DNA/16 
information from the public. 
EDF also suggests that lay summaries of recombinent DNA activ- 
ities be made available for each recombinant DNA activity. 
IV-A-4-e. PRG-NIH should specify what types of protocol changes 
must be submitted to the IBC for approval. EDF will discuss this 
concern in more detail later in these comments. 
IV-A-4-f. This section does not clearly indicate which recomb- 
inant DNA experiments may be initiated after IBC approval and which 
must await NIH approval. It seems to indicate that all activities 
can be initiated just on the basis of IBC approval. But other sections 
of PRG-NIH indicate that prior NIH approval is sometimes needed (see 
example Appendix C, section I-B and section D) . In our comments on 
Appendix C of PRG-NIH, EDF maintains that no new recombinant DNA 
activity or change in existing protocols (e.g., change in the source 
of DNA or host-vector system used) should be initiated without NIH 
approval. If NIH chooses to disregard this suggestion, the agency 
must rewrite Appendix C, lV-A-4-f, I-C, and IV-A-2-a to clarify the 
procedural requirements that must be met before a new or altered 
recombinant DNA activity can be initiated. 
This section should also specify a time limit for completion of 
changes mandated by ORDA (see section IV-A-l-d of these comments) . 
IV-A-4-ra. The principal investigator should notify the IBC in 
writing of compliance with this section. 
IV-A-4-n (3) and n(4). The principal investigator should halt 
any ongoing recombinant DNA activity if any work errors, work con- 
ditions, or problems in the operation of biological and physical con- 
tainment practices result in a failure to meet assigned containment 
requirements of. The IBC should be notified within 24 hours of such 
[A-351] 
