[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR101.2]

[Page 563-565]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 101_DEFINITIONS--Table of Contents
 
Sec.  101.2  Administrative terminology.

    The following administrative words and phrases shall mean:
    Adjacent herd. Adjacent herds are herds physically contiguous to the 
herd of origin; there are no herds between an adjacent herd and the herd 
of origin.
    Administrator. The Administrator, Animal and Plant Health Inspection 
Service, or any person authorized to act for the Administrator.
    Animal and Plant Health Inspection Service. The agency in the 
Department of Agriculture responsible for administering the Virus-Serum-
Toxin Act.
    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.
    (3) The term treatment shall mean the prevention, diagnosis, 
management, or cure of diseases of animals.
    Department. The U.S. Department of Agriculture.
    Distributor. A person who sells, distributes, or otherwise places in 
channels of trade, one or more biological

[[Page 564]]

products he does not produce or import.
    Division. A marketing unit established by the licensee which may be 
named on labels, advertisements and promotional material in addition to 
the name and address of the producer.
    Domestic animals. All animals, other than man, including poultry.
    Establishment. One or more premises designated on the establishment 
license.
    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 Virus-Serum-Toxin Act. Guidelines issued by the 
agency include Veterinary Biologics Licensing Considerations, Memoranda, 
Notices, and Supplemental Assay Methods.
    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 Animal and Plant Health 
Inspection Service who is authorized by the Administrator to do 
inspection work.
    Licensed establishment. An establishment operated by a person 
holding an unexpired, unsuspended, and unrevoked U.S. Veterinary 
Biologics Establishment License.
    Licensee. A person to whom an establishment license and at least one 
product license has been issued.
    Microorganisms. Microscopic or submicroscopic organisms, which are 
sometimes referred to as organisms, which may introduce or disseminate 
disease of animals.
    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.
    Permittee. A person who resides in the United States or operates a 
business establishment within the United States, to whom a permit to 
import biological products has been issued.
    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

[[Page 565]]

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 Animal and Plant 
Health Inspection Service of the Department.
    Virus-Serum-Toxin Act. The Act of March 4, 1913, 37 Stat. 832-833; 
as amended December 23, 1985, Public Law 99-198, 99 Stat. 1654-1655; and 
as further amended September 28, 1988, Public Law 100-449, 102 Stat. 
1868; 21 U.S.C. 151-159.
    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).

[38 FR 8426, Apr. 2, 1973; 38 FR 9221, Apr. 12, 1973, as amended at 40 
FR 46093, Oct. 6, 1975; 41 FR 44358, Oct. 8, 1976; 49 FR 22624, May 31, 
1984; 52 FR 30131, Aug. 13, 1987; 56 FR 66782, 66783, Dec. 26, 1991; 57 
FR 38756, Aug. 27, 1992; 62 FR 31328, June 9, 1997; 64 FR 43044, Aug. 9, 
1999]