IHI'AK I AU N I t > I- UKAI.I II N. HUMAN M KVK l.S 
Attachment VI - Page 1 
Public Health Service 
Food and Drug Administration 
Rockville MD 20857 
SEP I 3 i 
Dr. William J. Cartland, Jr. 
Director, Office of Recombinant DNA Activities 
NIAID 
Bldg. 31, Rm. 3B-10 
NIH 
Bet hesda , MD 20205 
Dear Bill, 
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 
somatic-cell gene therapy. As you are aware, the FDA has 
provided similar documents on a variety of subjects and these 
have, we are certain, expedited the submission and review 
process . 
My colleagues and I have reviewed carefully the current draft 
of the NIH's "Points to Consider," 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. As always, through our liaison 
representatives, we look forward to continued collaboration 
between NIH and FDA In this area. 
Sincerely yours, 
/• 
/ 
I. nLier, 
Henry I. MlN/Ler, MD 
Food & Drug Administration 
to the RAC 
Liaison 
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