; or (iii) the rights, safety, or welfare of the human subjects involved in the investigation. (g) Clinical hold (1) In general At any time, the Secretary may impose a clinical hold with respect to an investigation of an in vitro clinical test if the Secretary makes a written determination described in paragraph (2). The Secretary shall, in imposing such clinical hold, specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing. The applicant may immediately appeal any such determination pursuant to section 587P. (2) Determination (A) In general For purposes of paragraph (1), a determination described in this subparagraph with respect to a clinical hold is a determination that, based on credible evidence, the in vitro clinical test involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the in vitro clinical test, the design of the clinical investigation, the condition for which the in vitro clinical test is to be investigated, and the health status of the subjects involved. (B) Removal of clinical hold Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold. 587T. Comprehensive test information system (a) Establishment Not later than 2 years after the date of enactment of the VALID Act of 2023 , the Secretary shall make available a comprehensive test information system for in vitro clinical tests that is designed to— (1) provide a transparent interface on the website of the Food and Drug Administration for stakeholders, to the extent permitted by applicable law,