# Environmental Assessment; Categorical Exclusions
> **Food and Drug Administration** · Final rule. · Published 2005-11-15 · Effective 2005-12-15 · 70 FR 69276
## Document
- **Document number:** 05-22563
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 70 FR 69276
- **CFR reference:** 21 CFR 25
- **Publication date:** 2005-11-15
- **Effective date:** 2005-12-15
- **HHS docket:** Docket No. 2004N-0461
## Abstract

The Food and Drug Administration (FDA) is amending 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 an environmental impact statement (EIS) is required. FDA is taking this action in accordance with the National Environmental Policy Act (NEPA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2005/11/15/05-22563/environmental-assessment-categorical-exclusions)
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