Q1. How much are the ANDA and PAS fees?
The FY 2016 ANDA fee is $76,030; the PAS fee is $38,020. Additional information, including the methodology for calculating the fee, is available in the Federal Register: Generic Drug User Fee—Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016.
Individual fee amounts will be recalculated each fiscal year. Fees for FY 2017 will be adjusted for inflation and other factors, including the projected number of ANDAs and PASs based on experience. Notice will be provided in the Federal Register no more than 60 days before the start of each fiscal year (i.e., no more than 60 days before October 1 of each year).
Q2. When will ANDA and PAS fees be due?
Fees are due on the date of submission of the application.
Q3. If an ANDA or PAS is refused, is there any provision for partial refund of the application fee?
In certain circumstances, a partial refund may be possible. If the reason that the application was refused was not related to failure to pay fees, then 75 percent of the fee paid will be refunded to the applicant.
Q4. If such a previously refused application is then resubmitted, will the applicant be required to pay the full fee at the time of resubmission?
Q5. What is the penalty for failure to pay the ANDA or PAS fee?
The ANDA or PAS will not be received unless the fee is paid within 20 calendar days of the due date.
Q6. If an ANDA or PAS applicant pays its application fee more than 20 calendar days after the due date, what will FDA consider as the application’s date of submission?
If an applicant submits payment after the 20 calendar day grace period, its application will be deemed incomplete on the date of submission. It will be received within the meaning of section 505(j)(5)(A) of the Federal Food, Drug, and Cosmetic Act as of the date its payment in full is received – meaning that the receipt date of the application will be deemed to be the date all outstanding user fee obligations were satisfied.
Q7. What is a generic drug submission?
The phrase generic drug submission refers to an ANDA, an amendment to an ANDA, or a PAS to an ANDA.
Q8. If a generic drug submission includes API information other than by reference to a DMF – e.g., the applicant manufactures an API in its own facility or facilities – is the applicant required to pay an additional fee?
Yes. The applicant is required to pay an API-related fee for each API manufactured in its own facility or facilities for which it has not previously paid an API-related fee. As with a DMF fee, this fee is paid only once.
The amount of the API-related fee is a function of the number of APIs referenced in the application and the number of facilities in which those APIs are manufactured. If the ANDA references more than one facility as manufacturing each API, the applicant must pay the API-related fee for each such facility. See the examples that follow.
GDUFA specifies that the ANDA applicant must pay a fee for each API facility for which an API-related fee has not previously been paid that is described in the generic drug submission by means other than reference to a DMF.
Because the calculation is potentially confusing, we provide the following two examples.
An applicant submits an ANDA that describes manufacture of APIs, not by reference to DMFs.
Facility for which no API fee has previously
The applicant owes the following API-related fee:
Fee = [APIs (Alpha + Beta + Gamma) + extra facilities (Alpha 2 +
Alpha 3 + Beta 2) x DMF fee
= (3 APIs + 3 Extra Facilities) x DMF fee
= 6 x DMF fee
The applicant submits a new application for a second product with the following information about API manufacture other than by reference to a DMF:
The one-time fee has already been paid for Alpha, Beta and Gamma, so no additional fee is due for these components. In addition, the applicant has already paid for all of the extra facilities except for Gamma 2, so a fee is only owed for Gamma facility 2.
The applicant owes the following API-related fee:
Fee = [APIs (Delta) + extra facilities (Gamma 2)] x DMF fee
= (1 API + 1 Extra Facility) x DMF fee
= 2 x DMF fee
Q9. Are the references to fees for each API facility in the above question and answer different from the annual fee that each API facility must pay (discussed below)?
Yes. The reference to fees for each API facility in the calculation above is meant to replicate the DMF fee required if the information is submitted in a DMF. Annual API facility fees are discussed below and are required for each facility that makes an API for a generic drug, regardless of whether the API is identified in an ANDA or a DMF.
Q10. Is a PAS fee required for such changes as labeling and microbiology?
Yes. User fees are required for all PASs, including labeling and microbiology, that require prior approval under FDA regulations.
Q11. If a manufacturer submits a changes being effected (CBE) supplement, will FDA convert the supplement to a PAS?
If FDA determines that the proposed manufacturing change to an approved product was submitted incorrectly as a CBE, FDA will notify the applicant that the proposed change must be considered a PAS. The applicant must resubmit the change as a PAS along with payment of a PAS fee.
The criteria for submitting information as a CBE or a PAS were not changed by GDUFA. For additional information, please refer to 21 CFR 314.70, as well as related guidances, including, but not limited to, Scale-Up and Post Approval Changes (SUPAC) and Changes to an Approved New Drug Application (NDA) or ANDA.