{"data":{"id":"us/21-cfr-516.115","jurisdiction":"us","citation":"21 CFR 516.115","heading":"Definitions.","body":"(a) The following definitions of terms apply only in the context of subpart C of this part:\nDirector OMUMS means the Director of the Office of Minor Use and Minor Species Animal Drug Development of the FDA Center for Veterinary Medicine.\nHolder means the requestor of an index listing after the request is granted and the new animal drug is added to the index.\nIndex means FDA's list of legally marketed unapproved new animal drugs for minor species.\nIntended use has the same meaning as that given in § 516.13 of this chapter.\nQualified expert panel means a panel that is composed of experts qualified by scientific training and experience to evaluate the target animal safety and effectiveness of a new animal drug under consideration for indexing.\nRequestor means the person making a request for determination of eligibility for indexing or a request for addition to the index.\nTransgenic animal means an animal whose genome contains a nucleotide sequence that has been intentionally modified in vitro, and the progeny of such an animal, provided that the term ‘transgenic animal’ does not include an animal of which the nucleotide sequence of the genome has been modified solely by selective breeding.\n(b) The definitions of the following terms are given in § 514.3 of this chapter:\nAdverse drug experience.\nProduct defect/manufacturing defect.\nSerious adverse drug experience.\nUnexpected adverse drug experience.\n(c) The definitions of the following terms are given in § 516.3 of this chapter:\nSame dosage form.\nSame drug.\nSame intended use.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS","PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES","Subpart C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"d14e201841e57c95bcedf679b2374ecbe2b27d111c5816d63c68a4e356becaf3","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-516.111","next":"us/21-cfr-516.117"},"notice":"GroundRules: Original legal text. Not legal advice."}