Lilly Research Laboratories 
A Division of Eli Lilly and Company 
307 Easi McCarty Street 
Indianapolis. Indiana 46285 
Irving S. Johnson. Ph D 
Vice President 
January 31, 1984 
Dr. William J. Gartland, Jr. 
Director, Office of Recombinant 
DNA Activities 
National Institute of Allergy and 
Infectious Diseases 
National Institutes of Health 
Bethesda, Maryland 20205 
Re: Recombinant DNA Research; Proposed Actions Under Guidelines; 
49 Fed. Reg. 696 (January 5, 1984) 
Dear Dr. Gartland: 
We wish to submit comments on some of the proposed actions on the 
agenda for the next Recombinant DNA Advisory Committee (RAC) meeting. 
In particular, we wish to comment on the questions of RAC and 
National Institutes of Health (NIH) jurisdiction posed by Dr. Talbot. 
Eli Lilly and Company is engaged in the research, development, 
and manufacture of pharmaceutical and agricultural products; it has 
been a major developer of therapeutic agents in the field of human 
health for well over a century. The company has been responsible 
for the development, production, and commercial availability of the 
first human therapeutic product of recombinant DNA technology, bio- 
synthetic human insulin. Since before the Asilomar Conference in 
1975, through the moratorium on recombinant DNA experiments, the 
formation of the RAC, and the development of the NIH Guidelines, it 
has viewed carefully and cooperatively, the various issues of poten- 
tial risk, public awareness, environmental effects, and legislative 
proposals. Regarding recombinant DNA research, its representatives 
have regularly attended RAC meetings, have suggested various modifi- 
cations of the guidelines, and have studied and commented on 
proposals advanced by others. In the context of these continuing 
relationships, together with the experience of nearly ten years of 
active participation in recombinant DNA research and development, 
these comments are offered. 
Recombinant DNA technology has been developing in an unpreceden- 
ted scientific-political atmosphere in which the transfer of new 
basic scientific knowledge to the realm of practical commerical use 
