[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: 21CFR514.105]

[Page 80]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 514--NEW ANIMAL DRUG APPLICATIONS--Table of Contents
 
            Subpart B--Administrative Actions on Applications
 
Sec.  514.105  Approval of applications.

    (a) The Commissioner shall forward for publication in the Federal 
Register a regulation prescribing the conditions under which the new 
animal drug may be used, including the name and address of the 
applicant; the conditions and indications for use covered by the 
application; any tolerance, withdrawal period, or other use 
restrictions; any tolerance required for the new animal drug substance 
or its metabolites in edible products of food-producing animals; and, if 
such new animal drug is intended for use in animal feed, appropriate 
purposes and conditions of use (including special labeling requirements) 
applicable to any animal feed; and such other information the 
Commissioner deems necessary to assure safe and effective use.
    (b) He shall notify the applicant by sending him a copy of the 
proposed publication as described in paragraph (a)(1) of this section.

[40 FR 13825, Mar. 27, 1975, as amended at 51 FR 7392, Mar. 3, 1986; 64 
FR 63203, Nov. 19, 1999]