Abbreviated application

(1) Abbreviated application applies to an abbreviated new drug application and an abbreviated new animal drug application.

Source

21 CFR § 25.5


Scoping language

Definitions that apply to the terms used in this part are set forth in the CEQ regulations under 40 CFR part 1508. The terms and the sections of 40 CFR part 1508 in which they are defined follow:
(1) Categorical exclusion (40 CFR 1508.4).
(2) Cooperating agency (40 CFR 1508.5).
(3) Cumulative impact (40 CFR 1508.7).
(4) Effects (40 CFR 1508.8).
(5) Environmental assessment (EA) (40 CFR 1508.9).
(6) Environmental document (40 CFR 1508.10).
(7) Environmental impact statement (EIS) (40 CFR 1508.11).
(8) Federal agency (40 CFR 1508.12).
(9) Finding of no significant impact (40 CFR 1508.13).
(10) Human environment (40 CFR 1508.14).
(11) Lead agency (40 CFR 1508.16).
(12) Legislation (40 CFR 1508.17).
(13) Major Federal action (40 CFR 1508.18).
(14) Mitigation (40 CFR 1508.20).
(15) NEPA process (40 CFR 1508.21).
(16) Notice of intent (40 CFR 1508.22).
(17) Proposal (40 CFR 1508.23).
(18) Scope (40 CFR 1508.25).
(19) Significantly (40 CFR 1508.27).

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