DNA/8 
Must all HV applications be approved by RAC? If only some do, 
then which ones? Whose certification is needed before use of an HV 
can begin? Can the Director go against the recommendation of RAC? 
These questions are left unanswered by PRG-NIH. 
This section of PRG-NIH is another indication that the documents 
in the Federal Register package sometimes contradict each other. It 
also indicates that all information needed for compliance is not con- 
tained in PRG-NIH. For example, PRG-NIH do not describe the criteria 
for approval of EK2 HV. The reader of PRG-NIH would not know that 
such criteria exist. Yet DD-NIH (43 Fed . Reg . 33057) states, "It 
should be stressed that specific objective criteria do exist for 
approval of EK2 host-vector systems. These, however, do not appear 
in the Guidelines themselves, but rather as information in the Environ- 
mental Impact Assessment, Appendix H." 
II-D-2 Completely silent on the issue of public notice and 
comment. This is completely unsatisf actory . Public notice and com- 
ment must be provided and specified in PRG-NIH. Section IV-B-l-e 
of PRG-NIH states that the Director shall certify new HV after "appro- 
priate notice and opportunity for public comment." However, specific 
procedures must be written into II-D. Some discussion of this issue 
is contained in the DD-NIH (43 Fed . Reg . 33057)1 "i agree that prior 
notification to the public in the Federal Register should be given when 
the RAC considers applications for certification." 
Notification of receipt of applications for certification of new 
HV should be published i'n the Federal Register within 10 days of 
receipt of the application. The Federal Register notice should specify 
where the material submitted in support of the application can be ob- 
tained by the public. The Federal Register notice should also specify 
[A-343] 
