; or (II) if the procedures were not changed, an explanation as to why they were not changed; and (iv) if such a change necessitates a change to the procedures reviewed as part of the granted technology certification order, data from a representative in vitro clinical test or tests that support a showing that, in using the modified procedures, all eligible in vitro clinical tests within the scope of the technology certification will meet the applicable standard. (f) Temporary hold (1) In general Subject to the process specified in paragraph (2), and based on one or more findings under paragraph (4), the Secretary may issue a temporary hold prohibiting any holder of a technology certification order issued under this section from introducing into interstate commerce an in vitro clinical test that was not previously the subject of a listing under section 587J. The temporary hold shall identify the grounds for the temporary hold under paragraph (4) and the rationale for such finding. (2) Process for issuing a temporary hold If the Secretary makes a finding that a temporary hold may be warranted based on one or more grounds specified in paragraph (4), the Secretary shall promptly notify the holder of the technology certification order of such finding and provide 30 calendar days for the developer to come into compliance with or otherwise resolve the finding. (3) Written requests Any written request to the Secretary from the holder of a technology certification order that a temporary hold under paragraph (1) be removed shall receive a decision, in writing and specifying the reasons therefore, within 90 days after receipt of such request. Any such request shall include information to support the removal of the temporary hold. (4) Grounds for temporary hold The Secretary may initiate a temporary hold under this subsection upon a finding that the holder of a technology certification order— (A) is not in compliance with the conditions of the technology certification order pursuant to subsection (b)(1)(D)