[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: 21CFR515.22]

[Page 90-91]
 
                        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 B--Administrative Actions on Licenses
 
Sec.  515.22  Suspension and/or revocation of approval of a medicated feed mill license.

    (a) The Secretary of Health and Human Services may suspend a 
medicated feed mill license approved under section 512(m)(2) of the 
Federal Food, Drug, and Cosmetic Act (the act) and give the person 
holding the medicated feed mill license application prompt notice of 
this action and afford the applicant the opportunity for an expedited 
hearing on a finding that there is an imminent hazard to the health of 
man or of the animals for which such animal feed is intended.
    (b) The Commissioner of Food and Drugs (the Commissioner) shall 
notify in writing the person holding an application approved under 
section 512(m)(2) of the act and afford an opportunity for a hearing on 
a proposal to revoke approval of such application if the Commissioner 
finds:
    (1) That the application contains any untrue statement of a material 
fact; or

[[Page 91]]

    (2) That the applicant has made any changes that would cause the 
application to contain any untrue statements of material fact or that 
would affect the safety or effectiveness of the animal feeds 
manufactured at the facility unless the applicant has supplemented the 
application by filing a supplemental application under Sec.  515.11.
    (c) The Commissioner may notify in writing the person holding an 
application approved under section 512(m)(2) of the act and afford an 
opportunity for a hearing on a proposal to revoke approval of such 
application if the Commissioner finds:
    (1) That the applicant has failed to establish a system for 
maintaining required records, or has repeatedly or deliberately failed 
to maintain such records or to make required reports in accordance with 
a regulation or order under sections 512(m)(5)(A) or 504(a)(3)(A) of the 
act, or the applicant has refused to permit access to, or copying, or 
verification of, such records as required by sections 512(m)(5)(B) or 
504(a)(3)(B) of the act; or
    (2) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
methods used in, or the facilities and controls used for, the 
manufacture, processing, packing, and holding of such animal feed are 
inadequate to assure and preserve the identity, strength, quality, and 
purity of the new animal drug therein, and were not made adequate within 
a reasonable time after receipt of written notice from the Commissioner 
specifying the matter complained of; or
    (3) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
labeling of any animal feeds, based on a fair evaluation of all material 
facts, is false or misleading in any particular and was not corrected 
within a reasonable time after receipt of written notice from the 
Commissioner specifying the matter complained of; or
    (4) That on the basis of new information before him, evaluated 
together with the evidence before him when such license was issued, the 
facility has manufactured, processed, packed, or held animal feed 
bearing or containing a new animal drug adulterated under section 
501(a)(6) of the act, and the facility did not discontinue the 
manufacture, processing, packing, or holding of such animal feed within 
a reasonable time after receipt of written notice from the Commissioner 
specifying the matter complained of.