In anticipation of the reauthorization of the Generic Drug User Fee Amendment (known as GDUFA II), the Food and Drug Administration (FDA) has begun taking steps to ensure efficient administration of GDUFA for fiscal year (FY) 2018. It is projected that the GDUFA II legislation will include an annual program fee for which holders of approved abbreviated new drug application (ANDA) will be responsible.
Under GDUFA II, it is anticipated that affiliated companies will be grouped together and counted as a single entity for purposes of assessing the program fee. The term “affiliate” is defined as a business entity that has a relationship with a second business entity if, directly or indirectly, one business entity controls, or has the power to control, the other business entity; or a third party controls, or has the power to control, both of the business entities.
The program fee will be allocated among three tiers of application holders:
- Large (companies with 20 or more approved ANDAs);
- Medium (companies with between 6 and 19 approved ANDAs); and,
- Small (companies with 5 or fewer approved ANDAs).
To enable timely invoicing of FY 2018 GDUFA Fees, FDA has begun an inventory of all approved ANDAs, and has assembled a spreadsheet that lists all ANDA holders and the number of ANDAs associated with each entity. The current spreadsheet and instructions on how to use the list are available in the downloadable excel file located below.
The spreadsheet provided below is the subject of a Federal Register Notice. You may submit any comments about the spreadsheet by following the instructions provided in the Federal Register Notice, located at the Federal Register website: https://www.regulations.gov/document?D=FDA-2016-N-4508-0001.
FDA anticipates making available a revised spreadsheet based on the comments provided in the public docket of the Federal Register Notice. FDA plans to seek comment on the revised spreadsheet before compiling the final information that will be used as the basis for determining and assessing FY 2018 program fees.
- Program Fee Instructions (PDF - 1.19MB)
- Program Fee List - Excel file (731KB)
- Program Fee List - CSV file (506KB)
To meet its GDUFA II commitments, FDA must increase the overall capacity and capabilities of the generic drug application review program through a user fee structure that provides stable, predictable funding, is efficient in design and feasible to execute. FDA and industry agreed to jointly recommend these proposed changes for GDUFA II.
On October 28, 2016, CDER hosted a webinar titled "Overview of GDUFA II and Implementation of GDUFA II User Fees". The webinar provided a brief overview of upcoming changes to the user fee structure and described how CDER and Industry can best prepare for GDUFA II.
FY17 GDUFA Fees Table
On July 9, 2012, GDUFA was signed into law by the President. GDUFA is designed to speed the delivery of safe and effective generic drugs to the public and improve upon the predictability of the review process. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry to address a growing number of regulatory challenges. GDUFA reflects input received during an open process that included regular public meetings, posting of meeting minutes, and consideration of comments from a public docket. Agreed upon recommendations were sent to Congress, and Congress held hearings on GDUFA that included testimony from FDA, the generic drug industry, and other interested parties.
GDUFA aims to put FDA’s generic drug program on a firm financial footing and ensure timely access to safe, high-quality, affordable generic drugs. GDUFA enables FDA to assess user fees to fund critical and measurable enhancements to the performance of FDA’s generic drugs program, bringing greater predictability and timeliness to the review of generic drug applications.
- Generic Drug User Fee Amendments of 2012; Pub. L. 112-144, Title III
- FDA User Fee Corrections Act of 2012 signed into law Oct. 5, 2012 to enable collection of FY 2013 GDUFA user fees without enactment of an appropriations Act
- GDUFA Commitment Letter: Human Generic Drug Performance Goals and Procedures Fiscal Years 2013 through 2017 (PDF - 99KB)
- Backlog Fee Information
- FDA Announces Fiscal Year 2016 Generic Drug User Fee Rates
- Guidance For Industry: ANDA Submissions - Refuse-to-Receive Standards (RTR Standards guidance) (Final Guidance)
- Guidance for Industry: ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits (Draft Guidance)
- Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
- FDA posts Final Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
- Federal Register Notice: ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 183KB) (7/10/2014)
- Federal Register Notice: ANDA Submissions – Amendments and Easily Correctable Deficiencies Under GDUFA (PDF - 202KB) (7/10/2014)
- Federal Register Notice: Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Content and Format of Abbreviated New Drug Applications; Availability (6/12/2014)
- Federal Register Notice: Draft Generic Drug User Fee Act Information Technology Plan (12/26/2013)
- Federal Register Notice: Draft Guidance for Industry on Generic Drug User Fee Amendments of 2012 -- Questions and Answers (Revision 1); Availability (9/10/2013)
- Guidance (PDF - 482 KB)
- Federal Register Notice of Requirement: Self-Identification of Generic Drug Facilities, Sites and Organizations (10/2/2012)
- Federal Register Notice of Availability: Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments of 2012 (10/2/2012)
- Guidance (PDF - 137 KB)
To find older Federal Register Documents, please visit the Archive Page.
What are the fiscal year (FY) 2016 FDF and API facility fees for U.S. and foreign manufacturers?
The FY 2016 facility fees are:
Domestic FDF facility: $243,905
Foreign FDF facility: $258,905
Domestic API facility: $40,867
Foreign API facility: $55,867
Additional information 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.
Fees for FY 2017 will be adjusted for inflation and other factors, including the number of facilities that have self-identified each year. The fees will be published in the Federal Register approximately 60 days before the start of each fiscal year.
When will facility fees be due?
Facility fees will be due on the first business day on or after October 1 of each FY, or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for such year.
Under what conditions is a facility fee incurred?
A facility fee is incurred if a facility is identified in a generic drug submission that is pending or approved to produce an API or FDF and the facility is a business or other entity, under one management, either direct or indirect, and at one geographic location or address engaged in manufacturing or processing an API or FDF.
Do all facilities, sites, and organizations that have to self-identify also have to pay facility fees?
Please note that self-identification does not, in and of itself, trigger a liability to pay GDUFA facility fees. Most facilities that self-identify are required to pay an annual facility user fee. These include facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form (FDF) human generic drugs. Other sites and organizations must self-identify, but are not required to pay the annual facility user fee. These include facilities that solely manufacture positron emission tomography (PET) drugs, or sites and organizations that only perform testing, repackaging, or relabeling operations. Please note that while repackagers are not required to pay user fees, packagers are, in most cases, FDF manufacturers and subject to facility fees.
For more information on self-identification, please visit Generic Drug User Fee Amendments of 2012, and see the draft guidance on Self-Identification of Generic Drug Facilities, Sites, and Organizations.
If a facility is first identified in a pending or approved generic drug submission after the due date for payment of the facility fee for a fiscal year, is it required to pay the fee for that year?
No. The obligation to pay the fee depends on the status of the facility on the due date, the first business day on or after October 1 of each fiscal year. In most cases the critical question will be whether there is a generic drug submission pending or approved on the due date in which the facility is referenced.
If the facility is first identified in a pending or approved generic drug submission after the due date, its owner will be first obligated to pay a facility fee on the next due date. However, if a facility is identified in a pending or approved generic drug submission on the due date, and that reference to the facility is later withdrawn, or the drug submission is later withdrawn, the fee will not be refunded.
How can a facility be sure that it is no longer identified in an ANDA so that it no longer incurs new user fees?
An ANDA sponsor should remove from the ANDA any reference to a manufacturing facility when that facility no longer manufactures its API or FDF and when it no longer seeks to retain the facility as an approved manufacturer of the API or FDF. The ANDA sponsor may remove sites that are no longer used, but in some cases may need to provide justification if the site being removed has not been replaced by another appropriate site to continue the approved function.
An ANDA sponsor can identify a facility that it does not own in its application only if the owner of that facility has provided the ANDA sponsor permission to refer to the facility. If the owner of the facility withdraws that permission, FDA will consider that facility to no longer be identified in the application as of the date when FDA receives notice of that withdrawal. Please note that if the permission is withdrawn the facility will no longer be approved for manufacture of the FDF, or the API, covered by that application.
Since a facility continues to incur facility fees until FDA is notified of the facility’s withdrawal of permission, the Agency encourages a person who wishes to withdraw permission for its facility to be identified in an ANDA to take the following steps prior to the FY fee due date:
1. Notify the ANDA sponsor and/or DMF holder in writing that it is withdrawing its permission to reference the facility in its ANDA and/or DMF.
2. Send a copy of this letter to the standard application submission methods for ANDAs and DMFs via FDA electronic gateway or by mail to the ANDA archival file at the following address:
Office of Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Document Control Room
Metro Park North VII
7620 Standish Pl.
Rockville, MD 20855
3. In addition, email the copy of the withdrawal letter to the Division of User Fee Management and Budget Formulation at CDERCollections@fda.hhs.gov.
4. If you are a DMF holder, be sure to also update your DMF with this change.
Will a facility owner have to pay a GDUFA fee if the facility is manufacturing only non-generic APIs or FDFs, but is referenced in a generic drug submission?
Yes. An entity will incur facility fees if it manufactures any human drugs and is referenced in a generic drug submission on the facility fee due date.
Will a facility owner have to pay a GDUFA fee if the facility is referenced in a generic drug submission, but is only manufacturing drugs for the non-US market?
Does a facility that is not currently manufacturing an API or FDF have to pay the applicable facility fees?
A facility listed in a generic drug submission – pending or approved – incurs annual facility fees as long as it is identified in a generic drug submission, even if the facility has not started commercial-scale production of the API or FDF covered by that submission, or if the facility has stopped, temporarily or permanently, the production of that API or FDF. See question 38 for a description of how a facility can ensure that it is no longer identified in an ANDA.
The facility will cease to incur additional fees if it is no longer identified in any generic drug submission or has stopped manufacturing all APIs and FDFs (including both generic and non-generic APIs and FDFs) by the date that the fee is due. Any outstanding fee obligations will, however, remain due.
If a facility manufactures both FDFs and APIs for generic drugs, does it incur more than one facility fee?
Yes. Under GDUFA, such a facility incurs annual FDF and API facility fees. Any such facility incurs both fees regardless of whether the API is offered for sale as an API or is offered for sale only after it is further processed so as to become an FDF within the meaning of the statute.
Is a facility that manufactures an API excipient mixture or a mixture of two or more APIs used to produce FDFs required to pay an annual FDF facility fee?
Generally, manufacturers of API mixtures are required to pay the annual FDF facility fee. However, GDUFA provides one exception, for fee-paying purposes only, to the definition of in-process mixtures as FDF. GDUFA defines an API mixture as an API when it is produced because the API is unstable and cannot be transported on its own. Examples include: an API mixed with an antioxidant for chemical stability when the API is prone to oxidative degradation or an API excipient mixture for physical stability to maintain its amorphous form.
Any facility producing an API and further processing it with an excipient or another API is also required to pay an annual API fee, regardless of whether the API is offered for sale as an API or is offered for sale only after it is further processed so as to become an FDF within the meaning of the statute.
Who does FDA consider as a packager for purposes of GDUFA?
If you receive product prior to the point in the manufacturing process in which the drug is first packaged in a container/closure system specified in the “How Supplied” section of an approved ANDA and you package that product into such a container/closure system for the first time, you are a packager for purposes of GDUFA. Every ANDA specifies the forms in which the approved drug product may be distributed in the “How Supplied” section.
For example, if you receive bulk drugs and package them into the containers in which they are marketed, you are a packager.
You also are a packager if you receive product in a container/closure specified in the “How Supplied” section of an approved ANDA, and apply the FDA-approved prescription package labeling to that product for the first time.
Are facilities that manufacture atypical APIs required to pay API facility fees?
Facilities that process raw materials used to manufacture human generic drugs are generally required to pay annual facility fees if they supply a product that qualifies as an API as defined in GDUFA.
Are packagers required to pay FDF facility fees?
Packagers are considered to be manufacturers, regardless of whether that packaging is done pursuant to a contract or by the applicant itself. Such facilities are required to pay annual FDF facility fees. Repackagers are not required to pay facility fees under GDUFA.
Are quality control (QC) testing sites required to pay annual facility fees?
No. They are only required to self-identify.
Is there a difference in fees between foreign and domestic generic drug facilities?
Yes. GDUFA specifies that the amount of the fee for a facility located outside the United States and its territories and possessions shall not be less than $15,000 and not more than $30,000 higher than the amount of the fee for a domestic facility. The differential amount is designed to reflect the higher costs of inspections funded, in part, through GDUFA.
The cost differential is $15,000 and may be adjusted annually.
Do two locations of the same company have to pay separate facility fees?
The answer depends on geography. If the same company’s two locations manufacture a U.S. generic product and they are in different geographic locations, each has to pay an annual facility fee. However, separate buildings within close proximity are considered to be at one geographic location or address if:
- the activities in them are closely related to the same business enterprise;
- they are under the supervision of the same local management; and
- they are capable of being inspected by FDA during a single inspection
These are the same criteria used to evaluate whether separate FDA Facility Establishment Identifiers (FEIs) are necessary for multiple facilities (see draft guidance Self-Identification of Generic Drug Facilities, Sites, and Organizations).
If a firm believes that multiple FEIs have been assigned in error, the firm may request consolidation of the FEIs. Please note that consolidation of FEI numbers is not an appropriate mechanism to address a non-compliant facility. Domestic firms should submit the request to the appropriate FDA District office. Foreign firms should contact FDAGDUFAFEIRequest@fda.hhs.gov.
What is the penalty for failure to pay a facility fee?
There are several consequences for failure to pay a facility fee:
(1) no new generic drug submission referencing the facility will be received until the fee is paid
(2) the facility will be placed on a publicly available arrears list if the fee is not fully paid within 20 days of the due date
(3) FDA will notify the ANDA applicant of the facility’s failure to satisfy its user fee obligations.
Furthermore, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs manufactured in such a facility will be deemed misbranded. This means that it will be a violation of federal law to ship these products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products misbranded because of failure to pay facility fees are subject to being denied entry into the United States.
Additionally, goal dates will not apply to applications that have already been received but list facilities for which facility fees are owed. Please note that the fee is an obligation to the U.S. government, and the failure to pay the fee may result in collection activities by the government pursuant to applicable laws.
What is the FY 2016 DMF fees?
The FY 2016 DMF fee is $42,170.
Which DMFs incur fees?
Only DMFs that cover the manufacture of an API (Type II API DMFs) for use in a generic drug application incur fees. Specifically, each person who owns a Type II API DMF (DMF holder) 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 DMF fee.
When is a DMF fee incurred?
The owner of a DMF incurs the fee the first time that a generic drug submission references that DMF by an initial letter of authorization on or after October 1, 2012.
Do holders of DMFs submitted and reviewed by FDA before October 1, 2012, have to pay a DMF fee?
GDUFA does not make a distinction between DMFs submitted before or after October 1, 2012. Holders of DMFs reviewed prior to GDUFA implementation must pay the one-time DMF fee if their DMF is referenced in a new generic drug submission.
Do DMF holders incur a fee each time their DMF is referenced?
No. The DMF fee is a one-time fee, incurred on first reference of the DMF on or after October 1, 2012. This fee is not incurred every time a DMF is referenced.
When are DMF fees due?
DMF fees will be due no later than the date on which the first generic drug submission that references the associated DMF holder’s file is submitted.
Do DMF holders need to wait for a new ANDA applicant to request a letter of authorization before the DMF is assessed to be available for reference?
No. DMF holders can pay the fee before a letter of authorization is requested. The DMF will then undergo an initial completeness assessment, using factors articulated in the final guidance Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments. If the DMF passes the initial completeness assessment, FDA will identify the DMF on the Type II Drug Master Files – Available for Reference List.
Can an ANDA applicant pay the DMF fee for an API referenced in its submission?
What is the penalty for failure to pay the DMF fee?
The DMF will be deemed not available for reference. Once the DMF fee becomes due, no generic drug submission submitted referencing the DMF will be received unless the fee is paid and the DMF is deemed available for reference.
ANDA applicants that reference a DMF for which a fee is due but has not been paid will be provided notification of the DMF holder’s failure to satisfy the user fee obligation. If the DMF fee is not paid within 20 calendar days after notification, the ANDA referencing the DMF will not be received.
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).
When will ANDA and PAS filing fees be due?
ANDA and PAS fees will be due on the date of submission of the application.
If FDA refuses to receive an ANDA or PAS, is there any provision for a 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.
How does the ANDA sponsor receive the 75% refund if FDA has refused to receive the ANDA/PAS pursuant to section 505(j)(4) of the FD&C Act?
To request a refund, email CDERCollections@fda.hhs.gov and include your Tax ID number (required for all domestic companies) or DUNS number (required for all foreign companies), and the address where the refund should be sent. This information is required, and FDA cannot process a refund without it. To expedite the refund process, submit your refund request as soon as possible after an ANDA/PAS has been refused to receive. If you do not submit a refund request, FDA will initiate a refund during its periodic review of outstanding refunds.
If such a previously refused application is then resubmitted, will the applicant be required to pay another full fee at the time of resubmission?
When is a response to an RTR letter considered a resubmission?
A resubmission, which incurs a new ANDA filing fee, is a response to an RTR Letter that remedies all of the deficiencies (major, minor, eCTD) that are identified therein. A request for reconsideration without these remedies is not considered a resubmission and therefore not subject to a new ANDA filing fee.
What is the penalty for failure to pay the ANDA or PAS filing fee?
The ANDA or PAS will not be received unless the fee is paid within 20 calendar days of the due date.
If an ANDA or PAS applicant pays its filing fee more than 20 calendar days after the due date, what will FDA consider as the application’s date of submission?
If an applicant does not submit payment within 20 calendar days of the due date, its application will be deemed incomplete on the date of submission. So long as FDA finds that none of the disqualifications outlined in 21 CFR 314.101(d) and (e) apply, the application will be considered submitted as of the date all obligations are satisfied and the payments are received in full.
If an ANDA or PAS is withdrawn, will FDA issue a refund?
If an ANDA or PAS is withdrawn before the filing fee is paid, will the obligation to pay the fee remain?
Yes. An ANDA or PAS filing fee is incurred upon submission. Once the ANDA or PAS is submitted, the applicant is liable for paying that fee, even if the ANDA or PAS is withdrawn prior to satisfying the obligation.
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.
If a generic drug submission includes API information other than by reference to a DMF, 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 (XYZ Corp.) submits an ANDA that describes manufacture of APIs, not by reference to DMFs.
|Product||API||Facility that has not paid API fee|
|Drug X||Alpha||1, 2, 3|
In this example, XYZ Corp. 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
XYZ Corp. submits a new application for a second product with the following information about API manufacture other than by reference to a DMF:
|Drug Y||Alpha||1, 2, 3|
The one-time fee has already been paid for Alpha, Beta, and Gamma, so no additional fee is due for these components. In addition, XYZ Corp. has already paid for all of the extra facilities except for Gamma 2, so a new fee is only owed for Gamma 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
Are the references to fees for each API facility in the above example 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.
Is a PAS filing 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.
When should the application filing fee for a serially submitted ANDA be paid?
In some circumstances, ANDA applicants choose to serially submit complete ANDAs in anticipation of a patent being listed for a reference listed drug (RLD) that is protected by new chemical entity (NCE) exclusivity and has no other patents listed. This is done because the ANDA cannot be submitted until the final year of the five-year exclusivity period, and then only if the submitter is challenging the patent. A single payment for multiple submissions of the same ANDA is required.
Applicants who choose to serially submit complete ANDAs in anticipation of a patent being listed for a RLD that is protected by NCE exclusivity and has no other patents listed should refrain from remitting their application filing fee until such time as the applicant is instructed by OGD that it has a valid application. Once a patent has been listed and an application can therefore be received for review by OGD, an applicant will have 20 days in which to pay its user fee.
When is the GDUFA Cover Sheet required?
The GDUFA Cover Sheet is required for each of the following human generic drug user fees:
- Abbreviated new drug application (ANDA) or applicable amendment;
- Prior approval supplement (PAS) or applicable amendment;
- Type II active pharmaceutical ingredient (API) drug master file (DMF) that is referenced on or after October 1, 2012, in a generic drug submission to the FDA and for which the DMF fee has not already been paid;
- Generic drug facility which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce a finished dosage form (FDF) of a human generic drug or an API contained in a human generic drug; and
- Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date.
Note: A cover sheet is not required for all ANDA and PAS amendments. It is only applicable to an amendment that is adding API manufacturing information other than by reference to a Type II DMF which is subject to the Section 744B(a)(3)(F) fee under GDUFA.
How to fill out a GDUFA Cover Sheet?
Read the instructions below and then go to Create GDUFA Cover Sheet to fill out the form. A GDUFA Cover Sheet will be completed online using FDA’s User Fee System which requires the use of Microsoft Internet Explorer 7.0 or higher.
- Access the User Fee System at Create GDUFA Cover Sheet.
- Register your organization by providing information about your organization.
- Create a user account for your organization and provide contact information.
- Create a cover sheet by answering a series of questions and making appropriate selections.
- Submit the cover sheet to complete the process and determine the user fee amount owed. Upon submission, a User Fee Payment I.D. Number (PIN), which begins with the letters “GD”, is generated. The PIN must be referenced in your payment submission.
Additional instructions for the User Fee System and the process to create a GDUFA Cover Sheet can be located under the Frequently Asked Questions (FAQs) within the User Fee System. For detailed instructions to complete the GDUFA Cover Sheet, please access Form FDA 3794 - Instructions.
Note: A signed copy of a completed GDUFA Cover Sheet must be included in the following submissions to the FDA: ANDA or PAS submission (placed in the first volume with Form FDA 356h) and Type II API DMF submission.
What information is needed to complete a GDUFA Cover Sheet?
|Type II API DMF||
How are payments submitted?
A payment may be submitted by Pay.gov (electronic payment), check, bank draft, U.S. postal money order, or wire transfer. For all payment options, the payment must be made in U.S. currency drawn on a U.S. financial institution. FDA recommends that user fee payments be made in a timely manner to meet the required payment due date or to be received prior to an application submission. For application submissions, it is recommended that you send manual payments to the bank 4-5 business days before the application submission arrives at FDA so that there is no delay in starting the review of your application submission. Please follow the instructions below for your selected payment option:
|Pay.gov||Pay.gov is a web-based payment application that allows electronic payments to be made directly from your bank account. A payment can be initiated after submitting your cover sheet by clicking the “Pay Now” button and following the on-screen instructions to make payment. To pay later, log into your GDUFA User Fee account and access your cover sheet history page by clicking on the “Previous Cover Sheets” icon at the top of the page. Click the “Pay Now” link next to the User Fee Payment I.D. Number (PIN) you need to pay for.|
|Check, Bank Draft, or U.S. Postal Money Order||Payment must be made payable to the Food and Drug Administration and make reference to the User Fee Payment I.D. Number (PIN). The payment and a copy of your signed cover sheet must be mailed to one of the addresses shown below:
Payments by mail:
Payments by courier
Note: Contact the U.S. Bank at (314) 418-4013 if you have any questions concerning delivery by courier.
Contact your financial institution and provide the following information:
Bank Name | Telegraphic Name:
Account Number: 75060099
Routing Number: 021030004
SWIFT Number: FRNYUS33
Beneficiary: FDA | 8455 Colesville Road, COLE-14-14253| Silver Spring, MD 20993-0002
Description: Reference the User Fee Payment I.D. Number (PIN)
Note: Financial institutions may charge a wire transfer fee between $15 and $35. Please inquire about the wire transfer fee and include the additional amount with your user fee payment to ensure that your user fee is fully paid and to avoid making additional payments.
How to get help?
For technical assistance with the User Fee System or GDUFA Cover Sheet, please contact the User Fee Helpdesk at 301-796-7200 or email@example.com.
For assistance in understanding when a GDUFA Cover Sheet is required, please contact FDA’s Division of Drug Information at 866-405-5367 or 301-796-6707 or AskGDUFA@fda.hhs.gov.
Useful Links for GDUFA Cover Sheet and Payments:
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.
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.
To whom should correspondence be sent regarding user fee issues?
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 Office of User Fee Collections 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 Office of User Fee Collections 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 Office of User Fee Collections 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 firstname.lastname@example.org.
How does an applicant request a refund?
Persons should provide their written communication to the Office of User Fee Collections 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.
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.
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.
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.
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.
If a company believes that its appearance on the arrears list is in error, whom should it contact?
Persons should contact the Generic Drug User Fee staff at 301-796-7900 or CDERCollections@fda.hhs.gov.
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.
What is the start date for GDUFA fees?
The start date is October 1, 2012.
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.
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.
Questions for the Generic Drug User Fee staff? Email us at AskGDUFA@fda.hhs.gov or call us at 301-796-7900.
To send physical mail, please use the following addresses:
For US Mail:
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 3179
Silver Spring, MD 20993-0002
For Courier Delivery
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 3179
Silver Spring, MD 20903
Questions about making a payment or confirming the status of a payment? Email the User Fee Helpdesk at email@example.com or call 301-796-7200
Questions about Pay.gov? Email them at firstname.lastname@example.org or call 800-624-1373.