§ 5.501 - Approval of new animal drug applications, medicated feed mill license applications and their supplements.

(a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to perform all the functions of the Commissioner of Food and Drugs (Commissioner) with regard to the approval of new animal drug applications, and supplements thereto, for new animal drugs submitted under section 512 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360b).

(b) The following officials are authorized to perform all the functions of the Commissioner of Food and Drugs with regard to the approval of supplemental applications to approved new animal drugs submitted under section 512 of the act (21 U.S.C. 360b):

(1) The Director, the Deputy Director for Human Food Safety and Consultative Services, and the Deputy Director for Therapeutic and Production Drug Review, Office of New Animal Drug Evaluation, CVM.

(2) The Director and Deputy Director, Office of Surveillance and Compliance, CVM.

(c) The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of supplemental applications to new animal drug applications that are described by § 514.8(a)(4)(iii), (iv), and (v), and (d)(3) of this chapter.

(1) The Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM.

(2) The Director, Division of Epidemiology and Surveillance, Office of Surveillance and Compliance, CVM.

(d) The following officials are authorized to perform all the functions of the Commissioner with regard to the approval of medicated feed mill license applications for the manufacture of animal feeds containing new animal drugs under section 512(m) of the act (21 U.S.C. 360b(m), as amended by the Animal Drug Availability Act of 1996 (Public Law 104-250):

(1) The Director and Deputy Director, CVM.

(2) The Director, Division of Animal Feeds, Office of Surveillance and Compliance, CVM.

(3) The Leader, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM.

(4) The Medicated Feeds Specialist, Medicated Feeds Team, Division of Animal Feeds, Office of Surveillance and Compliance, CVM.

(e) These officials may not further redelegate these authorities.