USC Subpart 7

USC Subpart 7
in effect

21 U.S.C. § 379j–41 Definitions

For purposes of this subpart: (1) The term “abbreviated new drug application”—(A) means an application submitted under section 355(j) of this title, an abbreviated application submitted under section 357 of this title (as in effect on the day before November 21, 1997), or an abbreviated new drug application submitted pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984; and (B) does not include an application—(i) for a positron emission tomography drug; or (ii) submitted by a State or Federal governmental entity for a drug that is not distributed commercially. (2) The term “active pharmaceutical ingredient” means—(A) a substance, or a mixture when the substance is unstable or cannot be transported on its own, intended—(i) to be used as a component of a drug; and (ii) to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the human body; or (B) a substance intended for final crystallization, purification, or salt formation, or any combination of those activities, to become a substance or mixture described in subparagraph (A). (3) The term “adjustment factor” means a factor applicable to a fiscal year that is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2011. (4) The term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly—(A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has power to control, both of the business entities. (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. (6)(A) The term “facility”—(i) means a business or other entity—(I) under one management, either direct or indirect; and (II) at one geographic location or address engaged in manufacturing or processing an active pharmaceutical ingredient or a finished dosage form; and (ii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: repackaging, relabeling, or testing. (B) For purposes of subparagraph (A), separate buildings within close proximity are considered to be at one geographic location or address if the activities in them are—(i) closely related to the same business enterprise; (ii) under the supervision of the same local management; and (iii) capable of being inspected by the Food and Drug Administration during a single inspection. (C) If a business or other entity would meet the definition of a facility under this paragraph but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph. (7) The term “finished dosage form” means—(A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application; (B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or (C) any combination of an active pharmaceutical ingredient with another component of a drug product for purposes of production of a drug product described in subparagraph (A) or (B). (8) The term “generic drug submission” means an abbreviated new drug application, an amendment to an abbreviated new drug application, or a prior approval supplement to an abbreviated new drug application. (9) The term “human generic drug activities” means the following activities of the Secretary associated with generic drugs and inspection of facilities associated with generic drugs:(A) The activities necessary for the review of generic drug submissions, including review of drug master files referenced in such submissions. (B) The issuance of—(i) approval letters which approve abbreviated new drug applications or supplements to such applications; or (ii) complete response letters which set forth in detail the specific deficiencies in such applications and, where appropriate, the actions necessary to place such applications in condition for approval. (C) The issuance of letters related to Type II active pharmaceutical drug master files which—(i) set forth in detail the specific deficiencies in such submissions, and where appropriate, the actions necessary to resolve those deficiencies; or (ii) document that no deficiencies need to be addressed. (D) Inspections related to generic drugs. (E) Monitoring of research conducted in connection with the review of generic drug submissions and drug master files. (F) Postmarket safety activities with respect to drugs approved under abbreviated new drug applications or supplements, including the following activities:(i) Collecting, developing, and reviewing safety information on approved drugs, including adverse event reports. (ii) Developing and using improved adverse-event data-collection systems, including information technology systems. (iii) Developing and using improved analytical tools to assess potential safety problems, including access to external data bases. (iv) Implementing and enforcing section 355(o) of this title (relating to postapproval studies and clinical trials and labeling changes) and section 355(p) of this title (relating to risk evaluation and mitigation strategies) insofar as those activities relate to abbreviated new drug applications. (v) Carrying out section 355(k)(5) of this title (relating to adverse-event reports and postmarket safety activities). (G) Regulatory science activities related to generic drugs. (10) The term “positron emission tomography drug” has the meaning given to the term “compounded positron emission tomography drug” in section 321(ii) of this title, except that paragraph (1)(B) of such section shall not apply. (11) The term “prior approval supplement” means a request to the Secretary to approve a change in the drug substance, drug product, production process, quality controls, equipment, or facilities covered by an approved abbreviated new drug application when that change has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. (12) The term “resources allocated for human generic drug activities” means the expenses for—(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers and employees and to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) collecting fees under subsection (a) and accounting for resources allocated for the review of abbreviated new drug applications and supplements and inspection related to generic drugs. (13) The term “Type II active pharmaceutical ingredient drug master file” means a submission of information to the Secretary by a person that intends to authorize the Food and Drug Administration to reference the information to support approval of a generic drug submission without the submitter having to disclose the information to the generic drug submission applicant.

21 U.S.C. § 379j–42 Authority to assess and use human generic drug fees

(a) Types of feesBeginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section as follows:(1) One-time backlog fee for abbreviated new drug applications pending on October 1, 2012(A) In generalEach person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date, shall be subject to a fee for each such application, as calculated under subparagraph (B). (B) Method of fee amount calculationThe amount of each one-time backlog fee shall be calculated by dividing $50,000,000 by the total number of abbreviated new drug applications pending on October 1, 2012, that have not received a tentative approval as of that date. (C) NoticeNot later than October 31, 2012, the Secretary shall publish in the Federal Register a notice announcing the amount of the fee required by subparagraph (A). (D) Fee due dateThe fee required by subparagraph (A) shall be due no later than 30 calendar days after the date of the publication of the notice specified in subparagraph (C). (E) SunsetThis paragraph shall cease to be effective October 1, 2022. (2) Drug master file fee(A) In generalEach person that owns a Type II active pharmaceutical ingredient drug master file that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a drug master file fee. (B) One-time paymentIf a person has paid a drug master file fee for a Type II active pharmaceutical ingredient drug master file, the person shall not be required to pay a subsequent drug master file fee when that Type II active pharmaceutical ingredient drug master file is subsequently referenced in generic drug submissions. (C) NoticeNot later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the drug master file fee established by this paragraph for such fiscal year. (D) Availability for reference(i) In generalSubject to subsection (g)(2)(C), for a generic drug submission to reference a Type II active pharmaceutical ingredient drug master file, the drug master file must be deemed available for reference by the Secretary. (ii) ConditionsA drug master file shall be deemed available for reference by the Secretary if—(I) the person that owns a Type II active pharmaceutical ingredient drug master file has paid the fee required under subparagraph (A) within 20 calendar days after the applicable due date under subparagraph (E); and (II) the drug master file has not failed an initial completeness assessment by the Secretary, in accordance with criteria to be published by the Secretary. (iii) ListThe Secretary shall make publicly available on the Internet Web site of the Food and Drug Administration a list of the drug master file numbers that correspond to drug master files that have successfully undergone an initial completeness assessment, in accordance with criteria to be published by the Secretary, and are available for reference. (E) Fee due date(i) In generalSubject to clause (ii), a drug master file fee shall be due on the earlier of—(I) the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file; or (II) the date on which the drug master file holder requests the initial completeness assessment. (ii) LimitationNo fee shall be due under subparagraph (A) for a fiscal year until the later of—(I) 30 calendar days after publication of the notice provided for in subparagraph (C); or (II) 30 calendar days after the date of enactment of an appropriations Act providing for the collection and obligation of fees for such year under this section. (3) Abbreviated new drug application filing fee(A) In generalEach applicant that submits, on or after October 1, 2012, an abbreviated new drug application shall be subject to a fee for each such submission in the amount established under subsection (d). (B) NoticeNot later than 60 days before the start of each of fiscal years 2023 through 2027, the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year. (C) Fee due dateThe 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) Refund of fee if abbreviated new drug application is not considered to have been received, is withdrawn prior to being received, or is no longer received(i) Applications not considered to have been received and applications withdrawn prior to being receivedThe 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 355(j)(5)(A) of this title for a cause other than failure to pay fees, or that has been withdrawn prior to being received within the meaning of section 355(j)(5)(A) of this title. (ii) Applications no longer receivedThe 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 355(j)(5)(A) of this title 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 355(j)(5)(A) of this title. (E) Fee for an application the Secretary considers not to have been received, or that has been withdrawnAn abbreviated new drug application that was submitted on or after October 1, 2012, and that the Secretary considers not to have been received, or that has been withdrawn, shall, upon resubmission of the application or a subsequent new submission following the applicant’s withdrawal of the application, be subject to a full fee under subparagraph (A). (F) Additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master fileAn applicant that submits a generic drug submission on or after October 1, 2017, shall pay a fee, in the amount determined under subsection (d)(2), in addition to the fee required under subparagraph (A), if—(i) such submission contains information concerning the manufacture of an active pharmaceutical ingredient at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical drug master file; and (ii) a fee in the amount equal to the drug master file fee established in paragraph (2) has not been previously paid with respect to such information. (4) Generic drug facility fee and active pharmaceutical ingredient facility fee(A) In generalFacilities identified in at least one generic drug submission that is approved to produce a finished dosage form of a human generic drug or an active pharmaceutical ingredient contained in a human generic drug shall be subject to fees as follows:(i) Generic drug facilityEach person that owns a facility which is identified in at least one generic drug submission that is approved to produce one or more finished dosage forms of a human generic drug shall be assessed an annual fee for each such facility. (ii) Active pharmaceutical ingredient facilityEach person that owns a facility which 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 generic drug submission, shall be assessed an annual fee for each such facility. (iii) Facilities producing both active pharmaceutical ingredients and finished dosage formsEach person that owns a facility identified in at least one generic drug submission that is approved to produce both one or more finished dosage forms subject to clause (i) and one or more active pharmaceutical ingredients subject to clause (ii) shall be subject only to the fee attributable to the manufacture of the finished dosage forms for that facility. (B) AmountThe amount of fees established under subparagraph (A) shall be established under subsection (d). (C) NoticeWithin 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 dateFor each of fiscal years 2023 through 2027, 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. (5) Generic drug applicant program fee(A) In generalA generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E). (B) AmountThe amount of fees established under subparagraph (A) shall be established under subsection (d). (C) NoticeWithin 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 dateFor each of fiscal years 2023 through 2027, 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. (6) Date of submissionFor purposes of this chapter, a generic drug submission or Type II pharmaceutical master file is deemed to be “submitted” to the Food and Drug Administration—(A) if it is submitted via a Food and Drug Administration electronic gateway, on the day when transmission to that electronic gateway is completed, except that a submission or master file that arrives on a weekend, Federal holiday, or day when the Food and Drug Administration office that will review that submission is not otherwise open for business shall be deemed to be submitted on the next day when that office is open for business; or (B) if it is submitted in physical media form, on the day it arrives at the appropriate designated document room of the Food and Drug Administration. (b) Fee revenue amounts(1) In general(A) Fiscal year 2023For fiscal year 2023, fees under subsection (a) shall be established to generate a total estimated revenue amount under such subsection of $582,500,000. (B) Fiscal years 2024 through 2027(i) In generalFor each of the fiscal years 2024 through 2027, fees under paragraphs (2) through (5) of subsection (a) shall be established to generate a total estimated revenue amount under such subsection that is equal to the base revenue amount for the fiscal year under clause (ii), as adjusted pursuant to subsection (c). (ii) Base revenue amountThe base revenue amount for a fiscal year referred to in clause (i) is equal to the total revenue amount established under this paragraph for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(3). (2) Types of feesIn establishing fees under paragraph (1) to generate the revenue amounts specified in such paragraph for a fiscal year, such fees shall be derived from the fees under paragraphs (2) through (5) of subsection (a) as follows:(A) Five percent shall be derived from fees under subsection (a)(2) (relating to drug master files). (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 twenty-four percent 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) Six percent shall be derived from fees under subsection (a)(4)(A)(ii) (relating to active pharmaceutical ingredient facilities). 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, including its territories and possessions. (E)(i) Thirty-six 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(1) Inflation adjustmentFor fiscal year 2024 and subsequent fiscal years, the revenues established in subsection (b) shall be adjusted by the Secretary by notice, published in the Federal Register, for a fiscal year, to equal the base revenue amount for the fiscal year (as specified in subsection (b)(1)(B)(ii)) multiplied by an amount equal to the sum of—(A) one; (B) 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 human generic drug activities for the first 3 years of the preceding 4 fiscal years; and (C) the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC–VA–MD–WV; Not Seasonally 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 personnel compensation and benefits costs to total costs of human generic drug activities for the first 3 years of the preceding 4 fiscal years. (2) Capacity planning adjustment(A) In generalBeginning with fiscal year 2024, the Secretary shall, in addition to the adjustment under paragraph (1), further increase the fee revenue and fees under this section for a fiscal year, in accordance with this paragraph, to reflect changes in the resource capacity needs of the Secretary for human generic drug activities. (B) Capacity planning methodologyThe Secretary shall establish a capacity planning methodology for purposes of this paragraph, which shall—(i) be derived from the methodology and recommendations made in the report titled “Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology: Evaluation and Recommendations” announced in the Federal Register on August 3, 2020 (85 Fed. Reg. 46658); and (ii) incorporate approaches and attributes determined appropriate by the Secretary, including approaches and attributes made in such report, except that in incorporating such approaches and attributes the workload categories used in forecasting resources shall only be the workload categories specified in section VIII.B.2.e. of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022. (C) Limitations(i) In generalUnder no circumstances shall an adjustment under this paragraph result in fee revenue for a fiscal year that is less than the sum of the amounts under subsection (b)(1)(B)(ii) (the base revenue amount for the fiscal year) and paragraph (1) (the dollar amount of the inflation adjustment for the fiscal year). (ii) Additional limitationAn adjustment under this paragraph shall not exceed 3 percent of the sum described in clause (i) for the fiscal year, except that such limitation shall be 4 percent if—(I) for purposes of a fiscal year 2024 adjustment, the Secretary determines that during the period from April 1, 2021, through March 31, 2023—(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,000; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as that term is defined in section XI of the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022); (II) for purposes of a fiscal year 2025 adjustment, the Secretary determines that during the period from April 1, 2022, through March 31, 2024—(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); (III) for purposes of a fiscal year 2026 adjustment, the Secretary determines that during the period from April 1, 2023, through March 31, 2025—(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined); and (IV) for purposes of a fiscal year 2027 adjustment, the Secretary determines that during the period from April 1, 2024, through March 31, 2026—(aa) the total number of abbreviated new drug applications submitted was greater than or equal to 2,300; or (bb) thirty-five percent or more of abbreviated new drug applications submitted related to complex products (as so defined). (D) Publication in Federal RegisterThe Secretary shall publish in the Federal Register notice referred to in subsection (a) the fee revenue and fees resulting from the adjustment and the methodology under this paragraph. (3) Operating reserve adjustment(A) In generalFor fiscal year 2024 and each subsequent fiscal year, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees under this section for such fiscal year if such an adjustment is necessary to provide operating reserves of carryover user fees for human generic drug activities for not more than the number of weeks specified in subparagraph (B) with respect to that fiscal year. (B) Number of weeksThe number of weeks specified in this subparagraph is—(i) 8 weeks for fiscal year 2024; (ii) 9 weeks for fiscal year 2025; and (iii) 10 weeks for each of fiscal year 2026 and 2027. (C) DecreaseIf the Secretary has carryover balances for human generic drug activities in excess of 12 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 12 weeks of such operating reserves. (D) Rationale for adjustmentIf an adjustment under this paragraph 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 subsection (a) publishing the fee revenue and fees for the fiscal year involved. (d) Annual fee setting(1) Fiscal years 2023 through 2027Not later than 60 days before the first day of each of fiscal years 2023 through 2027, 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) Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master fileIn establishing the fee under paragraph (1), the amount of the fee under subsection (a)(3)(F) shall be determined by multiplying—(A) the sum of—(i) the total number of such active pharmaceutical ingredients in such submission; and (ii) for each such ingredient that is manufactured at more than one such facility, the total number of such additional facilities; and (B) the amount equal to the drug master file fee established in subsection (a)(2) for such submission. (e) Limitations(1) In generalThe total amount of fees charged, as adjusted under subsection (c), for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for human generic drug activities. (2) Leasing and necessary equipmentBeginning on October 1, 2023, the authorities under section 379j–41(12)(C) of this title shall include only leasing and necessary scientific equipment. (f) Identification of facilities(1) Required submission of facility identificationEach person that owns a facility described in subsection (a)(4)(A) or a site or organization required to be identified by paragraph (3) shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year, be submitted, updated, or reconfirmed on or before June 1 of the previous fiscal year. (2) Information required to be submittedAt a minimum, the submission required by paragraph (1) shall include for each such facility—(A) identification of a facility identified in an approved or pending generic drug submission; (B) whether the facility manufactures active pharmaceutical ingredients or finished dosage forms, or both; (C) whether or not the facility is located within the United States and its territories and possessions; (D) whether the facility manufactures positron emission tomography drugs solely, or in addition to other drugs; (E) whether the facility manufactures drugs that are not generic drugs; and (F) whether the facility is a contract manufacturing organization facility. (3) Certain sites and organizations(A) In generalAny person that owns or operates a site or organization described in subparagraph (B) shall submit to the Secretary information concerning the ownership, name, and address of the site or organization. (B) Sites and organizationsA site or organization is described in this subparagraph if it is identified in a generic drug submission and is—(i) a site in which a bioanalytical study is conducted; (ii) a clinical research organization; (iii) a contract analytical testing site; or (iv) a contract repackager site. (C) NoticeThe Secretary may, by notice published in the Federal Register, specify the means and format for submission of the information under subparagraph (A) and may specify, as necessary for purposes of this section, any additional information to be submitted. (D) Inspection authorityThe Secretary’s inspection authority under section 374(a)(1) of this title shall extend to all such sites and organizations. (g) Effect of failure to pay fees(1) Generic drug backlog feeFailure to pay the fee under subsection (a)(1) shall result in the Secretary placing the person that owns the abbreviated new drug application subject to that fee on a publicly available arrears list, such that no new abbreviated new drug applications or supplement submitted on or after October 1, 2012, from that person, or any affiliate of that person, will be received within the meaning of section 355(j)(5)(A) of this title until such outstanding fee is paid. This paragraph shall cease to be effective on October 1, 2022. (2) Drug master file fee(A) Failure to pay the fee under subsection (a)(2) within 20 calendar days after the applicable due date under subparagraph (E) of such subsection (as described in subsection (a)(2)(D)(ii)(I)) shall result in the Type II active pharmaceutical ingredient drug master file not being deemed available for reference. (B)(i) Any generic drug submission submitted on or after October 1, 2012, that references, by a letter of authorization, a Type II active pharmaceutical ingredient drug master file that has not been deemed available for reference shall not be received within the meaning of section 355(j)(5)(A) of this title unless the condition specified in clause (ii) is met. (ii) The condition specified in this clause is that the fee established under subsection (a)(2) has been paid within 20 calendar days of the Secretary providing the notification to the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the drug master file fee as specified in subparagraph (C). (C)(i) If an abbreviated new drug application or supplement to an abbreviated new drug application references a Type II active pharmaceutical ingredient drug master file for which a fee under subsection (a)(2)(A) has not been paid by the applicable date under subsection (a)(2)(E), the Secretary shall notify the sponsor of the abbreviated new drug application or supplement of the failure of the owner of the Type II active pharmaceutical ingredient drug master file to pay the applicable fee. (ii) If such fee is not paid within 20 calendar days of the Secretary providing the notification, the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 355(j)(5)(A) of this title. (3) Abbreviated new drug application feeFailure to pay a fee under subparagraph (A) or (F) of subsection (a)(3) within 20 calendar days of the applicable due date under subparagraph (C) of such subsection shall result in the abbreviated new drug application or the prior approval supplement to an abbreviated new drug application not being received within the meaning of section 355(j)(5)(A) of this title until such outstanding fee is paid. (4) Generic drug facility fee and active pharmaceutical ingredient facility fee(A) In generalFailure to pay the fee under subsection (a)(4) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:(i) The Secretary shall place the facility on a publicly available arrears list, such that no new abbreviated new drug application or supplement submitted on or after October 1, 2012, from the person that is responsible for paying such fee, or any affiliate of that person, will be received within the meaning of section 355(j)(5)(A) of this title. (ii) Any new generic drug submission submitted on or after October 1, 2012, that references such a facility shall not be received, within the meaning of section 355(j)(5)(A) of this title if the outstanding facility fee is not paid within 20 calendar days of the Secretary providing the notification to the sponsor of the failure of the owner of the facility to pay the facility fee under subsection (a)(4)(C). (iii) All drugs or active pharmaceutical ingredients manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(aa) of this title. (B) Application of penaltiesThe penalties under this paragraph shall apply until the fee established by subsection (a)(4) is paid or the facility is removed from all generic drug submissions that refer to the facility. (C) Nonreceival for nonpayment(i) NoticeIf an abbreviated new drug application or supplement to an abbreviated new drug application submitted on or after October 1, 2012, references a facility for which a facility fee has not been paid by the applicable date under subsection (a)(4)(C), the Secretary shall notify the sponsor of the generic drug submission of the failure of the owner of the facility to pay the facility fee. (ii) NonreceivalIf the facility fee is not paid within 20 calendar days of the Secretary providing the notification under clause (i), the abbreviated new drug application or supplement to an abbreviated new drug application shall not be received within the meaning of section 355(j)(5)(A) of this title. (5) Generic drug applicant program fee(A) In generalA 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 355(j)(5)(A) of this title. (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 352(aa) of this title. (B) Application of penaltiesThe penalties under subparagraph (A) shall apply until the fee required under subsection (a)(5) is paid. (h) Limitations(1) In generalFees under subsection (a) shall be refunded for a fiscal year beginning after fiscal year 2012, unless appropriations for salaries and expenses 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 appropriations for the salaries and expenses of the Food and Drug Administration for fiscal year 2009 (excluding the amount of fees appropriated for such fiscal year) multiplied by the adjustment factor (as defined in section 379j–41 of this title) applicable to the fiscal year involved. (2) AuthorityIf the Secretary does not assess fees under subsection (a) during any portion of a fiscal year and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate, at any time in such fiscal year notwithstanding the provisions of subsection (a) relating to the date fees are to be paid. (i) Crediting and availability of fees(1) In generalFees 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, subject to paragraph (2). Such fees are authorized to remain 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 human generic drug activities. (2) Collections and appropriation Acts(A) In generalThe 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 otherwise made available for obligation for such fiscal year; and (ii) shall be available—(I) for fiscal year 2023, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $97,000,000 multiplied by the adjustment factor defined in section 379j–41(3) of this title applicable to such fiscal year; and (II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of human generic drug activities (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, and other necessary materials and supplies in connection with human generic drug activities, is no less than $97,000,000 multiplied by the adjustment factor defined in section 379j–41(3) of this title applicable to the fiscal year involved. (B) ComplianceThe Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated as described in subclause (I) or (II) of such subparagraph, as applicable, are not more than 10 percent below the level specified in such subparagraph. (C) Provision for early paymentsPayment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act. (3) Authorization of appropriationsFor each of the fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equivalent to the total revenue amount determined under subsection (b) for the fiscal year, as adjusted under subsection (c), if applicable, or as otherwise affected under paragraph (2) of this subsection. (j) Collection of unpaid feesIn any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31. (k) ConstructionThis section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employees, and advisory committees not engaged in human generic drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged. (l) Positron emission tomography drugs(1) Exemption from feesSubmission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee under this section. Facilities that solely produce positron emission tomography drugs shall not be required to pay a facility fee as established in subsection (a)(4). (2) Identification requirementFacilities that produce positron emission tomography drugs or active pharmaceutical ingredients of such drugs are required to be identified pursuant to subsection (f). (m) Disputes concerning feesTo qualify for the return of a fee claimed to have been paid in error under this section, a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid. (n) Substantially complete applicationsAn abbreviated new drug application that is not considered to be received within the meaning of section 355(j)(5)(A) of this title because of failure to pay an applicable fee under this provision within the time period specified in subsection (g) shall be deemed not to have been “substantially complete” on the date of its submission within the meaning of section 355(j)(5)(B)(iv)(II)(cc) of this title. An abbreviated new drug application that is not substantially complete on the date of its submission solely because of failure to pay an applicable fee under the preceding sentence shall be deemed substantially complete and received within the meaning of section 355(j)(5)(A) of this title as of the date such applicable fee is received. (o) Information on abbreviated new drug applications owned by applicants and their affiliates(1) In generalBy 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 methodThe Secretary shall specify in guidance the format and method for submission of lists under this subsection.

21 U.S.C. § 379j–43 Reauthorization; reporting requirements

(a) Performance report(1) General requirementsNot later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 301(b) 11 See References in Text note below. of the Generic Drug User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. (2) Real time reporting(A) In generalNot later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection. (B) DataThe Secretary shall post the following data in accordance with subparagraph (A):(i) The number and titles of draft and final guidance on topics related to human generic drug activities and whether such guidances were issued as required by statute or pursuant to a commitment under the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022. (ii) The number and titles of public meetings held on topics related to human generic drug activities and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022. (3) Rationale for GDUFA program changesThe Secretary shall include in the annual report under paragraph (1)—(A) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 3001(b) of the Generic Drug User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j–42 of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner; (B) data, analysis, and discussion of the changes in the fee revenue amounts and costs for human generic drug activities, including—(i) identifying drivers of such changes; and (ii) changes in the total average cost per full-time equivalent in the generic drug review program; (C) for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and (D) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of abbreviated new drug application. (4) AnalysisFor each fiscal year, the Secretary shall include in the report an analysis of the following:(A) The difference between the aggregate number of abbreviated new drug applications filed and the aggregate number of approvals or aggregate number of complete response letters issued by the agency, accounting for—(i) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and (ii) the aggregate number of applications for each fiscal year that did not meet the goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year. (B) Relevant data to determine whether the Food and Drug Administration has met the performance enhancement goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year. (C) The most common causes and trends for external or other circumstances that affected the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022. (b) Fiscal reportNot later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year. (c) Corrective action reportFor each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit a corrective action report to the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate. The report shall include the following information, as applicable:(1) Goals metFor each fiscal year, if the Secretary determines, based on the analysis under subsection (a)(4), that each of the goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year have been met, the corrective action report shall include recommendations on ways in which the Secretary can improve and streamline the abbreviated new drug application review process. (2) Goals missedFor each of the goals identified by the letters described in section 301(b) 1 of the Generic Drug User Fee Amendments of 2022 for the applicable fiscal year that the Secretary determines to not have been met, the corrective action report shall include—(A) a detailed justification for such determination and a description, as applicable, of the types of circumstances and trends under which abbreviated new drug applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and (B) with respect to performance enhancement goals that were not achieved, a detailed description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such 22 So in original. fiscal year. (d) Enhanced communication(1) Communications with CongressEach fiscal year, as applicable and requested, representatives from the Centers with expertise in the review of human drugs shall meet with representatives from the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives to report on the contents described in the reports under this section. (2) Participation in congressional hearingEach fiscal year, as applicable and requested, representatives from the Food and Drug Administration shall participate in a public hearing before the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, to report on the contents described in the reports under this section. Such hearing shall occur not later than 120 days after the end of each fiscal year for which fees are collected under this subpart. (e) Public availabilityThe Secretary shall make the reports required under subsections (a) and (b) available to the public on the Internet Web site of the Food and Drug Administration. (f) Reauthorization(1) ConsultationIn developing recommendations to present to the Congress with respect to the goals, and plans for meeting the goals, for human generic drug activities for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—(A) the Committee on Energy and Commerce of the House of Representatives; (B) the Committee on Health, Education, Labor, and Pensions of the Senate; (C) scientific and academic experts; (D) health care professionals; (E) representatives of patient and consumer advocacy groups; and (F) the generic drug industry. (2) Prior public inputPrior to beginning negotiations with the generic drug industry on the reauthorization of this subpart, the Secretary shall—(A) publish a notice in the Federal Register requesting public input on the reauthorization; (B) hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in subsection (a); (C) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this subpart; and (D) publish the comments on the Food and Drug Administration’s Internet Web site. (3) Periodic consultationNot less frequently than once every month during negotiations with the generic drug industry, the Secretary shall hold discussions with representatives of patient and consumer advocacy groups to continue discussions of their views on the reauthorization and their suggestions for changes to this subpart as expressed under paragraph (2). (4) Updates to CongressThe Secretary, in consultation with regulated industry, shall provide regular updates on negotiations on the reauthorization of this part to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives. (5) Public review of recommendationsAfter negotiations with the generic drug industry, the Secretary shall—(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph; (B) publish such recommendations in the Federal Register; (C) provide for a period of 30 days for the public to provide written comments on such recommendations; (D) hold a meeting at which the public may present its views on such recommendations; and (E) after consideration of such public views and comments, revise such recommendations as necessary. (6) Transmittal of recommendationsNot later than January 15, 2027, the Secretary shall transmit to the Congress the revised recommendations under paragraph (4), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments. (7) Minutes of negotiation meetings(A) Public availabilityThe Secretary shall make publicly available, on the Internet Web site of the Food and Drug Administration, minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the generic drug industry, not later than 30 days after each such negotiation meeting. (B) ContentThe minutes described under subparagraph (A) shall summarize, in sufficient detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

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