---
kind: "section"
citation: "21 U.S.C. § 360fff–4"
title: "21"
title_heading: "Food and Drugs"
number: "360fff–4"
heading: "Guidance; other provisions"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360fff-4"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part I — Nonprescription Sunscreen and Other Active Ingredients"
---

# §360fff–4. Guidance; other provisions

- (a) **Guidance—**
  - (1) **In general—**
    - (A) **Draft guidance—** Not later than 1 year after November 26, 2014, the [Secretary](/usc/21/321.md?p=d) shall issue draft guidance on the implementation of, and compliance with, the requirements with respect to [sunscreen](/usc/21/360fff.md?p=9) under this part, including guidance on—
      - (i) the format and content of information submitted by a [sponsor](/usc/21/360fff.md?p=8) in support of a request under [section 360fff–1 of this title](/usc/21/360fff–1.md) or a [pending request](/usc/21/360fff.md?p=6);
      - (ii) the data required to meet the safety and efficacy standard for determining whether 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 [GRASE](/usc/21/360fff.md?p=3) and is not misbranded;
      - (iii) the process by which a request under [section 360fff–1 of this title](/usc/21/360fff–1.md) or a [pending request](/usc/21/360fff.md?p=6) is withdrawn; and
      - (iv) the process by which the [Secretary](/usc/21/321.md?p=d) will carry out [section 360fff–3(c) of this title](/usc/21/360fff–3.md?p=c), including with respect to how the [Secretary](/usc/21/321.md?p=d) will address the total number of requests received under [section 360fff–1 of this title](/usc/21/360fff–1.md) and [pending requests](/usc/21/360fff.md?p=6).
    - (B) **Final guidance—** The [Secretary](/usc/21/321.md?p=d) shall finalize the guidance described in [subparagraph (A)](#a-1-A) not later than 2 years after November 26, 2014.
    - (C) **Inapplicability of Paperwork Reduction Act—** [Chapter 35](/usc/44/chch35.md) of title 44 shall not apply to collections of information made for purposes of guidance under this subsection.
  - (2) **Submissions pending issuance of final guidance—** Irrespective of whether final guidance under [paragraph (1)](#a-1) has been issued—
    - (A) [persons](/usc/21/321.md?p=e) may, beginning on November 26, 2014, make submissions under this part; and
    - (B) the [Secretary](/usc/21/321.md?p=d) shall review and act upon such submissions in accordance with this part.
- (b) **Rules of construction—**
  - (1) **Currently marketed sunscreens—** Nothing in this part shall be construed to affect the marketing of [sunscreens](/usc/21/360fff.md?p=9) that are marketed in [interstate commerce](/usc/21/321.md?p=b) on or before November 26, 2014, except as otherwise provided in this part.
  - (2) **Ensuring safety and effectiveness—** Nothing in this part shall be construed to alter the authority of the [Secretary](/usc/21/321.md?p=d) with respect to prohibiting the marketing of a [sunscreen](/usc/21/360fff.md?p=9) that is not [safe](/usc/21/321.md?p=u) and effective or is misbranded, or with respect to imposing restrictions on the marketing of a [sunscreen](/usc/21/360fff.md?p=9) to ensure safety and effectiveness, except as otherwise provided in this part, including [section 360fff–3(e) of this title](/usc/21/360fff–3.md?p=e).
  - (3) **Other drugs—** Except as otherwise provided in [section 360fff–6 of this title](/usc/21/360fff–6.md), nothing in this part shall be construed to affect the authority of the [Secretary](/usc/21/321.md?p=d) under this chapter or the Public Health Service Act ([42 U.S.C. 201](/usc/42/201.md) et seq.) with respect to a [drug](/usc/21/321.md?p=g-1) other than a [nonprescription](/usc/21/360fff.md?p=5) [sunscreen](/usc/21/360fff.md?p=9).
  - (4) **Effect on drugs otherwise approved—** Nothing in this part shall affect the marketing of a [drug](/usc/21/321.md?p=g-1) approved under [section 355 of this title](/usc/21/355.md) or section 351 of the Public Health Service Act [[42 U.S.C. 262](/usc/42/262.md)].
- (c) **Timelines—** The timelines for the processes and procedures under paragraphs (1), (2), (5), and (6) of [section 360fff–3(a) of this title](/usc/21/360fff–3.md?p=a) shall not apply to any requests submitted to the [Secretary](/usc/21/321.md?p=d) under [section 360fff–1 of this title](/usc/21/360fff–1.md) after the date that is 6 years after November 26, 2014.

## Source credit

(June 25, 1938, ch. 675, § 586D, as added Pub. L. 113–195, § 2(a), Nov. 26, 2014, 128 Stat. 2044.)

## Notes

### Editorial Notes

### References in Text

The Public Health Service Act, referred to in subsec. (b)(3), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see Short Title note set out under section 201 of Title 42 and Tables.