21 USC 360 - Priority review to encourage treatments for agents that present national security threats

View all text of Part E [§ 360bbb - § 360bbb-8d]

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

(a) DefinitionsIn this section:

(1) Human drug application

(2) Priority review

(3) Priority review voucher

(4) Material threat medical countermeasure applicationThe 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;

(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) Priority review voucher

(1) In general

(2) Transferability

(3) Notification

(A) In general

(B) Transfer after notice

(1) In general

(2) Fee amount

(3) Annual fee setting

(4) Payment

(A) In general

(B) Complete application

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

(A)1

1 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)2

2 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) Notice of issuance of voucher and approval of products under voucherThe 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) Eligibility for other programs

(f) Relation to other provisions

(g) Sunset

(June 25, 1938, ch. 675, § 565A, as added Pub. L. 114–255, div. A, title III, § 3086, Dec. 13, 2016, 130 Stat. 1144; Pub. L. 117–9, § 1(a)(5), Apr. 23, 2021, 135 Stat. 258.)