[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: 21CFR515.21]

[Page 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 B--Administrative Actions on Licenses
 
Sec.  515.21  Refusal to approve a medicated feed mill license application.

    (a) The Commissioner of Food and Drugs (the Commissioner) shall 
within 90 days, or such additional period as may be agreed upon by the 
Commissioner and the applicant, after the filing of an application under 
Sec.  515.10, inform the applicant in writing of his/her intention to 
issue a notice of opportunity for a hearing on a proposal to refuse to 
approve the application, if the Commissioner determines upon the basis 
of the application, on the basis of a preapproval inspection, or upon 
the basis of any other information before him that:
    (1) The application is incomplete, false, or misleading in any 
particular; or
    (2) The methods used in and the facilities and controls used for the 
manufacturing, processing, and packaging of such animal feed are not 
adequate to preserve the identity, strength, quality, and purity of the 
new animal drug therein; or
    (3) The facility manufactures animal feeds bearing or containing new 
animal drugs in a manner that does not accord with the specifications 
for manufacture or labels animal feeds bearing or containing new animal 
drugs in a manner that does not accord with the conditions or 
indications of use that are published under section 512(i) of the act.
    (b) The Commissioner, as provided in Sec.  515.30, shall 
expeditiously notify the applicant of an opportunity for a hearing on 
the question of whether such application is approvable, unless by the 
30th day following the date of issuance of the letter informing the 
applicant of the intention to issue a notice of opportunity for a 
hearing the applicant:
    (1) Withdraws the application; or
    (2) Waives the opportunity for a hearing; or
    (3) Agrees with the Commissioner on an additional period to preceed 
issuance of such notice of hearing.