Environmental Assessments

Under the National Environmental Policy Act of 1969 (NEPA), all Federal agencies are required to assess the environmental impact of their actions and to ensure that the interested and affected public is informed of the environmental analyses. CDER's Environmental Assessment of Human Drug and Biologics Applications (Issued 7/1998, Posted 7/24/98) provides detailed information on a variety of topics related to preparing and filing environmental assessments (EAs).

In CDER, adherence to NEPA is demonstrated by the EA portion of the drug application. This section focuses on the environmental implications of consumer use and disposal from use of the candidate drug. However, because approval of many drugs are unlikely to have significant environmental effects, CDER has provisions for submission of abbreviated EAs rather than full EAs under certain circumstances or has categorically excluded certain classes of actions. FDA has reevaluated its NEPA regulations found in 21 CFR Part 25 and has proposed to improve its efficiency in the implementation of NEPA and reduce the number of EAs by increasing the number of applicable categorical exclusions. The notice of proposed rule making was posted in the Federal Register on April 3, 1996.