Dr. Walters reminded the committee that what was being considered 
only was referring to a small class of deliberate release 
experiments. 
Mr. Rogers again brought up the issue of public comment on this 
proposed change. Dr. Talbot explained that what was being 
contemplated by Dr. Epstein's proposed change was a constriction 
of exemptions, a tightening of the NIH Guidelines, as compared to 
what was published in the Federal Register at tab 1286/III/Option 
2/part c. This would result in fewer exemptions f rcm RAC 
oversight. In the past, the NIH Director has accepted such RAC 
changes without additional public comment. 
There being no further discussion. Dr. Epstein's amendment for 
modification of Section III-A-2-c was put to a vote by Mr. 
Mitchell. The motion was passed by a vote of 11 in favor, 4 
opposed, and 1 abstention. 
At this point, Mr. Mitchell called for a vote on the main motion, 
i.e. , to recanmend modification of Section III-A-2 of the NIH 
Guidelines as it appeared in the F ederal Register at tab 
12 86/III/Option 2 with Dr. Epstein's amendment of Section III-A- 
2-c. The motion passed with a vote of 15 in favor, one opposed, 
and no abstentions. 
V. PROPOSED AMENDMENT OF SECTIONS I- A AND III -A OF THE NIH 
GUIDELINES 
Dr. Johnson said he favored this proposal (tabs 1283, 1286/1) 
which would eliminate the requirement for concurrence by the NIH 
Office of Recombinant DNA Activities for approval of an 
experiment approved by another Federal agency. He said it is 
consistent with the new Federal coordination effort. He stated he 
believed there may be exclusions over which' the RAC may want to 
continue to maintain jurisdiction such as the human gene therapy. 
Dr. Korwek said he supported the proposal. However, he felt 
there was a problem in the wording of the proposal which deals 
with "approval' 4 by other agencies in that seme agencies do not 
approve certain requests but merely do not object to them. He 
cited Investigational New Drug (IND) applications which the FDA 
does not approve but which become effective for lack of FDA 
objection. He added the EPA does much the same in their PMN 
process where after 90 days with no agency objection the 
manufacturer may proceed. 
Dr. Davis said he supported the proposal since he was eager not 
to see bureaucratic restrictions proliferate and not to have 
multiple levels of review. In regard to Dr. Korwek‘,s problon 
with the word "approval". Dr. Davis offered the suggestion that 
perhaps "clearance" would be a better word. Dr. Korwek said that 
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