§360bbb–4a — Title 21 Food and Drugs | U.S. Code

Summary

Grants a special “priority review” voucher to the sponsor when the FDA approves a qualifying medical countermeasure. The voucher lets the holder get a single human drug application reviewed and acted on by the FDA within 6 months. A human drug application is the FDA’s filing for a new drug. Priority review means review and action within 6 months. A priority review voucher is the document that gives one fast review. A material threat medical countermeasure application is a drug or biologic meant to prevent or treat harm from agents officially named a material threat, or harm from a treatment given against such an agent; the FDA must find it eligible, it must be approved after December 13, 2016, and it must be for a new active moiety or ingredient not previously approved. The FDA gives the voucher when it approves the qualifying application. The voucher can be transferred or sold any number of times before use. A sponsor who plans to use a voucher must tell the FDA at least 90 days before submitting the human drug application and must pay a special priority review fee. The FDA sets that fee each fiscal year before the fiscal year begins (after September 30, 2016) based on past review costs. The fee is due when the application is filed, cannot be waived, and the application is incomplete if the fee is not paid. The FDA must publish notice within 30 days when a voucher is issued and when it is used for an approved drug. No sponsor may get more than one voucher for the same drug, the program adds to other incentive programs, and no new vouchers may be awarded after October 1, 2023.

Title 21, §360bbb–4a

Food and Drugs — Source: USLM XML via OLRC

(a)In this section:

(1)The term “human drug application” has the meaning given such term in section 379g(1) of this title.

(2)The term “priority review”, with respect to a human drug application, 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 in the Food and Drug Administration and goals identified in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act.

(3)The term “priority review voucher” means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure 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 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] after the date of approval of the material threat medical countermeasure application.

(4)The term “material threat medical countermeasure application” means an application that—

(A)is a human drug application for a drug intended for use—

(i)to prevent, or treat harm from a biological, chemical, radiological, or nuclear agent identified as a material threat under section 319F–2(c)(2)(A)(ii) of the Public Health Service Act [42 U.S.C. 247d–6b(c)(2)(A)(ii)]; or

(ii)to mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, or biological product against such agent; and

(B)the Secretary determines eligible for priority review;

(C)is approved after December 13, 2016; and

(D)is for—

(i)a human drug, no active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)) of which has been approved in any other application under section 355(b)(1) of this title; or

(ii)a biological product, no active ingredient of which has been approved in any other application under section 351 of the Public Health Service Act [42 U.S.C. 262].

(b)(1)The Secretary shall award a priority review voucher to the sponsor of a material threat medical countermeasure application upon approval by the Secretary of such material threat medical countermeasure application.

(2)The sponsor of a material threat medical countermeasure application 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 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] will be submitted after the date of the approval of the material threat medical countermeasure application. There is no limit on the number of times a priority review voucher may be transferred before such voucher is used.

(3)(A)The sponsor of a human drug application shall notify the Secretary not later than 90 calendar 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.

(B)The sponsor of a human drug application that provides notification of the intent of such sponsor to use the voucher for the human drug application under subparagraph (A) may transfer the voucher after such notification is provided, if such sponsor has not yet submitted the human drug application described in the notification.

(c)(1)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)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)The Secretary shall establish, before the beginning of each fiscal year beginning after September 30, 2016, for that fiscal year, the amount of the priority review user fee.

(4)(A)The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the priority review voucher is used.

(B)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.

(C)The Secretary may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section.

(5)Fees collected pursuant to this subsection for any fiscal year—

(A)11 So in original. No subpar. (B) has been enacted. shall be deposited and credited as offsetting collections to the account providing appropriations to the Food and Drug Administration; and

(6)22 So in original. Probably should be designated as subpar. (B). shall not be collected for any fiscal year except to the extent provided in advance in appropriation Acts.

(d)The Secretary shall publish a notice in the Federal Register and on the Internet website of the Food and Drug Administration not later than 30 calendar days after the occurrence of each of the following:

(1)The Secretary issues a priority review voucher under this section.

(2)The Secretary approves a drug pursuant to an application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for which the sponsor of the application used a priority review voucher issued under this section.

(e)Nothing in this section precludes a sponsor who seeks a priority review voucher under this section from participating in any other incentive program, including under this chapter, except that no sponsor of a material threat medical countermeasure application may receive more than one priority review voucher issued under any section of this chapter with respect to such drug.

(f)The provisions of this section shall supplement, not supplant, any other provisions of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] that encourage the development of medical countermeasures.

(g)The Secretary may not award any priority review vouchers under subsection (b) after October 1, 2023.

Notes & Related Subsidiaries

Editorial Notes

References in Text

section 101(b) of the Food and Drug Administration Safety and Innovation Act, referred to in subsec. (a)(2), is section 101(b) of Pub. L. 112–144, which is set out as a note under section 379g of this title. The Public Health Service Act, referred to in subsec. (f), is act July 1, 1944, ch. 373, 58 Stat. 682, which is classified generally to chapter 6A (§ 201 et seq.) of Title 42, The Public Health and Welfare. For complete classification of this Act to the Code, see

Short Title

note set out under section 201 of Title 42 and Tables.

Amendments

2021—Subsec. (a)(4)(D). Pub. L. 117–9 amended subpar. (D) generally. Prior to amendment, subpar. (D) 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 section 355(b)(1) of this title or section 351(a) of the Public Health Service Act.”

§360bbb–4a Priority review to encourage treatments for agents that present national security threats