Generic Drug User Fee Amendments
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of the Generic Drug User Fee Amendments (GDUFA) through September 2022. Congress first enacted GDUFA in 2012, following negotiations between the FDA and industry and with input from public stakeholders. Congress enacted GDUFA to ensure patients have access to safe, high-quality, and affordable generic drugs. GDUFA enables FDA to assess industry user fees to bring greater predictability and timeliness to the review of generic drug applications.
This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information. More information about GDUFA II is available on the Generic Drug User Fee Amendments Implementation Activities page.
- See below for an important notice about Human Drug Applications transmitted to the FDA during the recent lapse in funding.
- NEW! Visit Points of Contact for Questions Related to Generic Drugs for information on topics related to the Generic Drugs Program and GDUFA.
- In preparation for the Fiscal Year (FY) 2020 GDUFA Generic Drug Applicant Program Fee, please confirm your affiliates and the approved ANDAs owned by you and your affiliates via the FDA CDER Direct NextGen Collaboration Portal. Note that, in accordance with the Federal Food, Drug, and Cosmetic Act (FDCA) § 744B, 21 U.S.C. § 379j–42 (b)(2)(E)(ii), ANDA withdrawal requests submitted by April 1, 2019 will be deemed to have been withdrawn for purposes of program fee size determinations for FY 2020. To ensure the Agency has enough time to process Transfers of Ownership, FDA encourages Applicants to submit this information by April 1st as well. Please note, all Withdrawal requests and Transfers of Ownership must be sent to the official record of the ANDA via the Electronic Submissions Gateway (ESG).
- The Generic Drug User Fees for Fiscal Year 2019 have been published. Please see the table below for the 2019 and 2018 rates.
- The agency has published information on the FDA website regarding how NDA and ANDA holders can submit the required one-time marketing status report to FDA.
FY 2019 User Fee Rates
|User Fee Type||FY 2019||FY 2018|
|ANDA||$ 178,799||$ 171,823|
|DMF||$ 55,013||$ 47,829|
|Program||Large Size||$ 1,862,167||$ 1,590,792|
|Medium Size||$ 744,867||$ 636,317|
|Small Size||$ 186,217||$ 159,079|
|Facility||Domestic API||$ 44,226||$ 45,367|
|Foreign API||$ 59,226||$ 60,367|
|Domestic FDF||$ 211,305||$ 211,087|
|Foreign FDF||$ 226,305||$ 226,087|
|Domestic CMO||$ 70,435||$ 70,362|
|Foreign CMO||$ 85,435||$ 85,362|
|Backlog||$ 17,434||$ 17,434|
*The one-time backlog fee was set in FY 2013 only. Those who have not paid for the incurred backlog fee may email CDERCollections@fda.hhs.gov for further assistance.
On July 9, 2012, GDUFA was signed into law by the President as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). 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 must be reauthorized every five years. On August 18, 2017, the President signed the bill reauthorizing GDUFA through September 30, 2022.
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.
- FDA Reauthorization Act of 2017 (FDARA)
- 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
GDUFA II includes a Generic Drug Applicant Program Fee, which is assessed annually. Each company and its affiliates will be assessed an annual program fee depending on the number of approved ANDAs in their portfolio. To determine the fee amount, there are three tiers of the program fee:
Large: 20 or more approved ANDAs;
Medium: between 6 and 19 approved ANDAs;
Small: 5 or fewer approved ANDAs
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.
Effective October 1, 2018, generic drug applicants and their affiliates, or an authorized representative, can submit the list of all approved ANDAs via the CDER Direct NextGen Collaboration Portal. Submissions will be for the upcoming Fiscal Years 2020-2022.
To register for an account with the CDER Direct NextGen Collaboration Portal, navigate to https://edm.fda.gov.
For more on logging in: CDER Direct NextGen Collaboration Portal FAQs
Due to processing times, you might encounter data discrepancies that might have an impact on your portfolio. If you encounter any discrepancies in your portfolio, please update your portfolio in the portal and submit as appropriate. Please note that Withdrawal Requests and Transfers of Ownership must be sent to the official record of the ANDA via the Electronic Submissions Gateway (ESG).
When is the Program fee due?
The program fee is due on October 1 of the fiscal year. If October 1 falls on a weekend, federal holiday, or day when the FDA is otherwise closed, then the fee is due on the following business day. Any ANDA approved after October 1 will be included in the parent company’s portfolio for the following fiscal year.
What is the penalty for not paying the program fee?
There are three effects if an applicant fails to pay the program fee: (1) If the program fee is not paid within 20 calendar days after the due date, the parent company will be placed on a publicly available arrears list. (2) Any ANDA submitted by the applicant or its affiliates will not be received. (3) All drugs marketed pursuant to any abbreviated new drug application held by such applicant or an affiliate of such applicant shall be deemed misbranded.
Are discontinued ANDAs included in the calculation of Program fees?
Yes, discontinued ANDAs are still considered approved ANDAs for user fee purposes unless these ANDAs are officially withdrawn.
If Company A that has 4 approved ANDAs is affiliated with Company B that has 16 approved ANDAs, can they pay a small and medium fee? Or, must they pay one large fee?
If Company A and B are affiliated, then they must pay one large fee. According to 21 U.S.C. § 379j-42(b)(2)(E), if a person has affiliates, a single program fee shall be assessed.
If two companies are affiliated, does the parent company have to pay the program fee or can the affiliate pay the fee?
Either the parent company or any of the affiliated companies can pay the program fee on behalf of the parent company.
When is the deadline for making changes to the approved ANDA list?
For FY 2019 through FY 2022, an ANDA shall be deemed not to be approved if the applicant has submitted a request for withdrawal of approval of such ANDA by April 1 of the previous fiscal year.
- For example, if a company has 6 approved ANDAs and a withdrawal request is submitted for one ANDA before or on April 1, 2019, then the company’s program fee tier would change from medium tier to small tier for FY 2020.
For transfers of ownership, consolidations, and other changes to a company’s portfolio, FDA will use the information effective as of October 1 to determine program fee tier.
- For example, if a company has 6 approved ANDAs and requests a consolidation of 2 ANDAs into 1, but the Office of Generic Drugs does not grant the consolidation request until after October 1, 2019, then the company’s tier would remain medium tier for FY 2020 (total remains 6 ANDAs).
- For example, if a company with 5 approved ANDAs is determined to be affiliated with another company with 1 approved ANDA, and the date of affiliation is prior to October 1, 2019, then the company’s tier would be medium tier for FY 2020. If the company had already paid the small tier, they would need to pay the difference between the medium tier fee and the small tier fee.
For other scenarios not listed, please contact CDERCollections@fda.hhs.gov for assistance.
When should the industry inform the Agency about their affiliates?
By April 1 of each year, each person that owns an ANDA, or a designated affiliate of such person, shall submit, on behalf of the person and the affiliates of such person, to the Agency a list of (1) all approved ANDAs owned by such person, and (2) if any affiliate of such person also owns an ANDA, all affiliates that own any such ANDA and all approved ANDAs owned by any such affiliate.
Please submit your responses to the CDER Direct NextGen Collaboration Portal.
Are there any drugs or applications excluded from the Program fee?
The following are excluded from the program fee: Positron emission tomography (PET) drugs, and applications submitted by a State or Federal Government entity for a drug that is not distributed commercially.
How does a company pay the program fee?
A company can create a program fee cover sheet via the User Fee System and then pay via check, wire transfer, or pay.gov.
What if the wrong tier is displayed on the coversheet?
Please submit your responses to the CDER Direct NextGen Collaboration Portal
What are the fee facility fee types under GDUFA II?
There are three types of facility fees: (1) an active pharmaceutical ingredient (API) facility fee; (2) finished dosage form (FDF) facility fee; and (3) Contract Manufacturing Organization (CMO) facility fee. If considered an API/FDF manufacturer or a CMO, a facility owner is required to pay an annual facility fee. Please refer to the GDUFA Fees table above for the exact fee amounts of each facility fee type.
Each person who owns a facility that is identified in (1) at least one approved generic drug submission in which the facility is approved to produce one or more APIs, or (2) a Type II API drug master file referenced in at least one approved generic drug submission incurs the API facility fee.
Each person who owns a facility that is identified in at least one generic drug submission that is approved to produce one or more FDFs incurs the FDF facility fee. Some FDF facilities may be qualified as Contract Manufacturing Organizations (CMOs). An annual CMO facility fee is owed by each person who owns an FDF facility that is identified in at least one approved ANDA, where the facility is not identified in an approved ANDA held by the owner of that facility or its affiliates. The CMO facility fee is one-third the amount of the FDF facility fee. A facility owner who qualifies as a CMO will owe the CMO facility fee; no other facility fee amount will be assessed.
Is there a difference in fees between foreign and domestic generic drug facilities?
Yes. GDUFA II specifies that 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 domestic facility. The basis for this differential is the extra cost incurred by conducting an inspection outside the United States and its territories and possessions.
When are facility fees due?
Facility fees are incurred annually and due on the first business day on or after October 1 of each fiscal year, or the first business day after the enactment of an appropriations act providing for the collection of fees for such year.
Under what conditions is a facility fee incurred?
Under GDUFA II, the owner of a facility incurs a fee when both of the following conditions are met on the facility fee due date:
- the facility is referenced in an approved generic drug submission; and
- the facility is engaged in manufacturing or processing an API or FDF
A facility does not incur a fee for being referenced only in pending generic drug submissions under GDUFA II.
Do all facilities, sites, and organizations that have to self-identify also have to pay facility fees?
No. 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 API and/or FDF contained in 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, facilities that are only referenced in applications submitted by State and/or Federal Government entities for drugs that are not distributed commercially, 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, subject to FDF or CMO facility fees.
If a facility is first identified in an 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 fiscal year?
No. If a facility is first identified in an approved generic drug submission after the due date for payment of the facility fee for a fiscal year, the facility is not required to pay the fee for that fiscal year. In most cases the critical question is whether there is a generic drug submission approved on the due date in which the facility is referenced.
If the facility is first identified in an approved generic drug submission after the due date, its owner will owe a facility fee on the next due date. For example, if a facility is first identified in an approved abbreviated new drug application on October 31, 2019 (fiscal year 2020), it will incur facility fees starting in fiscal year 2021. If a facility is identified in an approved generic drug submission on the due date, and that reference to the facility or the drug submission is later withdrawn, the fee will not be refunded.
Is a facility owner required to pay a GDUFA fee if the facility is manufacturing only non-generic APIs or FDFs, but is referenced in an approved generic drug submission?
Is a facility owner required to pay a GDUFA fee if the facility is referenced in an approved generic drug submission, but is only manufacturing drugs for the non-US market?
Is a facility that is not currently manufacturing an API or FDF required to pay the applicable facility fees?
A facility listed in at least one approved generic drug submission 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.
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.
See Section VIII.F. of the guidance for industry Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 for a description of how a facility can ensure that it is no longer identified in an ANDA.
If a facility manufactures both APIs and FDFs for generic drugs, does it incur more than one facility fee?
No. Under GDUFA II, if a facility is identified in one or more approved generic drug submissions to produce both APIs and FDFs, the facility will only incur the annual FDF fee.
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.
Whom does FDA consider as a packager for purposes of GDUFA?
If a facility receives 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 it packages that product into such a container/closure system for the first time, the facility is a packager for the 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 a facility receives bulk drugs and packages them into the containers in which they are marketed, that facility is a packager.
A facility is also a packager if it receives product in a container/closure specified in the “How Supplied” section of an approved ANDA and applies 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 or CMO 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.
Are two locations of the same company required 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:
1. the activities in them are closely related to the same business enterprise;
2. they are under the supervision of the same local management; and
3. 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 final guidance for industry 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 ANDA or supplement submitted by the person responsible for paying the fee or that person’s affiliates will be received;
(2) No new generic drug submission referencing the facility will be received until the fee is paid;
(3) 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; and
(4) 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.
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 on whichever of the following dates occurs earlier: 1) the first time that a generic drug submission references that DMF by an initial letter of authorization on or after October 1, 2012, or 2) the date the DMF holder requests the initial completeness assessment.
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 after October 1, 2012.
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, or when the DMF holder requests the initial completeness assessment, whichever occurs earlier. This fee is not incurred every time a DMF is referenced.
When are DMF fees due?
A drug master file fee shall be due on the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file or the date the drug master file holder requests the initial completeness assessment, whichever occurs earlier.
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.
When will the ANDA filing fee be due?
>ANDA fees will be due on the date the application is deemed submitted.If FDA refuses to receive an ANDA, is there any provision for a partial refund of the application fee?
FDA will refund 75% of the application fee for the fiscal year in which the application is deemed submitted.
How does the ANDA sponsor receive the 75% refund if FDA has refused to receive the ANDA pursuant to section 505(j)(4) of the FD&C Act?
To request a refund, fill out Form 3913 and email the form to CDERCollections@fda.hhs.gov. Include the 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 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 of an ANDA is a formal response to a refuse-to-receive (RTR) determination and is submitted to the ANDA refused for receipt. Submission of a dispute of an RTR determination without attempting to remedy the deficiencies (i.e., without resubmitting the ANDA) is not considered a resubmission and is therefore not subject to a new ANDA filing fee.
What is the penalty for failure to pay the ANDA filing fee?
The application or supplement to an application will be deemed incomplete on the date of submission and will not be received.
If an ANDA 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?
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 is withdrawn, will FDA issue a refund?
Yes, companies are entitled to a 75% refund of the application fee if the application is withdrawn prior to being received.
If an ANDA is withdrawn before the filing fee is paid, will the obligation to pay the fee remain?
Yes. An ANDA filing fee is incurred upon submission. Once the ANDA is submitted, the applicant is liable for paying that fee.
What is a generic drug submission?
The phrase generic drug submission refers to an ANDA, an amendment to an ANDA, or a Prior Approval Supplement (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. An applicant is required to pay an API information fee for a generic drug submission that contains information concerning the manufacture of an API at a facility by means other than reference by a letter of authorization to a Type II active pharmaceutical DMF, and for which a fee in the amount equal to the DMF fee has not been previously paid. Similar to the DMF fee, this fee is paid only once.
An additional API information fee must be paid for each description, contained in a particular application, of the manufacture of an API by one facility. Therefore, the total amount of the API information fees for a particular application is a function of the number of APIs referenced in the application and the number of facilities in which those APIs are manufactured. The API information fee must be paid for each description of the manufacture of an API by a particular API facility, provided a DMF or API information fee has not already been paid for the manufacture of the same API by the same facility.
Because the calculation is potentially confusing, we provide the following two examples.
An applicant (XYZ Corp.) submits an ANDA that, rather than referencing a DMF, describes the manufacture of three APIs at one or more facilities. No previous API information or DMF fee has been paid for the manufacturing of the APIs by these facilities.
|Product||API||Facility that has not paid API fee|
|Drug X||Alpha||1, 2, 3|
In this example, XYZ Corp. owes the following API information fee:
Fee = (APIs (Alpha + Beta + Gamma) + extra facilities (Alpha 2 + Alpha 3 + Beta 2)) x DMF Fee Amount
= (3 APIs + 3 Extra facilities) x DMF Fee Amount
= 6 x DMF Fee Amount
XYZ Corp. then 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 the description of the manufacture of API Alpha at Facility 1, 2, and 3; API Beta at Facility 1 and 2, and API Gamma at Facility 1, so no additional fee is due with respect to these facilities.
The applicant owes and API information fee for the following:
Fee = (additional API Delta + manufacture of API Gamma at Facility 2) x DMF fee Amount
= (1 API + 1 extra facility) x DMF Fee Amount
= 2 x DMF Fee Amount
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.
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:
- Generic drug applicant program fee;
- Abbreviated new drug application (ANDA) 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 in not required for all ANDA amendments and PAS. It is only applicable to a PAS or 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 (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?
|Generic Drug Applicant Program Fee||
|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 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, 5901B Ammendale Road, Beltsville, MD, 20705.
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 firstname.lastname@example.org.
How does an applicant request a refund?
Persons should provide their written communication to the Division of User Fee Management and Budget Formulation 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?
Delinquent companies will receive an invoice from FDA detailing information on the user fee incurred, the due date, and payment instructions. If full payment is not received by the date specified on the invoice, interest will be charged at a rate set by the U.S. Department of the Treasury. In addition, delinquent invoices will have a $20 administrative fee assessed for each 30-day period that the invoice remains outstanding. A penalty of 6 percent per year will be assessed on any invoices delinquent for more than 90 days, in accordance with 45 CFR 30.18.
Are there any exemptions from the fees for categories of drugs?
Positron Emission Tomography (PET) drug manufacturers and State or Federal Government entities, sponsoring or manufacturing drugs that are not distributed commercially, are excluded from payment of GDUFA fees.
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 and program 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 Division of User Fee Management and Budget Formulation 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 for GDUFA I is October 1, 2012, and for GDUFA II is October 2, 2017.
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.
- GDUFA 5 Year Financial Plan (2018) (PDF - 420KB)
- User Fee Lists
- Self-Identification of Generic Drug Facilities, Sites and Organizations
- Guidance Documents and MAPPs
- Annual Reports and Plans
- GDUFA Regulatory Science
- GDUFA Presentations and Speeches
- GDUFA Glossary
- FAQ: How GDUFA Affects ANDA Submissions
- Fact Sheets - FDA Archive
Questions for the Division of User Fee Management and Budget Formulation? Email us at CDERCollections@fda.hhs.gov or call us at 301-796-7900.
To send physical mail, please use the following addresses:
For US Mail:
Division of User Fee Management and Budget Formulation
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993-0002
For Courier Delivery
Division of User Fee Management and Budget Formulation
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20903
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.
Questions about Pay.gov? Email them at firstname.lastname@example.org or call 800-624-1373.