Attachment III - Page 1 
SUMMARY 
PUBLIC COMMENTS ON 
"POINTS TO CONSIDER IN THE DESIGN AND SUBMISSION OF 
HUMAN SOMATIC-CELL GENE THERAPY PROTOCOLS" 
[ Federal Register 50(14): 2940-2945, January 1985) 
Introduction 
1. Add "and FDA regulations (21 CFR, Parts 50 and 56)" after the 
DHHS reference. Then clarify next sentence to read "These DHHS 
regulations", etc. 
2. Proprietary info could be disclosed in closed session — note 
avai lability . 
Miller 
Part I 
Section A 
Move same of the questions from IIC to this section. 
Juengst 
Section B 
l.b. Change "structure" to "composition." 
Add two sections — describe details for harvesting, 
extraction, and purification and removal of toxic 
chemicals introduced by these procedures; a warning re: 
penicillin and other beta-lactam-containing antibiotics 
used in production of materials for patient. 
Address questions re: potency of product to treat cells; 
consistency of product lots and 
usage; and stability of product 
( storage ) . 
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