Terms Used In 21 CFR Part 320 - Bioavailability and Bioequivalence Requirements

• Advice and consent: Under the Constitution, presidential nominations for executive and judicial posts take effect only when confirmed by the Senate, and international treaties become effective only when the Senate approves them by a two-thirds vote.
• Affidavit: A written statement of facts confirmed by the oath of the party making it, before a notary or officer having authority to administer oaths.
• Affirmed: In the practice of the appellate courts, the decree or order is declared valid and will stand as rendered in the lower court.
• Allegation: something that someone says happened.
• 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.
• Amortization: Paying off a loan by regular installments.
• Annuity: A periodic (usually annual) payment of a fixed sum of money for either the life of the recipient or for a fixed number of years. A series of payments under a contract from an insurance company, a trust company, or an individual. Annuity payments are made at regular intervals over a period of more than one full year.
• Answer: The formal written statement by a defendant responding to a civil complaint and setting forth the grounds for defense.
• Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
• Appellate: About appeals; an appellate court has the power to review the judgement of another lower court or tribunal.
• Appraisal: A determination of property value.
• Assets: (1) The property comprising the estate of a deceased person, or (2) the property in a trust account.
• Attachment: A procedure by which a person's property is seized to pay judgments levied by the court.
• Baseline: Projection of the receipts, outlays, and other budget amounts that would ensue in the future without any change in existing policy. Baseline projections are used to gauge the extent to which proposed legislation, if enacted into law, would alter current spending and revenue levels.
• Beneficiary: A person who is entitled to receive the benefits or proceeds of a will, trust, insurance policy, retirement plan, annuity, or other contract. ^{Source: OCC}
• Clerk of court: An officer appointed by the court to work with the chief judge in overseeing the court's administration, especially to assist in managing the flow of cases through the court and to maintain court records.
• Codicil: An addition, change, or supplement to a will executed with the same formalities required for the will itself.
• Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
• Contract: A legal written agreement that becomes binding when signed.
• Conviction: A judgement of guilt against a criminal defendant.
• Cross examine: Questioning of a witness by the attorney for the other side.
• Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
• Decedent: A deceased person.
• Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
• Dependent: A person dependent for support upon another.
• Deposition: An oral statement made before an officer authorized by law to administer oaths. Such statements are often taken to examine potential witnesses, to obtain discovery, or to be used later in trial.
• Dismissal: The dropping of a case by the judge without further consideration or hearing. ^Source:
• Docket: A log containing brief entries of court proceedings.
• Equitable: Pertaining to civil suits in "equity" rather than in "law." In English legal history, the courts of "law" could order the payment of damages and could afford no other remedy. See damages. A separate court of "equity" could order someone to do something or to cease to do something. See, e.g., injunction. In American jurisprudence, the federal courts have both legal and equitable power, but the distinction is still an important one. For example, a trial by jury is normally available in "law" cases but not in "equity" cases. ^{Source: U.S. Courts}
• Escheat: Reversion of real or personal property to the state when 1) a person dies without leaving a will and has no heirs, or 2) when the property (such as a bank account) has been inactive for a certain period of time. ^{Source: OCC}
• 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.
• Executor: A male person named in a will to carry out the decedent
• Extradition: The formal process of delivering an accused or convicted person from authorities in one state to authorities in another state.
• Fair market value: The price at which an asset would change hands in a transaction between a willing, informed buyer and a willing, informed seller.
• Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
• Fraud: Intentional deception resulting in injury to another.
• Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
• Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
• Injunction: An order of the court prohibiting (or compelling) the performance of a specific act to prevent irreparable damage or injury.
• Intangible property: Property that has no intrinsic value, but is merely the evidence of value such as stock certificates, bonds, and promissory notes.
• Intestate: Dying without leaving a will.
• Judgement: The official decision of a court finally determining the respective rights and claims of the parties to a suit.
• 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.
• Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). ^{Source: OCC}
• Legatee: A beneficiary of a decedent
• Litigation: A case, controversy, or lawsuit. Participants (plaintiffs and defendants) in lawsuits are called litigants.
• Oath: A promise to tell the truth.
• 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.
• Oral argument: An opportunity for lawyers to summarize their position before the court and also to answer the judges' questions.
• Personal property: All property that is not real property.
• Pleadings: Written statements of the parties in a civil case of their positions. In the federal courts, the principal pleadings are the complaint and the answer.
• Probable cause: A reasonable ground for belief that the offender violated a specific law.
• Probate: Proving a will
• Probation: A sentencing alternative to imprisonment in which the court releases convicted defendants under supervision as long as certain conditions are observed.
• Public law: A public bill or joint resolution that has passed both chambers and been enacted into law. Public laws have general applicability nationwide.
• Real property: Land, and all immovable fixtures erected on, growing on, or affixed to the land.
• Recess: A temporary interruption of the legislative business.
• Rescission: The cancellation of budget authority previously provided by Congress. The Impoundment Control Act of 1974 specifies that the President may propose to Congress that funds be rescinded. If both Houses have not approved a rescission proposal (by passing legislation) within 45 days of continuous session, any funds being withheld must be made available for obligation.
• Restitution: The court-ordered payment of money by the defendant to the victim for damages caused by the criminal action.
• restricted property: as used in this part does not include the restricted lands of the Five Civilized Tribes of Oklahoma or the Osage Nation. See 25 CFR 15.2
• Statute: A law passed by a legislature.
• Summons: Another word for subpoena used by the criminal justice system.
• Temporary restraining order: Prohibits a person from an action that is likely to cause irreparable harm. This differs from an injunction in that it may be granted immediately, without notice to the opposing party, and without a hearing. It is intended to last only until a hearing can be held.
• Testator: A male person who leaves a will at death.
• Testify: Answer questions in court.
• Testimony: Evidence presented orally by witnesses during trials or before grand juries.
• Tort: A civil wrong or breach of a duty to another person, as outlined by law. A very common tort is negligent operation of a motor vehicle that results in property damage and personal injury in an automobile accident.
• Transcript: A written, word-for-word record of what was said, either in a proceeding such as a trial or during some other conversation, as in a transcript of a hearing or oral deposition.
• Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
• Trustee: A person or institution holding and administering property in trust.
• Venue: The geographical location in which a case is tried.
• Verdict: The decision of a petit jury or a judge.