; and (2) the Secretary shall— (A) expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, for drugs that are developed using the qualified nonclinical testing method; and (B) allow the holder of the qualification or a person authorized by such holder to reference or rely upon, in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including a supplemental application, data and information about the qualification of the nonclinical testing method in the same context of use for which the qualification was granted. (e) Review of applications utilizing qualified nonclinical testing methods The Secretary shall expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act for drugs for which a nonclinical testing method qualified under this section is used. (f) Transparency (1) Submission of report to Congress Not later than 2 years after the date of enactment of this section and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing an evaluation of the process under this section. (2) Contents of report Each report under paragraph (1) shall include— (A) for the period covered by the report— (i) the types of nonclinical testing methods qualified under the process; (ii) the number of requests for qualification under subsection (a), and the number of such requests that have been granted; (iii) the average number of calendar days for the review of requests under subsection (a) before granting or denying such requests; (iv) an analysis of the factors that result in determinations to qualify or not qualify a nonclinical testing method under this section