21 USC 379 - Authority to assess and use human generic drug fees

View all text of Subpart 7 [§ 379j-41 - § 379j-43]

§ 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 general

(B) Method of fee amount calculation

(D) Fee due date

(E) Sunset

(2) Drug master file fee

(A) In general

(B) One-time payment

(D) Availability for reference

(i) In general

(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) List

(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 general

(B) Notice

(D) Refund of fee if abbreviated new drug application is not considered to have been received, is withdrawn prior to being received, or is no longer received

(i) Applications not considered to have been received and applications withdrawn prior to being received

(ii) Applications no longer received

(E) Fee for an application the Secretary considers not to have been received, or that has been withdrawn

(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

(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 facility

(ii) Active pharmaceutical ingredient facility

(iii) Facilities producing both active pharmaceutical ingredients and finished dosage forms

(B) Amount

(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 general

(B) Amount

(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 2023

(B) Fiscal years 2024 through 2027

(i) In general

(ii) Base revenue amount

(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.

(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 general

(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.

(i) In general

(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 Register

(3) Operating reserve adjustment

(A) In general

(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.

(D) Rationale for adjustment

(d) Annual fee setting

(1) Fiscal years 2023 through 2027

(2) Fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file

(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 general

(2) Leasing and necessary equipment

(f) Identification of facilities

(1) Required submission of facility identification

(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;

(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 general

(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.

(D) Inspection authority

(g) Effect of failure to pay fees

(1) Generic drug backlog fee

(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 fee

(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 penalties

(i) Notice

(ii) Nonreceival

(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 penalties

(h) Limitations

(1) In general

(2) Authority

(i) Crediting and availability of fees

(1) In general

(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) Compliance

(3) Authorization of appropriations

(j) Collection of unpaid fees

(k) Construction

(l) Positron emission tomography drugs

(1) Exemption from fees

(2) Identification requirement

(m) Disputes concerning fees

(n) Substantially complete applications

(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 method

(June 25, 1938, ch. 675, § 744B, as added Pub. L. 112–144, title III, § 302, July 9, 2012, 126 Stat. 1011; amended Pub. L. 112–193, § 2(b)(2), (3), Oct. 5, 2012, 126 Stat. 1443; Pub. L. 115–52, title III, § 303, title IX, § 905(b)(3), Aug. 18, 2017, 131 Stat. 1021, 1090; Pub. L. 117–180, div. F, title III, § 3002, Sept. 30, 2022, 136 Stat. 2155; Pub. L. 117–328, div. FF, title III, § 3625(c), Dec. 29, 2022, 136 Stat. 5881.)