HOFFMANN-LA ROCHE INC. 
NUTL 
NEW JERSEY 
! 0 
Drug Regulatory Affairs 
(201)235-5000 
January 20, 1987 
Director, Office of Recombinant 
DNA Activities 
National Institutes of Health 
Building 31, Room 3B10 
8800 Rockville Pike 
Bethesda, Maryland 20892 
Gentlemen : 
Hoffmann-La Roche Inc. would like to provide the following comments 
and recommendations to the notice published in the Federal Register. 
Vol . 51 , No. 244, Friday, December 19, 1986. 
Proposed Revisions of Appendices C-II, C- III, and C-IV 
We propose the following rewording of the two paragraphs on page 
45652 of the Federal Register notice; the new paragraph should read: 
"The appropriate physical containment conditions need be 
no greater than those of the host organism unmodified by 
recombinant DNA techniques for fermentation and the subsequent 
processing of fermentation broths and cell pastes at laboratory 
or production scale for host vector systems that are exempt 
from these Guidelines." 
The above modifications further clarify the word "experiments" and 
allow the processing of live cells in an uncontained mode. It is 
especially important to include research experiments and production 
activities, since other sections of the NIH Guidelines and amendments 
to the Guidelines reference "manufacture" of DNA-derived pharma- 
ceuticals approved by the Food and Drug Administration. 
Sincerely 
HOFFMANN-LA ROCHE INC. 
Linda S. Dujack, Ph.D. 
Associate Director 
Drug Regulatory Affairs 
(201) 235-2983 
LSD:gm 
HLR No. 87053 
Copy to: Dr. William Szkrybalo (PMA) 
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Recombinant DNA Research, Volume 1 1 
