COVINGTON & BURLING 
Gilbert S. Omenn, Ph.D., M.D. 
January 6, 1978 
Page Ten 
biological products, medical devices, and so forth — has 
issued extensive regulations providing that such trade 
secret information will be held in confidence by the agency 
and will not be released to the public. Enclosed is a 
copy of 21 C.F.R. Part 20, dealing generally with the 
release of information from FDA to the public, together 
with Section 314.14 relating to information in IND and NDA 
submissions (as an example of the way in which this in- 
formation is handled) . The courts have now definitively 
held that 18 U.S.C. 1905 does in fact protect all trade 
secrets from public disclosure by government agencies. 
Thus, all that is needed to resolve this concern of indus- 
try is to incorporate some of the routine practices for 
protection of trade secrets, that have long prevailed in 
other governmental agencies, into the regulations governing 
recombinant DNA research. 
Peter Barton Hutt 
PBH/mh 
Enclosures 
[Appendix A — 266] 
