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available to the members of the Recombinant Committee and can be considered. 
We think they are positive and constructive. 
I would prefer to restrict my comments to the section on roles and re- 
sponsibilities, where we see the problems relative to the protection of 
industrial property rights. In Section II-D there is a requirement for the 
certification and distribution of host-vector systems. In industrial research 
these systems could be considered and probably will be considered industrial 
property rights. We recognize the reasons for suggesting certification and 
distribution; however, this is something we feel must be taken under addition- 
al review by the Recombinant DNA Committee. 
In Section IV, relative to roles and responsibilities — specifically, in 
part A, under Principal Investigator — there is a requirement in Roman numeral 
v for securing the approval of proposed research prior to the initiation of 
the work. This simply does not apply in the case of industry at the present 
time. However, we feel that there can be some accommodation made in the 
present revision that would take care of this problem. 
Under Roman numeral vi there is a requirement for submitting informa- 
tion on purported HV2 and HV3 systems to the committee. Again, this is 
something that could involve revealing industrial property rights and is 
in need of modification. 
In Roman numeral viii there is a requirement for reporting to the 
institutional biohazards committee and/or the DNA Recombinant Advisory 
Committee. This, I think, needs some clarification, since in that portion 
of Chapter IV it might involve revealing very important industrial property 
in the process. 
Continuing in Chapter IV, under Institutions, there is a requirement 
for making minutes available. We have no particular objection to that, so 
long as those minutes could be edited to delete any reference to industrial 
property information. 
Under C, there is a requirement which is strictly for use in the case 
of NIH grantees concerning review by the initial review group. This again 
would involve industrial property information and needs some modification. 
We are pleased with the revision in the Guidelines that provides for 
an exemption by the Director on the recommendation of the Recombinant DNA 
Advisory Committee. We feel that it may be possible through that exemption 
to accommodate the concerns we have about the protection of industrial 
property rights, and we would ask the Committee and the Director to look 
very long and hard at the possibility for such accommodations through that 
mechanism. 
Finally, the Guidelines call for inspections by the staff of the MIH. 
I can tell you that we would have no objection to inspections so long as, 
again, industrial property rights could be protected. 
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