§ 516.11. Scope of this subpart.
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/us/cfr/t21/s§ 516.11·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
This subpart implements section 573 of the act. Specifically, this subpart sets forth the procedures and requirements for submissions to FDA of requests for designation of a new animal drug for a minor use or a minor species.