NOTICES 
3226 
[4110-08-M] 
DEPARTMENT OF HEALTH, 
EDUCATION, AND WELFARE 
National Institute* of Health 
RECOMBINANT DNA ADVISORY COMMITTEE 
Meeting 
Pursuant to Pub. L. 92-463, notice is 
hereby given of a meeting of the Re- 
combinant DNA Advisory Committee 
at the National Institutes of Health, 
Building 31, Conference Room 6. 9000 
Rockville Pike, Bethesda, Maryland 
20014, on February 15-16, 1979, from 
9:00 a.m. to 5:00 p.m. 
The entire meeting will be open to 
the public for consideration of: 
Lower Eukaryote Host-Vector Systems 
Prokaryote Host-Vectors Other Than 
E. coli K-12 
Amendment of Guidelines 
Exemptions for organisms that ex- 
change genetic information 
E. coli phage-vector systems 
EK2 host-vector systems 
HV2 Saccharomyces cerevisiae host- 
vector system 
Review of protocols for required con- 
tainment levels 
Criteria for and the handling of char- 
acterized clones 
Requests for lowering of containment 
levels on the basis of characteriza- 
tion of clones 
Other matters requiring necessary 
action by the Committee. 
Attendances by the public will be 
limited to space available. Dr. William 
J. Gartland, Executive Secretary, Re- 
combinant DNA Advisory Committee, 
National Institutes of Health, Building 
31, Room 4A52, telephone 301-496- 
6051, will provide materials to be dis- 
cussed at the meeting, rosters of com- 
mittee members and substantive pro- 
gram information. A summary of the 
meeting will be available at a later 
date. 
Dated: January 3, 1979. 
Suzanne L. Fremeau, 
Committee Management Officer, 
NIH. 
[FR Doc. 79-1090 Filed 1-12-79: 8:45 am] 
[4110-08-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- 
FEDERAL 
search Involving Recombinant DNA 
Molecules [Federal Register of De- 
cember 22, 1978 (43 FR 60108)1. 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 changes and 
amendments in the Guidelines for Re- 
search Involving Recombinant DNA 
Molecules, as well as actions under 
these guidelines. 
1. The RAC has recommended that 
Sections III-B-2 and III-C-5 include 
cloning “into a lambdoid phage 
vector.” The relevant paragraphs will 
read: 
Section III-B-2. Return of DNA seg- 
ment to Non-HVl host of origin * * * 
• * * For a prokaryote which does 
not exchange genetic information with 
E. coli (Host B), the following type of 
experiment may be carried out with- 
out Host B having been approved as a 
HV1 host: DNA from Host B may be 
inserted into a lambdoid phage vector 
or into a vector from a certified EK2 
host-vector system and propagated in 
E. coli K-12 under the appropriate 
containment conditions [see Section 
III-A-l-b-(2)l. Subsequently, this re- 
combinant DNA may be returned to 
Host B and propagated in Host B 
under PI conditions. [43] 
Section III-C-5. Fungal or Similar 
Lower Eukaryotic Host-Vector Systems 
• • + 
• • * In addition to the experiments 
described above, the following experi- 
ments may be carried out without the 
eukaryotic host (Host C) having been 
approved as an HV1 host: DNA from 
REGISTER, VOL 44, NO. 10— MONDAY, JANUARY 
Host C may be inserted into a lamb- 
doid phage vector or into a vector 
from a certified EK2 host-vector 
system and propagated in E. coli K-12 
under the appropriate containment 
conditions [see Section III-A-l-(a)- 
(5)]. Subsequently, this recombinant 
DNA may be returned to Host C and 
propagated there under PI conditions. 
[43] • * * 
This change has been recommended 
because the greater flexibility afford- 
ed with non-EK2 lambdoid phage vec- 
tors does not in any way compromise 
safety or containment in the final 
host. The continued requirement for 
EK2 plasmid vectors insures that this 
cloning procedure is used for self-clon- 
ing into the final host with a minimal 
introduction of E. coli genetic infor- 
mation. 
2. The RAC has also recommended 
that this type of experiment be per- 
mitted in higher eukaryotes. The fol- 
lowing section would be added to the 
Guidelines: 
III-C-6. Return of DNA Segments to 
a Higher Eukaryotic Host of Origin. 
DNA from a higher eukaryote (Host 
D) may be inserted into a lambdoid 
phage vector or into a vector from a 
certified EK2 host-vector system and 
propagated in E. coli K-12 under the 
appropriate containment conditions 
[see Section III-A-1], Subsequently, 
this recombinant DNA may be re- 
turned to Host D and propagated 
under conditions of physical contain- 
ment comparable to PI and appropri- 
ate to the organism under study. [2A] 
3. The RAC has recommended that 
Section III-C-2 concerning inverte- 
brate host-vector systems be divided 
into two parts. The first part III-C-2-a 
would retain the present wording of 
this section; the second part III-C-2-b 
would enable the use of nonviral vec- 
tors. Section III-C-2 would therefore 
be as follows: 
III-C-2. Invertebrate Host-vector 
Systems 
III-C-2-a. Insect viral vectors. As 
soon as information becomes available 
on the host range restrictions and on 
the infectivity, persistence, and inte- 
gration of the viral DNA in vertebrate 
and invertebrate cells, experiments in- 
volving the use of insect viruses to 
propagate DNA sequences will be eval- 
uated by NIH on a case-by-case basis 
[45] and will be conducted under the 
recommended physical containment 
conditions. (See Section IV-E-l-b-(3)- 
(c)) 
III-C-2-b. Nonviral vectors. Organ- 
elle, plasmid, and chromosomal DNAs 
may be used as vectors. DNA recom- 
binants formed between such vectors 
and host DNA, when propagated only 
in that host (or a closely related strain 
of the same species), are exempt from 
these Guidelines (see section I-E). 
DNA recombinants formed between 
15, 1979 
[ 44 ] 
