Page 2 - The Honorable Edward M. Kennedy 
Several of your questions are also directed to the NIH document published 
in the NIH Guide to Grants and Contracts in October 1977 that clarifies 
the roles and responsibilities of the NIH and local institutions for the 
implementation of the NIH Guidelines. This document was not intended to 
require NIH approval for all modifications of research protocols. But 
unfortunately, it could be, and in some places has been, literally 
interpreted that way. I have received a number of questions requiring 
clarification of what modifications would require prior approval. As 
explained in my answers to your questions, I am considering revisions 
that would delegate far greater authority to the local institutional 
biohazards committees for review, approval, and monitoring of all 
recombinant DNA research. 
Your questions raise important policy matters, all of which, I believe, 
we are addressing in the revisions of the NIH Guidelines under considera- 
tion. I would like to emphasize the extreme importance that I attach to 
having revisions completed on the NIH Guidelines before legislation is 
passed and regulations implemented. The revisions under consideration 
include changes for which there is overwhelming sentiment. This was 
apparent at the lengthy hearing of the Advisory Committee to the Director, 
NIH, in December, devoted to a public review of the revisions proposed 
by the Recombinant Advisory Committee (RAC). As requested at the hearing, 
several workshops have been held and another meeting of the RAC held in 
April to improve the revisions proposed earlier. My decision on the 
revisions, along with an environmental impact assessment, should be 
completed in June and promulgated for public comment for at least 30 
days. 
Thus, we are moving to promulgate these revisions as rapidly as is 
consistent with the Administrative Procedures and Practices Act, so that 
we can avoid the conversions of the current, outdated Guidelines to 
standards under the legislation. Enactment of legislation prior to 
completion of this process would put in abeyance the enormous effort 
over the past year and a half to develop the necessary revisions in the 
standards and implementation of the Guidelines. 
Thank you for this inquiry. I would be more than happy to discuss with 
you any further questions you may have specifically concerning my responses 
to your questions or to NIH policies regarding recombinant DNA research. 
Sincerely yours. 
Donald S. Fredrickson, M.D. 
Director 
Enclosures 
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