DEPARTMENT OF HEALTH fit HUMAN SERV ICES 
Public Health Service 
Food and Drug Administration 
Rockville MD 20857 
S8> 16 SB? 
William J. Gartland , Jr., Fh.D. 
Director, Office of Reccdb inant ENA 
Activities 
NIH 
12241 Parklawn Drive, Room 58 
Rockville, Maryland 20852 
Dear Bill, 
My colleagues and I have reviewed the proposed actions for the 
September 24th meeting of the RAC, and have a number of 
comments on them. 
First, with reference to the proposal by Edward L. Rogers of 
the Fovndation on Economic Trends, item I? 1293: 
1. The proposal would enlarge substantially what is considered 
a '‘project" supported by NIH finds to "all work that is 
reasonably forseeable when the NIH support is received 
L emphasis added J The proposed language is vague and 
would likely exert a chilling effect (by increasing the 
frequency of situations requiring certificates of 
compliance with foreign regulations) on the kinds of 
collegial exchanges of materials — probes, cell lines, 
restriction enzymes , bacterial clones, and so forth — that 
occur routinely between researchers in this country and 
abroad. These kinds of interactions between foreign 
researchers and intra- and extramural NIH researchers are, 
of course, commonplace. 
2. We are unaware of any need for the proposed change. Ch the 
contrary, one of the factors contributing to the monumental 
increase in knowledge from recombinant DNA techniques 
applied to molecular biology during the past 15 years has 
been the ease and frequency of international collaboration 
and the exchange of materials noted above. 
3. For these reasons, we oppose the proposed change. 
Recombinant DNA Research, Volume 13 
[351] 
