Code of Federal Regulations (Last Updated: July 5, 2024) |
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 |
§ 516.131 - Refuse to file a request for determination of eligibility for indexing.
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§ 516.131 Refuse to file a request for determination of eligibility for indexing.
(a) If a request for determination of eligibility for indexing contains all of the information required by § 516.129, FDA shall file it, and the filing date shall be the date FDA receives the request.
(b) If a request for a determination of eligibility lacks any of the information required by § 516.129, FDA will not file it, but will inform the requestor in writing within 30 days of receiving the request as to what information is lacking.