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portion of today's meeting to hear, review, debate, evaluate, and make a 
recarmendation concerning a proposal frcm Advanced Genetic Sciences, Inc., 
in open and closed session. The Foundation on Economic Trends is claiming 
the public had not been given proper notice of the cpen session. On 
February 3, 1984, Judge John Sirica of the U.S. District Court for the 
District of Colunfcia had ruled to deny the requested temporary restraining 
order. The Foundation on Economic Trends had appealed that ruling to the 
United States Court of Appeals for the District of Colunbia Circuit. 
Mr. Mitchell said he had now been notified that the Appellate Court had just 
reversed the lower court and enjoined the RAC frcm considering at this meeting 
in either open or closed session the proposal frcm Advanced Genetic Sciences, 
Inc. Therefore, this item would not be considered at this meeting. 
Dr. Talbot said a staff report of the Subccnmittee on Investigations and 
Oversight of the Committee on Science and Technology, U.S. House of Repre- 
sentatives , entitled "The Environmental Implications of Genetic Engineering" 
had just been delivered to RAC. The report is based on joint hearings held 
by the Subccnmittee on Investigations and Oversi^it and the Subccnmittee on 
Science, Research, and Technology on June 22, 1983. Mr. Mitchell said RAC 
would not carment on the report at this meeting as RAC menbers had not yet 
had an opportunity to review the report. 
X. QUESTIONS CONCERNING BOUNDARIES FOR NIH AND RAC OVERSIGHT 
Dr. Bernard Talbot, Deputy Director of the National Institute of Allergy and 
Infectious Diseases, reported that within the Executive Branch of government 
ccnmittees are currently being instituted to review the relative roles of 
the differ oat Federal agencies in the oversight and regulation of bio- 
technology. He had requested that a series of questions be issued for 
public carment and placed on the agenda (tab 1125, 1133/11, 1134, 1145) 
for the February 6, 1984, RAC meeting. Dr. Talbot wrote* 
"The NIH Guidelines for Research Involving Reccmbinant DNA Molecules 
were originally written to deal with NIH grantees doing bianedical 
research in the laboratory. They were subsequently adopted by other 
Federal agencies. Most of the meetings of the NIH Reccmbinant ENA 
Advisory Ccrrmittee (RAC) have been entirely open to the public. At 
the last RAC meeting a portion of the meeting was closed (not cpen) 
to deal with a request to field test (not confine in the laboratory) 
an agricultural (not bicmedical) submission frcm an industrial company 
(not an NIH grantee) . Questions have been raised as to whether NIH 
should not redefine more circumscribed boundaries for NIH ard RAC 
oversight, and possibly encourage other Federal agencies to provide 
oversight and/or regulation beyond these boundaries. 
"I request that the following questions be issued for public carment, 
and placed on the agenda of the next RAC meeting . NIH would benefit 
frcm the views of the public and of the RAC before formulating an 
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