APPENDIX A TO APPENDIX C 
VI. 
VII. 
A ward of Non-Competing Renewals and Incrementally- 
Funded Contracts 
Each non-competing renewal of a grant and subsequent budget 
period of an incrementally-funded contract utilizing recom- 
binant ENA technology must be accompanied by an updated 
Certification Statement from the institutional biohazards 
committee. Prior to any award of this type the program 
official in the awarding component has the responsibility 
for reviewing the application for conformity with the Guide- 
lines, for determining whether the proposed protocols do or 
do not require a higher level of containment than was required 
in the application as reviev;ed by the initial review group, 
and for ensuring that the required documents are properly 
executed. The program official will then forward to ORDA one 
copy of the application and the certification statement, along 
with a request for clearance to award. The latter will include 
a statement to the effect that the program official has reviewed 
the application for conformity with the Guidelines, and that 
the proposed containment levels are adequate. Thereafter, the 
procedures described in V will be followed, and BIDs will for- 
ward to ORDA a copy of all award statements involving these 
projects. 
If the investigator proposes to significantly alter an approved 
protocol at the time of the non-competing renewal or subsequent 
budget period of an incrementally-funded contract, then the pro- 
cedures described in VII must be followed. It is the responsi- 
bility of the program official to ensure that all the information 
and properly executed documents required in VII are present in 
the application prior to forwarding the request to ORDA. 
Changes In Awarded Projects 
Since in many cases the NIH supports projects for project periods 
longer than one year, a number of situations will arise in funded 
projects. One situation arises when an investigator makes a de- 
cision to utilize recombinant DNA technology after the project 
has been reviewed and awarded. Another situation arises when 
an investigator decides to clone DNA segments other than those 
originally reviewed, and for which higher levels of containment 
may be required. In these cases, and in all cases in which an 
investigator wishes to significantly alter an approved protocol, 
the investigator must first apply to the NIH awarding component 
for permission before proceeding. This requirement should be 
stated in the appropriate NIH instrument (NIH Manual, NIH Guide, 
etc.) The investigator will be required to submit to the awarding 
Appendix C — 10 
