; (ii) the scientific soundness of a plan submitted under subsection (c)(5); or (iii) the rights, safety, or welfare of the human subjects (if any) 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 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 or sponsor may immediately appeal any such determination pursuant to section 587O. (2) Determination For purposes of paragraph (1), a determination described in this subparagraph with respect to a clinical hold is a determination that— (A) 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) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish