COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
October 26, 1978 
Page Three 
For exemptions and large scale experiments. Sections 
1(E) (5) and 1(D) (6) seem to permit action by the Director 
only after notice and comment, thus precluding immediate 
action. In my judgment that is far too inflexible. Even the 
Administrative Procedure Act recognizes valid exceptions, 
which permit action to be taken after notice but before the 
comment is received, in the public interest. Thus, at the 
very minimum I believe that any notice-and-comment procedure 
should always provide for exceptions to permit expedited 
action in the public interest. (You should also spell out 
what kind of "notice" is intended. Unless you specify other- 
wise, it will be interpreted, as I interpret it, to require 
Federal Register publication.) 
Section III states, in the second paragraph, that 
biological and physical containment provisions can be changed 
by the Director. There is no requirement of notice and com- 
ment or of consultation with the RAC. I can see no rationale 
for changing these provisions in an entirely flexible and free 
way, while permitting exemptions and large scale experiments 
only after the most stringent procedures. If there is a 
rationale for these differences, it should be stated. I 
favor, of course, far greater flexibility in all of the pro- 
cedures . 
These are only examples of the problems that I con- 
tinue to find in the administrative procedures proposed re- 
vision of the guidelines. I would strongly urge that all of 
the procedural provisions be reviewed very carefully for 
flexibility and consistency. I would again urge that pro- 
vision be made for variances for individual experimentation 
immediately upon public notice whenever the Director concludes 
that this would advance the interests of science and the pub- 
lic without any significant health hazard. This would prevent 
any criticism that the guidelines were unnecessarily hindering 
scientific creativity. 
Finally, I wish to express my continuing support for 
the superb work that NIH has been doing on these guidelines. 
While I have had some questions about their content, I have 
never had the slightest doubt about the need for the guide- 
lines and the high quality and integrity of those who have 
been working so hard on them. 
PBH/mh 
[A-445] 
