; or (ii) deny the application if the Secretary finds (and sets forth the basis of such finding as part of or accompanying such denial) that one or more grounds for granting the application specified in paragraph (3) are not met. (B) Extension The timeline described in subparagraph (A) may be extended by mutual agreement between the Secretary and the applicant. (2) Deficient applications If, after receipt of an application under this section, the Secretary determines that any portion of such application is deficient, the Secretary, not later than 90 days after receipt of such application, shall provide to the applicant a description of such deficiencies and identify the information required to correct such deficiencies. (3) Approval The Secretary shall grant a technology certification order under this section if, on the basis of the information submitted to the Secretary as part of the application and any other information with respect to such applicant, the Secretary finds that— (A) in accordance with subsection (e)(2)(D), there is a showing of reasonable assurance of analytical validity for all eligible in vitro clinical tests within the proposed scope of the technology certification, as evidenced by the procedures for analytical validation; (B) in accordance with subsection (e)(2)(E), there is a showing of reasonable assurance of clinical validity for all eligible in vitro clinical tests within the proposed scope of the technology certification, as evidenced by the clinical program, including procedures for clinical validation; (C) the methods used in, or the facilities or controls used for, the development of eligible in vitro clinical tests covered by the proposed scope of the technology certification conform to the applicable requirements of section 587J; (D) based on a fair evaluation of all material facts, the applicant’s proposed labeling and advertising is not false or misleading in any particular; (E) the application does not contain a false statement of material fact