Director, Office of Recombinant DNA Activities 
February 1, 1984 
Page 2 
I. Should the NIH guidelines be limited strictly to work done 
in the laboratory? 
PMA believes it would not be in the public interest for the 
NIH guidelines and the considerations of the RAC to be limited 
strictly to work done in the laboratory. The basic scientific 
concepts involved in recombinant DNA technology, especially the 
construction and use of recombinant organisms, are the same 
regardless of the application. The essential exchange of know- 
ledge and experience gained in the various areas has been greatly 
facilitated by the existence and functioning of the RAC. Examin- 
ation of industrial issues by RAC can provide useful feedback for 
the scientists involved in the research limited strictly to the 
laboratory. 
II. Should NIH accept for review only individual proposals 
funded by NIH or only proposals funded by the federal 
government? 
PMA believes that to restrict the application of the guide- 
lines and especially considerations of the RAC to NIH or other 
federally funded research projects would diminish the valuable 
role of RAC in the development of knowledge, information, and 
concepts of use to the biotechnology industry, and threaten the 
continued acceptance of RAC as the forum for the resolution of 
complex issues involving both basic and applied research. The 
Committee members have expressed their willingness to continue a 
broad overview of biotechnology, and the consideration of the 
problems of industrial applications of recombinant DNA technology 
constitutes a public service of value to all segments of American 
society . 
The ultimate utility of government-funded research projects 
generally will be realized only through the applied research 
efforts such as those of the pharmaceutical industry. In this 
regard, I would commend to your attention the recently published 
Office of Technology Assessment (OTA) report on "Commercial 
Biotechnology and International Analysis." This report empha- 
sizes, among other things, the value of applied research to this 
country's continued preeminence in biotechnology. 
III. Should all portions of all RAC meetings be open to the 
publ ic? 
Government agencies, including NIH, routinely close portions 
of meetings when considering competitive, confidential, or sec- 
urity issues. Certain non-voting members of RAC represent agen- 
cies such as FDA, EPA, OSHA, and USDA that have regulatory res- 
ponsibilities which require this option for their own meetings, 
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