
[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46962-46963]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18621]



[[Page 46962]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]


Biosimilar User Fee Rates for Fiscal Year 2014

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) 2014. The Federal Food, 
Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar 
User Fee Act of 2012 (BsUFA), which was signed by the President on July 
9, 2012, authorizes FDA to assess and collect user fees for certain 
activities in connection with biosimilar biological product 
development, for certain applications and supplements for approval of 
biosimilar biological products, on establishments where approved 
biosimilar biological product products are made, and on biosimilar 
biological products after approval. 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, 2013, and will 
remain in effect through September 30, 2014.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial 
Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr., 
PI50, Rm. 210J, Rockville, MD 20850, 301-796-7103.

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 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 for the product, or within 5 calendar days after FDA grants 
the first BPD meeting for the product, whichever occurs first. A 
sponsor who has paid the initial BPD fee for a product 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 for the 
product is assessed beginning in 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 for the 
product.
    Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has 
discontinued participation in FDA's BPD Program for a product, and 
wants to again engage with FDA on development of the product as a 
biosimilar biological product, the sponsor must pay a reactivation fee 
to resume participation in the BPD Program for that product. The 
reactivation fee is assessed when the sponsor submits an IND for an 
investigation that FDA determines is intended to support a biosimilar 
biological product application, or within 5 calendar days after FDA 
grants the sponsor's request for a BPD meeting for a product, whichever 
occurs first. Annual BPD fees will resume beginning in the fiscal year 
after the year in which the reactivation fee was paid.
    BsUFA also establishes fees for certain types of applications and 
supplements for approval of biosimilar biological products, 
establishments where approved biosimilar biological products are made, 
and on biosimilar biological products after approval (section 
744H(a)(2), 744H(a)(3) and 744H(a)(4), respectively, of the FD&C Act). 
When certain conditions are met, FDA may grant small businesses a 
waiver from the 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 FY. 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.

II. Fee Amounts for FY 2014

    BsUFA directs FDA to use the yearly fee amounts established for 
PDUFA to calculate the biosimilar biological product fee rates in each 
fiscal year. For more information about BsUFA, please refer to the FDA 
Web site at http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm. PDUFA fee calculations for FY 
2014 are published elsewhere in this issue of the Federal Register. The 
BsUFA fee calculations for FY 2014 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 2014 fee for an application requiring 
clinical data under PDUFA is $2,169,100. Multiplying the PDUFA 
application fee, $2,169,100, by .1 results in FY 2014 initial and 
annual BPD fees of $216,910. Multiplying the PDUFA application fee, 
$2,169,100, by .2 results in an FY 2014 reactivation fee of $433,820.

B. Application and Supplement Fees

    The FY 2014 fee for a biosimilar biological product application 
requiring clinical data equals the PDUFA fee for an application 
requiring clinical data, $2,169,100, and the FY 2014 fee for a 
biosimilar biological product application not requiring clinical data 
equals half this amount, $1,084,550. However, under section 
744H(a)(2)(A) of the FD&C Act, if a sponsor that submits a biosimilar 
biological product application has previously paid initial BPD fees, 
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. The FY 2014 fee 
for a biosimilar biological product supplement with clinical data is 
$1,084,550, which is half the fee for a biosimilar biological product 
application requiring clinical data.

C. Establishment Fee

    The FY 2014 biosimilar biological product establishment fee is set 
equal to the FY 2014 PDUFA establishment fee of $554,600.

D. Product Fee

    The FY 2014 biosimilar biological product fee is set equal to the 
FY 2014 PDUFA product fee of $104,060.

III. Fee Schedule for FY 2014

    The fee rates for FY 2014 are set out in Table 1.

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                    Table 1--Fee Schedule for FY 2014
------------------------------------------------------------------------
                  Fee category                    Fee rates for FY 2014
------------------------------------------------------------------------
Initial BPD....................................                 $216,910
Annual BPD.....................................                  216,910
Reactivation...................................                  433,820
Applications \1\                                 .......................
  Requiring clinical data......................                2,169,100
  Not requiring clinical data..................                1,084,550
Supplement requiring clinical data.............                1,084,550
Establishment..................................                  554,600
Product........................................                  104,060
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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 initial BPD fees, 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, 2013. 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. For sponsors who have discontinued participation in the 
BPD Program, a reactivation fee will be due when the sponsor submits an 
IND for an investigation that FDA determines is intended to support a 
biosimilar biological product application, or within 5 calendar days 
after FDA grants the sponsor's request for a BPD meeting for a product, 
whichever occurs first.
    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, you must complete the Biosimilar User Fee Cover Sheet, 
available on FDA's Web site (http://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm) starting October 1, 2013, 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 order of 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 checks 
are to be sent by a courier that requests a street address, the courier 
can deliver the checks 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.) 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, 1350 Piccard Dr., 
Rockville, MD, 20850.
    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 2013. Payment instructions will be included 
in the invoices. Payment will be due on October 1, 2013. FDA will issue 
invoices in November 2014 for any annual BPD, products and 
establishments subject to fees for FY 2014 that qualify for fee 
assessments after the August 2013 billing.

    Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18621 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P


