COVINGTON & BURLING 
Donald S. Fredrickson, M.D. 
February 20, 1976 
Page Eight 
I recognize that the scientific community does not 
like the term "regulation", and indeed that NIH abhors the idea 
that it might in any way be an "enforcement agency." If it is 
useful from a psychological standpoint to preserve this fiction, 
I see no objection to continuing to call these requirements 
"guidelines." At the same time, however, no one should be 
misled into believing that they will not be rigidly and completely 
enforced, through the grant and denial of NIH funds. 
From a legal standpoint, I believe there is a substantial 
possibility that a court would determine that these guidelines 
may not be enforced by NIH even for funding purposes unless they 
are proposed for comment and adopted through publication in the 
Federal Register. Emerging case law indicates that requirements 
of this type cannot be adopted without the public procedures 
required by the Administrative Procedure Act, through Federal 
Register publication. 
Wholly apart from legal considerations, from the stand- 
point of sound public policy I believe that these guidelines 
should be published in the Federal Register for comment, and 
then republished in final form on the basis of all comments 
received. Everyone has acknowledged the courage and integrity 
of the scientists who have raised this matter as a public debate. 
I believe that this process should be continued to its logical 
conclusion, i.e., publication in the Federal Register. Any 
possible criticism that the issue has been debated only by 
scientists, and not by the public at large, would then be laid 
to rest forever. 
Publication in the Federal Register for general comment 
by the public would not mean that resolution of this matter, and 
the pursuit of important scientific research, would be delayed for 
yet another long period of time. On many occasions, proposed 
regulations have been implemented on an interim basis pending 
receipt of comment and publication of final regulations. I see 
no legal reason why the guidelines could not be implemented, 
for purposes of NIH funding, pending completion of the public pro- 
cedures established in the Administrative Procedure Act. 
Nor does publication of the guidelines as regulations 
in the Federal Register mean that the guidelines will forever 
be chiseled in stone as rigid requirements that cannot be changed 
as new scientific information becomes available. Two mechanisms 
are available to assure flexibility in regulations embodying com- 
plex scientific requirements. 
[481] 
