Assessing User Fees 
Under the Prescription 
Drug User Fee 
Amendments of 2017 
 
 
Guidance for Industry
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
November 2020 
User Fees 
 
   
   
Assessing User Fees 
Under the Prescription 
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 
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Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
and/or 
Office of Communication, Outreach and Development  
Center for Biologics Evaluation and Research 
 Food and Drug Administration 
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Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
   https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-
guidances 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
Center for Biologics Evaluation and Research (CBER) 
 
November 2020 
User Fees 
  Contains Nonbinding Recommendations 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  BACKGROUND ............................................................................................................... 2 
III.  DEFINITIONS .................................................................................................................. 2 
IV.  CHANGES TO THE STRUCTURE OF THE PDUFA USER FEE PROGRAM ...... 4 
V.  HUMAN DRUG APPLICATION FEES ........................................................................ 5 
VI.  PRESCRIPTION DRUG PROGRAM FEES ................................................................ 6 
VII.  WAIVERS OF PDUFA FEES ....................................................................................... 10 
VIII.  EFFECT OF FAILURE TO PAY FEES ...................................................................... 11 
IX.  PAYMENT INFORMATION AND PROCEDURES ................................................. 11 
X.        FEE WAIVER, REDUCTION, OR REFUND REQUESTS AND APPEALS        
PROCESS.........................................................................................................................12 
XI.      OTHER RESOURCES....................................................................................................14 
  Contains Nonbinding Recommendations 
 
Assessing User Fees Under the Prescription Drug 
User Fee Amendments of 2017 
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 staff responsible for this guidance as listed on the 
title page.   
 
 
 
 
I.  INTRODUCTION  
 
This guidance provides stakeholders information regarding FDAs implementation of the 
Prescription Drug User Fee Amendments of 2017 (PDUFA VI) under Title I of the FDA 
Reauthorization Act of 2017.  Because PDUFA VI created changes to the user fee program, this 
guidance explains the new fee structure created by the statute, and the types of fees for which 
entities are responsible.   
 
This guidance describes the types of user fees authorized by PDUFA VI, the process for 
submitting payments to FDA, the consequences for failing to pay application fees or prescription 
drug program fees, and the process for requesting a reconsideration of a user fee assessment.  
The guidance also describes how FDA determines which products are subject to a fee and 
discusses certain changes to FDAs policies under the new law.  FDA has separate guidance 
documents about PDUFA VI waivers, refunds, and reductions.  This guidance does not address 
how FDA determines and adjusts fees each fiscal year (FY); nor does it address FDAs 
implementation of other user fee programs (e.g., Biosimilar User Fee Amendments, Generic 
Drug User Fee Amendments).2  Throughout this guidance, references to user fees or the user-fee 
program are to prescription drug user fees collected under section 736 of the Federal Food, 
Drug, and Cosmetic Act (FD&C Act). 
 
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 
                                                 
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, in consultation with the Center for Biologics 
Evaluation and Research at the Food and Drug Administration.  
2 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 736(c)(5) of the FD&C Act. 
 
 
  1  Contains Nonbinding Recommendations 
 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
Changes to statutory provisions that are described in this guidance are effective with respect to 
fees assessed beginning on the first day of FY 2018. 3                            
 
II.  BACKGROUND 
 
The Prescription Drug User Fee Act of 1992 (PDUFA I) added sections 735 and 736 to the 
FD&C Act, authorizing FDA to collect user fees for a 5-year period from persons that submit 
certain human drug applications for review or that are named in approved applications as the 
sponsor of certain prescription drug products.  Since 1992, Congress has revised and extended 
PDUFA five times, each time for a 5-year period.  Fees authorized by this legislation help fund 
the process for the review of human drug applications and have played an important role in 
expediting the drug review and approval process.  The most recent reauthorization is Title I of 
the FDA Reauthorization Act of 2017, enacted on August 18, 2017. 
 
PDUFA VI extends FDAs authority to collect user fees for FY 2018 through 2022 and revises 
the fees that the Agency collects and how it collects some fees.  Discussions about the next 
reauthorization of PDUFA are expected to begin before FY 2022, the final fiscal year of PDUFA 
VI.  
 
III.  DEFINITIONS 
 
For purposes of this guidance: 
 
  The term affiliate means a business entity that has a relationship with a second business 
entity if, directly or indirectly, (1) one business entity controls, or has the power to 
control, the other business entity; or (2) a third party controls, or has the power to control, 
both of the business entities.4 
 
  The term applicant refers to the person who submits a human drug application or is 
named as the applicant in a human drug application. 
 
  The term drug includes drug and biological products.5 
 
  The term final dosage form means, with respect to a prescription drug product, a finished 
dosage form which is approved for administration to a patient without substantial further 
manufacturing (such as capsules, tablets, or lyophilized products before reconstitution).6   
 
                                                 
3 FDAs fiscal year begins on October 1 and ends on September 30. 
4 Section 735(11) of the FD&C Act. 
5 For the purposes of this guidance, the terms biologic and biological product have the same meaning.  
6 Section 735(4) of the FD&C Act. 
 
  2  Contains Nonbinding Recommendations 
 
  The term human drug application means an application for (1) approval of a new drug 
submitted under section 505(b) of the FD&C Act or (2) licensure of a biological product 
under subsection (a) of section 351 of the Public Health Service Act (PHS Act).7   
 
Such term does not include a supplement to such an application, does not include an 
application with respect to whole blood or a blood component for transfusion, does not 
include an application with respect to a bovine blood product for topical application 
licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic 
biologic product licensed under section 351 of the PHS Act, does not include an 
application with respect to a large volume parenteral drug product approved before 
September 1, 1992, does not include an application for a licensure of a biological product 
for further manufacturing use only, and does not include an application or supplement 
submitted by a State or Federal Government entity for a drug that is not distributed 
commercially. Such term does include an application for licensure of a large volume 
biological product intended for single dose injection for intravenous use or infusion. 
 
  The term person includes any affiliates of that person.8  The term person includes an 
individual, partnership, corporation, or association.9  
   
  The term prescription drug product means a specific strength or potency of a drug in 
final dosage form: 
o  for which a human drug application has been approved; 
o  which may be dispensed only by prescription under section 503(b) of the FD&C 
Act; and 
o  which is on the list of products described in section 505(j)(7)(A) of the FD&C Act 
(not including the discontinued section of such list) or is on a list created and 
maintained by the Secretary of Health and Human Services (Secretary) of products 
approved under human drug applications under section 351(a) of the PHS Act (not 
including the discontinued section of such list). 
Such term does not include: 
o  whole blood or a blood component for transfusion; 
o  a bovine blood product for topical application licensed before September 1, 1992, 
an allergenic extract product, or an in vitro diagnostic biologic product licensed 
under section 351 of the PHS Act; 
o  a biological product that is licensed for further manufacturing use only; and 
o  a drug that is not distributed commercially AND is the subject of an application or 
supplement submitted by a State or Federal Government entity. 
                                                 
7 Section 735(1) of the FD&C Act. 
8 Section 735(9) of the FD&C Act. 
9 Section 201(e) of the FD&C Act. 
 
  3  Contains Nonbinding Recommendations 
 
Such term does include a large volume biological product intended for single dose 
injection for intravenous use or infusion.10 
 
  The term supplement means a request to the Secretary to approve a change in a human 
drug application which has been approved.11 
 
IV.  CHANGES TO THE STRUCTURE OF THE PDUFA USER FEE PROGRAM  
 
PDUFA VI authorizes the collection of two types of fees: (1) human drug application fees, which 
are collected at the time certain human drug applications are submitted; and (2) prescription drug 
program fees, which are collected annually for certain prescription drug products.12  The statute 
directs FDA to set fee amounts for each fiscal year so that human drug application fees will 
account for 20 percent and prescription drug program fees will account for 80 percent of the total 
revenue amount for that fiscal year.13   
 
Previously, section 736 of the FD&C Act authorized FDA to collect (1) human drug application 
and supplement fees, (2) prescription drug establishment fees, and (3) prescription drug product 
fees.  PDUFA VI eliminates fees for supplements14 as well as for establishments.15  Applicants 
will be assessed annual prescription drug program fees for prescription drug products, rather than 
the prescription drug product fee assessed under PDUFA V.   
 
In addition, PDUFA VI eliminates a provision under which applicants could apply for a waiver 
or refund of user fees on the basis that the fees to be paid by such person will exceed the 
anticipated present and future costs incurred by the Secretary in conducting the process for the 
review of human drug applications for such person, also known as the the fees-exceed-costs 
waiver.   
 
The Agency will continue to establish human drug application fees and prescription drug 
program fees for each fiscal year based on revenue amounts set forth in the statute, and will 
publish, in the Federal Register, the fees and fee revenue amounts for a fiscal year not later than 
60 days before the start of that year.16  
 
                                                 
10 Section 735(3) of the FD&C Act. 
11 Section 735(2) of the FD&C Act. 
12 The terms prescription drug program fee and program fee have the same meaning. 
13 Section 736(b)(2)(A) of the FD&C Act. 
14 The Agency considers it useful to provide guidance to applicants distinguishing between an original application, 
amendment, and supplement to accurately assess user fees.   Information on what FDA believes should be submitted 
in marketing applications, amendments, or supplements to approved applications is provided in the guidance for 
industry Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees, 
available at:  
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079320.pdf. 
15 The establishment fee special rule that applied to establishments that manufacture positron emission tomography 
(PET) drugs was also eliminated.   
16 Section 736(c)(5) of the FD&C Act. 
 
  4  Contains Nonbinding Recommendations 
 
V.  HUMAN DRUG APPLICATION FEES 
Under PDUFA VI, FDA assesses a user fee for certain human drug applications.  Each person 
that submits a human drug application beginning in FY 2018 is assessed an application fee under 
PDUFA VI as follows: 
  A human drug application for which clinical data (other than bioavailability or 
bioequivalence studies) with respect to safety or effectiveness are required for approval is 
assessed a full application fee. 
  A human drug application for which clinical data (other than bioavailability or 
bioequivalence studies) with respect to safety or effectiveness are not required for 
approval is assessed one-half of a full fee.17 
Human drug application fees are due when the application is submitted.18 
A.  Exceptions to the Application Fee 
There are two exceptions to the PDUFA application fee, described below: 
(1) Previously Filed Applications.  If an application  
o  was submitted by a person that paid the fee for the application, 
o  was accepted for filing, and 
o  was not approved or was withdrawn (without a waiver), 
the submission of a human drug application for the same product by the same person (or 
the persons licensee, assignee, or successor) does not require an application fee.19 
(2) Designated Orphan Drug.  A human drug application for a prescription drug product that 
has been designated as a drug for a rare disease or condition pursuant to section 526 of 
the FD&C Act shall not be subject to an application fee unless the human drug 
application includes an indication for other than a rare disease or condition.20  More 
information is provided in the guidance for industry User Fee Waivers, Reductions, and 
Refunds for Drug and Biological Products (Waivers Guidance).21 
B.  Applications Refused for Filing or Withdrawn 
If an application is refused for filing or withdrawn without a waiver before filing, FDA will 
refund 75 percent of the application fee.22  If an application is withdrawn after it is filed, FDA 
                                                 
17 Section 736(a)(1)(A) of the FD&C Act. 
18 Section 736(a)(1)(B) of the FD&C Act. 
19 Section 736(a)(1)(C) of the FD&C Act. 
20 Section 736(a)(1)(F) of the FD&C Act. 
21 We update guidances periodically.  To make sure you have the most recent version of a guidance, check the FDA 
Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 
22 Section 736(a)(1)(D) of the FD&C Act. 
 
  5  Contains Nonbinding Recommendations 
 
may refund the fee or a portion of the fee if no substantial work was performed on the 
application after the application was filed.  FDA has the sole discretion to refund a fee or a 
portion of the fee.  The FDA's determination concerning a refund on this basis (no substantial 
work was performed on the application) is not reviewable.23   
 
An application that was submitted but refused for filing or withdrawn before being accepted or 
refused for filing, shall be subject to the full fee when resubmitted or filed under protest, unless 
the fee is waived or reduced under one of the provisions identified in section VII of this 
guidance.24  
 
VI.  PRESCRIPTION DRUG PROGRAM FEES  
 
In general, each person named as the applicant in a human drug application and that, after 
September 1, 1992, had pending with the FDA a human drug application or supplement is 
required to pay the annual prescription drug program fee for each prescription drug product that 
is identified in such a human drug application approved as of October 1 of such fiscal year.25, 26   
 
An applicant may not be assessed more than five prescription drug program fees for a fiscal year 
for prescription drug products identified in a single approved application.27, 28   
 
A prescription drug product is not assessed a prescription drug program fee if: 
     
  the product is on the list compiled under section 505(j)(7) with a potency described in 
terms of per 100 milliliters (large volume parenteral);29 or 
  the product is the same as another product approved under 
o  an application filed under sections 505(b) or 505(j) of the FD&C Act and that other 
product is not in the list of discontinued products compiled under section 505(j)(7) 
of the FD&C Act, 
o  an abbreviated application filed under section 507 of the FD&C Act (as in effect on 
the day before November 21, 1997), or 
o  an abbreviated new drug application (ANDA) prior to the implementation of the 
Drug Price Competition and Patent Term Restoration Act of 1984. 
                                                 
23 Section 736(a)(1)(G) of the FD&C Act. 
24 Section 736(a)(1)(E) of the FD&C Act. 
25 Section 736(a)(2)(A) of the FD&C Act.  
26 For example, if an application is approved before or on October 1, 2017, then the product that is identified in the 
application may be assessed a program fee for FY 2018 and subsequent fiscal years.  But, if an application is 
approved on or after October 2, 2017, then the product that is identified in the application may not be assessed a 
program fee for FY 2018; it would be eligible for assessment of program fees for subsequent fiscal years. 
27 Section 736(a)(2)(C) of the FD&C Act. 
28 For example, an applicant that has 10 drug products identified in a single approved NDA for 10 different strengths 
of tablet dosage form products is eligible for an assessment for a maximum of 5 program fees.  As another example, 
an applicant that has 6 biologic products identified in an approved BLA for 3 strengths of liquid injectable and 3 
strengths of lyophilized products will be assessed a maximum of 5 program fees. 
29 Section 736(a)(2)(B)(i) of the FD&C Act. 
 
  6  Contains Nonbinding Recommendations 
 
 
Prescription drug 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 fiscal year under this section.30  
Applicants may pay fees before the date on which they are due.31  
 
A.  When and Where Prescription Drug Products Are Listed 
   
Prescription drug products eligible for a prescription drug program fee are on the list of products 
described in section 505(j)(7)(A) of the FD&C Act (not including the discontinued section of 
such list) or on a list created and maintained by the Secretary of products approved under human 
drug applications under section 351(a) of the PHS Act (not including the discontinued section of 
such list).32 
 
1.  In general 
 
The list of products described in section 505(j)(7)(A) of the FD&C Act is the FDAs Approved 
Drug Products with Therapeutic Equivalence Evaluations33 (commonly known as the Orange 
Book), which includes products that are the subject of approved human drug applications 
submitted under section 505(b) and approved under section 505(c) of the FD&C Act.  FDA 
publishes updates to the list each month.34  Drugs are considered to be added to the Orange Book 
on the day they are approved rather than on the date FDA publishes its next Orange Book 
update.35  For example, if a drug product submitted for approval under section 505(b) of the 
FD&C Act is approved on September 15, it is considered to be added to the Orange Book on 
September 15.  Unless the drug product is moved from the Prescription Drug Product List in 
the Orange Book (the active list) to the Discontinued Drug Product List, it may be assessed a 
program fee for the next fiscal year even if FDA does not publish an update to the Orange Book 
before the day fees are due. 
 
FDA also maintains a list of products approved under human drug applications under section 
351(a) of the PHS Act and also considers such drugs to be added to the list on the date they are 
approved.  FDA periodically provides the public with information about its list by publication to 
the Agency website in two locations.  Biologics regulated by the Center for Drug Evaluation and 
Research (CDER) are listed on the CDER Billable Biologic Product List, and biologics regulated 
by the Center for Biologics Evaluation and Research (CBER) may be found on the list of User 
Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act 
(collectively, the Biologics Lists).36  
                                                 
30 Section 736(a)(2)(A) of the FD&C Act. 
31 Section 736(g)(2)(C) of the FD&C Act authorizes FDA to accept payment of PDUFA fees for a fiscal year prior 
to the due date for such fees, in accordance with authority provided in advance in a prior year appropriations Act.  
32 Section 735(3)(C) of the FD&C Act. 
33 The Orange Book is available at https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. 
34 Section 505(j)(7)(A)(ii) of the FD&C Act. 
35 Section 505(j)(7)(B) of the FD&C Act. 
36 The CDER list is available at 
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM164641.pdf.  The CBER list 
 
  7  Contains Nonbinding Recommendations 
 
 
Applicants may raise questions about product listings with the FDA as follows:  
 
  For NDA products, an applicant should contact the Orange Book staff at 
OrangeBook@fda.hhs.gov. 
 
  For CDER biological products, an applicant should contact CDER User Fee staff at 
CDERCollections@fda.hhs.gov.  
 
  For CBER biological products, an applicant should contact CBER User Fee staff at 
CBERPDUFAstaff@fda.hhs.gov. 
 
Sponsors should send CDER User Fee staff (CDERCollections@fda.hhs.gov) a courtesy copy of 
information sent to the Orange Book staff or CBER User Fee staff to help ensure accurate 
billing. 
 
2.  Moving a Drug Product to the Discontinued Section of the Orange Book or 
Biologics List 
 
A drug product is not assessed a prescription drug program fee for a fiscal year if it is in the 
discontinued section of the Orange Book or the discontinued section of the Biologics List on the 
date fees are assessed.37  Applicants that have decided to stop marketing a prescription drug 
product, or that have decided to delay launch of a product until after its approval date, should 
request to have the product moved to the discontinued section at their earliest opportunity to give 
FDA sufficient time to process the request before fees are assessed.  In most cases, we expect 
that an applicant intending to discontinue or delay marketing a drug product will notify FDA 
well in advance.38  If a drug product remains on the Prescription Drug Product List of the 
Orange Book or the Biologics List on the date fees are assessed, the applicant may be assessed a 
program fee for the drug even if it is not being marketed.   
 
Requests to move a product to the discontinued section should be submitted either (1) to the 
Orange Book staff, for products approved under section 505 of the FD&C Act, or (2) to the 
relevant User Fee staff (CDER or CBER) for products approved under section 351(a) of the PHS 
Act, at the relevant email address listed in section VI.A.1 of this guidance.  All requests should 
clearly identify the product to be moved, the date that its not-marketed status begins, and, if 
applicable, would end.  Upon receiving such a request, FDA may ask the applicant for further 
information to confirm the products not-marketed status.  If the applicant submits a request as 
                                                 
is available at  
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122936.htm. 
37 Sections 735(3) and 736(a)(2)(A) of the FD&C Act.    
38 Under new section 506I of the FD&C Act, added by section 804 of the FDA Reauthorization Act of 2017 
(FDARA), the holder of an application approved under section 505 of the FD&C Act is required to notify FDA in 
writing 180 days prior to withdrawing the approved drug from sale or, if that is not practicable, as soon as 
practicable but not later than the date of withdrawal, and is also required to notify FDA in writing within 180 
calendar days of the date of approval of the drug if the drug will not be available for sale within 180 calendar days of 
such date of approval.  
 
  8  Contains Nonbinding Recommendations 
 
set forth in this paragraph and FDA does not deny the request, then for purposes of assessing 
user fees, FDA intends to consider the product to have been moved to the discontinued section 
on the date that the request was received or on the date the product is no longer marketed, 
whichever is later.  
 
Please note that applicants seeking to move a prescription drug product to a discontinued list 
should clearly indicate the date on which their product is no longer marketed.  Applicants should 
not rely on communications with a review division, the product listing staff, or FDA components 
other than the Orange Book Staff or the CDER or CBER User Fee staff, as appropriate.  
Communication with the wrong division of FDA, or in a manner that does not make clear when a 
product is no longer marketed, may mean that a prescription drug product is not moved to the 
discontinued section of the Orange Book or the Biologics List before the date program fees are 
assessed and may result in the applicant being required to pay a fee for the product.   
   
B.  Liquid Parenteral Biological Products Approved under Section 351 of the 
PHS Act  
 
1.  Assessing the Strength or Potency of a Drug in Final Dosage Form 
 
As described above, applicants of approved applications are assessed an annual program fee for 
each eligible prescription drug product, up to a maximum of five program fees for a fiscal year 
for each approved application.   
 
When evaluating the specific strength or potency of a drug in final dosage form for purposes of 
assessing program fees for liquid parenteral biological products, FDA intends to take into 
consideration both the total amount of drug substance in mass or units of activity in a product 
and the concentration of drug substance (mass or units of activity per unit volume of product).  
Products considered to have a different strength or potency in a final dosage form will be given 
separate entries in the Biologics List and subject to separate program fees. FDA previously 
considered only the concentration of drug substance in liquid parenteral drug products approved 
under section 351 of the PHS Act, without taking into account the total amount of drug substance 
in the product, in determining the specific strength or potency of a drug in final dosage form for 
purposes of assessing product fees.  The approach described in this guidance is intended to align 
our treatment of products approved under section 351 of the PHS Act with the way the Agency 
generally assesses fees for products approved under section 505 of the FD&C Act, providing 
consistency in our implementation of the program fee.  FDA also notes that products subject to 
the prescription drug program fee will be capped by the limit of five prescription drug program 
fees for a fiscal year for each approved application.  
 
2.  Auto-Injectors, Prefilled Syringes, and Vials 
 
An auto-injector that has the same strength or potency as a prefilled syringe or vial will generally 
be assessed a separate prescription drug program fee. This is intended to align the Agencys 
  9  Contains Nonbinding Recommendations 
 
assessment of fees for products approved under section 351 of the PHS Act with its assessment 
of fees for products approved under section 505 of the FD&C Act.39 
 
C.  Orphan Drug Exemption 
 
A drug designated under section 526 of the FD&C Act for a rare disease or condition and 
approved under section 505 of the FD&C Act or under section 351 of the PHS Act shall be 
exempt from prescription drug program fees if the drug meets all of the following conditions: 
 
  the drug meets the public health requirements that are applied to requests for waivers 
for prescription drug program fees, and  
 
  the drug is owned or licensed and is marketed by a company, including its affiliates, 
that had less than $50 million in gross worldwide revenue during the previous year.40 
 
This exemption applies with respect to a drug only if the applicant involved submits a 
certification that its gross worldwide revenues did not exceed $50 million for the preceding 12 
months before the exemption was requested.41, 42   
 
VII.  WAIVERS OF PDUFA FEES 
 
Section 736(d) of the FD&C Act provides that FDA will grant a waiver of or reduction in one or 
more user fees assessed under section 736(a) of the FD&C Act where it finds that one or more of 
the following is true: 
 
  A waiver or reduction is necessary to protect the public health. 
 
  The assessment of the fee would present a significant barrier to innovation because of 
limited resources available to the person or other circumstances.43 
 
  The applicant is a small business submitting its first human drug application to the 
Secretary for review. 
 
                                                 
39 The distinction described in this guidance between (1) auto-injectors and (2) prefilled syringes or vials is for the 
purposes of assessing the prescription drug program fee only and not for any other purpose. 
40 Section 736(k)(1) of the FD&C Act. 
41 Section 736(k)(2) of the FD&C Act. 
42 More information is provided in the Waivers Guidance. 
43 Two special circumstances that may affect eligibility for waivers or reductions under the barrier to innovation 
waiver provision are addressed in separate waiver guidances.  Companies participating in the Presidents Emergency 
Plan for AIDS Relief should consult the guidance for industry User Fee Waivers for FDC and Co-Packaged HIV 
Drugs for PEPFAR.  Companies submitting combination products under 21 CFR 3.2(e) should see the guidance for 
industry Application User Fees for Combination Products. We update guidances periodically.  To make sure you 
have the most recent version of a guidance, check the FDA Drugs guidance web page at 
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
 
  10  Contains Nonbinding Recommendations 
 
For more information on these waiver and reduction provisions, sponsors may refer to the 
Waivers Guidance.  
 
VIII.  EFFECT OF FAILURE TO PAY FEES 
 
A human drug application or supplement submitted by a person subject to fees under section 
736(a) of the FD&C Act is considered incomplete and will not be accepted for consideration for 
filing until all such fees owed by the person have been paid.44  For example, if a person submits 
an application without an application fee or if the person is in arrears for nonpayment of any 
prescription drug program fees, the application will be incomplete and FDA will not accept it for 
filing.  Note that the term person as used here includes an affiliate of the person, which means 
that an affiliates failure to pay all of the user fees that it owes will affect the applicants ability 
to file an application. 
 
IX.  PAYMENT INFORMATION AND PROCEDURES  
 
This section briefly describes the general process for assessing and issuing annual invoices for 
prescription drug program fees under PDUFA VI. More detailed instructions will be provided in 
FDAs direct notice to affected applicants. 
 
A.  Prescription Drug Program Fee Notifications 
 
FDA will issue a notice to applicants regarding their prescription drug products in preparation for 
assessing prescription drug program fees. These notices will be sent before the due date for 
prescription drug program fees.  Applicants will have the opportunity to review the notice and 
notify FDA of any changes in contact information, changes in prescription drug product 
marketing status, or any other information the Agency needs to issue an accurate annual invoice.  
 
B.  Prescription Drug Program Fee Assessments and Payments 
 
FDA expects to issue invoices for prescription drug program fees around the end of September 
based on information available to the Agency at the time the invoices are prepared.  Payments 
are due either on the first business day on or after October 1 of each fiscal year or the first 
business day after the enactment of an appropriations Act providing for the collection and 
obligation of fees for that fiscal year, whichever occurs later.45 
 
FDA will issue additional invoices later, as needed, to capture program fees owed that were not 
previously invoiced.  For example, fee-eligible prescription drugs that are approved between the 
date annual notices are prepared and October 1 may be the subject of a billing during the fiscal 
year.  Invoices may also be issued after September for other reasons. 
 
 
 
                                                 
44 Section 736(e) of the FD&C Act. 
45 Section 736(a)(2)(A) of the FD&C Act. 
  11  Contains Nonbinding Recommendations 
 
X.  FEE WAIVER, REDUCTION, OR REFUND REQUESTS AND APPEALS 
PROCESS 
 
A.  Waiver, Reduction, or Refund Request 
 
An applicant may request a waiver or reduction of user fees, and may request a refund of fees it 
has paid, if it meets the statutory criteria.46  Policies for such requests, and the permissible 
grounds for a waiver, reduction, or refund, are discussed in more detail in the Waivers Guidance. 
Note that any request for a waiver, reduction, or refund must be submitted no later than 180 days 
after such fee is due.47 
 
B.  Reconsideration Request 
 
If FDA fully or partially denies a request for a waiver, refund, or reduction of user fees, the 
applicant 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 waiver, reduction, or refund of user fees.  
  
FDA recommends that requests for reconsideration state the applicants reasons for believing 
that FDAs decision is in error and include any additional information, including updated 
financial information that is relevant to the applicants position.  The Agency will issue a 
response upon reconsideration, setting forth the basis for the decision. 
 
All requests for reconsideration (regardless of whether the product is regulated by CDER or 
CBER) should be submitted via email to CDERCollections@fda.hhs.gov 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, an applicant 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/PrescriptionDrugUserFee/default.htm.  
 
C.  Appeal Request 
 
If a request is denied upon reconsideration, the applicant 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 waiver, refund, or reduction of user fees.  The following 
information should be included in the appeal: 
 
                                                 
46 The FD&C Act does not provide for deferral of user fees, and FDA does not grant deferrals of user fees, based on 
pending requests for a refund.  FDA therefore expects that all fees assessed will be paid when due without regard to 
a pending request for a refund.  
47 Section 736(i) of the FD&C Act. 
  12  Contains Nonbinding Recommendations 
 
  The original request; 
 
  The denial of the original request; 
 
  The reconsideration request; 
 
  The denial of the reconsideration request; and 
 
  A statement of the applicants reasons for believing that the prior conclusions were in 
error. 
 
No new information or new 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 for either CDER or CBER products should be submitted to the Director 
of CDERs Office of Management via CDERCollections@fda.hhs.gov, 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.48  Alternatively, an applicant 
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/PrescriptionDrugUserFee/default.htm.  
 
After FDA reviews the information submitted in the appeal request, for CDER regulated 
products, the Director of CDERs Office of Management will issue a written decision on the 
applicants request; for CBER regulated products, the Director of CBER will issue a written 
decision on the applicants request. 
     
CDER Products 
 
If the applicants appeal is denied at one management level, the applicant 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 applicant has exhausted the CDER management levels and 
remains unsatisfied with the decision, the applicant 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 the FDAs Ombudsman, with a copy provided to 
CDER.  Review of such matters by the Commissioner is discretionary.49   
 
 
 
                                                 
48 Available at 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm44
4092.htm.  
49 See 40 FR 40682, 40693 (September 3, 1975).  
  13  Contains Nonbinding Recommendations 
 
CBER Products 
 
If the applicants appeal is denied by the Director of CBER, the applicant may request review of 
the matter by the Commissioner under 21 CFR 10.75(c).  Requests for review by the 
Commissioner should be submitted to the FDAs Ombudsman, with a copy provided to CBER.  
Review of such matters by the Commissioner is discretionary. 
  
XI.   OTHER RESOURCES 
 
The following guidance documents may be helpful: 
 
  Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing 
User Fees50 
  User Fee Waivers, Reductions, and Refunds for Drug and Biological Products51 
  User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR52 
 
The following manuals of policies and procedures (MAPPs) may be helpful: 
 
  MAPP 6020.4 Classifying Resubmissions of Original NDAs, BLAs, and Efficacy 
Supplements in Response to Complete Response Letters53 
  MAPP 6050.1 Refusal to Accept Applications for Filing From Applicants in Arrears54 
 
Additional information is also available on the FDA User Fees web page.  For any questions, 
please email the Prescription Drug User Fee staff at CDERCollections@fda.hhs.gov or call 301-
796-7900. 
                                                 
50 Available at 
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079320.pdf.  
51 Available at 
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079298.pdf. 
52 Available at 
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079324.pdf. 
53 Available at 
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/Manualof
PoliciesProcedures/UCM082002.pdf. 
54 Available at 
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/Manualof
PoliciesProcedures/UCM082029.pdf. 
  14