Sec. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES
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## SEC. 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”; #####
(C)by amending subparagraphs
(B)and
(C)to read as follows: > > ##### “(B) 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 fees under subparagraph
(A)for such fiscal year. > > > ##### “(C) Fee due date > > The fees required by subparagraphs
(A)and
(F)shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.” > ; #####
(D)in subparagraph (D)— ######
(i)in the heading, by inserting “, is withdrawn prior to being received, or is no longer received” after “received”; and ######
(ii)by striking “ The Secretary shall ” and all that follows through the period and inserting the following: > > ###### “(i) Applications not considered to have been received and applications withdrawn prior to being received > > The Secretary shall refund 75 percent of the fee paid under subparagraph
(A)for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 505(j)(5)(A) for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 505(j)(5)(A). > > > ###### “(ii) Applications no longer received > > The Secretary shall refund 100 percent of the fee paid under subparagraph
(A)for any abbreviated new drug application if the Secretary initially receives the application under section 505(j)(5)(A) and subsequently determines that an exclusivity period for a listed drug should have prevented the Secretary from receiving such application, such that the abbreviated new drug application is no longer received within the meaning of section 505(j)(5)(A).” > ; #####
(E)in subparagraph (E), by striking “or prior approval supplement”; and #####
(F)in the matter preceding clause
(i)of subparagraph (F)— ######
(i)by striking “2012” and inserting “2017”; and ######
(ii)by striking “subsection (d)(3)” and inserting “subsection (d)(2)”; ####
(5)in paragraph (4)— #####
(A)in subparagraph (A)— ######
(i)in the matter preceding clause
(i)and in clause (iii), by striking “, or intended to be identified, in at least one generic drug submission that is pending or” and inserting “in at least one generic drug submission that is”; ######
(ii)in clause (i), by striking “or intended to be identified in at least one generic drug submission that is pending or” and inserting “in at least one generic drug submission that is”; ######
(iii)in clause (ii), by striking “produces,” and all that follows through “such a” and inserting “is identified in at least one generic drug submission in which the facility is approved to produce one or more active pharmaceutical ingredients or in a Type II active pharmaceutical ingredient drug master file referenced in at least one such”; and ######
(iv)in clause (iii), by striking “to fees under both such clauses” and inserting “only to the fee attributable to the manufacture of the finished dosage forms”; and #####
(B)by amending subparagraphs
(C)and
(D)to read as follows: > > ##### “(C) Notice > > Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph
(A)for such fiscal year. > > > ##### “(D) Fee due date > > For each of fiscal years 2018 through 2022, the fees under subparagraph
(A)for such fiscal year shall be due on the later of— > > > ###### “(i) > > the first business day on or after October 1 of each such year; or > > > ###### “(ii) > > the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section for such year.” > ; ####
(6)by redesignating paragraph
(5)as paragraph (6); and ####
(7)by inserting after paragraph
(4)the following: > > #### “(5) Generic drug applicant program fee > > > ##### “(A) In general > > A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E). > > > ##### “(B) Amount > > The amount of fees established under subparagraph
(A)shall be established under subsection (d). > > > ##### “(C) Notice > > Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph
(A)for such fiscal year. > > > ##### “(D) Fee due date > > For each of fiscal years 2018 through 2022, the fees under subparagraph
(A)for such fiscal year shall be due on the later of— > > > ###### “(i) > > the first business day on or after October 1 of each such fiscal year; or > > > ###### “(ii) > > the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section for such fiscal year.” > . ###
(b)Fee Revenue Amounts Section 744B(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is amended— ####
(1)in paragraph (1)— #####
(A)in subparagraph (A)— ######
(i)in the heading, by striking “2013” and inserting “2018”; ######
(ii)by striking “2013” and inserting “2018”; ######
(iii)by striking “$299,000,000” and inserting “$493,600,000”; and ######
(iv)by striking “Of that amount” and all that follows through the end of clause (ii); and #####
(B)in subparagraph (B)— ######
(i)in the heading, by striking “2014 through 2017” and inserting “2019 through 2022”; ######
(ii)by striking “2014 through 2017” and inserting “2019 through 2022”; ######
(iii)by striking “paragraphs
(2)through (4)” and inserting “paragraphs
(2)through (5)”; and ######
(iv)by striking “$299,000,000” and inserting “$493,600,000”; and ####
(2)in paragraph (2)— #####
(A)in the matter preceding subparagraph (A)— ######
(i)by striking “paragraph (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each of fiscal years 2014 through 2017” and inserting “such paragraph for a fiscal year”; and ######
(ii)by striking “through (4)” and inserting “through (5)”; #####
(B)in subparagraph (A), by striking “Six percent” and inserting “Five percent”; #####
(C)by amending subparagraphs
(B)and
(C)to read as follows: > > ##### “(B) > > Thirty-three percent shall be derived from fees under subsection (a)(3) (relating to abbreviated new drug applications). > > > ##### “(C) > > Twenty percent shall be derived from fees under subsection (a)(4)(A)(i) (relating to generic drug facilities). The amount of the fee for a contract manufacturing organization facility shall be equal to one-third the amount of the fee for a facility that is not a contract manufacturing organization facility. The amount of the fee for a facility located outside the United States and its territories and possessions shall be $15,000 higher than the amount of the fee for a facility located in the United States and its territories and possessions.” > ; #####
(D)in subparagraph (D)— ######
(i)by striking “Fourteen percent” and inserting “Seven percent”; ######
(ii)by striking “not less than $15,000 and not more than $30,000” and inserting “$15,000”; and ######
(iii)by striking “, as determined” and all that follows through the period at the end and inserting a period; and #####
(E)by adding at the end the following: > > ##### “(E) > > > ######
(i)> > Thirty-five percent shall be derived from fees under subsection (a)(5) (relating to generic drug applicant program fees). For purposes of this subparagraph, if a person has affiliates, a single program fee shall be assessed with respect to that person, including its affiliates, and may be paid by that person or any one of its affiliates. The Secretary shall determine the fees as follows: > > > ###### “(I) > > If a person (including its affiliates) owns at least one but not more than 5 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a small business generic drug applicant program fee equal to one-tenth of the large size operation generic drug applicant program fee. > > > ###### “(II) > > If a person (including its affiliates) owns at least 6 but not more than 19 approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a medium size operation generic drug applicant program fee equal to two-fifths of the large size operation generic drug applicant program fee. > > > ###### “(III) > > If a person (including its affiliates) owns 20 or more approved abbreviated new drug applications on the due date for the fee under this subsection, the person (including its affiliates) shall be assessed a large size operation generic drug applicant program fee. > > > ###### “(ii) > > For purposes of this subparagraph, an abbreviated new drug application shall be deemed not to be approved if the applicant has submitted a written request for withdrawal of approval of such abbreviated new drug application by April 1 of the previous fiscal year.” > . ###
(c)Adjustments Section 744B(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended— ####
(1)in paragraph (1)— #####
(A)by striking “2014” and inserting “2019”; #####
(B)by inserting “to equal the product of the total revenues established in such notice for the prior fiscal year multiplied” after “a fiscal year,”; and #####
(C)by striking the flush text following subparagraph (C); and ####
(2)in paragraph (2)— #####
(A)by striking “2017” each place it appears and inserting “2022”; #####
(B)by striking “the first 3 months of fiscal year 2018” and inserting “the first 3 months of fiscal year 2023”; and #####
(C)by striking “Such fees may only be used in fiscal year 2018.”. ###
(d)Annual fee setting Section 744B(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)) is amended— ####
(1)by striking paragraphs
(1)and
(2)and inserting the following: > > #### “(1) Fiscal years 2018 through 2022 > > Not more than 60 days before the first day of each of fiscal years 2018 through 2022, the Secretary shall establish the fees described in paragraphs
(2)through
(5)of subsection (a), based on the revenue amounts established under subsection
(b)and the adjustments provided under subsection (c).” > ; ####
(2)by redesignating paragraph
(3)as paragraph (2); and ####
(3)in paragraph
(2)(as so redesignated), in the matter preceding subparagraph (A), by striking “fees under paragraphs
(1)and (2)” and inserting “fee under paragraph (1)”. ###
(e)Identification of Facilities Section 744B(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f)) is amended— ####
(1)by striking paragraph (1); ####
(2)by redesignating paragraphs
(2)through
(4)as paragraphs
(1)through (3), respectively; ####
(3)in paragraph
(1)(as so redesignated)— #####
(A)by striking “paragraph (4)” and inserting “paragraph (3)”; and #####
(B)by striking “Such information shall” and all that follows through the end of subparagraph
(B)and inserting “Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year.”; and ####
(4)in paragraph (2), as so redesignated— #####
(A)in the heading, by striking “Contents of notice” and inserting “Information required to be submitted”; #####
(B)in the matter preceding subparagraph (A), by striking “paragraph (2)” and inserting “paragraph (1)”; #####
(C)in subparagraph (A), by striking “or intended to be identified”; #####
(D)in subparagraph (D), by striking “and” at the end; #####
(E)in subparagraph (E), by striking the period and inserting “; and”; and #####
(F)by adding at the end the following: > > ##### “(F) > > whether the facility is a contract manufacturing organization facility.” > . ###
(f)Effect of Failure To Pay Fees Section 744B(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(g)) is amended— ####
(1)in paragraph (1), by adding at the end the following: “This paragraph shall cease to be effective on October 1, 2022.”; ####
(2)in paragraph (2)(C)(ii), by striking “of 505(j)(5)(A)” and inserting “of section 505(j)(5)(A)”; and ####
(3)by adding at the end the following: > > #### “(5) Generic drug applicant program fee > > > ##### “(A) In general > > A person who fails to pay a fee as required under subsection (a)(5) by the date that is 20 calendar days after the due date, as specified in subparagraph
(D)of such subsection, shall be subject to the following: > > > ###### “(i) > > The Secretary shall place the person on a publicly available arrears list. > > > ###### “(ii) > > Any abbreviated new drug application submitted by the generic drug applicant or an affiliate of such applicant shall not be received, within the meaning of section 505(j)(5)(A). > > > ###### “(iii) > > All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded under section 502(aa). > > > ##### “(B) Application of penalties > > The penalties under subparagraph
(A)shall apply until the fee required under subsection (a)(5) is paid.” > . ###
(g)Limitations Section 744B(h)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(h)(2)) is amended by striking “for Type II active pharmaceutical ingredient drug master files, abbreviated new drug applications and prior approval supplements, and generic drug facilities and active pharmaceutical ingredient facilities”. ###
(h)Crediting and Availability of Fees Section 744B(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(i)) is amended— ####
(1)in paragraph (2)— #####
(A)in subparagraph (A), by striking “subparagraphs
(C)and (D)” and inserting “subparagraph (C)”; #####
(B)by striking subparagraph
(C)(relating to fee collection during first program year); #####
(C)in subparagraph (D)— ######
(i)in the heading, by striking “in subsequent years”; and ######
(ii)by striking “(after fiscal year 2013)”; and #####
(D)by redesignating subparagraph
(D)as subparagraph (C); and ####
(2)in paragraph (3), by striking “fiscal years 2013 through 2017” and inserting “fiscal years 2018 through 2022”. ###
(i)Information on Abbreviated New Drug Applications Owned by Applicants and Their Affiliates Section 744B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42) is amended by adding at the end the following: > > ### “(o) Information on Abbreviated New Drug Applications Owned by Applicants and Their Affiliates > > > #### “(1) In general > > By April 1 of each year, each person that owns an abbreviated new drug application, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Secretary a list of— > > > ##### “(A) > > all approved abbreviated new drug applications owned by such person; and > > > ##### “(B) > > if any affiliate of such person also owns an abbreviated new drug application, all affiliates that own any such abbreviated new drug application and all approved abbreviated new drug applications owned by any such affiliate. > > > #### “(2) Format and method > > The Secretary shall specify in guidance the format and method for submission of lists under this subsection.” > .
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Sec. 303
AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG FEES
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