; and (ii) within 3 years of the date of enactment of this Act, promulgate final regulations required under the amendments made by this Act; and (B) may take additional actions after the date of enactment that the Secretary determines necessary to ensure an orderly transition, including— (i) establishment of mitigating measures for an in vitro clinical test or category of in vitro clinical tests, which may not take effect until after the effective date described in paragraph (1)(A); and (ii) establishment of the comprehensive test information system under section 587T of the Federal Food, Drug, and Cosmetic Act, as added by section 3. (3) Applicability of guidance and regulations Notwithstanding the date on which guidance or regulations are issued under paragraph (2) and section 587K of the Federal Food, Drug, and Cosmetic Act, as added by section 3, no guidance or regulations issued pursuant to the amendments made by this Act shall be implemented or take effect until the effective date of this Act, except as otherwise specified in this Act (including the amendments made by this Act). (4) Implementation requirements In the event that the Secretary fails to promulgate the regulations required under section 587B(a)(4), 587D(j), or 587S(b)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 3, by the deadline described in subsection (a)(2)(A)(ii), the Secretary shall, within 15 days of such missed deadline— (A) submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives providing information related to the status of such regulations, including— (i) a rationale for missing the applicable deadline described in such subsection; (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