public discussion and review; FDA consideration of these 
proposals will not be public. 
Mr. Mitchell asked Dr. Talbot if an investigator proposing to do 
hunan gene therapy would have his choice under the proposal to 
submit the experiment for approval to NIH or to the FDA. Dr. 
Talbot replied that under the proposal, as published in the 
Federal Register at tab 1286/1, an investigator submitting such a 
proposal to FDA would not have to submit it to NIH. However, Dr. 
Talbot said that he supported Dr. Walters' proposed amendment to 
require RAC review and NIH approval. Dr. Korwek commented that 
there was no question that such a proposed experiment would have 
to be brought to FDA but that the issue was whether it should be 
brought before the RAC. 
Mr. Mitchell re-read Dr. Walters', amendment before putting it to 
a vote. Ihe motion passed by a vote of 12 in favor, one opposed, 
and 3 abstentions. 
Mr. Mitchell then called for further discussion on the main 
proposal. Dr. Korwek proposed an amendment to reword the second 
sentence of the proposal to read: 
"Once approval, or other applicable 
clearances, have been obtained from a Federal 
agency other than the NIH (whether the 
experiment is referred to that agency by the 
NIH, or sent there directly by the 
submitter), the experiment may proceed 
without the necessity for NIH review or 
approval . “ 
He explained the purpose of this would be to take into account 
the situation in which an agency does not “approve" an 
application but merely does not oppose it as in the IND situation 
that was discussed earlier. Dr. Davis seconded the motion. 
Dr. Margaret Mellon asked about cases which are within NIH's 
jurisdiction, and where USDA judges them to be outside of its 
jurisdiction. Dr. Talbot stated that in such a case the USDA 
would not give approval if they said it was out of its 
jurisdiction and this proposed paragraph in the NIH Guidelines 
would not be applicable since there would be no approval or 
clearance from USDA. 
Mr. Mitchell then called for a vote on the proposal as amended. 
The amended proposal is to delete a paragraph from Section III-A 
of the NIH Guidelines and add at the end of Section I-A of the 
NIH Guidelines the following: 
"Any recombinant DNA experiment which 
according to these guidelines requires 
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