21 U.S.C. § 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 under section 356, or as a device granted review priority under section 360e(d)(5). This designation may happen even before a sponsor or applicant requests it, and even before an application to investigate the drug is filed under section 355(i) or section 262(a)(3) of title 42. Nothing here stops a sponsor or applicant from declining the designation. (b) Use of animal trials. A drug for which approval is sought based on effectiveness evidence drawn from animal studies may still be designated a fast track product under this section. (c) Priority review of drugs and biological products. A priority countermeasure that is a drug or biological product is treated as a priority drug or biological product for purposes of the performance goals for priority products that the Commissioner of Food and Drugs has agreed to. (d) Definitions. "Priority countermeasure" has the meaning given in section 247d–6(h)(4) of title 42. "Priority drugs or biological products" means a drug or biological product that is the subject of an application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997.