DEPARTMENT OF HEALTH & HUM AN SERVICES 
Attachment IV - Page 19 
Public Health Service 
Food and Drug Administration 
Bethesda MD 20205 
FEB 2 0 1935 
Dr. William J. Gartland, Jr. 
Director, Office of Recombinant 
DNA Activities 
NIAID 
NIH 
Bethesda, MD ?0?.0S 
Dear Rill , 
The FDA appreciates the efforts of the RAC's Working Group on Human Gene 
Therapy to draft a document that will provide guidance to clinical 
investigators about to embark on gene therapy. As you are aware, the FDA has 
provided similar documents on a variety of subjects and these have, we are 
sure, expedited the submission and review process. 
My colleagues and I have reviewed the NIH's "Points to Consider" carefully, 
and on the following pages we offer some general and specific comments 
regarding the document. We believe that the document will require some 
revision prior to its promulgation in final form and hope that our comments 
will be helpful. In addition, through our liaison representatives, we look 
forward to continued collaboration between NIH and FDA in this area. 
Sincerely yours 
to the RAC 
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