DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE 
PUBLIC HEALTH SERVICE 
NATIONAL INSTITUTES OF HEALTH 
BETHESDA. MARYLAND 20014 
August 1, 1978 
On July 19, 1978, Secretary of Health, Education, and Welfare 
Joseph A. Califano, Jr., approved release by the National Institutes 
of Health of its Proposed Revised Guidelines for recombinant DNA 
research. Enclosed are the documents as published in the Federal 
Register on Friday, July 28, 1978. These include: (1) a Dec is ion of 
the Director , NIH , relating to publication of the proposed revisions, 
(2) the Proposed Revised Guidel ines — NIH , and (3) an Environmental 
Impact Assessment of the proposed action. 
The events leading to the proposed revisions are described in 
the "Introduction and Overview" to the Decision . Both the Decision 
document and the Assessment take into account all of the issues raised 
at the public hearing of the Advisory Committee to the Director, NIH, 
held in December 1977, and in correspondence received on this subject 
before and after that public hearing. 
A public hearing on the 
in September in Washington, 
period of 60 days after the 
July 28 will be considered ( 
be granted). Within 45 days 
period, final Guidelines wil 
Federal Register . 
se proposed revisions will be held late 
D.C. All comments received during a 
publication of the Federal Register of 
no extension of the comment period will 
after the conclusion of the comment 
1 be promulgated with a notice in the 
I want to emphasize that these Proposed Revised Guidelines are 
not final and that the NIH Guidelines on Recombinant DNA Research, as 
promulgated in July 1976, continue to govern NIH-suppor ted or -conducted 
recombinant DNA research. 
Because of your interest in the development of the NIH Guidelines, 
I would appreciate your reviewing these proposed revisions. Your 
comments are especially invited on the scientific and procedural 
aspects of the proposed revisions. All comments will be considered 
carefully prior to issuance of final Guidelines. 
"p\J 
Donald S. Fredrickson, M.D. 
Director 
Enc losure 
[ 1 ] 
