PART IV 
Attachment IV - Page 14 
The Workinq Group had the following co mments pertaining to the 
proposed structure of a biotechnology system: 
The Working Group did not have sufficient time in which to 
propose an alternate structure or structures. Further, it was the 
consensus that it did not possess the expertise to do so. However, 
there were numerous comments peirtaining to the proposed structure, 
and factors which should be included in any new mechanism. 
If there is to be an inter-agency structure providing for a 
supervising board, such supervising board must have effective 
authority over the other agencies for there to be any meaningful 
coordination, cooperation and communication. Otherwise, there 
will be confusion and uncertainty to the great detriment of the 
science and its commercial application. 
There was a general consensus that, notwithstanding the 
success of NIH being the lead agency over the last 10 years, 
because of the anticipated expansion of research and commercial 
applications, that any lead agency or supervising agency sho uld 
have broader resources and abilities to command the attentio n of 
the respective governmental agpncie*: . Congress and the general 
'public. IF was the general consensus that the lead agency or 
supervising agency should be placed in the Health and Welfare 
Agency with, p erhaps, the nf having 
€he primary responsibility for its operation and function. The 
primary supervising advisory committee or biotech committee 
should be placed with said agency. 
The issue of "structure" was discussed in the context of 
a dual paradigm: 
1. a cent ra l ag ency, or lead agency , would ha ve 
primary _ an t-hnf.i -nil h int-prhnnlogy rp.qp^rnh andrnmme rcia 1 
activity. A single unit at ASH wo uld not be unlike RAC. There 
could be an expansion ot membership to include other "disciplines . 
Additional working groups could be established in order to take 
up the increased workload which is anticipated, and to include 
subject matter or applications which are not now within the purview 
of an existing working group. The working groups would also serve 
as advisory committees to the respective regulatory agencies. 
The supervising advisory committee would have sufficient public 
members who would participate also as members of the working groups. 
All meetings of the supervising committee would be held in public, 
und would constitute the primary public forum for the discussion 
of biotechnical issues. 
2. The second paradigm would represent a decentralization 
and federalization of agencies involved in this technology. This 
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