[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR515.11]

[Page 89-90]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 515--MEDICATED FEED MILL LICENSE--Table of Contents
 
                         Subpart A--Applications
 
Sec.  515.11  Supplemental medicated feed mill license applications.

    (a) After approval of a medicated feed mill license application to 
manufacture animal feed, a supplemental application shall be submitted 
for a change in ownership and/or a change in mailing address of the 
facility site.
    (b) Each supplemental application should be accompanied by a fully 
completed Form FDA 3448 and include an explanation of the change.

[[Page 90]]

    (c) Within 30 working days after a supplemental application has been 
filed, if the Commissioner of Food and Drugs determines that the 
application provides adequate information respecting the change in 
ownership and/or postal address of the facility site, then an authorized 
employee of the Food and Drug Administration designated by the 
Commissioner shall notify the applicant that it is approved by signing 
and mailing to the applicant a copy of the Form FDA 3448. Supplemental 
applications that do not provide adequate information shall be returned 
to the applicant and all reasons for the return of the application shall 
be made known to the applicant.