Guidance for Industry 
User Fee Waivers, Reductions, 
and Refunds for Drug and 
Biological Products 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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) 
 
September 2011 
User Fees 
 
 
OMB Control No. 0910-0693 
Expiration Date 08/31/2017  (Note: Expiration date updated 01/05/2015) 
See additional PRA statement in section X of this guidance. 
   
Guidance for Industry 
User Fee Waivers, Reductions, 
and Refunds for Drug and 
Biological Products 
 
 
Additional copies are available from: 
Office of Communication 
Division of Drug Information, WO51, Room 2201 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Ave. 
Silver Spring, MD  20993  
Phone:  301-796-3400; Fax:  301-847-8714 
druginfo@fda.hhs.gov 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm  
 
and/or 
 
Office of Communication, Outreach, and Development (HFM-40) 
Center for Biologics Evaluation and Research 
Food and Drug Administration 
1401 Rockville Pike, Suite 200N 
Rockville, MD  20852-1448 
(Tel) 301-827-1800 or 800-835-4709 
ocod@fda.hhs.gov  
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm  
 
 
 
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) 
 
 
 
 
September 2011 
User Fees 
   
TABLE OF CONTENTS 
 
 
I.  INTRODUCTION............................................................................................................. 1 
 
II.  BACKGROUND ............................................................................................................... 1 
 
III.  DEFINITIONS .................................................................................................................. 2 
 
IV.  TYPES OF WAIVERS AND REDUCTIONS ................................................................ 4 
   
  A.  Public Health .................................................................................................................................. 4 
  B.  Barrier to Innovation ..................................................................................................................... 6 
  C.  Financial Considerations for Public Health and Barrier-to-Innovation Waivers and 
Reductions ...................................................................................................................................... 7 
  D.  Small Business ................................................................................................................................ 9 
 
V.  EXEMPTIONS AND REFUNDS .................................................................................. 11 
 
  A.  Orphan Designated Products ...................................................................................................... 11 
  B.  State or Federal Government Entity .......................................................................................... 12 
  C.  No Substantial Work ................................................................................................................... 12 
 
VI.  SUBMITTING REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS . 13 
 
  A.  Timing of Requests ...................................................................................................................... 13 
  B.  Content and Format of Requests ................................................................................................ 14 
  C.  Address for Submitting Requests ............................................................................................... 16 
 
VII.  FDA RESPONSES TO REQUESTS FOR WAIVERS AND REDUCTIONS .......... 16 
 
VIII.  RECONSIDERATIONS AND APPEALS .................................................................... 17 
 
  A.  Reconsideration Request ............................................................................................................. 17 
  B.  Appeal Request ............................................................................................................................ 17 
 
IX.  DISCLOSURE OF PUBLIC INFORMATION ........................................................... 18 
 
X.  PAPERWORK REDUCTION ACT OF 1995 .............................................................. 18 
 
  Contains Nonbinding Recommendations 
 
1
Guidance for Industry  
User Fee Waivers, Reductions, and Refunds  
for Drug and Biological Products 
 
 
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.  It 
does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  
You can use an alternative approach if the approach satisfies the requirements of the applicable statutes 
and regulations.  If you want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the appropriate 
number listed on the title page of this guidance.  
 
 
 
I.  INTRODUCTION 
 
This guidance provides recommendations to applicants regarding requests for waivers, refunds, 
and reductions of user fees assessed under sections 735 and 736 of the Federal Food, Drug, and 
Cosmetic Act (the Act) for drugs, including biological drug products.  This guidance is a revision 
of the draft guidance entitled Draft Interim Guidance Document for Waivers of and Reductions 
in User Fees (1993 interim guidance), issued July 16, 1993. 
 
This revised guidance describes (1) the types of waivers, refunds, and reductions available under 
the user fee provisions of the Act and (2) the procedures for requesting waivers, refunds, or 
reductions, and reconsiderations and appeals of FDA decisions on such requests.  The revised 
guidance also provides clarification on related issues such as user fee exemptions for orphan 
drugs. 
 
FDA's guidance documents, including this guidance, 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.  
 
 
II.  BACKGROUND 
 
The Prescription Drug User Fee Act of 1992 (PDUFA I) authorized FDA to assess user fees for 5 
years in conjunction with the review of human drug applications.  This authorization to assess 
user fees was for fiscal years (FY) 1993 through FY 1997.  PDUFA has been reauthorized three 
times.  The Food and Drug Administration Modernization Act of 1997 reauthorized the user fee 
                                                 
1 This guidance has been prepared by the Office of Regulatory Policy (ORP), Center for Drug Evaluation and 
Research (CDER), in consultation with the Center for Biologics Evaluation and Research. 
  Contains Nonbinding Recommendations 
 
provisions for 5 years, beginning in FY 1998 (PDUFA II).  The Prescription Drug User Fee 
Amendments of 2002 reauthorized the user fee program for another 5 years, beginning in FY 
2003 (PDUFA III), and the Food and Drug Administration Amendments Act of 2007 
reauthorized the user fee program for another 5 years beginning in FY 2008 (PDUFA IV).  The 
statute is up for reauthorization again in FY 2012. 
 
The Act authorizes FDA to assess application fees for certain human drug and biological product 
applications or supplements when those applications or supplements are submitted.  In addition, 
FDA can assess annual product fees for certain approved drug and biological products, and 
annual establishment fees for the facilities in which those products are made in final dosage 
form.2 
 
Because of the way the program is structured in the Act, the total amount FDA collects in user 
fees is independent of the number of waivers or reductions in fees that are granted.  Target 
revenues are established in accordance with a statutory formula, and the amount of each type of 
fee (application, product, and establishment) is determined based on historical data of how many 
applications, products, and establishments were assessed fees in the previous fiscal year.  
Therefore, the more waivers or reductions are granted, the more fees must be increased the 
following year for applications, products, and establishments subject to fees to meet the annual 
statutory revenue targets. 3     
 
 
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, (A) one business entity controls, or has the power to 
control, the other business entity; or (B) a third party controls, or has the power to 
control, both of the business entities.4 
 
  The term applicant means the owner, holder, or sponsor of a new drug application 
(NDA) or biologics license application (BLA). 
 
                                                 
2  Information on product, establishment, and application fees, including fee rates, PDUFA goals, and other various 
user fee related issues can be found on FDAs PDUFA Internet site:  
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm. 
3 Under the Act, FDA sets user fee target revenue each year.  For example, if the FDA is to collect $600 million in a 
fiscal year, the $600 million is divided by 3 and each category  applications, products, and establishments  
would be expected to provide $200 million.  FDA divides the target revenue in each category by the number of 
applications, products, or establishments it expects to assess fees to determine the fee for each individual 
application, product, or establishment.  The more product fees FDA waives, the higher the product fee is in the 
subsequent fiscal year.  For example, using the target revenue of $200 million, if we assessed fees for 2500 products 
for fiscal year A, the fee would be $80,000 per product.  If FDA waived fees for 100 products, we would expect 
2400 products to be assessed fees in the subsequent fiscal year, and the fee amount per product would increase 
($200 million divided by 2400 = $83,333 per product).  As a result, more companies might request waivers because 
of higher fee assessments. 
4 Section 735(11) of the Act. 
 
  2  Contains Nonbinding Recommendations 
 
  The term application includes both NDAs and BLAs. 
 
  The term drug includes drug and biologic products.  
 
  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.5  Substantial further manufacturing does not include packaging.6  FDA 
generally considers a product to be in final dosage form unless one or more of the 
following operations is required but has yet to be performed:  mixing, granulating, 
milling, molding, lyophilizing, tableting, encapsulating, coating, sterilizing, and filling 
sterile, aerosol, or gaseous drugs into dispensing containers. 
 
  The term human drug application means an application for (1) approval of a new drug 
submitted under section 505(b) of the Act or (2) licensure of a biological drug product 
under section 351 of the Public Health Service Act (PHS Act).7  For purposes of this 
guidance, the term human drug application does not include the following: 
 
  A supplement to such an application 
  An application with respect to whole blood or a blood component for transfusion 
  An application with respect to a bovine blood product for topical application licensed 
before September 1, 1992 
  An application for an allergenic extract product 
  An application for a device licensed under section 351 of the Public Health Service 
Act  
  An application with respect to a large volume parenteral drug product approved 
before September 1, 1992 
  An application for a licensure of a biological product for further manufacturing use 
only 
  An application submitted by a State or Federal Government entity for a drug that is 
not distributed commercially8 
 
  The term person means the person subject to fees and includes any affiliates of that 
person.9  The term person includes an individual, partnership, corporation, and 
association.10  This document will also use the term person when referring to an 
applicant. 
 
  The term supplement means a request to the Secretary to approve a change in a human 
drug application which has been approved.11 
 
                                                 
5 Section 735(4) of the Act. 
6 See section 735(5) of the Act.   
7 Section 735(1) of the Act. 
8 Id. 
9 Section 735(9) of the Act. 
10 Section 201(e) of the Act. 
11 Section 735(2) of the Act. 
 
  3  Contains Nonbinding Recommendations 
 
  The term financial resources means the total gross annual worldwide revenues and other 
available financial assets of an applicant and its affiliates.   
 
 
IV. TYPES OF WAIVERS AND REDUCTIONS 
 
According to section 736(d) of the Act, FDA will grant a waiver of or reduction in one or more 
user fees assessed under section 736(a) of the Act where it finds that an applicant meets the 
eligibility criteria under one of the following provisions: 
 
  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.12 
 
  The applicant is a small business submitting its first human drug application to the 
Secretary for review. 
 
The Act also provides for waiver or reduction of user fees if the fees would exceed the 
anticipated present and future costs incurred by the Secretary in conducting the process for the 
review of human drug applications for the person. Fees-exceed-the-costs waivers and reductions 
are not addressed in this guidance document.13    
 
A.  Public Health  
 
Under section 736(d)(1)(A) of the Act, an applicant may qualify for a waiver of or reduction in 
application, product, and/or establishment fees if the waiver or reduction is necessary to protect 
the public health.  Under this provision, FDA may grant a public health waiver of or reduction in 
user fees if the Agency finds that the following two criteria are met:  
 
  The product protects the public health; and 
 
  The applicant shows that a waiver or reduction is necessary to continue an activity that 
protects the public health. 
 
                                                 
12 There are two additional special circumstances that may affect eligibility for waivers or reductions under the 
barrier to innovation waiver provision.  Each is addressed in a separate waiver guidance.  Specifically, for 
companies participating in the Presidents Emergency Plan for AIDS Relief, see the guidance document, User Fee 
Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.  For companies submitting combination products 
under 21 Code of Federal Regulations 3.2(e), see the guidance for industry and FDA staff on 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 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
13 There is a separate guidance document that discusses the Agencys current thinking on the fees-exceed-the-costs 
waiver provision.  For more information, see the guidance document, Fees-Exceed-the-Costs Waivers Under the 
Prescription Drug User Fee Act, and its addendum at the guidance Web page.   
 
  4  Contains Nonbinding Recommendations 
 
To qualify for a waiver or reduction in user fees under this provision, an applicant must meet 
both criteria. 
 
1.  Does the product protect the public health? 
 
For user fee purposes, a product that has been approved for marketing in the United States is not 
automatically deemed to be a product that protects the public health.  In evaluating whether a 
product protects the public health, the Agency asks the following questions: 
 
  Is the drug product a significant improvement (or does it have the potential to be a 
significant improvement if the drug product is not yet approved) compared to other 
marketed products, including other dosage forms or routes of administration and non-
drug products or therapies?   
 
  Are there treatment alternatives?  The existence of alternatives would weigh against a 
determination that a product is necessary to protect the public health. 
 
  Is the drug product designated as a priority drug,14 has it been granted fast track status,15 
or has it been determined to be a new molecular entity?  Affirmative answers to these 
questions usually indicate that a product protects the public health.  Other questions the 
Agency may consider include: 
 
  Does the drug product demonstrate an increased effectiveness in the treatment, 
prevention, or diagnosis of disease?   
  Does it eliminate or substantially reduce a treatment-limiting drug reaction?   
  Does the drug product enhance patient adherence to treatment?   
  Has the drug product shown potential evidence of safety and effectiveness for a 
new or underserved subpopulation (e.g., treatment for a drug resistant microbe or 
response to a homeland security concern)? 
 
  Is the drug product intended for the treatment of a serious or life-threatening condition?   
 
  Does the drug product address unmet medical needs or demonstrate the potential to do 
so?   
 
  Is the product designated as a drug for a rare disease or condition under section 526 of the 
Act (i.e., does it have an orphan designation)? 
 
                                                 
14 Further information regarding priority drugs can be found in the Center for Drug Evaluation and Researchs 
(CDERs) Manual of Policies and Procedures (MAPP) 6020.3R, Review Classification Policy:  Priority (P) and 
Standard (S).  MAPP 6020.3R is available on the Internet at http://www.fda.gov, search by MAPP number. 
15 Further information regarding fast track status can be found in CDERs guidance for industry on Fast Track 
Development Programs  Designation, Development, and Application Review. 
 
  5  Contains Nonbinding Recommendations 
 
  If the product is approved, is it available to the public?  There is no benefit to the public 
health if a product is not made available to the public.16  
 
2.  Is the waiver or reduction necessary to continue an activity that protects the public 
health? 
 
To determine whether a waiver of or reduction in user fees is necessary to continue an activity 
that protects the public health, the Agency considers not only the benefit to the public health, but 
also whether the waiver or reduction is necessary.  The legislative history of PDUFA I states that 
FDA may waive or reduce fees unless such a waiver or reduction is not necessary to protect the 
public health, or it is apparent that the fee will not be a disincentive to innovation.17  It also 
expressly notes that FDA should consider the limited resources of the applicant when 
evaluating a request for a fee waiver or reduction under section 736(d).18  Therefore, the Agency 
believes that a financial test is appropriate for the public health waiver provision.  The Agency 
considers the relationship between the annualized cost of user fees and the financial resources of 
the applicant, including affiliates, requesting the waiver or reduction.  The financial 
considerations are discussed in section IV.C below. 
 
B.      Barrier to Innovation 
 
Under section 736(d)(1)(B) of the Act, an applicant may qualify for a waiver of or reduction in 
application, product, and/or establishment fees when the assessment of the fees would present a 
significant barrier to innovation because of limited resources available to the applicant or other 
circumstances.  Under this provision, FDA may grant a waiver of or reduction in user fees if:   
 
  The product or other products or technologies under development by the applicant are 
innovative; and  
 
  The fee(s) would be a significant barrier to the applicants ability to develop, 
manufacture, or market innovative products or to pursue innovative technology. 
 
To qualify for a waiver or reduction in user fees under this provision, an applicant must meet 
both criteria. 
 
1.  Is the product innovative or is the company pursuing other innovative drug products 
or technologies? 
 
A product that has been approved for marketing in the United States is not automatically deemed 
to be innovative for user fee purposes.  In evaluating requests for barrier-to-innovation user fee 
waivers or reductions, the Agency asks the following questions: 
 
                                                 
16 We would consider products stockpiled for homeland security concerns as available to the public for user fee 
waiver purposes. 
17  House Report 102-895 (1992) at 17.   
18 Id.  
 
  6  Contains Nonbinding Recommendations 
 
  Does the drug product or technology demonstrate advanced breakthrough research, 
new, progressive methods, and/or forward thinking in the treatment or diagnosis of 
disease, or does it have the potential to be at the forefront of new medical technology? 
 
  Does the drug product or technology introduce a unique or superior method for 
diagnosing, curing, mitigating, treating, or preventing a disease, or for affecting a 
structure or function of the body? 
 
  Is the drug product designated as a priority drug, has it been granted fast track status, or 
has it been determined to be a new molecular entity? 
 
  Does the applicant have an active investigational new drug application (IND) under 
which the applicant is evaluating a unique or superior method for diagnosing, curing, 
mitigating, treating, or preventing a disease, or for affecting a structure or function of the 
body? 
 
  Has the applicant recently received a Federal grant for innovation?  Two examples of 
such Federal grant programs that may qualify as innovative are (1) the National Institutes 
of Healths Small Business Innovative Research Program and (2) the National Institute of 
Standards and Technologys Advanced Technology Program.   
 
2.  Does the fee create a significant barrier to the applicants ability to develop, 
  manufacture, or market innovative products or to pursue innovative technology? 
  
To determine whether a fee would be a significant barrier to an applicants ability to develop, 
manufacture, or market innovative products or to pursue innovative technology, the Agency 
considers the relationship between the annualized cost of user fees and the gross annual revenues 
and financial resources of the applicant and its affiliates.  The revenue considerations are 
discussed below. 
 
C.  Financial Considerations for Public Health and Barrier-to-Innovation Waivers and 
Reductions 
 
1.  Whose revenues are considered when evaluating a waiver or reduction request? 
 
When evaluating requests for waivers of or reductions in user fees under the public health or 
barrier to innovation provisions, the Agency considers the financial resources of the applicant 
and its affiliates, regardless of who submits a request for a waiver or reduction of user fees. 
 
Section 736(d)(2) of the Act states that, in determining whether to grant a waiver or reduction of 
a user fee, FDA shall consider only the circumstances and financial resources of the applicant 
and any affiliate of the applicant.  Under the Act, the applicant is the person who is responsible 
for payment of the fees and the person who must qualify for a waiver or reduction of user fees.  
Accordingly, the statute does not allow persons other than those legally subject to user fees, such 
as a distributor that is not an affiliate, to qualify for or receive waivers or reductions of user fees.     
 
 
  7  Contains Nonbinding Recommendations 
 
2.  How does the Agency determine whether an applicant has limited financial 
resources? 
   
The limited financial resources of an applicant and its affiliates are an important indicator of 
whether user fees are a barrier to innovation or a waiver or reduction is necessary to protect the 
public health.19  FDA will consider the total annual revenue of an applicant and its affiliates in 
determining whether the applicant has limited financial resources.  Total annual revenue is an 
objective measure of the resources available to the applicant and is defined by generally accepted 
accounting principles.  FDA does not intend to deduct marketing costs, including expenses in 
foreign markets that are often incurred because of an applicants marketing decisions, when 
calculating total annual revenue. 
 
In addition to total annual revenue of the applicant and its affiliates, FDA considers other 
available financial assets, including net proceeds, cash, and total assets.  FDA may also consider 
the results of recent issuances of stock and the recently available capital raised from the sales of 
shares in the applicant company.   
 
Because even a very large applicant may have operating losses, FDA does not intend to consider 
lack of profitability as evidence of limited resources.  The Agency also does not intend to 
consider product sales figures to be evidence of limited resources, because even a large and 
profitable company can have low sales figures for an individual product, but not need a waiver to 
continue an activity that is necessary to protect the public health or because the fees would 
present a significant barrier to innovation.   
 
Ordinarily, beginning with fees assessed for FY 2011, the Agency expects to determine that an 
applicant with financial resources, including the financial resources of affiliates, of less than $20 
million has limited resources for user fee purposes.20  An applicant with $20 million or more in 
financial resources, including the financial resources of affiliates, generally will not be 
considered to have limited resources for user fee purposes. 
 
FDA considers the financial resources of applicants that are State or Federal government entities 
differently.  The Agency will consider State or Federal government entities with less than $20 
million in total annual revenues from the sale of drug to have limited resources for user fee 
purposes.  A government entity is able to devote only a small amount of money to drug 
development activities relative to the entitys budget and the total State or Federal budget.  In 
addition, government entities generally receive only a small amount of revenue, if any, from 
commercial distribution of a drug, as compared with total revenues.  FDA believes that Congress 
intended to minimize the burden on State and Federal government entities by focusing attention 
                                                 
19 As noted above, the legislative history states that FDA should consider the limited resources of an applicant 
when evaluating a request for a fee waiver or reduction under section 736(d).  See House Report  102-895 (1992) at 
17.  FDA therefore believes that a financial test is appropriate for both the public health and barrier-to-innovation 
waiver provisions.   
20 For waivers regarding fees for fiscal years prior to 2011, the Agency intends to continue to use as its general 
marker of limited resources the $10 million benchmark cited in the 1993 interim guidance, adjusted for inflation. 
 
  8  Contains Nonbinding Recommendations 
 
on their drug development revenues, not the overall revenues of the entity or the State or Federal 
government.21 
3.  Why did FDA choose $20 million as a marker? 
 
When the 1993 interim guidance was issued, the Agency used $10 million as a financial marker 
for evaluating whether a waiver or reduction was necessary to protect the public health and 
whether the fees were a significant barrier to innovation.  Since 1993, the Agency has received 
several requests to adjust the $10 million financial marker for inflation.  As stated in section II, 
the more fee waivers and reductions FDA grants, the more the fees for other applications, 
products, and establishments must be increased to ensure that FDA obtains the total annual fee 
revenues specified in the Act.  However, the Agency believes that the $10 million figure is 
outdated and should be adjusted.  Based on almost 20 years of experience in implementing the 
user fee program, FDA has determined that most applicants that have annual revenues and 
financial resources of less than $20 million are those least able to pay the fees.  Therefore, the 
Agency intends to use $20 million as its marker for evaluating whether an applicant and its 
affiliates have limited resources such that a waiver or reduction is necessary to protect the public 
health and/or whether the fees are a significant barrier to innovation.22 
 
D.  Small Business 
 
Under section 736(d)(1)(D) of the Act, an applicant is eligible for a waiver of the application fee 
if the applicant is a small business submitting its first human drug application to the Agency for 
review and does not have another product approved under a human drug application and 
introduced or delivered for introduction into interstate commerce.  An applicant is eligible for a 
small business waiver when: 
 
  The applicant employs fewer than 500 employees, including employees of affiliates;  
 
  The applicant does not have a drug product that has been approved under a human drug 
application and introduced or delivered for introduction into interstate commerce; and 
 
  The applicant, including its affiliates, is submitting its first human drug application. 
 
To qualify for a small business waiver, an applicant must meet all of these criteria. 
 
To determine the size of an applicant and its affiliates, the FDA works with the Small Business 
Administration (SBA).  FDA asks the SBA to determine what companies are affiliates of the 
applicant and the total number of employees for the applicant and its affiliates.  After receiving a 
request from the FDA, the SBA consults with the applicant and determines the number of 
employees the applicant and its affiliates have, based on SBA regulations.  According to these 
                                                 
21 For example, the Act exempts a State or Federal government entity from application, product, and establishment 
fees for a drug product that is not distributed commercially.  Sections 735(1) and (3) of the Act. 
22 If the $10 million benchmark in the 1993 guidance, which was written to be used under PDUFA I, were adjusted 
solely for inflation since the conclusion of the PDUFA I period in 1998, it would be less than $15 million in FY 
2011 dollars, so this adjustment to $20 million would be expected to anticipate and eliminate the need for any 
further adjustments for inflation for at least the next 10 years. 
 
  9  Contains Nonbinding Recommendations 
 
regulations, SBA may contact the applicant to request the following information in the 
appropriate formats and detail: 
 
  An application for size determination; 
 
  A copy of the companys Articles of Incorporation and Bylaws; 
 
  The companys last annual statement to shareholders; and 
 
  A breakdown of the number of persons employed full time, part time, temporarily, or 
otherwise during each of the pay periods for the 12 months preceding the companys 
certification. 
 
Companies should not submit the information requested by the SBA to FDA, nor should they 
submit this information to SBA until contacted.  If the information is not submitted to the SBA, 
the request for a small business waiver will be denied. 
 
The SBA recognizes, as does FDA, that some information provided by companies may be 
confidential.  Both the SBA and FDA will treat confidential commercial or financial information 
consistent with applicable federal laws and regulations (see section IX). 
 
Once the SBA has identified and confirmed the affiliates of the applicant and determined 
whether the applicant qualifies as a small business, FDA will evaluate whether the applicant 
meets the other criteria for the small business waiver.  Specifically, FDA searches its records to 
determine whether the applicant or its affiliates have previously submitted a human drug 
application or whether the applicant has a drug product that has been approved under a human 
drug application and introduced or delivered for introduction into interstate commerce.  If the 
waiver applicant meets all the criteria for a small business waiver, then FDA will notify the 
applicant that the waiver is granted.  
 
1.  Does a small business waiver have an expiration date? 
 
If a small business waiver is granted, the applicant should submit its human drug application 
within 1 year after the date of the SBA determination.  The reason for the 1 year time frame is 
that the circumstances supporting a small business waiver may change rapidly.  For example, an 
applicant could merge with a larger company and therefore no longer be considered a small 
business.  Similarly, an applicant could purchase an NDA from an unaffiliated company and, 
therefore, would have a drug product that has been approved under a human drug application and 
introduced into or delivered for introduction into interstate commerce.   
 
FDA understands that unforeseen circumstances may delay submission of an application.  If an 
applicant is granted a small business waiver and is not able to submit the application within 1 
year of the SBA determination, the applicant may ask FDA to extend the expiration date.   
If an extension is requested, the Agency will examine its records and will work with SBA to 
confirm that the applicant still meets the criteria for a small business waiver.  If the criteria are 
no longer met, the extension request will be denied.   
 
  10  Contains Nonbinding Recommendations 
 
 
2.  Can a small business receive a waiver of application fees for future human drug 
applications? 
 
After an applicant or its affiliate is granted a small business waiver and submits its first human 
drug application, the applicant cannot receive another small business waiver.  That means that 
the applicant or its affiliate is not eligible to receive a small business waiver for any subsequent 
human drug application or a supplement to an application.23   
 
After an applicant or its affiliate is granted a small business waiver and submits its first human 
drug application, the applicant or affiliate is ineligible for another small business waiver even if 
the application is withdrawn or refused for filing.  If an applicant does not submit the application 
for which it was granted a small business waiver, the applicant may qualify again for a small 
business waiver. 
 
3.  Can a small business receive a waiver or reduction of product and establishment 
fees? 
 
There is no specific provision in the Act for a waiver or reduction of product and establishment 
fees for small businesses.  However, small businesses may apply for a waiver or reduction of 
product and establishment fees through the public health or barrier-to-innovation waiver 
provisions.  See discussions in sections IV.A, IV.B, and IV.C above. 
 
V.  EXEMPTIONS AND REFUNDS 
  
A.  Orphan Designated Products 
 
1.  Application Fees  
 
Under section 736(a)(1)(F) of the Act, a human drug application for a product that has been 
designated as a drug for a rare disease or condition (referred to as an orphan drug) under section 
526 of the Act is not subject to an application fee unless the human drug application includes an 
indication for other than a rare disease or condition.  A supplement proposing to include a new 
indication for a rare disease or condition in a human drug application shall not be subject to an 
application fee if the drug has been designated under section 526 as a drug for a rare disease or 
condition with regard to the indication proposed in the supplement.   
 
If an application or supplement qualifies for an orphan exemption, the applicant does not need to 
send FDA a written request.  The applicant should simply notify FDA that it is claiming the 
orphan exemption when it completes and submits the User Fee Coversheet, Form FDA 3397.24  
The User Fee Coversheet should be included with the application or supplement, and a brief 
statement claiming the orphan exception should be included in the cover letter. 
                                                 
23 Section 736(d)(4)(B) of the Act.   
24 For more information about completion and submission of the User Fee Cover Sheets, see 
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm.  
 
  11  Contains Nonbinding Recommendations 
 
 
2.  Product and Establishment Fees 
Under section 736(k) of the Act, a drug product designated under section 526 of the Act for a 
rare disease or condition and approved under section 505 of the Act or section 351 of the Public 
Health Service Act is exempt from the product and establishment fees if it meets the public 
health requirements contained in the Act as such requirements are applied to requests for waivers 
of product and establishment fees.  In addition, the applicant must have less than $50 million in 
gross worldwide revenue during the year preceding the request for exemption.  An applicant 
seeking to avail itself of this exemption should submit a certification that its gross worldwide 
revenues, including affiliates, did not exceed $50 million for the 12 months before the request.  
See section VI for information about how to submit a request for an exemption from product and 
establishment fees. 
 
B.  State or Federal Government Entity 
 
An application submitted by a State or Federal government entity for a drug that is not 
distributed commercially is not considered a human drug application under section 735(1) of 
the Act.  If the application is not considered a human drug application, then application fees are 
not assessed and product and establishment fees do not apply. 
 
For the purposes of the State and Federal exemption from user fees under the Act, distributed 
commercially means any distribution in exchange for financial reimbursement, goods, or 
services, whether or not the amount of the charge covers the full costs associated with the 
product.  Any recovery by the applicant of all or part of the costs of manufacture or distribution 
of a product makes the distribution commercial. 
 
C.  No Substantial Work 
 
Under section 736(a)(1)(G) of the Act, if an application or supplement is withdrawn after the 
application or supplement is filed, FDA may refund the fee or a portion of the fee if no 
substantial work was performed on the application or supplement after the application or 
supplement was filed.   
 
 
  12  Contains Nonbinding Recommendations 
 
 
VI. SUBMITTING REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS  
 
A.  Timing of Requests 
 
1.  Is there a statutorily mandated deadline for requesting a waiver or reduction? 
 
Yes.  Under section 736(i) of the Act, to qualify for a waiver of or reduction in user fees as well 
as a refund for a fee paid, an applicant must submit to FDA a written request for a user fee 
waiver or reduction no later than 180 calendar days after the fee is due.  
 
For example, if an applicant receives a product and establishment fee invoice from FDA, we 
expect the invoice to be paid by the due date.  The applicant can then submit a written request for 
a waiver, reduction, or refund of the fee(s) within 180 days from the date when the invoice is 
due.  If the request is submitted within 180 days of the due date (i.e., if the request is timely), 
FDA will evaluate the applicants request.  If FDA determines that the applicant qualifies for a 
waiver, reduction, or refund, the Agency will grant the applicants request.   
 
To avoid having to pay a fee, an applicant can submit a request for waiver or reduction in 
advance of when the product and establishment fee invoice is due to be paid, or in advance of 
submitting an application (see sections VI.A.3 and 4 below). 
 
2.  Are there consequences if user fees are not paid because an applicant has not yet 
submitted a waiver or reduction request or because FDA has not yet responded to a 
waiver or reduction request? 
 
Yes.  According to section 736(e) of the Act, a human drug application or supplement submitted 
by a person subject to fees under section 736(a) is considered incomplete and will not be 
accepted for filing until all fees have been paid.  That means that if the applicant submits an 
application or a supplement without the application fee or is in arrears for nonpayment of an 
establishment or product fee, then the submission is incomplete and FDA will not review it.  
However, the review status of an application or supplement submitted before the invoice due 
date would not be affected (the review would continue and there would be no effect on the 
review goal date).25   
 
3.  Is there a recommended time frame to submit a waiver or reduction request if an 
applicant wants to avoid paying the application fee and then seeking a refund? 
 
Yes.  FDA encourages applicants to submit a request for a waiver of or reduction in an 
application fee approximately 3-4 months before submission of the application.  Under normal 
circumstances and depending on available resources, FDA will try to make its determination on 
the waiver request before the application is submitted and the fee is due. 
 
FDA discourages applicants from submitting application fee waiver or reduction requests more 
than 4 months before the submission of an application because the circumstances that support an 
                                                 
25 See CDERs MAPP 6050.1, Refusal to Accept Application for Filing From Applicants in Arrears. 
 
  13  Contains Nonbinding Recommendations 
 
applicants request are subject to change, and FDA considers it unreasonable to assume that 
those circumstances will continue to exist for longer than 4 months prior to the submission of an 
application.  For example, if an applicant submits an application fee waiver request on July 1 and 
plans to submit its application on March 1 of the next year, FDA considers it unreasonable to 
assume that the facts stated on July 1 will remain the same 8 months later, in the following 
March.  Therefore, FDA encourages sponsors to submit their waiver or reduction requests no 
more than 4 months prior to the submission of the application.   
 
4.  Is there a recommended time frame to submit a waiver or reduction request if the 
applicant wants to avoid paying the product and establishment fees and then seeking 
a refund? 
 
Yes.  The time frame is the same as for an advance request for an application fee waiver or 
reduction:  an applicant seeking a waiver or reduction of product and establishment fees may 
submit a request for a waiver or reduction 3 to 4 months before the fee is due.  Annual product 
and establishment fees are usually assessed in August and are due on October 1.26  Thus, an 
applicant that wishes to obtain a waiver or reduction in advance should submit its request 
between June 1 and July 1.  Under normal circumstances and depending on available resources, 
FDA will try to complete its evaluation of the request before the due date of the product and 
establishment fees. 
 
The Act does not provide for deferral of user fees, and FDA does not grant deferrals of user fees 
based on pending waiver or reduction requests.  FDA therefore expects that all product and 
establishment fees will be paid without regard to a pending request for a fee waiver or reduction.  
This approach will ensure that the steady funding stream Congress intended will be achieved, 
and should deter the filing of frivolous waiver or reduction requests.   
 
Ordinarily, FDA expects to grant a reduction or waiver of a product or establishment fee only for 
the current year.   If an applicant wishes to have a product or establishment fee waived or 
reduced for assessments in future years, it should make a new request for a waiver or reduction 
each year. 
 
B.  Content and Format of Requests 
 
1.  General Information for All Requests 
 
Requests for CDER and CBER user fee waivers, reductions, and refunds will be reviewed and 
granted or denied by CDERs Associate Director for Policy.27  However, reductions and refunds 
for products regulated by CBER will be reviewed and granted or denied by CBERs Center 
Director.   
 
FDA recommends that each waiver or reduction request be submitted in writing and that it 
contain the following information: 
                                                 
26 The fiscal year begins October 1 and ends September 30. 
27  Waivers and reductions under the fees-exceed-the-costs waiver provision are the responsibility of FDAs Office 
of Financial Management. 
 
  14  Contains Nonbinding Recommendations 
 
 
  Name of applicant requesting the waiver,28 including company name, address, contact, 
telephone and facsimile numbers, and e-mail address 
 
  Identification of the specific fee(s) for which the waiver, refund, or reduction is requested 
 
  Date on which payment was made or will be made of the fee for which a waiver or 
reduction is requested 
 
  Statutory provision under which a waiver or reduction is requested 
 
  Information and analyses showing that the criteria for the waiver or reduction have been 
met 
 
  Rationale for why the waiver, reduction or refund request should be granted 
 
  A list of the applicants affiliates 
 
  For public health and barrier to innovation waivers, a current annual financial report for 
the applicant and the applicants affiliates.  If a current annual financial report is not 
available, a report that includes total annual revenues, net proceeds, cash, and total assets.   
 
2.  Additional Specific Information for Application Fee Waiver or Reduction Requests 
 
In addition to the general information specified above, requests for waivers of or reductions in 
application fees should include the following: 
 
  NDA number (including supplement number and type if there is one) or BLA number 
 
  Trade and established names of products covered by the waiver request 
 
  Date the application was or will be submitted 
 
  Whether or not clinical data are required for approval 
 
3.  Additional Specific Information Requested for Product Fee Waiver or Reduction 
Requests 
 
In addition to the general information specified above, requests for waivers of or reductions in 
product fees should include the following: 
 
  NDA or BLA number 
 
                                                 
28 If an agent is submitting a waiver request on behalf of the waiver applicant, authorization from the waiver 
applicant for the agent to act on its behalf should also be included. 
 
  15  Contains Nonbinding Recommendations 
 
  Trade and established names of the product 
 
  National Drug Code (NDC) number 
 
  Name of the application holder 
 
  Specific strength, dosage form, and route of administration 
 
  Invoice date and number (or copy of the invoice sheet) 
 
4.  Additional Specific Information Requested for Establishment Fee Waiver and 
Reduction Requests 
 
In addition to the general information specified above, requests for waivers of or reductions in 
establishment fees should include the following: 
 
  Name of the establishment 
 
  Address of the manufacturing site (not a business, office, or headquarters address, but the 
actual address of the manufacturing site) 
 
  Establishment number as listed on the invoice 
 
  Invoice date and number (or a copy of the invoice sheet) 
 
C.  Address for Submitting Requests 
 
Original user fee waiver or reduction requests should be submitted in writing to: 
 
Associate Director for Policy 
Attention:  User Fee Waiver Office, Michael D. Jones 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Avenue 
Bldg. 51, Room 6216 
Silver Spring, MD  20993-0002 
 
 
VII.  FDA RESPONSES TO REQUESTS FOR WAIVERS AND REDUCTIONS 
 
FDA will review the waiver or reduction request, consulting with relevant Agency officials as 
appropriate.  FDA may request additional information from the applicant during the review 
period.  The Agency will respond to requests for waivers and reductions in a timely fashion 
based on available resources and collection time for additional information.  
 
 
  16  Contains Nonbinding Recommendations 
 
VIII.  RECONSIDERATIONS AND APPEALS 
 
A.  Reconsideration Request 
 
If FDA fully or partially denies a request for a waiver or reduction of user fees, the applicant 
may request reconsideration of that decision.  A request for reconsideration should be made 
within 30 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 the 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 reconsiderations should be submitted in writing to: 
 
Associate Director for Policy 
Attention:  User Fee Waiver Office, Michael D. Jones 
Center for Drug Evaluation and Research 
Food and Drug Administration 
10903 New Hampshire Avenue 
Bldg. 51, Room 6216 
Silver Spring, MD  20993-0002 
 
B.  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 days of the issuance of FDAs decision to affirm 
its denial of a request for a waiver, or reduction of user fees.  The following information should 
be included in the appeal. 
 
  The original waiver request 
 
  The denial of the original waiver request 
 
  The reconsideration request 
 
  The denial of the reconsideration request 
 
  A statement of the applicants belief that the prior conclusions were in error 
 
The appeal request should also contain particular references to information or analyses already 
submitted to the Agency that the applicant believes is relevant to its position.  No new 
information should be presented in the appeal request. 
 
All requests for appeals should be submitted in writing to: 
 
  17  Contains Nonbinding Recommendations 
 
 
Chief Scientist and Deputy Commissioner for Science and Public Health 
User Fee Appeals Officer 
Food and Drug Administration 
c/o Matthew Warren 
10903 New Hampshire Avenue 
Bldg. 32, Room 4210 
Silver Spring, MD  20993-0002 
Fax:  301-847-8617 
 
A copy of the request for appeal should also be submitted to the CDER Associate Director for 
Policy as noted in section VIII above.  After FDA reviews the information submitted in the 
appeal request, the Deputy Commissioner will issue a written decision on the applicants request.  
The written decision issued by the Deputy Commissioner will constitute final Agency action on 
that request. 
 
 
IX. DISCLOSURE OF PUBLIC INFORMATION 
 
FDA plans to disclose to the public information about its actions granting or denying waivers 
and reductions.  This disclosure will be consistent with the laws and regulations governing the 
disclosure of confidential commercial or financial information. 
 
 
X.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). 
 
The guidance also refers to collections of information for filling out and submitting Form FDA 
3397 (Prescription Drug User Fee Coversheet) previously approved under OMB control number 
0910-0297, and collections of information associated with a new drug application or biologics 
license application approved under OMB control numbers 0910-0001 and 0910-0338, 
respectively. 
 
The time required to complete this information collection is estimated to average 16 hours for a 
request for a waiver, reduction, or refund of certain user fees; 24 hours per response for a 
reconsideration of a request; and 12 hours for an appeal of a waiver, reduction, or refund 
decision.  These estimates include the time to review instructions, gather the data needed, and 
complete and review the information collection.  Send comments regarding this burden estimate 
or suggestions for reducing this burden to: 
 
Associate Director for Policy, Attention:  User Fee Waiver Office, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 51, Room 
6216, Silver Spring, MD  20993-0002. 
 
  18  Contains Nonbinding Recommendations 
 
 
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 control number. The OMB control number 
for this information collection is 0910-0693 (expires 08/31/2017 (Note:  Expiration date updated 
01/05/2015)). 
 
 
 
 
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