; and (v) the specimens are provided to the investigators without personally identifiable information and the supplier of the specimens has established policies and procedures to prevent the release of personally identifiable information. (d) Review of applications (1) In general The Secretary may issue an order approving an investigation as proposed, approving it with conditions or modifications, or disapproving it. (2) Failure to act Unless the Secretary, not later than the date that is 30 calendar days after the date of the submission of an investigational use application that meets the requirements of subsection (c)(2), issues an order under subsection (d)(1) and notifies the sponsor submitting the application, the application shall be treated as approved as of such date without further action by the Secretary. (3) Disapproval The Secretary may disapprove an investigational use application submitted under this subsection if the Secretary determines that the investigation with respect to which the application is submitted does not conform to the requirements of subsection (c)(3). A listing of such disapproval submitted to the sponsor with respect to such an application shall contain the order of disapproval and a complete statement of the reasons for the Secretary’s disapproval of the application. (e) Withdrawal of approval (1) In general The Secretary may, by administrative order, withdraw the approval of an exemption granted under this section with respect to an in vitro clinical test, including an exemption granted based on the Secretary’s failure to act pursuant to subsection (d)(2), if the Secretary determines that the test does not meet the applicable conditions under subsection (c)(3) for such approval. (2) Opportunity to be heard (A) In general Subject to subparagraph (B), an order withdrawing the approval of an exemption granted under this section may be issued only after the Secretary provides the applicant or sponsor of the test with an opportunity for an informal hearing. (B) Exception An order