section 505(j) or a new drug application approved under section 505(c) that seeks to transfer manufacturing of one or more finished dosage forms of a drug or one or more active pharmaceutical ingredients therein from one or more foreign establishments to one or more new or existing domestic establishments. (b) Before supplemental application submission (1) Development and pre-submission After an applicant submits a meeting request with respect to expedited review and approval of a supplemental application pursuant to subsection (a), the Secretary shall— (A) not later than 30 days after receiving such request, conduct a meeting with the applicant to— (i) discuss the information necessary to approve the supplemental application