Federal Register / Vol. 45, No. 164 / Thursday, August 21, 1980 / Notices 
55929 
completion of the large-scale facility 
according to those plans. The 
subcommittee will be responsible for 
expeditiously processing applications.” 
12. Request to include Vibrio cholerae 
in Appendix A. Dr. John A. Mekalanos, 
of Harvard Medical School, has 
requested the NIH to consider the 
addition of Vibrio cholerae to Sublist A 
in Appendix A of the Guidelines. The 
organisms on this list are those that are 
exempt from the Guidelines on the basis 
that they have been shown to exchange 
genetic material by known physiological 
processes. 
13. Request for consideration of 
appropriate containment levels. Drs. B. 
S. Montencourt and D. E. Eveleigh of 
Rutgers University, have requested 
permission to clone DNA derived from 
Pseudomonas strains that are non- 
pathogenic to plants or animals in an E. 
coli K-12 host and to be returned to 
Zymomonas mobilis. 
14. Proposed containment for cloning 
between members of the actinomycetes 
group. Dr. Dean Taylor of the Smith 
Kline and French Laboratories, has 
proposed that the third entry in 
Appendix E of the Guidelines be 
modified to read: 
“P2 physical containment shall be 
used for DNA recombinants produced 
between members of the Actinomycetes 
group except for those species which are 
known to be pathogenic for man, 
animals, or plants.” 
This proposal was made previously by 
the RAC Working Group on Prokaryotic 
Host-Vectors Other Than E. coli and 
appeared in the Federal Register, April 
13. 1979 44 (73): 22316. The RAC 
considered the proposal at its May 21- 
23. 1979 meeting and recommended to 
restrict this so that it did not include the 
entire Actinomycetes group but rather 
only the genera Streptomyces and 
Micromonospora. The Director, NIH, 
accepted this recommendation and the 
action was published in the Federal 
Register, July 20, 1979 44 (141): 42916, 
and appears as the third entry in 
Appendix E of the Guidelines. 
15. Request to clone 
Schizosaccharomyces pombe DNA in 
Schizosaccharomyces pombe. Dr. 
Benjamin Hall of the University of 
Washington, requests permission .to 
clone Schizosaccharomyces pombe 
DNA in Schizosaccharomyces pombe 
using approved HVI Saccharomyces/E. 
coli hybrid plasmids as vectors. Dr. Hall 
requests that PI be established as the 
appropriate level of physical 
containment. Dr. Hall points out that 
Schizosaccharomyces pombe has been 
the subject of intense genetic studies in 
the laboratory and traditionally has 
been used to ferment beverages for 
human consumption. 
Additional Announcements of the 
Director, NIH 
Section IV-E-l-b-(3)-(d) of the 
Guidelines gives responsibility to the 
Director, NIH, for “authorizing, under 
procedures specified by the RAC, large- 
scale experiments (i.e., involving more 
than 10 liters of culture) for recombinant 
DNAs that are rigorously characterized 
and free of harmful sequences." 
Accordingly, several requests for 
authorization to culture, on a large- 
scale, recombinant DNA host-vector 
systems have been received and 
reviewed by the NIH. 
1. Genentech, Inc. On the 
recommendation of the RAC, the 
following requests from Genentech, Inc., 
have been approved by the Director, 
NIH: 
A. On July 22, 1980, the Director, NIH, 
approved a request from Genentech, 
Inc., for the large-scale culture up to 750 
liters of EKl host-vector systems 
containing plasmids into which have 
been ligated a combination of 
chemically synthesized DNA and cloned 
cDNA coding for human growth 
hormone. 
B. On July 22, 1980, the Director, NIH, 
approved a request from Genentech, 
Inc., for the large-scale culture up to 750 
liters of EKl Host-vector systems 
containing plasmids into which have 
been ligated a combination of 
chemically synethesized DNA and 
cloned cDNA coding for human 
leukocyte or fibroblast interferon. 
Both requests were approved with the 
understanding that Genentech, Inc., has 
agreed to permit an observer, designated 
by NIH, to visit the facilities if NIH 
should choose to inspect the site, and to 
certain additional stipulations. 
The principal investigators are Drs. 
Michael Ross and Norm S. C. Lin. The 
work is to be done, as stipulated by the 
Genentech, Inc. submission, at the Pl-LS 
level of containment at the research and 
development facility at 460 Point San 
Bruno Boulevard, South San Francisco, 
California 94080. 
2. Bums-Biotec Laboratories, Inc. On 
July 22, 1980, The Director, NIH, 
approved a request from Bums-Biotec 
Laboratories, Inc., a wholly-owned 
subsidiary of Schering Corporation, for 
large-scale culture of an EKl host-vector 
system containing a plasmid coding for 
human leukocyte interferon in a 1000 
liter fermentor (up to 750 liter working 
volume) at the Pl-LS level of 
containment. 
This request was approved with the 
understanding that Bums-Biotec 
Laboratories, Inc., has agreed to permit 
an observer, designed by NIH, to visit 
the facilities if NIH should choose to 
inspect the site. The principal 
investigator for this project is Dr. 
Donald E. Baldwin. The large-scale 
growth of the organisms is to be carried 
out at plant facilities located in Elkhom, 
Nebraska. 
OMB's "Manadatory 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. 
Dated: August 14, 1980. 
Donald S. Fredrickson, 
Director, National Institutes of Health. 
[FR Doc. 80-25289 Filed S-2U-80; 8:45 am] 
BILLING CODE 4110-08-M 
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