- 6 - 
initiation of non-NIH funded projects below the P4 level, changes in any 
ongoing projects below the P4 level, and single-step reductions in contain- 
ment levels for experiments with purified DNA and characterized clones. 
The Federal Register documents cite two reasons for this significant 
change -- bureaucratic delays in NIH review of new projects and proposed 
changes in ongoing projects and neglect of other responsibilities of the 
Office of Recombinant DNA Activities. Compared to the importance of 
uniform application of the guidelines, both to protect the public and the 
environment and to establish common ground rules in a highly competitive 
research area, neither argument is persuasive. 
In answer to a question posed by Senator Kennedy earlier this year, 
Dr. Fredrickson stated that ORDA review of original memoranda of understanding 
and agreement and modifications of ongoing research grants "generally is 
completed in two to five days." Longer delays have been occasioned by 
transmittal of protocols through the individual Institutes of NIH, a problem 
that would apparently be corrected by the proposal to relieve the 
Institutes of responsibility to review compliance with the guidelines. 
The argument that ORDA should devote more time to interpretation of the 
guidelines and communication with researchers suggests that there will not 
be prompt and thorough review of protocols which are required to be sub- 
mitted after research has commenced. 
[A-424] 
