§ 25.23 - Actions that are excluded from the requirement to prepare an environmental assessment.

(a) Actions of a class that individually or cumulatively have been determined under § 25.24 not to significantly affect the quality of the human environment ordinarily are excluded from the preparation of an EA or an EIS.

(b) As required under 40 CFR 1508.4, FDA will require an EA for any specifc action that ordinarily is excluded if the agency has sufficient evidence to establish that the specific proposed action may significantly affect the quality of the human environment.

(c) A person submitting an application or petition of a type subject to categorical exclusion under § 25.24, or proposing to dispose of an article as provided in § 25.24 (a)(4) or (b)(9), is not required to submit an EA if the person specifies the provision of this part that excludes the action from the requirement for an EA and provides information, when appropriate, that establishes to the agency's satisfaction that the action requested is included within an excluded category and meets the criteria for the applicable exclusion.

(d) Failure to provide sufficient information, when appropriate, to establish that the requested action is subject to a categorical exclusion under § 25.24 may result in the agency's refusal to file or to approve the application or petition or to approve the proposed disposition of an article as provided in § 25.24 (a)(4) or (b)(9).

(Approved by the Office of Management and Budget under control number 0910-0190)