21 U.S.C. § 360bbb–4a — Priority review to encourage treatments for agents that present national security threats

(a) Definitions (1) "Human drug application" has the same meaning as in section 379g(1) of this title. (2) "Priority review" means the Secretary reviews and acts on a human drug application within 6 months of getting it, following FDA's Manual of Policies and Procedures and the goals in the letters described in section 101(b) of the Food and Drug Administration Safety and Innovation Act. (3) A "priority review voucher" is a voucher the Secretary gives to the sponsor of a "material threat medical countermeasure application." It lets the holder get priority review of one human drug application filed under section 355(b)(1) of this title or section 351(a) of the Public Health Service Act, once the material threat application has been approved. (4) A "material threat medical countermeasure application" is a human drug application that meets all of these: (A) it's for a drug meant either (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, or (ii) to prevent, treat, or lessen harm from a condition that could result from giving a drug or biological product against such an agent; (B) the Secretary decides it qualifies for priority review; (C) it's approved after December 13, 2016; and (D) it's for either (i) a human drug whose active moiety, as the Secretary defines that in 21 CFR 314.3, has never been approved in another application under section 355(b)(1), or (ii) a biological product whose active ingredient has never been approved under section 351 of the Public Health Service Act. (b) Priority review voucher (1) The Secretary must award a priority review voucher to a material threat countermeasure sponsor as soon as that application is approved. (2) The sponsor can transfer — including by selling — the right to use that voucher to a different sponsor, one who will later file a human drug application. A voucher can be transferred any number of times before it's finally used. (3) (A) Before using the voucher, the sponsor planning to use it must tell the Secretary at least 90 days ahead of submitting the human drug application, including the planned submission date. That notice is a binding promise to pay the required fee. (B) A sponsor who has given that notice can still transfer the voucher afterward, as long as it hasn't yet submitted the application. (c) Priority review user fee (1) The Secretary must run a user fee program: a sponsor using a priority review voucher pays this fee on top of any other required fees. (2) Each fiscal year, the Secretary sets the fee amount based on the average cost of reviewing a priority-review human drug application the year before. (3) The Secretary must set that fee before each fiscal year that starts after September 30, 2016. (4) (A) The fee is due when the sponsor submits the application that uses the voucher. (B) The application counts as incomplete if this fee, or any other required fee, isn't paid. (C) The Secretary cannot waive, exempt, reduce, or refund this fee under any circumstance. (5) Fees collected go into the FDA's own appropriations account as offsetting collections, and (6) they can only be spent if an appropriations law allows it for that fiscal year. (d) Notice of issuance of voucher and approval of products under voucher Within 30 days of each of these events, the Secretary must publish a notice in the Federal Register and on the FDA website: (1) issuing a priority review voucher, and (2) approving a drug application that used a voucher. (e) Eligibility for other programs Seeking a voucher under this section doesn't stop a sponsor from also using other incentive programs. But no sponsor can get more than one priority review voucher, under any section of this chapter, for the same drug. (f) Relation to other provisions This section adds to, rather than replaces, other laws that encourage countermeasure development. (g) Sunset The Secretary could not award any new priority review vouchers under subsection (b) after October 1, 2023.