[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.33]

[Page 245-246]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS--Table of Contents
 
                    Subpart C--Categorical Exclusions
 
Sec. 25.33  Animal drugs.

    The classes of actions listed in this section are categorically 
excluded and, therefore, ordinarily do not require the preparation of an 
EA or an EIS:
    (a) Action on an NADA, abbreviated application, or a supplement to 
such applications, if the action does not increase the use of the drug. 
Actions to which this categorical exclusion applies may include:
    (1) An animal drug to be marketed under the same conditions of 
approval as a previously approved animal drug;
    (2) A combination of previously approved animal drugs;
    (3) A new premix or other formulation of a previously approved 
animal drug;
    (4) Changes specified in Sec. 514.8 (a)(5), (a)(6), or (d) of this 
chapter;
    (5) A change of sponsor;
    (6) A previously approved animal drug to be contained in medicated 
feed blocks under Sec. 510.455 of this chapter or as a liquid feed 
supplement under Sec. 558.5 of this chapter; or
    (7) Approval of a drug for use in animal feeds if such drug has been 
approved under Sec. 514.2 or 514.9 of this chapter for other uses.
    (b) [Reserved]
    (c) Action on an NADA, abbreviated application, or a supplement to 
such applications, for substances that occur naturally in the 
environment when the action does not alter significantly the 
concentration or distribution of the substance, its metabolites, or 
degradation products in the environment.

[[Page 246]]

    (d) Action on an NADA, abbreviated application, or a supplement to 
such applications, for:
    (1) Drugs intended for use in nonfood animals;
    (2) Anesthetics, both local and general, that are individually 
administered;
    (3) Nonsystemic topical and ophthalmic animal drugs;
    (4) Drugs for minor species, including wildlife and endangered 
species, when the drug has been previously approved for use in another 
or the same species where similar animal management practices are used; 
and
    (5) Drugs intended for use under prescription or veterinarian's 
order for therapeutic use in terrestrial species.
    (e) Action on an INAD.
    (f) Action on an application submitted under section 512(m) of the 
act.
    (g) Withdrawal of approval of an NADA or an abbreviated NADA.
    (h) Withdrawal of approval of a food additive petition that reduces 
or eliminates animal feed uses of a food additive.