[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45634-45635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18712]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 301-796-7103.

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

[[Page 45635]]

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
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2013
------------------------------------------------------------------------
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]
BILLING CODE 4160-01-P