; (2) marketing of the drug subject to such application; and (3) determination by the Secretary that the drug has a sustained market presence. (c) Transferability (1) In general The recipient of a priority review voucher under subsection (a) may transfer (including by sale) the entitlement to such voucher. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used. (2) Notification to the Secretary Each person to whom a voucher is transferred shall notify the Secretary of such change in ownership of such voucher not later than 30 calendar days after such transfer. (d) Notification The sponsor shall notify the Secretary not later than 30 calendar days prior to the submission of a human drug application that is intended to be the subject of a priority review voucher, except in the case of such an application that was pending as of October 1, 2018, in which case the sponsor of such pending application shall notify the Secretary not later than 30 days after the date on which such voucher is awarded. (e) Fees (1) In general The sponsor of an application that is the subject of a priority review voucher shall be subject to the fees required under subchapter C of chapter VII. (2) Priority review user fee (A) In general The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under subparagraph (B). Such fee shall be in addition to any fee required to be submitted by the sponsor under subchapter C of chapter VII. (B) Fee amount The amount of the priority review user fee shall be determined each fiscal year by the Secretary, based on twice the difference between— (i) the average cost incurred by the Food and Drug Administration in the review of a human drug application subject to priority review under this section in the previous fiscal year