SCHEMING CORPORATION 
60 ORANGE STREET 
A" 
^7 
BLOOMFIELD, N. J. 07003 
TELEPHONE: (2011429-4000 
TELEX: 138183 
CABLES: SCHERING BLOOMFIELD, N.J. 
January 25, 1984 
Dr. William Gartland, Jr. 
Director, Office of Recombinant DNA Activities 
National Institutes of Health 
Bldg. 31, Room 3B10 
Bethesda, MD 20205 
Dear Dr. Gartland: 
Schering Corporation has reviewed the Federal Register notice (49 FR 696) 
of January 5, 1984 and offers the following comments regarding Item II 
"Questions Concerning Boundaries for NIH and RAC Oversight" for consideration 
by RAC. 
Throughout the development and application of recombinant DNA technology, 
our industry has not always been supportive of the regulatory direction which 
was taken. In recent years, however, we have observed the action of the RAC 
and the evolution of the NIH Guidelines and have grown increasingly confident 
that this combination represents a workable mechanism for adequate control of 
this technology. With RAC as the focal point for discussions of both research 
and industrial applications, public concern has been alleviated and rDNA 
technology has developed in an orderly fashion. We at Schering believe that 
the public's interest is best served by continuation of this process and urge 
the members of the RAC to reject any limitations to its oversight boundaries. 
If the RAC votes yes on these questions and limits its oversight to the 
boundries outlined, we can anticipate the following results: 
o a temporary vacuum would be created until the regulatory agencies 
could develop the necessary expertise and establish an alternate 
regulatory process. This void would result in no oversight for an 
undefined period of time, opening the door for a government-imposed 
moratorium on research in those areas not subject to NIH review. 
[624] 
