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)

Page Range		46005-46007
FR Document		2015-18908

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 Issue 148 (Monday, August 3, 2015)

[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.

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

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
------------------------------------------------------------------------
                                                              Fee rates
                        Fee category                         for FY 2016
------------------------------------------------------------------------
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
------------------------------------------------------------------------
\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

Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46005

211.198. FDA will consider whether to compounding. The commenter asked Burden Estimates:
provide additional guidance on SOPs, whether the reporting requirements The total estimated reporting and
but outsourcing facilities are required to apply to other activities such as recordkeeping burdens for the guidance
develop written procedures that enable repackaging. are as follows:
them to fulfill their review, reporting, FDA Response to Issue 24: The We estimate that approximately 55
and recordkeeping obligations even if guidance states that ‘‘for purposes of outsourcing facilities (‘‘Number of
FDA does not provide such guidance. reporting adverse drug experiences, the Respondents’’ and ‘‘Total Annual
Issue 23: One commenter suggests Responses’’ in table 1) will annually
term prescription drug products
using the MedWatch Form FDA 3500 submit adverse event reports to FDA as
voluntary reporting instead of the includes any compounded drug product
subject to the prescription requirements specified in the guidance, and that
mandatory Form FDA 3500A reporting preparing and submitting this
form. in section 503(b)(1) of the FD&C Act.’’
Reporting for other activities such as information will take approximately 1.1
FDA Response to Issue 23: FDA
repackaging will be addressed in hours per registrant (‘‘Average Burden
disagrees with this comment. Section
503B of the FD&C Act requires that separate guidance documents. For per Response’’ in table 1).
outsourcing facilities report adverse example, when finalized, FDA’s draft We estimate that approximately 55
events. Therefore, voluntary reporting guidance, ‘‘Repackaging of Certain outsourcing facilities (‘‘Number of
mechanisms such as the Form FDA Human Drug Products by Pharmacies Recordkeepers’’ in table 2) will annually
3500 would not be appropriate for and Outsourcing Facilities,’’ will maintain records of adverse events as
outsourcing facility adverse event describe adverse event reporting for specified in the guidance, and that
reporting. drug products repackaged by preparing and maintaining the records
Issue 24: One commenter asked for outsourcing facilities, if they will be will take approximately 16 hours per
clarification about the type of products expected to report adverse events registrant (‘‘average burden per
about which adverse event reports must associated with their repackaged recordkeeping’’ in table 2).
be submitted, noting that outsourcing products, as contemplated by the draft FDA estimates the burden of this
facilities often do more than guidance. collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
Compounding outsourcing facility responses per Total hours
respondents responses per response
respondent

Submission of adverse event reports in-
cluding copy of labeling and other in-
formation as described in the guid-
ance .................................................... 55 1 55 1.1 61
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Number of records Total annual Average burden
Type of recordkeeping Total hours
recordkeepers per recordkeeper records per recordkeeping

Records of adverse events, including
records of efforts to obtain the data
elements for each adverse event re-
port ..................................................... 55 1 55 16 880
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: July 28, 2015. ACTION: Notice. biosimilar biological product
Leslie Kux, application.
Associate Commissioner for Policy. SUMMARY: The Food and Drug BsUFA directs FDA to establish,
[FR Doc. 2015–18911 Filed 7–31–15; 8:45 am] Administration (FDA) is announcing the before the beginning of each fiscal year,
rates for biosimilar user fees for fiscal the initial and annual biosimilar
BILLING CODE 4164–01–P
year (FY) 2016. The Federal Food, Drug, biological product development (BPD)
and Cosmetic Act (the FD&C Act), as fees, the reactivation fee, and the
DEPARTMENT OF HEALTH AND amended by the Biosimilar User Fee Act biosimilar biological product
HUMAN SERVICES of 2012 (BsUFA), authorizes FDA to application, establishment, and product
assess and collect user fees for certain fees. These fees are effective on October
Food and Drug Administration activities in connection with biosimilar 1, 2015, and will remain in effect
through September 30, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES

biological product development, certain
applications and supplements for FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2015–N–0007]
approval of biosimilar biological Rachel Richter, Office of Financial
Biosimilar User Fee Rates for Fiscal products, establishments where Management, Food and Drug
Year 2016 approved biosimilar biological products Administration, 8455 Colesville Rd.,
are made, and a biosimilar biological COLE–14216, Silver Spring, MD 20993–
AGENCY: Food and Drug Administration, product fee for each biosimilar 0002, 301–796–7111.
HHS. biological product approved in a SUPPLEMENTARY INFORMATION:

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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46007

The application or supplement fee for product fees under the new fee schedule Management, Food and Drug
a biosimilar biological product is due in August 2015. Payment instructions Administration, 8455 Colesville Rd.,
upon submission of the application or will be included in the invoices. COLE–14216, Silver Spring, MD 20933–
supplement. Payment will be due on October 1, 2015. 0002, 301–796–7111.
To make a payment of the initial BPD, If sponsors join the BPD program after SUPPLEMENTARY INFORMATION:
reactivation, supplement, or application the annual BPD invoices have been
fee, complete the Biosimilar User Fee issued in August 2015, FDA will issue I. Background
Cover Sheet, available on FDA’s Web invoices in November 2015 to firms On November 27, 2013, President
site (http://www.fda.gov/bsufa) and subject to fees for FY 2016 that qualify Obama signed the Drug Quality and
generate a user fee identification (ID) for the annual BPD fee after the August Security Act (DQSA), legislation that
number. Payment must be made in U.S. 2015 billing. FDA will issue invoices in contains important provisions relating
currency by electronic check, check, November 2016 for any annual products to the oversight of compounding of
bank draft, U.S. postal money order, or and establishments subject to fees for human drugs. Title I of this law, the
wire transfer. FY 2016 that qualify for fee assessments Compounding Quality Act, creates a
FDA has partnered with the U.S. after the August 2015 billing. new section 503B in the FD&C Act (21
Department of the Treasury to use Dated: July 28, 2015. U.S.C. 353b). Under section 503B of the
Pay.gov, a Web-based payment FD&C Act, a human drug compounder
Leslie Kux,
application, for online electronic can become an ‘‘outsourcing facility.’’
payment. The Pay.gov feature is Associate Commissioner for Policy.
Outsourcing facilities, as defined in
available on FDA’s Web site after [FR Doc. 2015–18908 Filed 7–31–15; 8:45 am] section 503B(d)(4) of the FD&C Act, are
completing the Biosimilar User Fee BILLING CODE 4164–01–P facilities that meet all of the conditions
Cover Sheet and generating the user fee described in section 503B(a), including
ID number. registering with FDA as an outsourcing
Please include the user fee ID number DEPARTMENT OF HEALTH AND facility and paying an annual
on your check, bank draft, or postal HUMAN SERVICES establishment fee. If these conditions
money order, and make it payable to the are satisfied, a drug compounded by or
Food and Drug Administration
Food and Drug Administration. Your under the direct supervision of a
payment can be mailed to: Food and [Docket No. FDA–2015–N–0007] licensed pharmacist in an outsourcing
Drug Administration, P.O. Box 979108, facility is exempt from two sections of
St. Louis, MO 63197–9000. If you prefer Outsourcing Facility Fee Rates for the FD&C Act: (1) Section 502(f)(1) (21
to send a check by a courier such as Fiscal Year 2016 U.S.C. 352(f)(1)) concerning the labeling
Federal Express or United Parcel AGENCY: Food and Drug Administration, of drugs with adequate directions for
Service, the courier may deliver the HHS. use and (2) section 505 (21 U.S.C. 355)
check and printed copy of the cover ACTION: Notice. concerning the approval of human drug
sheet to: U.S. Bank, Attention: products under new drug applications
Government Lockbox 979108, 1005 SUMMARY: The Food and Drug (NDAs) or abbreviated new drug
Convention Plaza, St. Louis, MO 63101. Administration (FDA) is announcing the applications (ANDAs). Drugs
(Note: This U.S. Bank address is for fiscal year (FY) 2016 rates for the compounded in outsourcing facilities
courier delivery only. Contact U.S. Bank establishment and reinspection fees are not exempt from the requirements of
at 314–418–4013 if you have any related to human drug compounding section 501(a)(2)(B) of the FD&C Act (21
questions concerning courier delivery.) outsourcing facilities (outsourcing U.S.C. 351(a)(2)(B)) concerning current
Please make sure that the FDA post facilities) that elect to register under the good manufacturing practice for drugs.
office box number (P.O. Box 979108) is Federal Food, Drug, and Cosmetic Act Section 744K of the FD&C Act (21
written on the check, bank draft, or (the FD&C Act). The FD&C Act U.S.C. 379j–62) authorizes FDA to
postal money order. authorizes FDA to assess and collect an assess and collect the following fees
If paying by wire transfer, please annual establishment fee from associated with outsourcing facilities
reference your unique user fee ID outsourcing facilities that have elected that elect to register under section 503B
number when completing your transfer. to register, as well as a reinspection fee of the FD&C Act: (1) An annual
The originating financial institution for each reinspection of an outsourcing establishment fee from each outsourcing
may charge a wire transfer fee. Please facility. This document establishes the facility and (2) a reinspection fee from
ask your financial institution about the FY 2016 rates for the small business each outsourcing facility subject to a
fee and include it with your payment to establishment fee ($5,203), the non- reinspection (see section 744K(a)(1) of
ensure that your fee is fully paid. The small business establishment fee the FD&C Act). Under statutorily
account information is as follows: New ($16,465), and the reinspection fee defined conditions, a qualified
York Federal Reserve Bank, U.S. ($15,610) for outsourcing facilities; applicant may pay a reduced small
Department of Treasury, TREAS NYC, provides information on how the fees business establishment fee (see section
33 Liberty St., New York, NY 10045, for FY 2016 were determined; and 744K(c)(4) of the FD&C Act).
Acct. No.: 75060099, Routing No.: describes the payment procedures FDA announced in the Federal
021030004, SWIFT: FRNYUS33, outsourcing facilities should follow. Register of November 24, 2014 (79 FR
Beneficiary: FDA, 8455 Colesville Rd., FOR FURTHER INFORMATION CONTACT: 69856), the availability of a final
Silver Spring, MD 20993–0002. For information on pharmacy guidance for industry entitled ‘‘Fees for
mstockstill on DSK4VPTVN1PROD with NOTICES

The tax identification number of FDA compounding and pharmacy Human Drug Compounding Outsourcing
is 53–0196965. compounding user fees: Visit FDA’s Facilities Under Sections 503B and
Web site at http://www.fda.gov/Drugs/ 744K of the FD&C Act.’’ The guidance
B. Annual BPD, Establishment, and GuidanceComplianceRegulatory provides additional information on the
Product Fees Information/PharmacyCompounding/ annual fees for registered outsourcing
FDA will issue invoices for annual default.htm. facilities and adjustments required by
BPD, biosimilar biological product For questions relating to this notice: law, reinspection fees, how to submit
establishment, and biosimilar biological Rachel Richter, Office of Financial payment, the effect of failure to pay fees,

VerDate Sep<11>2014 18:35 Jul 31, 2015 Jkt 235001 PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 E:\FR\FM\03AUN1.SGM 03AUN1

Document Created: 2018-02-23 10:51:40
Document Modified: 2018-02-23 10:51:40

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
Contact		Rachel Richter, Office of Financial Management, Food and Drug Administration, 8455 Colesville Rd., COLE- 14216, Silver Spring, MD 20993-0002, 301-796-7111.
FR Citation		80 FR 46005

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration