a request filed over protest, as described in [clause (ii)(III)](#b-3-B-ii-III).
    - (C) **Submissions of additional data or other information—** Within 60 calendar days of any submission of additional data or other information under subparagraph [(A)(ii)](#b-3-A-ii) or [(B)(ii)(II)](#b-3-B-ii-II), the [Secretary](/usc/21/321.md?p=d) shall reconsider the previous determination made under [paragraph (2)](#b-2) with respect to the applicable request and make a new determination in accordance with [paragraph (2)](#b-2).
  - (4) **Public availability—**
    - (A) **Redactions for confidential information—** After the period of confidentiality described in [subsection (a)(3)(C)](#a-3-C), the [Secretary](/usc/21/321.md?p=d) shall make data and other information submitted in connection with a request under [section 360fff–1 of this title](/usc/21/360fff–1.md) publicly available, with redactions for information that is treated as confidential under [section 552(b) of title 5](/usc/5/552.md?p=b), [section 1905 of title 18](/usc/18/1905.md), or [section 331(j) of this title](/usc/21/331.md?p=j).
    - (B) **Identification of confidential information by sponsor—** A [person](/usc/21/321.md?p=e) submitting information under this section shall identify at the time of such submission the portions of such information that the [person](/usc/21/321.md?p=e) considers to be confidential information described in [subparagraph (A)](#b-4-A).

## Source credit

(June 25, 1938, ch. 675, § 586B, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2036.)