Page:United States Statutes at Large Volume 117.djvu/1381

 117 STAT. 1362

PUBLIC LAW 108–130—NOV. 18, 2003 animal drug application submitted under section 512(b)(2) or a supplemental animal drug application. ‘‘(2) The term ‘supplemental animal drug application’ means— ‘‘(A) a request to the Secretary to approve a change in an animal drug application which has been approved; or ‘‘(B) a request to the Secretary to approve a change to an application approved under section 512(c)(2) for which data with respect to safety or effectiveness are required. ‘‘(3) The term ‘animal drug product’ means each specific strength or potency of a particular active ingredient or ingredients in final dosage form marketed by a particular manufacturer or distributor, which is uniquely identified by the labeler code and product code portions of the national drug code, and for which an animal drug application or a supplemental animal drug application has been approved. ‘‘(4) The term ‘animal drug establishment’ means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within 5 miles of each other, at which one or more animal drug products are manufactured in final dosage form. ‘‘(5) The term ‘investigational animal drug submission’ means— ‘‘(A) the filing of a claim for an investigational exemption under section 512(j) 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. ‘‘(6) The term ‘animal drug sponsor’ means either an applicant named in an animal drug application, except for an approved application for which all subject products have been removed from listing under section 510, or a person who has submitted an investigational animal drug submission that has not been terminated or otherwise rendered inactive by the Secretary. ‘‘(7) The term ‘final dosage form’ means, with respect to an animal drug product, a finished dosage form which is approved for administration to an animal without substantial further manufacturing. Such term includes animal drug products intended for mixing in animal feeds. ‘‘(8) The term ‘process for the review of animal drug applications’ means the following activities of the Secretary with respect to the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions: ‘‘(A) The activities necessary for the review of animal drug applications, supplemental animal drug applications, and investigational animal drug submissions. ‘‘(B) The issuance of action letters which approve animal drug applications or supplemental animal drug applications or which set forth in detail the specific deficiencies in animal drug applications, supplemental animal

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