Code of Federal Regulations Title 21. Food and Drugs § 21.514.105 Approval of applications

(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.