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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 514 - New Animal Drug Applications |
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Subpart A - General Provisions |
§ 514.9 - Supplemental applications for animal feeds bearing or containing new animal drugs.
Latest version.
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(a) After an application for an animal feed bearing or containing a new animal drug has been approved, a supplemental application may propose changes.
(b) A supplemental application shall be submitted for any change which deviates from the conditions under which the application was originally approved.
(c) Each supplemental application shall be accompanied by a fully completed Form FDA 1900 in triplicate including an explanation of the changes proposed.