Requests for discontinuation from BPD program and /or to move products to discontinued section.

Assessing User Fees
Under the Biosimilar
User Fee Amendments
of 2017
Guidance for Industry

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
January 2020
User Fees
OMB Control Number 0910-0718
Expiration Date: 12/31/2021
(Note: OMB control number and expiration date added 12/17/2019)
See additional PRA statement in section XII
Revision 1

Assessing User Fees
Under the Biosimilar
User Fee Amendments
of 2017
Guidance for Industry
Additional copies are available from:
Office of Communications, Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor
Silver Spring, MD 20993-0002
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353;
Email: [email protected]
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs
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: [email protected]
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
January 2020
User Fees
Revision 1

TABLE OF CONTENTS
I.

INTRODUCTION............................................................................................................. 1

II.

BACKGROUND ............................................................................................................... 2

III.

DEFINITIONS .................................................................................................................. 2

IV.

CHANGES TO THE STRUCTURE OF THE BSUFA USER FEE PROGRAM ...... 3

V.

BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEES ........................ 4
A.

Initial BPD Fee ............................................................................................................................... 4

B.

Annual BPD Fee ............................................................................................................................. 4

C.

Request for Refund of Annual BPD Fee ...................................................................................... 5

D.

Discontinuation of Annual BPD Fee Obligation ......................................................................... 5

E.

Reactivation Fee ............................................................................................................................. 6

VI.

BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FEES............................ 7

A.

Exception to the Application Fee .................................................................................................. 7

B.

Refund of the Application Fee ...................................................................................................... 7

C.

Waiver of Application Fees ........................................................................................................... 8
1. Small Business Waiver and Refund Request .................................................................................... 8
2. Expiration Date of the Small Business Waiver ................................................................................ 9
3. Small Business Waivers of Application Fees for Future Biosimilar Biological Product
Applications .......................................................................................................................................... 9

VII.

BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEES ................................ 10

VIII. FAILURE TO PAY FEES.............................................................................................. 11
IX.

PAYMENT INFORMATION AND PROCEDURES ................................................. 11

A.

Initial BPD Fees, Reactivation Fees, and Application Fees...................................................... 12

B.

Annual Billing Cycle .................................................................................................................... 12

C.

Waiver or Refund Requests ........................................................................................................ 13

X.

APPEALS PROCESS ..................................................................................................... 13
A.

Reconsideration Request ............................................................................................................. 13

B.

Appeal Request ............................................................................................................................ 14

XI.

OTHER RESOURCES................................................................................................... 15

XII.

PAPERWORK REDUCTION ACT OF 1995 .............................................................. 16

Contains Nonbinding Recommendations

Assessing User Fees Under the Biosimilar User Fee
Amendments of 2017
Guidance for Industry 1

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on
this topic. It does not establish any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the
title page.

I.

INTRODUCTION

This guidance provides stakeholders information regarding FDA’s implementation of the
Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA
Reauthorization Act of 2017. Because BsUFA II created changes to the user fee program, this
guidance serves to provide an explanation about the new fee structure and types of fees for which
entities are responsible.
This guidance describes the types of user fees authorized by BsUFA II, the process for
submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process
for requesting a reconsideration of a user fee assessment. This guidance also describes how FDA
determines which products are subject to a fee and discusses certain changes to FDA’s policies
under the new law. This guidance does not address how FDA determines and adjusts fees each
fiscal year; nor does it address FDA’s implementation of other user fee programs (e.g.,
Prescription Drug User Fee Amendments, Generic Drug User Fee Amendments). 2 Throughout
this guidance, references to user fees or the user-fee program are to the user fee program for
biosimilar biological products under section 744H of the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only
as recommendations unless specific regulatory or statutory requirements are cited. The use of
1

This guidance has been prepared by the Division of User Fee Management and Budget Formulation, Office of
Management, in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics
Evaluation and Research at the Food and Drug Administration.
2
FDA will publish in the Federal Register the fee revenue and fees resulting from adjustment not later than 60 days
before the start of each fiscal year. Section 744H(c)(5) of the FD&C Act, as amended by the FDA Reauthorization
Act of 2017.

1

Contains Nonbinding Recommendations
the word should in Agency guidances means that something is suggested or recommended, but
not required.
Changes to statutory provisions that are described in this guidance are effective with respect to
fees assessed beginning on the first day of fiscal year 3 (FY) 2018.

II.

BACKGROUND

The Biosimilar User Fee Act of 2012 (BsUFA I) added sections 744G and 744H to the FD&C
Act, authorizing FDA to collect user fees for a 5-year period from persons that develop
biosimilar biological products. Fees authorized by this legislation help fund the process for the
review of biosimilar biological product applications, and have played an important role in
expediting the review and approval process. BsUFA was reauthorized for a five-year period in
2017 under Title IV of the FDA Reauthorization Act of 2017 (BsUFA II), enacted on August 18,
2017.
BsUFA II extends FDA’s authority to collect user fees from FY 2018 through FY 2022 and
revises the fees that the Agency collects and how it collects some fees. Discussions about the
reauthorization of BsUFA are expected to begin before FY 2022, the final fiscal year of BsUFA
II.

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 biosimilar biological product means a specific strength of a biological product
in final dosage form for which a biosimilar biological product application has been
approved. 5

•

Except as provided by section 744G(4)(B), the term biosimilar biological product
application means an application for licensure of a biological product under section
351(k) of the Public Health Service Act (PHS Act). 6

3

FDA’s fiscal year begins on October 1 and ends on September 30.
Section 744G(2) of the FD&C Act.
5
Section 744G(3) of the FD&C Act.
6
Section 744G(4)(A) of the FD&C Act.
4

2

Contains Nonbinding Recommendations

IV.

•

The term final dosage form means, with respect to a biosimilar biological product, a
finished dosage form which is approved for administration to a patient without substantial
further manufacturing (such as lyophilized products before reconstitution). 7

•

The term financial hold means an order issued by the Secretary to prohibit the sponsor of
a clinical investigation from continuing the investigation if the Secretary determines that
the investigation is intended to support a biosimilar biological product application and the
sponsor has failed to pay any of the biosimilar biological product development program
fees for the product. 8

•

The term person includes an affiliate of such person. 9 The term person includes an
individual, partnership, corporation, or association. 10 This document will also use the
term person when referring to a sponsor or applicant.

•

The term supplement means a request to the Secretary to approve a change in a
biosimilar biological product application which has been approved, including a
supplement requesting that the Secretary determine that the biosimilar biological product
meets the standards for interchangeability described in section 351(k)(4) of the PHS
Act. 11

CHANGES TO THE STRUCTURE OF THE BSUFA USER FEE PROGRAM

BsUFA II authorizes the collection of three types of fees: (1) biosimilar biological product
development program fees (BPD fees), (2) biosimilar biological product application fees
(application fees), and (3) biosimilar biological product program fees (program fees).
Previously, section 744H of the FD&C Act authorized FDA to collect (1) biosimilar
development program fees, (2) biosimilar biological product application and supplement fees,
(3) biosimilar biological product establishment fees, and (4) biosimilar biological product fees.
BsUFA II eliminates fees for supplements as well as for establishments. Applicants will be
assessed annual biosimilar biological product program fees, rather than the biosimilar biological
product fees assessed under BsUFA I.
Additionally, BsUFA II eliminates the reduction of an application fee by the cumulative amount
of fees paid by the applicant under the BPD program.
The Agency will establish BPD fees, biosimilar biological product application fees, and the
biosimilar biological product program fees for each fiscal year as set forth in the statute, and will

7

Section 744G(10) of the FD&C Act.
Section 744G(11) of the FD&C Act.
9
Section 744G(12) of the FD&C Act.
10
Section 201(e) of the FD&C Act.
11
Section 744G(14) of the FD&C Act.
8

3

Contains Nonbinding Recommendations
publish the fees and fee revenue amounts for a fiscal year in the Federal Register not later than
60 days before the start of that year. 12

V.

BIOSIMILAR BIOLOGICAL PRODUCT DEVELOPMENT FEES

BsUFA II BPD fees are assessed for products in FDA’s BPD program. BPD fees include the
initial BPD fee, the annual BPD fee, and the reactivation fee.
A. Initial BPD Fee
Under section 744H(a)(1)(A) of the FD&C Act, an initial BPD fee is a one-time fee that is
assessed to a sponsor to enter the BPD program. A sponsor can enter the BPD program through
one of two ways:
•

The sponsor submits to FDA a meeting request for a BPD meeting for a product; or

•

The sponsor submits a clinical protocol for an investigational new drug application
(IND) describing an investigation that FDA determines is intended to support a
biosimilar biological product application.

There is no fee for a biosimilar initial advisory meeting.
The initial BPD fee is due within 5 calendar days after FDA grants the first BPD meeting for the
product or upon submission of an IND for the product that FDA determines is intended to
support a biosimilar biological product application, whichever occurs first. 13 Refer to section
VIII of this guidance for consequences of failing to pay the required fees.
B. Annual BPD Fee
Beginning in the next fiscal year after a sponsor has paid the initial BPD fee, the sponsor must
pay an annual BPD fee 14 for the product in each fiscal year. The annual BPD fee for a product
is due on the first business day on or after October 1 of each fiscal year 15 or the first business day
after the enactment of an appropriations Act providing for the collection and obligation of such
fees for the year, whichever is later, unless the sponsor has discontinued participation in the BPD
program for the product or has submitted a marketing application for the product that was
accepted for filing. 16

12

Section 744H(c)(5) of the FD&C Act.
Section 744H(a)(1)(A)(iv) of the FD&C Act.
14
Section 744H(a)(1)(B) of the FD&C Act.
15
Section 744H(a)(1)(B)(ii) of the FD&C Act.
16
Section 744H(a)(1)(B)(iii) of the FD&C Act.
13

4

Contains Nonbinding Recommendations
C. Request for Refund of Annual BPD Fee
If a person submits a biosimilar biological product application before October 1 of the fiscal year
and the application is accepted for filing on or after October 1 of that fiscal year, the applicant
may request a refund of the annual BPD fee paid by the applicant for such fiscal year. 17 FDA
must receive a written request for a refund not later than 180 calendar days after the application
is accepted for filing. 18
For example, if an applicant submits a biosimilar biological product application for a product in
the BPD program on September 15, 2017, the annual BPD fee for the product for FY 2018 is due
on the first business day on or after October 1, 2017 (unless one of the exceptions applies; see
section V.B of this guidance). If the application is accepted for filing by FDA on or after
October 1, 2017, the applicant may submit Form FDA 3913 (User Fee Payment Refund
Request) 19 to [email protected] to request a refund of the annual BPD fee paid for
the product for fiscal year 2018 within 180 calendar days from the date the application was
accepted for filing.
D. Discontinuation of Annual BPD Fee Obligation
A sponsor may discontinue participation in the BPD program for a product, effective October 1
of a fiscal year, by notifying FDA on or before August 1 of the preceding fiscal year as
follows: 20
•

If the sponsor has not yet submitted an IND – By submitting a written declaration to FDA
that the sponsor has no present intention of further developing the product as a biosimilar
biological product. 21 The sponsor should send a courtesy copy to
[email protected] and include the following information in the letter:
o Sponsor’s contact information including name, address, email, and telephone
number
o Identification of the request at the top of the cover letter as “Request to
Discontinue Participation in the BPD Program”
o Name of product
o Pre-IND number

•

If the sponsor has already submitted an IND and wishes to discontinue participation in
the BPD program – By withdrawing the IND for the product in accordance with Part 312
of Title 21 of the Code of Federal Regulations (available at https://www.ecfr.gov/cgibin/text-

17

Section 744H(a)(1)(B)(iv) of the FD&C Act.
Section 744H(a)(1)(B)(iv) of the FD&C Act.
19
https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM492188.pdf
20
Section 744H(a)(1)(C) of the FD&C Act.
21
Section 744H(a)(1)(C)(i) of the FD&C Act.
18

5

Contains Nonbinding Recommendations
idx?SID=63f7c466f2cfc85163fc45a67be57ddb&mc=true&node=pt21.5.312&rgn=div5)
22

In addition to withdrawing the IND, a sponsor who has already submitted an IND and wishes to
discontinue participation should also submit to FDA a written request to discontinue
participation in the BPD program, as described above, with a courtesy copy to
[email protected].
Requests to discontinue participation in the BPD program can be submitted to the FDA
Electronic Submissions Gateway or mailed to:
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Beltsville, MD 20705-1266
FDA must receive the request by August 1 of the preceding fiscal year to avoid assessment of the
annual BPD fee. If FDA receives a request to discontinue participation in the BPD program after
August 1 of the fiscal year, the sponsor will receive an annual BPD fee invoice for the upcoming
fiscal year and must pay the invoice amount by the due date. Under section 744H(a)(1)(F)(i),
FDA shall not refund any BPD fee (initial, annual, or reactivation), except as provided in section
744H(a)(1)(B)(iv) (see section V.C of this guidance).
E. Reactivation Fee
A sponsor that has discontinued participation in the BPD program for a product and wants to
resume participation in the BPD program for the product must pay a reactivation fee. 23 A
sponsor may resume participation in the BPD program for a product in one of two ways:
•

The sponsor requests a BPD meeting for the product; or

•

The sponsor submits a clinical protocol for an IND describing an investigation that
FDA determines is intended to support a biosimilar biological product application for
the product.

The reactivation fee is due within 5 calendar days after FDA grants a BPD meeting for the
product or upon submission of an IND describing an investigation that FDA determines is
intended to support a biosimilar biological product application for the product, whichever occurs
first. The reactivation fee for a fiscal year will be equal to twice the amount of the annual BPD
fee established for that fiscal year. 24 Refer to section VIII of this guidance for consequences of
failing to pay the required fees.

22

Section 744H(a)(1)(C)(ii) of the FD&C Act.
Section 744H(a)(1)(D) of the FD&C Act.
24
Section 744H(b)(3)(D) of the FD&C Act.
23

6

Contains Nonbinding Recommendations
Beginning in the next fiscal year after a sponsor has paid the reactivation fee, the sponsor must
pay an annual BPD fee.
VI.

BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION FEES

FDA assesses a user fee for each biosimilar biological product application. Under BsUFA II,
application fees are not assessed for supplements to approved biosimilar biological product
applications.
Beginning in FY 2018, each person that submits an application is assessed an application fee as
follows:
•

A biosimilar biological product application for which clinical data (other than
comparative bioavailability studies) with respect to safety or effectiveness are required
for approval is assessed a full application fee. 25

•

A biosimilar biological product application for which clinical data (other than
comparative bioavailability studies) with respect to safety or effectiveness are not
required for approval is assessed one-half of a full application fee. 26

Under BsUFA II, application fees are not reduced by the cumulative amount of BPD fees paid
for the product that is the subject of the application. 27 Application fees are due when the
application is submitted. 28
A. Exception to the Application Fee
If a biosimilar biological product application:
•
•
•

was submitted by a person that paid the fee for the application,
was accepted for filing, and
was not approved or was withdrawn (without a waiver),

the submission of a biosimilar biological product application for the same product by the same
person (or the person’s licensee, assignee, or successor) does not require an application fee. 29
B. Refund of the Application Fee

25

Section 744H(a)(2)(A)(i) of the FD&C Act.
Section 744H(a)(2)(A)(ii) of the FD&C Act.
27
See section 744H(a)(2)(B) of the FD&C Act. For application fees assessed under BsUFA I, the application fee
was reduced by the cumulative amount of BPD fees paid for a product that was the subject of the application.
28
Section 744H(a)(2)(C) of the FD&C Act.
29
Section 744H(a)(2)(D) of the FD&C Act.
26

7

Contains Nonbinding Recommendations
If an application is refused for filing or is withdrawn without a waiver before filing, FDA will
refund seventy-five percent of the application fee paid. 30 A written refund request is not
required. An application that was withdrawn before filing or refused for filing will be subject to
the full application fee when resubmitted, unless a waiver applies. 31
C. Waiver of Application Fees
Under section 744H(d)(1) 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 biosimilar biological
product application to the Agency for review and does not have another product that has been
approved under a human drug application or a biosimilar biological product application and
introduced or delivered for introduction into interstate commerce.
To qualify for a small business waiver of the application fee, an applicant must meet all of the
following criteria:
•

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 or a biosimilar biological product application and introduced or delivered for
introduction into interstate commerce; and

•

The applicant, including its affiliates, is submitting its first biosimilar biological product
application.
1.

Small Business Waiver and Refund Request

To qualify for a small business waiver of the biosimilar biological product application fee, 32 an
applicant should submit to FDA Form FDA 3971, attached as Appendix I, at least four months
prior to the submission of the application. If an applicant submitted an application with payment
and would like to request a small business waiver and refund, the applicant should complete and
submit Form FDA 3971 to request the refund. Such a request must be made within 180 calendar
days of when the application fee was due. 33 The completed form should be submitted via email
to [email protected].
Upon receipt of Form FDA 3971, FDA may contact the applicant to request additional
information and to clarify information provided in Form FDA 3971. Examples of requested
information include, but are not limited to, the following:
•

An application for size determination;

•

A copy of the applicant’s Articles of Incorporation and Bylaws;

30

Section 744H(a)(2)(E) of the FD&C Act.
Section 744H(a)(2)(F) of the FD&C Act.
32
Section 744H(d)(1) of the FD&C Act.
33
Section 744H(h) of the FD&C Act.
31

8

Contains Nonbinding Recommendations

•

The applicant’s most recent annual financial statement to shareholders; or

•

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 applicant’s certification.

Occasionally, FDA finds entities affiliated with the applicant that the applicant did not identify
as one of its affiliates. In such cases, FDA recommends that the applicant submit any
agreements between an applicant and the other entities that demonstrate the nature of the
relationship the applicant has with the entity.
If the requested information is not submitted, FDA may deny the small business waiver request
because there is insufficient evidence that the applicant meets the criteria described in section
744H(d)(1) of the FD&C Act.
2.

Expiration Date of the Small Business Waiver

If a small business waiver is granted, the applicant should submit its biosimilar biological
product application within 1 year after the date of the small business determination since
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 a new drug application (NDA) or biologics
license application (BLA) from an unaffiliated company and, therefore, would have a drug
product that has been approved under a human drug application or a biosimilar biological
product 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. The
Agency will examine its records to confirm that the applicant still meets the criteria for a small
business waiver. If the criteria are no longer met, the small business waiver request will be
denied. If the criteria are still met, the Agency will renew the small business waiver for another
year.
3.

Small Business Waivers of Application Fees for Future Biosimilar Biological
Product Applications

After an applicant or its affiliate is granted a small business waiver and submits its first
biosimilar biological product application, the applicant cannot receive another small business
waiver. 34 That means the applicant or its affiliate is not eligible to receive a small business
waiver for any subsequent biosimilar biological product application. In addition, 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.
34

See section 744H(d)(1) of the FD&C Act.

9

Contains Nonbinding Recommendations

VII.

BIOSIMILAR BIOLOGICAL PRODUCT PROGRAM FEES

The biosimilar biological product program fee is assessed annually for each eligible biosimilar
biological product. Program fees are assessed for a fiscal year to each person 35 who is named as
the applicant in a biosimilar biological product application for each biosimilar biological product
identified in a biosimilar biological product application approved as of October 1 of such fiscal
year, 36 where the product does not appear on a list of discontinued biosimilar biological products
(as of October 1 of such fiscal year). 37 For example, if approval of a biosimilar biological
product application occurs on or before October 1, 2017, and the products identified in the
approved application are not on the discontinued list as of October 1, 2017, then program fees
will be assessed for the products for FY 2018. However, if approval of a biosimilar biological
product application occurs after October 1, 2017, then program fees are not assessed for the
products identified in the application for FY 2018.
The program fees are due on the first business day on or after October 1 of each fiscal year or the
first business day after the enactment of an appropriations Act providing for the collection and
obligation of such fees for the year, whichever is later. 38
Applicants may not be assessed more than five program fees for biosimilar biological products
identified in each approved application for each fiscal year. 39 For example, if seven biosimilar
biological products are approved under the same BLA, the applicant would be assessed five
program fees for the fiscal year.
Program fees for liquid parenteral biosimilar biological products. BsUFA II clarifies the
definition of a “biosimilar biological product” to mean “a specific strength of a biological
product in final dosage form for which a biosimilar biological product application has been
approved.” 40 For the purposes of assessing program fees for liquid parenteral biosimilar
biological products, FDA intends to take into consideration both the total quantity of drug
substance in mass or units of activity in a product and the concentration of the drug substance in
mass or units of activity per unit volume of product. For example, two biosimilar biological
products in final dosage form with the same concentration but with different fill volumes would
be considered two separate biosimilar biological products for the purpose of assessing program
fees. The applicant would be assessed two program fees for these products. If the applicant has
more than five concentrations or fill volumes approved in the BLA, it will not be assessed more
than five program fees for each fiscal year for products identified in such application.

35

“The term ‘person’ includes an affiliate of such person.” Section 744G(12) of the FD&C Act. See section III of
this document for more information on the meaning of the term “person” for purposes of this guidance.
36
Section 744H(a)(3)(A)(i) of the FD&C Act.
37
Section 744H(a)(3)(A)(ii) of the FD&C Act.
38
Section 744H(a)(3)(B) of the FD&C Act.
39
Section 744H(a)(3)(D) of the FD&C Act.
40
Section 744G(3) of the FD&C Act.

10

Contains Nonbinding Recommendations
An auto-injector that has the same strength or potency in final dosage form as a prefilled syringe
or vial will generally be assessed a separate program fee. This is intended to align the Agency’s
assessment of fees for biological products approved under section 351(k) of the PHS Act with its
assessment of fees for products approved under section 351(a) of the PHS Act or section 505 of
the FD&C Act. 41, 42

VIII. FAILURE TO PAY FEES
Under section 744H(a)(1)(E) of the FD&C Act, if a person has failed to pay any BPD fee (initial,
annual, or reactivation) for a product as required:
•

FDA shall not provide a BPD meeting relating to the product for which fees are owed. 43

•

Except in extraordinary circumstances, FDA shall not consider an IND submitted for the
product to have been received under section 505(i)(2) of the FD&C Act if FDA
determines that the investigation is intended to support a biosimilar biological product
application. 44

•

Except in extraordinary circumstances, FDA shall prohibit the sponsor of a clinical
investigation from continuing the investigation (this is referred to as a “financial hold”) if
FDA determines that the investigation is intended to support a biosimilar biological
product application. 45

Under sections 744H(a)(1)(E)(iv) and 744H(e) and of the FD&C Act, a biosimilar biological
product application or supplement submitted by a person subject to BsUFA fees shall be
considered incomplete and shall not be accepted for filing until all BsUFA fees owed by such
person have been paid.

IX.

PAYMENT INFORMATION AND PROCEDURES

This section briefly describes the procedures for assessing and issuing annual invoices for the
annual BPD fee and the biosimilar biological product program fees under BsUFA II. More
detailed instructions will be provided in FDA’s direct notice to affected persons by issuing a
“Notification of Annual BsUFA Fees” correspondence.

41

See guidance for industry Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017
(https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM580099.pdf).
42
The distinction in this guidance between (1) auto-injectors and (2) prefilled syringes or vials is for the purposes of
assessing the biosimilar biological product program fee only and not for any other purpose.
43
Section 744H(a)(1)(E)(i) of the FD&C Act.
44
Section 744H(a)(1)(E)(ii) of the FD&C Act.
45
Section 744H(a)(1)(E)(iii) of the FD&C Act.

11

Contains Nonbinding Recommendations
A. Initial BPD Fees, Reactivation Fees, and Application Fees
Applicants should complete a Biosimilar User Fee Cover Sheet (Form FDA 3792) online and
pay by electronic check, wire transfer, money order, or bank draft. Instruction on accessing and
completing the Biosimilar User Fee Cover Sheet is located on the BsUFA website
(https://www.fda.gov/bsufa).
B. Annual Billing Cycle
1. BPD Sponsor Survey
FDA intends to send sponsors an annual survey to gather pertinent information to assist with fee
setting for the next fiscal year. FDA anticipates sending the survey in the third quarter of each
fiscal year.
2. Notification of Annual BsUFA Fees Correspondence
FDA will issue a “Notification of Annual BsUFA Fees” correspondence to affected sponsors by
July of each fiscal year regarding their active BPD programs and approved biosimilar biological
products. Sponsors should review the correspondence and notify FDA of any changes in contact
information, changes in the status of Pre-IND/INDs in the BPD program, changes in biosimilar
biological product marketing status, and any other information pertinent for the Agency to issue
an accurate invoice to the proper person.
3. Annual Invoicing
FDA expects to issue annual invoices by September. Because sponsors are invoiced for annual
BPD fees and program fees in advance of the upcoming fiscal year, the invoices may not reflect
the actual data available as of October 1. FDA will issue additional invoices later, as needed, to
capture any new BPD sponsors and program fee-eligible biosimilar biological products that
should have been invoiced. For example, if a sponsor pays a FY 2017 initial BPD fee on
September 15, 2017, the sponsor can expect to receive a FY 2018 annual BPD fee invoice in
December 2017.
Payment instructions are included on the invoice.
4. Moving a Product to the Discontinued Section of the Biosimilar List
FDA maintains a list of approved biosimilar biological products that are user fee-eligible and
products that are not marketed (discontinued). This list will be available on the BsUFA website
(https://www.fda.gov/bsufa). A biosimilar biological product is not assessed a program fee if it
is in the discontinued section of the biosimilar list on the date that fees are assessed as of October
1 of the fiscal year. Applicants who have decided to stop marketing a product, or have decided
to delay launch of a product after its approval date, should request to have the product moved to
the discontinued section. If a biosimilar biological product remains on the biosimilar list, and
has not been moved to the discontinued section, on the date that fees are assessed for a fiscal

12

Contains Nonbinding Recommendations
year, the applicant will be assessed a program fee for the product even if it is not being
marketed. 46
Requests to move an approved biosimilar biological product to the discontinued section of the
biosimilar list should be submitted to [email protected] no later than September 30
of the preceding fiscal year. The request should clearly identify the product to be moved and the
date that its not-marketed status begins and, if applicable, would end. If the applicant submits a
request as set forth in this paragraph, FDA intends to consider the product to have been moved to
the discontinued section on the date that the request was received or on the date the product is no
longer marketed, whichever is later.
Please note that applicants seeking to move a biosimilar biological product to the discontinued
section should clearly indicate the date on which their product is no longer marketed. Applicants
should not rely on communications with a review division. Communication with the wrong
division of FDA, or in a manner that does not make clear when a product is no longer marketed,
may mean that the biosimilar biological product is not moved to the discontinued section of the
biosimilar list before the date program fees are assessed, and may result in the applicant being
required to pay a program fee for the product.
C. Waiver or Refund Requests
An applicant may request a waiver of the application fee, and may request a refund of fees it has
paid, if it meets the applicable statutory criteria. 47 The written waiver or refund request must be
submitted not later than 180 calendar days after such fee is due. 48 To request a small business
waiver of the application fee, see section VI.C of this guidance. To request a refund of fees paid,
the applicant should complete Form FDA 3913 (User Fee Payment Refund Request) and submit
to [email protected]. This form can be accessed from the User Fees website
(https://www.fda.gov/ForIndustry/UserFees/). Any questions can be directed to
[email protected].

X.

APPEALS PROCESS
A. Reconsideration Request

If FDA fully or partially denies a request for a waiver or refund 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 FDA’s decision to fully or partially deny a request for a waiver
or refund of user fees.

46

Section 744H(a)(3)(A) of the FD&C Act.
Sections 744H(a)(1)(F) and 744H(d)(1) of the FD&C Act. The FD&C Act does not provide for deferral of user
fees, and FDA does not grant deferral of user fees based on pending requests for a refund. FDA therefore expects
that all BsUFA fees assessed will be paid when due without regard to a pending request for a refund.
48
Section 744H(h) of the FD&C Act.
47

13

Contains Nonbinding Recommendations
FDA recommends that requests for reconsideration state the applicant’s reasons for believing
that FDA’s decision is in error and include any additional information, including updated
financial information that is relevant to the applicant’s position. The Agency will issue a
response upon reconsideration, setting forth the basis for the decision.
All requests for reconsideration (regardless of whether the product is regulated by CDER or
CBER) should be submitted via email to [email protected] and should be
addressed to the following:
Division of User Fee Management and Budget Formulation
Attention: Division Director
Center for Drug Evaluation and Research
Alternatively, 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: https://www.fda.gov/bsufa.
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 FDA’s decision
to affirm its denial of a request for a waiver or refund of user fees. The following information
should be included in the appeal:
•
•
•
•
•

The original request;
The denial of the original request;
The reconsideration request;
The denial of the reconsideration request; and
A statement of the applicant’s reasons for believing that the prior conclusions were in
error.

No new information or new analyses should be presented in the appeal request. If new
information or analyses are presented in the appeal request the appeal will not be accepted and
the matter will be referred back to the original deciding authority to consider the new
information or analyses.
All requests for appeals for either CDER or CBER products should be submitted to the Director
of CDER’s Office of Management via [email protected] and a copy should be
submitted to the CDER Formal Dispute Resolution Project Manager. The contact information
can be found on the CDER Formal Dispute Resolution Web page. 49 Alternatively, an applicant
can mail the request to FDA via carrier of its choice. For the most updated mailing address, visit
the following FDA website: https://www.fda.gov/bsufa.

49

See
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ContactCDER/ucm44
4092.htm.

14

Contains Nonbinding Recommendations
After FDA reviews the information submitted in the appeal request, for CDER regulated
products the Director of CDER’s Office of Management will issue a written decision on the
applicant’s request; for CBER regulated products the Director of CBER will issue a written
decision on the applicant’s request.
CDER Products
If the applicant’s 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 Center’s 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 C.F.R. §10.75(c). Requests for
review by the Commissioner should be submitted to FDA’s Ombudsman, with a copy provided
to the Center. Review of such matters by the Commissioner is discretionary. 50
CBER Products
If the applicant’s appeal is denied by the Director of CBER, the applicant may request review of
the matter by the Commissioner under 21 C.F.R. § 10.75(c). Requests for review by the
Commissioner should be submitted to the FDA’s Ombudsman, with copies provided to the
center that denied the appeal. Review of such matters by the Commissioner is discretionary.

XI.

OTHER RESOURCES

The following guidance documents may be helpful:
• Guidance for Industry - Submitting Separate Marketing Applications and Clinical Data
for Purposes of Assessing User Fees 51
The following manuals of policies and procedures (MAPP) may be helpful:
• MAPP 6050.1 Refusal to Accept Applications for Filing From Applicants in Arrears 52
Additional information is also available on the FDA User Fees web page. For any questions,
please email the Biosimilar User Fee staff at [email protected] or call 301-7967900.

50

See 40 FR 40682, 40693 (September 3, 1975).
See
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079320.pdf.
52
See
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/Manualof
PoliciesProcedures/UCM082029.pdf.
51

15

Contains Nonbinding Recommendations
XII.

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 time required to complete this information collection is estimated to average:
•
•
•
•
•
•
•

1 hour to request a discontinuation from the BPD program
½ hour to request that products be moved to the discontinued section of the biosimilar list
16 hours to complete a small business waiver request (Form FDA 3971) and collect
supporting documents
24 hours to request a small business waiver reconsideration
12 hours to request a small business waiver appeal
1 hour to complete an annual fee determination survey
2 hours to collect information in response to annual BsUFA fees correspondence

These estimates include the time to review instructions, search existing data sources, gather the
data needed, and complete and review the information collection. 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
[email protected]
The guidance also refers to collections of information for requesting a BsUFA small business
waiver using Form FDA 3971, approved under 0910-0693; collections of information for filling
out and submitting Forms FDA 3913 and 3914 (User Fee Payment Refund and Transfer
Requests) approved under OMB control number 0910-0805; collections of information
associated with review of investigational new drug applications, approved under OMB control
number 0910-0014; and collections of information associated with review of new drug
applications under the FD&C Act, or biologics license applications submitted under section
351(a) or 351(k) of the PHS Act, approved under OMB control numbers 0910-0001, 0910-0338,
and 0910-0719, respectively.
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 0910-0718 (expires 12/31/2021).

16

Contains Nonbinding Recommendations

APPENDIX I: 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)

Address 1 (Street address)

5. Federal Tax ID Number (Required for all
U.S. applicants)

Address 2 (Apartment, suite, unit, building, floor, etc.)

6. DUNS Number

City

7. Number of Employees

4. Address (No P.O. boxes allowed)

State/Province/Region

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

Is this the first application the Applicant has submitted to the FDA for review?

Application Status (Select from drop-down list)

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

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.)

Section II: Affiliate Information (Enter information for each entity affiliated with the Applicant)
Provide information for each of the Applicant’s 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)

PSC Publishing Services (301) 443-6740

EF

14. DUNS Number

13. Affiliate Address (No P.O. boxes allowed)
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 Affiliate’s 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
Add Affiliate

Click for an additional set of Section II affiliate entries (includes items 12 through 20). May be repeated.

21. Did the Applicant pay a fee for this application for
requesting this Small Business Waiver?

prior to
Product Name

Yes
NDA or BLA Number

Payment Amount

No
PIN/Invoice Number

Payment Reference
Number

Refund Amount
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)

22. Name of Applicant’s Responsible Official

23. Title

24. Telephone Number

25. Email Address

26. Responsible Official’s Address
Address 1 (Street address)

Address 2 (Apartment, suite, unit, building, floor, etc.)

City

State/Province/Region

Country

ZIP or Postal Code

28. Date (mm/dd/yyyy)

27. Signature
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): [email protected]
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 FDA’s use of information is
available online: Privacy Act and Website Policies.

FORM FDA 3971 (12/16)

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
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB number.”

FORM FDA 3971 (12/16)