DEPARTMENT OF HEALTH & HUMAN SERVICES 
P-clic Health Service 
t 
National Institutes of health 
National Heart. Lung, and 
Blood Institute 
Bethesda. Maryland 20892 
September 9, 1983 
Gerald J. McGarrity, Ph.D., Chairman 
Recombinanc DNA Advisory Committee 
Office of Recombinant DNA Activities 
12441 Parklawn Drive, Suite 53 
Rockville, MD 20852 
Dear Dr. McGarrity: 
We look forward to the RAC Committee Meeting on October 3, 1988, at which 
our human gene transfer protocol will be considered. ORDA has already sent to 
RAC members a mailing containing our protocol as well as all of the other 
materials that were previously submitted to the Human Gene Therapy Subcommittee. 
As you know, our protocol received aoprovals (with stipulations) from the NCI IR3 
(6/20/88), the NKL3I IR3 (6/21/83), and the NIH I3C (7/13/88). In addition, it 
was reviewed by the Human Gene Therapy Subcommittee on 7/29/88. The Subcommittee 
deferred a final decision but made recommendations concerning the additional data 
they felt should be obtained. They plan to conduct a telephone conference call 
prior to October 3, but, since a considerable proportion of the Subcommittee 
members present on July 29 will be at the October 3 RAC meeting, it was decided 
that we should present at the full RAC even if a conference call could not be 
arranged. 
The Subcommittee, as well as the three local committees, made a number of 
recommendations. In addition, the Subcommittee requested input from experts in 
several areas. Written comments were received before the Subcommittee meeting 
from Dr. Howard Temin. We will address all of these recommendations and comments 
in this communication. We do want to point out, however, that it will never be 
possible to satisfy every suggestion of every expert. We feel that our present 
data are sufficient to demonstrate the probable efficacy and safety of our 
proposal . 
Recombinant DNA Research, Volume 13 
