; and (II) any proposed restrictions, mitigating measures, or conditions of approval under section 587B(e)(2)(B), as applicable; or (ii) provide a notification to the applicant that the accredited person cannot find that the criteria for approval of the application under section 587B(e)(2)(A) are met and the reasons for such decision. (B) Requesting missing or clarifying information After receipt of an application from an accredited person under this section, the Secretary may request missing or clarifying information from the applicant concerning the application, which the accredited person shall promptly provide. (C) Secretary action on recommendation that approval criteria are met If the accredited person transmits a recommendation to the Secretary under subparagraph (A)(i), then prior to the date that is 45 calendar days after the transmittal date, the Secretary shall consider such recommendation and make a determination to— (i) approve the application for premarket approval under section 587B(e)(2) with appropriate restrictions, mitigating measures, or conditions of approval, as applicable; or (ii) deny approval of the application by issuing a written notice that reflects appropriate management input and concurrence to the accredited person and the applicant detailing the scientific basis for the Secretary’s determination that the criteria for issuance of an approval under section 587B(e)(2)(A) have not been met. (D) Effect of inaction on recommendation If the Secretary fails to take an action under subparagraph (C) the Secretary shall— (i) within 45 calendar days after the transmittal date, provide written feedback to the applicant that— (I) includes all outstanding issues with the application preventing the Secretary from taking an action under subparagraph (B); (II) reflects appropriate management input and concurrence