(a) Process for qualification (1) In general The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which- (A) (i) a requestor initiates such process by submitting a letter of intent to the Secretary; and (ii) the Secretary accepts or declines to accept such letter of intent; (B) (i) if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and (ii) the Secretary accepts or declines