notify the Secretary in writing of the reasons for the recommendation concerning the application. (ii) Time period for review Not later than 30 calendar days after the date on which the Secretary is notified of a recommendation under this section with respect to an application for premarket approval or technology certification, the Secretary shall make a determination with respect to the application. (C) Lack of applications within 2-year timeframe If the Secretary does not receive applications from persons that meet the criteria under subsection (c) within such period, the Secretary— (i) may accredit persons under this paragraph after the 2-year period described in subparagraph (A)