Assessing User Fees 
Under the Generic Drug 
User Fee Amendments 
of 2022 
 
Guidance for Industry 
 
FINAL GUIDANCE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
June 2023 
User Fees 
 
 
   
 
Assessing User Fees 
Under the Generic Drug 
User Fee Amendments 
of 2022 
 
Guidance for Industry 
 
 
Additional copies are available from: 
 
Office of Communications, Division of Drug Information 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor 
Silver Spring, MD 20993-0002 
Phone: 855-543-3784 or 301-796-3400; Fax: 301-847-8714 
Email: druginfo@fda.hhs.gov 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
June 2023 
User Fees 
 
 
  Contains Nonbinding Recommendations 
 
TABLE OF CONTENTS 
Contents 
I.  INTRODUCTION ...............................................................................................................1 
II.  BACKGROUND ..................................................................................................................2 
III.  DEFINITIONS .....................................................................................................................2 
IV.  CHANGES TO THE FEE STRUCTURE OF THE GDUFA USER FEE PROGRAM
  4 
V.  BACKLOG FEES ................................................................................................................5 
VI.  DRUG MASTER FILE FEES ............................................................................................5 
VII.  ABBREVIATED NEW DRUG APPLICATION FILING FEES ...................................6 
A.  Refunds or Transfers for Refusal to Receive, Withdrawals, and Inappropriate 
Receipts .......................................................................................................................................6 
B.  Resubmissions .....................................................................................................................7 
C.  Exemptions to the Application Filing Fee .........................................................................7 
D.  Fee for API Information Not Included by Reference to DMF - (a)(3)(F) Fee ...............8 
E.  Serially Submitted ANDAs.................................................................................................8 
F.  Withdrawn ANDAs .............................................................................................................9 
VIII.  FACILITY FEES ................................................................................................................9 
A.  API and FDF Facility Fees ...............................................................................................10 
B.  Exceptions to Facility Fees ...............................................................................................10 
C.  Dual Operation Facilities Only Incur FDF Facility Fees ..............................................10 
D.  Contract Manufacturing Organizations .........................................................................11 
E.  Foreign-Facility Fee Differential .....................................................................................11 
F.  Withdrawal of Facility from Reference ..........................................................................11 
G.  Packagers and Repackagers.............................................................................................13 
H.  API-Excipient Mixtures....................................................................................................14 
I.  Atypical APIs .....................................................................................................................14 
i  Contains Nonbinding Recommendations 
J.  Facilities That Cease Manufacturing ..............................................................................15 
K.  Fees for Multiple Locations of the Same Entity .............................................................15 
IX.  GENERIC DRUG APPLICANT PROGRAM FEE ......................................................16 
A.  GDUFA Program Fee Structure ......................................................................................16 
B.  Single Fee for an ANDA Applicant and Its Affiliates ....................................................17 
C.  Submitting Information to FDA ......................................................................................17 
D.  Timing for Withdrawal of ANDAs ..................................................................................17 
X.  DETERMINING AFFILIATION ....................................................................................17 
XI.  FAILURE TO PAY FEES ................................................................................................18 
A.  Backlog Fees ......................................................................................................................18 
B.  DMF Fees ...........................................................................................................................18 
C.  ANDA Filing Fees .............................................................................................................19 
D.  Fee for API Information Not Included by Reference to DMF - (a)(3)(F) Fee .............19 
E.  Facility Fees .......................................................................................................................19 
F.  GDUFA Program Fees .....................................................................................................20 
XII.  PAYMENT INFORMATION AND PROCEDURES ....................................................20 
A.  Payment Procedures for GDUFA Fees ...........................................................................20 
B.  Acceptable Forms of Payment .........................................................................................21 
C.  Timely Payment of Fees ....................................................................................................21 
D.  Refund and Transfer Requests ....................................................................................21 
E.  Non-Payment of GDUFA Fees .........................................................................................22 
F.  Cover Sheet for PET Manufacturers and Non-Commercial Government Entities ...22 
G.  Waivers of and Reductions to GDUFA Fees ..................................................................22 
H.  Arrears Lists ......................................................................................................................23 
I.  Submitting Generic Drug Submissions ...........................................................................23 
XIII.  APPEALS PROCESS .......................................................................................................24 
ii  Contains Nonbinding Recommendations 
A.  Reconsideration Request ..................................................................................................24 
B.  Appeal Request..................................................................................................................24 
XIV.  OTHER RESOURCES .....................................................................................................25 
APPENDIX 1: FORM FDA 3913 ...............................................................................................26 
APPENDIX 2: FORM FDA 3914 ...............................................................................................27 
 
 
 
iii  Contains Nonbinding Recommendations 
Assessing User Fees Under the Generic Drug User Fee 
Amendments of 2022 
Guidance for Industry1
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations. To discuss an alternative approach, contact the FDA office 
responsible for this guidance as listed on the title page.  
 
 
I.  INTRODUCTION 
 
This guidance provides information to stakeholders regarding FDAs implementation of the 
Generic Drug User Fee Amendments of 2022 (GDUFA III) under Title III of the FDA User Fee 
Reauthorization Act of 2022.2  Because GDUFA III created changes to the user fee structure, 
this guidance serves to provide an explanation about the new fee structure and types of fees for 
which entities are responsible.  
 
This guidance describes the types of user fees authorized by GDUFA III, and the processes for 
submitting payments to FDA, the consequences for failing to pay generic drug user fees, and the 
process for requesting a reconsideration of a user fee assessment previously developed under 
earlier GDUFA authorizations.  This guidance also describes how FDA determines affiliation 
for purposes of assessing generic drug user fees.  FDA will issue separate guidance documents 
regarding GDUFA III non-user fee requirements and processes.  This guidance does not address 
how FDA determines and adjusts fees for each fiscal year,3 nor does it address FDAs 
implementation of other user fee programs (e.g., under the Prescription Drug User Fee Act 
(PDUFA) or Biosimilar User Fee Act (BsUFA)).  Throughout this guidance, references to user 
fees or the user fee program indicate generic drug user fees assessed and collected under section 
744B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). 
 
Changes to statutory provisions described in this guidance are effective with respect to fees 
assessed beginning on the first day of fiscal year (FY) 2023.4 
 
 
1 This guidance has been prepared by the Division of User Fee Management, Office of Management, in the Center 
for Drug Evaluation and Research at the Food and Drug Administration. You may submit comments on this 
guidance at any time.  Submit comments to Docket No. FDA-2017-D-6821 (available at 
https://www.regulations.gov/docket?D=FDA-2017-D-6821).  See the instructions in that docket for submitting 
comments on this and other Level 2 guidances.   
2 Division F of the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, P.L. 117-180. 
3 In general, FDA will publish in the Federal Register the fee revenue and fee amounts for each fiscal year not later 
than 60 days before the start of each fiscal year (section 744B(d)(1) of the FD&C Act (21 U.S.C 379j-42)).   
4 FDAs fiscal year begins on October 1 and ends on September 30. 
1 
  Contains Nonbinding Recommendations 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
II.  BACKGROUND 
 
The Generic Drug User Fee Amendments of 2012 (GDUFA I)5 amended the FD&C Act to 
authorize FDA to assess and collect user fees to provide the Agency with resources to help 
ensure patients have access to quality, affordable, safe, and effective generic drugs.  GDUFA fee 
resources6 bring greater predictability and timeliness to the review of generic drug applications.   
GDUFA has been reauthorized every five years to continue FDAs ability to assess and collect 
GDUFA fees and this user fee program has been reauthorized two times since GDUFA I, most 
recently in Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023.7  As 
described in the GDUFA III commitment letter applicable to this latest reauthorization,8 FDA 
has agreed to performance goals and program enhancements regarding aspects of the generic 
drug assessment program that build on previous authorizations of GDUFA.  New enhancements 
to the program are designed to maximize the efficiency and utility of each assessment cycle, with 
the intent of reducing the number of assessment cycles for ANDAs and facilitating timely access 
to generic medicines for American patients.  
 
GDUFA III extends FDAs authority to assess and collect user fees for FY 2023 through FY 
2027 and revises the fees that the Agency collects and how it collects some fees.  
 
III.  DEFINITIONS 
 
For purposes of this guidance: 
 
  The term abbreviated new drug application means an application submitted under 
section 505(j) of the FD&C Act (21 U.S.C. 355(j)), an abbreviated application submitted 
under former section 507 of the FD&C Act (now repealed), or an abbreviated new drug 
application submitted pursuant to regulations in effect prior to the implementation of the 
Drug Price Competition and Patent Term Restoration Act of 1984.  The term does not 
include an application for a positron emission tomography drug and does not include an 
application submitted by a State or Federal Government entity for a drug that is not 
distributed commercially.9 
 
  The term active pharmaceutical ingredient means (A) a substance, or a mixture when 
the substance is unstable or cannot be transported on its own, intended (i) to be used as a 
 
5 Title III of the Food and Drug Administration Safety and Innovation Act (Public Law 112-144). 
6 User fees are available for obligation in accordance with appropriations acts. 
7 See Division F, Title III of the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 
(Public Law 117-180). 
8 The GDUFA III Commitment Letter is available at https://www.fda.gov/media/153631/download. 
9 Section 744A(1) of the FD&C Act. 
2 
  Contains Nonbinding Recommendations 
component of a drug; and (ii) to furnish pharmacological activity or other direct effect in 
the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the 
structure or any function of the human body; or (B) a substance intended for final 
crystallization, purification, or salt formation, or any combination of those activities, to 
become a substance or mixture as described in (A) above.10 
 
  The term affiliate means a business entity that has a relationship with a second business 
entity if, directly or indirectly (A) one business entity controls, or has the power to 
control, the other business entity; or (B) a third-party controls, or has power to control, 
both of the business entities.11 
 
  The term contract manufacturing organization facility means a manufacturing facility 
of a finished dosage form of a drug approved pursuant to an ANDA where such 
manufacturing facility is not identified in an approved ANDA held by the owner of such 
facility or an affiliate of such owner or facility.12 
 
  The term facility means 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 active pharmaceutical ingredient or a finished dosage form and does not 
include a business or other entity whose only manufacturing or processing activities are 
one or more of the following: repackaging, relabeling, or testing.  
 
o  For the purposes of facility as defined here, 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, under the supervision of the same 
local management, and capable of being inspected by the FDA during a single 
inspection.   
 
o  If a business or other entity would meet the definition of a facility as defined here but 
for being under multiple management, the business or other entity is deemed to 
constitute multiple facilities, one per management entity, for purposes of this 
guidance.13  
 
  The term finished dosage form (FDF) means (A) a drug product in the form in which it 
will be administered to a patient, such as a tablet, capsule, solution, or topical application; 
(B) a drug product in a form in which reconstitution is necessary prior to administration 
to a patient, such as oral suspensions or lyophilized powders; or (C) any combination of 
an active pharmaceutical ingredient with another component of a drug product for 
purposes of production of a drug product described in (A) or (B) above.14 
 
 
10 Section 744A(2) of the FD&C Act. 
11 Section 744A(4) of the FD&C Act. 
12 Section 744A(5) of the FD&C Act; see Sections IV (Changes to the Fee Structure of the GDUFA User Fee 
Program) and Section VIII (Facility Fees) for more information. 
13 Section 744A(6) of the FD&C Act.  The FDA Establishment Identifier (FEI) is used to identify unique facilities. 
14 Section 744A(7) of the FD&C Act. 
3 
  Contains Nonbinding Recommendations 
  The term generic drug submission means an ANDA, an amendment to an ANDA, or a 
prior approval supplement to an ANDA.15  
 
  The term person includes an individual, partnership, corporation, and association.16 
 
  The term positron emission tomography drug means a drug that exhibits spontaneous 
disintegration of unstable nuclei by the emission of positrons and is used for the purpose 
of providing dual photon positron emission tomographic diagnostic images, and includes 
any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target 
material, electronic synthesizer, or other apparatus or computer program to be used in the 
preparation of such a drug.17 
 
  The term prior approval supplement means a request to the Secretary to approve a 
change in the drug substance, drug product, production process, quality controls, 
equipment, or facilities covered by an approved ANDA when that change has a 
substantial potential to have an adverse effect on the identity, strength, quality, purity, or 
potency of the drug product as these factors may relate to the safety or effectiveness of 
the drug product.18  
         
  The term Type II active pharmaceutical ingredient drug master file means a submission 
of information to the Secretary by a person that intends to authorize FDA to reference the 
information to support approval of a generic drug submission without the submitter 
having to disclose the information to the generic drug submission applicant.19 
 
IV.  CHANGES TO THE FEE STRUCTURE OF THE GDUFA USER FEE 
PROGRAM 
 
Previously, section 744B directed FDA to set annual fee amounts for each fiscal year so that 
drug master file (DMF) fees would account for 5 percent, ANDA fees 33 percent, active 
pharmaceutical ingredient (API) facility fees 7 percent, generic drug FDF facility fees 20 
percent, and generic drug applicant program fees (GDUFA program fees) 35 percent of the total 
revenue amount determined for a fiscal year.20  In addition, under GDUFA II, facilities that 
qualified as contract manufacturing organizations (CMOs) paid 1/3 the amount of the FDF 
facility fee.21     
 
Under GDUFA III, DMF fees will account for 5 percent (no change), ANDA fees 33 percent (no 
change), API facility fees 6 percent (a change from 7 percent), FDF facility fees 20 percent (no 
change), and GDUFA program fees 36 percent (a change from 35 percent) of the total revenue 
 
15 Section 744A(8) of the FD&C Act. 
16 Section 201(e) of the FD&C Act; (21 U.S.C. 321(e). 
17 Section 744A(10) of the FD&C Act; section 201(ii) of the FD&C Act. 
18 Section 744A(11) of the FD&C Act. 
19 Section 744A(13) of the FD&C Act. 
20 Section 744B(b) of the FD&C Act (2018 ed.).  While in almost all cases applicants that owed backlog fees have 
now paid those fees, this obligation remains part of the statute.  
21 Section 744B(b)(2)(C) of the FD&C Act (2018 ed.). 
4 
  Contains Nonbinding Recommendations 
amount determined for a fiscal year.  In addition, under GDUFA III, CMOs will pay 24 percent 
of the FDF facility fee.   
  
V.  BACKLOG FEES 
 
Under GDUFA, each person that owns an ANDA that was pending on October 1, 2012, and that 
has not received a tentative approval prior to that date, owes a backlog fee for such application.22 
 
The backlog fee was due no later than November 26, 2012.  The final backlog fee is $17,434. 
See Federal Register notice Generic Drug User Fee  Backlog Fee Rate for Fiscal Year 2013 
for additional details (77 FR 65199 (October 25, 2012), available at 
https://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/2012-26257.pdf). 
 
An original ANDA was considered to be pending and subject to the backlog fee if, as of 
September 28, 2012, FDA had not tentatively approved, approved, or refused to receive the 
application.23  See Federal Register Notice of Opportunity to Withdraw Abbreviated New Drug 
Applications to Avoid Backlog Fee Obligations for additional details (77 FR 51816 (August 27, 
2012), available at https://www.gpo.gov/fdsys/pkg/FR-2012-08-27/html/2012-20947.htm). 
 
VI.  DRUG MASTER FILE FEES 
 
Each person that owns a Type II API DMF that is referenced on or after October 1, 2012, in a 
generic drug submission by any initial letter of authorization is assessed a one-time DMF fee 
under GDUFA.24  
 
The DMF fee is due on the earlier of the following:  
 
  The date on which the first generic drug submission is submitted that references the 
associated Type II API DMF by an initial letter of authorization. 
  The date the DMF holder requests the initial completeness assessment.25 
 
For a DMF referenced in an ANDA prior to GDUFA I implementation, the one-time DMF fee 
must be paid if the DMF is newly referenced in a generic drug submission on or after October 1, 
2012.  
 
Type II API DMF holders do not need to wait for a new ANDA applicant to request a letter of 
authorization before the DMF is assessed to be available for reference.  DMF holders can pay 
the fee before a letter of authorization is requested by ANDA applicants.  FDA strongly 
encourages the DMF holder to submit a complete DMF and pay the DMF fee at least 6 months 
prior to the submission of an ANDA or PAS that will rely on the DMF.  The DMF will then 
 
22 Section 744B(a)(1)(A) of the FD&C Act.  GDUFA II contains a sunset provision of October 1, 2022, for backlog 
fees (see section 744B(a)(1)(E) of the FD&C Act). 
23 Receipt of an ANDA means that FDA has made a threshold determination that the ANDA is substantially 
complete (21 CFR 314.101(b)(1)). 
24 Section 744B(a)(2)(A) of the FD&C Act. 
25 Section 744B(a)(2)(E)(i) of the FD&C Act. 
5 
  Contains Nonbinding Recommendations 
undergo an initial completeness assessment using factors articulated in FDAs guidance for 
industry Completeness Assessments for Type II API DMFs Under GDUFA (October 2017, rev. 
1).26  DMFs for which the fee has been paid and which have not been found incomplete in 
accordance with the completeness assessment will be identified on FDAs Type II Drug Master 
Files  Available for Reference List,27 as available, for reference in support of a generic drug 
submission. 
 
VII.  ABBREVIATED NEW DRUG APPLICATION FILING FEES 
 
GDUFA III continues to authorize the assessment of a user fee on certain human generic drug 
applications.  A fee is assessed for each ANDA submitted to FDA on or after October 1, 2012.  
ANDA fees are due no later than the date of submission of the ANDA.28 
 
A.  Refunds or Transfers for Refusal to Receive, Withdrawals, and 
Inappropriate Receipts 
 
If FDA considers an ANDA not to have been received for reasons not related to failure to pay fees 
(i.e., FDA determines that the ANDA is not substantially complete), then 75 percent of the filing 
fee paid will be refunded to the applicant without requiring the applicant to submit a written 
refund request.  Under the current GDUFA authorization, 75 percent of the application filing fee 
paid will continue to be refunded for an application that has been withdrawn prior to being 
received within the meaning of section 505(j)(5)(A) of the FD&C Act.29  
 
If FDA initially receives an ANDA and subsequently determines that a period of exclusivity for 
the reference listed drug should have prevented that receipt so that the ANDA is no longer 
considered received, FDA will refund 100 percent of the fee paid for that ANDA.30  
 
FDA encourages applicants to submit refund requests as soon as possible to expedite the refund 
process.  To request a refund, applicants should fill out Form FDA 3913 and email the form to 
CDERCollections@fda.hhs.gov.  Form FDA 3913 is attached as Appendix 1 and is available at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492188.pdf.  
 
Applicants should include the Federal Tax Identification Number (TIN), also known as the 
Employer Identification Number (EIN) (for all domestic companies) or Data Universal 
Numbering System (DUNS) number (for all foreign companies) and the address where the 
refund should be sent.31  This information is necessary for FDA to process a refund, and FDA 
cannot process a refund without it.  If an applicant is entitled to a refund and does not submit a 
 
26 FDA updates guidances periodically.  For the most recent version of a guidance, check the FDA guidance web 
page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.  
27 Available at https://www.fda.gov/drugs/forms-submission-requirements/drug-master-files-dmfs.  
28 Section 744B(a)(3)(C) of the FD&C Act. 
29 Section 744B(a)(3)(D)(i) of the FD&C Act.  
30 Section 744B(a)(3)(D)(ii) of the FD&C Act. 
31 GDUFA Cover Sheet Clarifications: Facility, available at 
https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm393190.htm.  
6 
  Contains Nonbinding Recommendations 
refund request, FDA may initiate a refund during its periodic review of outstanding refunds (see 
Section XII.D below).  
 
If an applicant resubmits an application that FDA previously considered not to have been 
received, the applicant will be required to pay the full fee at the time of resubmission.  Similarly, 
an applicant who withdraws an application before it is received for substantive technical review 
and then submits a new ANDA for that product must pay the full fee upon submission of the new 
ANDA.32 
 
In either circumstance, if an applicant plans to resubmit the application in the near future, FDA 
no longer permits the administrative action of applying a previously paid GDUFA fee (also 
referred to as a transfer) from a closed-out fiscal year cover sheet to a different fiscal year 
cover sheet.  
  
For additional information regarding refund and transfer requests, please see Section XII.D. 
 
B.  Resubmissions 
 
A resubmission of an ANDA is a formal response to a refuse-to-receive determination and is 
submitted to the ANDA that was refused for receipt.33  Accordingly, a full ANDA filing fee is 
due upon resubmission of the ANDA that FDA had refused to receive.  Submission of a dispute 
of a refuse-to-receive 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. 
 
FDA no longer permits the administrative action of applying a previously paid GDUFA fee (also 
referred to as a transfer) from a closed-out fiscal year cover sheet to a different fiscal year 
cover sheet.  For additional information regarding transfer requests, please see Section XII.D. 
 
C.  Exemptions to the Application Filing Fee 
 
An applicant will not incur an ANDA filing fee under the following circumstances:34 
 
  The application is for a positron emission tomography (PET) drug. 
  The application is submitted by a State or Federal Government entity for a drug that is not 
distributed commercially. 
 
Approved applications of the types described in this section will also not be considered in the 
determination of GDUFA program fees (see Section IX below).  
 
 
 
 
32 Section 744B(a)(3)(E) of the FD&C Act. 
33 See FDAs draft guidance for industry ANDA Submissions  Refuse-to-Receive Standards: Questions and 
Answers (October 2017).  When final, this guidance will represent the FDAs current thinking on this topic. 
34 Sections 744A(1)(B) and 744B(l) of the FD&C Act. 
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  Contains Nonbinding Recommendations 
D.  Fee for API Information Not Included by Reference to DMF - (a)(3)(F) Fee 
 
An applicant is required to pay an additional fee, also known as the (a)(3)(F) fee (because this 
fee is referenced in section 744B(a)(3)(F) of the FD&C Act), 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 API DMF. 
 
Under GDUFA, this (a)(3)(F) fee must be paid for each combination of API and the APIs 
manufacturing facility, provided that a DMF fee or (a)(3)(F) fee has not already been paid for the 
manufacture of the same API by the same facility.  The (a)(3)(F) fee amount for each API and 
facility combination is equal to the DMF fee and is paid only once. 
 
Example: 
 
An applicant (XYZ Corp.) submits an ANDA that, rather than referencing a DMF, describes the 
manufacture of three APIs at one or more facilities.  The (a)(3)(F) fee has been paid for the 
combination of API Beta manufactured at Facility 2. 
 
Product  API  API Manufacturing Facility 
Drug X  Alpha  1, 2, 3 
  Beta  1, 2 
  Gamma   1 
 
In this example, the calculation for the (a)(3)(F) fee that XYZ Corp. owes is as follows: 
 
(a)(3)(F) Fee API-Facility combinations:  
 
(Alpha-Facility 1) + (Alpha-Facility 2) + (Alpha-Facility 3) + (Beta-Facility 1) + (Gamma-
Facility 1) = 5 unpaid API-Facility combinations* 
*Note: The Beta-Facility 2 combination has been paid and is, therefore, not included. 
 
(a)(3)(F) fee amount = (5 API-Facility combinations) x DMF fee amount 
 
= 5 x DMF fee amount 
 
This information must be listed correctly in the Generic Drug User Fee Cover Sheet (Form FDA 
3794) for the generic drug submission. 
 
E.  Serially Submitted ANDAs 
 
In the past, some ANDA applicants chose to serially submit complete ANDAs containing 
paragraph IV certifications in anticipation of a newly listed patent for a reference listed drug.35 
However, these serial submissions with such paragraph IV certifications are not permitted 
 
35 For a description of ANDA patent certifications, see FDAs draft guidance for industry 180-day Exclusivity: 
Questions and Answers (January 2017).  When final, this guidance will represent FDAs current thinking on this 
topic.  
8 
  Contains Nonbinding Recommendations 
under FDA regulations.36  ANDA applicants must not submit a paragraph IV certification earlier 
than the first working day after the day the patent is listed in FDAs Approved Drug Products 
with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.37  The 
regulations reflect FDAs judgment that permitting serial submissions of amendments and 
multiple notices of paragraph IV certifications is overly burdensome to FDA and new drug 
application applicants.  In this situation, applicants should remit their application filing fee with 
their ANDA on the first working day after the day the relevant patent is listed in the Orange Book 
or, if the application is not submitted on that date, the application filing fee should be remitted on 
the date the application is submitted. 
 
F.  Withdrawn ANDAs 
 
Once a fee is incurred, it must be paid notwithstanding what happens to the application. 
Accordingly, an ANDA that is withdrawn still owes the fee.  However, if an application is 
withdrawn before being received, the applicant is eligible for a 75 percent refund of the ANDA 
filing fee.38 
 
VIII.  FACILITY FEES 
 
Under the current GDUFA authorization, the owner of a facility continues to incur 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.39 
 
See Section VIII.J for further discussion of when fees may be incurred. 
 
A facility does not incur a fee for being referenced only in pending generic drug submissions. 
 
Note that under the statute, an entity meeting the two criteria above will incur a facility fee 
liability regardless of whether it is actually manufacturing or processing the API or FDF for 
which the facility is referenced in the approved generic drug submission.  For example, if a 
facility is referenced in an approved generic drug submission, and at the time of fee assessment it 
is manufacturing any API or FDF, including only brand-name FDF (or only API used in a brand-
 
36 See 81 FR 69580, 69610 (October 6, 2016), citing 21 CFR 314.94(a)(12)(viii)(C)(1)(ii) and 21 CFR 314.95(b)(2). 
37 Available at https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-
equivalence-evaluations-orange-book. See 21 CFR 314.94(a)(12)(viii)(C)(1)(ii) (An applicant must submit an 
appropriate patent certification or statement under paragraph (a)(12)(i) and/or (iii) of this section if, after submission 
of the ANDA, a new patent is issued by the U.S. Patent and Trademark Office that, in the opinion of the applicant 
and to the best of its knowledge, claims the reference listed drug or that claims an approved use for such reference 
listed drug and for which information is required to be filed under section 505(b) and (c) of the Federal Food, Drug, 
and Cosmetic Act and 21 CFR 314.53.  For a paragraph IV certification, the certification must not be submitted 
earlier than the first working day after the day the patent is published in the list.). 
38 Section 744B(a)(3)(D)(i) of the FD&C Act. 
39 Section 744B(a)(4)(A) of the FD&C Act; see section 744A(6) of the FD&C Act. 
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  Contains Nonbinding Recommendations 
name FDF), it will continue to be assessed a facility fee under the current GDUFA 
authorization.40   
 
Facility fees are due on the later of (i) the first business day on or after October 1 of each fiscal 
year, or (ii) the first business day after the enactment of an appropriations Act providing for 
the collection and obligation of GDUFA fees for such year.41 
 
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.  
 
A.  API and FDF Facility Fees 
 
Each person that owns a facility will incur an API facility fee when the facility is identified in: 
 
  At least one generic drug submission that is approved to produce one or more APIs, or  
  A Type II API DMF referenced in at least one such generic drug submission.42 
 
Each person that owns a facility will incur an FDF facility fee when the facility is identified in at 
least one generic drug submission that is approved to produce one or more FDFs.43 
 
B.  Exceptions to Facility Fees 
 
The following entities will continue to not incur facility fees under the current GDUFA 
authorization:44 
 
  Facilities that solely produce PET drugs. 
  Facilities that are only listed in applications submitted by State and/or Federal 
government entities for drugs that are not distributed commercially. 
  A business or other entity whose only manufacturing or processing activities are one or 
more of the following: repackaging, relabeling, or testing. 
 
C.  Dual Operation Facilities Only Incur FDF Facility Fees 
 
If a facility is identified in one or more approved generic drug submissions to produce both APIs 
and FDFs, the facility will only incur an FDF facility fee.45 
 
 
40 As described in section 744B(a)(4)(A) of the FD&C Act, this provision imposes fees on facilities identified in at 
least one generic drug submission that is approved to produce one or more FDF or API of a human generic drug (or 
identified in a Type II API drug master file referenced in at least one such generic drug submission).   
41 Section 744B(a)(4)(D) of the FD&C Act. 
42 Section 744B(a)(4)(A)(ii) of the FD&C Act. 
43 Section 744B(a)(4)(A)(i) of the FD&C Act. 
44 Section 744B(l) of the FD&C Act (exempting facilities that solely produce PET drugs from GDUFA facility fees), 
section 744A(1)(B) of the FD&C Act (excluding certain applications from the definition of "ANDA"), and section 
744A(6)(A)(ii) of the FD&C Act (excluding certain entities from the definition of "facility"). 
45 Section 744B(a)(4)(A)(iii). 
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  Contains Nonbinding Recommendations 
D.  Contract Manufacturing Organizations 
 
An FDF manufacturer facility that is not identified in an approved ANDA held by the owner of 
that facility or its affiliates is considered a CMO for GDUFA user fee purposes.46  Under 
GDUFA III, CMOs pay a reduced facility fee of 24 percent of the FDF facility fee. 
 
For example, if the FDF facility is referenced in an ANDA held by the facilitys owner, that FDF 
facility would not be a CMO.  However, if the owner of the FDF facility holds an ANDA, so 
long as the facility is not referenced in its owners or its owners affiliates ANDAs, then it 
qualifies as a CMO and pays 24 percent of the FDF facility fee when referenced in another 
ANDA.47  Similarly, if an FDF facility owner is affiliated with Company X, and Company X 
references that FDF facility in its ANDA, the FDF facility is not a CMO.  
 
A facilitys qualification as a CMO depends on the FDF manufacturing activities of that facility 
and not on its manufacturing activities related to an API.  For example, a facility referenced in 
one or more ANDAs as both an API and FDF manufacturer (i.e., a dual operation facility) may 
qualify as a CMO, for purposes of an approved ANDA held by the facility owner or affiliate, so 
long as that ANDA does not reference the facility as an FDF manufacturer.    
 
E.  Foreign-Facility Fee Differential 
 
GDUFA specifies that the amount of the fee for a facility located outside the United States, and 
its territories and possessions, is $15,000 higher than the amount of the fee for a domestic 
facility.  The $15,000 differential applies to all facilities that incur a fee under GDUFA, 
including those facilities defined as CMOs under GDUFA.  For example, a foreign CMO facility 
will pay 24 percent of the FDF facility fee plus $15,000.48  
 
F.  Withdrawal of Facility from Reference 
 
If an ANDA applicant or holder does not want to retain a manufacturing facility subject to 
GDUFA user fees in its application, the ANDA applicant or holder should submit an amendment 
(for a pending application) or an appropriate post-approval supplement or post approval report 
(for an approved application) to remove the manufacturing facility from the ANDA.  The 
amendment or post-approval supplement should provide an explanation for the removal of the 
facility.  If the amendment or post-approval supplement is seeking to replace the facility, the 
request to remove the prior facility and to add the new facility may be included in the same 
amendment or post-approval supplement.  Post-approval supplements are described in 21 CFR 
314.70; post-approval reports are described in 21 CFR 314.81; and all submission types are 
addressed in relevant guidance.49   
 
 
46 Section 744A(5) of the FD&C Act. 
47 Id.; see section 744B(b)(2)(C) of the FD&C Act. 
48 Section 744B(b)(2)(C) of the FD&C Act. 
49 For a description of post-approval supplements and reports, see FDAs guidances for industry Changes to an 
Approved NDA or ANDA (April 2004, rev. 1) and CMC Postapproval Manufacturing Changes To Be Documented 
in Annual Reports (March 2014). 
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  Contains Nonbinding Recommendations 
The owner of a facility will incur facility fees if that facility produces any APIs or FDFs and is 
referenced in an approved generic drug submission on the facility fee due date, regardless of 
whether the facility is actually performing the manufacturing operations referenced in the 
approved application.  For example, a facility that currently manufactures APIs or FDFs for only 
non-generic drugs, or only drugs for the non-U.S. market, would have to pay a facility fee if it is 
referenced in an approved ANDA.  The facility is ultimately responsible for the assessed fee 
once incurred.  If the fee is not paid, all FDFs or APIs manufactured in the non-paying facility 
and all FDFs containing APIs manufactured in such a facility will be deemed misbranded.50  
Furthermore, any new generic drug submission that is submitted by or references the facility or 
its affiliates will not be received until the fee is paid.51 
 
To prevent a facility that is not manufacturing for an approved ANDA from incurring a facility 
fee, the ANDA holder should submit a post-approval supplement prior to the fiscal year due date. 
If a facility identified in an approved ANDA wants to be removed from that ANDA, the facility 
should work with the ANDA holder to remove itself from the application prior to the facility fee 
due date.  It is the ANDA holders responsibility to maintain an accurate and complete 
application, including an updated list of manufacturing facilities. 
 
For user fee purposes only, FDA will no longer consider the facility to be identified in the 
application as of the date FDA receives notice of the withdrawal from the ANDA holder via a 
post-approval supplement, or if the facility follows the instructions below. 
 
An API or FDF facility seeking to be removed from an approved ANDA to avoid a fee should 
contact the applicant well in advance of the facility fee due date.  On rare occasions, if timely 
good faith efforts and communications requesting removal from the ANDA have been made and 
the facility has reason to believe the ANDA holder will not act in time to prevent a facility fee 
from being incurred, the facility owner may submit a letter to FDA, copying the ANDA holder, 
requesting that the facility be removed from the approved ANDA.  The letter to the FDA should 
contain: 
 
  A statement that the facility is not involved in manufacturing activities52 for any 
approved ANDA that would incur a fee; 
  Copies of the facilitys communications to the ANDA holder(s) or DMF holder(s); and 
  A list of all known, approved generic drug submissions and DMFs that reference the 
facility which has communicated with the ANDA holder(s) and DMF holder(s) (as 
applicable), but for which there is reason to believe the facility will remain named in the 
application on the first business day of October. 
 
 
50 Section 744B(g)(4)(A)(iii) of the FD&C Act.  It is a violation of federal law to ship products misbranded into 
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. 
51 Section 744B(g)(4)(A)(ii) of the FD&C Act. 
52 See the definition of "manufacture" in 21 CFR 207.1; see also section 744A(6)(A)(ii), which excludes from the 
definition of "facility" an entity whose only manufacturing or processing activities consist of repackaging, 
relabeling, or testing.  
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  Contains Nonbinding Recommendations 
If the facility owner submits this letter after the facility fee due date, and if FDA agrees that a 
good faith effort has been made by the facility to work with the ANDA holder to withdraw itself 
without response by the ANDA holder, the facility will be considered withdrawn for user fee 
purposes for the next fiscal year.53  For purposes of this section and in addition to the actions 
outlined above, FDA considers a good faith effort by a facility requesting to be withdrawn from 
an ANDA to include the facilitys submission of this letter to FDA no earlier than 30 calendar 
days following the facilitys initial withdrawal request to the ANDA holder, but before the first 
business day of October, the facility fee due date.  Facility owners who fail to submit this letter 
to the FDA prior to the facility fee due date will be assessed a facility fee for that fiscal year. 
  
Letters should be submitted by July 1 or as far in advance of the first business day of October as 
possible.  Letters received after July 1 may not be processed before the first business day of 
October, in which case facilities will incur the fee if the ANDA holder still has not submitted a 
post-approval supplement before the first business day of October.  The letter should be sent to 
the following address with a copy to CDERCollections@fda.hhs.gov: 
 
Office of Generic Drugs (HFD-600) 
Center for Drug Evaluation and Research  
Food and Drug Administration  
Central Document Room 
5901B Ammendale Road 
Beltsville, MD 20705 
 
If a facility is identified in an approved generic drug submission on the first business day of 
October and the facility is subsequently withdrawn, the fee will not be waived or refunded.  
Accordingly, withdrawal of a facility from generic drug submissions will not remove the 
requirement of the facility to pay previously incurred facility fees. 
 
G.  Packagers and Repackagers 
 
Packagers of drug products are considered manufacturers, regardless of whether that packaging 
is done pursuant to a contract or by the applicant itself.  Such facility operations are fee-
incurring, and the facility would incur annual FDF facility fees if the conditions in Section VIII 
are met.  A packaging facility may incur only 24 percent of the FDF facility fee if it qualifies as a 
CMO (see definitions section and Section VIII.D above).54    
 
A facility is considered a packager for the purposes of GDUFA if it 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/STORAGE AND HANDLING section of labeling 
for an approved ANDA and packages that product into such a container/closure system for the 
first time.  Every ANDA specifies the forms or configuration in which the approved drug product 
may be packaged and distributed in the HOW SUPPLIED/STORAGE AND HANDLING 
 
53 The applicant is still expected to report the change to the approved application in a manner consistent with 21 
CFR 314.70. 
54 Section 744B(b)(2)(C) of the FD&C Act.  
13 
  Contains Nonbinding Recommendations 
section of approved labeling.  For example, if a facility receives bulk drugs and packages them 
into the containers in which they are marketed, it is a packager.  
 
A facility is also considered a manufacturer if it receives product in a container/closure specified 
in the HOW SUPPLIED/STORAGE AND HANDLING section of labeling for an approved 
ANDA and applies the FDA-approved prescription package labeling to that product for the first 
time. 
 
Repackagers are not required to pay facility fees under GDUFA.55  Repackagers include facilities 
that remove a drug from a primary container/closure system and subdivide the contents into a 
different primary container/closure system.  For example, a facility that takes tablets out of a 
plastic bottle and packages the tablets into blister packaging is considered a repackager.56  
 
H.  API-Excipient Mixtures 
 
Generally, manufacturers of API-excipient mixtures are required to pay the annual FDF facility 
fee.57  However, GDUFA provides one exception, for fee-paying purposes only, to the definition 
of FDF as inclusive of in-process materials.  GDUFA defines an API-excipient mixture as an API 
when the mixture is produced because the API is unstable or cannot be transported on its own.58   
In such cases, mixing the API with one or more excipients may prevent the loss of one or more 
critical quality attributes that allow the API to be made into a finished dosage form.  Examples 
include an API mixed with an antioxidant for chemical stability when the API is prone to 
oxidative degradation or a highly potent API mixed with a polymer to facilitate safe handling.  
Additional examples include an API-excipient mixture for physical stability to maintain the 
APIs amorphous form or an API mixed with a lubricant to prevent agglomeration or 
solidification of a powder.  When claiming this exception, the rationale should be clearly stated 
and accompanied by supporting information in the DMF or application, as appropriate, for each 
excipient added for stability purposes.  APIs mixed with one or more excipients for commercial 
convenience only are not considered to fall under this exception to characterization as FDF. 
 
I.  Atypical APIs 
 
Some ingredients are used as APIs in certain generic drug submissions but are more commonly 
used as inactive pharmaceutical ingredients (excipients) or as ingredients in non-drug products 
such as foods.  Facilities that manufacture these atypical APIs are subject to API facility fees 
when the ingredient is intended for use as a component of a drug and furnishes pharmacological 
activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of 
disease, and the ingredient is referenced in an approved ANDA.59 
 
 
55 Section 744A(6)(A)(ii) of the FD&C Act, relating to the definition of "facility." 
56 See SPL Industry Technical Specification Information: Electronic SelfIdentification of Generic Drug Facilities or 
Sites (August 2017) at 7. 
57 Sections 744A(7)(C) and 744B(a)(4)(A)(i) of the FD&C Act. 
58 Section 744A(2)(A) of the FD&C Act. 
59 Section 744A(2)(A)(i) and (ii) of the FD&C Act. 
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  Contains Nonbinding Recommendations 
J.  Facilities That Cease Manufacturing 
  
A facility incurs annual facility fees as long as it is identified in an approved ANDA and 
manufacturers or processes any FDF or API, 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 covered API or FDF.  See Section VIII.F for a 
description of how a facility can ensure that it is no longer identified in an ANDA.  
  
The facility will cease to incur facility fees if (1) it is no longer identified in any approved 
generic drug submission or (2) it has stopped manufacturing or processing all human APIs and 
FDFs (including both generic and non-generic FDFs) and the facility or applicant has 
documented its ceasing of such operations to FDA by following the procedures outlined in 
Section VIII.F above by the date that the fee is due.  If an entity has ceased manufacturing or 
processing all human APIs and FDFs, the entity no longer qualifies as a facility under GDUFA 
(see the definition of facility in Section III above).60  Any outstanding fee obligations will, 
however, remain due. 
 
A facility that ceases such manufacturing or processing should follow the steps outlined in 
Section VIII.F so it will be removed from all ANDA references.  If a facility goes out of 
business, it should contact the applicants, DMF holder (if applicable), and FDA to notify the 
Agency of its status. 
 
K.  Fees for Multiple Locations of the Same Entity 
 
If an entity has multiple sites manufacturing a product approved under a human generic drug 
submission and those sites are in different geographic locations, each facility is generally 
assessed 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;  
  Under the supervision of the same local management; and  
  Capable of being inspected by FDA during a single inspection.61  
 
These are the same criteria used by FDAs Office of Regulatory Affairs to evaluate whether 
separate FDA Facility Establishment Identifiers (FEIs) are necessary for multiple facilities.62 
 
If an entity believes that multiple FEIs have been assigned in error or that its separate facilities 
qualify for a single FEI, the entity may request consolidation of the FEIs.  Domestic entities 
should submit the request to the appropriate FDA district office.  Contact information is available 
 
60 Section 744A(6)(A)(i) of the FD&C Act. 
61 Section 744A(6) of the FD&C Act.  The statute further states that if a business or other entity would meet the 
definition of a facility but for being under multiple management, the business or entity is deemed to constitute 
multiple facilities, one per management entity, for purposes of this paragraph. 
62 See FDAs guidance for industry Self-Identification of Generic Drug Facilities, Sites, and Organizations 
(September 2016).  
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  Contains Nonbinding Recommendations 
at http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123522.pdf.  Foreign entities 
should contact FDAGDUFAFEIRequest@fda.hhs.gov. 
 
Once a facility fee has been incurred, the fee is not waived, reduced, or refunded if FDA 
subsequently agrees to consolidate FEI numbers. 
 
IX.  GENERIC DRUG APPLICANT PROGRAM FEE 
 
Under the current GDUFA authorization, a GDUFA program fee will continue to be assessed 
annually based on the number of approved applications that an entity and its affiliates own.63  
Affiliated companies will be grouped together and counted as a single entity for purposes of 
assessing the GDUFA program fee.64  An ANDA applicant and its affiliates cannot choose to pay 
multiple smaller fees to avoid paying the fee associated with larger tiers.  
 
GDUFA program fees are due on the later of 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 and obligation of fees for such year.65 
 
A.  GDUFA Program Fee Structure 
 
The GDUFA program fee will be allocated among three tiers of ANDA owners: 
 
  Small (companies with 5 or fewer approved ANDAs) 
  Medium (companies with 6 to 19 approved ANDAs) 
  Large (companies with 20 or more approved ANDAs) 
 
If a person and its affiliates own at least one but not more than five approved ANDAs on the 
GDUFA program fee due date, the person and its affiliates will be assessed a small-size 
operation GDUFA program fee equal to one-tenth of the large-size operation GDUFA program 
fee.  
 
If a person and its affiliates own at least 6 but not more than 19 approved ANDAs on the 
GDUFA program fee due date, the person and its affiliates will be assessed a medium-size 
operation GDUFA program fee equal to two-fifths of the large-size operation GDUFA program 
fee. 
 
If a person and its affiliates own at least 20 approved ANDAs on the GDUFA program fee due 
date, the person and its affiliates will be assessed a large-size operation GDUFA program fee.66 
 
See FDAs GDUFA website (www.fda.gov/GDUFA) for the current fiscal years fee amounts.  
 
 
63 Section 744B(a)(5)(A) of the FD&C Act. 
64 Section 744B(b)(2)(E)(i) of the FD&C Act. 
65 Section 744B(a)(5)(D) of the FD&C Act. 
66 Section 744B(b)(2)(E) of the FD&C Act. 
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  Contains Nonbinding Recommendations 
B.  Single Fee for an ANDA Applicant and Its Affiliates 
 
An ANDA applicant and its affiliates together will only incur one GDUFA program fee per year.  
The current GDUFA authorization continues to mandate that a single program fee shall be 
assessed for an ANDA applicant and its affiliates.67  The ANDA applicant who is responsible 
for submitting the affiliate information on behalf of the company and its affiliates must submit 
complete information so that FDA will assess one GDUFA program fee for the applicant.  If 
FDA finds an affiliation that was not reported to the Agency, FDA will reassess the fees for both 
the affiliate and parent company, potentially resulting in an invoice if FDA finds that the entity 
should have paid a higher amount. 
 
C.  Submitting Information to FDA 
 
By April 1 of each year, each person that owns an ANDA (or a designated affiliate of such 
person) shall submit to the Secretary, on behalf of the person and the affiliates of such person, a 
list of (A) all approved ANDAs owned by such person; and (B) 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.68  Please see FDAs GDUFA website section discussing the GDUFA program 
fee (www.fda.gov/GDUFA) for more information on the format and method for submission of a 
list of all owned ANDAs. 
 
D.  Timing for Withdrawal of ANDAs 
 
An ANDA shall be deemed not to be approved for purposes of the GDUFA program fee if the 
applicant has submitted a written request for withdrawal of approval of such ANDA by April 1 
of the previous fiscal year.69  
 
If such a request to withdraw an ANDA is made after April 1, FDA may not be able to withdraw 
the approved ANDA by the October 1 GDUFA program fee due date for that fee, and the 
applicant should expect that that ANDA will be counted as approved when determining the tier 
in which an applicant and its affiliates are placed for purposes of the GDUFA program fee 
assessment. 
 
X.  DETERMINING AFFILIATION 
 
When determining whether parties are affiliated, the critical factor is whether one party controls 
or has the power to control another entity, or if a third party has the power to control both 
entities.  
 
FDA may contact an ANDA applicant to request additional information and clarification of the 
information asserted by the applicant regarding its affiliates.  Examples of requested information 
include, but are not limited to:  
 
67 Id. 
68 Section 744B(o) of the FD&C Act. 
69 Section 744B(b)(2)(E)(ii) of the FD&C Act. 
 
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  Contains Nonbinding Recommendations 
 
  A copy of the applicants Articles of Incorporation and Bylaws. 
  The applicants last annual statement to shareholders. 
  A breakdown of entities that may directly or indirectly exert control or influence over the 
applicant. 
  A breakdown of entities over which the applicant directly or indirectly exerts control or 
influence. 
  Identification of persons in leadership and management positions of the applicant as well 
as affiliated businesses. 
 
Occasionally, FDA finds entities affiliated with the applicant that the applicant did not identify 
as one of its affiliates.  In response to such a finding, FDA recommends that the applicant submit 
any agreements between an applicant and the other entities that demonstrate the nature of the 
relationship the applicant has with the entity.  
 
FDA recognizes that some information provided by entities may be confidential.  FDA will treat 
confidential commercial or financial information consistent with applicable federal laws and 
regulations. 
 
XI.  FAILURE TO PAY FEES 
 
Failure to remit payment in full for user fees incurred pursuant to GDUFA will result in certain 
penalties on an entity and/or its affiliates based on the type of fee.  These penalties apply until 
the outstanding user fees are fully satisfied.  Outstanding user fees are an obligation to the U.S. 
Government and the failure to pay fees may lead to collection activities by the Government 
pursuant to applicable laws. 
 
A.  Backlog Fees 
 
Any person who owned an original ANDA that failed to pay the backlog fee was placed on a 
publicly available arrears list available at www.fda.gov/GDUFA.  FDA will not receive  within 
the meaning of section 505(j)(5)(A) of the FD&C Act70  a new ANDA or supplement submitted 
by that person, or any affiliate of that person, until the outstanding fee is paid.71 
 
B.  DMF Fees 
 
A DMF will be deemed available for reference if both the DMF fee is paid in full and the DMF 
has not failed an initial completeness assessment.  No generic drug submission 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 holders failure to satisfy the user fee obligation.  If the DMF 
 
70 This provision references the receipt of ANDAs by FDA.  The Agency evaluates an ANDA after it is submitted 
to determine whether it may be received.  Receipt of an ANDA means that FDA has made a threshold determination 
that the ANDA is substantially complete; 21 CFR 314.101(b)(1). 
71 Section 744B(g)(1) of the FD&C Act. 
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  Contains Nonbinding Recommendations 
fee is not paid within 20 calendar days after notification, the generic drug submission referencing 
the DMF will not be received.72 
 
C.  ANDA Filing Fees 
 
If an applicant does not submit payment of the ANDA filing fee within 20 calendar days of the 
due date, its application will be deemed incomplete on the date of submission and will not be 
received.73  So long as FDA finds that none of the disqualifications outlined in 21 CFR 
314.101(d) and (e) apply (i.e., the ANDA is otherwise substantially complete), the application will 
be considered submitted as of the date all user fee obligations are satisfied in full.  
 
D.  Fee for API Information Not Included by Reference to DMF - (a)(3)(F) Fee  
 
If a generic drug applicant submission 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 API DMF, 
and a fee equal to the DMF fee has not been previously paid with respect to such submission, 
then the applicant shall pay a fee in the amount described in section VII.D, in addition to the 
applicable ANDA filing fee.74  If these fees are not submitted within 20 calendar days of the due 
date then the submission will not be received.75  So long as FDA finds that none of the 
disqualifications outlined in 21 CFR 314.101(d) and (e) apply (i.e., the ANDA is otherwise 
substantially complete), the application will be considered submitted as of the date all user fee 
obligations are satisfied in full.  
 
E.  Facility Fees  
 
Failure to pay the facility fee within 20 calendar days of the due date will result in the following 
penalties:76 
  
  No new ANDA or supplement submitted by the person responsible for paying the fee or 
that persons affiliates will be received. 
  No new generic drug submission referencing the facility will be received until the fee is 
paid. 
  The facility will be placed on a publicly available arrears list.  
  FDA will notify the referencing ANDA applicant of the facilitys failure to satisfy its user 
fee obligations. 
 
Further, all FDFs or APIs manufactured in the non-paying facility and all FDFs containing APIs 
manufactured in such a facility will be deemed misbranded.77  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 
 
72 Section 744B(g)(2) of the FD&C Act. 
73 Section 744B(g)(3) of the FD&C Act. 
74 Section 744B(a)(3)(F) of the FD&C Act. 
75 Section 744B(g)(3) of the FD&C Act. 
76 Section 744B(g)(4) of the FD&C Act. 
77 Id. 
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  Contains Nonbinding Recommendations 
seizures of misbranded products.  Products deemed misbranded are subject to being denied entry 
into the United States.  
 
F.  GDUFA Program Fees 
 
Failure to pay the GDUFA program fee within 20 calendar days of the GDUFA program fee due 
date will result in the following penalties:78 
  
  Applicants will be placed on a publicly available arrears list. 
  Any ANDAs submitted by the applicant or an affiliate of that applicant will not be 
received. 
 
Further, all drugs marketed pursuant to ANDAs held by such applicant or an affiliate of that 
applicant will be deemed misbranded.79  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 deemed misbranded are subject to being denied entry into the United States.  
 
However, if an application or supplement was already received by FDA prior to the applicant 
being placed in arrears, FDA will continue the review of and accept amendments to those 
applications. 
 
XII.  PAYMENT INFORMATION AND PROCEDURES 
 
The payment process for GDUFA III is similar to the previous iterations of the program and 
other FDA user fees.  The FDA website80 contains instructions for paying the fees. 
 
A.  Payment Procedures for GDUFA Fees 
 
  Those responsible for payment of fees enter required information on FDAs User Fee 
System to generate a GDUFA cover sheet. 
  The cover sheet is designed to provide the minimum necessary information to determine 
if a person has satisfied all relevant user fee obligations. 
  The cover sheet is submitted to FDA electronically generating a user fee payment 
identification number (PIN) to assist in tracking payment. 
 
Cover sheets for ANDA filing fees should be submitted with ANDA submissions.  The Generic 
Drug User Fee Cover Sheet and additional payment information is available on the GDUFA 
website (www.fda.gov/GDUFA). 
 
 
 
 
78 Section 744B(g)(5) of the FD&C Act. 
79 Id. 
80 https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments.  
20 
  Contains Nonbinding Recommendations 
B.  Acceptable Forms of Payment 
 
Payment must be made in U.S. currency drawn on a U.S. bank.81  Fee payers may pay online by 
credit card or Automated Clearing House (ACH) electronic check or send payment by check, 
bank draft, U.S. postal money order, or wire transfer.  
 
C.  Timely Payment of Fees 
 
FDAs expectation is for full and timely payment of all GDUFA fees.  Penalties associated with 
non-payment, including, but not limited to, refusal to receive a generic drug submission, drug 
product deemed misbranded, and failure of a DMF to be placed on a publicly available reference 
list, will apply until such obligations are satisfied in full.  
 
One entity may pay GDUFA fees on behalf of another entity.  Those paying fees are responsible 
for determining all financial institution transaction fees that may be deducted from an entitys 
authorized amount for payment to FDA.  These include wire transfer and foreign exchange fees.  
 
D.  Refund and Transfer Requests 
 
Other than as described in section VII.A, FDA will only fully refund payments of fees made in 
error.  If a fee was properly incurred, there will be no refund of the payment.  
 
To qualify for the return of a fee claimed to have been paid in error, a person shall submit to the 
Secretary a written request justifying such return within 180 calendar days after such fee was 
paid.82  The format for submitting refund requests is Form FDA 3913, attached as Appendix 1 
and available at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492188.pdf.  
 
A Form FDA 3913 written refund request should be submitted to the Division of User Fee 
Management at CDERCollections@fda.hhs.gov. 
 
FDA no longer permits the administrative action of applying a previously paid GDUFA fee 
(also referred to as a transfer) from a closed-out fiscal year cover sheet to a different fiscal 
year cover sheet.83  Instead, payments from closed-out fiscal year cover sheets will only be 
processed as refunds to the original payors, provided that the request is made within 180 
calendar days from when the original payment was made.   
 
Requests for the transfer of payments within the same fiscal year or open fiscal year may be 
permitted for the same fee type and for a fee obligation of the same payor, provided that the 
request is made within 180 calendar days from the original payment date.  For example, a 
request to transfer a fee payment from a FY 2023 cover sheet to another FY 2023 cover sheet 
 
81  See 87 FR 61601 (October 12, 2022), available at https://www.govinfo.gov/content/pkg/FR-2022-10-
12/pdf/2022-22099.pdf. 
82 Section 744B(m) of the FD&C Act. 
83 FDAs fiscal year begins on October 1 and ends on September 30, with the fiscal year being designated by the 
calendar year in which it ends (e.g., FY 2023 begins on October 1, 2022, and ends on September 30, 2023).   
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within the same fee type (perhaps due to an incorrect FEI) by the same payor will be processed, 
provided the request is made within 180 calendar days of the original payment date. 
 
As another example, during September 2023 (FY 2023), an applicant may request a transfer 
of a fee to a FY 2024 cover sheet of the same fee type because FY 2023 has not yet been 
closed-out.  However, if an applicant requests a transfer of a fee from a FY 2023 cover sheet 
during FY 2024 (beginning October 1, 2023, through September 30, 2024), this transaction will 
not be permitted as FY 2023 has already been closed-out.   
 
To request a transfer, applicants should complete Form FDA 3914 and email the form to 
CDERCollections@fda.hhs.gov.  Form FDA 3914 is attached as Appendix 2 and is available at 
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492195.pdf 
 
FDA may not issue a refund or process a transfer if a written request is made past 180 calendar 
days from the payment receipt date.  For example, a payment transfer request submitted after 
180 calendar days from the payment receipt date to correct a FEI number may not be processed.  
Similarly, a request to transfer payment from one cover sheet to another cover sheet to correct 
a DMF number may not be processed if it is received after 180 calendar days from the payment 
receipt date. 
 
E.  Non-Payment of GDUFA Fees 
      
Delinquent entities 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 invoice delinquent for more than 90 days in 
accordance with 45 CFR 30.18. 
 
F.  Cover Sheet for PET Manufacturers and Non-Commercial Government 
Entities  
 
PET drug manufacturers and State or Federal Government entities which sponsor or manufacture 
drugs but do not distribute them commercially do not incur GDUFA fees.  However, FDA 
requests that all drug manufacturers, including generic PET manufacturers and non-commercial 
government entities, complete a facility user fee cover sheet in the user fee system. 
 
G.  Waivers of and Reductions to GDUFA Fees 
 
Waivers of and reductions to GDUFA fees are not available.  However, facilities that qualify as 
CMOs only incur 24 percent of the facility FDF fee.  See Section VIII.D for more information on 
CMOs. 
 
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H.  Arrears Lists 
 
The GDUFA Backlog Arrears List, Generic Drug Applicant Program Fee Arrears List, GDUFA 
Facility Arrears List, and GDUFA Outstanding Facility Fees-Not on Arrears List are available on 
the GDUFA website (https://www.fda.gov/industry/generic-drug-user-fee-amendments/user-fee-
lists) and are updated regularly. 
 
FDA cannot receive generic drug submissions from applicants or their affiliates until those 
applicants and their affiliates satisfy all outstanding user fee obligations.  See the definitions in 
Section III above regarding affiliates for more information. 
 
FDA may not necessarily notify applicants before refusing to receive a submission.84  Applicants 
continue to be in the best position to monitor their business affiliates for compliance with the 
current GDUFA authorization.  It is the applicants responsibility to ensure that its user fee 
obligations, as well as those of its affiliates, are satisfied before submitting a new generic drug 
submission. 
 
If an entity believes that its appearance on a GDUFA arrears list is in error, it should contact the 
Division of User Fee Management at CDERCollections@fda.hhs.gov and provide a rationale for 
why the facility should not be included on an arrears list. 
 
I.  Submitting Generic Drug Submissions 
 
A generic drug submission or Type II API DMF is deemed submitted to FDA on the calendar 
day when the electronic submission arrives at FDA's electronic gateway, except when a 
submission is made on a weekend, a Federal holiday, or a day when the FDA office that will 
review the submission is not otherwise open for business.85,86  In those cases, the submission will 
be deemed to be submitted on the next day that office is open for business.  If it is submitted in 
physical media form, it will be deemed to be submitted on the day it arrives at the appropriate 
designated document room of the Food and Drug Administration. 
 
When a lapse in appropriations or closing of the relevant FDA office occurs, FDA is considered 
not open for business and will not receive generic drug submissions until the next day that FDA 
is open for business. 87 
 
84 Section 744B(g) of the FD&C Act. 
85 Section 744B(a)(6) of the FD&C Act. 
86 See guidance for industry Providing Regulatory Submissions in Electronic Format  Receipt Dates (February 
2014).  All ANDAs are required to be submitted electronically as of May 5, 2017, and all DMFs must be submitted 
electronically as of May 5, 2018.  See section 745A(a) of the FD&C Act; (21 U.S.C. 379k-1(a)(1)); see also FDAs 
guidance for industry Providing Regulatory Submissions in Electronic Format  Certain Human Pharmaceutical 
Product Applications and Related Submissions Using the eCTD Specifications (February 2020, rev. 7). 
87 See FDAs guidance for industry Providing Regulatory Submissions in Electronic Format  Receipt Dates 
(February 2014), at 4, note 9.  Note that, in situations in which work on generic drug applications during a lapse in 
appropriations is financed by carryover GDUFA funding, FDA will be able to accept submissions for which 
payment was made before the lapse in appropriations occurs and the received date will reflect such payment date.  
However, FDA will be considered not open for business to receive fees during the lapse and thus will not receive 
applications for which applicable fees were not paid before the lapse.  
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XIII.  APPEALS PROCESS 
 
A.  Reconsideration Request 
 
If FDA fully or partially denies a request for a refund, the entity may request reconsideration of 
that decision.  A request for reconsideration should be made within 30 calendar days of the 
issuance of FDAs decision to fully or partially deny a request for a refund or reduction of user 
fees.  
 
FDA recommends that requests for reconsideration state the entitys reasons for believing that 
FDAs decision is in error and include any additional information that is relevant to the entitys 
position.  The Agency will issue a response upon reconsideration setting forth the basis for the 
decision. 
 
All requests for reconsideration should be submitted via email to CDERCollections@fda.hhs.gov 
and should be addressed to the following:  
 
Division of User Fee Management  
Attention: Division Director 
Center for Drug Evaluation and Research 
 
Alternatively, the entity can mail the request to FDA via the carrier of its choice. For the most 
updated mailing address, visit the following FDA website at www.fda.gov/GDUFA. 
 
B.  Appeal Request 
 
If a request is denied upon reconsideration, the entity may choose to appeal the denial.  A request 
for an appeal should be made within 30 calendar days of the issuance of FDAs decision to 
affirm its denial of a request for a refund or reduction of user fees.  The following information 
should be included in the appeal:  
 
  The original request 
  The denial of the original request 
  The reconsideration request 
  The denial of the reconsideration request 
  A statement of the entitys reasons for believing that the prior conclusions were in error 
 
No new information or analyses should be presented in the appeal request.  If new 
information or analyses are presented in the appeal request, the appeal will not be accepted, and 
the matter will be referred back to the original deciding authority to consider the new 
information or analyses. 
 
All requests for appeals should be submitted to the Director of the Center for Drug Evaluation 
and Researchs (CDER) Office of Management via CDERCollections@fda.hhs.gov, and a copy 
should be submitted to the CDER Formal Dispute Resolution Project Manager.  The contact 
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information can be found on the CDER Formal Dispute Resolution webpage.88  Alternatively, 
the entity can mail the request to FDA via the carrier of its choice.  For the most updated mailing 
address, visit www.fda.gov/GDUFA. 
 
After FDA reviews the information submitted in the appeal request, the Director of CDERs 
Office of Management will issue a written decision on the entitys request. 
 
If the entitys appeal is denied at one management level, the entity can appeal the same matter to 
the next higher management level in the CDER chain of command.  A new request should be 
submitted for each appeal to the next management level and should follow the process provided 
in this guidance.  If the entity has exhausted CDERs management levels and remains unsatisfied 
with the decision, the entity may request review of the matter by the Commissioner of Food and 
Drugs (Commissioner) under 21 CFR 10.75(c).  Requests for review by the Commissioner 
should be submitted to FDAs Ombudsman,89 with a copy provided to CDER.  Review of such 
matters by the Commissioner is discretionary.90  
 
XIV.  OTHER RESOURCES 
 
The following guidance documents may be helpful: 
 
  Completeness Assessments for Type II API DMFs Under GDUFA (Oct. 2017, rev. 1),  
  Self-Identification of Generic Drug Facilities, Sites, and Organizations (Sept. 2016),  
  Formal Dispute Resolution: Appeals Above the Division Level, (Nov. 2017, rev. 1).  
 
Additional information is also available on the FDA User Fees web page.  For any questions, 
please email the GDUFA User Fee staff at CDERCollections@fda.hhs.gov or call 301-796-7900. 
 
 
88 Available at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm44
4092.htm.  
89 Available at https://www.fda.gov/about-fda/office-chief-scientist/fda-ombudsman. 
90 See 40 FR 40682 at 40693 (September 3, 1975); see 21 CFR 10.75.  
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Appendix 1: Form FDA 3913 
 
Form 3913 is available at https://www.fda.gov/media/96650/download. 
 
If you are experiencing difficulties accessing the form, please contact the FDA forms manager at 
FormsManager@OC.FDA.GOV for assistance. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Appendix 2: Form FDA 3914 
 
Form 3914 is available at https://www.fda.gov/media/96658/download. 
If you are experiencing difficulties accessing the form, please contact the FDA forms manager at 
FormsManager@OC.FDA.GOVfor assistance. 
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