80 FR 46005 - Biosimilar User Fee Rates for Fiscal Year 2016

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 148 (August 3, 2015)

The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application. BsUFA directs FDA to establish, before the beginning of each fiscal year, the initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application, establishment, and product fees. These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016.

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46005-46007]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0007]


Biosimilar User Fee Rates for Fiscal Year 2016

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) 2016. The Federal Food, 
Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar 
User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user 
fees for certain activities in connection with biosimilar biological 
product development, certain applications and supplements for approval 
of biosimilar biological products, establishments where approved 
biosimilar biological products are made, and a biosimilar biological 
product fee for each biosimilar biological product approved in a 
biosimilar biological product application.
    BsUFA directs FDA to establish, before the beginning of each fiscal 
year, the initial and annual biosimilar biological product development 
(BPD) fees, the reactivation fee, and the biosimilar biological product 
application, establishment, and product fees. These fees are effective 
on October 1, 2015, and will remain in effect through September 30, 
2016.

FOR FURTHER INFORMATION CONTACT: Rachel Richter, Office of Financial 
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14216, Silver Spring, MD 20993-0002, 301-796-7111.

SUPPLEMENTARY INFORMATION:

[[Page 46006]]

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51, 
379j-52, and 379j-53), as added by BsUFA (Title IV of the Food and Drug 
Administration Safety and Innovation Act, Pub. L. 112-144), establish 
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 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 also establishes fees for certain applications and 
supplements, establishments where approved biosimilar biological 
products are made in final dosage form, and for each biosimilar 
biological product approved in a biosimilar biological product 
application (section 744H(a)(2), 744H(a)(3), and 744H(a)(4), 
respectively, 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(c)(1) of the FD&C Act).
    Under BsUFA, the initial and annual BPD fee rates for a fiscal year 
are equal to 10 percent of the fee rate established under the 
Prescription Drug User Fee Act (PDUFA) for an application requiring 
clinical data for that fiscal year. The reactivation fee is equal to 20 
percent of the fee rate established under PDUFA for an application 
requiring clinical data for that fiscal year. Finally, the application, 
establishment, and product fee rates under BsUFA are equal to the 
application, establishment, and product fee rates under PDUFA, 
respectively (section 744H(b)(1) of the FD&C Act).

II. Fee Amounts for FY 2016

    BsUFA directs FDA to establish the biosimilar biological product 
fee rates in each fiscal year by reference to the user fees established 
under PDUFA for that fiscal year. For more information about BsUFA, 
please refer to the FDA Web site at http://www.fda.gov/bsufa. PDUFA fee 
calculations for FY 2016 are published elsewhere in this issue of the 
Federal Register. The BsUFA fee calculations for FY 2016 are described 
in this document.

A. Initial and Annual BPD Fees, Reactivation Fees

    Under BsUFA, the initial and annual BPD fees equal 10 percent of 
the PDUFA fee for an application requiring clinical data, and the 
reactivation fee equals 20 percent of the PDUFA fee for an application 
requiring clinical data. The FY 2016 fee for an application requiring 
clinical data under PDUFA is $2,374,200. Multiplying the PDUFA 
application fee, $2,374,200, by 0.1 results in FY 2016 initial and 
annual BPD fees of $237,420. Multiplying the PDUFA application fee, 
$2,374,200, by 0.2 results in a FY 2016 reactivation fee of $474,840.

B. Application and Supplement Fees

    The FY 2016 fee for a biosimilar biological product application 
requiring clinical data equals the PDUFA fee for an application 
requiring clinical data, $2,374,200. The FY 2016 fee for a biosimilar 
biological product application not requiring clinical data equals half 
this amount, $1,187,100. However, under section 744H(a)(2)(A) of the 
FD&C Act, if a sponsor submitting a biosimilar biological product 
application has previously paid an initial BPD fee, annual BPD fee(s), 
and/or reactivation fee(s) for the product that is the subject of the 
application, the fee for the application is reduced by the cumulative 
amount of these previously paid fees. The FY 2016 fee for a biosimilar 
biological product supplement with clinical data is $1,187,100, which 
is half the fee for a biosimilar biological product application 
requiring clinical data.

C. Establishment Fee

    The FY 2016 biosimilar biological product establishment fee for 
establishments where approved biosimilar biological products are made 
is equal to the FY 2016 PDUFA establishment fee of $585,200.

D. Product Fee

    The FY 2016 biosimilar biological product fee for each biosimilar 
biological product approved in a biosimilar biological product 
application is equal to the FY 2016 PDUFA product fee of $114,450.

III. Fee Schedule for FY 2016

    The fee rates for FY 2016 are provided in table 1.

                    Table 1--Fee Schedule for FY 2016
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                                                              Fee rates
                        Fee category                         for FY 2016
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Initial BPD................................................     $237,420
    Annual BPD.............................................      237,420
Reactivation...............................................      474,840
Applications \1\
    Requiring clinical data................................    2,374,200
    Not requiring clinical data............................    1,187,100
Supplement requiring clinical data.........................    1,187,100
Establishment..............................................      585,200
Product....................................................      114,450
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\1\ Under section 744H(a)(2)(A) of the FD&C Act, if a sponsor that
  submits a biosimilar biological product application has previously
  paid an initial BPD fee, annual BPD fees, and/or reactivation fees for
  the product that is the subject of the application, the fee for the
  application is reduced by the cumulative amount of these previously
  paid fees.

IV. Fee Payment Options and Procedures

A. Initial BPD, Reactivation, Application, and Supplement Fees

    The fees established in the new fee schedule are effective October 
1, 2015. 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 
submission of an IND describing an investigation that FDA determines is 
intended to support a biosimilar biological product application.

[[Page 46007]]

    The application or supplement fee for a biosimilar biological 
product is due upon submission of the application or supplement.
    To make a payment of the initial BPD, reactivation, supplement, 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.
    FDA has partnered with the U.S. Department of the Treasury to use 
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. If you 
prefer to send a check by a courier such as Federal Express or United 
Parcel Service, the courier may deliver the check and printed copy of 
the cover sheet to: U.S. Bank, Attention: 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 your 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 is as follows: New 
York Federal Reserve Bank, 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., 
Silver Spring, MD 20993-0002.
    The tax identification number of FDA is 53-0196965.

B. Annual BPD, Establishment, and Product Fees

    FDA will issue invoices for annual BPD, biosimilar biological 
product establishment, and biosimilar biological product fees under the 
new fee schedule in August 2015. Payment instructions will be included 
in the invoices. Payment will be due on October 1, 2015. If sponsors 
join the BPD program after the annual BPD invoices have been issued in 
August 2015, FDA will issue invoices in November 2015 to firms subject 
to fees for FY 2016 that qualify for the annual BPD fee after the 
August 2015 billing. FDA will issue invoices in November 2016 for any 
annual products and establishments subject to fees for FY 2016 that 
qualify for fee assessments after the August 2015 billing.

    Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18908 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P