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5(1906 Federal Register / 
Biotechnology: Biotechnology is the 
application of biological systems and 
organisms to technical and industrial 
processes. 
Cell conjugation: The one-way 
transfer of DNA between bacteria in 
cellular contact. 
Cell fusion: Formation of a single 
hybrid cell with nuclei and cytoplasm 
from different cells. 
Cell line: Cell that acquires the ability 
to multiply indefinitely in vitro. 
Cell microencapsulation: Techniques 
using liposomes to entrap and then 
transfer nucleic acids into cells. 
Cell microinjection: A technique in 
which nucleic acids are injected into a 
cell. 
Chemical synthesis of nucleic acids: 
In vitro techniques used to synthesize 
nucleic acids from simpler molecules 
without mediation by organisms. 
Clinical trial: One of the stages in the 
collection of data for approval of 
pharmaceuticals, where the drug is 
tested in humans. (For FDA's regulatory 
definition, see 21 CFR 50.3(c) or 
56.102(c).) 
Clone: A group of genetically identical 
cells or organisms produced asexually 
from a common ancestor. 
Coding sequence: The region of a gene 
(DNA) that encodes the amino acid 
sequence of a protein, 
Diagnostic products: Products that 
recognize molecules associated with 
disease or other biologic conditions of 
man or animals and are used to 
diagnose these conditions. 
Drug: Any chemical compound that 
may be administered to humans or 
animals as an aid in the treatment of 
disease (For FDA'a regulatory definition, 
see 21 U.S.C. 321 (g).) 
Enzyme : Any of a group of catalytic 
proteins that are produced by living 
cells and that mediate or promote the 
chemical process of life without 
themselves being altered or destroyed. 
Escherichia coli (E coli): A species of 
bacteria that inhabits the intestional 
tract of most vertebrates. Some strains 
are pathogenic to humans and animals. 
Many nonpathogenic strains are used 
experimentally as hosts for rDNA. 
Eukaryote: A cell or organism with 
membrane-bound, structurally discrete 
nuclei and well developed cell 
organelles. Eukaryotes include plants, 
animals, fungi and protists. (Compare 
prokaryote.) 
Exons: Any segment of an interrupted 
gene that is represented in the mature 
RNA product. 
Fermentation: The decomposition of 
complex molecules under the influence 
of ferments or enzymes. Fermentation is 
used in various industrial processes for 
the manufacture of products such as 
Vol. 49, No. 252 / Monday," December 
alcohols, acids, and cheese by the action 
of yeasts, molds and bacteria. 
Food additivie (or food ingredient): A 
substance that becomes a component of 
food or affects the characteristics of 
food and, as such, is regulated by the 
U.S. Food and Drug Administration. (For 
FDA's regulatory definition, see 21 
U.S.C. 321(s).) 
Fungus: Primarily multinucleate 
organism with eukaryotic nuclei in 
walled mycelium, absorptive nutrition, 
and lacking photo-synthetic ability. 
Gene: The basic unit of heredity; an 
ordered sequence of nucleotide bases, 
comprising a segment of DNA. A gene 
contains the sequence of DNA that 
encodes one polyeptide chain (via 
RNA). 
Gene pooh Total genetic information 
possessed by a population whose 
members naturally exchange genetic 
information. 
Gene therapy: The insertion of a gene 
into a patient in a way that it corrects a 
genetic defect. 
Gene transfer: The use of genetic or 
physical manipulation to introduce 
foreign genes into host cells to achieve 
desired characteristics in progeny. 
Genetic engineering: A technology 
used to alter the hereditary apparatus of 
a living cell so that the cell can produce 
more or different chemicals or perform 
completely new functions. These altered 
cells are then used in industrial 
production. 
Genetic material: DNA, genes, 
chromosomes which constitute an 
organism's hereditary material; RNA in 
certain viruses. 
Genome: The basic chromosome set of 
an organism or the sum total of its 
genes. The total complement of DNA of 
a cell carrying the blueprint for 
organization and function. 
Genotype: The genetic constitution of 
an individual or group. 
Germplasm: The total genetic 
variability available to an organism, 
represented by the pool of germ cells or 
seed. 
Host-vector system: Compatible 
combinations of host (e.g., bacterium) 
and vector (e.g., plasmid) that allow 
stable introduction of foreign DNA into 
cells. 
Hybrid: The offspring genetically 
dissimilar parents (e.g., a new variety of 
plant or animal that results from cross- 
breeding two different existing varieties, 
a cell derived from two different 
cultured cell lines that have fused). 
Hybridoma: Product of fusion 
between myeloma cell (which divides 
continuously in culture and is 
''immortal") and lymphocyte (antibody- 
producing cell); the resulting cell grows 
31, 1984 / Notices 
in culture and produces monoclonal 
antibodies. 
Intron: A non-coding segment of the 
DNA of a gene that is removed from the 
transcribed RNA of cells in higher 
organisms before translation. 
Medical Device: An instrument or 
apparatus (including an in vitro reagent 
such as MAbs) intended for use in the 
diagnosis or treatment of a disease or 
other condition and which does not 
achieve its intended purpose through 
chemical action within or on the body. 
(For FDA's regulatory definition, see 21 
U.S.C. 321(h).) 
Microorganism: An organism that is a 
fungus, prokaryote, protist, or virus. 
Monoclonal antibodies (MAbs): 
Homogeneous antibodies derived from a 
single clone of cells; MAbs recognize 
only one chemical structure. MAbs are 
useful in a variety of industrial and 
medical capabilities since they are 
easily produced in large quantities and 
have remarkable specificity. 
Monoclonal antibody technology: The 
use of hybridoma3 that produce 
monoclonal antibodies for a variety of 
purposes. Hybridomas are maintained in 
cell culture or, on a large scale, as 
tumors (ascites) in mice. 
Mutagenesis: The induction of 
mutation in the genetic materials of an 
organism; researchers may use physical 
or chemical means to cause mutations 
that improve the production capabilities 
of organisms. 
Mutant An organism with one or 
more DNA mutations, making its genetic 
function or structure different from that 
of a corresponding wild-type organism. 
Mutation: A permanent inheritable 
change in a DNA sequence or 
chromosome. 
New Drugs: Those not recognized by 
qualified experts as safe and effective. 
(For FDA’s regulatory definition, see 21 
USC 321(p).) 
Non-indigenous organism: Naturally 
occurring organisms placed in 
environments where they are not native. 
Nucleic Acid: Linear polymer 
consisting of purines or pyrimidine 
bases bound to a ribose sugar (RNA) or 
a deoxyribose sugar (DNA) which is in 
turn bound to a phosphate group. 
Organism: Any biological entity, 
cellular or noncellular, with capacity for 
self-perpetuation and response to 
evolutionary forces: includes plants, 
animals, fungi, protists, prokaryotes, and 
viruses. 
Peptide: A linear polymer of amino 
acids. A polymer of numerous amino 
acids is called a polypeptide. 
Polypeptides may be grouped by 
function, such as “neuroactive” 
polypeptides. 
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