Genentech, Inc 
460 Point San Bruno Boulevard 
South San Francisco, CA 94080 
(415) 952-1000 
TWX: 9103717168 
January 30, 1984 
Dr. William J. Gartland, Jr. 
Director, Office of Recombinant DNA Activities 
Building 31, 3 B10 
National Institutes of Health 
Bethesda, MD 20205 
Dear Dr. Gartland: 
Subject: Federal Register Doc. 84-5 
Notice of Recombinant DNA Advisory Committee (RAC) 
Meeting and Proposed Actions Under the Guidelines 
We are writing in response to subject January 5, 1984 notice which advised 
that the issue of boundaries for NIH/RAC oversight would be placed on the 
February 6, 1984 RAC meeting agenda, and also solicited comments on the 
subject. The specific questions for which comment was asked are: 
1) Should the NIH Guidelines be limited strictly to work done in the 
laboratory? 
2) Should NIH accept. for review only individual proposals funded by NIH 
or the Federal government? 
3) Should all portions of all RAC meetings be open to the public? 
4) Should the NIH Guidelines be limited strictly to biomedical research? 
In response to questions 1, 2 and 4 regarding the scope and nature of RAC 
review, Genentech believes that the committee should continue to function 
as a central advisory group to the nation as a whole including all present/ 
potential regulatory bodies which do/will regulate recombinant DNA products. 
We believe this to be appropriate because the committee has accrued the 
necessary expertise, experience, and a vast storehouse of knowledge to 
address the varied range of recombinant DNA proposals from NIH grantees 
and others. Such an advisory body is appropriately a central resource, 
even in areas where regulation already exists, since the technology and our 
understanding are continuously evolving. In addition, the desire to protect 
the environment, public health and our technological leadership as a nation, 
demand centralized consistancy, fairness and timeliness. RAC has provided 
a framework for review which has given continuity to the research and 
development of rDNA products in academia and the private and public sector. 
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