Title 21, Food and DrugsRelease 119-110

§360b–1 Priority Zoonotic Animal Drugs

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part A — Drugs and Devices › § 360b–1

Last updated Sep 22, 2026|Official source

Summary

The Secretary must speed up the development and review of a new animal drug when early clinical evidence shows the drug, alone or with others, might prevent or treat a disease animals can pass to people (including vector-borne diseases) that could cause serious or life‑threatening harm to humans. The company developing the drug can ask for a “priority zoonotic” designation when it opens an investigational file or files an approval or conditional approval application, or any time after. The Secretary must decide within 60 calendar days. If approved, the agency must move the review faster. Steps may include using efficient trial designs (like new designs or biomarkers to cut the number of animals), giving fast, interactive advice and meetings with the sponsor, involving experienced senior staff for cross-disciplinary review, and making other administrative changes to speed things up.

Full Legal Text

Title 21, §360b–1

Food and Drugs, Source: USLM XML via OLRC

(a)In general

The Secretary shall, at the request of the sponsor intending to submit an application for approval of a new animal drug under section 360b(b)(1) of this title or an application for conditional approval of a new animal drug under section 360ccc of this title, expedite the development and review of such new animal drug if preliminary clinical evidence indicates that the new animal drug, alone or in combination with 1 or more other animal drugs, 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 of a new animal drug may request the Secretary to designate a new animal drug described in subsection (a) as a priority zoonotic animal drug. A request for the designation may be made concurrently with, or at any time after, the opening of an investigational new animal drug file under section 360b(j) of this title or the filing of an application under section 360b(b)(1) or 360ccc of this title.

(c)Designation

(1)In general

Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether the new animal drug that is the subject of the request meets the criteria described in subsection (a). If the Secretary determines that the new animal drug meets the criteria, the Secretary shall designate the new animal drug as a priority zoonotic animal drug 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.

(2)Actions

The actions to expedite the development and review of an application under paragraph (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 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 (which may include meetings with the sponsor and review team) regarding the development of the new animal drug 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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 360b–1

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110