21 USC 360bbb-4a - Priority review to encourage treatments for agents that present national security threats

U.S Code last checked for updates: Nov 22, 2024

§ 360bbb–4a.

Priority review to encourage treatments for agents that present national security threats

(a)

Definitions

In this section:

(1)

Human drug application

(2)

Priority review

(3)

Priority review voucher

(4)

Material threat medical countermeasure application

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)

Priority review voucher

(1)

In general

(2)

Transferability

(3)

Notification

(A)

In general

(B)

Transfer after notice

(c)

Priority review user fee

(1)

In general

(2)

Fee amount

(3)

Annual fee setting

(4)

Payment

(A)

In general

(B)

Complete application

(C)

No waivers, exemptions, reductions, or refunds

(5)

Offsetting collections

Fees collected pursuant to this subsection for any fiscal year—

(A)

 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)

 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 voucher

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)

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.)

cite as: 21 USC 360bbb-4a