---
kind: "section"
citation: "21 U.S.C. § 360ccc–2"
title: "21"
title_heading: "Food and Drugs"
number: "360ccc–2"
heading: "Designated new animal drugs for minor use or minor species"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360ccc-2"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part F — New Animal Drugs for Minor Use and Minor Species"
---

# §360ccc–2. Designated new animal drugs for minor use or minor species

- (a) **Designation—**
  - (1) The [manufacturer](/usc/21/360hh.md?p=3) or the [sponsor](/usc/21/360fff.md?p=8) of a [new animal drug](/usc/21/321.md?p=v) for a [minor use](/usc/21/321.md?p=pp) or use in a [minor species](/usc/21/321.md?p=oo) may request that the [Secretary](/usc/21/321.md?p=d) declare that [drug](/usc/21/321.md?p=g-1) a “designated [new animal drug](/usc/21/321.md?p=v)”. A request for designation of a [new animal drug](/usc/21/321.md?p=v) shall be made before the submission of an application under [section 360b(b) of this title](/usc/21/360b.md?p=b) or [section 360ccc of this title](/usc/21/360ccc.md) for the [new animal drug](/usc/21/321.md?p=v).
  - (2) The [Secretary](/usc/21/321.md?p=d) may declare a [new animal drug](/usc/21/321.md?p=v) a “designated [new animal drug](/usc/21/321.md?p=v)” if—
    - (A) it is intended for a [minor use](/usc/21/321.md?p=pp) or use in a [minor species](/usc/21/321.md?p=oo); and
    - (B) the same [drug](/usc/21/321.md?p=g-1) in the same dosage form for the same intended use is not approved under section [360b](/usc/21/360b.md) or [360ccc](/usc/21/360ccc.md) of this title or designated under this section at the time the request is made.
  - (3) Regarding the termination of a designation—
    - (A) the [sponsor](/usc/21/360fff.md?p=8) of a [new animal drug](/usc/21/321.md?p=v) shall notify the [Secretary](/usc/21/321.md?p=d) of any decision to discontinue active pursuit of approval under section [360b](/usc/21/360b.md) or [360ccc](/usc/21/360ccc.md) of this title of an application for a designated [new animal drug](/usc/21/321.md?p=v). The [Secretary](/usc/21/321.md?p=d) shall terminate the designation upon such notification;
    - (B) the [Secretary](/usc/21/321.md?p=d) may also terminate designation if the [Secretary](/usc/21/321.md?p=d) independently determines that the [sponsor](/usc/21/360fff.md?p=8) is not actively pursuing approval under section [360b](/usc/21/360b.md) or [360ccc](/usc/21/360ccc.md) of this title with due diligence;
    - (C) the [sponsor](/usc/21/360fff.md?p=8) of an approved designated [new animal drug](/usc/21/321.md?p=v) shall notify the [Secretary](/usc/21/321.md?p=d) of any discontinuance of the manufacture of such [new animal drug](/usc/21/321.md?p=v) at least one year before discontinuance. The [Secretary](/usc/21/321.md?p=d) shall terminate the designation upon such notification; and
    - (D) the designation shall terminate upon the expiration of any applicable exclusivity period under [subsection (c)](#c).
  - (4) Notice respecting the designation or termination of designation of a [new animal drug](/usc/21/321.md?p=v) shall be made available to the public.
- (b) **Grants and contracts for development of designated new animal drugs—**
  - (1) The [Secretary](/usc/21/321.md?p=d) may make grants to and enter into contracts with public and private entities and individuals to assist in defraying the costs of qualified safety and effectiveness testing expenses and manufacturing expenses incurred in connection with the development of designated [new animal drugs](/usc/21/321.md?p=v).
  - (2) For purposes of [paragraph (1)](#b-1) of this section—
    - (A) The term “qualified safety and effectiveness testing” means testing—
      - (i) which occurs after the date such [new animal drug](/usc/21/321.md?p=v) is designated under this section and before the date on which an application with respect to such [drug](/usc/21/321.md?p=g-1) is submitted under [section 360b of this title](/usc/21/360b.md); and
      - (ii) which is carried out under an investigational exemption under [section 360b(j) of this title](/usc/21/360b.md?p=j).
    - (B) The term “manufacturing expenses” means expenses incurred in developing processes and procedures associated with manufacture of the designated [new animal drug](/usc/21/321.md?p=v) which occur after the [new animal drug](/usc/21/321.md?p=v) is designated under this section and before the date on which an application with respect to such [new animal drug](/usc/21/321.md?p=v) is submitted under section [360b](/usc/21/360b.md) or [360ccc](/usc/21/360ccc.md) of this title.
- (c) **Exclusivity for designated new animal drugs—**
  - (1) Except as provided in [subsection (c)(2)](#c-2), if the [Secretary](/usc/21/321.md?p=d) approves or conditionally approves an application for a designated [new animal drug](/usc/21/321.md?p=v), the [Secretary](/usc/21/321.md?p=d) may not approve or conditionally approve another application submitted for such [new animal drug](/usc/21/321.md?p=v) with the same intended use as the designated [new animal drug](/usc/21/321.md?p=v) for another applicant before the expiration of seven years from the date of approval or conditional approval of the application.
  - (2) If an application filed pursuant to [section 360b of this title](/usc/21/360b.md) or [section 360ccc of this title](/usc/21/360ccc.md) is approved for a designated [new animal drug](/usc/21/321.md?p=v), the [Secretary](/usc/21/321.md?p=d) may, during the 7-year exclusivity period beginning on the date of the application approval or conditional approval, approve or conditionally approve another application under [section 360b of this title](/usc/21/360b.md) or [section 360ccc of this title](/usc/21/360ccc.md) for such [drug](/usc/21/321.md?p=g-1) for such [minor use](/usc/21/321.md?p=pp) or [minor species](/usc/21/321.md?p=oo) for another applicant if—
    - (A) the [Secretary](/usc/21/321.md?p=d) finds, after providing the holder of such an approved application notice and opportunity for the submission of views, that in the granted exclusivity period the holder of the approved application cannot assure the availability of sufficient quantities of the [drug](/usc/21/321.md?p=g-1) to meet the needs for which the [drug](/usc/21/321.md?p=g-1) was designated; or
    - (B) such holder provides written consent to the [Secretary](/usc/21/321.md?p=d) for the approval or conditional approval of other applications before the expiration of such exclusivity period.
  - (3) For purposes of determining the 7-year period of exclusivity under [paragraph (1)](#c-1) for a [drug](/usc/21/321.md?p=g-1) for which the [Secretary](/usc/21/321.md?p=d) intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act [[21 U.S.C. 801](/usc/21/801.md) et seq.], the [drug](/usc/21/321.md?p=g-1) shall not be considered approved or conditionally approved until the date that the interim final rule controlling the [drug](/usc/21/321.md?p=g-1) is issued in accordance with section 201(j) of the Controlled Substances Act [[21 U.S.C. 811(j)](/usc/21/811.md?p=j)].

## Source credit

(June 25, 1938, ch. 675, § 573, as added Pub. L. 108–282, title I, § 102(b)(4), Aug. 2, 2004, 118 Stat. 900; amended Pub. L. 114–89, § 2(a)(4), Nov. 25, 2015, 129 Stat. 700.)

## Notes

### Editorial Notes

### References in Text

The Controlled Substances Act, referred to in subsec. (c)(3), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.

### Amendments

2015—Subsec. (c)(3). Pub. L. 114–89 added par. (3).