; or (D) the availability of which is in the best interest of patients or public health. (d) Designation (1) Request To receive breakthrough designation under this section, an applicant may request that the Secretary designate the in vitro clinical test for expedited development and priority review. Any such request for designation may be made at any time prior to, or at the time of, the submission of an application under section 587B or 587D, and shall include information demonstrating that the test meets the criteria described in subsection (c). (2) Determination Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether the in vitro clinical test that is the subject of the request meets the criteria described in subsection (c). If the Secretary determines that the test meets the criteria, the Secretary shall designate the test for expedited development and priority review. (3) Review Review of a request under paragraph (1) shall be undertaken by a team that is composed of experienced staff and senior managers of the Food and Drug Administration. (4) Withdrawal (A) In general The designation of an in vitro clinical test under this subsection is deemed to be withdrawn, and such in vitro clinical test shall no longer be eligible for designation under this section, if an application for approval for such test under section 587B or 587D is denied. Such test shall be eligible for breakthrough designation upon a new request for such designation. (B) Exception The Secretary may not withdraw a designation granted under this subsection based on the subsequent approval or technology certification of another in vitro clinical test that— (i) is designated under this section