21 C.F.R. § 514.105

Current through May 31, 2024
Section 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.

21 C.F.R. §514.105

40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64 FR 63203, Nov. 19, 1999