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II-E-1. Protocols for Which Prior NIH Approval Is Not Required . 
The procedures described in this section apply only to protocols for 
which prior NIH approval is not required (see Section I-B of this Supple- 
ment for prior approval requirements). Depending upon the IBC's judgment 
as to whether the proposed changes are major or minor, the procedures 
described in Sections II-E-l-a and -b below are to be followed. 
II-E-l-a. Major Changes . A new or revised MUA is required for 
major changes in the recombinant DNA aspects of an ongoing project. 
Exanples of such changes are (i) a significant change in hosts or vectors, 
(ii) a significant change in the donor species or the nature of the DNA 
segment selected, (iii) a major change in the physical location of the 
experiments, or (iv) a change of the responsible investigator. 
For such major changes, a new or revised MUA must be submitted to 
the IBC. Once the IBC has approved a project not requiring prior NIH 
approval (see Section I-B of this Supplement), the experiment(s) may be 
initiated. The Institution must then forward the MUA directly to the 
program administrator of the awarding NIH Bureau, Institute, or Division 
within 30 days of the IBC approval. The MUA must identify the project 
by grant number. The Principal Investigator and the IBC will be notified 
regarding the NIH review of the new or revised MUA. If ORDA finds that 
an MUA, or certain aspects of an MUA, do not conform to standards set 
forth in the Guidelines, immediate action must be taken to bring the 
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