[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46955-46958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18619]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0007]
Animal Drug User Fee Rates and Payment Procedures 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
and payment procedures for fiscal year (FY) 2014 animal drug user fees.
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by
the Animal Drug User Fee Amendments of 2013, which was signed by the
President on June 13, 2013 (ADUFA III), authorizes FDA to collect user
fees for certain animal drug applications and supplements, for certain
animal drug products, for certain establishments where such products
are made, and for certain sponsors of such animal drug applications
and/or investigational animal drug submissions. This notice establishes
the fee rates for FY 2014.
FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm
or contact Lisa Kable, Center for Veterinary Medicine (HFV-10), Food
and Drug Administration, 7529 Standish Pl., Rockville, MD 20855, 240-
276-9718. For general questions, you may also email the Center for
Veterinary Medicine (CVM) at: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 740 of the FD&C Act (21 U.S.C. 379j-12) establishes four
different types of user fees: (1) Fees for certain types of animal drug
applications and supplements; (2) annual fees for certain animal drug
products; (3) annual fees for certain establishments where such
products are made; and (4) annual fees for certain sponsors of animal
drug applications and/or investigational animal drug submissions (21
U.S.C. 379j-12(a)). When certain conditions are met, FDA will waive or
reduce fees (21 U.S.C. 379j-12(d)).
For FY 2014 through FY 2018, the FD&C Act establishes aggregate
yearly base revenue amounts for each fiscal year (21 U.S.C. 379j-
12(b)(1)). Base revenue amounts established for years after FY 2014 are
subject to adjustment
[[Page 46956]]
for inflation and workload (21 U.S.C. 379j-12(c)). Fees for
applications, establishments, products, and sponsors are to be
established each year by FDA so that the percentages of the total
revenue that is derived from each type of user fee will be as follows:
Revenue from application fees will be 20 percent of total fee revenue;
revenue from product fees will be 27 percent of total fee revenue;
revenue from establishment fees shall be 26 percent of total fee
revenue; and revenue from sponsor fees shall be 27 percent of total fee
revenue (21 U.S.C. 379j-12(b)(2)).
For FY 2014, the animal drug user fee rates are: $396,600 for an
animal drug application; $198,300 for a supplemental animal drug
application for which safety or effectiveness data are required and for
an animal drug application subject to the criteria set forth in section
512(d)(4) of the FD&C Act (21 U.S.C. 360b(d)(4)); $9,075 for an annual
product fee; $105,800 for an annual establishment fee; and $101,150 for
an annual sponsor fee. FDA will issue invoices for FY 2014 product,
establishment, and sponsor fees by December 31, 2013, and payment will
be due by January 31, 2014. The application fee rates are effective for
applications submitted on or after October 1, 2013, and will remain in
effect through September 30, 2014. Applications will not be accepted
for review until FDA has received full payment of application fees and
any other animal drug user fees owed under ADUFA.
II. Revenue Amount for FY 2014
A. Statutory Fee Revenue Amounts
ADUFA III (Title I of Pub. L. 113-14) specifies that the aggregate
revenue amount for FY 2014 for all animal drug user fee categories is
$23,600,000. (21 U.S.C. 379j-12(b)(1)(A).)
B. Inflation Adjustment to Fee Revenue Amount
The amount established in ADUFA III for FY 2014 includes an
inflation adjustment; therefore, no further inflation adjustment is
required for FY 2014. For FY 2015 and subsequent years an inflation
adjustment will be made (21 U.S.C. 379j-12(c)(2)).
C. Workload Adjustment to Inflation Adjusted Fee Revenue Amount
The amount established in ADUFA III for FY 2014 is not to be
further adjusted for workload. For FY 2015 and subsequent years a
workload adjustment will be calculated (21 U.S.C. 379j-12(c)(3)).
D. FY 2014 Fee Revenue Amounts
ADUFA III specifies a total revenue amount of $23,600,000 for FY
2014. Of this amount: 20 percent, or a total of $4,720,000, is to come
from application fees; 27 percent, or a total of $6,372,000, is to come
from product fees; 26 percent, or a total of $6,136,000, is to come
from establishment fees; and 27 percent, or a total of $6,372,000, is
to come from sponsor fees (21 U.S.C. 379j-12(b)).
III. Application Fee Calculations for FY 2014
The terms ``animal drug application'' and ``supplemental animal
drug application'' are defined in section 739 of the FD&C Act (21
U.S.C. 379j-11(1) and (2)).
A. Application Fee Revenues and Numbers of Fee-Paying Applications
The application fee must be paid for any animal drug application or
supplemental animal drug application that is subject to fees under
ADUFA and that is submitted on or after September 1, 2003. The
application fees are to be set so that they will generate $4,720,000 in
fee revenue for FY 2014. This is the amount derived in section II.D of
this document. The fee for a supplemental animal drug application for
which safety or effectiveness data are required and for an animal drug
application subject to criteria set forth in section 512(d)(4) of the
FD&C Act is to be set at 50 percent of the animal drug application fee
(21 U.S.C. 379j-12(a)(1)(A)(ii)).
To set animal drug application fees and supplemental animal drug
application fees to realize $4,720,000 FDA must first make some
assumptions about the number of fee-paying applications and supplements
the Agency will receive in FY 2014.
The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates significantly from
year to year. In estimating the fee revenue to be generated by animal
drug application fees in FY 2014, FDA is assuming that the number of
applications that will pay fees in FY 2014 will equal the average
number of submissions over the 5 most recent completed years (FY 2008-
FY 2012). This may not fully account for possible year to year
fluctuations in numbers of fee-paying applications, but FDA believes
that this is a reasonable approach after 10 years of experience with
this program.
Over the 5 most recent completed years, the average number of
animal drug applications that would have been subject to the full fee
was 7.2. Over this same period, the average number of supplemental
applications and applications subject to the criteria set forth in
section 512(d)(4) of the FD&C Act that would have been subject to half
of the full fee was 9.4.
B. Fee Rates for FY 2014
FDA must set the fee rates for FY 2014 so that the estimated 7.2
applications that pay the full fee and the estimated 9.4 supplemental
applications and applications subject to the criteria set forth in
section 512(d)(4) of the FD&C Act that pay half of the full fee will
generate a total of $4,720,000. To generate this amount, the fee for an
animal drug application, rounded to the nearest $100, will have to be
$396,600, and the fee for a supplemental animal drug application for
which safety or effectiveness data are required and for applications
subject to the criteria set forth in section 512(d)(4) of the FD&C Act
will have to be $198,300.
IV. Product Fee Calculations for FY 2014
A. Product Fee Revenues and Numbers of Fee-Paying Products
The animal drug product fee (also referred to as the product fee)
must be paid annually by the person named as the applicant in a new
animal drug application or supplemental new animal drug application for
an animal drug product submitted for listing under section 510 of the
FD&C Act (21 U.S.C. 360), and who had an animal drug application or
supplemental animal drug application pending at FDA after September 1,
2003. (See 21 U.S.C. 379j-12(a)(2).) The term ``animal drug product''
means each specific strength or potency of a particular active
ingredient or ingredients in final dosage form marketed by a particular
manufacturer or distributor, which is uniquely identified by the
labeler code and product code portions of the national drug code, and
for which an animal drug application or a supplemental animal drug
application has been approved (21 U.S.C. 379j-11(3)). The product fees
are to be set so that they will generate $6,372,000 in fee revenue for
FY 2014. This is the amount derived in section II.D of this document.
To set animal drug product fees to realize $6,372,000, FDA must
make some assumptions about the number of products for which these fees
will be paid in FY 2014. FDA developed data on all animal drug products
that have been submitted for listing under section 510 of the FD&C Act
and matched this to the list of all persons who had an
[[Page 46957]]
animal drug application or supplement pending after September 1, 2003.
As of June 2013, FDA estimates that there are a total of 747 products
submitted for listing by persons who had an animal drug application or
supplemental animal drug application pending after September 1, 2003.
Based on this, FDA estimates that a total of 747 products will be
subject to this fee in FY 2014.
In estimating the fee revenue to be generated by animal drug
product fees in FY 2014, FDA is assuming that 6 percent of the products
invoiced, or 45, will not pay fees in FY 2014 due to fee waivers and
reductions. FDA has reduced the estimate of the percentage of products
that will not pay fees from 10 percent to 6 percent this year, based on
historical data over the past 5 years. Based on experience with other
user fee programs and the first 10 years of ADUFA, FDA believes that
this is a reasonable basis for estimating the number of fee-paying
products in FY 2014.
Accordingly, the Agency estimates that a total of 702 (747 minus
45) products will be subject to product fees in FY 2014.
B. Product Fee Rates for FY 2014
FDA must set the fee rates for FY 2014 so that the estimated 702
products that pay fees will generate a total of $6,372,000. To generate
this amount will require the fee for an animal drug product, rounded to
the nearest $5, to be $9,075.
V. Establishment Fee Calculations for FY 2014
A. Establishment Fee Revenues and Numbers of Fee-Paying Establishments
The animal drug establishment fee (also referred to as the
establishment fee) must be paid annually by the person who: (1) Owns or
operates, directly or through an affiliate, an animal drug
establishment; (2) is named as the applicant in an animal drug
application or supplemental animal drug application for an animal drug
product submitted for listing under section 510 of the FD&C Act; (3)
had an animal drug application or supplemental animal drug application
pending at FDA after September 1, 2003; and (4) whose establishment
engaged in the manufacture of the animal drug product during the fiscal
year. (See 21 U.S.C. 379j-12(a)(3).) An establishment subject to animal
drug establishment fees is assessed only one such fee per fiscal year.
(See 21 U.S.C. 379j-12(a)(3).) The term ``animal drug establishment''
is defined in 21 U.S.C. 379j-11(4). The establishment fees are to be
set so that they will generate $6,136,000 in fee revenue for FY 2014.
This is the amount derived in section II.D of this document.
To set animal drug establishment fees to realize $6,136,000, FDA
must make some assumptions about the number of establishments for which
these fees will be paid in FY 2014. FDA developed data on all animal
drug establishments and matched this to the list of all persons who had
an animal drug application or supplement pending after September 1,
2003. As of June 2013, FDA estimates that there are a total of 66
establishments owned or operated by persons who had an animal drug
application or supplemental animal drug application pending after
September 1, 2003. Based on this, FDA believes that 66 establishments
will be subject to this fee in FY 2014.
In estimating the fee revenue to be generated by animal drug
establishment fees in FY 2014, FDA is assuming that 12 percent of the
establishments invoiced, or 8, will not pay fees in FY 2014 due to fee
waivers and reductions. FDA has increased the estimate of the
percentage of establishments that will not pay fees from 10 percent to
12 percent this year, based on historical data over the past 5 years.
Based on experience with the first 10 years of ADUFA, FDA believes that
this is a reasonable basis for estimating the number of fee-paying
establishments in FY 2014.
Accordingly, the Agency estimates that a total of 58 establishments
(66 minus 8) will be subject to establishment fees in FY 2014.
B. Establishment Fee Rates for FY 2014
FDA must set the fee rates for FY 2014 so that the estimated 58
establishments that pay fees will generate a total of $6,136,000. To
generate this amount will require the fee for an animal drug
establishment, rounded to the nearest $50, to be $105,800.
VI. Sponsor Fee Calculations for FY 2014
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The animal drug sponsor fee (also referred to as the sponsor fee)
must be paid annually by each person who: (1) Is named as the applicant
in an animal drug application, except for an approved application for
which all subject products have been removed from listing under section
510 of the FD&C Act, or has submitted an investigational animal drug
submission that has not been terminated or otherwise rendered inactive
and (2) had an animal drug application, supplemental animal drug
application, or investigational animal drug submission pending at FDA
after September 1, 2003. (See 21 U.S.C. 379j-11(6) and 379j-12(a)(4).)
An animal drug sponsor is subject to only one such fee each fiscal
year. (See 21 U.S.C. 379j-12(a)(4).) The sponsor fees are to be set so
that they will generate $6,372,000 in fee revenue for FY 2014. This is
the amount derived in section II.D of this document.
To set animal drug sponsor fees to realize $6,372,000, FDA must
make some assumptions about the number of sponsors who will pay these
fees in FY 2014. Based on the number of firms that would have met this
definition in each of the past 10 years, FDA estimates that a total of
181 sponsors will meet this definition in FY 2014.
Careful review indicates that about one third or 33 percent of all
of these sponsors will qualify for minor use/minor species waiver or
reduction (21 U.S.C. 379j-12(d)(1)(D)). Based on the Agency's
experience to date with sponsor fees, FDA's current best estimate is
that an additional 32 percent will qualify for other waivers or
reductions, for a total of 65 percent of the sponsors invoiced, or 118,
who will not pay fees in FY 2014 due to fee waivers and reductions. FDA
has increased the estimate of the percentage of sponsors that will not
pay fees from 60 percent to 65 percent this year, based on historical
data over the past 5 years. FDA believes that this is a reasonable
basis for estimating the number of fee-paying sponsors in FY 2014.
Accordingly, the Agency estimates that a total of 63 sponsors (181
minus 118) will be subject to and pay sponsor fees in FY 2014.
B. Sponsor Fee Rates for FY 2014
FDA must set the fee rates for FY 2014 so that the estimated 63
sponsors that pay fees will generate a total of $6,372,000. To generate
this amount will require the fee for an animal drug sponsor, rounded to
the nearest $50, to be $101,150.
VII. Fee Schedule for FY 2014
The fee rates for FY 2014 are summarized in table 1 of this
document.
Table 1--FY 2014 Fee Rates
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Fee rate for
Animal drug user fee category FY 2014
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Animal Drug Application Fees:
Animal Drug Application............................... $396,600
[[Page 46958]]
Supplemental Animal Drug Application for which Safety 198,300
or Effectiveness Data are Required or Animal Drug
Application Subject to the Criteria Set Forth in
Section 512(d)(4) of the FD&C Act....................
Animal Drug Product Fee................................. 9,075
Animal Drug Establishment Fee \1\....................... 105,800
Animal Drug Sponsor Fee \2\............................. 101,150
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\1\ An animal drug establishment is subject to only one such fee each
fiscal year.
\2\An animal drug sponsor is subject to only one such fee each fiscal
year.
VIII. Procedures for Paying the FY 2014 Fees
A. Application Fees and Payment Instructions
The appropriate application fee established in the new fee schedule
must be paid for an animal drug application or supplement subject to
fees under ADUFA that is submitted after September 30, 2013. Payment
must be made in U.S. currency by check, bank draft, or U.S. postal
money order payable to the order of the Food and Drug Administration,
by wire transfer, or electronically using Pay.gov. (The Pay.gov payment
option is available to you after you submit a cover sheet. Click the
``Pay Now'' button.) On your check, bank draft, or U.S. postal money
order, please write your application's unique Payment Identification
Number (PIN), beginning with the letters AD, from the upper right-hand
corner of your completed Animal Drug User Fee Cover Sheet. Also write
the FDA post office box number (P.O. Box 953877) on the enclosed check,
bank draft, or money order. Your payment and a copy of the completed
Animal Drug User Fee Cover Sheet can be mailed to: Food and Drug
Administration, P.O. Box 953877, St. Louis, MO 63195-3877.
If payment is made by wire transfer, send payment to: U.S.
Department of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045,
FDA Deposit Account Number: 75060099, U.S. Department of Treasury
routing/transit number: 021030004, SWIFT Number: FRNYUS33. You are
responsible for any administrative costs associated with the processing
of a wire transfer. Contact your bank or financial institution about
the fee and add it to your payment to ensure that your fee is fully
paid.
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, Attn: Government Lockbox 953877,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for
courier delivery only. If you have any questions concerning courier
delivery contact the U.S. Bank at 314-418-4013. This telephone number
is only for questions about courier delivery.)
The tax identification number of FDA is 53-0196965. (Note: In no
case should the payment for the fee be submitted to FDA with the
application.)
It is helpful if the fee arrives at the bank at least a day or two
before the application arrives at FDA's CVM. FDA records the official
application receipt date as the later of the following: The date the
application was received by FDA's CVM, or the date U.S. Bank notifies
FDA that your payment in the full amount has been received, or when the
U.S. Treasury notifies FDA of receipt of an electronic or wire transfer
payment. U.S. Bank and the U.S. Treasury are required to notify FDA
within 1 working day, using the PIN described previously.
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log on to the ADUFA
Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/default.htm and, under Tools and Resources,
click ``The Animal Drug User Fee Cover Sheet'' and then click ``Create
ADUFA User Fee Cover Sheet.'' For security reasons, each firm
submitting an application will be assigned an organization
identification number, and each user will also be required to set up a
user account and password the first time you use this site. Online
instructions will walk you through this process.
Step Two--Create an Animal Drug User Cover Sheet, transmit it to
FDA, and print a copy. After logging into your account with your user
name and password, complete the steps required to create an Animal Drug
User Fee Cover Sheet. One cover sheet is needed for each animal drug
application or supplement. Once you are satisfied that the data on the
cover sheet is accurate and you have finalized the cover sheet, you
will be able to transmit it electronically to FDA and you will be able
to print a copy of your cover sheet showing your unique PIN.
Step Three--Send the payment for your application as described in
section VIII.A of this document.
Step Four--Please submit your application and a copy of the
completed Animal Drug User Fee Cover Sheet to the following address:
Food and Drug Administration, Center for Veterinary Medicine, Document
Control Unit (HFV-199), 7500 Standish Pl., Rockville, MD 20855.
C. Product, Establishment, and Sponsor Fees
By December 31, 2013, FDA will issue invoices and payment
instructions for product, establishment, and sponsor fees for FY 2014
using this fee schedule. Payment will be due by January 31, 2014. FDA
will issue invoices in November 2014 for any products, establishments,
and sponsors subject to fees for FY 2014 that qualify for fees after
the December 2013 billing.
Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18619 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P