§ 360n. Priority review to encourage treatments for tropical diseases
(a)
Definitions
In this section:
(1)
Priority review
The term “priority review”, with respect to a human drug application as defined in section
379g
(1) of this title, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.
(2)
Priority review voucher
The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a tropical disease product application that entitles the holder of such voucher to priority review of a single human drug application submitted under section
355
(b)(1) of this title or section
262 of title
42 after the date of approval of the tropical disease product application.
(4)
Tropical disease product application
The term “tropical disease product application” means an application that—
(b)
Priority review voucher
(1)
In general
The Secretary shall award a priority review voucher to the sponsor of a tropical disease product application upon approval by the Secretary of such tropical disease product application.
(2)
Transferability
The sponsor of a tropical disease product that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section
355
(b)(1) of this title or section
262 of title
42 will be submitted after the date of the approval of the tropical disease product application.
(3)
Limitation
(4)
Notification
The sponsor of a human drug application shall notify the Secretary not later than 365 days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application. Such notification shall be a legally binding commitment to pay for the user fee to be assessed in accordance with this section.
(c)
Priority review user fee
(1)
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 paragraph (2). Such fee shall be in addition to any fee required to be submitted by the sponsor under subchapter VII.
(2)
Fee amount
The amount of the priority review user fee shall be determined each fiscal year by the Secretary and based on the average cost incurred by the agency in the review of a human drug application subject to priority review in the previous fiscal year.
(3)
Annual fee setting
The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2007, for that fiscal year, the amount of the priority review user fee.
(4)
Payment
(B)
Complete application
An application described under subparagraph (A) for which the sponsor requests the use of a priority review voucher shall be considered incomplete if the fee required by this subsection and all other applicable user fees are not paid in accordance with the Secretary’s procedures for paying such fees.