[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45634-45635]
[FR Doc No: 2012-18712]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0007]

Biosimilar User Fee Rates for Fiscal Year 2013

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) 2013. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar
User Fee Act of 2012 (BsUFA) (Title IV of the Food and Drug
Administration Safety and Innovation Act, Public Law 112-144, 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.
    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 (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. This document, which establishes FY 2013 rates for BsUFA
fees, uses the PDUFA application, establishment, and product fee
amounts for FY 2013 published elsewhere in this issue of the Federal
Register.
    The FY 2013 rates for BsUFA fees are as follows: Initial and annual
biosimilar BPD fees ($195,880), reactivation fee ($391,760), fee for a
biosimilar biological product application requiring clinical data
($1,958,800), fee for a biosimilar biological product application not
requiring clinical data ($979,400), fee for a biosimilar biological
product supplement requiring clinical data ($979,400), biosimilar
biological product establishment fee ($526,500), and biosimilar
biological product fee ($98,380). These fees are effective on October
1, 2012, and will remain in effect through September 30, 2013.

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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act, as added by BsUFA,
establish fees for biosimilar biological products. Under section
744H(a)(1)(A), 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. For a
sponsor that submitted an IND for a biosimilar biological product prior
to the date of enactment of BsUFA, FDA expects the initial BPD fee to
be paid by December 1, 2012, or within 5 calendar days after FDA grants
the first BPD meeting for the product, whichever occurs first. A
sponsor that 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 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).

II. Fee Amounts for FY 2013

    BsUFA directs FDA to use the yearly fee amounts for PDUFA to
calculate the biosimilar 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 2013 are published elsewhere in this
issue of the Federal Register. The BsUFA fee calculations for FY 2013
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 2013 fee for an application
requiring clinical data under PDUFA is $1,958,800. Multiplying the
PDUFA application fee, $1,958,800, by 0.1 results in FY 2013 initial
and annual BPD fees of $195,880. Multiplying the PDUFA application fee,
$1,958,800, by 0.2 results in an FY 2013 reactivation fee of $391,760.

B. Application and Supplement Fees

    The FY 2013 fee for a biosimilar biological product application
requiring clinical data equals the PDUFA fee for an application
requiring clinical data, $1,958,800, and the FY 2013 fee for a
biosimilar biological product application not requiring clinical data
equals half this amount, $979,400. 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 2013 fee for a
biosimilar biological product supplement with clinical data is
$979,400, which is half the fee for a biosimilar biological product
application requiring clinical data.

C. Establishment Fee

    The FY 2013 biosimilar biological product establishment fee is set
equal to the FY 2013 PDUFA establishment fee of $526,500.

D. Product Fee

    The FY 2013 biosimilar biological product fee is set equal to the
FY 2013 PDUFA product fee of $98,380.

III. Fee Schedule for FY 2013

    The fee rates for FY 2013 are set out in table 1 of this document.

                    Table 1--Fee Schedule for FY 2013
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                                                           Fee rates for
                      Fee category                            FY 2013
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Initial BPD.............................................        $195,880
Annual BPD..............................................         195,880
Reactivation............................................         391,760
Applications \1\:
    Requiring Clinical Data.............................     * 1,958,800
    Not Requiring Clinical Data.........................       * 979,400
Supplement Requiring Clinical Data......................         979,400
Establishment...........................................         526,500
Product.................................................          98,380
------------------------------------------------------------------------
\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, 2012. For a sponsor that submitted an IND for a biosimilar
biological product prior to the date of enactment of BsUFA, FDA expects
to receive the initial BPD fee by December 1, 2012 (unless the IND is
withdrawn before the fee due date), or within 5 calendar days after FDA
grants the first BPD meeting for the product, whichever occurs first.
Otherwise, 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 that 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 the FDA Web site starting October 1, 2012, 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
utilize Pay.gov, a Web-based payment application, for online electronic
payment. The www.Pay.gov feature is available on the FDA 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 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 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 between $15.00 and $35.00.
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,
Account Number: 75060099, Routing Number: 021030004, Swift Number:
FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD 20850.
    The tax identification number of the Food and Drug Administration
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. Payment
instructions will be included in the invoices. No annual BPD invoices
will be issued for FY 2013. FDA will issue invoices in November 2013
for any products and establishments subject to fees for FY 2013.

    Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18712 Filed 7-31-12; 8:45 am]
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