Attachment II - Page 15 
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4. Public-health considerations 
Describe any potential benefits and hazards of the preposed 
therapy to persons other them the patients being treated. 
Specifically: 
a. On what basis are potential public health benefits or hazards 
postulated? 
b. Is there a significant likelihood that the added CNA will 
spread from the patient bo other persons or to the environment? 
c. Will any precautions be taken against such spread (e.g. , to 
patients sharing a roan, health-oare workers, or family members)? 
d. What measures will be undertaken to mitigate the risks, if any, to 
public health? 
5. Qualifications of investigators, adequacy of laboratory and clinical 
facilities 
Indicate the relevant training and experience of the personnel who 
will be involved in the preclinical studies and clinical administra- 
tion of gene therapy. In addition, please describe the laboratory 
and clinical facilities where the proposed study will be performed. 
a. What professional personnel (medical and nonmedical) will be 
involved in the proposed study? What are their specific quali- 
fications and experience with respect to the disease to be 
treated and with respect to the techniques employed in molecular 
biology? Please provide curricula vitae (see Section III-E). 
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