Attachment II - Page 5 
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(2) that laboratory studies have been performed in intact 
laboratory animals? With which species of animals? What 
have been the results of these studies with respect to the 
following points? 
(a) Integration sites of vector and inserted DtA within 
the genomic D1A 
(b) Integration sites within the body, by cell or tissue 
types, including possible germ- line-cell integration 
(c) Structural stability of vector and inserted DNA, 
absence of other adventitious reccmbinational events, 
or other variant DtAs 
(d) Expression of inserted gene: its expression, stability, 
and regulation (including time and amount of expression) 
(e) Toxicity, Lmnunogenicity , tumorigenicity , and mutagenicity 
of vector and inserted D1CV in test animals 
c. Clinical and public-health considerations 
(1) To which cells of patients will vectors and added DMA be 
delivered? By what mode of delivery? In what volume and 
over what period of time? 
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