; (ii) a description of actions taken to the date of submission of the report to promulgate each such regulations; (iii) the expected timeline for promulgating each such regulations; (iv) an assessment of the impact of the delay in promulgating such regulations on developers of in vitro clinical tests, including an economic assessment; and (v) an assessment of the impact of the delay in promulgating such regulations on patients; and (B) open a public docket for purposes of soliciting public comments on the impact of the delay in promulgating such regulations. (b) Application of authorities to in vitro clinical tests under review on the effective date of this act For any in vitro clinical test for which a submission for approval under section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e ), clearance under section 510(k) of such Act ( 21 U.S.C. 360(k) ), authorization under section 513(f)(2) of such Act ( 21 U.S.C. 360c(f)(2) ), or licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) is pending on the effective date of this Act, including transitional in vitro clinical tests as described in subsection (c), the Secretary may review and take action on such submission after the effective date of this Act according to the statutory provision under which such submission was submitted. (c) Application of authorities to transitional In vitro clinical tests (1) Definition For purposes of this section, the term transitional in vitro clinical test means an in vitro clinical test that— (A) (i) is first offered for clinical use during the period beginning on the date that is 45 days after the date of enactment of this Act and ending on the effective date of this Act; or (ii) is offered solely for investigational use during the period beginning on the date of enactment of this Act and ending on the effective date of this Act