25.5—Terminology.
(a)
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:
(b)
The following terms are defined solely for the purpose of implementing the supplemental procedures provided by this part and are not necessarily applicable to any other statutory or regulatory requirements:
(1)
Abbreviated application applies to an abbreviated new drug application and an abbreviated new animal drug application.
(2)
Active moiety means the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex chelate or clathrate) of the molecule responsible for the physiological or pharmacological action of the drug substance.
(4)
Increased use of a drug or biologic product may occur if the drug will be administered at higher dosage levels, for longer duration or for different indications than were previously in effect, or if the drug is a new molecular entity. The term “use” also encompasses disposal of FDA-regulated articles by consumers.
(5)
Responsible agency official means the agency decisionmaker designated in the delegated authority for the underlying actions.