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Federal Register / Vol. 46. No. 233 / Friday. December 4. 1981 / Notices 
Ill-C-l-b. Simian Virus 40. 
IIl-C-l-b-{l). Productive Virus-Cell 
Interactions. 
m-C-l-b-{lHa)- SV40 DNA, 
rendered unconditionally defective by a 
deletion in an essential gene, with 
appropriate helper, can be used in P2 
conditions to propagate DN'A sequences 
from; 
Ill-C-l-b-(lHaHf)- bacteria of Class 
1 or Class 2.(1] or their phages or 
plasmids, except for those that produce 
potent polypeptide toxins;[34| 
lIl-C-1-lHlHaH-?)- uninfected 
African green monkey kidney cell 
cultures. 
IU_C-l-b-flHb) SV40 DNA. 
rendered unconditionally defective by a 
deletion in an essential gene, with an 
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). 
Ul-i-l-b^lHc). Experiments 
involving the use of defective SV40 
genomes to propagate DNA sequences 
mm 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 
rV-E-l-b-(3Hc).) 
ID-C-l-b-(2). NonproducUve 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 hel[>er): 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(45j and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-tH3Hc).) 
ID-C-l-c Human Adenoviruses 2 and 
5. 
ID-C-l-o-(l)- Productive Virus-Cell 
Interactions. 
ni-C-l-c-{lH*)- 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: 
ID-C-l-c-{l)-{a)-{7). bacteria of Class 
1 or Class 2(1] or their phages or 
plasmids except for those that produce 
potent polypeptide toxins;[34] 
ID-C-l-c^lHaH'^- eukaryotic 
organisms that do not produce potent 
polypeptide toxins(34] (shotgun 
experiments or purified DNA). 
III-C-l-c-{l)-{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 
rV-E-l-b-{3)-^c).) 
ni-C-l-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-l-b-(3)-(c).) 
Ill-C-l-d. Murine Adenovirus Strain 
FL 
llI-C-l-d-(I)- Productive Virus-Cell 
Interactions. 
IIl-C-l-iHlHa)- Unconditionally 
defective murine adenovirus strain FL 
genomes, with appropriate helper, can 
be used in P2 conditions to propagate 
DNA sequences from: 
IIl-C-l-d-{lH*Hf)- bacteria of Class 
1 or Class 2(1] or their phages or 
plasmids except for those that produce 
potent polypeptide toxins:[34] 
IIl-C-l-iHl)-(aH^)- eukaryotic 
organisms that do not produce potent 
polypeptide toxins(34] (shotgun 
experiments or purified DNA). 
IIl-C-l-d-{l}^). Experiments 
involving the use of whole murine 
adenovirus strain FL genomes to 
propagate DNA sequences from 
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-l-lH3)-(c).) 
lU-C-l-^lHc). Experiments 
involving the use of unconditionally 
defective murine adenovirus 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 
rV-E-l-b-(3)-(c).) 
ni-C-l-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).) 
Ill-C-l-e. AH Viral Vectors. 
lll-C-l-e-(l). Other experiments 
involving eukaryotic virus vectors can 
be done as follows: 
IIl-C-l-(l)-(a). Recombinant DNA 
molecules containing no more than two- 
thirds of the genome of any eukaryotic 
virus (all viruses from a single Family 
(36) being considered identical (50)] may 
be propagated and maintained in cells in 
tissue culture using Pi containment: For 
such experiments, it must be shown that 
the cells lack helper virus for the 
specific Families of defective viruses 
being used. The DNA may contain 
fragments of the genomes of viruses 
from more than one Family but each 
fragment must be less than two-thirds of 
a genome. 
III-C-l-e-{l)-{b). Recombinants with 
less than two-thirds of the genome of 
any eukaryotic virus may be rescued 
with helper virus using K containment 
if wild t^e strains of the virus are CDC 
Class 1 or 2 agents, or using P3 
containment if wild type strains of the 
virus are CDC Class 3 agents (1). 
III-C-l-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 
rV-E-l-4>-{3)-(c).) 
NIH will also review on a case-by- 
case basis(45] all experiments involving 
the use of virus vectors in animals and 
will prescribed the physical and 
biological containment conditions 
appropriate for such studies. (See 
SecUon IV-E-l-b-(3)-(c).) 
Ill-C-l-f. Non viral Vectors. 
Organelle, plasmid, and chromosomal 
DNAs may be used as vectors. DNA 
recombinants formed between such 
vectors and host DNA, when propagated 
only in that host (or a closely related 
strain of the same species), are 
exempted from these Guidelines (see 
Section I-E). DNA recombinants formed 
between such vectors and nonviral DNA 
from cells other than the host species 
( 299 ) 
