82 FR 43241 - Biosimilar User Fee Rates for Fiscal Year 2018

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 177 (September 14, 2017)

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2017, through September 30, 2018.

[Federal Register Volume 82, Number 177 (Thursday, September 14, 2017)]
[Notices]
[Pages 43241-43243]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-19493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0007]


Biosimilar User Fee Rates for Fiscal Year 2018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rates 
for biosimilar user fees for fiscal year (FY) 2018. The Federal Food, 
Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar 
User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and 
collect user fees for certain activities in connection with biosimilar 
biological product development; review of certain applications for 
approval of biosimilar biological products; and each biosimilar 
biological product approved in a biosimilar biological product 
application.
    BsUFA II directs FDA to establish, before the beginning of each 
fiscal year, the amount of initial and annual biosimilar biological 
product development (BPD) fees, the reactivation fee, and the 
biosimilar biological product application and program fees for such 
year. These fees apply to the period from October 1, 2017, through 
September 30, 2018.

FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial 
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14202I, Silver Spring, MD 20993-0002, 240-402-9845.

SUPPLEMENTARY INFORMATION: 

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51, 
379j-52, and 379j-53), as amended by BsUFA II (title IV of the FDA 
Reauthorization Act of 2017, Pub. L. 115-52), authorizes the program of 
fees for biosimilar biological products. Under section 744H(a)(1)(A) of 
the FD&C Act, the initial BPD fee for a product is due when the sponsor 
submits an investigational new drug (IND) application that FDA 
determines is intended to support a biosimilar biological product 
application or within 5 calendar days after FDA grants the first BPD 
meeting, whichever occurs first. A sponsor who has paid the initial BPD 
fee is considered to be participating in FDA's BPD program for that 
product.
    Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has 
paid the initial BPD fee for a product, the annual BPD fee is assessed 
beginning with the next fiscal year. The annual BPD fee is assessed for 
the product each fiscal year until the sponsor submits a marketing 
application for the product that is accepted for filing, or 
discontinues participation in FDA's BPD program.
    Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has 
discontinued participation in FDA's BPD program and wants to re-engage 
with FDA on development of the product, the sponsor must pay a 
reactivation fee to resume participation in the program. The sponsor 
must pay the reactivation fee by the earlier of the following dates: No 
later than 5 calendar days after FDA grants the sponsor's request for a 
BPD meeting for that product, or upon the date of submission by the 
sponsor of an IND describing an investigation that FDA determines is 
intended to support a biosimilar biological product application. The 
sponsor will be assessed an annual BPD fee beginning with the first 
fiscal year after payment of the reactivation fee.
    BsUFA II also authorizes fees for certain biosimilar biological 
product applications and for each biosimilar biological product 
identified in an approved biosimilar biological product application 
(sections 744H(a)(2) and 744H(a)(3) of the FD&C Act). Under certain 
conditions, FDA may grant a small business a waiver from its first 
biosimilar biological product application fee (section 744H(d)(1) of 
the FD&C Act).
    For FY 2018, the fee revenue amount is $45,000,000, adjusted as 
needed to reflect an updated assessment of the workload for the process 
for the review of biosimilar biological product applications. FDA is 
adjusting the FY 2018 revenue amount to $40,214,000 (rounded to the 
nearest thousand dollars) reflecting its updated assessment of the 
likely workload for the BsUFA program in FY 2018.
    This document provides fee rates for FY 2018 for the initial and 
annual BPD fee ($227,213), for the reactivation fee ($454,426), for an 
application requiring clinical data ($1,746,745), for an application 
not requiring clinical data ($873,373), and for the program fee 
($304,162). These fees apply to the period from October 1, 2017, 
through September 30, 2018. For applications that are submitted for 
this period, this FY 2018 fee schedule must be used.

II. Fee Revenue Amount for FY 2018

    The fee revenue amount for FY 2018 is $45,000,000 adjusted for 
updated workload estimates (see sections 744H(b)(1) and 744H(c)(4) of 
the FD&C Act).

A. Statutory Fee Revenue Adjustments for Inflation

    BsUFA II specifies that the annual fee revenue amount is to be 
further adjusted for inflation increases for FY 2019 through FY 2022 
using two separate adjustments--one for personnel

[[Page 43242]]

compensation and benefits (PC&B) and one for non-PC&B costs (see 
section 744H(c)(1) of the FD&C Act). Because the adjustment for 
inflation does not take effect until FY 2019, FDA will not adjust the 
FY 2018 fee revenue amount for inflation.

B. FY 2018 Statutory Fee Revenue Adjustment for Workload

    BsUFA II specifies that for FY 2018, the fee revenue amount 
includes an adjustment to reflect an updated assessment of the workload 
for the process for the review of biosimilar biological product 
applications (see section 744H(c)(4) of the FD&C Act).
    In considering the appropriate FY 2018 fee revenue adjustment, FDA 
considered a range of factors including its best estimated level of 
submissions and activities (including forecasts of new BPDs, new 
351(k)s, resubmitted 351(k)s, advisory committee meetings, 
interchangeability supplements, industry meetings, inspection activity, 
science and research activities, policy work, and other activities). 
Considering the totality of work forecasted for FY 2018 (and 
recognizing the inherent uncertainty of any forecast), FDA has 
determined that the appropriate adjusted level of the FY 2018 BsUFA fee 
revenue amount to be $40,214,000 (rounded to the nearest thousand 
dollars). FDA will use this amount as the target revenue amount for FY 
2018.

III. Fee Amounts for FY 2018

    Under section 744H(b)(3)(A) of the FD&C Act, FDA must determine the 
percentage of the total revenue amount for a fiscal year to be derived 
from: (1) Initial and annual BPD fees and reactivation fees, (2) 
biosimilar biological product application fees, and (3) biosimilar 
biological product program fees. In establishing the fee amounts for 
the first year of BsUFA II, FDA considered how best to balance the fee 
allocation to provide stable funding and reasonable fee amounts, and 
utilized benchmarks as described below. In future years, FDA will 
consider the most appropriate means of allocating the fee amounts to 
collect the adjusted target revenue amount, subject to the relevant 
statutory provisions.

A. Application Fees

    In establishing the biosimilar biological product application fee 
amount for FY 2018, FDA estimated the total number of fee-paying full 
applications equivalents (FAEs) it expects to receive in FY 2018. A 
full original 351(k) submission requiring clinical data counts as one 
FAE. An original 351(k) application not requiring clinical data counts 
as one-half of an FAE. An application that is withdrawn before filing, 
or refused for filing, counts as one-fourth of an FAE if the applicant 
initially paid a full application fee. An application that is 
withdrawn, or refused for filing, counts as one-eighth of an FAE if the 
applicant initially paid one-half of the full application fee.
    FDA considered the likelihood of submissions based on various 
indicators including a survey of sponsors on their intention to submit 
a 351(k) application. Based on the available information, FDA estimates 
it may receive 13 351(k) applications in FY 2018.
    FDA has determined that the amount of the biosimilar biological 
product application fee for FY 2018 is $1,746,745, which is estimated 
to provide a total of $22,707,685, representing 56 percent (rounded to 
the nearest one) of the FY 2018 target revenue amount.

B. Biosimilar Biological Product Program Fee

    BsUFA II renamed the product fee as the biosimilar biological 
product program fee (``program fee''); in addition, BsUFA II introduced 
a limitation that a person who is named as an applicant in a 351(k) 
application shall not be assessed more than five program fees for a 
fiscal year for biosimilar biological products identified in each 
351(k) application (see FD&C Act section 744H(a)(3)(D)). The program 
fee was also modified so that applicants are assessed a program fee 
only for biosimilar biological products identified in a biosimilar 
biological product application approved as of October 1 of such fiscal 
year.
    FDA estimates up to nine program fees will be invoiced in FY 2018, 
including currently approved products and products with the potential 
to be approved in pending applications with goal dates in FY 2017. For 
products invoiced in the FY 2018 regular billing cycle, FDA anticipates 
that zero program fees will be refunded. This prediction is based on 
observations dating to 2015, when the first biosimilar product was 
approved.
    FDA has determined that the amount of the biosimilar biological 
product program fee for FY 2018 is $304,162, which is estimated to 
provide a total of $2,737,458, representing 7 percent (rounded to the 
nearest one) of the FY 2018 target revenue amount.

C. Initial and Annual BPD Fees, Reactivation Fees

    To estimate the number of participants in the BPD program in FY 
2018, FDA must consider the number of new participants in the BPD 
program (initial BPD), the number of current participants (annual BPD), 
and the number of participants who will re-enter the BPD program 
(reactivation). FDA uses internal data, a survey of BPD sponsors, 
market sales data on reference products, and expected reference product 
expiration dates to estimate the total number of participants in the 
BPD program. FDA estimates 10 participants entering the BPD program, 
zero reactivations, and 55 participants to be invoiced for the annual 
BPD fee for a total of 65 participants in the BPD program in FY 2018.
    The remainder of the target revenue of $14,768,857, or 37 percent 
(rounded to the nearest one), is to be collected from the BPD fees. 
Dividing this amount by the estimated 65 BPD fees to be paid equals a 
BPD fee amount of $227,213. The reactivation fee is set at twice the 
initial/annual BPD amount at $454,426. FDA estimates zero reactivation 
fees will be paid, as none have yet been paid in the history of the 
BsUFA program.

IV. Fee Schedule for FY 2018

    The fee rates for FY 2018 are provided in table 1.

                    Table 1--Fee Schedule for FY 2018
------------------------------------------------------------------------
                                                          Fee rates  for
                      Fee category                         FY 2018  ($)
------------------------------------------------------------------------
Initial BPD.............................................         227,213
Annual BPD..............................................         227,213
Reactivation............................................         454,426
Applications:
  Requiring clinical data...............................       1,746,745
  Not requiring clinical data...........................         873,373
Program.................................................         304,162
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V. Fee Payment Options and Procedures

A. Initial BPD, Reactivation, and Application Fees

    The fees established in the new fee schedule apply to FY 2018, 
i.e., the period from October 1, 2017, through September 30, 2018. The 
initial BPD fee for a product is due when the sponsor submits an IND 
that FDA determines is intended to support a biosimilar biological 
product application for the product or within 5 calendar days after FDA 
grants the first BPD meeting for the product, whichever occurs first. 
Sponsors who have discontinued participation in the BPD program must 
pay the reactivation fee by the earlier of the following dates: No 
later than 5 calendar days after FDA grants the sponsor's request for a 
BPD meeting for that product, or upon the date of

[[Page 43243]]

submission by the sponsor of an IND describing an investigation that 
FDA determines is intended to support a biosimilar biological product 
application.
    The application fee for a biosimilar biological product is due upon 
submission of the application (see section 744H(a)(2)(C) of the FD&C 
Act).
    To make a payment of the initial BPD, reactivation, or application 
fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's 
Web site (http://www.fda.gov/bsufa) and generate a user fee 
identification (ID) number. Payment must be made in U.S. currency by 
electronic check, check, bank draft, U.S. postal money order, or wire 
transfer. The preferred payment method is online using electronic check 
(Automated Clearing House (ACH) also known as eCheck) or credit card 
(Discover, VISA, MasterCard, American Express). Secure electronic 
payments can be submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No 
partial payments can be made online). Once you search for your invoice, 
click ``Pay Now'' to be redirected to Pay.gov. Electronic payment 
options are based on the balance due. Payment by credit card is 
available for balances that are less than $25,000. If the balance 
exceeds this amount, only the ACH option is available. Payments must be 
made using U.S. bank accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to use 
http://www.pay.gov, a web-based payment application, for online 
electronic payment. The Pay.gov feature is available on FDA's Web site 
after completing the Biosimilar User Fee Cover Sheet and generating the 
user fee ID number.
    Please include the user fee ID number on your check, bank draft, or 
postal money order, and make it payable to the Food and Drug 
Administration. Your payment can be mailed to: Food and Drug 
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. To send a 
check by a courier such as Federal Express or United Parcel Service, 
the courier must deliver the check and printed copy of the cover sheet 
to: U.S. Bank, ATTN: Government Lockbox 979108, 1005 Convention Plaza, 
St. Louis, MO 63101. (Note: This U.S. Bank address is for courier 
delivery only. Contact U.S. Bank at 314-418-4013 if you have any 
questions concerning courier delivery.) Please make sure that the FDA 
post office box number (P.O. Box 979108) is written on the check, bank 
draft, or postal money order.
    If paying by wire transfer, please reference your unique user fee 
ID number when completing the transfer. The originating financial 
institution may charge a wire transfer fee. Please ask your financial 
institution about the fee and include it with your payment to ensure 
that your fee is fully paid. The account information for wire transfers 
is as follows: U.S. Department of Treasury, TREAS NYC, 33 Liberty St., 
New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: 
FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor, Silver 
Spring, MD 20993-0002. If needed, FDA's tax identification number is 
53-0196965.

B. Annual BPD and Program Fees

    FDA will issue invoices for annual BPD and program fees for FY 2018 
under the new fee schedule in September 2017. Payment instructions will 
be included in the invoices, including payment due dates. If sponsors 
join the BPD program after the annual BPD invoices have been issued in 
September 2017, FDA will issue invoices in December 2017 to firms 
subject to fees for FY 2018 that qualify for the annual BPD fee after 
the September 2017 billing. FDA will issue invoices in December 2017 
for any annual program fees for FY 2018 that qualify for fee 
assessments and were not issued in September 2017.

    Dated: September 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-19493 Filed 9-13-17; 8:45 am]
 BILLING CODE 4164-01-P