AREA CODE 6 □ 0 
PHONE 262-2177 
MEDICAL CENTER 
UNIVERSITY OF WISCONSIN • MADISON, WISCONSIN 53706 
McARDLE LABORATORY 
FOR CANCER RESEARCH 
February 1, 1978 
Dr. Donald S. Fredrickson, Director 
National Institutes of Health 
Bethesda, MD 20014 
Dear Doctor Fredrickson: 
Thank you for your kind letter of January 16, 1978 pertaining to the 
proposed revisions of the N.I.H. Guidelines. 
I would like to emphasize again the urgency of Instituting a prompt 
change In the Guidelines that would permit Immediate exclusion from under 
the M.U.A. requirements of all experiments on recombining genes of col 1 
K-12, Its phages and plasmids (Intraspeclf 1c £. col 1 K-12 cloning). There 
was uniform agreement among the members of your Advisory Committee as to 
this change, and even Bob Sinshelmer advocated It. I am sure that you 
could do so by a simple official announcement. 
The damage being done by the regulations based on the Guidelines and 
the ensuing bureaucracy Is tremendous. Many scientists waste time, 
effort and taxpayers' money by trying to do research without applying 
the recombinant DNA technique, just because they do not want to be drawn 
Into the bureaucratic mire. Merely to get simple permission to clone 
E.. col 1 or X phage DNA in an £. col i plasmid takes several months, 
piles of paper and hours and hours of wasted time and effort. Also, 
your Office of Recombinant DNA and the local Biosafety Committees are 
overburdened. 
I shall try to telephone you early In February to learn whether you 
will exclude early this Spring the Intraspecific E_. col 1 K-12 cloning 
from the bureaucratic requirements of the M.U.A. 's. I realize that any 
of your decisions could be criticized either as "bureaucratic delay" 
and "foot dragging" or as "unnecessary haste". Thus, the selective 
policy of (1) rapid approval of uncontested changes and (2) careful 
consideration and somewhat delayed approval of disputed aspects of the 
revised Guidelines appears to me to be the wisest course of action, 
combining the best of both alternatives and showing the flexibility and 
responsiveness of the administrative process and your courageous leadership. 
With best personal regards, 
/ waciaw ozyDaiSKi 
C Professor of Oncology 
WS :ms 
[Appendix A — 231] 
