21 U.S.C. § 379h — Authority to assess and use drug fees

Page 527 TITLE 21—FOOD AND DRUGS § 379h § 379h. Authority to assess and use drug fees (a) Types of fees Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows: (1) Human drug application fee (A) In general Each person that submits, on or after Sep- tember 1, 1992, a human drug application shall be subject to a fee as follows: (i) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bio- availability or bioequivalence studies) with respect to safety or effectiveness are required for approval. (ii) A fee established under subsection (c)(6) for a human drug application for which clinical data (other than bio- availability or bioequivalence studies) with respect to safety or effectiveness are not required for approval. Such fee shall be half of the amount of the fee established under clause (i). (B) Payment The fee required by subparagraph (A) shall be due upon submission of the application. (C) Exception for previously filed application If a human drug application was submitted by a person that paid the fee for such appli- cation, was accepted for filing, and was not approved or was withdrawn prior to approval (without a waiver), the submission of a human drug application for the same prod- uct by the same person (or the person’s li- censee, assignee, or successor) shall not be subject to a fee under subparagraph (A). (D) Refund of fee if application refused for filing or withdrawn before filing The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any application which is refused for filing or withdrawn without a waiver before filing. (E) Fees for applications previously refused for filing or withdrawn before filing A human drug application that was sub- mitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resub- mitted or filed over protest, unless the fee is waived or reduced under subsection (d). (F) Exception for designated orphan drug A human drug application for a prescrip- tion drug product that has been designated as a drug for a rare disease or condition pur- suant to section 360bb of this title shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition. (G) Refund of fee if application withdrawn If an application is withdrawn after the ap- plication was filed, the Secretary may re- fund the fee or a portion of the fee if no sub- stantial work was performed on the applica- tion after the application was filed. The Sec- retary shall have the sole discretion to re- fund a fee or a portion of the fee under this subparagraph. A determination by the Sec- retary concerning a refund under this para- graph shall not be reviewable. (H) Exception for skin-test diagnostic prod- ucts A human drug application for a skin-test diagnostic product shall not be subject to a fee under subparagraph (A). (2) Prescription drug program fee (A) In general (i) Payment of fees Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pend- ing before the Secretary a human drug ap- plication or supplement, shall pay the an- nual prescription drug program fee estab- lished for a fiscal year under subsection (c)(6) for each prescription drug product that is identified in such a human drug ap- plication approved as of October 1 of such fiscal year. Such fee shall be due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an ap- propriations Act providing for the collec- tion and obligation of fees for such fiscal year under this section. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable. (ii) Special rule for previously discon- tinued drug products If a drug product that is identified in a human drug application approved as of Oc- tober 1 of a fiscal year is not a prescription drug product as of that date because the drug product is in the discontinued section of a list referenced in section 379g(3)(A)(iii) of this title, and on any subsequent day during such fiscal year the drug product is a prescription drug product, then except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application with respect to such product, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual prescription drug pro- gram fee established for a fiscal year under subsection (c)(6) for such prescription drug product. Such fee shall be due on the last business day of such fiscal year and shall be paid only once for each such product for a fiscal year in which the fee is payable. (B) Exception for certain prescription drug products A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is— (i) a large volume parenteral product (a sterile aqueous drug product packaged in a single-dose container with a volume great- er than or equal to 100 mL, not including Page 528 TITLE 21—FOOD AND DRUGS § 379h powders for reconstitution or pharmacy bulk packages) identified on the list com- piled under section 355(j)(7) of this title; (ii) pharmaceutically equivalent (as de- fined in section 314.3 of title 21, Code of Federal Regulations (or any successor reg- ulation)) to another product on the list of products compiled under section 355(j)(7) of this title (not including the discontinued section of such list); or (iii) a skin-test diagnostic product. (C) Limitation A person who is named as the applicant in an approved human drug application shall not be assessed more than 5 prescription drug program fees for a fiscal year for pre- scription drug products identified in such approved human drug application. (b) Fee revenue amounts (1) In general For each of the fiscal years 2023 through 2027, fees under subsection (a) shall, except as provided in subsections (c), (d), (f), and (g), be established to generate a total revenue amount under such subsection that is equal to the sum of— (A) the annual base revenue for the fiscal year (as determined under paragraph (3)); (B) the dollar amount equal to the infla- tion adjustment for the fiscal year (as deter- mined under subsection (c)(1)); (C) the dollar amount equal to the stra- tegic hiring and retention adjustment for the fiscal year (as determined under sub- section (c)(2)); (D) the dollar amount equal to the capac- ity planning adjustment for the fiscal year (as determined under subsection (c)(3)); (E) the dollar amount equal to the oper- ating reserve adjustment for the fiscal year, if applicable (as determined under sub- section (c)(4)); (F) the dollar amount equal to the addi- tional direct cost adjustment for the fiscal year (as determined under subsection (c)(5)); and (G) additional dollar amounts for each fis- cal year as follows: (i) $65,773,693 for fiscal year 2023. (ii) $25,097,671 for fiscal year 2024. (iii) $14,154,169 for fiscal year 2025. (iv) $4,864,860 for fiscal year 2026. (v) $1,314,620 for fiscal year 2027. (2) Types of fees Of the total revenue amount determined for a fiscal year under paragraph (1)— (A) 20 percent shall be derived from human drug application fees under subsection (a)(1); and (B) 80 percent shall be derived from pre- scription drug program fees under sub- section (a)(2). (3) Annual base revenue For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be— (A) for fiscal year 2023, $1,151,522,958; and (B) for fiscal years 2024 through 2027, the dollar amount of the total revenue amount established under paragraph (1) for the pre- vious fiscal year, not including any adjust- ments made under subsection (c)(4) or (c)(5). (c) Adjustments; annual fee setting (1) Inflation adjustment (A) In general For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of— (i) such annual base revenue for the fis- cal year under subsection (b)(1)(A); and (ii) the inflation adjustment percentage under subparagraph (B). (B) Inflation adjustment percentage The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of— (i) the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years; and (ii) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arling- ton-Alexandria, DC–VA–MD–WV; Not Sea- sonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than per- sonnel compensation and benefits costs to total costs of the process for the review of human drug applications (as defined in section 379g(6) of this title) for the first 3 years of the preceding 4 fiscal years. (2) Strategic hiring and retention adjustment For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted for inflation in accordance with para- graph (1), the Secretary shall further increase the fee revenue and fees by the following amounts: (A) For fiscal year 2023, $9,000,000. (B) For each of fiscal years 2024 through 2027, $4,000,000. (3) Capacity planning adjustment (A) In general For each fiscal year, after the annual base revenue established in subsection (b)(1)(A) is adjusted in accordance with paragraphs (1) and (2), such revenue shall be adjusted fur- ther for such fiscal year, in accordance with this paragraph, to reflect changes in the re- source capacity needs of the Secretary for the process for the review of human drug ap- plications. (B) Methodology For purposes of this paragraph, the Sec- retary shall employ the capacity planning Page 529 TITLE 21—FOOD AND DRUGS § 379h 1 So in original. The word ‘‘of’’ probably should not appear. See sections 379j–42(c)(2)(D) and 379j–52(c)(3)(D) of this title. methodology utilized by the Secretary in setting fees for fiscal year 2021, as described in the notice titled ‘‘Prescription Drug User Fee Rates for Fiscal Year 2021’’ published in the Federal Register on August 3, 2020 (85 Fed. Reg. 46651). The workload categories used in applying such methodology in fore- casting shall include only the activities de- scribed in that notice and, as feasible, addi- tional activities that are directly related to the direct review of applications and supple- ments, including additional formal meeting types, the direct review of postmarketing commitments and requirements, the direct review of risk evaluation and mitigation strategies, and the direct review of annual reports for approved prescription drug prod- ucts. Subject to the exceptions in the pre- ceding sentence, the Secretary shall not in- clude as workload categories in applying such methodology in forecasting any non- core review activities, including those ac- tivities that the Secretary referenced for po- tential future use in such notice but did not utilize in setting fees for fiscal year 2021. (C) Limitation Under no circumstances shall an adjust- ment under this paragraph result in fee rev- enue for a fiscal year that is less than the sum of the amounts under subsections (b)(1)(A) (the annual base revenue for the fis- cal year), (b)(1)(B) (the dollar amount of the inflation adjustment for the fiscal year), and (b)(1)(C) (the dollar amount of the strategic hiring and retention adjustment for the fis- cal year). (D) Publication in Federal Register The Secretary shall publish in the Federal Register notice under paragraph (6) of 1 the fee revenue and fees resulting from the ad- justment and the methodologies under this paragraph. (4) Operating reserve adjustment (A) Increase For fiscal year 2023 and subsequent fiscal years, the Secretary shall, in addition to ad- justments under paragraphs (1), (2), and (3), further increase the fee revenue and fees if such an adjustment is necessary to provide for operating reserves of carryover user fees for the process for the review of human drug applications for each fiscal year in at least the following amounts: (i) For fiscal year 2023, at least 8 weeks of operating reserves. (ii) For fiscal year 2024, at least 9 weeks of operating reserves. (iii) For fiscal year 2025 and subsequent fiscal years, at least 10 weeks of operating reserves. (B) Decrease If the Secretary has carryover balances for such process in excess of 14 weeks of such op- erating reserves, the Secretary shall de- crease such fee revenue and fees to provide for not more than 14 weeks of such operating reserves. (C) Notice of rationale If an adjustment under subparagraph (A) or (B) is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (6) establishing fee revenue and fees for the fiscal year involved. (5) Additional direct cost adjustment (A) Increase The Secretary shall, in addition to adjust- ments under paragraphs (1), (2), (3), and (4), further increase the fee revenue and fees— (i) for fiscal year 2023, by $44,386,150; and (ii) for each of fiscal years 2024 through 2027, by the amount set forth in clauses (i) through (iv) of subparagraph (B), as appli- cable, multiplied by the Consumer Price Index for urban consumers (Washington- Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally Adjusted; All Items; An- nual Index) for the most recent year of available data, divided by such Index for 2021. (B) Applicable amounts The amounts referred to in subparagraph (A)(ii) are the following: (i) For fiscal year 2024, $60,967,993. (ii) For fiscal year 2025, $35,799,314. (iii) For fiscal year 2026, $35,799, 314. (iv) For fiscal year 2027, $35,799,314. (6) Annual fee setting The Secretary shall, not later than 60 days before the start of each fiscal year that begins after September 30, 2022— (A) establish, for each such fiscal year, human drug application fees and prescrip- tion drug program fees under subsection (a), based on the revenue amounts established under subsection (b) and the adjustments provided under this subsection; and (B) publish such fee revenue and fees in the Federal Register. (7) Limit The total amount of fees charged, as ad- justed under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of human drug applications. (d) Fee waiver or reduction (1) In general The Secretary shall grant to a person who is named as the applicant in a human drug appli- cation a waiver from or a reduction of one or more fees assessed to that person under sub- section (a) where the Secretary finds that— (A) such waiver or reduction is necessary to protect the public health, (B) the assessment of the fee would present a significant barrier to innovation because of limited resources available to such person or other circumstances, or (C) the applicant involved is a small busi- ness submitting its first human drug appli- cation to the Secretary for review. Page 530 TITLE 21—FOOD AND DRUGS § 379h (2) Considerations In determining whether to grant a waiver or reduction of a fee under paragraph (1), the Sec- retary shall consider only the circumstances and assets of the applicant involved and any affiliate of the applicant. (3) Rules relating to small businesses (A) ‘‘Small business’’ defined In paragraph (1)(C), the term ‘‘small busi- ness’’ means an entity that has fewer than 500 employees, including employees of affili- ates, and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce. (B) Waiver of application fee The Secretary shall waive under paragraph (1)(C) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay application fees for all subsequent human drug applications sub- mitted to the Secretary for review in the same manner as an entity that does not qualify as a small business. (e) Effect of failure to pay fees A human drug application or supplement sub- mitted by a person subject to fees under sub- section (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all such fees owed by such person have been paid. (f) Limitations (1) In general Fees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 1997 unless appropriations for salaries and ex- penses of the Food and Drug Administration for such fiscal year (excluding the amount of fees appropriated for such fiscal year) are equal to or greater than the amount of appro- priations for the salaries and expenses of the Food and Drug Administration for the fiscal year 1997 (excluding the amount of fees appro- priated for such fiscal year) multiplied by the adjustment factor applicable to the fiscal year involved. (2) Authority If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may as- sess such fees, the Secretary may assess and collect such fees, without any modification in the rate, for human drug applications and pre- scription drug program fees at any time in such fiscal year notwithstanding the provi- sions of subsection (a) relating to the date fees are to be paid. (3) Limitation Beginning on October 1, 2023, the authorities under section 379g(7)(C) of this title shall in- clude only expenditures for leasing and nec- essary scientific equipment. (g) Crediting and availability of fees (1) In general Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appro- priations Acts. Such fees are authorized to re- main available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications. (2) Collections and appropriation acts (A) In general The fees authorized by this section— (i) subject to subparagraph (C), shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or other- wise made available for obligation, for such fiscal year, and (ii) shall be available— (I) for fiscal year 2023, to defray in- creases in the costs of the resources allo- cated for the process for the review of human drug applications (including in- creases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997 multiplied by the ad- justment factor; and (II) for fiscal year 2024 and each subse- quent fiscal year, to defray the costs of the resources allocated for the process for the review of human drug applica- tions (including such costs for an addi- tional number of full-time equivalent po- sitions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees col- lected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, fur- niture, and other necessary materials and supplies in connection with the proc- ess for the review of human drug applica- tions, is no less than the amount allo- cated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 1997, multiplied by the adjustment factor. (B) Compliance The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by ap- propriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable— (i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or Page 531 TITLE 21—FOOD AND DRUGS § 379h (ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in such subparagraph; and (II) such costs are not more than 5 per- cent below the level specified in such sub- paragraph. (C) Provision for early payments Payment of fees authorized under this sec- tion for a fiscal year, prior to the due date for such fees, may be accepted by the Sec- retary in accordance with authority pro- vided in advance in a prior year appropria- tions Act. (3) Authorization of appropriations For each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the total revenue amount determined under sub- section (b) for the fiscal year, as adjusted or otherwise affected under subsection (c). (h) Collection of unpaid fees In any case where the Secretary does not re- ceive payment of a fee assessed under subsection (a) within 30 days after it is due, such fee shall be treated as a claim of the United States Gov- ernment subject to subchapter II of chapter 37 of title 31. (i) Written requests for waivers, reductions, ex- emptions, and returns; disputes concerning fees To qualify for consideration for a waiver or re- duction under subsection (d), an exemption under subsection (k), or the return of any fee paid under this section, including if the fee is claimed to have been paid in error, a person shall— (1) not later than 180 days after such fee is due, submit to the Secretary a written request justifying such waiver, reduction, exemption, or return; and (2) include in the request any legal authori- ties under which the request is made. (j) Construction This section may not be construed to require that the number of full-time equivalent posi- tions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in the process of the re- view of human drug applications, be reduced to offset the number of officers, employees, and ad- visory committees so engaged. (k) Orphan drugs (1) Exemption A drug designated under section 360bb of this title for a rare disease or condition and ap- proved under section 355 of this title or under section 262 of title 42 shall be exempt from pre- scription drug program fees under this section, if the drug meets all of the following condi- tions: (A) The drug meets the public health re- quirements contained in this chapter as such requirements are applied to requests for waivers for prescription drug program fees. (B) The drug is owned or licensed and is marketed by a company that had less than $50,000,000 in gross worldwide revenue as de- termined under paragraph (2). (2) Evidence of qualification An exemption under paragraph (1) applies with respect to a drug only if the applicant in- volved submits a certification that the appli- cant’s gross annual revenues did not exceed $50,000,000 for the last calendar year ending prior to the fiscal year for which the exemp- tion is requested. Such certification shall be supported by— (A) tax returns submitted to the United States Internal Revenue Service; or (B) as necessary, other appropriate finan- cial information. (June 25, 1938, ch. 675, § 736, as added Pub. L. 102–571, title I, § 103, Oct. 29, 1992, 106 Stat. 4494; amended Pub. L. 105–115, title I, § 103(a)–(g), Nov. 21, 1997, 111 Stat. 2299–2304; Pub. L. 107–109, § 5(a), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–188, title V, § 504, June 12, 2002, 116 Stat. 689; Pub. L. 110–85, title I, § 103(a)–(h)(1), Sept. 27, 2007, 121 Stat. 826–832; Pub. L. 112–144, title I, § 103, July 9, 2012, 126 Stat. 996; Pub. L. 115–52, title I, § 102(a)(1), (b)–(h), title IX, § 905(b)(1), Aug. 18, 2017, 131 Stat. 1007–1012, 1090; Pub. L. 117–180, div. F, title I, § 1003, Sept. 30, 2022, 136 Stat. 2142; Pub. L. 117–328, div. FF, title III, § 3625(a), Dec. 29, 2022, 136 Stat. 5880.) TERMINATION OF SECTION For termination of section by section 1005(a) of Pub. L. 117–180, see Termination Date note below. Editorial Notes AMENDMENTS 2022—Subsec. (a). Pub. L. 117–180, § 1003(a)(1)(A), sub- stituted ‘‘fiscal year 2023’’ for ‘‘fiscal year 2018’’ in in- troductory provisions. Subsec. (a)(1)(A). Pub. L. 117–180, § 1003(a)(1)(B), sub- stituted ‘‘(c)(6)’’ for ‘‘(c)(5)’’ in cls. (i) and (ii). Subsec. (a)(1)(C). Pub. L. 117–180, § 1003(a)(1)(C), in- serted ‘‘prior to approval’’ after ‘‘or was withdrawn’’. Subsec. (a)(1)(H). Pub. L. 117–180, § 1003(a)(1)(D), added subpar. (H). Subsec. (a)(2)(A). Pub. L. 117–180, § 1003(a)(2)(A), des- ignated existing provisions as cl. (i) and inserted head- ing, substituted ‘‘subsection (c)(6)’’ for ‘‘subsection (c)(5)’’, and added cl. (ii). Subsec. (a)(2)(B). Pub. L. 117–180, § 1003(a)(2)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: ‘‘A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is— ‘‘(i) identified on the list compiled under section 355(j)(7) of this title with a potency described in terms of per 100 mL; ‘‘(ii) the same product as another product that— ‘‘(I) was approved under an application filed under section 355(b) or 355(j) of this title; and ‘‘(II) is not in the list of discontinued products compiled under section 355(j)(7) of this title; ‘‘(iii) the same product as another product that was approved under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997); or ‘‘(iv) the same product as another product that was approved under an abbreviated new drug application pursuant to regulations in effect prior to the imple- mentation of the Drug Price Competition and Patent Term Restoration Act of 1984.’’ Page 532 TITLE 21—FOOD AND DRUGS § 379h Subsec. (b)(1). Pub. L. 117–180, § 1003(b)(1), amended par. (1) generally. Prior to amendment, par. (1) related to fees for fiscal years 2018 through 2022. Subsec. (b)(3). Pub. L. 117–180, § 1003(b)(2), amended par. (3) generally. Prior to amendment, par. (3) related to annual base revenue for fiscal years 2018 through 2022. Subsec. (c)(1)(B)(ii). Pub. L. 117–180, § 1003(c)(1), sub- stituted ‘‘Washington-Arlington-Alexandria, DC–VA–MD–WV’’ for ‘‘Washington-Baltimore, DC–MD–VA–WV’’. Subsec. (c)(2). Pub. L. 117–180, § 1003(c)(2)(B), added par. (2). Former par. (2) redesignated (3). Subsec. (c)(3). Pub. L. 117–180, § 1003(c)(2)(A), (3), redes- ignated par. (2) as (3) and amended it generally. Prior to amendment, par. related to establishment of a ca- pacity planning methodology and interim method- ology. Former par. (3) redesignated (4). Subsec. (c)(4). Pub. L. 117–180, § 1003(c)(2)(A), redesig- nated par. (3) as (4). Former par. (4) redesignated (5). Subsec. (c)(4)(A). Pub. L. 117–180, § 1003(c)(4)(A), amended subpar. (A) generally. Prior to amendment, text read as follows: ‘‘For fiscal year 2018 and subse- quent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further in- crease the fee revenue and fees if such an adjustment is necessary to provide for not more than 14 weeks of op- erating reserves of carryover user fees for the process for the review of human drug applications.’’ Subsec. (c)(4)(C). Pub. L. 117–180, § 1003(c)(4)(B), sub- stituted ‘‘paragraph (6)’’ for ‘‘paragraph (5)’’. Subsec. (c)(5). Pub. L. 117–180, § 1003(c)(2)(A), (5), redes- ignated par. (4) as (5) and amended it generally. Prior to amendment, par. related to additional direct cost adjustment for fiscal years 2018, 2019, and subsequent fiscal years. Former par. (5) redesignated (6). Subsec. (c)(6). Pub. L. 117–180, § 1003(c)(2)(A), (6), redes- ignated par. (5) as (6) and substituted ‘‘September 30, 2022’’ for ‘‘September 30, 2017’’ in introductory provi- sions. Former par. (6) redesignated (7). Subsec. (c)(7). Pub. L. 117–180, § 1003(c)(2)(A), redesig- nated par. (6) as (7). Subsec. (g)(2)(A)(ii). Pub. L. 117–328, § 3625(a)(1), sub- stituted ‘‘shall be available—’’ for ‘‘shall be available to defray’’, designated remainder of existing provisions as subcl. (I), inserted ‘‘for fiscal year 2023, to defray’’ before ‘‘increases in the costs’’, and added subcl. (II). Subsec. (g)(2)(B). Pub. L. 117–328, § 3625(a)(2), sub- stituted ‘‘as described in subclause (I) or (II) of such subparagraph, as applicable’’ for ‘‘for the process for the review of human drug applications’’ in introductory provisions. Subsec. (g)(3). Pub. L. 117–180, § 1003(d), substituted ‘‘fiscal years 2023 through 2027’’ for ‘‘fiscal years 2018 through 2022’’. Subsec. (i). Pub. L. 117–180, § 1003(e), amended subsec. (i) generally. Prior to amendment, text read as follows: ‘‘To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall sub- mit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.’’ Subsec. (k)(1)(B). Pub. L. 117–180, § 1003(f)(1), sub- stituted ‘‘as determined under paragraph (2)’’ for ‘‘dur- ing the previous year’’. Subsec. (k)(2). Pub. L. 117–180, § 1003(f)(2), amended par. (2) generally. Prior to amendment, text read as fol- lows: ‘‘An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for the preceding 12 months before the exemption was requested.’’ 2017—Subsec. (a). Pub. L. 115–52, § 102(a)(1)(A), sub- stituted ‘‘fiscal year 2018’’ for ‘‘fiscal year 2013’’ in in- troductory provisions. Subsec. (a)(1). Pub. L. 115–52, § 102(a)(1)(B), (C), struck out ‘‘and supplement’’ before ‘‘fee’’ in heading and struck out ‘‘or a supplement’’ and ‘‘or supplement’’ wherever appearing in text. Subsec. (a)(1)(A)(i). Pub. L. 115–52, § 102(a)(1)(D)(i), substituted ‘‘(c)(5)’’ for ‘‘(c)(4)’’. Subsec. (a)(1)(A)(ii). Pub. L. 115–52, § 102(a)(1)(C), (D)(ii), substituted ‘‘A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence stud- ies) with respect to safety or effectiveness are not re- quired for approval.’’ for ‘‘A fee established under sub- section (c)(4) for a human drug application for which clinical data with respect to safety or effectiveness are not required for which clinical data (other than bio- availability or bioequivalence studies) with respect to safety or effectiveness are required.’’ Subsec. (a)(1)(C). Pub. L. 115–52, § 102(a)(1)(E), struck out ‘‘or supplement’’ after ‘‘application’’ in heading. Subsec. (a)(1)(F). Pub. L. 115–52, § 102(a)(1)(F), struck out ‘‘or indication’’ after ‘‘drug’’ in heading and ‘‘A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section 360bb of this title as a drug for a rare disease or condition with regard to the indication proposed in such supple- ment.’’ in text. Subsec. (a)(2). Pub. L. 115–52, § 102(a)(1)(G)–(I), redesig- nated par. (3) as (2), substituted ‘‘Prescription drug pro- gram fee’’ for ‘‘Prescription drug product fee’’ in head- ing, and struck out former par. (2) which related to pre- scription drug establishment fee. Subsec. (a)(2)(A). Pub. L. 115–52, § 102(a)(1)(J), sub- stituted ‘‘Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay the annual pre- scription drug program fee established for a fiscal year under subsection (c)(5) for each prescription drug prod- uct that is identified in such a human drug application approved as of October 1 of such fiscal year.’’ for ‘‘Ex- cept as provided in subparagraph (B), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay for each such prescription drug product the annual fee established under subsection (c)(4).’’ Subsec. (a)(2)(B). Pub. L. 115–52, § 102(a)(1)(K), inserted ‘‘for certain prescription drug products’’ after ‘‘Excep- tion’’ in heading and substituted ‘‘A prescription drug program fee shall not be assessed for a prescription drug product’’ for ‘‘A prescription drug product shall not be assessed a fee’’ in introductory provisions. Subsec. (a)(2)(C). Pub. L. 115–52, § 102(a)(1)(L), added subpar. (C). Subsec. (a)(3). Pub. L. 115–52, § 102(a)(1)(H), redesig- nated par. (3) as (2). Subsec. (b). Pub. L. 115–52, § 102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee revenue amounts for fiscal years 2013 through 2017. Subsec. (c). Pub. L. 115–52, § 102(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to adjustment of revenues for inflation and changes in workload, final year adjustment, setting of annual fee, and limit on total amount of fees charged. Subsec. (d)(1)(C), (D). Pub. L. 115–52, § 102(d)(1), redes- ignated subpar. (D) as (C) and struck out former sub- par. (C) which read as follows: ‘‘the fees to be paid by such person will exceed the anticipated present and fu- ture costs incurred by the Secretary in conducting the process for the review of human drug applications for such person, or’’. Subsec. (d)(3). Pub. L. 115–52, § 102(d)(2), (3), redesig- nated par. (4) as (3) and struck out former par. (3). Text read as follows: ‘‘In making the finding in paragraph (1)(C), the Secretary may use standard costs.’’ Subsec. (d)(3)(A). Pub. L. 115–52, § 102(d)(4)(A), sub- stituted ‘‘paragraph (1)(C)’’ for ‘‘paragraph (1)(D)’’. Subsec. (d)(3)(B). Pub. L. 115–52, § 102(d)(4), substituted ‘‘paragraph (1)(C)’’ for ‘‘paragraph (1)(D)’’, struck out cl. (i) designation before ‘‘application fees’’, substituted Page 533 TITLE 21—FOOD AND DRUGS § 379h a period for ‘‘; and’’ after ‘‘qualify as a small business’’, and struck out cl. (ii), which read as follows: ‘‘all sup- plement fees for all supplements to human drug appli- cations submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.’’ Subsec. (d)(4). Pub. L. 115–52, § 102(d)(3), redesignated par. (4) as (3). Subsec. (e). Pub. L. 115–52, § 102(e), substituted ‘‘all such fees’’ for ‘‘all fees’’. Subsec. (f)(2). Pub. L. 115–52, § 102(f), substituted ‘‘pre- scription drug program fees’’ for ‘‘supplements, pre- scription drug establishments, and prescription drug products’’. Subsec. (f)(3). Pub. L. 115–52, § 905(b)(1), added par. (3). Subsec. (g)(3). Pub. L. 115–52, § 102(g)(1), substituted ‘‘2018 through 2022’’ for ‘‘2013 through 2017’’ and struck out ‘‘and paragraph (4) of this subsection’’ after ‘‘sub- section (c)’’. Subsec. (g)(4). Pub. L. 115–52, § 102(g)(2), struck out par. (4). Prior to amendment, text read as follows: ‘‘If the sum of the cumulative amount of fees collected under this section for the fiscal years 2013 through 2015 and the amount of fees estimated to be collected under this section for fiscal year 2016 exceeds the cumulative amount appropriated under paragraph (3) for the fiscal years 2013 through 2016, the excess shall be credited to the appropriation account of the Food and Drug Ad- ministration as provided in paragraph (1), and shall be subtracted from the amount of fees that would other- wise be authorized to be collected under this section pursuant to appropriation Acts for fiscal year 2017.’’ Subsec. (k)(1). Pub. L. 115–52, § 102(h), substituted ‘‘prescription drug program fees’’ for ‘‘product and es- tablishment fees’’ in two places. 2012—Subsec. (a). Pub. L. 112–144, § 103(1)(A), sub- stituted ‘‘fiscal year 2013’’ for ‘‘fiscal year 2008’’ in in- troductory provisions. Subsec. (a)(1)(A). Pub. L. 112–144, § 103(1)(B), sub- stituted ‘‘(c)(4)’’ for ‘‘(c)(5)’’ in cls. (i) and (ii). Subsec. (a)(2)(A). Pub. L. 112–144, § 103(1)(C), sub- stituted ‘‘(c)(4)’’ for ‘‘(c)(5)’’ and ‘‘due on the later of the first business day on or after October 1 of each fis- cal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section’’ for ‘‘payable on or before October 1 of each year’’ in concluding provisions. Subsec. (a)(3)(A). Pub. L. 112–144, § 103(1)(D)(i), sub- stituted ‘‘subsection (c)(4)’’ for ‘‘subsection (c)(5)’’ and ‘‘due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such fiscal year under this section.’’ for ‘‘payable on or before Oc- tober 1 of each year.’’ Subsec. (a)(3)(B). Pub. L. 112–144, § 103(1)(D)(ii), amended subpar. (B) generally. Prior to amendment, text read as follows: ‘‘A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an applica- tion filed under section 355(b) or 355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the imple- mentation of the Drug Price Competition and Patent Term Restoration Act of 1984.’’ Subsec. (b)(1). Pub. L. 112–144, § 103(2)(A)(i), sub- stituted ‘‘fiscal years 2013 through 2017’’ for ‘‘fiscal years 2008 through 2012’’ in introductory provisions. Subsec. (b)(1)(A). Pub. L. 112–144, § 103(2)(A)(ii), sub- stituted ‘‘$693,099,000;’’ for ‘‘$392,783,000; and’’. Subsec. (b)(1)(B), (C). Pub. L. 112–144, § 103(2)(A)(iii), added subpars. (B) and (C) and struck out former sub- par. (B) which read as follows: ‘‘an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3)).’’ Subsec. (b)(3), (4). Pub. L. 112–144, § 103(2)(B), added par. (3) and struck out former pars. (3) and (4) which re- lated to the modified workload adjustment factor for fiscal year 2007 and additional fee revenues for drug safety for fiscal years 2008 through 2012, respectively. Subsec. (c). Pub. L. 112–144, § 103(3), added subsec. (c) and struck out former subsec. (c) which related to in- flation adjustment for fiscal year 2009 and subsequent fiscal years, workload adjustment for fiscal year 2009 and subsequent fiscal years, rent and rent-related cost adjustment for fiscal year 2010 and each subsequent fis- cal year, final year adjustment for fiscal year 2012, an- nual fee setting for each fiscal year that began after Sept. 30, 2007, and the limit on the total amount of fees charged for a fiscal year. Subsec. (g)(1). Pub. L. 112–144, § 103(4)(A), substituted ‘‘Subject to paragraph (2)(C), fees authorized’’ for ‘‘Fees authorized’’. Subsec. (g)(2)(A)(i). Pub. L. 112–144, § 103(4)(B)(i), sub- stituted ‘‘subject to subparagraph (C), shall be col- lected and available’’ for ‘‘shall be retained’’. Subsec. (g)(2)(A)(ii). Pub. L. 112–144, § 103(4)(B)(ii), substituted ‘‘shall be available’’ for ‘‘shall only be col- lected and available’’. Subsec. (g)(2)(C). Pub. L. 112–144, § 103(4)(B)(iii), added subpar. (C). Subsec. (g)(3). Pub. L. 112–144, § 103(4)(C), substituted ‘‘fiscal years 2013 through 2017’’ for ‘‘fiscal years 2008 through 2012’’. Subsec. (g)(4). Pub. L. 112–144, § 103(4)(D), substituted ‘‘fiscal years 2013 through 2015’’ for ‘‘fiscal years 2008 through 2010’’, ‘‘fiscal year 2016’’ for ‘‘fiscal year 2011’’, ‘‘fiscal years 2013 through 2016’’ for ‘‘fiscal years 2008 through 2011’’, and ‘‘fiscal year 2017’’ for ‘‘fiscal year 2012’’. 2007—Subsec. (a). Pub. L. 110–85, § 103(a)(1), sub- stituted ‘‘2008’’ for ‘‘2003’’ in introductory provisions. Subsec. (a)(1)(A). Pub. L. 110–85, § 103(g), substituted ‘‘(c)(5)’’ for ‘‘(c)(4)’’ in cls. (i) and (ii). Subsec. (a)(1)(D). Pub. L. 110–85, § 103(a)(2)(A), inserted ‘‘or withdrawn before filing’’ after ‘‘refused for filing’’ in heading and ‘‘or withdrawn without a waiver before filing’’ before period at end of text. Subsec. (a)(1)(E) to (G). Pub. L. 110–85, § 103(a)(2)(B), (C), added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively. Subsec. (a)(2)(A). Pub. L. 110–85, § 103(a)(3)(A), (g), sub- stituted ‘‘subparagraphs (B) and (C)’’ for ‘‘subparagraph (B)’’ in introductory provisions and ‘‘(c)(5)’’ for ‘‘(c)(4)’’ in concluding provisions. Subsec. (a)(2)(C). Pub. L. 110–85, § 103(a)(3)(B), added subpar. (C). Subsec. (a)(3)(A). Pub. L. 110–85, § 103(g), substituted ‘‘(c)(5)’’ for ‘‘(c)(4)’’. Subsec. (b). Pub. L. 110–85, § 103(b), amended subsec. (b) generally, substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions re- lating to fee schedules for fiscal years 2003 to 2007. Subsec. (c)(1). Pub. L. 110–85, § 103(c)(1), amended par. (1) by substituting ‘‘For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)’’ for ‘‘The revenues established in subsection (b)’’ in in- troductory provisions, adding subpar. (C), and sub- stituting ‘‘fiscal year 2008’’ for ‘‘fiscal year 2003’’ in concluding provisions. Subsec. (c)(2). Pub. L. 110–85, § 103(c)(2)(A), substituted ‘‘For fiscal year 2009 and subsequent fiscal years,’’ for ‘‘Beginning with fiscal year 2004,’’ in introductory pro- visions. Subsec. (c)(2)(A). Pub. L. 110–85, § 103(c)(2)(B), sub- stituted ‘‘human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supple- ments, and manufacturing supplements submitted to the Secretary, and the change in the total number of active commercial investigational new drug applica- tions (adjusted for changes in review activities, as so described) during the most recent 12-month period for Page 534 TITLE 21—FOOD AND DRUGS § 379h which data on such submissions is available.’’ for ‘‘human drug applications, commercial investigational new drug applications, efficacy supplements, and man- ufacturing supplements submitted to the Secretary.’’ in first sentence. Subsec. (c)(2)(B). Pub. L. 110–85, § 103(c)(2)(C), inserted at end ‘‘Any adjustment for changes in review activi- ties made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjust- ment being more than 2 percentage points higher than it would have been in the absence of the adjustment for changes in review activities.’’ Subsec. (c)(2)(C). Pub. L. 110–85, § 103(c)(2)(D), added subpar. (C). Subsec. (c)(3). Pub. L. 110–85, § 103(c)(3), added par. (3). Former par. (3) redesignated (4). Subsec. (c)(4). Pub. L. 110–85, § 103(c)(3)(A), (4), redes- ignated par. (3) as (4) and amended it generally. Prior to amendment, text read as follows: ‘‘For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees established in subsection (b) of this section if such an adjustment is necessary to provide for not more than three months of operating reserves of carryover user fees for the process for the review of human drug applications for the first three months of fiscal year 2008. If such an adjustment is necessary, the rationale for the amount of the increase shall be con- tained in the annual notice establishing fee revenues and fees for fiscal year 2007. If the Secretary has carry- over balances for such process in excess of three months of such operating reserves, the adjustment under this paragraph shall not be made.’’ Former par. (4) redesignated (5). Subsec. (c)(5). Pub. L. 110–85, § 103(c)(3)(A), (5), redes- ignated par. (4) as (5) and substituted ‘‘2007’’ for ‘‘2002’’. Former par. (5) redesignated (6). Subsec. (c)(6). Pub. L. 110–85, § 103(c)(3)(A), redesig- nated par. (5) as (6). Subsec. (d)(1). Pub. L. 110–85, § 103(d)(1), inserted ‘‘to a person who is named as the applicant in a human drug application’’ after ‘‘The Secretary shall grant’’ and ‘‘to that person’’ after ‘‘one or more fees assessed’’ in intro- ductory provisions. Subsec. (d)(2), (3). Pub. L. 110–85, § 103(d)(2), (3), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4). Subsec. (d)(4). Pub. L. 110–85, § 103(d)(2), redesignated par. (3) as (4). Subsec. (d)(4)(A). Pub. L. 110–85, § 103(d)(4), inserted before period at end ‘‘, and that does not have a drug product that has been approved under a human drug ap- plication and introduced or delivered for introduction into interstate commerce’’. Subsec. (g)(1). Pub. L. 110–85, § 103(h)(1), substituted ‘‘Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until ex- pended.’’ for ‘‘Fees collected for a fiscal year pursuant to subsection (a) of this section shall be credited to the appropriation account for salaries and expenses of the Food and Drug Administration and shall be available in accordance with appropriation Acts until expended without fiscal year limitation.’’ Subsec. (g)(3). Pub. L. 110–85, § 103(e)(1), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007. Subsec. (g)(4). Pub. L. 110–85, § 103(e)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: ‘‘Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in ap- propriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Ad- ministration as provided in paragraph (1), and shall be subtracted from the amount of fees that would other- wise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.’’ Subsec. (k). Pub. L. 110–85, § 103(f), added subsec. (k). 2002—Subsec. (a). Pub. L. 107–188, § 504(a)(1), sub- stituted ‘‘fiscal year 2003’’ for ‘‘fiscal year 1998’’ in in- troductory provisions. Subsec. (a)(1)(A)(i). Pub. L. 107–188, § 504(a)(2)(A), sub- stituted ‘‘under subsection (c)(4)’’ for ‘‘in subsection (b)’’. Subsec. (a)(1)(A)(ii). Pub. L. 107–188, § 504(a)(2), sub- stituted ‘‘under subsection (c)(4)’’ for ‘‘in subsection (b)’’ and inserted ‘‘Such fee shall be half of the amount of the fee established under clause (i).’’ at end. Subsec. (a)(1)(F), (G). Pub. L. 107–109 redesignated subpar. (G) as (F) and struck out heading and text of former subpar. (F). Text read as follows: ‘‘A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A).’’ Subsec. (a)(2)(A). Pub. L. 107–188, § 504(a)(3), in con- cluding provisions, substituted ‘‘under subsection (c)(4)’’ for ‘‘in subsection (b)’’ and ‘‘payable on or before October 1’’ for ‘‘payable on or before January 31’’. Subsec. (a)(3)(A). Pub. L. 107–188, § 504(a)(4)(A), amend- ed heading and text of subpar. (A) generally. Prior to amendment, text read as follows: ‘‘Except as provided in subparagraph (B), each person— ‘‘(i) who is named as the applicant in a human drug application for a prescription drug product which has been submitted for listing under section 360 of this title, and ‘‘(ii) who, after September 1, 1992, had pending be- fore the Secretary a human drug application or sup- plement, shall pay for each such prescription drug product the annual fee established in subsection (b) of this section. Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under sec- tion 360 of this title if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before Janu- ary 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is pay- able.’’ Subsec. (a)(3)(B). Pub. L. 107–188, § 504(a)(4)(B), sub- stituted ‘‘A prescription drug product shall not be as- sessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such product is the same product as another product approved under an application filed under sec- tion 355(b)’’ for ‘‘The listing of a prescription drug prod- uct under section 360 of this title shall not require the person who listed such product to pay the fee pre- scribed by subparagraph (A) if such product is the same product as a product approved under an application filed under section 355(b)(2)’’. Subsec. (b). Pub. L. 107–188, § 504(b), amended heading and text of subsec. (b) generally, substituting ‘‘Fee rev- enue amounts’’ for ‘‘Fee amounts’’ in heading and sub- stituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002. Subsec. (c)(1). Pub. L. 107–188, § 504(c)(1)(A), (D), sub- stituted ‘‘revenues’’ for ‘‘fees and total fee revenues’’ in introductory provisions and ‘‘fiscal year 2003’’ for ‘‘fis- cal year 1997’’ in concluding provisions. Subsec. (c)(1)(A). Pub. L. 107–188, § 504(c)(1)(B), struck out ‘‘during the preceding fiscal year’’ before ‘‘in the Consumer Price Index’’ and substituted ‘‘for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or’’ for ‘‘, or’’. Subsec. (c)(1)(B). Pub. L. 107–188, § 504(c)(1)(C), sub- stituted ‘‘for the previous fiscal year’’ for ‘‘for such fis- cal year’’. Subsec. (c)(2) to (5). Pub. L. 107–188, § 504(c)(2)–(4), added pars. (2) and (3), redesignated former pars. (2) and (3) as (4) and (5), respectively, and amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: ‘‘Subject to the amount appro- priated for a fiscal year under subsection (g) of this sec- tion, the Secretary shall, within 60 days after the end Page 535 TITLE 21—FOOD AND DRUGS § 379h of each fiscal year beginning after September 30, 1997, adjust the establishment and product fees described in subsection (b) of this section for the fiscal year in which the adjustment occurs so that the revenues col- lected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) of this section shall be set to be equal to the revenues collected from the category of application and supplement fees de- scribed in paragraph (1) of subsection (b) of this sec- tion.’’ Subsec. (d)(1)(C) to (E). Pub. L. 107–188, § 504(d)(1), in- serted ‘‘or’’ at end of subpar. (C), redesignated subpar. (E) as (D), and struck out former subpar. (D) which read as follows: ‘‘assessment of the fee for an application or a supplement filed under section 355(b)(1) of this title pertaining to a drug containing an active ingredient would be inequitable because an application for a prod- uct containing the same active ingredient filed by an- other person under section 355(b)(2) of this title could not be assessed fees under subsection (a)(1) of this sec- tion, or’’. Subsec. (d)(3)(A), (B). Pub. L. 107–188, § 504(d)(2), sub- stituted ‘‘paragraph (1)(D)’’ for ‘‘paragraph (1)(E)’’. Subsec. (f). Pub. L. 107–188, § 504(e)(1), substituted ‘‘Limitations’’ for ‘‘Assessment of fees’’ in heading. Subsec. (f)(1). Pub. L. 107–188, § 504(e)(2), substituted ‘‘In general’’ for ‘‘Limitation’’ in heading and ‘‘Fees under subsection (a) shall be refunded for a fiscal year beginning’’ for ‘‘Fees may not be assessed under sub- section (a) for a fiscal year beginning’’ in text. Subsec. (g)(1). Pub. L. 107–188, § 504(f)(1), which di- rected the amendment of par. (1) by striking ‘‘Fees col- lected for a fiscal year’’ and all that follows through ‘‘fiscal year limitation.’’ and inserting ‘‘Fees author- ized under subsection (a) shall be collected and avail- able for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until ex- pended.’’, was not executed because the phrase ‘‘fiscal year limitation.’’ appeared in two places and because of the corrective amendment by Pub. L. 110–85, § 103(h)(1), which is effective as if included in Pub. L. 107–188, § 504. See 2007 Amendment note above and Effective Date of 2007 Amendment note below. Subsec. (g)(2). Pub. L. 107–188, § 504(f)(2), amended par. (2) by designating existing provisions as subpar. (A), in- serting subpar. (A) heading, adding subpar. (B), redesig- nating former subpars. (A) and (B) as cls. (i) and (ii), re- spectively, of subpar. (A), substituting ‘‘shall be re- tained in each fiscal year in an amount not to exceed the amount specified’’ for ‘‘shall be collected in each fiscal year in an amount equal to the amount speci- fied’’ in cl. (i), and realigning margin of cl. (ii). Subsec. (g)(3)(A) to (E). Pub. L. 107–188, § 504(f)(3), added subpars. (A) to (E) and struck out former sub- pars. (A) to (E) which read as follows: ‘‘(A) $106,800,000 for fiscal year 1998; ‘‘(B) $109,200,000 for fiscal year 1999; ‘‘(C) $109,200,000 for fiscal year 2000; ‘‘(D) $114,000,000 for fiscal year 2001; and ‘‘(E) $110,100,000 for fiscal year 2002,’’. 1997—Subsec. (a). Pub. L. 105–115, § 103(a)(1), sub- stituted ‘‘Beginning in fiscal year 1998’’ for ‘‘Beginning in fiscal year 1993’’ in introductory provisions. Subsec. (a)(1)(B). Pub. L. 105–115, § 103(a)(2)(A), amend- ed heading and text of subpar. (B) generally. Prior to amendment, text read as follows: ‘‘(i) FIRST PAYMENT.—50 percent of the fee required by subparagraph (A) shall be due upon submission of the application or supplement. ‘‘(ii) FINAL PAYMENT.—The remaining 50 percent of the fee required by subparagraph (A) shall be due upon— ‘‘(I) the expiration of 30 days from the date the Sec- retary sends to the applicant a letter designated by the Secretary as an action letter described in section 379g(6)(B) of this title, or ‘‘(II) the withdrawal of the application or supple- ment after it is filed unless the Secretary waives the fee or a portion of the fee because no substantial work was performed on such application or supple- ment after it was filed. The designation under subclause (I) or the waiver under subclause (II) shall be solely in the discretion of the Secretary and shall not be reviewable.’’ Subsec. (a)(1)(D). Pub. L. 105–115, § 103(a)(2)(B), sub- stituted ‘‘refused’’ for ‘‘not accepted’’ in heading and ‘‘75 percent’’ for ‘‘50 percent’’, ‘‘subparagraph (B)’’ for ‘‘subparagraph (B)(i)’’, and ‘‘refused’’ for ‘‘not accept- ed’’ in text. Subsec. (a)(1)(E) to (G). Pub. L. 105–115, § 103(a)(2)(C), added subpars. (E) to (G). Subsec. (a)(2). Pub. L. 105–115, § 103(a)(3), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: ‘‘Each person that— ‘‘(A) owns a prescription drug establishment, at which is manufactured at least 1 prescription drug product which is not the, or not the same as a, prod- uct approved under an application filed under section 355(b)(2) or 355(j) of this title, and ‘‘(B) after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall be subject to the annual fee established in sub- section (b) of this section for each such establishment, payable on or before January 31 of each year.’’ Subsec. (a)(3)(A). Pub. L. 105–115, § 103(a)(4)(A), sub- stituted, in cl. (i), ‘‘has been submitted for listing’’ for ‘‘is listed’’ and, in closing provisions, ‘‘Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitted for relisting under section 360 of this title if the product has been withdrawn from listing and re- listed. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.’’ for ‘‘Such fee shall be payable at the time of the first such listing of such product in each calendar year. Such fee shall be paid only once each year for each listed prescription drug product irrespective of the number of times such product is listed under section 360 of this title.’’ Subsec. (a)(3)(B). Pub. L. 105–115, § 103(a)(4)(B), sub- stituted ‘‘355(j) of this title, under an abbreviated appli- cation filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbre- viated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.’’ for ‘‘355(j) of this title.’’. Subsec. (b). Pub. L. 105–115, § 103(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2). Subsec. (c). Pub. L. 105–115, § 103(c)(1), substituted ‘‘Adjustments’’ for ‘‘Increases and adjustments’’ in heading. Subsec. (c)(1). Pub. L. 105–115, § 103(c)(2), substituted ‘‘Inflation adjustment’’ for ‘‘Revenue increase’’ in heading, ‘‘The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary’’ for ‘‘The total fee revenues established by the schedule in subsection (b)(1) shall be increased by the Secretary’’ in introductory provisions, and ‘‘change’’ for ‘‘in- crease’’ after ‘‘total percentage’’ in subpars. (A) and (B), and inserted at end ‘‘The adjustment made each fiscal year by this subsection will be added on a com- pounded basis to the sum of all adjustments made each fiscal year after fiscal year 1997 under this subsection.’’ Subsec. (c)(2). Pub. L. 105–115, § 103(c)(3), substituted ‘‘September 30, 1997, adjust the establishment and prod- uct fees described in subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) shall be set to be equal to the revenues collected from the category of application and supplement fees described in para- graph (1) of subsection (b).’’ for ‘‘October 1, 1992, adjust the fees established by the schedule in subsection (b)(1) Page 536 TITLE 21—FOOD AND DRUGS § 379h–1 for the following fiscal year to achieve the total fee revenues, as may be increased under paragraph (1). Such fees shall be adjusted under this paragraph to maintain the proportions established in such sched- ule.’’ Subsec. (c)(3). Pub. L. 105–115, § 103(c)(4), substituted ‘‘this subsection’’ for ‘‘paragraph (2)’’. Subsec. (d). Pub. L. 105–115, § 103(d), struck out intro- ductory provisions which read ‘‘The Secretary shall grant a waiver from or a reduction of 1 or more fees under subsection (a) of this section where the Secretary finds that—’’ and closing provisions which read ‘‘In making the finding in paragraph (3), the Secretary may use standard costs.’’, inserted designation, heading, and introductory provisions of par. (1), redesignated former pars. (1) to (4) as subpars. (A) to (D), respectively, of par. (1), and added pars. (1)(E), (2), and (3). Subsec. (f)(1). Pub. L. 105–115, § 103(e), substituted ‘‘fiscal year 1997’’ for ‘‘fiscal year 1993’’ and ‘‘fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)’’ for ‘‘fiscal year 1992’’. Subsec. (g)(1). Pub. L. 105–115, § 103(f)(1), inserted at end ‘‘Such sums as may be necessary may be trans- ferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the proc- ess for the review of human drug applications.’’ Subsec. (g)(2)(A). Pub. L. 105–115, § 103(f)(2)(A), sub- stituted ‘‘Acts, or otherwise made available for obliga- tion,’’ for ‘‘Acts’’. Subsec. (g)(2)(B). Pub. L. 105–115, § 103(f)(2)(B), sub- stituted ‘‘over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997’’ for ‘‘over such costs for fiscal year 1992’’. Subsec. (g)(3), (4). Pub. L. 105–115, § 103(f)(3), added pars. (3) and (4) and struck out heading and text of former par. (3). Text read as follows: ‘‘There are author- ized to be appropriated for fees under this section— ‘‘(A) $36,000,000 for fiscal year 1993, ‘‘(B) $54,000,000 for fiscal year 1994, ‘‘(C) $75,000,000 for fiscal year 1995, ‘‘(D) $78,000,000 for fiscal year 1996, and ‘‘(E) $84,000,000 for fiscal year 1997, as adjusted to reflect increases in the total fee reve- nues made under subsection (c)(1) of this section.’’ Subsecs. (i), (j). Pub. L. 105–115, § 103(g), added subsec. (i) and redesignated former subsec. (i) as (j). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Amendment by Pub. L. 117–180 effective Oct. 1, 2022, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2022, see section 1006 of Pub. L. 117–180, set out as a note under section 379g of this title. EFFECTIVE DATE OF 2017 AMENDMENT Amendment by section 102 of Pub. L. 115–52 effective Oct. 1, 2017, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2017, see section 105 of Pub. L. 115–52, set out as a note under section 379g of this title. EFFECTIVE DATE OF 2012 AMENDMENT Amendment by Pub. L. 112–144 effective Oct. 1, 2012, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2012, see section 106 of Pub. L. 112–144, set out as a note under section 379g of this title. EFFECTIVE DATE OF 2007 AMENDMENT Pub. L. 110–85, title I, § 103(h)(2), Sept. 27, 2007, 121 Stat. 832, provided that: ‘‘Paragraph (1) [amending this section] shall take effect as if included in section 504 of the Prescription Drug User Fee Amendments of 2002 (Public Law 107–188; 116 Stat. 687) [amending this sec- tion].’’ Amendment by Pub. L. 110–85 effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an Ef- fective and Termination Dates of 2007 Amendment note under section 379g of this title. EFFECTIVE DATE OF 2002 AMENDMENT Amendment by Pub. L. 107–188 effective Oct. 1, 2002, see section 508 of Pub. L. 107–188, set out as a note under section 356b of this title. EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105–115 effective Oct. 1, 1997, see section 106 of Pub. L. 105–115, set out as an Effective and Termination Dates of 1997 Amendment note under section 379g of this title. TERMINATION DATE Section ceases to be effective Oct. 1, 2027, see section 1005(a) of Pub. L. 117–180, set out as a note under sec- tion 379g of this title. SPECIAL RULE FOR WAIVERS AND REFUNDS Pub. L. 105–115, title I, § 103(h), Nov. 21, 1997, 111 Stat. 2304, provided that: ‘‘Any requests for waivers or re- funds for fees assessed under section 736 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the date of enactment of this Act [Nov. 21, 1997] shall be submitted in writing to the Secretary of Health and Human Services within 1 year after the date of enact- ment of this Act. Any requests for waivers or refunds pertaining to a fee for a human drug application or sup- plement accepted for filing prior to October 1, 1997 or to a product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998, shall be evaluated according to the terms of the Prescription Drug User Fee Act of 1992 [see section 101(a) of Pub. L. 102–571, set out as a Short Title of 1992 Amendment note under sec- tion 301 of this title] (as in effect on September 30, 1997) and part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 379g et seq.] (as in effect on September 30, 1997). The term ‘person’ in such Acts shall continue to include an affiliate thereof.’’ § 379h–1. Fees relating to advisory review of pre- scription-drug television advertising (a) Types of direct-to-consumer television adver- tisement review fees Beginning in fiscal year 2008, the Secretary shall assess and collect fees in accordance with this section as follows: (1) Advisory review fee (A) In general With respect to a proposed direct-to-con- sumer television advertisement (referred to in this section as a ‘‘DTC advertisement’’), each person that on or after October 1, 2007, submits such an advertisement for advisory review by the Secretary prior to its initial public dissemination shall, except as pro- vided in subparagraph (B), be subject to a fee established under subsection (c)(3). (B) Exception for required submissions A DTC advertisement that is required to be submitted to the Secretary prior to ini- tial public dissemination is not subject to a fee under subparagraph (A) unless the spon- sor designates the submission as a submis- sion for advisory review. (C) Notice to Secretary of number of adver- tisements Not later than June 1 of each fiscal year, the Secretary shall publish a notice in the