Food and Drug Administration
Food and Drug Administration's Categorical Exclusions (opens in new tab)Categorical Exclusion
§25.31 Human drugs and biologics.
Exclusion Text
(b) Action on an NDA, abbreviated application, or a supplement to such applications, or action on an OTC monograph, if the action increases the use of the active moiety, but the estimated concentration of the substance at the point of entry into the aquatic environment will be below 1 part per billion.
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.
