19 
and complex that industry would be discouraged from seeking RAC review. 
Drs. Landy and Friedman ageeded. Dr. Friedman pointed out, however, that 
industry complies with the NIH Guidelines in part because of tort law 
considerations. Dr. Landy said that industry in many cases does not 
want to reveal what it is doing. 
Mr. Marsh said information contained in RAC sulxnissions is of a very 
competitive nature. He said it is not so much the general concepts as 
most companies knew in general terms what their competitors are doing, 
but the specifics described in the proposals which must be protected. 
The definition of confidentiality then has to lie with the submitter, not 
the reviewer. To that extent, the possibility of industries submitting 
proposals for public review poses a number of serious problems. Mr. Marsh 
felt industrial submissions could probably be divided into confidential and 
non-conf idential material, but he thought even if this were done some dis- 
satisfaction would still be expressed, over the amount and type of 
material labeled confidential. 
Dr. Miller said FCA and EPA have a great deal of experience in discriminating 
between proprietary and nonproprietary information. These agencies would 
be willing to help RAC discriminate between these types of information. 
He pointed out, however, that confidentiality issues are often subtle. For 
example, FDA considers the existence of an application from a given manufac- 
turer for a given product to be a trade secret and not to be divulged until 
knowledge of the existence of that application becomes part of the public 
domain. 
Mr. Daloz asked who oversees the IBCs. Dr. Gartland replied that the IRCs 
are registered by ORDA and that NIH has sponsored two meetings of IBC 
chairpeople to discuss pertinent topics. A detailed study of California 
IBCs has also been conducted by a group at Stanford University. 
Mr. Daloz asked if procedures to delete two subcommittees from the RAC 
charter and institute two others had been initiated. Dr. Gartland replied 
that they had been initiated; a request has been sent from the Director, 
NIH, to the Secretary of Health and Human Services to amend the charter. 
Mr. Mitchell asked the members if a RAC meeting might conveniently be 
scheduled for January or February 1984. Many memters felt December would 
be more convenient. Mr. Mitchell said he would entertain a motion for 
adjournment. Dr. Landy moved adjournment. Dr. Mills seconded. The motion 
passed by voice vote. 
The meeting was adjourned at 3:45 p.m. 
[ 203 ] 
A 
