§ 5.84 - Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications.

(a) The Director and Deputy Director, Center for Veterinary Medicine (CVM), are authorized to:

(1) Issue notices of opportunity for a hearing on proposals to refuse approval or to withdraw approval of new animal drug applications, and supplements thereto, for drugs for animal use and proposals to refuse approval or to revoke approval of medicated feed mill license applications, and supplements thereto, submitted pursuant to section 512(m) of the Federal Food, Drug, and Cosmetic Act, as amended by the Animal Drug Availability Act of 1996 (Pub. L. 104-250).

(2) Issue notices refusing or withdrawing approval when opportunity for hearing has been waived; and

(3) Issue proposals and orders to revoke and amend regulations for new animal drugs for animal use and medicated feed mill licenses, corresponding to said act on such applications.

(b) The Director and Deputy Director, CVM, are authorized to issue notices of availability of Public Master Files containing data acceptable for use in applications for new animal drugs for drugs for animal use and feeds bearing or containing new animal drugs.