1. Short title This Act may be cited as the FDA Modernization Act 3.0 . 2. Nonclinical testing methods qualification process at the Food and Drug Administration (a) In general Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by inserting after section 507 the following: 507A. Nonclinical testing methods qualification process (a) In general (1) Process description The Secretary shall establish a process for the qualification of a nonclinical testing method, with respect to drugs, under which— (A) persons may request qualification of a nonclinical testing method for a particular context of use; and (B) the Secretary shall grant or deny such request in accordance with this section. (2) Initiation The Secretary shall initiate the process under paragraph (1) not later than 1 year after the date of enactment of this section. (b) Eligible nonclinical testing methods To be eligible for qualification under this section, a nonclinical testing method shall— (1) be intended to replace or reduce animal testing; and (2) either— (A) improve the predictivity of nonclinical testing for safety and efficacy; or (B) reduce development time for a drug (including any biological product). (c) Qualification of nonclinical testing methods (1) Process The Secretary shall establish a process for submission of a request under subsection (a). (2) Contents At a minimum, a request under subsection (a) shall include preliminary information demonstrating that the nonclinical testing method meets the criteria described in subsection (b) in a particular context of use. (3) Advice regarding the method of nonclinical testing The Secretary may facilitate the development and review of preliminary information submitted pursuant to paragraph (2) in a request under subsection (a) by— (A) providing timely advice to, and interaction with, the person submitting the request regarding the development of the method of nonclinical testing