---
kind: "section"
citation: "21 U.S.C. § 356–1"
title: "21"
title_heading: "Food and Drugs"
number: "356–1"
heading: "Accelerated approval of priority countermeasures"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/356-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §356–1. Accelerated approval of priority countermeasures

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) of Health and Human Services may designate a priority countermeasure as a fast-track [product](/usc/21/360eee.md?p=13) pursuant to [section 356 of this title](/usc/21/356.md) or as a [device](/usc/21/321.md?p=h-1) granted review priority pursuant to [section 360e(d)(5)](/usc/21/360e.md?p=d-5)[^1] of this title. Such a designation may be made prior to the submission of—
  - (1) a request for designation by the [sponsor](/usc/21/360fff.md?p=8) or applicant; or
  - (2) an application for the investigation of the [drug](/usc/21/321.md?p=g-1) under [section 355(i) of this title](/usc/21/355.md?p=i) or [section 262(a)(3) of title 42](/usc/42/262.md?p=a-3).

  Nothing in this subsection shall be construed to prohibit a [sponsor](/usc/21/360fff.md?p=8) or applicant from declining such a designation.

- (b) **Use of animal trials—** A [drug](/usc/21/321.md?p=g-1) for which approval is sought under [section 355(b) of this title](/usc/21/355.md?p=b) or [section 262 of title 42](/usc/42/262.md) on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123[^1] may be designated as a fast track [product](/usc/21/360eee.md?p=13) for purposes of this section.
- (c) **Priority review of drugs and biological products—** A priority countermeasure that is a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) shall be considered a priority [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) for purposes of performance goals for priority [drugs](/usc/21/321.md?p=g-1) or biological [products](/usc/21/360eee.md?p=13) agreed to by the [Commissioner](/usc/21/321.md?p=ee) of [Food](/usc/21/321.md?p=f) and [Drugs](/usc/21/321.md?p=g-1).
- (d) **Definitions—** For purposes of this title:[^1]
  - (1) The term “priority countermeasure” has the meaning given such term in section 247d–6(h)(4)[^1] of title 42.
  - (2) The term “priority [drugs](/usc/21/321.md?p=g-1) or biological [products](/usc/21/360eee.md?p=13)” means a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) that is the subject of a [drug](/usc/21/321.md?p=g-1) or biologics application referred to in [section 101(4)](/usc/21/101.md) of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration Modernization Act of 1997.

## Footnotes

[^1]: See References in Text note below.

## Source credit

(Pub. L. 107–188, title I, § 122, June 12, 2002, 116 Stat. 613.)

## Notes

### Editorial Notes

### References in Text

Section 360e(d)(5) of this title, referred to in subsec. (a), was struck out and former subsec. (d)(6) redesignated subsec. (d)(5) of section 360e by Pub. L. 114–255, div. A, title III, § 3051(c)(1), Dec. 13, 2016, 130 Stat. 1124. Section 360e(d)(5) no longer relates to grants of review priority.

Section 123, referred to in subsec. (b), is section 123 of Pub. L. 107–188, title I, June 12, 2002, 116 Stat. 613, which is not classified to the Code.

This title, referred to in subsec. (d), is title I of Pub. L. 107–188, June 12, 2002, 116 Stat. 596, which enacted this section, section 669a of Title 29, Labor, and sections 244, 245, 247d–3a, 247d–3b, 247d–7a to 247d–7d, 300hh, 300hh–11 to 300hh–13, 1320b–5, and 7257d of Title 42, The Public Health and Welfare, amended sections 247d to 247d–6, 264, 266, 290hh–1, and 5196b of Title 42, and enacted provisions set out as notes preceding section 8101 of Title 38, Veterans’ Benefits, and under sections 201, 244, 247d, 247d–6, 300hh, 300hh–12, and 1320b–5 of Title 42. For complete classification of this title to the Code, see Tables.

Section 247d–6(h)(4) of title 42, referred to in subsec. (d)(1), was redesignated section 247d–6(e)(4) by Pub. L. 109–417, title III, § 304(3), Dec. 19, 2006, 120 Stat. 2861.

Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in subsec. (d)(2), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of this title.

### Codification

Section was enacted as part of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.