1. Short title This Act may be cited as Leo’s Law . 2. Mitigation of effects of COVID–19 pandemic on orphan-drug development incentives (a) In general In the case of a covered orphan drug, each of the following exclusivity periods is deemed to be extended by 180 days, so long as such period is not expired: (1) The 12-year period referred to in subparagraph (A) of section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ). (2) The 5-year period 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 ). (3) The 3-year period referred to in each of clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ). (4) The 7-year period referred to in section 527(a) of the Federal, Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc ). (5) In the case of a covered orphan drug with one or more certifications specified in clauses (ii), (iii), and (iv) of section 505(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b)(2)(A) ), or in subclauses (II), (III), and (IV) of section 505(j)(2)(A)(vii) of such Act ( 21 U.S.C. 355(j)(2)(A)(vii) ), each corresponding patent-related approval-delay period (other than a patent for which the information required pursuant to subsection (b) or (c) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) has not been filed). (b) Conforming extensions In addition to the periods extended under subsection (a) for a covered orphan drug, the following periods are each deemed to be extended by 180 days: (1) The 4-year period referred to in subparagraph (B) of section 351(k)(7) of the Public 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)