§ 514.105. Approval of applications.
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/us/cfr/t21/s§ 514.105·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64 FR 63203, Nov. 19, 1999]
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§ 514.105
Approval of applications.
Fed. Reg.×13
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