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Code of Federal Regulations (Last Updated: April 5, 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 516 - New Animal Drugs for Minor Use and Minor Species |
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Subpart C - Index of Legally Marketed Unapproved New Animal Drugs for Minor Species |
§ 516.151 - Granting a request for addition to the index.
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§ 516.151 Granting a request for addition to the index.
(a) FDA will grant the request for addition of a new animal drug to the index if none of the reasons described in § 516.149 for denying such a request applies.
(b) When a request for addition of a new animal drug to the index is granted, FDA will notify the requestor in accordance with § 516.153.