Within 30 days after such comments, the licensee will file a revised Study Plan.1 This revision must include all oral and written comments, describe efforts to resolve disputes, and again comply with the study criteria.2 A participant may file comments on this revision within 15 days of such filing.3
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See 18 C.F.R. § 5.13(a).
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See id.
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See 18 C.F.R. § 5.13(b)
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