Federal Register / Vol. 45, No. 227 / Friday, November 21, 1980 / Notices 
77381 
required contents of a registration 
document. 
The revised “Application Procedures 
for Large-Scale Recombinant DNA 
Experiments” differ from the previous 
version (adopted at the September 1979 
RAC meeting) in requiring that the 
application specify a “P-LS” level at 
which the work will be done, rather than 
requiring individual details of physcial 
containment. In other respects the 
Application Procedures adopted at the 
September 1979 RAC meeting remain 
identical in the revised Application 
Procedures promulgated today. As noted 
in the minutes of the September 6-7, 
1979 RAC meeting, review of each large- 
scale proposal by the RAC, “might be at 
a meeting, but it also might be through 
mail ballot." This option will be 
retained. 
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 1 
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. 
I. Genentech, Inc. 
On November 4, 1980, the Director, 
NIH, on the recommendation of the 
RAC, 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 cDNA coding 
for human leukocyte interferons. 
This request was 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. 
The ^principal investigators are Drs. 
Michael Ross and Norm S. C. Lin. The 
work is to be done at the Pl-LS level of 
containment at the research and 
development facility at 460 Point San 
Bruno Boulevard, South San Francisco, 
California 94080. 
II. Burns-Biotec Laboratories, Inc,. 
On November 4, 1980, the Director, 
NIH, approved requests from Burns- 
Biotec Laboratories, Inc., a wholly- 
owned subsidiary of Schering 
Corporation, for large-scale culture of 
EKl host-vector systems containing 
plasmids coding for human leukocyte 
interferon, and certain derivatives 
thereof, in a 1000 liter fermentor (up to 
750 liter working volume) at the Pl-LS 
level of containment. 
The request was approved with the 
understanding that Burns-Biotec 
Laboratories, Inc., has agreed to permit 
an observer, designated 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 Elkhorn, 
Nebraska. 
Dated: November 14, 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 of 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. 80-36315 Filed 11-20-80; 8:45 am) 
BILLING CODE 4110-08-M 
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