DEPARTMENTOF HEALTH & HUMAN SERVICES 
Public Health Service 
Food and Drug Administration 
Rockville MD 20857 
JUL 2 5 1985 
Dr. W.J. Gartland, Jr. 
ORDA 
Building 31, Room 3B-10 
NIH 
Bethesda, Maryland 20205 
Dear Bill, 
I wish to convey briefly FDA’s views on the revision of the NIH 
Guidelines proposed by the Committee for Responsible Genetics 
in their communication dated March 26, 1986. In summary, we 
believe that while the proposals raise some important generic 
medical-ethical Issues, the proposals are unnecessary. Current 
regulations and guidelines are adequate to address the kinds of 
situations apparently of concern to the Committee for 
Responsible Genetics, and at the same time provide the 
flexibility that is necessary for regulating clinical 
Investigations, especially in areas of evolving medical 
technologies. Moreover, the rather rigid proposals, if 
adopted, would diminish the flexibility that is one of the 
strengths of the RAC's function of advice and consent. We urge 
their rejection by the Working Group. 
I look forward to the meeting of the Working Group on August 8. 
Sincerely, 
Henry I. Miller, M.D. 
Office of the Commissioner 
Recombinant DNA Research, Volume 1 1 
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