Q1. What happens if a person pays less than the full amount of required GDUFA fee(s)?
FDA’s expectation is for full and timely payment of all GDUFA fees. Penalties associated with non-payment, including refusal to receive a generic drug submission and failure of a DMF to be placed on a publicly available reference list, will apply until such obligations are satisfied in full.
Those paying fees are responsible for determining all financial institution transaction fees that may be deducted from a company’s authorized amount for payment to FDA. These include wire transfer and foreign exchange fees. Please ask your financial institution about fees to make sure FDA receives full payment.
Q2. What happens if a person inadvertently pays too high a fee?
Such person will need to make a written request for return of the overpayment within 180 days of the payment. The person must submit a written request justifying the return of the fee within 180 calendar days of the payment receipt date. Note that if a written request is not made within 180 calendar days, no return of fees is permitted.
Q3. To whom should correspondence be sent regarding user fee issues?
A: Persons responding to a letter received from the FDA regarding a user fee issue – for example, a notification that your application refers to a DMF that is not on the ‘available for reference’ list due to failure to satisfy its user fee obligations should send a copy of that response to the attention of Division of User Fee Management and Budget Formulation at CDERCollections@fda.hhs.gov in addition to the standard application submission methods (via FDA electronic gateway or by mail to the ANDA archival file at the following address: Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Document Control Room, Metro Park North VII, 7620 Standish Pl., Rockville, MD 20855.
This will ensure that the Division of User Fee Management and Budget Formulation, which is responsible for handling user fee payment questions, is able to work with you to resolve any outstanding questions. Given the time-sensitive nature of user fee issues, contacting the Office of Generic Drugs directly, without including the Division of User Fee Management and Budget Formulation, will significantly increase the risk that the communication will not be given the attention it needs in time to prevent the application of statutory penalties for failure to satisfy user fee obligations.
If an applicant has a user fee question unrelated to an issued user fee correspondence from FDA, please email email@example.com.
Q4. How does an applicant request a refund?
Persons should provide their written communication to the Division of User Fee Management and Budget Formulation at the Office of Management at CDERCollections@fda.hhs.gov.
In addition, applicants should submit the written notification of the correspondence by standard application submission methods via the FDA electronic gateway or by mail to the ANDA archival file at the following address: Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Document Control Room, Metro Park North VII, 7620 Standish Pl., Rockville, MD 20855.
Q5. Will companies be invoiced for fees?
No. It is FDA’s expectation that firms will self-identify and pay. However, in rare and unusual circumstances, FDA may find it necessary to issue an invoice.
Q6. Are there any exemptions from the fees for categories of drugs?
Positron Emission Tomography (PET) drug manufacturers are the only human generic drug manufacturers excluded from payment of GDUFA fees. They are, however, required to self-identify. FDA also requests that all drug manufacturers, including generic PET manufacturers, submit a user fee cover sheet with any new FDA submissions. PET manufacturers should complete a generic drug user fee cover sheet for $0.
Q7. Are reduced fees available for small businesses or others?
No. The majority of generic companies are small companies that are expected to benefit significantly from reductions in the review time needed to commercialize their products and from the certainty associated with performance review metrics and program efficiencies.
In addition to diminishing the fee-paying base, the cost of a fee waiver or reduction provision would have added to the administrative cost of the GDUFA program. As such, no fee waiver or reduction provision was included. Congress specifically considered this issue and agreed with the decision not to have a fee waiver or reduction mechanism in GDUFA, whose individual fee amounts are expected to be orders of magnitude less than those in PDUFA.
Q8. How will FDA communicate and update the arrears list?
The arrears list will be available to the public on the FDA’s website. FDA plans to update the arrears list following each annual facility fee payment deadline. In addition, FDA anticipates more frequent updates to reflect payment activity.
Q9. If a company believes that its appearance on the arrears list is in error, whom should it contact?
Persons should contact the Generic Drug Collections Team at the Office of Management at 301-796-7900 or
Q10. How does FDA determine the date and time of submission when a generic drug submission or Type II DMF is sent electronically?
A generic drug submission or Type II API DMF is deemed to be submitted to FDA on the calendar day when the electronic submission arrives at FDA's electronic gateway, except that a submission made on a weekend, Federal holiday, or a day when the FDA office that will review the submission is not otherwise open for business will be deemed to be submitted on the next day when that Office is open for business. For a generic drug submission or Type II API DMF that is submitted in physical media form, the date of submission will be the day it arrives at the appropriate designated FDA document room.
Q11. What is the start date for GDUFA fees?
The start date is October 1, 2012.
Q12. Do GDUFA fees apply to drugs that are not generic drugs or not human generic drugs?
No. GDUFA fees apply only to generic drugs manufactured for human use.
Q13. Does GDUFA provide any mechanism for disputes concerning fees?
A person may submit a written request to the Secretary requesting the return of a fee claimed to have been paid in error. The request justifying the return of the fee must be submitted within 180 calendar days of the payment receipt date. Note that if a written request is not made within 180 calendar days, no return of fees is permitted.