Part 1 General Enforcement Regulations
Part 2 General Administrative Rulings and Decisions
Part 3 Product Jurisdiction
Part 4 Regulation of Combination Products
Part 5 Organization
Part 7 Enforcement Policy
Part 10 Administrative Practices and Procedures
Part 11 Electronic Records; Electronic Signatures
Part 12 Formal Evidentiary Public Hearing
Part 13 Public Hearing Before a Public Board of Inquiry
Part 14 Public Hearing Before a Public Advisory Committee
Part 15 Public Hearing Before the Commissioner
Part 16 Regulatory Hearing Before the Food and Drug Administration
Part 17 Civil Money Penalties Hearings
Part 19 Standards of Conduct and Conflicts of Interest
Part 20 Public Information
Part 21 Protection of Privacy
Part 25 Environmental Impact Considerations
Part 26 Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
Part 50 Protection of Human Subjects
Part 54 Financial Disclosure by Clinical Investigators
Part 56 Institutional Review Boards
Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
Part 60 Patent Term Restoration
Part 70 Color Additives
Part 71 Color Additive Petitions
Part 73 Listing of Color Additives Exempt From Certification
Part 74 Listing of Color Additives Subject to Certification
Part 80 Color Additive Certification
Part 81 General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
Part 82 Listing of Certified Provisionally Listed Colors and Specifications
Part 99 Dissemination of Information On Unapproved/New Uses for Marketed Drugs, Biologics, and Devices

Terms Used In CFR > Title 21 > Chapter I > Subchapter A - General

  • Act: when used in this subpart refers to the Act of July 23, 1955. See 43 CFR 3710.0-3
  • Adjourn: A motion to adjourn a legislative chamber or a committee, if passed, ends that day's session.
  • affected source: as used in this part , is separate and distinct from any other use of that term in EPA regulations such as those implementing title IV of the Act. See 40 CFR 63.2
  • 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.
  • Answer: The formal written statement by a defendant responding to a civil complaint and setting forth the grounds for defense.
  • 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.
  • Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
  • Arrest: Taking physical custody of a person by lawful authority.
  • 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.
  • Bankruptcy: Refers to statutes and judicial proceedings involving persons or businesses that cannot pay their debts and seek the assistance of the court in getting a fresh start. Under the protection of the bankruptcy court, debtors may discharge their debts, perhaps by paying a portion of each debt. Bankruptcy judges preside over these proceedings.
  • 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
  • Case law: The law as laid down in cases that have been decided in the decisions of the courts.
  • Chambers: A judge's office.
  • clay: means any of the following six classifications of clay defined by the U. See 40 CFR 63.9824
  • coal: includes synthetic fuels derived from coal, including but not limited to, solvent-refined coal, coal-oil mixtures, and coal-water mixtures. See 40 CFR 63.7575
  • Committee membership: Legislators are assigned to specific committees by their party. Seniority, regional balance, and political philosophy are the most prominent factors in the committee assignment process.
  • Common law: The legal system that originated in England and is now in use in the United States. It is based on judicial decisions rather than legislative action.
  • Concurrent resolution: A legislative measure, designated "S. Con. Res." and numbered consecutively upon introduction, generally employed to address the sentiments of both chambers, to deal with issues or matters affecting both houses, such as a concurrent budget resolution, or to create a temporary joint committee. Concurrent resolutions are not submitted to the President/Governor and thus do not have the force of law.
  • Continuance: Putting off of a hearing ot trial until a later time.
  • Contract: A legal written agreement that becomes binding when signed.
  • Conviction: A judgement of guilt against a criminal defendant.
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • Counterclaim: A claim that a defendant makes against a plaintiff.
  • Credit report: A detailed report of an individual's credit history prepared by a credit bureau and used by a lender in determining a loan applicant's creditworthiness. Source: OCC
  • Credit Score: A number, roughly between 300 and 800, that measures an individual's credit worthiness. The most well-known type of credit score is the FICO score. This score represents the answer from a mathematical formula that assigns numerical values to various pieces of information in your credit report. Source: OCC
  • Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
  • Deed: The legal instrument used to transfer title in real property from one person to another.
  • 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.
  • Donor: The person who makes a gift.
  • Electronic funds transfer: The transfer of money between accounts by consumer electronic systems-such as automated teller machines (ATMs) and electronic payment of bills-rather than by check or cash. (Wire transfers, checks, drafts, and paper instruments do not fall into this category.) Source: OCC
  • Embezzlement: In most states, embezzlement is defined as theft/larceny of assets (money or property) by a person in a position of trust or responsibility over those assets. Embezzlement typically occurs in the employment and corporate settings. Source: OCC
  • Enterprises: means , collectively, the Federal National Mortgage Association and the Federal Home Loan Mortgage Corporation. See 12 CFR 1206.2
  • Equal Credit Opportunity Act: Prohibits creditors from discriminating against credit applicants on the basis of race, color, religion, national origin, sex, marital status, age, or because an applicant receives income from a public assistance program. Source: OCC
  • 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
  • Escrow: Money given to a third party to be held for payment until certain conditions are met.
  • Executor: A male person named in a will to carry out the decedent
  • Fair Credit Reporting Act: A federal law, established in 1971 and revised in 1997, that gives consumers the right to see their credit records and correct any mistakes. Source: OCC
  • Fair Debt Collection Practices Act: The Fair Debt Collection Practices Act is a set of United States statutes added as Title VIII of the Consumer Credit Protection Act. Its purpose is to ensure ethical practices in the collection of consumer debts and to provide consumers with an avenue for disputing and obtaining validation of debt information in order to ensure the information's accuracy. It is often used in conjunction with the Fair Credit Reporting Act. Source: OCC
  • 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.
  • farm: includes operations that, in addition to these activities:

    (i) Pack or hold raw agricultural commodities;

    (ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in paragraph (1)(iii)(B)(1) of this definition; and

    (iii) Manufacture/process food, provided that:

    (A) All food used in such activities is consumed on that farm or another farm under the same management; or

    (B) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:

    (1) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);

    (2) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and

    (3) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or

    (2) Secondary activities farm. See 21 CFR 1.227

  • farm: includes operations that, in addition to these activities:

    (i) Pack or hold raw agricultural commodities;

    (ii) Pack or hold processed food, provided that all processed food used in such activities is either consumed on that farm or another farm under the same management, or is processed food identified in paragraph (1)(iii)(B)(1) of this definition; and

    (iii) Manufacture/process food, provided that:

    (A) All food used in such activities is consumed on that farm or another farm under the same management; or

    (B) Any manufacturing/processing of food that is not consumed on that farm or another farm under the same management consists only of:

    (1) Drying/dehydrating raw agricultural commodities to create a distinct commodity (such as drying/dehydrating grapes to produce raisins), and packaging and labeling such commodities, without additional manufacturing/processing (an example of additional manufacturing/processing is slicing);

    (2) Treatment to manipulate the ripening of raw agricultural commodities (such as by treating produce with ethylene gas), and packaging and labeling treated raw agricultural commodities, without additional manufacturing/processing; and

    (3) Packaging and labeling raw agricultural commodities, when these activities do not involve additional manufacturing/processing (an example of additional manufacturing/processing is irradiation); or

    (2) Secondary activities farm. See 21 CFR 1.328

  • farm: means all poultry houses and grounds immediately surrounding the poultry houses covered under a single biosecurity program, as set forth in § 118. See 21 CFR 1.1310
  • farm-operated business: means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s). See 21 CFR 1.227
  • farm-operated business: means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s). See 21 CFR 1.1310
  • Federal Deposit Insurance Corporation: A government corporation that insures the deposits of all national and state banks that are members of the Federal Reserve System. Source: OCC
  • Federal Reserve System: The central bank of the United States. The Fed, as it is commonly called, regulates the U.S. monetary and financial system. The Federal Reserve System is composed of a central governmental agency in Washington, D.C. (the Board of Governors) and twelve regional Federal Reserve Banks in major cities throughout the United States. Source: OCC
  • Fee simple: Absolute title to property with no limitations or restrictions regarding the person who may inherit it.
  • Fiduciary: A trustee, executor, or administrator.
  • Food Traceability List: includes both the foods specifically listed and foods that contain listed foods as ingredients, provided that the listed food that is used as an ingredient remains in the same form (e. See 21 CFR 1.1310
  • Forbearance: A means of handling a delinquent loan. A
  • Forgery: The fraudulent signing or alteration of another's name to an instrument such as a deed, mortgage, or check. The intent of the forgery is to deceive or defraud. Source: OCC
  • Fraud: Intentional deception resulting in injury to another.
  • Fraud Alert: A key provision of the Fair and Accurate Credit Transactions Act of 2003 is the consumer's ability to place a fraud alert on their credit record. A consumer would use this option if they believe they were a victim of identity theft. Source: OCC
  • 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
  • Germane: On the subject of the pending bill or other business; a strict standard of relevance.
  • Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
  • Grace period: The number of days you'll have to pay your bill for purchases in full without triggering a finance charge. Source: Federal Reserve
  • Grand jury: agreement providing that a lender will delay exercising its rights (in the case of a mortgage,
  • Guarantor: A party who agrees to be responsible for the payment of another party's debts should that party default. Source: OCC
  • 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.
  • 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
  • In forma pauperis: In the manner of a pauper. Permission given to a person to sue without payment of court fees on claim of indigence or poverty.
  • Indemnification: In general, a collateral contract or assurance under which one person agrees to secure another person against either anticipated financial losses or potential adverse legal consequences. Source: FDIC
  • Indictment: The formal charge issued by a grand jury stating that there is enough evidence that the defendant committed the crime to justify having a trial; it is used primarily for felonies.
  • initial proffered permit: as used in this part refers to the first time a permit is sent to the applicant. See 33 CFR 331.2
  • 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.
  • Inter vivos: Transfer of property from one living person to another living person.
  • Interest rate: The amount paid by a borrower to a lender in exchange for the use of the lender's money for a certain period of time. Interest is paid on loans or on debt instruments, such as notes or bonds, either at regular intervals or as part of a lump sum payment when the issue matures. Source: OCC
  • Interrogatories: Written questions asked by one party of an opposing party, who must answer them in writing under oath; a discovery device in a lawsuit.
  • Irrevocable trust: A trust arrangement that cannot be revoked, rescinded, or repealed by the grantor.
  • Joint committee: Committees including membership from both houses of teh legislature. Joint committees are usually established with narrow jurisdictions and normally lack authority to report legislation.
  • 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.
  • Law clerk: Assist judges with research and drafting of opinions.
  • Lawsuit: A legal action started by a plaintiff against a defendant based on a complaint that the defendant failed to perform a legal duty, resulting in harm to the plaintiff.
  • 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
  • Liabilities: The aggregate of all debts and other legal obligations of a particular person or legal entity.
  • Lien: A claim against real or personal property in satisfaction of a debt.
  • Markup: The process by which congressional committees and subcommittees debate, amend, and rewrite proposed legislation.
  • Mortgage loan: A loan made by a lender to a borrower for the financing of real property. Source: OCC
  • Mortgagee: The person to whom property is mortgaged and who has loaned the money.
  • National Credit Union Administration: The federal regulatory agency that charters and supervises federal credit unions. (NCUA also administers the National Credit Union Share Insurance Fund, which insures the deposits of federal credit unions.) Source: OCC
  • Nolo contendere: No contest-has the same effect as a plea of guilty, as far as the criminal sentence is concerned, but may not be considered as an admission of guilt for any other purpose.
  • 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.
  • Open-end credit: A credit agreement (typically a credit card) that allows a customer to borrow against a preapproved credit line when purchasing goods and services. The borrower is only billed for the amount that is actually borrowed plus any interest due. (Also called a charge account or revolving credit.) Source: OCC
  • Oral argument: An opportunity for lawyers to summarize their position before the court and also to answer the judges' questions.
  • Outlays: Outlays are payments made (generally through the issuance of checks or disbursement of cash) to liquidate obligations. Outlays during a fiscal year may be for payment of obligations incurred in prior years or in the same year.
  • Oversight: Committee review of the activities of a Federal agency or program.
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • Personal property: All property that is not real property.
  • Plaintiff: The person who files the complaint in a civil lawsuit.
  • Plea: In a criminal case, the defendant's statement pleading "guilty" or "not guilty" in answer to the charges, a declaration made in open court.
  • 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.
  • Power of attorney: A written instrument which authorizes one person to act as another's agent or attorney. The power of attorney may be for a definite, specific act, or it may be general in nature. The terms of the written power of attorney may specify when it will expire. If not, the power of attorney usually expires when the person granting it dies. Source: OCC
  • Precedent: A court decision in an earlier case with facts and law similar to a dispute currently before a court. Precedent will ordinarily govern the decision of a later similar case, unless a party can show that it was wrongly decided or that it differed in some significant way.
  • Presiding officer: A majority-party Senator who presides over the Senate and is charged with maintaining order and decorum, recognizing Members to speak, and interpreting the Senate's rules, practices and precedents.
  • Probable cause: A reasonable ground for belief that the offender violated a specific law.
  • Probation: A sentencing alternative to imprisonment in which the court releases convicted defendants under supervision as long as certain conditions are observed.
  • processing: means operations that alter the general state of the commodity, such as canning, cooking, freezing, dehydration, milling, grinding, pasteurization, or homogenization. See 21 CFR 1.1310
  • proffered permit: as used in this part refers to the second permit that is sent to the applicant. See 33 CFR 331.2
  • Prosecute: To charge someone with a crime. A prosecutor tries a criminal case on behalf of the government.
  • Public law: A public bill or joint resolution that has passed both chambers and been enacted into law. Public laws have general applicability nationwide.
  • public scoping process: refers to that portion of the scoping process where the public is invited to participate, as described at 40 CFR 1501. See 10 CFR 1021.104
  • Quorum: The number of legislators that must be present to do business.
  • Real property: Land, and all immovable fixtures erected on, growing on, or affixed to the land.
  • Recourse: An arrangement in which a bank retains, in form or in substance, any credit risk directly or indirectly associated with an asset it has sold (in accordance with generally accepted accounting principles) that exceeds a pro rata share of the bank's claim on the asset. If a bank has no claim on an asset it has sold, then the retention of any credit risk is recourse. Source: FDIC
  • Remainder: An interest in property that takes effect in the future at a specified time or after the occurrence of some event, such as the death of a life tenant.
  • Remand: When an appellate court sends a case back to a lower court for further proceedings.
  • Reporter: Makes a record of court proceedings and prepares a transcript, and also publishes the court's opinions or decisions (in the courts of appeals).
  • 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.
  • retail food establishment: includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. See 21 CFR 1.227
  • retail food establishment: includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. See 21 CFR 1.1310
  • Sequester: To separate. Sometimes juries are sequestered from outside influences during their deliberations.
  • Service of process: The service of writs or summonses to the appropriate party.
  • source: means the country from which the commodity was shipped to the free port or bonded warehouse. See 22 CFR 228.01
  • 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.
  • Subpoena: A command to a witness to appear and give testimony.
  • Subpoena duces tecum: A command to a witness to produce documents.
  • Summons: Another word for subpoena used by the criminal justice system.
  • 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.
  • Total equipment: includes the sensor, mechanical components, electronic components, data acquisition system, data recording system, electrical wiring, and other components of a CPMS. See 40 CFR 63.9824
  • 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.
  • Trust account: A general term that covers all types of accounts in a trust department, such as estates, guardianships, and agencies. Source: OCC
  • Trustee: A person or institution holding and administering property in trust.
  • Truth in Lending Act: The Truth in Lending Act is a federal law that requires lenders to provide standardized information so that borrowers can compare loan terms. In general, lenders must provide information on Source: OCC
  • Uphold: The decision of an appellate court not to reverse a lower court decision.
  • Usury: Charging an illegally high interest rate on a loan. Source: OCC
  • Venue: The geographical location in which a case is tried.
  • Verdict: The decision of a petit jury or a judge.