; (B) an application under section 505(b) of the Federal Food, Drug, and Cosmetic Act or under section 351(a) of the Public Health Service Act (or a supplemental application, as the case may be) is approved pursuant to the investigational new drug application referred to in paragraph (1); and (C) there is no approved indication that is not for a rare disease or condition. (2) The term corresponding patent-related approval delay period , with respect to a covered orphan drug, means the period ending with the last applicable date for the approval of an application within the meaning of subparagraph (A), (B), or (C) of section 505(c)(3) of the Federal, Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(c)(3) ), or clause (i), (ii), or (iii) of section 505(j)(5)(B) of such Act ( 21 U.S.C. 355(j)(5)(B) ), whichever applies pursuant to the applicable patent certification. (3) The term orphan drug means a drug that the Secretary has designated as a drug for a rare disease or condition under section 526(a) of the Federal, Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb(a) ). (4) The term COVID–19 emergency period means the period beginning on December 1, 2019, and ending on the date that is not later than 120 days before the date on which the emergency period (as defined in section 1135(g)(1)(B) of the Social Security Act ( 42 U.S.C. 1320b–5(g)(1)(B) )) terminates. (5) The term rare disease or condition has the meaning given such term in section 526 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bb ). (d) Effective date This section takes effect upon the date of the enactment of this Act, without regard to whether the Secretary has issued guidance or regulations regarding the implementation of this Act.