19 
Mr. Walsh said the Cabinet Council Working Group had not discussed the NIH Guide- 
lines nor the impact of the Federal Register announcement on the NIH Guidelines. 
Mr. Mitchell asked if the Biotechnology Science Board would be able to modify 
the NIH Guidelines. Dr. Clcwas said the NIH Guidelines would have to be subject 
to the board. If the NIH Guidelines were not subject to board control, the 
guidelines of the other agencies would not be subject to board control . Such 
independence would destroy the intended purpose of the board. 
Dr. McKinney suggested the working group document ask vh ether the NIH Guidelines 
would be allowed to continue to evolve as they have in the past. He said RAC 
has a proven track record and on the basis of that record the board could dele- 
gate to the NIH authority to control its own NIH Guidelines. He felt it was 
inappropriate at this time to muddy the waters by forcing the NIH to report to 
the board before it advises the NIH Director. 
Dr. McKinney felt strongly that NIH and RAC must have the authority to modify 
the NIH Guidelines. Dr. Clowes pointed out that RAC would then be completely 
independent of the the Biotechnology Science Board. 
Dr. Lardy said RAC desires autonomy in overseeing basic research; he felt very 
strongly that research should not be included under the scheme proposed in the 
December 31, 1984, Federal Register . Dr. Lardy said the structure proposed in 
the December 31, 1984, Federal Register is not sacrosanct. It could be modified 
if consideration suggests it will not work well. He questioned the need for a 
new structure which he felt would be cumbersome. 
Dr. Gottesman said the working group could explicitly state research should 
not be part of the proposed oversight structure. She said the issues vhich 
must be considered in overseeing laboratory research are quite different from 
the considerations of the regulatory agencies. Dr. Pirone agreed. He felt 
the December 31, 1984, Federal Register was an attempt to regulate ccnmerciai 
biotechnology ; science and research should not be mentioned in the Federal 
Register scheme. Mr. Mitchell said the NIH should not be associated with 
regulatory agencies in the proposed oversight scheme . 
Dr. Walters suggested the word "science" be deleted from the name of the board. 
If the word "science" is removed from the title, scientific research would not 
be part of the oversight scheme. 
Dr. Gartland observed that the working group appeared to be seceding from the 
planned federation of agencies. Dr. Landy said the NIH should justify this 
action on the basis of its long experience and tradition. 
Mr. Mitchell asked Mr. Walsh to describe the development of the proposed overs i^it 
scheme by the Cabinet Council Working Group. Mr. Walsh said the Cabinet Council 
originally considered three methods of providing oversight. These three methods 
were: (1) A "super-RAC" would be established at the NIH or at the level of the 
Assistant Secretary for Health in DHHS. This super-RAC would offer advise to 
the various agencies. (2) Each agency would establish its own autonomous RAC. 
(3) A federation of agencies would be formed with a Biotechnology Science 
[349] 
