1900 Oak Terrace Lane/Thousand Oaks, California 91 320/Telephone 80 5 499-5725 
ITT Telex # 4994440 Telecopier 805 499-9315 
Ralph Smalling 
Regulatory Attairs Specialist 
January 19, 1987 
Director, Office of Recombinant DNA Activities 
Building 31, Room 3810 
National Institutes of Health 
Bethesda, MO 20892 
Ladies/Gentlemen, 
Amgen, a California-based biotechnology company, wishes to comment on the 
proposals to be considered by the Recombinant DNA Advisory Committee (RAC), as 
outlined in The Federal Reqister, Vol. 51, No. 244, dated Friday, December 19, 
1986. 
We believe these proposals are progressive steps in the rational oversight of 
experiments using recombinant DNA technology. The proposals seem to us to 
reflect the scientific data which has been, and continues to be, gathered in 
this field. Amgen agrees with the concept that experiments involving dele- 
tions, single-base changes and rearrangements within a single genome (work in 
which no foreign DNA is inserted) need not be subjected to special regulation 
as recombinant DNA experiments. In addition, initiation of experiments in- 
volving r-DNA technology following approval by the federal agency with appro- 
priate jurisdiction, without the need for NIH approval, should eliminate 
unnecessary delay and duplication of effort. It is hoped that the new BSCC 
framework will insure a consistent approach to such agency reviews. 
Amgen agrees that the requirement for BL1-LS containment for the production of 
r-DNA derived products from low-risk microorganisms is expensive, unwieldy, 
and unnecessary. We support the proposal that large-scale (LS) fermentation 
physical containment conditions need be no greater than those for the host 
organism unmodified by r-DNA techniques. We hope the NIH viewpoint concerning 
BL1-LS conditions will be extended to other governmental agencies with author- 
ity for reviewing manufacturing applications. Such a position is consistent 
with the long and distinguished history of U.S. industrial fermentation, and 
the recognition that BL1-LS conditions are unnecessary for the manufacture of 
the five DNA-derived pharmaceuticals currently approved by FDA. 
Recombinant DNA Research, Volume 1 1 
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