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DEPARTMENT OF HEALTH & HUMAN SERVICES 
Attachment TV - Page 5 
Public Health Service 
National Institutes of Health 
Bethesda, Maryland 20205 
January 30, 1985 
Dr. William Gartland, Director 
Office of Recombinant DNA Activities 
Building 31, Room 3 BIO 
National Institutes of Health 
Bethesda, Maryland 20205 
Dear Bill: 
This is in response to the request for comment on the "Points to Consider 
in the Design and Submission of Human Somatic Gene Therapy Protocols" which 
appeared in the Federal Register, January 22, 1985. 
The comments I offer are as follows: 
1. Re: paragraphs I.B.3.f, I.B.3.g. and I.B.3.h. 
It is suggested that a new section i.e. IV - Reporting Requirements 
be created and these paragraphs be incorporated under the new 
section. 
The cited paragraphs cover information that would not be available 
at the time of initial submittal and therefore, would be best 
separated from that body. Additionally, separating these paragraphs 
under the proposed section would clearly identify the future 
requirements. 
It is also suggested that the word "should" in the second line of 
I.B.3.f. and I.B.3.g. be replaced with the words "are to." The word 
"should" tends to be permissive. 
Lastly, it is suggested that paragraph I.B.3.h. be amended to 
require the submittal of autopsy findings (if an autopsy is 
performed) as a separate report. 
2. Re: paragraph I.B.5.a. 
It is suggested that a cross-reference to paragraph III.D be 
inserted at the end after the word "vitae. " 
3. Re: paragraph I.B.5.b. 
It is suggested that this paragraph be amended to include all 
facilities at which either primary treatment and/or follow-up 
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