[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: 21CFR515.10]

[Page 89]
 
                        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.  515.10  Medicated feed mill license applications.


    (a) Medicated feed mill license applications (Forms FDA 3448) may be 
obtained from the Public Health Service, Consolidated Forms and 
Publications Distribution Center, Washington Commerce Center, 3222 
Hubbard Rd., Landover, MD 20785, or electronically from the Center for 
Veterinary Medicine home page at ``http://www.fda.gov/cvm''.
    (b) A completed medicated feed mill license must contain the 
following information:
    (1) The full business name and address of the facility at which the 
manufacturing is to take place.
    (2) The facility's FDA registration number as required by section 
510 of the Federal Food, Drug, and Cosmetic Act (the act).
    (3) The name, title, and signature of the responsible individual or 
individuals for that facility.
    (4) A certification that the animal feeds bearing or containing new 
animal drugs are manufactured and labeled in accordance with the 
applicable regulations published under section 512(i) of the act.
    (5) A certification that the methods used in, and the facilities and 
controls used for, manufacturing, processing, packaging, and holding 
such animal feeds conform to current good manufacturing practice as 
described in section 501(a)(2)(B) of the act and in part 225 of this 
chapter.
    (6) A certification that the facility will establish and maintain 
all records required by regulation or order issued under sections 
512(m)(5)(A) or 504(a)(3)(A) of the act, and will permit access to, or 
copying or verification of such records.
    (7) A commitment that current approved Type B and/or Type C 
medicated feed labeling for each Type B and/or Type C medicated feed to 
be manufactured will be in the possession of the feed manufacturing 
facility prior to receiving the Type A medicated article containing such 
drug.
    (8) A commitment to renew registration every year with FDA as 
required in Sec. Sec.  207.20 and 207.21 of this chapter.
    (c) Applications must be completed, signed, and submitted to the 
Division of Animal Feeds (HFV-220), Center for Veterinary Medicine, Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
    (d) Applications that are facially deficient will be returned to the 
applicant. All reasons for the return of the application will be made 
known to the applicant.
    (e) Upon approval, the original copy of the application will be 
signed by an authorized employee of FDA designated by the Commissioner 
of Food and Drugs, and a copy will be returned to the applicant.