U.S. CODE

U.S. Code

§ 356-1. Accelerated approval of priority countermeasures

(a) In general

The Secretary of Health and Human Services may designate a priority countermeasure as a fast-track product pursuant to section 356 of this title or as a device granted review priority pursuant to section 360e (d)(5) of this title. Such a designation may be made prior to the submission of—

(1) a request for designation by the sponsor or applicant; or

(2) an application for the investigation of the drug under section 355 (i) of this title or section 262 (a)(3) of title 42.

Nothing in this subsection shall be construed to prohibit a sponsor or applicant from declining such a designation.

(b) Use of animal trials

A drug for which approval is sought under section 355 (b) of this title or section 262 of title 42 on the basis of evidence of effectiveness that is derived from animal studies pursuant to section 123 ^[1] may be designated as a fast track product for purposes of this section.

A priority countermeasure that is a drug or biological product shall be considered a priority drug or biological product for purposes of performance goals for priority drugs or biological products agreed to by the Commissioner of Food and Drugs.

(d) Definitions

For purposes of this title: ^[1]

(1) The term “priority countermeasure” has the meaning given such term in section 247d–6 (h)(4) of title 42.

(2) The term “priority drugs or biological products” means a drug or biological product that is the subject of a drug or biologics application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.

[1] See References in Text note below.

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