3 
to the original MUA in order to facilitate appropriate changes in 
the ORDA registry of ongoing research. 
When IBC approval has been obtained for projects other than those 
requiring prior NIH approval (see below), the experiments may 
be initiated. 
V. Prior Approval Requirements 
Under the revised Guidelines, an institution receiving NIH funds 
for recombinant DNA research must obtain approval from NIH, or 
another funding agency designated by NIH for this purpose, prior to 
initiation of the following activities (See Section I-B of the 
Administrative Practices Supplement) : 
• Projects for which containment levels are not explicitly 
specified by the NIH Guidelines or NIH. (The setting of 
containment levels for these classes of experiments will 
require review by NIH, often after recommendation by the 
Recombinant DNA Advisory Gcmmittee. Investigators are 
urged to provide to ORDA, in writing, full information on 
the proposed experiments prior to submission of a formal 
MUA), 
• Projects requiring the P4 level of physical containment, 
• Reductions of more than one step in containment levels for 
characterized clones (see Section III-A-3 of the Guidelines), 
• Reductions of containment levels for projects involving 
primate DNA (see Section III-A-3 of the Guidelines), 
• Reductions of containment to levels below Pi + EK1 for 
purified DNA and characterized clones (see Section III-A-3 
of the Guidelines), 
• Initiation of the first project conducted in a facility at 
the P3 level of physical containment, 
• Initiation of the first recombinant DNA project subject to 
the Guidelines conducted at an institution. (Institutions 
which have already had an NIH-approved MUA satisfy this 
requirement) . 
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