Sec. 201 Generic priority review voucher
“506G. Generic priority review voucher
“(a) Definitions—In this section:
“(1) The term priority review with respect to an application under section 505(j) means review and action by the Secretary on such application by the Secretary not later than 180 calendar days after such application has been submitted and accepted for review.
“(2) The term priority review voucher means a voucher for priority review for an application under section 505(j). Such voucher shall be awarded upon the approval of the application described in 505(j)(11)(A), unless such application contains a certification under section 505(j)(2)(A)(vii)(IV).
“(b) Generic Priority Review Vouchers, in general—Beginning on October 1, 2018, the Secretary shall award a priority review voucher to the sponsor of an application described in section 505(j)(11)(A) upon—
“(1) approval by the Secretary of such application;
“(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; 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; and
“(ii) shall not be collected for any fiscal year except to the extent provided in advance in appropriations Acts.
“(f) Clarification—Nothing in this section affects any period of exclusivity under this Act or the protection of any patent.
“(g) Sunset—The authority of the Secretary to carry out the generic priority review voucher program under this section shall terminate on October 1, 2023.”