; and (ii) the average cost incurred by the Food and Drug Administration in the review of a human drug application under section 505(j) that is not subject to priority review under this section in the previous fiscal year. (C) Annual fee setting The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2018, and in accordance with subparagraph (B), the amount of the priority review user fee for that fiscal year. (D) Payment (i) In general The priority review user fee required by this paragraph shall be due upon the notification by a sponsor of the intent of such sponsor to use the voucher, as specified in subsection (d). All other user fees associated with the human drug application shall be due as required by the Secretary or under applicable law. (ii) Complete application An application described in clause (i) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this paragraph and all other applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees. (iii) No waivers, exemptions, reductions, or refunds The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this paragraph. (E) Offsetting collections Fees collected pursuant to this paragraph for any fiscal year— (i) shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration