14 
Working Group on Biotechnology has recently been restructured into a 
working group of the Domestic Policy Council. 
Dr. Healy began by stating that: 
"The inportance of the RAC to this area, both nationally and inter- 
nationally, is undisputed; and it is everyone's expectation and hcpe 
that the NIH RAC will continue to exist and play a vigorous role." 
Dr. Healy said a number of comments were received in response to the 
December 31, 1984, Federal Register proposal. The primary concern expressed 
in these comments was that the preposed two-tier scientific review mechanism 
would be too cunberscme, slew, and rigid. Industry was also concerned about 
confidentiality. The Domestic Policy Council Working Group on Biotechnology 
thus attempted to develop an alternative framework. 
Dr. Healy said severed important issues had to be considered in developing 
a scientific review mechanism: (1) Redundant reviews should be avoided. 
(2) A coordinated scientific advisory system should be aware of the 
issues faced by the various agencies. (3) Confidentiality and statutory 
requirements render it difficult for a group with extramural membership to 
review all applications. (4) A central review board probably would not be 
able to meet frequently enough to review in detail every application sub- 
mitted to every agency. 
Dr. Healy said one proposed structure involved a "super^RAC, " a single 
scientific advisory ccnmittee similar to the NIH RAC, to be located in the 
Office of the Assistant Secretary for Health (ASH) of the Department of 
Health and Human Services (DHHS). The "super-RAC" would coordinate bio- 
technology issues across all Federal agencies. Sane canmentors suggested 
the NIH RAC be transformed into the "super-RAC." 
Dr. Healy said the "super-RAC" proposal was widely discussed and received 
a certain amount of support within the Domestic Policy Council Working 
Group. However, a "super-RAC" structure was not feasible for several 
reasons: (1) The RAC meets only about four times a year and would , 
not be able to respond to the statutory time requirements of severed, of 
the agencies. (2) Confidentiality problems would be almost insurmountable 
for a committee such as RAC. (3) RAC may not possess the expertise needed 
to deal with seme of the proposals submitted to regulatory agencies. RAC 
would have to be substantially modified or at the very least would have to 
be augmented in order to be transformed into a "super-RAC." 
Dr. Healy said a variation of the super-RAC proposal would have created a 
RAC clone in ASH; the RAC would have remained at the NIH. The obvious 
question, however, that arises from such an arrangement is "who's on first." 
[396] 
