7 
Dr. Walters said the second minor technical change appears in paragraph (10) 
of the Introduction; the sulworking group deleted the article "The" preceding 
"two possible undesirable consequences" of scmatic-cell therapy. 
Dr. Walters said the third minor modification occurs in Section I-B-l-a-(l) ; 
additional descriptive adjectives were added to the second sentence in the 
section. The subworking group modified that section to read: 
"Describe the gene (genomic or cDNA), the bacterial plasmid or phage 
vector, and the delivery vector (if any). Provide conplete nucleotide 
sequence analysis or a detailed restriction enzyme map of the total 
construct. " 
Dr. Walters said language was added to Section I-B-l-b-(l)-(b) ; the last 
sentence of that section new reads as follows: 
"What steps are being taken (and assays used with their sensitivity) 
to detect and eliminate any contaminating materials (nucleic acids, 
proteins , etc . ) or contaminating viruses or other organisms in the 
cells or serum used for preparation of the virus stock?" 
Dr. Walters said the fifth change was made in Section I-B-2; the subworking 
group deleted the word "laboratory" since the phrase "laboratory animals" 
suggests mice and rats to many investigators. 
Dr. Walters said Dr. Temin had suggested the word "added" be substituted 
for the word "inserted" in Section I-B-2 -a- (2), Section I-B-2 -a- (4), Section 
I-B-2-b, and Section I-B-4-b of the document since DNA might be added to 
cells but not inserted in the chromosome. The subworking group accepted 
this suggestion for Section I-B-2-a-(2 ) , Section I-B-4-b, the second sen- 
tence of Section I-B-2-a-(4), and the first sentence of Section I-B-2-b. 
Dr. Walters said the subworking group had also modified the third sentence 
of Section I-B-2-b to clearly state its interest in expression of the 
"added" DNA. 
Dr. Walters said a typographical error in Section I-B-5-a was corrected; 
that section should refer to Section III-E rather than to Section III-D. 
Dr. Wcilters said Section I-D-4 has been modified to inquire "how" patients 
or guardians will be informed that the innovative character of gene therapy 
may stimulate great media interest in the procedures and subjects. A 
second question referring to the protection of patients' privacy was 
deleted frem this section because that topic is adequately covered in 
Section I-E. 
[389] 
