9 CFR 101.2 - Administrative terminology.
The following administrative words and phrases shall mean:
Administrator. The Administrator,
Adverse event. Any observation in animals, whether or not the cause of the event is known, that is unfavorable and unintended, and that occurs after any use (as indicated on the label or any off-label use) of a biological product, including events related to a suspected lack of expected efficacy. For products intended to diagnose disease, adverse events refer to a failure in product performance that hinders an expected discovery of the correct diagnosis.
Adverse event report. Direct communication concerning the occurrence of an adverse event from an identifiable first-hand reporter which includes the following information:
(1) An identifiable reporter;
(2) An identifiable animal;
(3) An identifiable biologic product; and
(4) One or more adverse events.
Biological products. The term biological products, also referred to in this subchapter as biologics, biologicals, or products, shall mean all viruses, serums, toxins (excluding substances that are selectively toxic to microorganisms, e.g., antibiotics), or analogous products at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which act primarily through the direct stimulation, supplementation, enhancement, or modulation of the immune system or immune response. The term “biological products” includes but is not limited to vaccines, bacterins, allergens, antibodies, antitoxins, toxoids, immunostimulants, certain cytokines, antigenic or immunizing components of live organisms, and diagnostic components, that are of natural or synthetic origin, or that are derived from synthesizing or altering various substances or components of substances such as microorganisms, genes or genetic sequences, carbohydrates, proteins, antigens, allergens, or antibodies.
(1) A product's intended use shall be determined through an objective standard and not a subjective one, and would be dependent on factors such as representations, claims (either oral or written), packaging, labeling, or appearance.
(2) The term analogous products shall include:
(i) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals and which are similar in function to biological products in that they act, or are intended to act, through the stimulation, supplementation, enhancement, or modulation of the immune system or immune response; or
(ii) Substances, at any stage of production, shipment, distribution, or sale, which are intended for use in the treatment of animals through the detection or measurement of antigens, antibodies, nucleic acids, or immunity; or
(iii) Substances, at any stage of production, shipment, distribution, or sale, which resemble or are represented as biological products intended for use in the treatment of animals through appearance, packaging, labeling, claims (either oral or written), representations, or through any other means.
Department. The U.S.
Guidelines. Guidelines establish principles or practices related to test procedures, manufacturing practices, product standards, scientific protocols, labeling, and other technical or policy considerations. Guidelines contain procedures or standards of general applicability that are usually not regulatory in nature, but that are related to matters that fall under the
Herd. Any group of animals, including birds, fish, and reptiles, maintained at a common location (e.g. lot, farm or ranch) for any purpose. The herd (or flock) includes all animals subsequently housed at the common location. If the principal animals of a group are moved to a different location, the group is still considered the same herd.
Herd of origin. The herd from which the microorganism used as seed for production of an autogenous biologic is isolated. Offspring and excess breeding stock (not the principal animals) moved or sold from one group of animals to another have changed herds and are no longer considered part of the herd they originated from. Groups of animals under the same ownership but at different locations are separate herds.
Inspection. An examination made by an inspector to determine the fitness of animals, establishments, facilities, and procedures used in connection with the preparation, testing, and distribution of biological products and the examination or testing of biological products.
Inspector. Any officer or employee of
Nonadjacent herd. Nonadjacent herds are all herds other than the herd of origin and other than herds adjacent to the herd of origin. Herds adjacent to the herd of origin but in a different State from the herd of origin are also considered nonadjacent herds.
Person. Any individual, firm, partnership, corporation, company, association, educational institution, State or local governmental agency, or other organized group of any of the foregoing, or any agent, officer, or employee of any thereof.
Premises. All buildings, appurtenances, and equipment used to produce and store biological products located within a particular land area shown on building plans or drawings furnished by the applicant or the licensee and designated by an address adequate for identification.
Prepare or preparation. Sometimes referred to as manufacture or produce, means the steps and procedures used in the processing, testing, packaging, labeling, and storing of a biological product.
Regulations. The provisions in parts 101 through 118 of this subchapter.
Research investigator or research sponsor. A person who has requested authorization to ship an experimental biological product for the purpose of evaluating such product, or has been granted such authorization.
Secretary. The Secretary of Agriculture of the United States or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.
Subsidiary. A corporation in which a corporate licensee owns in excess of 50 percent of the voting stock.
Veterinary Services. Veterinary Services unit of
U.S. Veterinary Biological Product License. A document, sometimes referred to as a product license, which is issued pursuant to part 102 of this subchapter to the holder of an establishment license, as a part of and ancillary to the establishment license, and which authorizes production of a specified biological product in the designated licensed establishment.
U.S. Veterinary Biological Product Permit. A document, sometimes referred to as a permit, issued to a person authorizing the importation of specified biological products subject to restrictions and controls as provided in the regulations.
U.S. Veterinary Biologics Establishment License. A document referred to as an establishment license, which is issued pursuant to part 102 of this subchapter, authorizing the use of designated premises for production of biological products specified in one or more unexpired, unsuspended, and unrevoked product license(s).