{"data":{"id":"us/21-cfr-514.105","jurisdiction":"us","citation":"21 CFR 514.105","heading":"Approval of applications.","body":"(a) The Commissioner shall forward for publication in the Federal Register a regulation prescribing the conditions under which the new animal drug may be used, including the name and address of the applicant; the conditions and indications for use covered by the application; any tolerance, withdrawal period, or other use restrictions; any tolerance required for the new animal drug substance or its metabolites in edible products of food-producing animals; and, if such new animal drug is intended for use in animal feed, appropriate purposes and conditions of use (including special labeling requirements) applicable to any animal feed; and such other information the Commissioner deems necessary to assure safe and effective use.\n(b) He shall notify the applicant by sending him a copy of the proposed publication as described in paragraph (a)(1) of this section.","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 514—NEW ANIMAL DRUG APPLICATIONS","Subpart B—Administrative Actions on Applications"],"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":"bec4873dff680d40122001402b9fc68f8c997d6b00e4f828bd39928f5102a019","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-514.100","next":"us/21-cfr-514.106"},"notice":"GroundRules: Original legal text. Not legal advice."}