Recombinant DNA Advisory Committee - 21^191 
Dr. Mclvor asked if the revised protocol included a detailed proposal on how the homing 
experiments are going to be done with the clinical materials collected from the 
experiments. Dr. Lx)tze replied that his recollection was that the revised protocol 
contained a paragraph stating that the investigators would obtain blood, skin biopsies 
and tumor biopsies, when possible, at fixed intervals. 
Dr. Geiduschek pointed out that this seemed to be a technically difficult problem to 
assess, and he expressed a hope that the expertise around the table was sufficient to be 
able to quickly assess the revised protocol. He asked if it was possible to assess homing 
using blood, skin and tumor biopsies. Dr. Lotze said that it was possible in light of 
experiments performed by Dr. Rosenberg in which he was able to define homing of TILs 
to sites of tumor with radiolabeled markers using blood and skin as controls. Since 
radionuclide markers dissipate quickly, there is no ability for long-term testing. 
Dr. R. Murray called the question on the substitute motion. 
Dr. Anderson called for a point of order on whether such a motion was consistent with 
the Administrative Procedures Act which required voting to occur in a public meeting. 
Dr. R. Murray said that the intent of his motion was that the vote on the protocol be 
delayed until later in this meeting pending receipt and review of the revised protocol. If 
the reviewers were unable to comment on the revised protocol during today's meeting, 
then it would become necessary to delay any vote until the next meeting of the RAC. 
Dr. McGarrity underlined that in either case it would be voted on in a full, open meeting 
of the RAC. 
Dr. McGarrity called for a vote on Dr. R. Murray's request to call the question on the 
substitute motion. The vote was unanimous, 16 in favor, 0 opposed, and no abstentions, 
to call the question. Dr. McGarrity then called for a vote on the substitute motion 
offered by Dr. R. Murray. The motion passed by a vote of 13 in favor, 2 opposed, and 1 
abstention. 
Dr. R. Murray clarified that the sense of his motion was that the reviewers must be able 
to clearly identify the responses to the concerns expressed. If it were not possible to do 
that during today's meeting, a vote on the protocol would not be taken until the next 
meeting of the RAC or such later time when the materials were made available and 
review had been completed. 
Mr. Mannix noted that the RAC was governed by the Federal Advisory Committee Act, 
not the Administrative Procedures Act, as alluded to by Dr. Anderson. Dr. Anderson 
said he had misspoken, and that he had quoted the wrong act. 
Dr. McGarrity suggested that the revised protocol be copied in sufficient quantities as to 
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