PART II (Cont'd) 
Pjqc Five 
Attachment IV - Page 9 
5 . Conogrn was expressed that in establishing five (5 ) 
separate RACs there" would be undue duplication of work and an 
o verl appin g of activity. This, in turn, would cause dela y in 
fiiakinq final determinations on applications for research as 
well as commercial products, and would undoubtedly increase the 
cost to all concerned. 
6. A concern was expressed that the proposals did not 
address the successful mechanism in effect between RAC and 
industry. This mechanism has allowed industry, under voluntary 
compliance, to participate in a very meaningful manner in the 
advance of this technology pursuant to safeguards established 
by the NIH-RAC Guidelines. It is suggested that this success- 
ful interaction between NIH and industry should be reviewed and 
hopefully applied in any new mechanism established. 
7. Another concern addressed itself to the fact that RAC 
has established an agreement on a number of scientific issues, 
as the result of its experience over the last 10 years. It 
would be pointless for other agencies who become involved in 
the technology to again raise these issues which have already 
been decided insofar as the scientific community is concerned. A 
means to share and communicate this information should be 
established and other agencies should be admonished that they 
should not expend resources on issues which have already been 
resolved. 
8. A mandate of the Cabinet Council Working Group, as 
published in the Federal Register, indicates that it would make 
a review of the function of NIH-RAC role in biotechnology. A 
review of such proposals apoears to fail to address this vital 
issue. The NIH-RAC mechanism should be set forth so that any 
new mechanism could be compared with the existing system. 
9. A conclusion is stated in the proposals published in 
the Federal Register that the United States enjoys a world 
leadership position. It would appear appropriate to analyze and 
set forth the factors which have established this leadership 
position. The favorable factors should be included in any new 
mechanism. 
[419] 
