2 
proposed guidelines to the Director of NIH which were reviewed at a 
public hearing in February 1976. As released on June 23, 1976, these 
guidelines had been revised in light of a number of suggestions presented 
by the public commentators. Accompanying the release was a Director's 
Decision document addressing the issues raised at the public hearing and 
in subsequent correspondence. 
The NIH Guidelines were published in the Federal Register on July 7, 
1976, for further public comment. In response to suggestions of public 
commentators, NIH also undertook an environmental impact assessment of 
recombinant DNA research and filed a Draft Environmental Impact Statement 
in the Federal Register on September 9, also for public comment. 
In June, shortly before the release of the Guidelines, Dr. Robert 
M. Rosenzweig, Vice President for Public Affairs at Stanford University, 
sent me a letter asking NIH to review DHEW policies relating to the 
patenting of recombinant DNA research inventions. Dr. Rosenzweig noted 
that both Stanford and the University of California were applying for 
patent protection for recombinant DNA research inventions developed by 
their investigators under NIH support. However, in view of the intense 
public interest in this research generally, the two universities felt the 
need for a formal advisory opinion by NIH on the patenting of recombinant 
DNA inventions developed under NIH grants or contracts. A number of other 
universities indicated similar interest in obtaining the official views 
of NIH. 
Prior to making an official pronouncement of DHEW-NIH policy with 
respect to patenting of recombinant DNA research inventions, NIH decided 
to solicit comments from a broad range of individuals and institutions. 
[ 4 ] 
