Definitions
Priority review
section 379g(1) of this titleThe term “priority review”, with respect to a human drug application as defined in , 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.
Priority review voucher
section 355(b)(1) of this titlesection 262 of title 42The 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 or after the date of approval of the tropical disease product application.
Tropical disease
Tropical disease product application
Priority review voucher
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.
Transferability
section 355(b)(1) of this titlesection 262 of title 42The 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 or will be submitted after the date of the approval of the tropical disease product application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.
Limitation
No award for prior approved application
A sponsor of a tropical disease product may not receive a priority review voucher under this section if the tropical disease product application was submitted to the Secretary prior to .
One-year waiting period
The Secretary shall issue a priority review voucher to the sponsor of a tropical disease product no earlier than the date that is 1 year after .
Notification
The sponsor of a human drug application shall notify the Secretary not later than 90 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.
Priority review user fee
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.
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.
Annual fee setting
The Secretary shall establish, before the beginning of each fiscal year beginning after , for that fiscal year, the amount of the priority review user fee.
Payment
In general
section 355(b)(1) of this titlesection 262 of title 42The priority review user fee required by this subsection shall be due upon the submission of a human drug application under or for which the priority review voucher is used.
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.
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 section.
Offsetting collections
June 25, 1938, ch. 675, § 524Pub. L. 110–85, title XI, § 1102121 Stat. 972Pub. L. 113–233, § 2128 Stat. 2127Pub. L. 114–146, § 2130 Stat. 357Pub. L. 114–255, div. A, title III, § 3101(a)(2)(M)130 Stat. 1154Pub. L. 115–52, title VI, § 611(a)131 Stat. 1054Pub. L. 117–9, § 1(a)(3)135 Stat. 257(, as added , , ; amended , , ; , , ; , , ; , , ; , , .)
Editorial Notes
References in Text
section 101(c) of Pub. L. 110–85section 379g of this titleSection 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in subsec. (a)(1), is , which is set out as a note under .
Amendments
Pub. L. 117–9section 355(b)(1) of this titlesection 262 of title 422021—Subsec. (a)(4)(C). amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “is for a human drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under or .”
Pub. L. 115–522017—Subsec. (a)(4)(A)(iii), (iv). added cls. (iii) and (iv).
Pub. L. 114–146, § 2(2)2016—Subsec. (a)(3)(Q). , substituted “Filovirus Diseases” for “Filoviruses”.
Pub. L. 114–146, § 2(1)Subsec. (a)(3)(R), (S). , (3), added subpar. (R) and redesignated former subpar. (R) as (S).
Pub. L. 114–255section 262 of title 42Subsec. (c)(4)(A). made technical amendment to reference in original act which appears in text as reference to .
Pub. L. 113–233, § 2(1)2014—Subsec. (a)(3)(Q), (R). , added subpar. (Q), redesignated former subpar. (Q) as (R), and in subpar. (R) substituted “order of” for “regulation by”.
Pub. L. 113–233, § 2(2)(A)Subsec. (b)(2). , inserted at end “There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.”
Pub. L. 113–233, § 2(2)(B)Subsec. (b)(4). , substituted “90 days” for “365 days”.
Statutory Notes and Related Subsidiaries
Effective Date of 2017 Amendment
Pub. L. 115–52, title VI, § 611(b)131 Stat. 1054