Page:United States Statutes at Large Volume 118.djvu/931

 118 STAT. 901 PUBLIC LAW 108–282—AUG. 2, 2004 be made before the submission of an application under section 512(b) or section 571 for the new animal drug. ‘‘(2) The Secretary may declare a new animal drug a ‘des ignated 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 512 or 571 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 512 or 571 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 512 or 571 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 expira tion 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 512; and ‘‘(ii) which is carried out under an investigational exemption under section 512(j). ‘‘(B) The term ‘manufacturing expenses’ means expenses incurred in developing processes and procedures associated with manufacture of the designated new animal drug which occur after the new animal drug is designated under this section and before the date on which an applica tion with respect to such new animal drug is submitted under section 512 or 571. ‘‘(c) EXCLUSIVITY FOR DESIGNATED NEW ANIMAL DRUGS.— Notifications. Terminations.

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