COVINGTON 5, BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Sixteen 
It is beyond the scope of this letter to suggest 
specific procedures for any of the above-listed areas. Some 
general comments on procedures that will enhance the flexi- 
bility of the Guidelines, while assuring adequate public 
notice and participation, were contained in my letter of 
February 20, 1976. I would urge that persons who are ex- 
perienced in developing regulatory control mechanisms of 
this type be consulted on this matter. 
I must emphasize, as I did in my letter of Febru- 
ary 20, 1976, that inclusion of specific procedures need 
not require that the Guidelines become more stringent or 
inflexible. Indeed, the use of specific written procedures 
incorporated into the Guidelines can do much to eliminate 
the present rigidity of the Guidelines and assure greater 
flexibility in order more rapidly to respond to developing 
scientific knowledge. The concept of open and fair pro- 
cedures, including public notice and participation, can 
readily be reconciled with the goal of administrative flexi- 
bility. Certainly, the idea of having an advisory committee 
of the type that was convened in February 1976 and December 
1977 deliberate all changes in the Guidelines, or all ex- 
ceptions and exemptions that are granted, would be unworkable. 
Unduly cumbersome administrative procedures of that type must 
be avoided at all costs. 
Leaving these administrative procedures wholly up 
to the ad hoc judgment of NIH employees is far more likely 
to result in the type of confusion and clear errors that 
will generate enormous delay and inflexibility than are the 
inclusion of specific flexible procedures in the Guidelines 
themselves. This is best illustrated by the problem that 
you now face in repairing the procedural error caused by the 
inadequate preamble to the proposed modification of- the 
Guidelines and the failure to make public the scientific 
basis for that proposal. 
The procedural inadequacy of the Guidelines them- 
selves stand in stark contrast to the extraordinarily careful 
and fair procedures you have employed in the February 1976 
and December 1977 meetings held to provide a forum for pub- 
lic debate on the Guidelines. I have nothing but admiration 
for the way in which those two public meetings have been 
conducted. The steps taken to assure that all points of 
view have been adequately heard and considered have been noth- 
ing short of extraordinary. No person who has attended those 
[Appendix A — 254] 
