21 U.S.C. § 356-1 : US Code - Section 356-1: Accelerated approval of priority countermeasures

Search 21 U.S.C. § 356-1 : US Code - Section 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.
(c) Priority review of drugs and biological products
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.