Within 45 days of the same deadline, the licensee must file a proposed Study Plan.¹ This must identify the studies the licensee proposes to undertake and otherwise respond to each timely study request. The plan must show that each proposed study, or each rejection of a study request, complies with the study criteria discussed in Section 4.2.5.² In other words, the licensee, like a commenter, must address the utility of each study for the licensing decision, as well as cost. In addition, the plan must include a detailed description of the scope, method, and schedule of each study and must provide for continuing consultation with participants and progress reports.³

4.2.6 Scoping Document 2

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4.2.8 Comments on Proposed Study Plan