; or (2) the test is exempt under section 587A from premarket review under this section. (b) Transparency and predictability (1) Pre-submission meeting or request for informal feedback Pursuant to section 587H, prior to filing an application under subsection (c) or (d), any person may request a meeting or written correspondence with the Secretary to discuss the eligibility of an in vitro clinical test for premarket review or other information related to the filing of an application. The Secretary shall respond to such request within 45 calendar days. (2) Streamlining of applications (A) Premarket application and technology certification If a person files a premarket application under this section and provides any additional documentation required under section 587D, the in vitro clinical test that is the subject of the application may be utilized as the representative test reviewed by the Secretary to provide an approval for both a premarket application under this section and a technology certification order under section 587D. (B) Representative assays for premarket approval With respect to a technology certification application filed under section 587D, the representative test, as described in subparagraph (A), used to issue a technology certification order under section 587D shall be deemed a test with premarket approval under this section. (c) Application (1) Filing Any person may file with the Secretary an application for premarket approval of an in vitro clinical test. (2) Application content An application submitted under paragraph (1) with respect to an in vitro clinical test shall include the following, in such format as the Secretary specifies: (A) General information regarding the in vitro clinical test, including— (i) the name and address of the applicant; (ii) the table of contents for the application and the identification of the information the applicant claims as trade secret or confidential commercial or financial information; (iii) a description of the test’s intended use