Under 21 CFR 312.8(d)(3), to support its calculation of recoverable costs, a sponsor must provide documentation to show that its calculation is consistent with the requirements of § 312.8(d)(1), describing recovery of direct costs and, if applicable, the requirements of § 312.8(d)(2), describing certain additional costs that may be recovered for intermediate-size patient population expanded access uses or treatment INDs or protocols. This documentation must be accompanied by a statement that an independent, certified public accountant has reviewed and approved the calculations.

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