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WELCOMING REMARKS* 
by 
Donald S. Fredrickson, M.Q.** 
I am aware that the RAC has engaged in much discussion of the task it has 
accepted to review applications involving proprietary information. Usually, 
these are submitted by private concerns not supported by federal funds and 
in voluntary compliance with the NIH Guidelines. Particularly, some members 
of the RAC have chafed under the need for examination and approval of scale-up 
operations in industry, a result of the 10-liter limit in the Guidelines. 
Certainly, most members find the task onerous and not a few still find 
distasteful the scientific review of information which is subject to safeguards 
including criminal penalties for violation. Some members of the RAC also are 
of the opinion: 
1. that the task involves judgments about apparatus for physical 
containment which do not rest upon the same experience and 
training useful for decisions about molecular biology and 
other aspects of recombinant technology; or 
2. that when the judgments about physical containment require 
site inspections in industry, such visits belie the insistence 
of NIH, and its Director, that this agency eschews a regulatory 
role; and several members believe 
3. consideration of any part of an application from the private 
sector, perhaps even any proprietary data, should be done only 
by a regulatory agency, which NIH is not. 
* Presented at the meeting of the Recombinant DMA Advisory Committee (RAC) at NIH 
on June 5, 1980. 
** Director. National Institutes of Health, Bethesda, MD. 
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