; and (2) by adding at the end the following new subclause: (III) Applicant approval The Secretary may approve an application containing a certification described in paragraph (2)(A)(vii)(IV) that is for a drug for which a first applicant has submitted an application containing such a certification, notwithstanding the eligibility of a first applicant for the 180-day exclusivity period described in subclause (II)(aa), if each of the following conditions is met: (aa) The approval of such application could be made effective, but for the eligibility of a first applicant for 180-day exclusivity under this clause. (bb) The applicant of such application has submitted a certification to the abbreviated new drug application that there are no conditions that would prevent the applicant from commercial marketing within 75 days after the date of approval and that the applicant intends to so market the drug. (cc) At least 33 months have passed since the date of submission of an application for the drug by at least one first applicant. (dd) Approval of an application for the drug submitted by at least one first applicant is not precluded under clause (iii). (ee) No application for the drug submitted by any first applicant is effectively approved on the date that the conditions under items (aa), (bb), (cc), and (dd) are all met and maintained. . (b) Special approval status rule for certain subsequent applicants Section 505(j)(5)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355 (j)(5)(D)) is amended at the end by adding the following: (v) Special approval status rule for certain subsequent applicants An application that is approved pursuant to subclause (III) of subparagraph (B)(iv) is deemed to be tentatively approved and to no longer have an effective approval pursuant to such subclause (III) on the date that is 76 days after the date on which the approval has been made effective pursuant to such subclause (III) if the applicant fails to commercially market such drug within the 75-day period after the date on