60120 
NOTICES 
ate helper, if necessary, can be used in 
P2 conditions to propagate DNA se- 
quences: 
III-C-l-a-GMaMf ). from bacteria 
of class 1 or class 2[1] or their phages 
or plasmids, except for those that pro- 
duce potent polypeptide toxins; [34] 
III-C-l-ar-(l )-(&>-( 2). from mice; 
III-C-l-a-(lMaM.5). from eukaryo- 
tic organisms that do not produce 
potent polypeptide toxins, [34] pro- 
vided that the DNA segment is > 99% 
pure. 
III-C-l-a-tlMb). Defective polyoma 
genomes, with appropriate helper, if 
necessary, can be used in P2 conditions 
for shotgun experiments to propagate 
DNA sequences from eukaryotic or- 
ganisms that do not produce potent 
polypeptide toxins. [34] 
Hl-C-l-a-dWc). Whole virus gen- 
omes with appropriate helper, if neces- 
sary, can be used in P3 conditions for 
shotgun experiments to propagate 
DNA sequences from eukaryotic or- 
ganisms that do not produce poten po- 
lypeptide toxins. [34] 
III-C-l-a-(l)-(d). Experiments in- 
volving the use of defective polyoma 
virus genomes to propagate DNA se- 
quences from eukaryotic viruses will 
be evaluated by NTH on a case-by-case 
basis [451 and will be conducted under 
the prescribed physical and biological 
containment conditions. (See Section 
IV-E-l-tM3Me).) 
III-C-l-a-(2). Nonproductive Virus- 
Cell Interactions. Defective or whole 
polyoma virus genomes can be used as 
vectors in P2 conditions when produc- 
tion of viral particles cannot occur 
(e.g., transformation of nonpermissive 
cells or propagation of an uncondition- 
ally defective recombinant genome in 
the absence of helper), provided the 
inserted DNA sequences are not de- 
rived from eukaryotic viruses. In the 
latter case, such experiments will be 
evaluated by NIH on a case- by -case 
basis [451 and will be conducted under 
the prescribed physical and biological 
containment conditions, (See Section 
TV -E- L-b-( 3>— ( e). ) 
m-C-l-b. Simian Virus 40. 
m-C-l-b-ax Productive Virus-Cell 
Interactions. 
III-C-l-b-(lMa). SV4U DNA. ren- 
dered unconditionally defective by a 
deletion in an essential gene, with ap- 
propriate helper, can be used in P2 
conditions to propagate DNA se- 
quences from: 
IH-C-l-b-dMaWJ). bacteria of 
Class 1 or Class 2, -1] or their phages 
or plasmids, except for those that pro- 
duce potent polypeptide toxins; [34] 
m-C- 1-b-Cl M a M 2 ). uninfected Af- 
rican green monkey kidney cell cul- 
tures. 
in-c-l-b-awb). SV40 DNA, ren- 
dered unconditionally defective by a 
deletion in an essential gene, with an 
appropriate helper, can be used in P3 
conditions to propagate DNA se- 
quences from eukaryotic organisms 
that do not produce potent polypep- 
tide toxins [34] (shotgun experiments 
or purified DNA). 
III-C-l-b-<lMc). Experiments in- 
volving the use of defective SV40 gen- 
omes to propagate DNA sequences 
from eukaryotic viruses will be evalu- 
ated by NTH on a case-by-case basis 
[45> and will be conducted under the 
prescribed physical and biological con- 
tainment conditions. (See Section IV- 
E-l-b-(3Hc).) 
IH-C-l-tM2). 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., trans- 
formation of nonpermissive cells or 
propagation of an unconditionally de- 
fective recombinant genome in the ab- 
sence 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. 
HI-C-l-c-(l): Productive Virus-Cell 
Interactions. 
III-C-l-c-(l)-(a). Human adenovir- 
uses 2 and 5, rendered unconditionally 
defective by deletion of at least two es- 
sential genes, with appropriate helper, 
can be used in P3 conditions to propa- 
gate DNA sequences from: 
HI-C-l-c-dMaHl). bacteria of 
Class 1 or Class 2[1] or their phages or 
plasmids except for those that pro- 
duce potent polypeptide toxinsr [34J 
HI-C-l-c-(lWaH2). eukaryotic or- 
ganisms that do not produce potent 
polypeptide toxins[34] (shotgun ex- 
periments or purified DNA). 
HI-C-l-c-dHb). Experiments in- 
volving the use of unconditionally de- 
fective human adenovirus 2 and 5 gen- 
omes to propagate DNA sequences 
from, eukaryotic viruses will be evalu- 
ated by NIH on a case-by-case basis 
[45] and will be conducted under the 
prescribed physical and biological con- 
tainment conditions. (See Section IV- 
E-l-b-(3Mc>.) 
III-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 recombin- 
ant genome in the absence of helper), 
provided the inserted DNA sequences 
are not derived from eukaryotic vir- 
uses. In the latter case, such experi- 
ments will be evaluated by NIH on a 
case-by-case basis [451 and will be con- 
ducted under the prescribed physical 
and biological containment conditions. 
(See Section IV-E-l-b-(3)-(c).) 
III-C-1-d. Murine Adenovirus Strain 
FL. 
III-C-l-d-<l). Productive Virus-Cell 
Interactions. 
IIT-C-l-d-dWa). Unconditionally 
defective murine adenovirus strain FL 
genomes, with appropriate helper, can 
be used in P2 conditions to propagate 
DNA sequences from: 
III-C-l-d-(l)-(a)-(f ). bacteria of 
Class 1 or Class 2111 or their phages or 
plasmids except for those that pro- 
duce potent polypeptide toxins;[34] 
III-C-l-d-(l)-(a)-(2). eukaryotic or- 
ganisms that do not produce potent 
polypeptide toxins[34] (shotgun ex- 
periments or purified DNA). 
III-C-l-d-dMb). Experiments in- 
volving the use of whole murine aden- 
ovirus 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-b-(3)- 
(c).) 
III-C-l-d-dMc). Experiments in- 
volving the use of unconditionally de- 
fective murine adenovirus strain FL 
genomes to propagate DNA sequences 
from eukaryotic viruses will be evalu- 
ated 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-OMc).) 
IH-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 recombin- 
ant genome in the absence of helper), 
provided the inserted DNA sequences 
axe not derived from eukaryotic vir- 
uses. In the latter case, such experi- 
ments will be evaluated by NIH on a 
case-by-case basis[451 and will be con- 
ducted under the prescribed physical 
and biological containment conditions. 
(See Section IV-E-l-b-<3 Me).) 
irr-C-l-e. All Other Potential Viral 
Vectors. 
ni-C-l-e-<l). Experiments involving 
recombinant DNA molecules contain- 
ing- viral DNA segments consisting of 
25% or less of the virus genome can be 
done: 
III-C-l-e-dHa). 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 addition- 
al DNA sequences are not derived 
from a eukaryotic virus. In the latter 
case, such experiments will be evaluat- 
ed by NIH on a case-by-case basis [45] 
FEDERAL REGISTER, VOt. 43, NO. 247— FRIDAY, DECEMBER 22, 1978 
[ 42 ] 
