Environmental Impact Considerations

This information collection supports FDA implementation of the National Environmental Policy Act (NEPA). NEPA requires the preparation of an environmental impact statement (EIS) for every major Federal action that will significantly affect the quality of the human environment or, in the alternative, the assertion of a categorical exclusion. Agency regulations governing NEPA compliance are found in 21 CFR part 25.

The latest form for Environmental Impact Considerations expires 2028-11-30 and can be found here.