Dr. Donald Fredrickson 
Page 4 
September 22, 1978 
decision within which to institute suit in a United States 
District Court to enjoin release of the records involved. 
If suit is brought , the Secretary or his designee will not 
disclose the records involved until the matter and all re- 
lated appeals have been concluded. 
Justification 
Persons who are engaged in recombinant DNA research and to 
whom the Proposed Revised Guidelines would apply only if they 
voluntarily registered under IV-C-2, would be more likely to 
register if they could be assured that their confidential or 
proprietary data and information would not be disclosed un- 
necessarily. Furthermore, the suggestion in IV-C-4 that the 
institution "consider applying for a patent before submitting 
information to DHEW" is not practical because the institution, 
if it voluntarily registered its DNA research projects with 
NIH, in many cases would be required to submit confidential 
or proprietary data and information to ORDA before beginning 
such experiments and in all other cases ORDA will receive the 
information as soon as approval is granted by the IBC. Experi- 
ence has shown that in many cases, the information that is 
available prior to beginning an experiment is often inadequate 
to support a patent application. Thus, DHEW could disclose the 
confidential or proprietary data and information before an 
institution could obtain adequate protection under the patent 
laws of the United States or many foreign countries. This is 
especially true with respect to the patent laws of certain 
foreign countries. As previously noted, not all confidential 
or proprietary data and information are patentable. In the 
latter case, such data and information are regarded as trade 
secrets and even though unpatented they can be very valuable 
assets. The proposed amendment is based on the Public Informa- 
tion Regulations of the Federal Food and Drug Administration 
(21 C.F.R. 20.45; 20.46). If adopted, it is submitted that 
it would encourage institutions to voluntarily register NDA 
research projects with NIH. 
Finally, we wish to note that we are in complete agreement with the 
principle of flexibility that has been built into the Proposed Re- 
vised Guidelines. We believe that the Director of the National 
Institutes of Health should have the authority given to him in 
Section I-E-5, for example, to exempt "other classes of recombinant 
DNA molecules if the Director, NIH, on the recommendation of the 
[A-259] 
