National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions-Small Entity Compliance Guide; Guidance for Industry; Availability

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions--Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand the recent changes to FDA's National Environmental Policy Act (NEPA)-implementing regulations, which will allow certain classes of actions on tobacco product marketing applications to be excluded from the requirements to prepare an environmental assessment (EA) or an environmental impact statement (EIS). This will decrease the amount of time required for industry to complete, and for FDA to review, applications.