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- US Code
- Title 21. FOOD AND DRUGS
- Chapter 9. Federal Food, Drug, and Cosmetic Act
- Subchapter V. Drugs and Devices
- Part F. New Animal Drugs For Minor Use and Minor Species
21 U.S.C. § 360ccc-2 Designated New Animal Drugs For Minor Use Or Minor Species
(a) Designation
(1) The manufacturer or the sponsor of a new animal drug for a minor use or use in a minor species may request that the Secretary declare that drug a "designated new animal drug". A request for designation of a new animal drug shall be made before the submission of an application under section 360b(b) of this title or section 360ccc of this title for the new animal drug.
(2) The Secretary may declare a new animal drug a "designated new animal drug" if-
(A) it is intended for a minor use or use in a minor species; and
(B) the same drug in the same dosage form for the same intended use is not approved under section 360b or 360ccc 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 of a new animal drug shall notify the Secretary of any decision to discontinue active pursuit of approval under section 360b or 360ccc of this title of an application for a designated new animal drug. The Secretary shall terminate the designation upon such notification;
(B) the Secretary may also terminate designation if the Secretary independently determines that the sponsor is not actively pursuing approval under section 360b or 360ccc of this title with due diligence;
(C) the sponsor of an approved designated new animal drug shall notify the Secretary of any discontinuance of the manufacture of such new animal drug at least one year before discontinuance. The Secretary shall terminate the designation upon such notification; and
(D) the designation shall terminate upon the expiration of any applicable exclusivity period under subsection (c).
(4) Notice respecting the designation or termination of designation of a new animal drug shall be made available to the public.
(b) Grants and contracts for development of designated new animal drugs
(1) The Secretary 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.
(2) For purposes of paragraph (1) of this section-
(A) The term "qualified safety and effectiveness testing" means testing-
(i) which occurs after the date such new animal drug is designated under this section and before the date on which an application with respect to such drug is submitted under section 360b of this title; and
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