Food and Drug Administration
Food and Drug Administration's Categorical Exclusions (opens in new tab)Categorical Exclusion
§25.33 Animal drugs.
Exclusion Text
(a) Action on an NADA, abbreviated application, request for determination of eligibility for indexing, a supplement to such applications, or a modification of an index listing, 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 §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 §510.455 of this chapter or as a liquid feed supplement under §558.5 of this chapter.
Disclaimer
This CE Explorer tool is not an authoritative source and creates no rights or obligations. When using the CE Explorer Tool, Federal agencies and stakeholders should review the relevant agency's NEPA procedures for information about how to apply the CE, including any limitations or potential extraordinary circumstances, and to ensure that a CE is current and applicable to a given proposed action. For ease of use, a link to each agency's NEPA procedures and CEs is provided along with the text of the CE. To adopt and use another agency's categorical exclusion, an agency must follow the steps described in section 109 of NEPA, 42 U.S.C. 4336c.
