18 
notify ORDA in writing of all such actions. Notification must clearly 
indicate the name of the Principal Investigator and identify the project. 
Prior NIH approval is required for the use of primate DNA, reduction 
of containment by more than one level, or reduction to levels below Pi + 
EK1. In these three cases, complete information must be submitted to 
ORDA. 
I I- I . Exceptions to Prohibitions and Exemptions from the Guidelines . 
II-I-l. Exceptions . Requests for exceptions to prohibited 
experiments (see Guidelines, Section I-D) must be submitted with the con- 
currence of the IBC. Such exceptions require express approval by the 
Director, NIH, with advice of the Recombinant DNA Advisory Committee (RAC) 
after appropriate notice and opportunity for public comment [see Section 
IV-E-l-b- ( 1 ) of the Guidelines] . 
II-I-2. Exemptions . Classes of experiments that are exempt from 
the Guidelines are cited in the Guidelines, Section I-E. It is anticipated 
that additions to the lists under I-E- 4 and I-E- 5 will be approved by the 
Director, NIH, on the RAC's recommendation and after appropriate notice 
and opportunity for public comment. 
II-I-3. Requests for Exceptions and Exemptions . Requests for an 
exception to a prohibition or an exemption from the Guidelines must be 
submitted to ORDA, with adequate documentation. Because the handling of 
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