5 
I. CALL TO ORDER AND OPENING REMARKS 
Mr. Mitchell, Chair, cal led the September 23, 1985, meeting of the Recom- 
binant DNA Advisory Ccrrmittee (RAC) to order. Mr. Mitchell said formal 
notice of this public meeting had been given in the August 19, 1985, Federal 
Register (50 FR 33462). 
Dr. Gartland informed Mr. Mitchell a quorum was present at the meeting. 
He announced to RAC that Mr. Mitchell had been reappointed Chair of the 
RAC through June 1987. 
Mr. Mitchell said he would recognize speakers in the following order: 
primary reviewers; other RAC members; ad hoc consultants; non-voting repre- 
sentatives to the RAC; RAC's administrative staff; members of the public 
who submitted written documents or comments; and finally other members of 
the public who wish to comment. 
Mr. Mitchell introduced the ad hoc consultants to this meeting of the RAC: 
Dr. John R. Collier of Harvard Medical School; Dr. Robert K. Mortimer of 
the University of California, Berkeley; Dr. Anthony MacQuillan of the 
University of Maryland; and Dr. Thomas A. Waldmann of the National Cancer 
Institute of the National Institutes of Health (NIH). 
II. MINUTES OF THE MAY 3, 1985, RAC MEETING 
Mr. Daloz said he had reviewed the minutes (tab 1234) of the May 3, 1985, 
RAC meeting. He called attention to Dr. Gottesman ' s remarks concerning 
education of the public in the ethical, moral, and legal issues surrounding 
recombinant DNA. 
Dr. Mills said he had also reviewed the minutes of the May 3, 1985, meeting 
and to the best of his knowledge the minutes are correct. 
Dr. Johnson moved acceptance of the minutes. Dr. Gottesman seconded the 
motion. By a vote of seventeen in favor, none opposed, and no abstentions 
the minutes were accepted. 
III. REPORT OF WORKING GROUP ON HUMAN GENE THERAPY 
Mr. Mitchell asked Dr. Walters, the Chair of the RAC Working Group on Human 
Gene Therapy, to report on the progress of this working group's attempt to 
develop a guidance document (tabs 1232, 1235/lV, 1243, 1244, 1245, 1246) 
for investigators submitting proposals involving human gene therapy. 
Dr. Walters reported that the Working Group on Human Gene Therapy published 
an initial version of the "Points to Consider in the Design and Submission 
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