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Summary: National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions (Final Rule)

In accordance with the National Environmental Policy Act of 1969 (NEPA) and the Council on Environmental Quality (CEQ) Regulations Implementing NEPA (CEQ regulations), the Food and Drug Administration (FDA or the Agency) is issuing a final rule to revise its NEPA implementing regulations to provide categorical exclusions for certain actions related to substantial equivalence (SE) reports, SE exemption requests, and tobacco product applications, and the rescission (order withdrawing an order) or suspension of orders regarding the marketing of tobacco products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). FDA is also amending its NEPA implementing regulations to include tobacco products, where appropriate, in light of its new authority under the Tobacco Control Act.

Regulatory Impact Analysis

National Environmental Policy Act; Environmental Assessments for Tobacco Products; Categorical Exclusions (final rule) (PDF - 130KB)

Federal Register: 80 FR 57531, Sept 24, 2015

Docket: FDA-2013-N-1282