Federal Register / Vol. 46, No. 126 / Wednesday, July 1, 1981 / Notices 
34473 
subsections of Section Ill-C-l-e Involve 
the use of all viral vectors including the 
speciHc viral vectors considered in the 
subsections of Sections III-C-1 -a, -b, -c 
and -d. as well as any other viral vector. 
When the reader finds that the 
containment level given for a specific 
experiment in a subsection of Section 
III- C-l-e is different from the 
containment level given in a subsection 
of Section IH-C-l -a. -b. -c. or -d, he 
may choose which of the two 
containment levels he wishes to use for 
the experiment. 
lll-<>l-a. Polyoma Virus. 
IU-C-l-a-{l). Productive Virus-Cell 
Interactions. 
III-C-l-a-{l )-(*)• Defective or whole 
polyoma virus genomes, with 
appropriate helper, if necessary, can be 
used in P2 conditions to propagate DNA 
sequences: 
IlI-C-l-a-{lHaHl)- fron' bacteria of 
Class 1 or Class 2 (i) or their phages or 
plasmids, except for those that produce 
potent polypeptide toxins; [34] 
IIl-C-l-a-{lH«H^- from mice; 
Ill-C-l-a-(lHaH'3)- fro™ eukaryotic 
organisms that do not produce potent 
polypeptide toxins. (34) provided that 
the DNA segment is >9^ pure. 
ni-C-l-a-(l)-{b}. Defective polyoma 
genomes, with appropriate helper, if 
necessary, can be used in P2 conditions 
for shotgun experiments to propagate 
DNA sequences from eukaryotic 
organisms that do not produce potent 
polypeptide toxins. [34] 
lII-C-l-a-{l)-{c). Whole virus 
genomes with appropriate helper, if 
necessary, can be used in P3 conditions 
for shotgun experiments to propagate 
DNA sequences from eukaryotic 
organisms that do not produce potent 
polypeptide toxins. (34) 
IIl-C-l-a-(lHd). Experiments 
involving the use of defective polyoma 
virsu 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).) 
ID-C-1-^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 
genomes 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 
rV-E-l-b-(3Hc).) 
Ill-C-l-b. Simian Virus 40. 
III-C-l-b-{l). Productive Virus-Cell 
Interactions. 
IlI-C-l-MlHa). 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-l-b-(l)-(a)-(7). Bacteria of 
Class 1 or Class 2, [1] or their phages or 
plasmids, except for those that produce 
potential polypeptide toxins; (34) 
IIl_C-l-b-(l)-(a)-{2). Uninfected 
African green monkey kidney cell 
cultmes. 
m-C-l-b-(lHb). 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). 
m-i-l-b^l)-(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 
basis (45) and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-tH3}-(c).) 
III-C-l-b-(2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
SV40 genomes can be used as vectors in 
F*2 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-l-c. Human Adenoviruses 2 and 
5. 
ni-C-l-c-{l). Productive Virus-Cell 
Interactions. 
IlI-C-l-c-{l)-(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: 
Ill-C-l-c-(l)-(a)-(7). Bacteria of Class 
1 or Class 2 (7) or their phages or 
plasmids except for those that produce 
potent polypeptide toxins; (34) 
llI-C-l-c-(l)-(a)-(2). Eukaryotic 
organisms that do not produce potent 
polypeptide toxins (34) (shotgim 
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 
lV-E-l-b-(3)-(c).) 
IIl-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-{3Hc).) 
lll-C-l-d. Murine Adenovirus Strain 
FL. 
III-C-l-d-(l). Productive Virus-Cell 
Interactions. 
III-C-l-d-(l)-(a). 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-(lHaH^)- 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). 
III-C-l-d-(lHb). 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-M3)-(c).) 
IIl-C-l-^l)-^c). 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 
IV-E-l-b-(3)-(c).) 
III-C-l-d-(2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
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