SEP 22 1978 
UNITED STATES DEPARTMENT OF COMMERCE 
The Assistant Secretary for Science and Technology 
Washington, D.C. 20230 
(202) 377-3111 
Dr. Donald S. Fredrickson 
Director 
National Institutes of Health 
Bethesda, Maryland 20014 
Dear Dr. Fredrickson: 
I have reviewed the Proposed Revised Guidelines to control 
recombinant DNA research funded by the National Institutes 
of Health (NIH), as published in the Federal Register on 
Friday, July 28, 1978 (43 FR 33042), and offer the following 
comments for your consideration. 
In the light of the development over the last two or three 
years of host-vector systems which cannot survive outside 
of carefully controlled laboratory conditions, and of the 
shifts in general scientific opinion based on increased 
knowledge about risks and benefits of recombinant DNA 
activities, I welcome the move toward guidelines somewhat 
less restrictive than those published in 1976. As you have 
pointed out (43 FR 33044, column 1, paragraph 1), ". . .no 
evidence has come to light of a product created by these 
techniques that has been harmful to man or the environment." 
I am very much in favor of the opportunity which would be 
provided under Section IV-C-2 for voluntary registration of 
projects by institutions not required to comply with the 
guidelines and certification of host-vector systems proposed 
by such institutions. 
In the "Decision of the Director" at 43 FR 33066, it is indicated 
that NIH was urged to provide the private sector, along with 
registration and certification, advice on interpretation of 
the guidelines and on the operation of institutional biosafety 
committees. We note that Section IV-B-3-a. Would require that 
the NIH Office of Recombinant DNA Activities (0RDA) "provide 
advice to all within and outside NIH . including institutions. „ ." 
[A-276] 
