DNA/9 
the closing date for public comment. The comment period should be no 
shorter than 45 days and should end in time for submissions to be 
circulated to whomever (RAC, ORDA, etc.) will be responsible for 
assessing the merits of the application. Notice of RAC meetings 
dealing with the application should also be published in the Federal 
Register and the meetings should be open to the public. Notice of 
NIH's final action should also be published in the Federal Register. 
Roles and Responsibilities 
IV-A-l-ra. This section should specify a time by which the IBC 
must be established. EDF recommends that the IBC be established within 
45 days of final promulgation of the PRG-NIH. The failure to specify 
a time limit for formation of the IBC is indicative of the overall 
failure of PRG-NIH to provide the specifity needed to guarantee com- 
pliance with the intent of the PRG-NIH. Without such a time limit, 
institutions are free to delay addition of needed public representatives 
for an unlimited time. 
IV-A-l-d. Once again, this section fails to provide a time limit 
for IBCs to bring protocols into compliance with PRG-NIH. Without 
such a time limit, research not conforming to the safety requirements 
of PRG-NIH can continue for an unlimited amount of time. It is 
shocking that so elementary a regulatory concept is missing from PRG- 
NIH. (As described in our comments on I-C and Appendix C of PRG-NIH, 
EDF maintains that no recombinant DNA research at an institution re- 
ceiving NIH funds for any purpose should continue unless NIH formally 
indicates that the containment requirements specified by the IBC are 
appropriate. Under this procedure the IBC would provide NIH with its 
assessment of the appropriate containment levels plus certification 
[A-344J 
B 
