; or (ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially. ; (2) by redesignating paragraphs (5) through (12) as paragraphs (6) through (13), respectively; and (3) by inserting after paragraph (4) the following: (5) The term contract manufacturing organization facility means a manufacturing facility of a finished dosage form of a drug approved pursuant to an abbreviated new drug application, where such manufacturing facility is not identified in an approved abbreviated new drug application held by the owner of such facility or an affiliate of such owner or facility. . 303. Authority to assess and use human generic drug fees (a) Types of fees Section 744B(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–42(a) ) is amended— (1) in the matter preceding paragraph (1), by striking fiscal year 2013 and inserting fiscal year 2018 ; (2) in paragraph (1), by adding at the end the following: (E) Sunset This paragraph shall cease to be effective October 1, 2022. ; (3) in paragraph (2)— (A) by amending subparagraph (C) to read as follows: (C) Notice Not later than 60 days before the start of each of fiscal years 2018 through 2022, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year. ; and (B) in subparagraph (E)— (i) in clause (i)— (I) by striking no later than the date and inserting “on the earlier of— (I) the date ; (II) by striking the period and inserting ; or ; and (III) by adding at the end the following: (II) the date on which the drug master file holder requests the initial completeness assessment. ; and (ii) in clause (ii), by striking notice provided for in clause (i) or (ii) of subparagraph (C), as applicable and inserting notice provided for in subparagraph (C) ; (4) in paragraph (3)— (A) in the heading, by striking and prior approval supplement ; (B) in subparagraph (A), by striking or a prior approval supplement to an abbreviated new drug application