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Federal Register / Vol. 45, No. 20 / Tuesday, January 29, 1980 / Notices 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
Ill— C— 1— a— (2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
polyoma virus genomes can be used as 
vectors in P2 conditions when 
production of viral particles cannot 
occur (e.g., transformation of 
nonpermissive cells or propagation of an 
unconditionally defective recombinant 
genome in the absence of helper), 
provided the inserted DNA sequences 
are not derived from eukaryotic viruses. 
In the latter case, such experiments will 
be evaluated by NIH on a case-by-case 
basis ( 45 ) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
I V— E— 1— b— (3)— (c).) 
III-C-1-b. Simian Virus 40. 
Ill-C-l-b-(l). Productive Virus-Cell 
Interactions. 
Ill— C— 1— b— (1)— (a). SV40 DNA, 
rendered unconditionally defective by a 
deletion in an essential gene, with 
appropriate helper, can be used in P2 
conditions to propagate DNA sequences 
from: 
III— C— 1— b— (1)— (a)— (7). bacteria of Class 
1 or Class 2, (7) or their phages or 
plasmids, except for those that produce 
potent polypeptide toxins; ( 34 ) 
IIl-C-l-b-(l)-(a)-(2). Unifected 
African green monkey kidney cell 
cultures. 
Ill— C— 1— b— (1)— (b). SV40 DNA. 
rendered unconditionally defective by a 
deletion in an essential gene, with a 
appropriate helper, can be used in P3 
conditions to propagate DNA sequences 
from eukaryotic organisms that do not 
produce potent polypeptide toxins ( 34 ) 
(shotgun experiments or purified DNA). 
Ill— C— 1— b— (1)— (c). Experiments 
involving the use of defective SV40 
genomes to propagate DNA sequences 
from eukaryotic viruses will be 
evaluated by NIH on a case-by-case 
hasis[45] and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV— E— 1— b— (3)— (c).) 
Ill— C— 1— b— (2). Nonproductive Virus- 
Cell Interactions. Defective. or whole 
SV40 genomes can be used as vectors in 
P2 conditions when production of viral 
particles cannot occur (e.g., 
transformation of nonpermissive cells or 
propagation of an unconditionally 
defective recombinant genome in the 
absence of helper), provided the 
inserted DNA sequences are not derived 
from eukaryotic viruses. In the latter 
case, such experiments will be 
evaluated by NIH on a case-by-case 
basis [45] and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
I V— E— 1— b— (3)— (c).) 
III-C-l-c. Human Adenoviruses 2 and 
5. 
Ill— C— 1— c— (1). Productive Virus-Cell 
Interactions. 
Ill— C— 1— c— (1)— (a). Human 
adenoviruses 2 and 5, rendered 
unconditionally defective by deletion of 
at least two essential genes, with 
appropriate helper, can be used in P3 
conditions to propagate DNA sequences 
from: 
I II— C— 1 — c— ( 1)— (a)— (7). bacteria of Class 
1 or Class 2 (7) or their phages or 
plasmids except for those that produce 
potent polypeptide toxins; [34] 
III-C-l-c-(l)-(a)-(2). eukaryotic 
organisms that do not produce potent 
polypeptide toxins[34] (shotgun 
experiments or purified DNA). 
Ill— C— 1— (c)— (1)— (b). Experiments 
involving the use of unconditionally 
defective human adenovirus 2 and 5 
genomes to propagate DNA sequences 
from eukaryotic viruses will be 
evaluated by NIH on a case-by-case 
basis [45] and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
Ill— C— 1— c— (2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
human adenovirus 2 and 5 genomes can 
be used as vectors in P2 conditions 
when production of viral particles 
cannot occur (e.g., transformation of 
nonpermissive cells or propagation of an 
unconditionally defective recombinant 
genome in the absence of helper), 
provided the inserted DNA sequences 
are not derived from eukaryotic viruses. 
In the latter case, such experiments will 
be evaluated by NIH on a case-by-case 
basis (45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV— E— 1— b— (3)— (c).) 
Ill— C— 1— d. Murine Adenovirus Strain 
FL. - 
III— C— 1— d— (1). Productive Virus-Cell 
Interactions. 
Ill— C— 1— d— ( 1 )— ( a ) . Unconditionally 
defective murine adenovirus strain FL 
genomes, with appropriate helper, can 
be used in P2 conditions to propagate 
DNA sequences from: 
III— C— 1— d— (1)— (a)— (7). bacteria of Class 
1 or Class 2 (7) or their phages or 
plasmids except for those that produce 
potent polypeptide toxins;[34] 
III-C-l-d-(l)-(a)-(2). eukaryotic 
organisms that do not produce potent 
polypeptide toxins[34] (shotgun 
experiments or purified DNA). 
Ill— C— 1— d— (1)— (b). Experiments 
involving the use of whole murine 
adenovirus strain FL genomes to 
propagate DNA sequences from 
[ 28 ] 
prokaryotic or eukaryotic organisms will 
be evaluated by NIH on a case-by-case 
basis[45] and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV— E— 1— b— (3)— (c).) 
Ill— C— 1— d— (1)— (c). Experiments 
.involving the use of unconditionally 
defective murine adenorvirus strain FL 
genomes to propagate DNA sequences 
from eukaryotic viruses will be 
evaluated by NIH on a case-by-case 
basis (45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV— E— 1— b— (3)— (c).) 
Ill— C— 1— d— (2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
murine adenovirus strain FL genomes 
can be used as vectors in P2 conditions 
when production of viral particles 
cannot occur (e.g., transformation of 
nonpermissive cells or propagation of an 
unconditionally defective recombinant 
genome in the absence of helper), 
provided the inserted DNA sequences 
are not derived from eukaryotic viruses. 
In the latter case, such experiments will 
be evaluated by NIH on a case-by-case 
basis [45] and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
III-C-1-e. All Other Potential Viral 
Vectors. 
Ill— C— 1— e— (1). Experiments involving 
recombinant DNA molecules containing 
viral DNA segments consisting of 25% or 
less of the virus genome can be done: 
III— C— 1— e— (1 )— ( a ) . in P2 conditions 
when the recombinant DNA is to be 
integrated into the cell genome or is 
known to replicate as a plasmid in cells 
in culture, provided the additional DNA 
sequences are not derived from a 
eukaryotic virus.'In the latter case, such 
experiments will be evaluated by NIH 
on a case-by-case basis [45] and will be 
conducted under the prescribed physical 
and biological containment conditions. 
(See Section IV— E— 1— b— (3)— (c).) 
Ill— C— 1— e— (1)— (b). under physical and 
biological containment conditions to be 
determined by NIH (45) when a viral 
helper will be used to propagate DNA 
sequences from prokaryotic or 
eukaryotic organisms. (See Section IV- 
E— 1— b— (3)— (c).) 
Ill— C— 1— e— (2). Experiments involving 
the use of other whole or defective virus 
genomes to propagate DNA sequences 
from prokaryotic or eukaryotic 
organisms (and viruses), or as vectors to 
transform nonpermissive cells, will be 
evaluated by NIH on a case-by-case 
basis (45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-b-(3)-(c).) 
