1030 1 5rh srreer, nw • Washington, dc 20005-1598 • (202) 452-8240 
February 3, 1984 
Director 
Office of Recombinant DNA Activities 
Bldg. 31 Room 3B10 
National Institutes of Health 
9000 Rockville Pike 
Bethesda, Maryland 20205 
Dear Dr. Gar t land: 
On behalf of the Health Industry Manufacturers Association, we submit 
herewith comments on the questions raised by Dr. Bernard Talbot concerning 
the boundaries for NIH and RAC Oversight as requested in the January 5, 1984 
Federal Register (49 FR 696-700). 
HIMA is a trade association representing more than 300 manufacturers of 
medical device and diagnostic products. These companies are responsible for 
more than 90% of the sales in this 15 billion dollar segment of the economy. 
Approximately 60 of ,our members either sell products derived through biotech- 
nology (where biotechnology products are taken to mean recombinant DNA (R-DNA) 
engineered products or those utilizing monoclonal antibodies) or they are 
actively pursuing the development of such products in their own laboratories 
or through working relationships with the several biotechnology start-up firms 
so typical of this growing segment of the economy. HIMA has a Biotechnology 
Committee with more than 70 scientific and regulatory affairs representatives 
from these companies. This group has as one its goals the timely and appropriate 
submission of comments to government agencies concerned with the ordered develop- 
ment of this field. We welcome this opportunity to present our association's 
position to NIH and RAC. 
In responding to the Federal Register notice, we would like to note that 
while we have some reservations concerning the need for the Guidelines, both 
the Guidelines and RAC have served a useful public function. RAC's mix of 
scientific expertise and public representation is a combination that has, we 
believe, won the trust of the public at large. It is not likely that such a 
group could be easily constituted within any of the other governmental agencies 
particularly since they tend to be more regulatory and less science oriented 
than NIH. NIH's Office of Recombinant DNA Activities has proven that it has 
the scientific and managerial expertise necessary to insure that the composition 
of RAC retains its high caliber. 
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