; and (B) information on each laboratory identified pursuant to subparagraph (A), including— (i) the name and address of the laboratory; (ii) the CLIA certificate number; (iii) the laboratory type; (iv) the certificate type; and (v) the complexity level. 543. Manufacturer reporting of test distribution (a) In general A commercial manufacturer of an in vitro diagnostic or serological COVID–19 test shall, on a weekly basis, submit a notification to the Secretary regarding distribution of each such test, which notification— (1) shall include the number of tests distributed and the entities to which the tests are distributed; and (2) may include the quantity of such tests distributed by the manufacturer. (b) Confidentiality Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. (c) Failure to meet requirements If a manufacturer fails to submit a notification as required under subsection (a), the following applies: (1) The Secretary shall issue a letter to such manufacturer informing such manufacturer of such failure. (2) Not later than 7 calendar days after the issuance of a letter under paragraph (1), the manufacturer to whom such letter is issued shall submit to the Secretary a written response to such letter— (A) setting forth the basis for noncompliance; and (B) providing information as required under subsection (a). (3) Not later than 14 calendar days after the issuance of a letter under paragraph (1), the Secretary shall make such letter and any response to such letter under paragraph (2) available to the public on the internet website of the Food and Drug Administration, with appropriate redactions made to protect information described in subsection (b). The preceding sentence shall not apply if the Secretary determines that— (A) the letter under paragraph (1) was issued in error