Subpart A General Provisions
Subpart B Ingredients
Subpart C Labeling

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Terms Used In 21 CFR Part 328 - Over-the-Counter Drug Products Intended for Oral Ingestion That Contain Alcohol

  • Act: refers to the Communications Act of 1934, as amended. See 47 CFR 54.5
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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
  • 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.
  • Decedent: A deceased person.
  • 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.
  • Fiduciary: A trustee, executor, or administrator.
  • 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.
  • 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
  • health care provider: is a ny:

    (1) Post-secondary educational institution offering health care instruction, including a teaching hospital or medical school;

    (2) Community health center or health center providing health care to migrants;

    (3) Local health department or agency;

    (4) Community mental health center;

    (5) Not-for-profit hospital;

    (6) Rural health clinic;

    (7) Skilled nursing facility (as defined in section 395i-3(a) of Title 42); or a

    (8) Consortium of health care providers consisting of one or more entities described in paragraphs (b)(1) through (7) in this section. See 47 CFR 54.600

  • 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
  • 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.
  • Personal property: All property that is not real property.
  • Probate: Proving a will
  • 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
  • rural area: is a n area that is entirely outside of a Core Based Statistical Area; is within a Core Based Statistical Area that does not have any Urban Area with a population of 25,000 or greater; or is in a Core Based Statistical Area that contains an Urban Area with a population of 25,000 or greater, but is within a specific census tract that itself does not contain any part of a Place or Urban Area with a population of greater than 25,000. See 47 CFR 54.600
  • rural health care provider: is a n eligible health care provider site located in a rural area. See 47 CFR 54.600
  • state commission: means the commission, board or official (by whatever name designated) that, under the laws of any state, has regulatory jurisdiction with respect to intrastate operations of carriers. See 47 CFR 54.5
  • Statute: A law passed by a legislature.
  • telecommunications carrier: is a ny provider of telecommunications services, except that such term does not include aggregators of telecommunications services as defined in section 226 of the Act. See 47 CFR 54.5