3228 
NOTICES 
c. Asporogenic mutant derivatives of 
B. subtilis can be accepted as the host 
component of an HV1 system. These 
derivatives must not revert to spore- 
formers with a frequency greater than 
lO"* data confirming this requirement 
must be presented to NIH for certifi- 
cation. The following plasmids are ac- 
cepted as the vector components of 
certified B. subtilis HV1 systems: 
pUBllO, pC194. pS194, pSA2100, 
PE2194, pT127, pUB112, pC221, pC223. 
d. Non-HVl Systems. Section III-B-3 
states: “Containment levels for other 
classes of experiments involving on- 
HV1 systems may be approved by the 
Director, NIH * * This section is to 
be amended by addition of the follow- 
ing: 
In those cases where genetic ex- 
change has not been demonstrated be- 
tween two bacterial species A and B, 
neither of which is pathogenic for 
man, animals, or plants, recombinant 
DNA experiments involving only A 
and B can be conducted under P3 
containment. [2A] 
8. It has been recommended that 
Sections III-A-l-a(l) and (2), which 
designate the containment levels for 
experiments involving the shotgun 
cloning of DNA from primates and 
other mammals, be amended to in- 
clude P3 + EK1 as an alternative to 
the present P2 + EK2 containment. 
This option already appears in other 
sections of the Guidelines. These sec- 
tions would read as follows: 
III-A-l-a-(l). Primates. P2 physical 
containment + an EK2 host-vector or 
P3 + EK1. Any lowering of contain- 
ment below these levels (i.e., for puri- 
fied DNA or characterized clones) 
cannot be made solely by an institu- 
tional biosafety committee but re- 
quires NIH approval. (See Section IV- 
E-l-b-(3).) 
III-A-l-a-(2). Other Mammals P2 
physical containment + an EK2 host- 
vector or P3 + EK1. 
Dated: January 4, 1979. 
Donald S. Fredrickson, M.D., 
Director, 
National Institutes of Health. 
(FR Doc. 79-1091 Filed 1-12-79: 8:45 am] 
[41 10-08-M] 
RECOMBINANT DNA RESEARCH 
Proposed Actions Under Guidelines 
AGENCY: National Institutes of 
Health. 
ACTION: Notice of proposed actions 
under the NIH Guidelines for Recom- 
binant DNA Research: 
SUMMARY: This notice sets forth 
proposals for actions to be taken 
under the 1978 NIH Guidelines for Re- 
search Involving Recombinant DNA 
Molecules [Federal Register of De- 
cember 22, 1978 (43 FR 60108)]. Inter- 
ested parties are invited to submit 
comments concerning these proposals. 
After consideration of these proposals 
and comments by the NIH Recombin- 
ant DNA Advisory Committee (RAC) 
at its February 15-16, 1978 meeting, 
the Director of the National Institutes 
of Health will issue decisions on these 
proposals in accord with the Guide- 
lines. 
DATE: Comments must be received by 
February 14, 1979. 
ADDRESS: Written comments and 
recommendations should be submitted 
to the Director, Office of Recombin- 
ant DNA Activities, Building 31, Room 
4A52, National Institutes of Health. 
Bethesda, Maryland 20014. All com- 
ments received in timely response to 
this notice will be considered and will 
be available for public inspection in 
the above office on weekdays between 
the hours of 8:30 a.m. and 5 p.m. 
FOR FURTHER INFORMATION 
CONTACT: 
Additional information can be ob- 
tained from Drs. Michael Resnick or 
Stanley Barban, Office of Recombin- 
ant DNA Activities. National Insti- 
tutes of Health. Bethesda, Maryland 
20014, (301) 496-6051. 
SUPPLEMENTARY INFORMATION: 
The National Institutes of Health will 
consider the following actions under 
the Guidelines for Research Involving 
Recombinant DNA Molecules. 
1. Prokaryote host-vector systems. 
Proposals from Dr. Stanley Cohen of 
Stanford University and Dr. Gary 
Wilson of the University of Rochester 
to allow: 
a. cloning In Bacillus subtilis, under 
P2 conditions, of DNA derived from E. 
coli K-12 and Streptomyces coelicolor 
using NIH-approved Staphylococcus 
aureus plasmids as vectors: 
b. cloning in B. subtilis, under P2 
conditions, of DNA derived from 
either E. coli K-12 or Saccharomyces 
cerevisiae using NIH-approved EK2 
plasmid vectors: 
c. cloning in Streptomyces coelicolor, 
under P2 conditions, of DNA from Ba- 
cillus subtilis, E. coli K-12, and from 
Staphylococcous aureus plasmid vec- 
tors which have been approved for use 
in Bacillus subtilis. Any plasmid indi- 
ginous to Streptomyces coelicolor or 
able to replicate in that host by natu- 
ral biological mechanisms may be used 
as a vector. 
2. A proposed lambda bacteriophage 
EK2 vector. A proposal from Dr. John 
M. Tabor and Dr. Vernon C. Bode of 
Kansas State University for the use of 
the vector A gt Aamal Lam 439 
Oam29. A >3 as an EK2 vector will be 
considered by the RAC. The proposal 
is available from the Office of Recom- 
binant DNA Activities. 
Dated: January 5. 1979. 
Donald S. Frederickson, M.D., 
Director, 
National Institutes of Health. 
[FR Doc. 79-1092 Filed 1-12-79; 8:45 am] 
FEDERAL REGISTER, VOL 44, NO. 10— MONDAY, JANUARY 15, 1979 
[ 46 ] 
