21 CFR § 25.41 - Findings of no significant impact.
---identifier: "/us/cfr/t21/s25.41"source: "ecfr"legal_status: "authoritative_unofficial"title: "21 CFR § 25.41 - Findings of no significant impact."title_number: 21title_name: "Food and Drugs"section_number: "25.41"section_name: "Findings of no significant impact."chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"subchapter_number: "A"subchapter_name: "GENERAL"part_number: "25"part_name: "ENVIRONMENTAL IMPACT CONSIDERATIONS"positive_law: falsecurrency: "2026-04-05"last_updated: "2026-04-05"format_version: "1.1.0"generator: "[email protected]"authority: "21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360."regulatory_source: "62 FR 40592, July 29, 1997, unless otherwise noted."cfr_part: "25"---
Identifier
/us/cfr/t21/s25.41
Currency
2026-04-05
Positive Law
No
Updated
2026-04-05
Chapter
Food and Drug Administration, Department of Health and Human Services
Authority
21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp.... 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C. 4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR, 1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR, 1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980 Comp., p. 356-360.
# 25.41 Findings of no significant impact.(a) As defined by the CEQ regulations (40 CFR 1508.13), a FONSI is a document prepared by a Federal agency stating briefly why an action, not otherwise excluded, will not significantly affect the human environment and for which, therefore, an EIS will not be prepared. A FONSI includes the EA or a summary of it and a reference to any other related environmental documents.(b) The agency official(s) responsible for approving the FONSI will sign the document, thereby establishing that the official(s) approve(s) the conclusion not to prepare an EIS for the action under consideration.