COVINGTON 5. BURLING 
Donald S. Fredrickson, M.D. 
March 3, 1978 
Page Seven 
Particular reference was made, at the December 1977 
meeting, to the Falmouth Conference (attendance at which was 
by invitation only) and unpublished scientific data that are 
not yet generally available. It is apparent that you place 
strong reliance upon both the unpublished data and the con- 
clusions of the Falmouth Conference in proposing the revisions 
of the Guidelines as published in the Federal Register of 
September 27, 1977. Yet none of this data and information 
was referred to explicitly in the preamble to the proposal, 
and none of it was made available to the public for review 
in connection with this matter. 
Whether or not one regards the Guidelines legally 
as "regulations," and thus as subject to the procedural re- 
quirements of the Administrative Procedure Act, it is 
apparent that the procedure that has been utilized to pro- 
pose these revisions in the Guidelines is seriously flawed. 
I need not rehearse the two-year history of intense public 
interest in these Guidelines. It is simply not tenable now 
to propose modifications that would exempt some experiments 
from the Guidelines, and reduce the level of control over 
others, without specifying, discussing in some detail, and 
making public the scientific basis for those modifications. 
By attempting to short-cut this process, NIH has unfortunately 
acted in unseemly and unnecessary haste, and has given an 
impression that can only intensify the concern and suspicion 
of those who believe that inadequate controls exist for this 
type of research. 
In order to remedy this situation, I would recommend 
that the proposal published in the Federal Register of Septem- 
ber 27, 1977 be republished as a new proposal, with an ade- 
quate preamble fully explaining all of the revisions and the 
reasons for them. All of the unpublished scientific data 
and information supporting the proposal, including a full 
transcript of the Falmouth Conference, should be placed on 
the public record for inspection and comment, and its avail- 
ability should specifically be mentioned in the preamble. 
Of course, adequate time must again be given for 
public comment on this proposal. I suggested at the Decem- 
ber 1977 meeting that 30 days might be a sufficient time for 
additional comment. In view of the fact that the unpublished 
data and the transcript of the Falmouth Conference have not 
yet been made public, however, I would suggest that this 
time period for comment be 60 days rather than 30 days. 
[Appendix A — 245] 
