Prescription Drug User 
Fee Act Waivers, 
Reductions, and 
Refunds for Drug and 
Biological Products 
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) 
 
October 2019 
User Fees 
   
Prescription Drug User 
Fee Act Waivers, 
Reductions, and 
Refunds for Drug and 
Biological Products 
 
Guidance for Industry
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
http://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 
10903 New Hampshire Ave., Bldg. 71, Room 3128 
Silver Spring, MD 20993-0002 
Phone: 800-835-4709 or 240-402-8010 
Email: ocod@fda.hhs.gov 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/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) 
 
October 2019 
User Fees 
   
TABLE OF CONTENTS 
 
I.  INTRODUCTION............................................................................................................. 1 
 
II.  BACKGROUND ............................................................................................................... 2 
 
III.  DEFINITIONS .................................................................................................................. 2 
 
IV.  TYPES OF WAIVERS AND REDUCTIONS ................................................................ 4 
 
A.  Public Health .................................................................................................................................. 5 
B.  Barrier to Innovation ..................................................................................................................... 7 
C.  Financial Considerations for Public Health and Barrier-to-Innovation Waivers and 
Reductions ...................................................................................................................................... 8 
D.  Small Business .............................................................................................................................. 10 
 
V.  EXEMPTIONS AND REFUNDS .................................................................................. 11 
 
A.  Orphan Designated Products ...................................................................................................... 11 
B.  State or Federal Government Entity .......................................................................................... 12 
C.  No Substantial Work ................................................................................................................... 13 
 
VI.  SUBMITTING REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS . 13 
 
A.  Address for Submitting Requests ............................................................................................... 13 
B.  Timing of Requests ...................................................................................................................... 13 
C.  Content and Format of Requests, Excluding Small Business Waiver Requests .................... 15 
D.  Content and Format of Requests for a Small Business Waiver ............................................... 17 
E.  Refund Requests .......................................................................................................................... 18 
 
VII.  FDA RESPONSES TO REQUESTS FOR WAIVERS, REDUCTIONS, AND 
REFUNDS ........................................................................................................................ 18 
 
VIII.  APPEALS PROCESS ..................................................................................................... 19 
 
A.  Reconsideration Request ............................................................................................................. 19 
B.  Appeal Request ............................................................................................................................ 19 
 
   
IX.  DISCLOSURE OF PUBLIC INFORMATION ........................................................... 20 
 
X.  PAPERWORK REDUCTION ACT OF 1995 .............................................................. 21 
 
APPENDIX 1: FORM FDA 3971 .............................................................................................. 22 
  Contains Nonbinding Recommendations 
Prescription Drug User Fee Act Waivers, Reductions,  
and Refunds for Drug and Biological Products 
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 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 FD&C Act) for drugs, including biological products.2  This guidance is a 
revision of the guidance for industry entitled User Fee Waivers, Reductions, and Refunds for 
Drug and Biological Products, issued in September 2011. 
 
This revised guidance describes (1) the types of waivers, refunds, and reductions available under 
the user fee provisions of the FD&C Act, (2) the procedures for requesting waivers, refunds, or 
reductions, and (3) the process for requesting a reconsideration or appeal of an FDA decision.  
The guidance also provides clarification on related issues such as user fee exemptions for orphan 
drugs. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
 
 
 
                                                 
1 This guidance has been prepared by the Division of User Fee Management and Budget Formulation, Office of 
Management, Center for Drug Evaluation and Research, in consultation with the Center for Biologics Evaluation 
and Research. 
2 For the purposes of this document, unless otherwise specified, references to drugs or drug products include 
drugs submitted under section 505(b) of the FD&C Act and biological products licensed under section 351(a) of the 
PHS Act, other than biological products that also meet the definition of a device in section 201(h) of the FD&C Act 
(21 U.S.C. 321(h)). 
  Contains Nonbinding Recommendation 
II.  BACKGROUND 
 
The Prescription Drug User Fee Act of 1992 (PDUFA I) amended the FD&C Act, and authorized 
FDA to collect user fees for 5 years from companies that produce certain human drug and 
biological products.  PDUFA must be reauthorized every 5 years, and has been reauthorized 5 
times since PDUFA I, most recently in 2017 under Title I of the FDA Reauthorization Act of 
2017 (PDUFA VI). 
 
PDUFA VI authorizes FDA to assess application fees for certain human drug and biological 
product applications when those applications are submitted.  In addition, PDUFA VI authorizes 
FDA to assess annual prescription drug program fees (program fees) for certain approved drug 
and biological products.3 
 
Because of the way the user fee program is structured in the FD&C 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 and program) is determined based on historical data of how many 
applications and products were assessed fees in the previous fiscal years.  Therefore, the number 
of waivers, refunds, and reductions granted in a fiscal year is factored into the statutory formula 
and may result in an increase or decrease in application and program fees for the following year 
to meet the annual statutory revenue targets. 
 
 
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), submitted under section 505 of the FD&C Act, or biologics license application 
(BLA), submitted under section 351(a) of the Public Health Service (PHS) Act. 
 
  The term application includes both NDAs, submitted under section 505 of the FD&C 
Act, and BLAs, submitted under section 351(a) of the PHS Act. 
 
  The term drug includes drug and biological products.  
                                                 
3 Information on application and program fees, including fee rates, PDUFA goals, and other user fee related issues 
can be found on FDAs PDUFA website:  
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm. 
4 Section 735(11) of the FD&C Act. 
 
 
  2  Contains Nonbinding Recommendation 
  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 section 351(a) of the PHS Act.5  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 in vitro diagnostic biologic product licensed under section 351 of the PHS 
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; and 
  An application submitted by a State or Federal Government entity for a drug 
that is not distributed commercially.6 
 
  The term person means the person subject to fees and includes any affiliates of that 
person.7  The term person includes an individual, partnership, corporation, and 
association.8  This document will also use the term person when referring to an applicant. 
 
  The term prescription drug product means a specific strength or potency of a drug in 
final dosage form --  
 
  for which a human drug application has been approved,  
  which may be dispensed only by prescription under section 503(b) of the FD&C Act, 
and 
  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 FDA of products approved under human drug applications under 
section 351(a) of the PHS Act (not including the discontinued section of such list).9 
 
For purposes of this guidance, such term does not include: 
 
  Whole blood or a blood component for transfusion; 
  A bovine blood product for topical application licensed before September 1, 1992; 
                                                 
5 Section 735(1) of the FD&C Act. 
6 Id. 
7 Section 735(9) of the FD&C Act. 
8 Section 201(e) of the FD&C Act. 
9 Section 735(3) of the FD&C Act. 
 
 
  3  Contains Nonbinding Recommendation 
  An allergenic extract product; 
  An in vitro diagnostic biologic product licensed under section 351 of the PHS Act; 
  A biological product that is licensed for further manufacturing use only; and 
  A drug that is not distributed commercially and is the subject of an application or 
supplement submitted by a State or Federal Government entity.10 
 
  The term supplement means a request to FDA to approve a change in a human drug 
application that has been approved.11 
 
  The term financial resources means the current financial assets, including cash and any 
other income available other than cash in the form of liquid securities and credit lines, of 
an applicant and its affiliates.  See section IV.C. for more information.  
 
 
IV. TYPES OF WAIVERS AND REDUCTIONS 
 
According to section 736(d) of the FD&C Act, FDA will grant to an applicant 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:  
 
  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; or 
 
  The applicant is a small business submitting its first human drug application to FDA for 
review. 
 
Sections IV.A through IV.D describe FDAs considerations for each type of waiver.12   
                                                 
10 Section 735(3) of the FD&C Act. 
11 Section 735(2) of the FD&C Act. 
12 There are three additional special circumstances that may affect an applicants eligibility for waivers or reductions 
under the public health and barrier to innovation waiver provision:  
(1) for applicants participating in the Presidents Emergency Plan for AIDS Relief (PEPFAR), see guidance 
for industry, User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR;  
(2) for applicants submitting combination products under 21 Code of Federal Regulations 3.2(e), see 
guidance for industry, Application User Fees for Combination Products; and  
(3) for applicants submitting applications for certain types of positron emission tomography (PET) drugs 
(specifically, FDG F 18 injection, ammonia N 13 injection, and sodium fluoride F 18 injection), see 21 FR 12999, 
13004 (Mar. 10, 2000), and guidance for industry, FDA Oversight of PET Drug Products: Questions and Answers.  
Please note that the waivers for these PET drugs only apply to application fees; applicants who would like program 
fees waived may request a public health or barrier-to-innovation waiver, as is further described in this guidance. 
Any applicant submitting an application that may present these special circumstances should consult the relevant 
guidance and statutory provisions.  FDA updates guidances periodically.  To make sure you have the most recent 
version of a guidance, visit the FDA Drugs guidance website at 
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.  
 
  4  Contains Nonbinding Recommendation 
A.  Public Health  
 
Under section 736(d)(1)(A) of the FD&C Act, an applicant may qualify for a waiver of or 
reduction in application or program fees if the waiver or reduction is necessary to protect the 
public health.  Under this provision, FDA considers the following questions in determining 
whether to grant a public health waiver or reduction in user fees:  
 
  Does the product protect the public health? 
 
  Is the waiver or reduction necessary to continue an activity that protects the public 
health? 
 
Applicants should address both of these questions when applying for a public health waiver or 
reduction in fees. 
 
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 generally intends to ask, for example, questions 
similar to the following: 
 
  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 other treatment alternatives in the U.S. market?  The existence of comparable 
treatment alternatives would weigh against a determination that a product is necessary to 
protect the public health. 
 
  Has the drug product been designated as a priority drug, accepted into one of FDAs 
expedited programs for serious conditions,13 granted fast track status,14 or determined to 
be a new molecular entity?  Affirmative answers to these questions may indicate that a 
product protects the public health. 
 
  Does the drug product demonstrate an increased effectiveness in the treatment, 
prevention, or diagnosis of disease? 
                                                 
13 Further information regarding priority drugs can be found in the guidance for industry, Expedited Programs for 
Serious Conditions  Drugs and Biologics, available at 
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf, and in 
CDERs Manual of Policies and Procedures (MAPP) 6020.3R, Review Designation Policy: Priority (P) and 
Standard (S).  MAPP 6020.3R is available at 
https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesp
rocedures/ucm082000.pdf. 
14 Further information regarding fast track status is available at 
https://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm. 
 
  5  Contains Nonbinding Recommendation 
 
  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 diagnosis or 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 
FD&C Act (i.e., does it have an orphan designation)? 
 
  If the drug product is approved, is the product recognized as an effective treatment option 
that significantly impacts the public health? 
 
  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.15 
 
2.  Is the waiver or reduction necessary to continue an activity that protects the public 
health? 
 
To determine whether a waiver or reduction in user fees is necessary to continue an activity that 
protects the public health, the Agency considers not only the benefit of the activity to the public 
health, but also whether the waiver or reduction is necessary.  The legislative history of PDUFA 
I indicates 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.16  
It also indicates that FDA should consider the limited resources of the applicant when 
evaluating a request for a fee waiver or reduction under section 736(d).17  Therefore, the Agency 
believes that a financial test is appropriate for the public health waiver provision.  The Agency 
considers the relationship between current liabilities and the financial resources of the applicant, 
including affiliates, requesting the waiver or reduction.  The financial considerations are 
discussed in section IV.C. 
 
                                                 
15 FDA would consider products stockpiled for homeland security concerns as available to the public for user fee 
waiver purposes. 
16 See House Report 102-895 (1992) at 17; 138 Cong. Rec. S. 17239 (Oct. 7, 1992). 
17 Id. 
 
  6  Contains Nonbinding Recommendation 
B.  Barrier to Innovation 
 
Under section 736(d)(1)(B) of the FD&C Act, an applicant may qualify for a waiver or reduction 
in application or program 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 considers the following questions in deciding whether 
to grant a barrier-to-innovation waiver:  
 
  Is the product or other products or technologies under development by the applicant 
innovative?  
 
  Would the fee(s) 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 should address 
both questions. 
 
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 generally intends to consider the following questions: 
 
  Does the drug product or technology demonstrate advanced breakthrough research; 
new progressive methods and forward thinking in the treatment or diagnosis of disease; 
or has it demonstrated the potential to be at the forefront of new medical technology? 
 
  Are there other treatment alternatives available in the U.S. market?  The existence of 
comparable alternatives would weigh against a determination that a product is innovative. 
 
  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?   
 
  Does the applicant have an active investigational new drug application (IND) under 
which the applicant is evaluating a potentially unique or superior method for diagnosing, 
curing, mitigating, treating, or preventing a disease, or for affecting a structure or 
function of the body?  To determine whether an applicants IND would be considered 
active, the Agency may consider the following: 
 
  Is the applicant currently conducting a clinical trial for the investigational drug?18 
                                                 
18 FDA may use any available information, including but not limited to ClinicalTrials.gov, to determine whether the 
applicant is currently conducting a clinical trial.  
 
  7  Contains Nonbinding Recommendation 
  Has the applicant recently participated in meetings and discussions with FDA 
about the IND progress? 
  Is the applicant actively developing the investigational drug?  Does the applicant 
detail such development in its IND annual report? 
 
  Has the drug product been designated as a priority drug, accepted into one of FDAs 
expedited programs for serious conditions,19 granted fast track status,20 or determined to 
be a new molecular entity? 
 
  Has the applicant recently received a Federal grant for innovation?  An example of a 
Federal grant program that may qualify as innovative is the National Institutes of 
Healths Small Business Innovative Research 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 current liabilities and financial resources of the applicant 
and its affiliates.  The financial considerations are discussed below. 
 
C.  Financial Considerations for Public Health and Barrier-to-Innovation Waivers and 
Reductions 
 
1.  Financial Resources of the Applicant and Affiliates 
 
When evaluating requests for waivers 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. 
 
Section 736(d)(2) of the FD&C Act states that, in determining whether to grant a waiver or 
reduction in a user fee, FDA shall consider only the circumstances and financial resources of the 
applicant and any affiliate of the applicant.  Under the FD&C Act, the applicant is the person21 
who is responsible for payment of the fees and the person who must qualify for a waiver or 
reduction in user fees.22  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. 
                                                 
19 Further information regarding priority drugs can be found in the guidance for industry, Expedited Programs for 
Serious Conditions  Drugs and Biologics, available at 
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf, and in 
CDERs MAPP 6020.3R, Review Designation Policy:  Priority (P) and Standard (S).  MAPP 6020.3R available at 
https://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesp
rocedures/ucm082000.pdf. 
20 Further information regarding fast track status is available on the internet at 
https://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm.  
21 Under section 735(9) of the FD&C Act, person includes an affiliate thereof. 
22 See sections 736(a)(1), 736(a) (2), and 736(d) of the FD&C Act. 
 
  8  Contains Nonbinding Recommendation 
2.  Consideration of 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.  Based on over 25 years of experience in implementing the user fee program, FDA 
has determined that most applicants that, including the resources of their affiliates, have financial 
resources of less than $20 million of working capital are those least able to pay the fees.  
Therefore, the Agency generally 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 whether the fees are a significant barrier to innovation.  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 generally intends to consider the working capital of an applicant and its affiliates to 
determine whether the applicant has limited financial resources.  Working capital is an objective 
measure of the resources available to the applicant and is defined by generally accepted 
accounting principles.  To calculate working capital, FDA intends to review current assets and 
current liabilities of applicants and their affiliates to determine if an applicant has limited 
financial resources.  In addition, net proceeds that increase the cash flow of an applicant and 
affiliates may also be an important factor in determining whether the applicant and its affiliates 
have limited financial resources.  FDA recommends that applicants provide financial information 
according to the fiscal year, which begins October 1 and ends September 30.  If an applicants 
financial records are not organized by the U.S. governments fiscal year, an applicant may 
submit financial information from the 12 months preceding the date of the waiver request.  
Section VI.C. provides more information on the type of documentation applicants may submit to 
support its assertions of its limited resources.  If such information is not provided, FDA may not 
be able to determine whether the applicant and its affiliates have limited resources and therefore 
may deny the public health or barrier-to-innovation waiver request. 
 
FDA does not intend to deduct marketing costs when calculating an applicants working capital.  
Because even a very large applicant with extensive financial resources 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.  In such cases, the fees would not present a significant barrier to innovation. 
 
FDA considers the financial resources of applicants that are State or Federal government entities 
differently.  The Agency generally intends to consider State or Federal government entities with 
less than $20 million in total annual revenue from the sale of the drug being evaluated by the 
Agency for a waiver or reduction 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 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 on their drug development revenues, 
 
  9  Contains Nonbinding Recommendation 
not the overall revenues of the entity or the State or Federal government.23  Section V.B. 
provides information on exemptions from application and program fees for State or Federal 
government entities that do not distribute commercially. 
 
D.  Small Business 
 
Under section 736(d)(1)(C) of the FD&C 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.24 
 
To qualify for a small business waiver of the application fee, an applicant must: 
 
  Employ fewer than 500 employees, including employees of affiliates;25  
 
  Not have a drug product that has been approved under a human drug application and 
introduced or delivered for introduction into interstate commerce;26 and 
 
  Be submitting its first human drug application, including its affiliates. 27 
 
1.  Small Business Waiver and Refund Requests 
 
To qualify for a small business waiver of the application fee, an applicant should submit to FDA 
Form FDA 3971, attached as Appendix 1 and available at 
https://www.fda.gov/media/108984/download.  If an applicant submitted an NDA or BLA with a 
payment and would like to request a small business waiver and refund, the applicant should 
submit Form FDA 3971 to request the refund within 180 calendar days of when the application 
fee is due.  Section VI.D provides further information about Form FDA 3971 and the waiver 
request process. 
 
FDA recognizes that some information provided by companies may be confidential.  FDA will 
treat confidential commercial or financial information consistent with applicable federal laws 
and regulations (see section IX). 
 
2.  Expiration Date of the Small Business Waiver 
 
If a small business waiver is granted, the applicant should submit its human drug application 
within 1 year after the date of the small business determination since circumstances supporting a 
small business waiver can change rapidly.  For example, an applicant could merge with a larger 
                                                 
23 For example, the FD&C Act exempts a State or Federal government entity from application and program fees for 
a drug product that is not distributed commercially.  Sections 735(1) and (3) of the FD&C Act. 
24 There is no specific provision in the FD&C Act for a waiver or reduction of program fees for small businesses.  
However, small businesses may apply for a waiver or reduction of program fees through the public health or barrier-
to-innovation waiver provisions.  See discussions in sections IV.A-IV.C. 
25 Section 736(d)(3)(A) of the FD&C Act. 
26 Id. 
27 Section 736(d)(1)(C) of the FD&C Act. 
 
  10  Contains Nonbinding Recommendation 
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.   
 
If an applicant is granted a small business waiver and is unable to submit the application within 1 
year of the determination, the applicant should request a new small business waiver by following 
the instructions provided in section VI.D.  The Agency generally intends to examine the newly 
submitted information to confirm that the applicant is still eligible for a small business waiver.   
 
3. Small Business Waivers 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 and all affiliates are no longer eligible for a 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, even if the first application is withdrawn or 
refused for filing.28  An applicant that received a small business waiver for an application that 
was later refused for filing or withdrawn, however, may renew its request for a small business 
waiver if the applicant resubmits the same application.   
 
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.  Applicants should contact the 
Division of User Fee Management and Budget Formulation at CDERCollections@fda.hhs.gov 
for further guidance. 
 
 
V.  EXEMPTIONS AND REFUNDS 
  
A.  Orphan Designated Products 
 
1.  Application Fees  
 
Under section 736(a)(1)(F) of the FD&C 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 FD&C Act is not subject to an application fee unless the human drug 
application includes an indication for other than a rare disease or condition. 
 
If an application 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 Cover Sheet, Form FDA 3397.29  The 
User Fee Cover Sheet should be included with the application, and a brief statement claiming the 
orphan exception should be included in the cover letter.  If the applicant paid the application fee 
                                                 
28 Section 736(d)(3)(B) of the FD&C Act.   
29 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 Recommendation 
in advance of receiving the orphan drug designation, the applicant must submit a written 
request for a refund no later than 180 calendar days after such fee was due.30  For an applicant 
who paid the application fee in advance and has not yet received an orphan drug designation, 
FDA recommends that the applicant request a refund in the cover letter at the time the applicant 
submits the application, in anticipation of receiving orphan drug designation.  If orphan 
designation is granted more than 180 calendar days after the application is submitted, the 
applicant will not be eligible for a refund at that time unless it submitted a refund request within 
180 calendar days of submitting the application.  Section VI provides further information about 
refund requests. 
 
2.  Program Fees 
 
Under section 736(k) of the FD&C Act, a drug product 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 
section 351 of the PHS Act is exempt from the program fee if it meets the public health 
requirements contained in the FD&C Act as such requirements are applied to requests for 
waivers of the program fee.  In addition, the applicant must have less than $50 million in gross 
worldwide revenue during the year preceding the request for exemption.31 
 
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.32  The applicant should also submit financial documentation that supports the 
certification, such as financial statements that show intangible assets, other income, net gain on 
financial assets, foreign exchange gains, and interest income. 
 
Upon review of an applicants certification and accompanying information, FDA may contact 
the applicant to request further information, if needed, and for clarification of the information 
asserted in the applicants certification.  FDA may request information about the applicant and 
its affiliates, such as financial statements, annual reports, and documents identifying affiliate 
relationships.  If such information is not provided, FDA may not be able to verify an applicants 
certification and therefore may deny the orphan drug exemption request.  Section VI provides 
information about how to submit a request for an exemption or refund of the program fee. 
 
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 FD&C Act.  If the application is not considered a human drug application, then application 
fees are not assessed and the program fee does not apply. 
 
For the purposes of the State and Federal exemption from user fees under the FD&C Act, FDA 
interprets distributed commercially to mean any distribution in exchange for financial 
reimbursement, goods, or services, whether or not the amount of the charge covers the full costs 
                                                 
30 Section 736(i) of the FD&C Act. 
31 Section 736(k)(1)(B) of the FD&C Act. 
32 Section 736(k)(2) of the FD&C Act. 
 
  12  Contains Nonbinding Recommendation 
associated with the product.  Under FDAs interpretations, any recovery by the applicant of all or 
part of the costs of manufacture or distribution of a product would make the distribution 
commercial. 
 
C.  No Substantial Work 
 
Under section 736(a)(1)(G) of the FD&C Act, if an application is withdrawn after the application 
is filed, FDA 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 sole discretion in determining whether 
any portion of the fee may be refunded.  A determination by FDA concerning a refund in such 
instance is not eligible for review.33 
 
 
VI. SUBMITTING REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS  
 
A.  Address for Submitting Requests 
 
Applicants may submit written requests (for both CDER and CBER products) via email to 
CDERCollections@fda.hhs.gov. 
 
Please indicate the type of request and the applicant name in the subject line of the email.  
Examples of types of request that may be used in the subject line are: Orphan Drug Exemption, 
Public Health Waiver Request, Barrier-to-Innovation Waiver Request, and Small Business 
Waiver Request. 
 
Alternatively, applicants may mail requests to FDA via the carrier of their choice.  For the most 
updated mailing address, visit the following FDA website: 
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm. 
 
B.  Timing of Requests 
 
1.  Deadline to Request a Waiver, Reduction, or Refund 
 
Under section 736(i) of the FD&C 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, reduction, or refund no later than 180 calendar days after the fee is due. 
 
For example, if an applicant receives a program fee invoice from FDA, FDA expects 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 calendar days from the date when the invoice is due.  
If the request is submitted within 180 calendar days of the due date (i.e., if the request is timely), 
FDA will evaluate the applicants request.  If FDA determines that the applicant made a timely 
request and qualifies for a waiver, reduction, or refund, the Agency will grant the applicants 
request. 
 
                                                 
33 Section 736(a)(1)(G) of the FD&C Act. 
 
  13  Contains Nonbinding Recommendation 
To avoid having to pay a fee, an applicant can submit a request for a waiver or reduction in 
advance of when the program fee invoice is due, or in advance of submitting an application (see 
sections VI.B.3 and 4). 
 
If the applicant submits a waiver or exemption request and pays the relevant fee before receiving 
a determination from FDA on the waiver or exemption, the applicant should submit a refund 
request not later than 180 calendar days after such fee is due in order to qualify for a refund. 
 
2.  Consequences for Failure to Pay User Fees Due to Waiver or Reduction Delays 
 
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 filing until all 
such fees owed by the person have been paid.  For example, if a person submits an application 
without an application fee or if the person is in arrears34 for nonpayment of any prescription drug 
program fees,35 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. 
 
3.  Recommended Time Frame to Submit a Request for a Waiver or Reduction of the 
Application Fee 
 
FDA encourages applicants to submit a request for a waiver of or reduction in an application fee 
approximately 3 to 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 upon which 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 
applicants request are subject to change.  FDA considers it unreasonable to assume that those 
circumstances will continue to exist for longer than 4 months before the submission of an 
application. 
 
4.  Recommended Time Frame to Submit a Request for a Waiver or Reduction of the 
Program Fee 
 
The time frame to submit a request for a waiver or reduction of the program fee is the same as 
for an advance request for an application fee waiver or reduction: an applicant seeking a waiver 
or reduction of the program fee should generally submit a request for a waiver or reduction 3 to 4 
months before the fee is due.  Annual program fees are due on October 1, or the first business 
day after the enactment of the appropriations act providing for the collection and obligation of 
                                                 
34 Section 736(e) of the FD&C Act. 
35 Annual program fees are due on October 1, or the first business day after the enactment of the appropriations act 
providing for the collection and obligation of PDUFA fees for that fiscal year, whichever occurs later.  Section 
736(a)(2)(A) of the FD&C Act. 
 
 
  14  Contains Nonbinding Recommendation 
PDUFA fees for that fiscal year, whichever occurs later.36, 37  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 program fee. 
 
The FD&C 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 program 
fees will be paid without regard to a pending request for a fee waiver or reduction.  This 
approach ensures that the steady funding stream Congress intended will be achieved, and it 
should deter the filing of frivolous waiver or reduction requests. 
 
Ordinarily, FDA expects to grant a reduction or waiver of a program fee only for the current 
year.  If an applicant wishes to have a program fee waived or reduced for assessments in future 
years, it should make a new request for a waiver or reduction each year. 
 
C.  Content and Format of Requests, Excluding Small Business Waiver Requests 
 
1.  General Information  
 
Requests for CDER user fee waivers, reductions, and refunds will be reviewed and granted or 
denied by the Division of User Fee Management and Budget Formulation within CDER.  
Requests for CBER user fee waivers, reductions, and refunds will be reviewed and granted or 
denied by CBERs Center Director or designee.  
 
FDA recommends that each waiver, reduction, or refund request be submitted in writing on 
official company letterhead and that it contain the following information: 
 
  Name of applicant requesting the waiver, reduction, or refund, including company name, 
address, contact, telephone number, and email address 
 
  Tax Identification Number (required for all U.S. applicants) and/or DUNS Number 
 
  If an agent is submitting the request on behalf of an applicant, authorization from the 
applicant for the agent to act on the applicants behalf 
 
  Application number, i.e., NDA, BLA, or IND 
 
  Trade and established names of product(s) covered by the request 
 
  Identification of the specific fee(s) for which the waiver, refund, or reduction is requested 
 
  Date on which the user fee payment was made or will be made for which a waiver, 
reduction or refund is requested 
                                                 
36 Section 736(a)(2)(A) of the FD&C Act.  
37 Section 736(e) of the FD&C Act. 
 
  15  Contains Nonbinding Recommendation 
 
  Statutory provision under which a waiver, reduction, or refund is requested 
 
  Information and analyses demonstrating eligibility for the waiver, reduction, or refund 
 
  Rationale for why the waiver, reduction, or refund request should be granted 
 
  List of the applicants affiliates38 
 
  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 cash and cash equivalents, accounts receivables, 
inventories, short and long-term investment marketable securities, deferred revenue, 
prepaid expenses, and any other net proceeds received during the fiscal year that will 
increase the applicants and its affiliates cash flow even if not recorded under current 
assets. 
 
  For requests for an orphan drug exemption to the program fee, a certification that its 
gross worldwide revenues, including affiliates, did not exceed $50 million for the 12 
months before the request and financial documentation that supports the certification, 
such as financial statements that show intangible assets, other income, net gain on 
financial assets, foreign exchange gains, interest income, and net proceeds. 
 
2.  Additional Specific Information for Application Fee Waiver or Reduction Requests 
 
In addition to the general information specified above, requests for waivers or reductions in 
application fees should include the following: 
 
  Date the application was or is intended to be submitted 
 
  Whether clinical data are expected to be required for approval 
 
3.  Additional Specific Information Requested for Program Fee Waiver or Reduction 
Requests 
 
In addition to the general information specified above, requests for waivers of or reductions in 
the program fee should include the following: 
 
  Name of the application holder, if different from the name of the applicant requesting the 
waiver 
 
  Specific strength, dosage form, and route of administration 
                                                 
38 When determining whether parties are affiliated, the critical factor is whether one party controls or has the power 
to control another entity, or if a third party has the power to control both entities.  In such cases, FDA recommends 
that the applicant submit any agreements between an applicant and the other entities that demonstrate the nature of 
the relationship the applicant has with the entity. 
 
  16  Contains Nonbinding Recommendation 
 
  Invoice date and number (or copy of the invoice) 
 
D.  Content and Format of Request for a Small Business Waiver 
 
To qualify for a small business waiver of the application fee, an entity must submit to FDA a 
written request for such a waiver and a certification that the entity meets the requirements for the 
waiver.  Applicants should submit requests for a small business waiver of the application fee and 
refund due to the small business waiver via Form FDA 3971, attached as Appendix 1 and 
available at https://www.fda.gov/media/108984/download.  The completed form should be 
submitted via email to CDERCollections@fda.hhs.gov with the subject line, Small Business 
Waiver Request  [Applicant Name]. 
 
Upon receipt of Form FDA 3971, FDA may contact the applicant to request additional 
information and clarification of the information supporting the assertions in Form FDA 3971.  
Examples of information that may be requested include, but are not limited to the following: 
 
  A copy of the applicants Articles of Incorporation and Bylaws; 
 
  The applicants last annual statement to shareholders; and 
 
  A breakdown of the number of persons employed full time, part time, temporarily, or 
otherwise by the applicant and affiliates during each of the pay periods for the 12 months 
preceding the companys certification. 
 
Occasionally, FDA finds entities to be affiliated with the applicant that the applicant did not 
identify as one of its affiliates in its initial waiver or exemption submission.  When determining 
whether parties are affiliated for purposes of user fee assessment under PDUFA, the critical 
factor is whether one party controls or has the power to control another entity, or if a third party 
has the power to control both entities.39  In such cases, FDA recommends that the applicant 
submit copies of any agreements between an applicant and the other entities that demonstrate the 
nature of the relationship the applicant has with the entity.  If the requested supporting 
documentation is not submitted, FDA may deny the small business waiver request on the 
grounds that there is insufficient evidence that the applicant meets the requirements in section 
736(d)(1)(C) of the FD&C Act. 
 
Once FDA has identified and confirmed which entities are properly considered affiliates of the 
applicant and determined whether the applicant qualifies as a small business, it will evaluate 
whether the applicant is eligible for the small business waiver.  Specifically, FDA determines 
whether the applicant or any of its affiliates has previously submitted a human drug application, 
and 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.  After FDA 
assesses the applicants eligibility for a small business waiver FDA will notify the applicant 
whether the waiver is granted. 
                                                 
39 See section 735(11) of the FD&C Act. 
 
  17  Contains Nonbinding Recommendation 
 
E.  Refund Requests 
 
To qualify for an application or program fee refund, an applicant must submit to FDA a written 
request for a refund not later than 180 calendar days from the date the fee is due.40  This is the 
case even if the applicant has submitted a citizen petition that may relate to a potential claim for 
a refund (e.g., a citizen petition requesting that FDA determine that a drug product is 
therapeutically equivalent to another drug product for the purposes of the same product as 
another product exception under section 736(a)(2)(B)(ii) of the FD&C Act).  Further, if a 
pending refund request does not expressly cover a subsequent time frame for which an applicant 
wishes to claim a refund, FDA interprets the statute to require that the applicant to submit 
another written request for refund that expressly covers the subsequent time frame.  For example, 
if an applicant has a request for a FY 2020 program fee refund that is pending at the time of a 
program fee assessment for FY 2021, and the applicant believes it is also eligible for a refund for 
FY 2021 and wishes to claim a FY 2021 refund, a timely request for a refund for FY 2021 must 
be submitted.41 
 
Applicants may submit their written request for an application fee refund in the submission cover 
letter of their application.  A copy of the cover letter or program fee refund request (for both 
CBER and CDER products) should be submitted via email to CDERCollections@fda.hhs.gov. 
 
Alternatively, an applicant may 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. 
 
 
VII.  FDA RESPONSES TO REQUESTS FOR WAIVERS, REDUCTIONS, AND 
REFUNDS  
 
FDA will review waiver, refund, and reduction requests, consulting with relevant Agency 
officials and official Agency records or other resources as appropriate.  If needed to support 
applicants assertions that the applicant qualifies, FDA may request additional information and 
documentation from the applicant during its review of a waiver, reduction, or refund request.  
Failure to provide the requested information or documentation may result in a denial of a waiver, 
reduction, or refund.  The Agency will respond to all such requests in a timely fashion based on 
available resources and collection time for additional information. 
 
 
                                                 
40 Section 736(i) of the FD&C Act. 
41 See id. 
 
  18  Contains Nonbinding Recommendation 
VIII.  APPEALS PROCESS 
 
A.  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, refund, or reduction 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 reconsideration (for both CBER and CDER regulated products) should be 
submitted via email to CDERCollections@fda.hhs.gov and should be addressed to the Division 
of User Fee Management and Budget Formulation, Attention: Division Director, Center for Drug 
Evaluation and Research. 
 
Alternatively, an applicant may 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. 
 
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 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: 
 
  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. 
 
No new information or new analyses should be presented in the appeal request.  If new 
information and/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 official to consider the new 
information or analyses. 
 
 
  19  Contains Nonbinding Recommendation 
All requests for appeals (for both CBER and CDER 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, whose contact 
information can be found on the CDER Formal Dispute Resolution Web page.42   
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 Center chain of command.  A new request 
should be submitted for each appeal to the next management level and should follow the process 
provided in this guidance.  If the applicant has exhausted the Centers 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 FDAs Ombudsman, with copies provided to the 
Center that denied the appeal.  Review of such matters by the Commissioner is discretionary.43 
 
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 copies provided to the 
Center that denied the appeal.  Review of such matters by the Commissioner is discretionary. 
 
 
IX. DISCLOSURE OF PUBLIC INFORMATION 
 
FDA may disclose information publicly about its actions granting or denying waivers, refunds 
and reductions.  This disclosure will be consistent with the laws and regulations governing the 
disclosure of confidential commercial or financial information. 
 
 
                                                 
42 See 
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm44
4092.htm. 
43 See 40 FR 40682, 40693 (Sep. 3, 1975). 
 
  20  Contains Nonbinding Recommendation 
X.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance contains information collection provisions that are subject to review and approval 
by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520).  Collection of information is defined in 44 U.S.C. 3502(3) and 5 
C.F.R. 1320.3(c) and includes Agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party.  The guidance refers to the 
following forms: (1) Form FDA 3397 and (2) Form FDA 3971.  
 
The information collections of this guidance have been submitted for OMB renewal of approval 
under OMB control number 0910-0693.   
 
Collection of information for completing and submitting Form FDA 3397 (Prescription Drug 
User Fee Cover Sheet) is previously approved under OMB control number 0910-0297.  
Collections of information associated with the submission of a new drug application or biologics 
license application are approved under OMB control numbers 0910-0001 and 0910-0338, 
respectively. 
 
The time required to complete the information collections included in this guidance are estimated 
to average 16 hours for a request for a waiver, reduction, refund, or exemption 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.   
 
Form FDA 3971 is the collection of information submitted when requesting the small business 
waiver.  Use of Form FDA 3971 does not change the burden previously approved under OMB 
control number 0910-0693 for submitting or evaluating small business waivers.  It facilitates the 
presentation of the information required for evaluation of the small business waiver with the use 
of a standardized form and an electronic fillable format.   
 
Send any comments regarding the burden estimate or suggestions for reducing this burden to the 
following: 
 
        Department of Health and Human Services 
Food and Drug Administration 
Office of Operations 
Paperwork Reduction Act (PRA) Staff 
PRAStaff@fda.hhs.gov 
 
 
 
 
  21  Contains Nonbinding Recommendation 
APPENDIX 1: FORM FDA 3971 
 
 
 
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Food and Drug Administration  Form Approved: OMB No. 0910-0693 
Expiration Date: October 31, 2020 
Prescription Drug and Biosimilar User Fee Acts 
See PRA Statement on last page. 
Small Business Waiver and Refund Request 
Section I: Applicant Information 
1. Applicant Name 
 
 
Former Names (if applicable)   
 
 
2. Telephone Number (Including area and country codes)  3. Fax Number (Including area and country codes) 
4. Address (No P.O. boxes allowed)   5. Federal Tax ID Number (Required for all 
U.S. applicants) 
  Address 1 (Street address) 
Address 2 (Apartment, suite, unit, building, floor, etc.)  6. DUNS Number 
City  State/Province/Region  7. Number of Employees 
Country  ZIP or Postal Code   
 8. User Fee Program for which the action is requested (Select one)     
PDUFA  BsUFA 
 
9. Human Drug/Biosimilar Biological Product Applications (Applicant) 
  Product Name 
Application Number  Submission Date  Application Status (Select from drop-down list) 
Is this the first application the Applicant has submitted to the FDA for review?   
Yes  No
10. Human Drug/Biosimilar Biological Products (Applicant) 
  Does the Applicant have drug products approved under a human drug or biosimilar biological product 
application by the FDA that have been introduced or delivered for introduction into interstate commerce?  Yes  No 
11. Small Business Waiver (Applicant) 
  Has the Applicant previously received a Small Business Waiver for a human drug or biosimilar biological 
product? (See instructions for details.)  Yes  No 
Section II: Affiliate Information (Enter information for each entity affiliated with the Applicant) 
Provide information for each of the Applicants domestic and foreign affiliates. For multiple affiliates, click the Add Affiliate 
button for each additional entry. Refer to Instructions, Section II for additional information. 
 
 
The Applicant does NOT have any Affiliates (Check if applicable): 
 
12. Affiliate Name   
 
 
 
  FORM FDA 3971 (12/16)  Page 1 of 4  PSC Publishing Services (301) 443-6740      EF   
13. Affiliate Address (No P.O. boxes allowed)    14. DUNS Number 
 
  Address 1 (Street address) 
 
  15. Number of Employees 
  Address 2 (Apartment, suite, unit, building, floor, etc.) 
 
 
 
City  State/Province/Region 
 
 
  Country  ZIP or Postal Code 
 
 
 
16. Name of Affiliates Point of Contact  17. E-mail Address  18. Telephone Number 
19. Small Business Waiver (Affiliate) 
  Has the Affiliate previously received a Small Business Waiver for a human drug or biosimilar biological 
product application? (See instructions for details.)  Yes  No 
20. Human Drug/Biosimilar Biological Product Applications (Affiliate) 
  Has the Affiliate ever submitted a human drug or biosimilar biological product application?   
Yes  No
 
Click for an additional set of Section II affiliate entries (includes items 12 through 20). May be repeated.  AAdddd  AAffffiilliiaattee  
 
 
 
21. Did the Applicant pay a fee for this application for  prior to 
requesting this Small Business Waiver?    Product Name 
Yes  No 
 
NDA or BLA Number  Payment Amount  PIN/Invoice Number  Payment Reference  Refund Amount 
Number  Requested 
Section IV: Certification 
Review, sign, and date the following certification statement: 
I certify that     
Applicant Name (must be identical to item 1) 
BsUFA: 
i  Has fewer than 500 employees, including employees of Affiliates; 
ii.  Does not have a drug product that has been approved under a human drug application or biosimilar biological 
product application by the FDA and introduced or delivered for introduction into interstate commerce; 
iii.  Requests a Small Business Waiver for the first biosimilar biological product application that the Applicant or its 
Affiliate has submitted. 
PDUFA: 
i  Has fewer than 500 employees, including employees of Affiliates; 
ii.  Does not have a drug product that has been approved under a human drug application by the FDA and introduced 
or delivered for introduction into interstate commerce; 
iii.  Requests a Small Business Waiver for the first human drug application that the Applicant or its Affiliate has 
submitted. 
I further certify that, to the best of my knowledge, the information I have provided in this form is complete, accurate and 
has been verified. I understand that submission of a false certification may subject me to criminal penalties under 18 
U.S.C.  1001 and other applicable federal statutes. 
 
 
  FORM FDA 3971 (12/16)  Page 2 of 4   
 
22. Name of Applicants Responsible Official  23. Title 
24. Telephone Number  25. Email Address 
26. Responsible Officials Address   
  Address 1 (Street address) 
Address 2 (Apartment, suite, unit, building, floor, etc.) 
City  State/Province/Region 
Country  ZIP or Postal Code 
27. Signature  28. Date (mm/dd/yyyy) 
 
To enable the signature field, please fill out all prior required fields. For a list of required fields 
which have not yet been filled out, please click here. 
Send Completed Form FDA 3971 to FDA via 
Email (preferred):  CDERCollections@FDA.HHS.GOV  or  Physical Mail:  Division of User Fee Management and 
Budget Formulation 
Food and Drug Administration 10001 New Hampshire Ave. Silver Spring, MD 20993-0002 
 
FDA Use Only 
 
Date Received:     Approved  Denied 
 
Privacy Act Notice: This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C.  552a. The collection of this 
information is authorized by 21 U.S.C.  379h and 21 U.S.C.  379j-52. FDA will use the information to assess, collect   and 
process user fee payments, and, facilitate debt collection under the Debt Collection Improvement Act. FDA may disclose 
information to courts and the Department of Justice in the context of litigation and requests for legal advice; to other Federal 
agencies in response to subpoenas issued by such agencies; to HHS and FDA employees and contractors to perform user fee 
services; to the National Archives and Records Administration and General Services Administration for records management 
inspections; to the Department of Homeland Security and other Federal agencies and contractors 
in order to respond to system breaches; to banks in order to process payment made by credit card; to Dun and Bradstreet to 
validate submitter contact information, and to other entities as permitted under the Debt Collection Improvement Act. 
Furnishing the requested information is mandatory unless otherwise indicated. Failure to supply the information could 
prevent FDA from processing user fee payments and waivers. Additional detail regarding FDAs use of information is 
available online: Privacy Act and Website Policies. 
  FORM FDA 3971 (12/16)  Page 3 of 4  Contains Nonbinding Recommendations 
   
This section applies only to requirements of the Paperwork Reduction Act of 1995. 
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS 
BELOW.* 
The burden time for this collection of information is estimated to average 40 minutes per response, 
including the time to review instructions, search existing data sources, gather and maintain the data 
needed and complete  and review the collection of information. Send comments regarding this 
burden estimate or any other aspect of this information collection, including suggestions for reducing 
this burden, to: 
Department of Health and Human 
Services Food and Drug Administration 
Office of Operations 
    Paperwork Reduction Act (PRA) Staff 
PRAStaff@fda.hhs.gov 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB number.