---
kind: "section"
citation: "21 U.S.C. § 360b–1"
title: "21"
title_heading: "Food and Drugs"
number: "360b–1"
heading: "Priority zoonotic animal drugs"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360b-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360b–1. Priority zoonotic animal drugs

- (a) **In general—** The [Secretary](/usc/21/321.md?p=d) shall, at the request of the [sponsor](/usc/21/360fff.md?p=8) intending to submit an application for approval of a [new animal drug](/usc/21/321.md?p=v) under [section 360b(b)(1) of this title](/usc/21/360b.md?p=b-1) or an application for conditional approval of a [new animal drug](/usc/21/321.md?p=v) under [section 360ccc of this title](/usc/21/360ccc.md), expedite the development and review of such [new animal drug](/usc/21/321.md?p=v) if preliminary clinical evidence indicates that the [new animal drug](/usc/21/321.md?p=v), alone or in combination with 1 or more other animal [drugs](/usc/21/321.md?p=g-1), has the potential to prevent or treat a zoonotic disease in animals, including a vector borne-disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in, humans.
- (b) **Request for designation—** The [sponsor](/usc/21/360fff.md?p=8) of a [new animal drug](/usc/21/321.md?p=v) may request the [Secretary](/usc/21/321.md?p=d) to designate a [new animal drug](/usc/21/321.md?p=v) described in [subsection (a)](#a) as a priority zoonotic animal [drug](/usc/21/321.md?p=g-1). A request for the designation may be made concurrently with, or at any time after, the opening of an investigational [new animal drug](/usc/21/321.md?p=v) file under [section 360b(j) of this title](/usc/21/360b.md?p=j) or the filing of an application under section [360b(b)(1)](/usc/21/360b.md?p=b-1) or [360ccc](/usc/21/360ccc.md) of this title.
- (c) **Designation—**
  - (1) **In general—** Not later than 60 calendar days after the receipt of a request under [subsection (b)](#b), the [Secretary](/usc/21/321.md?p=d) shall determine whether the [new animal drug](/usc/21/321.md?p=v) that is the subject of the request meets the criteria described in [subsection (a)](#a). If the [Secretary](/usc/21/321.md?p=d) determines that the [new animal drug](/usc/21/321.md?p=v) meets the criteria, the [Secretary](/usc/21/321.md?p=d) shall designate the [new animal drug](/usc/21/321.md?p=v) as a priority zoonotic animal [drug](/usc/21/321.md?p=g-1) and shall take such actions as are appropriate to expedite the development and review of the application for approval or conditional approval of such [new animal drug](/usc/21/321.md?p=v).
  - (2) **Actions—** The actions to expedite the development and review of an application under [paragraph (1)](#c-1) may include, as appropriate—
    - (A) taking steps to ensure that the design of clinical trials is as efficient as practicable, when scientifically appropriate, such as by utilizing novel trial designs or [drug](/usc/21/321.md?p=g-1) development tools (including biomarkers) that may reduce the number of animals needed for studies;
    - (B) providing timely advice to, and interactive communication with, the [sponsor](/usc/21/360fff.md?p=8) (which may include meetings with the [sponsor](/usc/21/360fff.md?p=8) and review team) regarding the development of the [new animal drug](/usc/21/321.md?p=v) to ensure that the development program to gather the nonclinical and clinical data necessary for approval is as efficient as practicable;
    - (C) involving senior managers and review staff with experience in zoonotic or vector-borne disease to facilitate collaborative, cross-disciplinary review, including, as appropriate, across agency centers; and
    - (D) implementing additional administrative or process enhancements, as necessary, to facilitate an efficient review and development program.

## Source credit

(June 25, 1938, ch. 675, § 512A, as added Pub. L. 116–136, div. A, title III, § 3302, Mar. 27, 2020, 134 Stat. 384.)