0 1 HIAlty 
DEPARTMENT OF HEALTH & HUMAN SERVICES 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20892 
Building : 31 
Room : 3B10 
(301) 496- 6051 
February 25, 1986 
MEMORANDUM 
To: Interested Parties 
Fran: Executive Secretary 
Working Group on Hurra n Gene Therapy 
Recorihinant DNA Mvisory Committee 
Subject: Review of Preclinical Data 
The Working Group on Hunan Gene Therapy of the Recorihinant DNA Advisory 
Committee, at its meeting on December 16, 1985, indicated that it is willing 
to accept preclinical cbta on construction and packaging of vectors, studies 
in tissue culture and intact aniirals, etc. leading towards development of 
techniques for human scmatic-cell gene therapy. The working group errphasized 
that submission of such preclinical data will not be part of the formal 
review and approval process stipulated by Section I II -A— 4 of the NTH 
Guidelines for Research Involving Recombinant ENA Molecules, but rather 
will be for information purposes and part of an education process for 
the working group ard submitters . 
I am attaching a copy of the Points to Consider In the Design and Submission 
of Human Scmatic-Cell Gene Therapy Protocols . Please feel free to contact 
me at (301) 496-6051 for additional information. 
I 
I 
William J. Gartland, Jr., Fh.D. 
Attachment 
[ 210 ] 
Recombinant DNA Research, Volume 11 
