; (ii) to review the progress of the investigation involved; and (iii) to evaluate the ability to meet the applicable standard. (4) Conditions for exemption An application for an investigational use exemption with respect to a significant risk study shall be granted if each of the following conditions is met: (A) The risks to the subjects of the in vitro clinical test are outweighed by the anticipated benefits of the test to the subjects and the importance of the knowledge to be gained, and adequate assurance of informed consent is provided in accordance with paragraphs (6)(B) and (6)(C). (B) The proposed labeling for the in vitro clinical test involved clearly and conspicuously states For investigational use only . (C) Such other requirements the Secretary determines— (i) are necessary for the protection of the public health and safety; and (ii) do not unduly delay investigation. (5) Coordination with investigational new drug applications Any requirement for the submission of a report to the Secretary pursuant to an application for an investigational new drug exemption involving an in vitro clinical test shall supersede the reporting requirement under paragraph (3)(B), but only to the extent the requirement with respect to the application for exemption with respect to the drug is duplicative of the reporting requirement under such paragraph. (6) Investigational plan, procedures, and conditions With respect to an investigational plan submitted under paragraph (3), the sponsor submitting such plan shall— (A) promptly notify the Secretary of the approval or the suspension or termination of the approval of such plan by an institutional review committee