---
kind: "section"
citation: "21 U.S.C. § 360fff–6"
title: "21"
title_heading: "Food and Drugs"
number: "360fff–6"
heading: "Non-sunscreen time and extent applications"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360fff-6"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part I — Nonprescription Sunscreen and Other Active Ingredients"
---

# §360fff–6. Non-sunscreen time and extent applications

- (a) **Pending time and extent applications—**
  - (1) **In general—**
    - (A) **Request for framework for review—** If, prior to November 26, 2014, an application was submitted pursuant to section 330.14 of title 21, Code of Federal Regulations for a [GRASE determination](/usc/21/360fff.md?p=4) for a [drug](/usc/21/321.md?p=g-1) other than 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) and such [drug](/usc/21/321.md?p=g-1) was found to be eligible to be considered for inclusion in the over-the-counter [drug](/usc/21/321.md?p=g-1) monograph system pursuant to section 330.14 of title 21, Code of Federal Regulations, the [sponsor](/usc/21/360fff.md?p=8) of such application may request that the [Secretary](/usc/21/321.md?p=d) provide a framework under [paragraph (2)](#a-2) for the review of such application.
    - (B) **Request requirements—** A request for a framework for review of an application made under [subparagraph (A)](#a-1-A) shall be made within 180 calendar days of November 26, 2014, and shall include the preference of such [sponsor](/usc/21/360fff.md?p=8) as to whether such application is reviewed by the [Secretary](/usc/21/321.md?p=d) in accordance with—
      - (i) the processes and procedures set forth for [pending requests](/usc/21/360fff.md?p=6) under [section 360fff–3(b) of this title](/usc/21/360fff–3.md?p=b), except that specific timelines shall be determined in accordance with other applicable requirements under this section;
      - (ii) the processes and procedures set forth under part 330 of title 21, Code of Federal Regulations (or any successor regulations);
      - (iii) an initial filing determination under the processes and procedures described in [section 360fff–2(b) of this title](/usc/21/360fff–2.md?p=b) and the processes and procedures set forth for [pending requests](/usc/21/360fff.md?p=6) under [section 360fff–3(b) of this title](/usc/21/360fff–3.md?p=b), except that specific timelines shall be determined in accordance with other applicable requirements under this section; or
      - (iv) an initial filing determination under the processes and procedures described in [section 360fff–2(b) of this title](/usc/21/360fff–2.md?p=b) and the processes and procedures set forth under part 330 of title 21, Code of Federal Regulations (or any successor regulations).
    - (C) **No request—** If a [sponsor](/usc/21/360fff.md?p=8) described in [subparagraph (A)](#a-1-A) does not make such request within 180 calendar days of November 26, 2014, such application shall be reviewed by the [Secretary](/usc/21/321.md?p=d) in accordance with the timelines of the applicable regulations when such regulations are finalized under [subsection (b)](#b).
  - (2) **Framework—** Not later than 1 year after November 26, 2014, the [Secretary](/usc/21/321.md?p=d) shall provide, in writing, a framework to each [sponsor](/usc/21/360fff.md?p=8) that submitted a request under [paragraph (1)](#a-1). Such framework shall set forth the various timelines, in calendar days, with respect to the processes and procedures for review under clauses [(i)](#a-1-B-i), [(ii)](#a-1-B-ii), [(iii)](#a-1-B-iii), and [(iv)](#a-1-B-iv) of paragraph (1)(B) and—
    - (A) such timelines shall account for the considerations under [paragraph (5)](#a-5); and
    - (B) the timelines for the various processes and procedures shall not be shorter than the timelines set forth for [pending requests](/usc/21/360fff.md?p=6) under sections [360fff–2(b)](/usc/21/360fff–2.md?p=b) and [360fff–3(b)](/usc/21/360fff–3.md?p=b) of this title, as applicable.
  - (3) **Governing processes and procedures for review—**
    - (A) **Election—** Not later than 60 calendar days after the [Secretary](/usc/21/321.md?p=d) provides a framework to a [sponsor](/usc/21/360fff.md?p=8) under [paragraph (2)](#a-2), such [sponsor](/usc/21/360fff.md?p=8) may provide an election to the [Secretary](/usc/21/321.md?p=d) regarding the processes and procedures for review under clause [(i)](#a-1-B-i), [(ii)](#a-1-B-ii), [(iii)](#a-1-B-iii), or [(iv)](#a-1-B-iv) of paragraph (1)(B). If such [sponsor](/usc/21/360fff.md?p=8) makes such election, the [Secretary](/usc/21/321.md?p=d) shall review the application that is the subject of such election pursuant to the processes and procedures elected by such [sponsor](/usc/21/360fff.md?p=8) and the applicable timelines in calendar days set forth under such framework, which the [Secretary](/usc/21/321.md?p=d) shall confirm in writing to the [sponsor](/usc/21/360fff.md?p=8) not later than the date upon which the [Secretary](/usc/21/321.md?p=d) provides a report under [paragraph (4)](#a-4). If such [sponsor](/usc/21/360fff.md?p=8) does not make such election, such application shall be reviewed by the [Secretary](/usc/21/321.md?p=d) in accordance with the timelines of the applicable regulations when such regulations are finalized under [subsection (b)](#b).
    - (B) **Different processes and procedures—** At any time during review of an application, the [Secretary](/usc/21/321.md?p=d) may review such application under different processes and procedures under clause [(i)](#a-1-B-i), [(ii)](#a-1-B-ii), [(iii)](#a-1-B-iii), or [(iv)](#a-1-B-iv) of paragraph (1)(B) than the processes and procedures the [sponsor](/usc/21/360fff.md?p=8) elected in accordance with [subparagraph (A)](#a-3-A), so long as the [Secretary](/usc/21/321.md?p=d) proposes, in writing, the change and the [sponsor](/usc/21/360fff.md?p=8) agrees, in writing, to such change.
    - (C) **Inclusion of ingredients in monographs—** If the [sponsor](/usc/21/360fff.md?p=8) elects to use the processes and procedures for review in accordance with clause [(i)](#a-1-B-i) or [(iii)](#a-1-B-iii) of paragraph (1)(B), the [Secretary](/usc/21/321.md?p=d) may incorporate any resulting final order into a regulation addressing the conditions under which other [drugs](/usc/21/321.md?p=g-1) in the same therapeutic category are [GRASE](/usc/21/360fff.md?p=3) and not misbranded, including through direct final rulemaking, and the final order so incorporated shall cease to be effective on the effective date of the final regulation that addresses such [drug](/usc/21/321.md?p=g-1).
  - (4) **Letter regarding pending applications—** Not later than 18 months after November 26, 2014, the [Secretary](/usc/21/321.md?p=d) shall report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives, in writing, regarding all pending applications subject to [paragraph (1)](#a-1). In such letter, the [Secretary](/usc/21/321.md?p=d) shall provide a report on the review of such applications, including the timelines, in calendar days, for the review and [GRASE determination](/usc/21/360fff.md?p=4) for each application. Such timelines shall account for the considerations under [paragraph (5)](#a-5).
  - (5) **Timelines—** The timelines in calendar days established by the [Secretary](/usc/21/321.md?p=d) pursuant to this subsection—
    - (A) may vary based on the content, complexity, and format of the application submitted to the [Secretary](/usc/21/321.md?p=d); and
    - (B) shall—
      - (i) reflect the public health priorities of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, including the potential public health benefits posed by the inclusion of additional [drugs](/usc/21/321.md?p=g-1) in the over-the-counter [drug](/usc/21/321.md?p=g-1) monograph system;
      - (ii) take into consideration the resources available to the [Secretary](/usc/21/321.md?p=d) for carrying out such priorities and the processes and procedures described in paragraphs [(1)(B)](#a-1-B) and [(2)](#a-2); and
      - (iii) be reasonable, taking into consideration the requirements described in clauses [(i)](#a-5-B-i) and [(ii)](#a-5-B-ii).
- (b) **New time and extent applications—**
  - (1) **In general—** Not later than 18 months after November 26, 2014, the [Secretary](/usc/21/321.md?p=d) shall issue proposed regulations establishing timelines for the review of applications for [GRASE determinations](/usc/21/360fff.md?p=4) for [drugs](/usc/21/321.md?p=g-1) other than [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredients](/usc/21/360fff.md?p=10) or combinations of [nonprescription](/usc/21/360fff.md?p=5) [sunscreen active ingredients](/usc/21/360fff.md?p=10) that are submitted to the [Secretary](/usc/21/321.md?p=d) after November 26, 2014, under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations), and that are found to be eligible to be considered for inclusion in the over-the-counter [drug](/usc/21/321.md?p=g-1) monograph system pursuant to section 330.14 of title 21, Code of Federal Regulations (or any successor regulations), or that are subject to this subsection pursuant to paragraph [(1)](#a-1) or [(3)](#a-3) of subsection (a), as applicable, providing—
    - (A) timely and efficient completion of evaluations of applications under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations) for [drugs](/usc/21/321.md?p=g-1) other than [sunscreens](/usc/21/360fff.md?p=9); and
    - (B) timely and efficient completion of the review of the safety and effectiveness submissions pursuant to such applications, including establishing—
      - (i) reasonable timelines, in calendar days, for the applicable proposed and final regulations for applications of various content, complexity, and format, and timelines for internal procedures related to such processes; and
      - (ii) measurable metrics for tracking the extent to which the timelines set forth in the regulations are met.
  - (2) **Timelines—** The timelines in calendar days established in the regulations under [paragraph (1)](#b-1)—
    - (A) may vary based on the content, complexity, and format of the application submitted to the [Secretary](/usc/21/321.md?p=d); and
    - (B) shall—
      - (i) reflect the public health priorities of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, including the potential public health benefits posed by the inclusion of additional [drugs](/usc/21/321.md?p=g-1) in the over-the-counter [drug](/usc/21/321.md?p=g-1) monograph system;
      - (ii) take into consideration the resources available to the [Secretary](/usc/21/321.md?p=d) for carrying out such priorities and the processes and procedures described in [paragraph (1)](#b-1); and
      - (iii) be reasonable, taking into consideration the requirements described in clauses [(i)](#b-2-B-i) and [(ii)](#b-2-B-ii).
  - (3) **Procedure—** In promulgating regulations under this subsection, the [Secretary](/usc/21/321.md?p=d) shall issue a notice of proposed rulemaking that includes a copy of the proposed regulation, provide a period of not less than 60 calendar days for comments on the proposed regulation, and publish the final regulation not less than 30 calendar days before the effective date of the regulation.
  - (4) **Restrictions—** Notwithstanding any other provision of law, the [Secretary](/usc/21/321.md?p=d) shall promulgate regulations implementing this section only as described in paragraphs [(1)](#b-1), [(2)](#b-2), and [(3)](#b-3).
  - (5) **Final regulations—** The [Secretary](/usc/21/321.md?p=d) shall finalize the regulations under this section not later than 27 months after November 26, 2014.

## Source credit

(June 25, 1938, ch. 675, § 586F, as added Pub. L. 113–195, § 3, Nov. 26, 2014, 128 Stat. 2046.)

## Notes

### Statutory Notes and Related Subsidiaries

### Treatment of Non-Sunscreen Time and Extent Applications

Pub. L. 116–136, div. A, title III, § 3854(d), Mar. 27, 2020, 134 Stat. 457, provided that: In general.—Any application described in section 586F of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360fff–6) that was submitted to the Secretary pursuant to section 330.14 of title 21, Code of Federal Regulations, as such provisions were in effect immediately prior to the date of enactment date of this Act [Mar. 27, 2020], shall be extinguished as of such date of enactment, subject to paragraph (2). Order request.—Nothing in paragraph (1) precludes the submission of an order request under section 505G(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355h(b)], as added by section 3851 of this subtitle, with respect to a drug that was the subject of an application extinguished under paragraph (1).”