investigational animal drug submission
(5) The term “investigational animal drug submission” means— (A) the filing of a claim for an investigational exemption under section 360b(j) of this title for a new animal drug intended to be the subject of an animal drug application or a supplemental animal drug application; or (B) the submission of information for the purpose of enabling the Secretary to evaluate the safety or effectiveness of an animal drug application or supplemental animal drug application in the event of their filing.