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Assessing User Fees
Under the Generic Drug
User Fee Amendments
of 2017
Guidance for Industry
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit electronic comments to https://www.regulations.gov. Submit written
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the
docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document, contact (CDER) Office of Management, Division of
User Fee Management and Budget Formulation, Phone: 301-786-7900.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
October 2017
User Fees
Assessing User Fees
Under the Generic Drug
User Fee Amendments
of 2017
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: [email protected]
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)
October 2017
User Fees
Contains Nonbinding Recommendations
Draft — Not for Implementation
TABLE OF CONTENTS
I.
II.
III.
IV.
V.
VI.
VII.
A.
B.
C.
D.
E.
F.
VIII.
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
IX.
A.
B.
C.
D.
X.
XI.
A.
B.
C.
D.
E.
INTRODUCTION ........................................................................................................................... 1
BACKGROUND .............................................................................................................................. 2
DEFINITIONS................................................................................................................................. 2
CHANGES TO THE STRUCTURE OF THE GDUFA USER FEE PROGRAM .................... 4
BACKLOG FEES............................................................................................................................ 5
DRUG MASTER FILE FEES ........................................................................................................ 5
ABBREVIATED NEW DRUG APPLICATION FILING FEES ............................................... 6
Refund for Refusal to Receive and Withdrawals and Inappropriate Receipts ......................... 6
Resubmissions ................................................................................................................................. 7
Exemptions to the Application Filing Fee ..................................................................................... 7
Fee for API Information Not Included by Reference to DMF - (a)(3)(F) Fee ........................... 8
Serially Submitted ANDAs............................................................................................................. 9
Withdrawn ANDAs....................................................................................................................... 10
FACILITY FEES........................................................................................................................... 10
API and FDF Facility Fees ........................................................................................................... 11
Exceptions to Facility Fees ........................................................................................................... 11
Dual Operation Facilities Only Incur FDF Facility Fees .......................................................... 11
Contract Manufacturing Organizations ..................................................................................... 11
Foreign-Facility Fee Differential ................................................................................................. 12
Withdrawal of Facility From Reference ..................................................................................... 12
Packagers and Repackagers......................................................................................................... 14
API and Excipient Mixtures......................................................................................................... 15
Atypical APIs................................................................................................................................. 15
Facilities That Cease Manufacturing .......................................................................................... 15
Fees for Multiple Locations of the Same Company ................................................................... 15
GENERIC DRUG APPLICANT PROGRAM FEE ................................................................... 16
GDUFA Program Fee Structure .................................................................................................. 16
Single Fee for Applicant and its Affiliates .................................................................................. 17
Submitting Information to FDA .................................................................................................. 17
Timing for Withdrawal of ANDAs .............................................................................................. 18
DETERMINING AFFILIATION ................................................................................................ 18
FAILURE TO PAY FEES ............................................................................................................ 18
Backlog Fees .................................................................................................................................. 19
DMF Fees....................................................................................................................................... 19
ANDA Filing Fees ......................................................................................................................... 19
Facility Fees ................................................................................................................................... 19
GDUFA Program Fees.................................................................................................................. 20
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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 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 .................................................................................................................................. 22
I. Submitting Generic Drug Submissions ....................................................................................... 23
XIII. APPEALS PROCESS ................................................................................................................... 23
A. Reconsideration Request .............................................................................................................. 23
B. Appeal Request.............................................................................................................................. 24
XIV. OTHER RESOURCES ................................................................................................................. 25
APPENDIX 1: FORM FDA 3913 ............................................................................................................ 26
APPENDIX 2: FORM FDA 3914 ............................................................................................................ 30
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Assessing User Fees Under the Generic Drug User Fee
Amendments of 2017
Guidance for Industry1
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This draft guidance, when finalized, will represent 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 stakeholders information regarding FDA’s implementation of the
Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA
Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, 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 II, the process 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. This guidance also describes
how FDA determines affiliation for purposes of assessing generic drug user fees. FDA will
issue separate guidance documents regarding GDUFA II non-user fee requirements and
processes. This guidance does not address how FDA determines and adjusts fees each fiscal
year; nor does it address FDA’s implementation of other user fee programs (e.g. Prescription
Drug User Fee Amendments, Biosimilar Biological User Fee Amendments).2 Throughout this
guidance, references to user fees or the user-fee program are to generic drug user fees collected
under section 744B of the Federal Food Drug and Cosmetic Act (FD&C Act).
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s 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.
1
This guidance has been prepared by the Division of User Fee Management and Budget Formulation, Office of
Management, in the Center for Drug Evaluation and Research at the Food and Drug Administration.
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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.
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Changes to statutory provisions that are described in this guidance are effective with respect to
fees assessed beginning on the first day of fiscal year (FY) 2018.
II.
BACKGROUND
The Generic Drug User Fee Amendments of 2012 (GDUFA I) added sections 744A and 744B to
the FD&C Act, authorizing FDA to collect user fees for a 5-year period from persons that submit
certain abbreviated new drug applications (ANDAs) for review, or that are referenced in certain
ANDAs. Fees authorized by this legislation help fund the process for the review of generic drug
applications and have played an important role in expediting the drug review and approval
process. GDUFA was reauthorized for a five-year period in 2017 (GDUFA II) under the FDA
Reauthorization Act of 2017, enacted on August 18, 2017.
GDUFA II extends FDA’s authority to collect user fees for FY3 2018 to FY 2022 and revised the
fees that the Agency collects and how it collects some fees. Discussions about the further
reauthorization of GDUFA are expected to begin before or during FY 2022, the final fiscal year
of GDUFA II.
III.
DEFINITIONS
For purposes of this guidance:
The term abbreviated new drug application means an application submitted under section
505 of the FD&C Act (21 U.S.C. § 355(j)), under former section 507 of the Act (now
repealed), or 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.4
The term active pharmaceutical ingredient means a substance, or a mixture when the
substance is unstable or cannot be transported on its own, intended (A) to be used as a
component of a drug; and (B) 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 a substance intended for final crystallization,
purification, or salt formation, or any combination of those activities, to become a
substance or mixture as described above.5
3
FDA’s fiscal year begins on October 1 and ends on September 30.
See Section 744A(1) of the FD&C Act.
5
See Section 744A(2) of the FD&C Act.
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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.6
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. The term facility 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.7
The term finished dosage form 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 subparagraph (A) or (B).8
The term generic drug submission means an abbreviated new drug application, an
amendment to an abbreviated new drug application, or a prior approval supplement to an
abbreviated new drug application.9
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.10
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 abbreviated new drug application 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.11
6
See Section 744A(4) of the FD&C Act.
See Section 744A(6) of the FD&C Act. The FDA Establishment Identifier (FEI) is used to identify unique
facilities.
8
See Section 744A(7) of the FD&C Act.
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See Section 744A(8) of the FD&C Act.
10
See Section 744A(10) of the FD&C Act; See Section 201(ii) of the FD&C Act.
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See Section 744A(11) of the FD&C Act.
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IV.
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 the Food and Drug
Administration 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.12
The term contract manufacturing organization facility means a manufacturing facility of
a finished dosage form of a drug approved pursuant to an ANDA which is not identified in
an ANDA held by the owner of that facility or its affiliates.13
CHANGES TO THE STRUCTURE OF THE GDUFA USER FEE PROGRAM
GDUFA II authorizes the collection of five types of fees: (1) backlog fees; (2) drug master file
(DMF) fees; (3) ANDA filing fees; (4) active pharmaceutical ingredient (API) and finished
dosage form (FDF) facility fees; and (5) generic drug applicant program fees (GDUFA Program
Fees). The statute directs FDA to set annual fee amounts for each fiscal year so that DMF fees
will account for 5 percent, ANDA fees 33 percent, API facility fees 7 percent, FDF facility fees
20 percent, and GDUFA Program Fees 35 percent of the total revenue amount determined for a
fiscal year.14 Under GDUFA II, applications submitted by State and/or Federal government
entities for drugs that are not distributed commercially also do not incur fees.
Previously, section 744B of the FD&C Act authorized FDA to collect (1) backlog fees; (2) DMF
fees; (3) ANDA and prior approval supplement (PAS) fees; and (4) API and FDF facility fees.
GDUFA II establishes a new fee structure that eliminates PAS fees and adds GDUFA Program
Fees.
Additionally, facilities that manufacture both APIs and FDFs will only incur FDF fees instead of
owing both API and FDF facility fees. A facility no longer incurs a fee if it is only referenced in
pending generic drug submissions because the facility fee obligation now applies only to
facilities referenced in approved generic drug submissions. Facilities that qualify as contract
manufacturing organizations (CMOs) pay one-third the amount of the facility fee incurred by
FDF facilities that do not qualify as CMOs.15
12
See Section 744A(13) of the FD&C Act.
See Section 744A(5) of the FD&C Act; See Section IV (Changes to the Structure of the GDUFA User Fee
Program) and Section VII (Facility Fees) for more information.
14
See Section 744B(b) of the FD&C Act. While in almost all cases applicants that owed backlog fees have now paid
those fees, this obligation remains part of the statute.
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See Section 744B(b)(2)(C) of the FD&C Act.
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The Agency will continue to establish generic drug user fees for each fiscal year based on
revenue amounts set forth in the statute, and will publish the fees and fee revenue amounts for a
fiscal year in the Federal Register not later than 60 days before the start of that year.16
V.
BACKLOG FEES
Under GDUFA II, 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 each such
application.17
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 (available at https://www.gpo.gov/fdsys/pkg/FR-2012-10-25/pdf/201226257.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 (RTR)
the application.18 See Federal Register: “Notice of Opportunity to Withdraw Abbreviated New
Drug Applications to Avoid Backlog Fee Obligations” for additional details (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 active pharmaceutical ingredient 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 II.19
The DMF fee is due on whichever of the following dates occurs earlier:
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; or
The date the DMF holder requests the initial completeness assessment.20
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Section 744B(a) of the FD&C Act.
See 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.
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Receipt of an ANDA means that FDA has made a threshold determination that the ANDA is sufficiently complete
to permit a substantive review. 21 CFR § 314.101(b)(1).
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See Section 744B(a)(2)(A) of the FD&C Act.
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See Section 744B(a)(2)(E)(i) of the FD&C Act.
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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. The DMF will then undergo an initial
completeness assessment, using factors articulated in the final guidance Completeness
Assessments for Type II API DMFs Under GDUFA (available at
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/
UCM321884.pdf). If the DMF passes the initial completeness assessment, FDA will include the
DMF on the Type II Drug Master Files – Available for Reference List (available at
http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM332875.xls).
VII.
ABBREVIATED NEW DRUG APPLICATION FILING FEES
GDUFA II levies a user fee on certain human generic drug applications. A fee is assessed for
each ANDA submitted to FDA after October 1, 2012. A prior approval supplement filing fee,
which was required under GDUFA I, is no longer required under GDUFA II.21
ANDA fees are due on the date of submission of the application.22
A.
Refund for Refusal to Receive and Withdrawals and Inappropriate Receipts
If FDA refuses to receive an ANDA for reasons not related to failure to pay fees, then 75 percent
of the filing fee paid will automatically be refunded to the applicant. Under GDUFA II, a 75
percent refund of the application filing fee paid will also be remitted for an application that has
been withdrawn prior to being received within the meaning of section 355(j)(5)(A) of the FD&C
Act.23
If FDA initially receives an ANDA and subsequently determines that exclusivity should have
prevented that receipt so that the ANDA is no longer considered received, FDA will refund
100% of the fee paid for that ANDA.24
21
Unpaid fees for supplements submitted under GDUFA I will not automatically be considered met once GDUFA II
takes effect in FY 2018. These supplements will continue to be considered as refused to receive by the Agency.
The ANDA applicant may submit a new supplement in FY 2018 under GDUFA II, which will not incur a
supplement fee.
22
See Section 744B(a)(3)(C)(i) of the FD&C Act.
23
See Section 744B(a)(3)(D)(i) of the FD&C Act.
24
See Section 744B(a)(3)(D)(ii) of the FD&C Act.
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Although certain GDUFA refunds are automatic, 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 [email protected]. Form
FDA 3913 is attached as Appendix 1, and available on the internet at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492188.pdf.
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. If an applicant does not submit a refund
request, FDA will initiate a refund during its periodic review of outstanding refunds.
If an application that FDA previously refused to receive is resubmitted, 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 and then submits a new ANDA for that product must pay the
full fee upon submission. If the applicant notifies FDA that it plans to resubmit the application
in the near future, the Agency may hold the refund and initiate a transfer of the funds to the
resubmission upon the request of the applicant. To request a transfer, applicants should fill out
Form FDA 3914 and email the form to [email protected]. Form FDA 3914 is
attached as Appendix 2, and available on the internet at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492195.pdf.
B.
Resubmissions
A resubmission of an ANDA attempts to remedy deficiencies (major, minor, Electronic Common
Technical Document) indicated in a RTR letter. A full ANDA filing fee is due upon
resubmission of the ANDA that FDA refused to receive. Dispute of a RTR decision without
attempting to remedy the deficiencies is not considered a resubmission and is therefore not
subject to a new ANDA filing fee.
C.
Exemptions to the Application Filing Fee
An applicant will not incur an ANDA filing fee under the following circumstances:
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; or
The submitted application is a serial submission (see subsection E. below).
Approved applications of the types described in this subsection will also not be considered in
determination of GDUFA Program Fees (see section IX below).
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D.
Fee for API Information Not Included by Reference to DMF - (a)(3)(F) Fee
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.25
GDUFA II specifies that an additional API information fee must be paid for each manufacture of
an API by one facility described in an application, when such a fee has not already been paid for
the manufacture of that API by that 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 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, please see the following two examples:
Example One:
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
Drug X
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API
Alpha
Beta
Gamma
Facility that has not paid API fee
1, 2, 3
1, 2
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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
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See Section 744B(a)(3)(F) of the FD&C Act.
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Example Two:
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:
Product
Drug Y
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API
Alpha
Beta
Gamma
Delta
Facility
1, 2, 3
1, 2
1, 2
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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 an 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
The fees, referenced in the above calculations, for each API manufacturing facility that
manufactures a particular API included in an application is meant to replicate the applicable DMF
fee if the information had been submitted in a DMF. Annual API facility fees are discussed
below and are required for each facility that is identified in an ANDA or a DMF.
E.
Serially Submitted ANDAs
In some circumstances, ANDA applicants choose to serially submit complete ANDAs containing
“paragraph IV certifications” in anticipation of a patent being listed for a reference listed drug.26
Note that under 21 CFR § 314.94, serial submissions are prohibited: “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 FDA’s “Approved Drug Products With Therapeutic Equivalence
Evaluations,” commonly known as the Orange Book. The regulation reflects FDA’s judgment
that permitting serial submissions of amendments and multiple notices of paragraph IV
26
For a description of ANDA patent certifications see draft guidance for industry 180-day Exclusivity: Questions
and Answers (Jan 2017) available at
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM536725.pdf.
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certifications is overly burdensome to FDA and NDA holders.27 Applications submitted prior to
the time specified in the cited regulation are not considered to be in the possession of the
Agency. However, applicants who nonetheless choose to serially submit complete ANDAs in
anticipation of a new patent being listed in the Orange Book should remit their application filing
fee 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, 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% refund.
VIII. FACILITY FEES
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.28
A facility does not incur a fee for being referenced only in pending generic drug submissions in
GDUFA II.
Note that an entity meeting the two criteria above will incur a facility fee liability regardless of
whether it is manufacturing or producing generic or non-generic human drugs. For example, if a
facility is referenced in an approved ANDA and is manufacturing only brand-name drugs, it will
be assessed a facility fee under GDUFA II.
Facility 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.29
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.
27
See 81 FR 69580, 69610.
See Section 744B(a)(4)(A) of the FD&C Act; See Section 744A(5) of the FD&C Act.
29
See Section 744B(a)(4)(D) of the FD&C Act.
28
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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 in which the facility is approved to produce one or
more APIs, or
A Type II API DMF referenced in an approved generic drug submission.30
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.31
B.
Exceptions to Facility Fees
The following entities will not incur facility fees under GDUFA II:
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.
Facilities 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 fee.32 This differs from the treatment under
GDUFA I, which required that such facilities pay both API and FDF fees.
D.
Contract Manufacturing Organizations
CMOs are independent firms with no ownership stake (either directly or through affiliates) in the
ANDAs for the drug products they manufacture. 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.33
For example, if the FDF facility is referenced in an ANDA held by its owner, that FDF facility
would not be a CMO. However, even if the owner of the FDF facility holds an ANDA, so long
as the facility is not referenced in its owner’s or its owner’s affiliates’ ANDAs, then it qualifies
as a CMO and pays one-third the amount of the FDF facility fee if referenced in another
30
See Section 744B(a)(4)(A)(ii) of the FD&C Act.
See Section 744B(a)(4)(A)(iii) of the FD&C Act.
32
Id.
33
See Section 744A(5) of the FD&C Act.
31
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ANDA. 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 facility’s qualification as a CMO depends only on the FDF manufacturing activities of that
facility. A facility that is referenced in one or more ANDAs as both an API and FDF
manufacturer may qualify as a CMO even if it is referenced as an API manufacturer in its own or
its affiliates’ ANDA. As long as a dual facility is not referenced as an FDF manufacturer in its
own or its affiliates’ ANDAs, it may qualify as a CMO.
E.
Foreign-Facility Fee Differential
GDUFA II 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.
For example, a foreign facility will pay one-third the FDF facility fee plus $15,000. 35
The
$15,000 differential applies to all facilities that incur a fee under GDUFA II, including those
facilities defined as CMOs. The differential amount is designed to reflect the higher costs of
foreign inspections funded, in part, through GDUFA II.
F.
Withdrawal of Facility From Reference
If an ANDA sponsor determines that a manufacturing facility no longer manufactures its API or
FDF and the ANDA sponsor no longer seeks to retain the facility as an approved manufacturer of
the API or FDF, the ANDA sponsor should submit an appropriate notification to remove the
manufacturing facility from the ANDA. The supplement should provide a justification if the site
being removed is not considered redundant (i.e., the particular facility’s manufacturing role is not
replaced by another appropriate site to continue the approved function). If approval of another
facility is desired, the notification to remove the prior facility may be included in the supplement
to add the new facility to the ANDA. If a facility identified in an ANDA wishes to be removed
from that ANDA, the Agency encourages the owner of the facility to contact the ANDA sponsor
and/or DMF holder and work together to effect the facility’s removal from the application.
In the rare situation when the ANDA sponsor or DMF holder does not file a notification to
remove an approved manufacturing facility for its API or FDF, a facility may remove itself from
reference in all ANDAs to prevent incurring future user fees through the process described in the
following paragraphs.
An ANDA sponsor can identify a facility that it does not own in its application only if the owner
of that facility has provided the ANDA sponsor permission to refer to the facility. If the owner
of the facility submits a notification to FDA to withdraw that permission—and thus no longer be
approved for use by the ANDA applicant—FDA will consider the facility to be no longer
identified in the application as of the date FDA receives notice of the withdrawal via the process
34
35
See Section 744B(b)(2)(C) of the FD&C Act.
Id.
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described below. The facility will no longer be approved for manufacture of the FDF, or the
API, for that application.
Since a facility continues to incur facility fees until FDA is notified of the facility’s withdrawal,
the Agency encourages the owner of the facility identified in an ANDA to take the following
steps prior to the fiscal year fee due date:
Notify the ANDA sponsor and/or DMF holder in writing that it is withdrawing its
permission to reference the facility in its ANDA and/or DMF.
Send a copy of this letter to the standard application submission methods for ANDAs and
DMFs via FDA electronic gateway or by mail to the ANDA archival file at the following
address:
Office of Generic Drugs (HFD-600)
Center for Drug Evaluation and Research
Food and Drug Administration
Document Control Room
Metro Park North VII
7620 Standish Pl.
Rockville, MD 20855
If the facility owner is also a DMF holder, update the DMF with this change. See
FDA’s DMF website for more information
(https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequireme
nts/DrugMasterFilesDMFs/default.htm).
In addition, email a copy of the withdrawal letter to the Division of User Fee
Management and Budget Formulation at [email protected].
An entity will incur facility fees if it manufactures any human drugs and is referenced in an
approved generic drug submission on the facility fee due date, regardless of whether it
manufactures only non-generic APIs or FDFs. Similarly, a facility owner will have to pay a
facility fee if the facility is referenced in an approved generic drug submission, even if it is only
manufacturing drugs for the non-US market. For example, a facility that is only manufacturing
one non-generic drug for a non-US market and is referenced in an approved ANDA as an API
manufacturer on the facility fee due date will incur an API facility fee.
Self-identification does not, in and of itself, trigger a liability to pay GDUFA facility fees.
Many—but not all—facilities that self-identify are required to pay an annual facility user
fee. Those that do incur the fee include facilities manufacturing API of human generic drugs
and/or FDF human generic drugs. Other sites and organizations must self-identify but are not
required to pay the annual facility user fee. These include facilities that solely manufacture PET
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drugs, or sites and organizations that only perform testing, repackaging, or relabeling
operations. While repackagers are not required to pay user fees, packagers are, in most cases,
FDF or CMO FDF manufacturers and subject to facility fees. Removal of a facility from selfidentification will not prevent the facility from incurring facility fees.
For more information on self-identification, please visit
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm, and see the final
guidance Self-Identification of Generic Drug Facilities, Sites, and Organizations
(https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/uc
m316672.pdf).
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.
Accordingly, withdrawal of all reference to facilities in generic drug submissions after the due
date will not absolve the facility owner from the requirement to pay previously incurred facility
fees.
G.
Packagers and Repackagers
Packagers are considered to be manufacturers, regardless of whether that packaging is done
pursuant to a contract or by the applicant itself. Such facilities are required to pay annual FDF
facility fees. A packaging facility may incur only one-third of the FDF facility fee if it qualifies
as a CMO (see definitions section above).
A facility is considered a packager for the purposes of GDUFA II 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” section of 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” section. 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 to be a manufacturer 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.
Repackagers are not required to pay facility fees under GDUFA II. 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.36
See guidance for industry SPL Industry Technical Specification Information: Electronic Self‐Identification of
Generic Drug Facilities or Sites (2017) at 7, available at
https://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM329269.pdf.
36
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H.
API and Excipient Mixtures
Generally, manufacturers of API mixtures are required to pay the annual FDF facility fee.
However, GDUFA II provides one exception, for fee-paying purposes only, to the definition of
in-process mixtures as FDF. GDUFA II defines an API and excipient 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.
I.
Atypical APIs
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 II. For example, if a facility manufactures an ingredient which is used 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, that facility may incur a facility fee.
J.
Facilities That Cease Manufacturing
A facility incurs annual facility fees as long as it is so identified, even if the facility has not
started commercial-scale production of the API or FDF covered by that submission, or if the
facility has stopped, temporarily or permanently, the production of that API or FDF. See above
for a description of how a facility can ensure that it is no longer identified in an ANDA.
The facility will cease to incur additional fees if it is no longer identified in any generic drug
submission or has stopped manufacturing all APIs and FDFs (including both generic and nongeneric APIs and FDFs) by the date that the fee is due. In the latter case, the entity no longer
qualifies as a facility under GDUFA II – see the definition of facility in Section III above. Any
outstanding fee obligations will, however, remain due.
A facility is encouraged to contact its ANDA holder to withdraw its permission to be referenced
in an ANDA or follow the steps outlined in the “Withdrawal of Facility from Reference” section
to remove itself from all ANDA references. If a facility goes out of business, it should contact
FDA to notify the Agency of its status.
K.
Fees for Multiple Locations of the Same Company
If a 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:
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The activities in them are closely related to the same business enterprise;
They are under the supervision of the same local management; and
They are capable of being inspected by FDA during a single inspection.37
These are the same criteria used by the FDA’s Office of Regulatory Affairs to evaluate whether
separate FDA Facility Establishment Identifiers (FEIs) are necessary for multiple facilities (see
final guidance Self-Identification of Generic Drug Facilities, Sites, and Organizations, available
at
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm
316672.pdf).
If a firm believes that multiple FEIs have been assigned in error or that its separate facilities
qualify for a single FEI, the firm may request consolidation of the FEIs. Once a facility fee is
incurred, the fee remains outstanding regardless of whether FDA later agrees to consolidation
of FEI numbers. Domestic firms should submit the request to the appropriate FDA District
office. Contact information is available at
http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM123522.pdf. Foreign firms should
contact [email protected].
IX.
GENERIC DRUG APPLICANT PROGRAM FEE
Under GDUFA II, a GDUFA Program Fee will be assessed annually based on the number of
approved applications that an entity and its affiliates own. Affiliated companies will be grouped
together and counted as a single entity for purposes of assessing the GDUFA Program Fee.38 An
ANDA sponsor 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.39
A.
GDUFA Program Fee Structure
The GDUFA Program Fee will be allocated among three tiers of application holders:
Small (companies with 5 or fewer approved ANDAs).
Medium (companies with between 6 and 19 approved ANDAs).
37
See Section 744A(5) 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.
38
See Federal Register Notice, 82 FR 2381.
39
See Section 744B(a)(5) of the FD&C Act.
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Large (companies with 20 or more approved ANDAs).
If a person and its affiliates own at least one but not more than five ANDAs on the GDUFA
Program Fee due date, the person and its affiliates shall owe 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 six but not more than 19 ANDAs on the GDUFA
Program Fee due date, the person and its affiliates shall owe 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 twenty ANDAs on the GDUFA Program Fee due date,
the person and its affiliates shall owe a large size operation GDUFA Program Fee.40
See FDA’s GDUFA website for the current fiscal year’s fee amounts
(https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm).
B.
Single Fee for Applicant and its Affiliates
An applicant and its affiliates together will only incur one GDUFA Program Fee per year.
GDUFA II mandates that a “single fee shall be assessed” for an ANDA sponsor and its
affiliates.41 The ANDA sponsor 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 sponsor. If FDA finds an affiliation that was not
reported to the Agency, FDA will re-assess the fees for both the affiliate and parent company,
potentially resulting in an invoice if FDA finds that the firm should have paid a higher amount.
C.
Submitting Information to FDA
Each person that owns an ANDA shall submit to the Secretary, by April 1 of each year, a list of
all ANDAs held by such person; except that, if an affiliate of such person also owns ANDAs, the
person or its affiliate must submit, on behalf of the person and its affiliates, a list identifying all
affiliates that own such applications and the ANDAs owned by the person and its affiliates.
Please see FDA’s GDUFA website
(https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm) for more
information.
40
41
See Section 744B(b)(2)(E) of the FD&C Act.
Id.
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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. If such a request to withdraw an ANDA is made after April 1st, FDA
may not be able to withdraw the approved ANDA by the October 1 due date for that fee and the
applicant should expect that that ANDA will be counted as approved when determining which
tier an applicant and its affiliates are placed.
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 the applicant to request additional information and clarification of the
information asserted by the applicant. Examples of requested information include, but are not
limited to the following:
A copy of the applicant’s Articles of Incorporation and Bylaws;
The applicant’s last annual statement to shareholders;
A breakdown of entities that maintain ownership of the applicant’s company; and
Identification of persons in leadership and management positions at the applicant’s
company.
Occasionally, FDA finds entities affiliated with the applicant that the applicant did not identify
as one of its affiliates. In such cases, 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 companies 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 for user fees incurred pursuant to GDUFA II will result in certain
penalties based on the type of fee. 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.
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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
https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm. FDA will not
receive—within the meaning of section 505(j)(5)(A) of the FD&C Act (21 U.S.C. §
355(j)(5)(A))42—a new ANDA or supplement submitted by that person, or any affiliate of that
person, until the outstanding fee is paid.43
B.
DMF Fees
Unless the DMF fee is paid in full, the DMF will not be deemed available for reference. 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 holder’s failure to satisfy the user fee obligation. If the DMF
fee is not paid within 20 calendar days after notification, any generic drug submission
referencing the DMF will not be received for user fee reasons and no refund of the fee will be
allowed.44
C.
ANDA Filing Fees
If an applicant does not submit payment within 20 calendar days of the due date, its application
or supplement to an application will be deemed incomplete on the date of submission and will
not be received. 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.45
D.
Facility Fees
There are several consequences for failure to pay a facility fee:
No new ANDA or supplement submitted by the person responsible for paying the fee or
that person’s affiliates will be received.
42
This provision references the “receipt” of ANDAs by FDA. The agency does an initial review of the application
to determine whether it may be received. Receipt represents a threshold determination that the ANDA is sufficiently
complete to permit a substantive review. 21 CFR 314.101(b). An application that is not received will not be
reviewed substantively and will not be approved. References to receiving applications in this section of the guidance
refer to receipt under this process.
43
See Section 744B(g)(1) of the FD&C Act.
44
See Section 744B(g)(2) of the FD&C Act.
45
See Section 744B(g)(3) of the FD&C Act.
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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 if the fee is not fully paid
within 20 days of the due date.
FDA will notify the referencing 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 deemed misbranded are subject to being denied entry
into the United States.46
Additionally, goal dates may not apply to applications that have already been received but that
reference facilities for which facility fees are owed.
E.
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:
Applicants that have not paid the GDUFA Program Fee 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.
All drugs marketed pursuant to ANDAs held by such applicant or an affiliate of that
applicant will be deemed misbranded.47
These penalties apply until the GDUFA Program Fee is paid.
XII.
PAYMENT INFORMATION AND PROCEDURES
The payment process for GDUFA II is similar to the previous iteration of the program and other
FDA user fees. The FDA website contains instructions for paying the fees.
A.
Payment Procedures for GDUFA Fees
Those responsible for payment of fees enter required information on FDA’s User Fee
System to generate a GDUFA cover sheet.
The cover sheet is designed to provide the minimum necessary information to determine
46
47
See Section 744B(g)(4) of the FD&C Act.
See Section 744B(g)(5) of the FD&C Act.
20
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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 should be submitted with generic drug submissions and DMFs. The Generic Drug
User Fee Cover Sheet and additional payment information is available on the GDUFA website
(https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm).
B.
Acceptable Forms of Payment
Payment must be made in U.S. currency drawn on a U.S. bank. 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
FDA’s 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 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 a company’s
authorized amount for payment to FDA. These include wire transfer and foreign exchange fees.
D.
Refund Requests
FDA will only 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. The format for submitting refund requests is Form FDA 3913, attached as Appendix 1.
Form FDA 3913 is available on the internet at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492188.pdf.
FDA will not permit a refund if a written request is made past 180 calendar days from the date of
payment.
A written refund request should be submitted to the Division of User Fee Management and
Budget Formulation at [email protected].
21
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E.
Non-Payment of GDUFA 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.
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 are excluded from payment of GDUFA fees.
However, FDA requests that all drug manufacturers, including generic PET manufacturers and
non-commercial government entities, complete a facility user fee coversheet in the user fee
system.
G.
Waivers of and Reductions to GDUFA Fees
Waiver and reductions to GDUFA fees are generally not available. However, facilities that
qualify as CMOs only incur one-third of the facility FDF fee.
H.
Arrears Lists
The backlog arrears list, GDUFA Program Fee arrears list, facility arrears list, and outstanding
facility fees—not on arrears list are available on the GDUFA website
(https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm) and are updated
regularly.
FDA cannot receive generic drug submissions from sponsors or their affiliates until the sponsor
and its affiliates satisfy all outstanding user fee obligations. See the Definitions section (Section
III) above regarding affiliates for more information.
FDA will not notify sponsors before refusing to receive a submission.48 Companies are in the
best position to monitor their business affiliates for compliance with GDUFA II. It is an
applicant’s responsibility to ensure that its user fee obligations, as well as those of its affiliates,
are satisfied before submitting a new generic drug submission.
48
See Section 744B(g) of the FD&C Act.
22
Contains Nonbinding Recommendations
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If a company believes that its appearance on the arrears list is in error, it should contact the
Division of User Fee Management and Budget Formulation at [email protected].
A concise rationale for why the facility should not be included on the arrears list should be
provided.
I.
Submitting Generic Drug Submissions
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 when a
submission is made on a weekend, Federal holiday, or a day when the FDA office that will
review the submission is not otherwise open for business. In those cases, the submission will be
deemed to be submitted on the next day 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,
except when a submission arrives on a weekend or a day when the FDA office is not otherwise
open for business. In those cases, the submission will be deemed to be submitted on the next day
that office is open for business.
When a government-wide shutdown or closing of the relevant FDA office because of inclement
weather 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.49
XIII. APPEALS PROCESS
A.
Reconsideration Request
If FDA fully or partially denies a request for a refund or reduction of user fees, the entity may
request reconsideration of that decision. A request for reconsideration should be made within 30
calendar days of the issuance of FDA’s decision to fully or partially deny a request for a refund
or reduction of user fees.
FDA recommends that requests for reconsideration state the entity’s reasons for believing that
the decision is in error and include any additional information, including updated financial
information, that is relevant to the entity’s position. The Agency will issue a response upon
reconsideration, setting forth the basis for the decision.
49
See guidance for industry Providing Regulatory Submissions in Electronic Format – Certain Human
Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, available at
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm333969.pdf.
23
Contains Nonbinding Recommendations
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All requests for reconsiderations should be submitted via email to
[email protected] and should be addressed to the following:
Division of User Fee Management and Budget Formulation
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:
http://www.fda.gov/forindustry/userfees/genericdruguserfees/default.htm.
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 FDA’s 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 request
The reconsideration request
The denial of the reconsideration request; and
A statement of the entity’s belief 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 CDER’s Office of Management
via [email protected] and a copy should be submitted to the CDER Formal
Dispute Resolution Project Manager. The contact information can be found on the CDER
Formal Dispute Resolution Web page.50 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: http://www.fda.gov/forindustry/userfees/genericdruguserfees/default.htm.
After FDA reviews the information submitted in the appeal request, the Director of CDER’s
Office of Management will issue a written decision on the entity’s request.
50
See
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm44
4092.htm.
24
Contains Nonbinding Recommendations
Draft — Not for Implementation
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If the entity’s appeal is denied at one management level, the entity can appeal the same matter to
the next higher management level in the center 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 sponsor has exhausted the center’s management levels and remains
unsatisfied with the decision, the sponsor 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 FDA’s Ombudsman, with copies provided to the centers.
Review of such matters by the Commissioner is discretionary.51
XIV. OTHER RESOURCES
The following guidance documents may be helpful:
Completeness Assessments for Type II API DMFs Under GDUFA
(https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Gui
dances/UCM321884.pdf)
Self-Identification of Generic Drug Facilities, Sites, and Organizations
(https://www.fda.gov/downloads/drugs/guidances/ucm316672.pdf)
Formal Dispute Resolution: Appeals Above the Division Level, Revision 2 (September
2015)
(https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidan
ces/ucm343101.pdf)
Additional information is also available on the FDA User Fees web page. For any questions,
please email the GDUFA User Fee staff at [email protected] or call 301-796-7900.
51
See 40 FR 40682, 40693 (September 3, 1975); See 21 CFR 10.75.
25
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0805
Expiration Date: November 30, 2018
User Fee Payment Refund Request
See PRA Statement on page 4.
Section A: Organization Information
1. Date of Request (mm/dd/yyyy)
2. Organization Name
3. Organization Address
Address 1 (Street address. No P.O. Boxes allowed)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
State/Province/Region
Country
ZIP or Postal Code
5. TIN/EIN (Nine-digit number required for all U.S. vendors.) Without this entry,
4. Type of Vendor (Select applicable)
U.S. vendor
Foreign vendor
refund cannot be processed.
6. DUNS (Nine-digit number required for all
foreign vendors. See instructions for additional
information.) Without this entry, refund cannot
be processed.
Information for U.S. vendors: To facilitate your request, visit https://www.sam.
gov/portal/public/SAM/ and register with Central Contractor Registration (CCR).
CCR electronically validates registrant information and shares the encrypted data
securely with the FDA. For questions about CCR, call (334) 206-7828.
Section B: Contact Information
7. Contact Name
8. Contact Title/Position
9. Contact Phone Number (Include area code)
10. Contact Email Address
Section C: Payment Information
11. Payment Amount
12. Payment Reference Number
13. PIN or Invoice Number
14. Refund Amount
15. Is this a FURLS refund request? (See instructions for more information.)
(a) FURLS Request Type
Used PIN
Yes
No (Proceed to field 16)
(b) Registration or Owner/Operator Number
Unused PIN (Proceed to field 16)
(c) Why did your facility originally pay the fee?
(d) Why do you believe your facility is not required to pay the fee?
(e) List all activities performed at your facility
(Section C continued, next page)
FORM FDA 3913 (9/16)
Page 1 of 4
PSC Publishing Services (301) 443-6740
EF
Section C: Payment Information (Continued)
15. Is this a FURLS refund request? (Continued)
(f) List all products manufactured at your facility
16. Reason for Request (Please explain)
17. ACKNOWLEDGEMENT: By signing this document I acknowledge that I am the official listed on this form, authorized to
execute this request on behalf of my organization. Any questions regarding this request can be directed to me via the
contact information provided.
18. Signature
Date of Signature (mm/dd/yyyy)
To enable the signature field, please fill out all prior required fields. For a list of required fields
which have not yet been filled out, please click here.
Section D: FDA Acknowledgement
19. FDA Received Date (mm/dd/yyyy)
20. Center Decision
Approved
Denied
21. If Denied, State Reason
22. Decision Date (mm/dd/yyyy)
23. Center Contact Name
OFM Use Only
24. Request Executed?
Yes
25. If No, State Reason
No
26. Final Action
27. Date of Final Action (mm/dd/yyyy)
Completed – Refunded
Completed – Not Refunded
28. OFM Contact Name
Instructions for Completing User Fee Payment Refund Request – Form FDA 3913
Form FDA 3913 is to be completed online at http://www.
fda.gov/forindustry/userfees/default.htm and is to be
used when requesting the transfer of user fee payments
received by the FDA. If you need assistance in
completing this form contact the User Fee Helpdesk via
phone at (301) 796-7200 or email [email protected].
Section A: Payment Information
1. Date of Request: Enter calendar date the form is
being completed.
2. Organization Name: This is name of the
organization submitting the request.
3. Organization Address: Enter the following
elements of the organization’s address.
FORM FDA 3913 (9/16)
Page 2 of 4
Address 1 – Enter organization’s physical street
address where the refund is to be sent. No P.O.
Boxes are allowed.
Address 2 – As needed, enter apartment, suite,
unit, building, floor, etc.
City – Enter the city where organization is located.
State/Province/Region – Enter the state, province
or region where organization is located.
Country – Enter country where organization is
located.
ZIP or Postal Code – Enter zip code or postal
code of the organization’s location.
Instructions (Continued)
4. Type of Vendor: Select the appropriate box to
indicate whether the organization is a U.S. or
foreign vendor.
Center for Devices and Radiological Health
(CDRH). Check “Unused PIN” if PIN was not used
to register, and proceed to field 16.
5. TIN/EIN: (U.S. vendor only) Enter organization’s
nine-digit federal Taxpayer Identification Number
(TIN) or Employer Identification Number (EIN).
Without this entry, the refund request cannot be
processed.
(b) Registration or Owner/Operator
Number – Enter FURLS registration or owner/
operator number.
(c) Why did your facility originally pay the fee?
– Provide reason why the user fee was paid.
6. DUNS: (Foreign vendor only) Enter organization’s
nine-digit Dun & Bradstreet Data Universal
Numbering System (DUNS) number. If you do not
know your DUNS number or need to request one,
visit www.dnb.com or call (800) 234-3867. Without
this entry the refund cannot be processed.
(d) Why do you believe your facility is not
required to pay the fee? – Provide reason why
the facility should not be required to pay the fee.
(e) List all activities performed at your
facility – Provide list of all activities currently
performed at your facility (i.e. manufacture medical
device, contract sterilizer, etc.).
Section B: Contact Information
(f) List all products manufactured at your
facility – Provide list of all products associated
with each activity.
7. Contact Name: Enter the name of the person
requesting the refund.
8. Contact Title/Position: Enter the position/title of
the person requesting the refund.
16. Reason for Request: Provide a brief description of
why refund is being requested.
9. Contact Phone Number: Enter the phone number
of the person requesting the refund.
10. Contact Email Address: Enter the email address
of the person requesting the refund.
Section C: Payment Information
11. Payment Amount: Enter the amount (in U.S.
Dollars) of the original payment issued to the FDA.
12. Payment Reference Number: If payment was
remitted via check, money order or bank draft,
enter the check or money order number; if made
electronically via Automated Clearing House (ACH)
or credit card, enter the confirmation number; if
made via wire transfer, enter the trace or Input
Message Accountability Data (IMAD) number.
13. PIN or Invoice Number: Enter the Payment
Identification Number (PIN) or invoice number
where payment was applied.
17. Acknowledgement: Review acknowledgment,
confirming that you are the authorized
representative listed on this form and have
provided valid contact information in the event that
there are questions pertaining to the request.
18. Signature: Place signature of listed authorizing
official here.
Date of Signature – Date document is signed by
authorizing official.
Section D: FDA Acknowledgement
This section is for FDA use only. An FDA
representative will fill out the following items:
19. FDA Received Date: Enter date that request was
received by FDA.
20. Center Decision: Check appropriate box,
indicating if request was approved or denied.
14. Refund Amount: Enter the amount (in U.S.
Dollars) that is to be refunded.
21. If Denied, State Reason: If response to field 20
was “Denied”, provide reason.
15. Is this a FURLS refund request? If request is for
fees paid for registration within the FDA Unified
Registration and Listing System (FURLS), check
the appropriate box. If response is “Yes”, complete
fields (a) through (f). If response is “No”, proceed to
field 16.
22. Decision Date: Enter date decision was made.
(a) FURLS Request Type – Check “Used PIN” if
PIN was used to register your facility with FDA’s
FORM FDA 3913 (9/16)
23. Center Contact Name: Enter name of the Center’s
action officer.
24. Request Executed: Check the appropriate box,
indicating if request was executed.
25. If No, State Reason: If response to field 24 was
“No”, provide reason.
Page 3 of 4
Instructions (Continued)
26. Final Action: Check the appropriate box, indicating
if request was refunded or not refunded.
28. OFM Contact Name: Enter name of the OFM
action officer.
27. Date of Final Action: Enter date that final action
was taken on request.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 0.40 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”
FORM FDA 3913 (9/16)
Page 4 of 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0805
Expiration Date: November 30, 2018
User Fee Payment Transfer Request
See PRA Statement on page 3.
Section A: Payment Information
1. Date of Request (mm/dd/yyyy)
2. Payment Amount
3. Payment Reference Number
4. Transfer Funds From
5. Transfer Funds To
6. Transfer Amount
7. Transfer Reason (Please explain)
Section B: Contact Information
8. Organization Name
9. Organization Address
Address 1 (Street address. No P.O. Boxes allowed)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
Country
State/Province/Region
ZIP or Postal Code
10. Contact Name
11. Contact Title/Position
12. Contact Phone Number (Include area code)
13. Contact Email Address
14. ACKNOWLEDGEMENT: By signing this document I acknowledge that I am the official listed on this form, authorized to
execute this request on behalf of my organization. Any questions regarding this request can be directed to me via the
contact information provided.
15. Signature
Date of Signature (mm/dd/yyyy)
To enable the signature field, please fill out all prior required fields. For a list of required fields
which have not yet been filled out, please click here.
Section C: FDA Acknowledgement
16. FDA Received Date (mm/dd/yyyy)
17. Center Decision
Approved
Denied
18. If Denied, State Reason
19. Decision Date (mm/dd/yyyy)
20. Center Contact Name
(FDA Acknowledgement continued, next page)
FORM FDA 3914 (12/15)
Page 1 of 3
PSC Publishing Services (301) 443-6740
EF
Section C: FDA Acknowledgement (Continued)
OFM Use Only
21. Request Executed?
Yes
22. If No, State Reason
No
23. Final Action
24. Date of Final Action (mm/dd/yyyy)
Completed – Transferred
Completed – Not Transferred
25. OFM Contact Name
Instructions for Completing User Fee Payment Transfer Request – Form FDA 3914
Form FDA 3914 is to be completed online at http://
www.fda.gov/forindustry/userfees/default.htm and is
to be used when requesting the transfer of user fee
payments received by the FDA. If you need assistance
in completing the form contact the User Fee Helpdesk
via phone at (301) 796-7200 or email userfees@fda.
gov.
Address 1 – Enter organization’s physical street
address. No P.O. Boxes are allowed.
Section A: Payment Information
Country – Enter country where organization is
located.
Address 2 – As needed, enter apartment, suite,
unit, building, floor, etc.
City – Enter the city where organization is located.
State/Province/Region – Enter the state, province
or region where organization is located.
1. Date of Request: Enter calendar date the form is
being completed.
ZIP or Postal Code – Enter zip code or postal
code of the organization’s location.
2. Payment Amount: Enter the amount (in U.S.
Dollars) of the original payment.
3. Payment Reference Number: If payment was
remitted via check, money order or bank draft,
enter the check or money order number; if made
electronically via Automated Clearing House (ACH)
or credit card, enter the confirmation number; if
made via wire transfer, enter the trace or Input
Message Accountability Data (IMAD) number.
4. Transfer Funds From: Enter the Payment
Identification Number (PIN) or invoice number
where payment is coming from.
10. Contact Name: Enter the name of the person
requesting the transfer.
11. Contact Title/Position: Enter the position/title of
the person requesting the transfer.
12. Contact Phone Number: Enter the phone number
of the person requesting the transfer.
13. Contact Email Address: Enter the email address
of the person requesting the transfer.
14. Acknowledgement: Review acknowledgment,
confirming that you are the authorized
representative listed on this form and have
provided valid contact information in the event that
there are questions pertaining to the request.
5. Transfer Funds To: Enter the PIN or invoice
number where payment is to be applied.
6. Transfer Amount: Enter the amount (in U.S.
Dollars) that is to be transferred.
15. Signature: Place signature of listed authorizing
official here.
7. Transfer Reason: Provide a brief description of
why funds are being transferred.
Date of Signature – Date document is signed by
authorizing official.
Section B: Contact Information
8. Organization Name: This is name of the
organization listed on the cover sheet or invoice.
Entry should match both old and new cover sheets
or invoices as listed in items 4 and 5.
9. Organization Address: Enter the following
elements of the organization address.
FORM FDA 3914 (12/15)
Section C: FDA Acknowledgement
This section is for FDA use only. An FDA
representative will fill out the following items:
16. FDA Received Date: Enter date that request was
received by FDA.
Page 2 of 3
Instructions (Continued)
17. Center Decision: Check appropriate box,
indicating if request was approved or denied.
22. If No, State Reason: If response to field 21 was
“No”, provide reason.
18. If Denied, State Reason: If response to field 17
was “Denied”, provide reason.
23. Final Action: Check the appropriate box, indicating
if request was transferred or not transferred.
19. Decision Date: Enter date decision was made.
24. Date of Final Action: Enter date that final action
was taken on request.
20. Center Contact Name: Enter name of the Center’s
action officer.
21. Request Executed: Check the appropriate box,
indicating if request was executed.
25. OFM Contact Name: Enter name of the OFM
action officer.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 0.25 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”
FORM FDA 3914 (12/15)
Page 3 of 3
| File Type | application/pdf |
| File Title | Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry |
| Subject | Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry |
| Author | FDA/CDER/Ladean.Rosenberg |
| File Modified | 2019-02-26 |
| File Created | 2017-10-26 |