; (3) in the case of a complex product, assigning a cross-disciplinary project lead for the review team to facilitate an efficient review of the development program and application, including manufacturing inspections; and (4) in the case of a complex product, including drug-device combinations, involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review. (e) Reporting requirement A sponsor of a drug expedited under this section shall report to the Secretary, one year following approval of an application under section 505(j), on whether the approved drug has been marketed in interstate commerce since approval. . 202. List of generic drugs with limited competition Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq.) is amended by inserting after section 506H, as added by section 201, the following: 506I. Drug listing (a) Removal, withdrawal, or transfer The holder of an application approved under subsection (b) or (j) of section 505 shall notify the Secretary within 180 days of removing the drug that is the subject of such application from interstate commerce, withdrawing such approved application, or transferring such approved application, and a reason for such removal, withdrawal, or transfer. If compliance with this subsection within such 180-day period is not practicable, then the holder shall comply as soon as practicable. The Secretary shall cross-reference information listed pursuant to section 506C where applicable to avoid duplicative reporting. Notification to the Secretary by a manufacturer in accordance with section 506C(a) shall be deemed to be in compliance with this section. (b) Drugs with limited competition (1) Information The Secretary shall— (A) maintain information with respect to applications approved under section 505(j); and (B) publish on the Internet website of the Food and Drug Administration such information under subparagraph (A) with respect to drugs for which there are 3 or fewer application holders