WAIS Document Retrieval[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR5.502]

[Page 63]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION--Table of Contents
 
           Subpart G--Animal Drugs; Redelegations of Authority
 
Sec. 5.502  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 under section 512(m) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(m)), as amended 
by the Animal Drug Availability Act of 1996 (Public Law 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 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.
    (c) These officials may not further redelegate these authorities.