Terms Used In 21 CFR Part 7 - Enforcement Policy

• Amendment: A proposal to alter the text of a pending bill or other measure by striking out some of it, by inserting new language, or both. Before an amendment becomes part of the measure, thelegislature must agree to it.
• Answer: The formal written statement by a defendant responding to a civil complaint and setting forth the grounds for defense.
• Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
• Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
• Freedom of Information Act: A federal law that mandates that all the records created and kept by federal agencies in the executive branch of government must be open for public inspection and copying. The only exceptions are those records that fall into one of nine exempted categories listed in the statute. ^{Source: OCC}
• Handicapped persons: means any person who (i) has a physical or mental impairment which substantially limits one or more major life activities, (ii) has a record of such an impairment, or (iii) is regarded as having such an impairment. See 22 CFR 217.3
• Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
• Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
• Prosecute: To charge someone with a crime. A prosecutor tries a criminal case on behalf of the government.
• Statute: A law passed by a legislature.
• Statute of limitations: A law that sets the time within which parties must take action to enforce their rights.