COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
October 26, 1978 
Page Two 
public hearing, conducted on December 15-16, 1977. In many 
respects, this proposal is a distinct improvement both over 
the last proposal and over the current guidelines. 
One particular problem, however, continues to exist. 
The administrative procedures incorporated in the guideline 
still contain significant deficiencies. It is this aspect 
of the latest proposal on which I again wish to offer comment. 
First, nothing in the guidelines (as contrasted with 
the preamble to the guidelines) relates to the composition 
or selection of the Recombinant Advisory Committee (RAC) . 
Nor does any provision in the guidelines inform the public 
how future changes in the guidelines can be proposed and con- 
sidered. I continue to believe that very simple provisions 
which explicitly state that NIH will solicit nominations for 
the RAC from all interested persons, that there will be "pub- 
lic" members of the RAC as well as expert scientists, and 
that changes in the guidelines can be suggested by petitions 
from interested lay persons or scientists, would be very help- 
ful additions. 
Second, I continue to find the administrative pro- 
cedures unclear and confusing. The language appears to be 
different for each procedure, thus raising uncertainty whether 
all of the procedures are indeed intended to be different or 
are in fact similar or identical to each other. Standardized 
language should be adopted for standardized procedures. In 
addition, some of the proposed procedures appear to be need- 
lessly stringent and to preclude legitimate flexibility. 
Finally, the rationale for the different procedures adopted 
for the various different administrative actions is nowhere 
stated, which may account for what appears to me to be a lack 
of consistency among these procedures. 
Approaching the matter conceptually, there appear to 
be two possible sources of action under the guidelines: the 
Director or the RAC. (Section 11(D) (ii) (a) states that certi- 
fication of a host-vector system is actually done by "NIH" 
but I assume that this will be changed. NIH must act either 
through the Director or the RAC.) Action taken by the Director 
can, in turn, be taken in four ways: after notice and comment, 
after notice but before the comment is received and analyzed, 
without any notice or comment but upon the advice of the RAC, 
and without any notice or comment or advice by the RAC. 
[A-444] 
