he had alternative language which he would propose after further 
discussion of the proposal. 
Dr. Sharpies said that the NIH up to this point has been 
collecting information on a wide variety of things and at this 
point is a repository of information regarding recombinant DNA 
technology. She asked if this change in submittal policy might 
nob cause the NIH in future years to have to reconstruct a system 
to collect the information which it may not possess if this 
proposal is put in place and the NIH is bypassed. 
Dr. Talbot said that today many applications from industry are 
going directly to EPA or FDA without NIH having any information 
concerning them. Individuals desiring information can go 
directly to each of the relevant agencies and ask what they have 
approved. 
Dr. Walters said he agreed with the thrust of the proposal as he 
believed it of value to eliminate duplication in coordination 
among Federal agencies. However, the proposal should be modified 
to retain RAC oversight of human gene therapy. Therefore, he 
proposed the following additional language be added at the end of 
the proposed text: 
“However, any experiment that involves the 
adninis tra tion of gene therapy to human 
subj ects (see Section III-A-4 of the NIH 
Guidelines) may not proceed without prior 
review by the NIH Recombinant DNA Advisory 
Committee and NIH approval." 
He said that since the RAC and the NIH have made such a strong 
commitment to public review for NIH funded human gene therapy 
experiments that it would be unwise to withdraw that commitment 
at this point. Dr. Epstein seconded the motion. 
Dr. Miller stated that the FDA strongly supported the proposal 
but would object to Dr. Walters' amendment in that, 
"...especially in human gene therapy there is an even greater 
acute need to avoid reduplication of reviews and delays than in 
other areas...." He said human gene therapy proposals will be 
reviewed by the local Institutional Review Boards (IRBs) and by 
the FDA and that going through the Human Gene Therapy Working 
Group and and the full RAC would be an extra layer of 
bureaucracy. He said that when a need for rapid approval has 
been necessary, such as in anti-AIDS therapeutics, the FDA has 
managed to react and approve these very quickly, some within a 
week of submission. 
Dr. Walters pointed out that over the last 2 1/2 years the RAC 
has consistently made the judgnent that there are important 
reasons to bring human gene therapy proposals before the RAC for 
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