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November 14, 1977 
Donald S." Fredrickson, M. D. 
Director 
National Institutes of Health 
Department of Health, Education, and W elfare 
Bethesda, Md. 20014 
Dear Doctor Fredrickson: 
This letter is written in response to your request of October 5 for comments 
on the proposed revision of the NIH Guidelines for Recombinant DNA Research, 
published in the Federal Register, Volume 42, 187, September 27, 1977, 
We are pleased to learn of the progress made in the deliberations of the Recom- 
binant DNA Molecule Program Advisory Committee resulting in the present 
proposed revision. In our opinion, the revision in general reflects a more 
reasonable approach to the surveillance of such research and is an improve- 
ment over the original Guidelines of June 23, 1976. We are also in agreement 
with the observation in the new proposal that "everything we have learned tends 
to diminish our estimate of the risk associated with recombinant DNA in E. coli 
K12". We appreciate too the reason.s why "the revised Guidelines continue to be 
deliberately restrictive, with the intent of erring on the side of caution". With 
additional experience in this field of research, it seems certain that some of 
the present restrictions will be modified and we are confident that the review 
mechanism now in place will assure timely consideration of such changes. 
The following specific comments and recommendations on the revised Guidelines 
are offered for your consideration. 
I. Introduction 
We are in agreement with the exclusion from the Guidelines of recombinant 
DNA molecules formed from any combination where the components are 
derived from genomes known to replicate within the organism used to prop- 
ogate the recombinant molecules. 
Representing manufacturers cf prescription pharmaceuticals, 
medical devices and diagnostic products 
[Appendix A--62] 
