Designated new animal drugs for minor use or minor species

The Secretary may declare a new animal drug a “designated new animal drug” if— Regarding the termination of a designation— For purposes of paragraph (1) of this section— The term “qualified safety and effectiveness testing” means testing— If an application filed pursuant to section 360b of this title or section 360ccc of this title is approved for a designated new animal drug, the Secretary 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 or section 360ccc of this title for such drug for such minor use or minor species for another applicant if—