Zdrowie i gospodarka · 24.11.2004
Environmental Assessment; Categorical Exclusions
The Food and Drug Administration (FDA) is proposing to amend its regulation on environmental impact considerations to expand existing categorical exclusions to include approvals of humanitarian device exemptions (HDEs) and establishment of special controls as categories of actions that do not individually or cumulatively have a significant effect on the human environment and for which neither an environmental assessment (EA) nor environmental impact statement (EIS) is required. Regulations issued by the Council on Environmental Quality require that all Federal Agencies assess the environmental impact of their major actions and ensure that the interested and affected public is informed of environmental analyses. FDA is taking this action in accordance with the National Environmental Policy Act (NEPA).