194 
up by any particular group that have not undergone the public procedures 
in the Administrative Procedures Act which affect all of our rights. I 
therefore believe that while these should go into effect on an interim basis 
before a Federal Register publication, that they should definitely receive 
the scrutiny and the protection that goes along with Federal Register 
publication. 
Now, this leads then to the next question, because many scientists and 
members of the public erroneously believe that if you put anything in the 
Federal Register it is cast in iron for all time, it is impossible to 
change or at least very difficult, it will slow down scientific progress, 
et cetera. I have heard those arguments all the time I was in the Food and 
Drug Administration. 
First of all, and I believe my comments to Dr. Brown of yesterday 
dwelled on this, albeit only briefly, there are two mechanisms for change. 
One is, of course, the amendment of the regulations themselves. All of you 
will say that takes time, and I agree. Therefore, that in itself is not 
sufficient to provide flexibility. But it is also possible to use what I 
referred to yesterday as the variance mechanism. 
A procedure can be built into regulations, assuming that these guide- 
lines were to become regulations, which would provide that anyone wishing 
to have Federal funds could request a grant, and in that request for the 
grant could also request a variance for good and sufficient reason that 
would have to be spelled out in the request, and that the advisory commit- 
tee, the technical advisory committee would then advise the Director of NIH 
whether there are sufficient grounds to assure the public safety and to 
grant the variance at the same time in order to assure a public record. 
This is a procedure, I might add, which has been used in regulations before, 
and I could provide models for this. 
In order to assure public awareness of this, the request for the vari- 
ance and the written grant or denial, which can be relatively brief, would 
be then placed on the public record so that anyone who wished to be aware of 
it could see that decision. 
Now, a variance can be granted on an ad hoc basis; it could also be 
granted on a broader basis while the regulations themselves are being re- 
vised. I urge all of you not to accept the stereotype that regulations are 
impossible to deal with and rigid. They can be as flexible as the limits of 
the English language. For that reason I do believe that they should go in 
the Federal Register , and that a system of flexibility be worked out. 
Now, Don, I have a number of specific problems with the guidelines as 
written. I will simply sort of list them, and then give them to you in 
greater depth at a later time. 
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