Lilly Research Laboratories 
A Division of Eli Lilly and Company 
Lilly Corporate Center 
Indianapolis Indiana J6285 
(317) 276-2C00 
May 23, 1988 
Dr. William J. Gartlard, Jr. 
Director, Office of Fecamb inant DNA 
Activities 
12441 Parklawn Drive, Suite 58 
Rockville, MD 20852 
FE: Notice of Proposed Actions Under NIH Guidelines for 
Pesearch Involving Feccmb inant DNA Molecules 
(53 FR 12752-12754, April 18, 1988) 
Dear Dr. Gartland: 
Eli Lilly and Ccnpany (Lilly) is a research-based corporation 
that develops, manufactures and markets human medicines, 
medical instruments, diagnostic products and agricultural 
products. Lilly is actively involved in recent) inant DNA 
research in several areas of life sciences and submits the 
following cannents. 
Lilly supports the amendment to Section III-B-5 requested by 
Novo Laboratories , Inc. This amendment is compatible with 
recommendations presented in the June 26, 1986, OSTP 
"Coordinated Framework for Regulation of Biotechnology" 
document, the OECD concept of good industrial large-scale 
practice (GILSP) , and the August 24, 1987, amendment to the 
large-scale guidelines regarding containment for E. coli 
K-12, Saccharanyces cerevisiae, and Bacillus subtilis. In 
addition, the changes should enhance the competitive position 
of the U.S. biotechnology and pharmaceutical industries while 
at the same time adequately protecting the environment and 
human health. 
Recombinant DNA Research, Volume 13 
[375] 
