21 U.S.C. § 379j-42 Authority to Assess and Use Human Generic Drug Fees

• Library: United States Statutes
• Edition: 2023
• Currency: Current through P.L. 118-34 (published on www.congress.gov on 12/26/2023), except for [P. L. 118-31]
• Year: 2023
• Citation: 21 U.S.C. § 379j-42

(a) Types of fees

Beginning 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

Each 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 calculation

The 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) Notice

Not 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 date

The 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) Sunset

This paragraph shall cease to be effective October 1, 2022.

(2) Drug master file fee

(A) In general

Each 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 payment

If 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) Notice

Not 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 general

Subject 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) Conditions

A 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

The 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 general

Subject 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) Limitation

No 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

Each 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) Notice

Not 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 date

The fees required by subparagraphs (A) and (F) shall be due no later than the date of submission of the abbreviated new drug application or prior approval supplement for which such fee applies.

(D) 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

The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any abbreviated new drug application that the Secretary considers not to have been received within the meaning of section 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 received

The Secretary shall refund 100 percent of the fee paid under subparagraph (A) for any abbreviated new drug application if the Secretary initially receives the application under section 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 withdrawn

An 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 file

An 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 general

Facilities 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

Each 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 facility

Each 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 forms

Each 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) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C) Notice

Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D) Fee due date

For each of fiscal years 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

A generic drug applicant program fee shall be assessed annually as described in subsection (b)(2)(E).

(B) Amount

The amount of fees established under subparagraph (A) shall be established under subsection (d).

(C) Notice

Within the timeframe specified in subsection (d)(1), the Secretary shall publish in the Federal Register the amount of the fees under subparagraph (A) for such fiscal year.

(D) Fee due date

For each of fiscal years 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 submission

For 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-