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Federal Register / Vol. 45, No. 182 / Wednesday, September 17, 1980 / Notices 
and found not to be transposable, that is 
gene movement and insertion at a new 
site by a mechanism which does not 
Involve the homologous recombination 
system of the host strain. 
Since the fragment is not capable of 
autonomous replication, plasmid pJT353, 
a recombinant plasmid containing 
NR79-R1-G1 cloned into the EcoRI site 
of pBR322, is the suggested way of 
propagating this fragment. Stocks of E. 
coh strain KH802 containing pJT353 
have been preserved for the propagation 
and isolation of NR79-R1-G1. Protocols 
used for the isolation of purified plasmid 
pJT353 (NR79-R1-G1 and pBR322) and 
purified NR79-R1-G1 fragment are 
available. 
b. A contract has been awarded to the 
University of Minnesota to develop a 
Comprehensive Course on 
Microbiological Principles and 
Techniques for Work with Potentially 
Biohazardous Agents Including 
Recombinant DNA. The Principal 
Investigator will work with the Board of 
Education and Training of the American 
Society for Microbiology (ASM) in 
developing the materials. 
In 1977, the ASM undertook a study to 
devise standards of training for t 
recombinant DNA research workers. A 
proper state of training of the laboratory 
workers is the first line of containment 
and it was their opinion that such 
training standards should be set by 
knowledgeable professionals. The 
product of that study was not standards 
but rather an outline of a body of 
knowledge which it was felt that any 
Principal Investigator should be aware 
of before independently embarking on 
recombinant DNA research. This 
contract will develop all necessary 
resources to present a course based on 
the ASM findings. 
The plan is for the NIAID to support 
the development of the resource 
materials and once that phase is 
completed, the NIH Division of Safety 
will have the materials reproduced and 
distributed to the various Institutions 
where the NIH supports research to 
assist them in performing their own 
local training responsibilities. We will 
devise both a standard lecture/ 
laboratory course and self study aides. 
Eukaryotic Host-Vector Systems 
Lower eukaryotic and higher 
eukaryotic host-vector systems were 
given a lower priority in the Final Plan 
than prokaryotic systems. 
After discussion at both the Ma’ cb 
and June 1980 meetings, the RAC 
recommended modifying the Guidelines 
to include Saccharomyces cerevisiae , 
host-vector systems under section III— O. 
During their consideration the RAC 
considered information that: (1) S. 
cerevisiae is nonpathogenic, (2) it does 
not implant in the intestine, (3} the dilute 
conditions in which it is found in nature 
are extremely unfavorable for mating. 
(4) it does not efficiently compete with 
wild strains of S. cerevisiae, (5) it is 
fully sensitive to autoclaving and 
disinfection by standard agents, and (6) 
mammalian genes cloned in 5. 
cerevisiae are not expressed. 
RAC also considered the question of 
proper physical containment for higher 
eukaryotic viral vectors. The Guidelines 
have been modified to permit work at 
more relaxed levels of physical 
containment that previously required. 
The Guidelines have been modified to 
permit recombinant DNA molecules 
containing no more than two-thirds of 
the genome of any eukaryotic virus (all 
viruses from a single Family being 
considered identical) to be propagated 
and maintained in cells in tissue culture 
using Pi containment. 
It must be shown that the cells lack 
helper virus for the specific families of 
the defective viruses being used. The 
DNA may contain fragments of the 
S ienomes of viruses from more than one 
amily but each fragment muBt be less 
than two thirds of a genome. 
No initiatives have been started to 
directly answer the issues raised in the 
Final Plan relative to eukaryotic host- 
vector systems. NIH will continue to 
monitor the results of free ranging 
research to collect useful data that can 
be analyzed as part of the risk 
assessment process. 
III. Implementation 
The Final Plan stated that NIAID 
would recruit and appoint an eminent 
scientist as a Special Assistant to the 
Director, NIAID for Risk Assessment. 
Attempts to recruit a person to fill this 
position were made including national 
advertising. No individual with the 
desired level of credentials and broad 
recognition by the various scientific 
disciplines was identified who was 
willing to undertake this work at the 
NIH under the conditions we could 
offer. By mid-year it had become evident 
that the probable scope and number of 
various activities encompassed by the 
Risk Assessment Plan would probably 
stabilize at the current level and not 
Increase further. Consequently the 
necessity for a Special Assistant was 
reconsidered and alternatives for 
satisfying the needs were evaluated. A 
decision was made to distribute the 
proposed functions of the Special 
Assistant to the Office of Recombinant 
DNA Activities and the Office of 
Specialized Research and Facilities, 
both within the NIAID. When 
appropriate these offices will use ad hoc 
consultants in fulfilling the tasks 
originally described for the Special 
Assistant and for which staff and the 
RAC Risk Assessment Subcommittee 
feel that additional or specific expertise 
is required. 
The remainder of the Implementation 
section of the plan remains in effect as 
stated. Most implementation actions 
have been cited earlier in this document, 
however, an important part of the Plan 
are periodic reports to the RAC. In this 
regard, the Director, NIAID reports to 
the RAC at each meeting on activities 
related to risk assessment and provides 
thereby an important and continuing 
review of progress and receives the 
advice or comment of this advisory 
group. 
Dated: September 8, 1980. 
Donald S. Fredrickson, 
Director, National Institutes of Health. 
OMB's “Mandatory Information 
Requirements for Federal Assistance Program 
•Announcements" (45 FR 39592) requires a 
statement concerning the official government 
programs contained in the Catalog of Federal 
Domestic Assistance. 
Normally NIH lists in its announcements 
the number and title of affected individual 
programs for the guidance of the public. 
Because the guidance in this notice covers 
not only virtually every NIH program but also 
essentially every federal research program in 
which DNA recombinant molecule techniques 
could be used, it has been determined to be 
not cost effective or in the public interest to 
attempt to list these programs. Such a list 
would likely require several additional pages. 
In addition. NIH could not be certain that 
every federal program would be included as 
many federal agencies, as well as private 
organizations, both national and 
international, have elected to follow the NIH 
Guidelines. In lieu of the individual program 
listing, NIH invites readers to direct 
questions to the information address above 
about whether individual programs listed in 
the Catalog of Federal Domestic Assistance 
are affected. 
NIH programs are not covered by OMB 
Circular A-95 because they fit the description 
of "programs not considered appropriate" in 
Section 8(b) (4) and (5) of that Circular. 
|FR Doc SO-2S4S3 Filed S-IS-SO. MS «m] 
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