Federal Register / Vol. 46. No. 48 / Thursday, March, 12, 1981 / Notices 
16457 
determine whether the submission 
represents a minor modification of an 
approved experiment. If so. the request 
will be submitted promptly to a working 
group of at least two RAC members. If 
possible, these members should have 
been present at the RAC discussion of 
approval of the original experiment. If 
any member of the working group does 
not agree that the request represents a 
minor modification, the application will 
then be referred to the fuU RAC at its 
next meeting. If the working group is 
unanimous in concluding that the 
changes do not alter the organism in a 
way that is likely to affect containment 
of the organism or the vector, or the 
nature of the expressed product 
significantly from that presented 
originally to RAC, recommendation for 
approval will be transmitted to ORDA, 
and, through ORDA, to the submitters. 
Consideration of requests by working 
groups should explicitly address the 
following issues: Is the change likely to 
compromise biological containment 
provided by the host or the vector? Does 
the change add to the biological 
activities associated with the expressed 
products in a way not considered by the 
original submission? 
“7. Should a clone, previously 
approved for scale-up at one facility, be 
proposed to be moved to a second 
facility, the IBC with oversight 
responsibility at the second site shall 
submit to ORDA a registration 
document and receive ORDA approval, 
prior to initiating scale-up. No ^C 
review would be required. 
“8. These procedures may be refined 
or revised on the basis of discussion and 
action by the NIH Recombinant DNA 
Advisorj’ Committee." 
Additional Announcements of the 
Director, NIH 
Section IV-E-l-b-{3)-{tl) 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 cultme) 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 NOT 
/. Genentech, Inc. 
On February 2, 1981, the Director, 
NIH, on the recommendation of the 
RAC. approved a request fit)m 
Genentech. Inc., for the large-scale 
culture of EKl host-vector systems 
containing plasmids 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 facilitiea if NIH 
should choose to inspect the site. 
The principal investigator is Dr. 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 Bnmo Boulevard, South San 
Francisco, California 94080. 
II. Genentech, Inc. 
On February 2, 1981, the Director, 
NIH, on the recommendation of the 
RAC, approved a request fi-om 
Genentech, Inc., for the large-scale 
culture of EKl host-vector systems 
containing plasmids coding for bovine 
growth hormone. 
This request was approved with the 
understanding that Genentech, Inc., has 
agreed to permit an observer, designated 
by NUi to visit the facilities should NIH 
choose to inspect the site. 
The principal investigator is Dr. Norm 
S. C. L^. The work is to be done at the 
Pl-LS level of containment at the 
research facility at 460 Point San Bruno 
Boulevard, South San Francisco, 
California 94080. 
III. Hoffman-LaRoche, Inc. 
On February 2, 1981, the Director, 
NIH, on the recommendation of the 
RAC, approved a request from Hofiman- 
LaRoche, Inc., for the large-scale culture 
of EKl host-vector systems containing 
plasmids coding for human leukocyte 
and fibroblast interferons. 
This request was approved with the 
understeinding that Hoffman-LaRoche, 
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. 
Philip A. Miller and Vishra Rai. The 
work is to be done at the Pl-LS level of 
containment at the research and 
development facilities at 340 Kingsland 
Avenue, Nutley, New Jersey 07110. 
IV. Bums-Biotec Laboratories, Inc. 
On February 20, 1981, the Director, 
NIH, on the recommendation of the 
RAC, approved a request from Bums- 
Biotec, Inc., a wholly owned subsidiary 
of Schering-Plough Corporation, for the 
large-scale culture of EKl host-vector 
systems containing plasmids coding for 
human leukocyte interferon. 
This request was approved with the 
imderstanding that Bums-Biotec, 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 is Dr. 
Donald Baldwin. The work is to be 
performed at the Pl^^ level of 
containment at the facilities in Elkhom, 
Indiana 68022. 
V. Schering-Plough Corporation 
On Febmary 20, 1981, the Director, 
NIH, on the recommendation of the 
RAC, approved a request from Schering- 
Plough Corporation for the large-scale 
culture of ^1 host-vector systems 
containing plasmids coding for human 
leukocyte interferon. 
This request was approved with the 
understanding that S^ering-Plough 
Corporation has agreed to permit an 
observer, designated by NW, to visit the 
facilities if NIH should choose to inspect 
the site. 
The principal investigator is Dr. Paul J. 
Leibowitz. The work is to be performed 
at the Pl-LS level of containment at the 
research and development facilities in 
Bloomfield, New Jersey 07003. 
Dated: March 4, 1981. 
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 progranis contained 
in the Catalog of Federal Domestic 
Assistance. Normally NIH lists in its 
aimouncements 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 detennined to be not cost 
effective or in the pubfic 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 Circiidar A-05 because they fit the 
description of “programs not considered 
appropriate" in Section 8-(b}-(4) and (5) 
of that Circular. 
[FR Doc. S1-7S43 Filed 3-11-81: 8:45 am] 
BI LUNG CODE 4110-08-H 
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