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5.2 First-Stage Consultation

In First Stage Consultation, the licensee prepares a Study Plan by undertaking a joint meeting with agencies and other participants, and then considers written study requests and comments. A study plan dispute may be referred to the OEP Director for voluntary resolution.1

 

  1. See 18 C.F.R. ยงยง 4.38(c)(2), 16.8(c)(2).


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