[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46962-46963]
From the Federal Register Online via the Government Publishing 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.
[[Page 46963]]
Table 1--Fee Schedule for FY 2014
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Fee category Fee rates for FY 2014
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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