21 CFR 514.105
§ 514.105 Approval of applications.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 514.105, § 514.105 Approval of applications, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86959
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Full text
(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.
(b) He shall notify the applicant by sending him a copy of the proposed publication as described in paragraph (a)(1) of this section.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.