National Environmental Policy Act; Revision of Policies and Procedures

The Food and Drug Administration (FDA) is amending its regulations governing compliance with the National Environmental Policy Act of 1969 (NEPA) as implemented by the regulations of the Council on Environmental Quality (CEQ). The primary purpose of this final rule is to increase the efficiency of FDA's implementation of NEPA and to reduce the number of NEPA evaluations by providing for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant effect on the human environment and for which, therefore, neither an environmental impact statement (EIS) nor an environmental assessment (EA) is required. FDA is also amending its regulations to make its NEPA procedures more concise and understandable to the public and to reflect current FDA policy with respect to environmental considerations. The amendments to FDA's regulations governing compliance with NEPA reflect FDA's continuing review of its policies and procedures to determine whether revisions are necessary to ensure full compliance with the purpose and provisions of NEPA and implement the President's reinventing Government initiatives announced in ``Reinventing Drug and Medical Device Regulations,'' April 1995, and ``Reinventing Food Regulations,'' January 1996.