[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR25.33]
[Page 241]
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(b)(3), (b)(4), or (c)(3) 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.
(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.
[62 FR 40592, July 29, 1997, as amended at 71 FR 74782, Dec. 13, 2006]
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