Genentech, Inc 
460 Point San Bruno Boulevard 
South San Francisco, CA 94080 
(415) 952-1000 
TWX: 9103717168 
April 25, 1985 
Dr. William S. Gartland, Jr. 
Director, Office of Recombinant DNA Activities 
National Institute of Health 
Building 31 , Room 3B10 
Bethesda, Maryland 20205 
Dear Dr. Gartland: 
Subject: FR Doc 85 - 7064 
Recombinant DNA: Notice of Meeting and Proposed 
Actions Udner Guidelines for Research 
We are writing to comment on the proposed Amendment to Part III-A-1 
of the Guidelines for Research Involving Recombinant DNA Molecules. 
Such amendment would establish a procedure for handling research 
proposals which are submitted concurrently to RAC and another Federal 
agency for review and approval. The amendment would permit NIH the 
option of deferring review and approval to the other Federal agency. 
At the present time, the Office of Recombinant DNA Activities and 
the NIH Recombinant DNA Advisory Committee represent the only formal 
government body with the expertise and large base of experience to 
evaluate research proposals. Genentech agrees that dual review of 
proposals would seem unnecessary; however, concern also exists that 
at this time, various Federal agencies presented with rDNA proposals 
may not have all of the necessary expertise and pertinent experience 
in-house to thoroughly review the proposals. Since the function of 
such review includes determination that the experiment will not 
adversely affect man and/or the environment, it is especially 
important that the appropriate experts evaluate the information. To 
receive proper evaluation, and until such time that Federal agencies 
have in place a biotechnology review policy such as that proposed by 
the Office of Science Technology Policy, Genentech suggests a revision 
of Dr. Talbot's amendment to read as follows: 
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