Health Service Act ( 42 U.S.C. 262(k)(7) ). (2) The 4-year, 48-month, and 7 and one-half-year periods referred to in subsection (c)(3)(E)(ii) and subsection (j)(5)(F)(ii) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ). (c) Definitions In this section: (1) The term covered orphan drug means an orphan drug for which— (A) an application is submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ) during the COVID–19 emergency period (without regard to whether the same applicant has submitted such applications for the same drug before December 1, 2019, for a different rare disease or condition)