[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46012-46015]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18909]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0007]
Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2016
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the fee
rates and payment procedures for fiscal year (FY) 2016 generic new
animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the
FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of
2013 (AGDUFA II), authorizes FDA to collect user fees for certain
abbreviated applications for generic new animal drugs, for certain
generic new animal drug products, and for certain sponsors of such
abbreviated applications for generic new animal drugs and/or
investigational submissions for generic new animal drugs. This notice
establishes the fee rates for FY 2016.
FOR FURTHER INFORMATION CONTACT: Visit FDA's Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/default.htm, or contact Lisa Kable, Center for Veterinary Medicine
(HFV-10), Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-402-6888. For general questions, you may also email the
Center for Veterinary Medicine (CVM) at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Section 741 of the FD&C Act (21 U.S.C. 379j-21) establishes three
different types of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs; (2) annual fees for certain
generic new animal drug products; and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs (21 U.S.C.
379j-21(a)). When certain conditions are met, FDA will waive or reduce
fees for generic new animal drugs intended solely to provide for a
minor use or minor species indication (21 U.S.C. 379j-21(d)).
For FY 2014 through FY 2018, the FD&C Act establishes aggregate
yearly base revenue amounts for each of these fee categories. Base
revenue amounts established for fiscal years after FY 2014 may be
adjusted for workload. The target revenue amounts for each fee category
for FY 2016, after the adjustment for workload, are as follows: For
application fees the target revenue amount is $2,426,000; for product
fees the target revenue amount is $3,639,000; and for sponsor fees the
target revenue amount is $3,639,000.
For FY 2016, the generic new animal drug user fee rates are:
$233,300 for each abbreviated application for a generic new animal drug
other than those subject to the criteria in section 512(d)(4) of the
FD&C Act (21 U.S.C. 360b(d)(4)); $116,650 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4); $8,705 for each generic new animal drug product;
$83,800 for each generic new animal drug sponsor paying 100 percent of
the sponsor fee; $62,850 for each generic new animal drug sponsor
paying 75 percent of the sponsor fee; and $41,900 for each generic new
animal drug sponsor paying 50 percent of the sponsor fee. FDA will
issue invoices for FY 2016 product and sponsor fees by December 31,
2015. These fees will be due by January 31, 2016. The application fee
rates are effective for all abbreviated applications for a generic new
animal drug submitted on or after October 1, 2015, and will remain in
effect through September 30, 2016. Applications will not be accepted
for review until FDA has received full payment of related application
fees and any other fees owed under the Animal Generic Drug User Fee
program.
II. Revenue Amount for FY 2016
A. Statutory Fee Revenue Amounts
AGDUFA II, Title II of Public Law 113-14, specifies that the
aggregate revenue amount for FY 2016 for abbreviated application fees
is $1,857,000 and each of the other two generic new animal drug user
fee categories, annual product fees and annual sponsor fees, is
$2,786,000 each (see 21 U.S.C. 379j-21(b)).
B. Inflation Adjustment to Fee Revenue Amount
The amounts established in AGDUFA II for each year for FY 2014
through FY 2018 include an inflation adjustment; therefore, no further
inflation adjustment is required.
C. Workload Adjustment Fee Revenue Amount
For each FY beginning after FY 2014, AGDUFA provides that statutory
fee revenue amounts shall be further adjusted to reflect changes in
review workload. (See 21 U.S.C. 379j-21(c)(2).)
FDA calculated the average number of each of the four types of
applications and submissions specified in the workload adjustment
provision (abbreviated applications for generic new animal drugs,
manufacturing supplemental abbreviated applications for generic new
animal drugs, investigational generic new animal drug study
submissions, and investigational generic new animal drug protocol
submissions) received over the 5-year period that ended on September
30, 2013 (the base years), and the average number of each of these
types of applications and submissions over the most recent 5-year
period that ended on June 30, 2015.
The results of these calculations are presented in the first two
columns in table 1. Column 3 reflects the percent change in workload
over the two 5-year periods. Column 4 shows the weighting factor for
each type of application, reflecting how much of the total FDA generic
new animal drug review workload was accounted for by each type of
application or submission in the table during the most recent 5 years.
Column 5 is the weighted percent change in each category of workload
and was derived by multiplying the weighting factor in each line in
column 4 by the percent change from the base years in column 3. At the
bottom right of table 1, the sum of the values in column 5 is
calculated, reflecting a total change in workload of 30.6305 percent
for FY 2016. This is the workload adjuster for FY 2016.
[[Page 46013]]
Table 1--Workload Adjuster Calculation
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Column 1 5-year Column 5
Application type average (base Column 2 latest Column 3 percent Column 4 weighted percent
years) 5-year average change weighting factor change
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Abbreviated New Animal Drug Applications (ANADAs)........ 25.0 29.2 17 0.3741 6.2855
Manufacturing Supplements ANADAs......................... 128.0 143.2 12 0.2780 3.3015
Generic Investigational Study Submissions................ 23.0 39.2 70 0.2217 15.6183
Generic Investigational Protocol Submissions............. 17.2 24.6 43 0.1261 5.4252
FY 2016 AGDUFA Workload Adjuster......................... ................. ................. ................. ................. 30.6305
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Over the last year FDA has continued to see more sponsors getting
involved in the generic animal drug approval process including pioneer
sponsors. This has contributed to small sustained increases in the
number of ANADAs, manufacturing supplements, and protocols submitted.
Additionally, more sponsors continue to pursue drug approvals that do
not qualify for a waiver of the requirement to conduct an in vivo
bioequivalence study. For this reason we are seeing a large sustained
increase in the number of generic investigational new animal drug study
submissions.
As a result, the statutory revenue amount for each category of fees
for FY 2016 ($1,857,000 for application fees and $2,786,000 for both
product and sponsor fees) must now be increased by 30.6305 percent, for
a total fee revenue target in FY 2016 of $9,705,000 (rounded to the
nearest thousand dollars) for fees from all three categories. The
target for application fee revenue is $1,857,000 times 30.6305 percent,
for a total of $2,426,000, rounded to the nearest thousand. The target
for product fee revenue is $2,786,000 times 30.6305 percent, for a
total of $3,639,000, rounded to the nearest thousand dollars, and the
target for sponsor fee revenue is the same as for product fees
($3,639,000, rounded to the nearest thousand dollars).
III. Abbreviated Application Fee Calculations for FY 2016
The term ``abbreviated application for a generic new animal drug''
is defined in 21 U.S.C. 379j-21(k)(1).
A. Application Fee Revenues and Numbers of Fee-Paying Applications
The application fee must be paid for abbreviated applications for a
generic new animal drug that is subject to fees under AGDUFA and that
is submitted on or after July 1, 2008. The application fees are to be
set so that they will generate $2,426,000 in fee revenue for FY 2016.
This is the amount set out in the statute (21 U.S.C. 379j-21(b)(1))
after applying the workload adjuster.
To set fees for abbreviated applications for generic new animal
drugs to realize $2,426,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2016.
The Agency knows the number of applications that have been
submitted in previous years. That number fluctuates from year to year.
FDA is making estimates and applying different assumptions for two
types of full fee submissions: Original submissions of abbreviated
applications for generic new animal drugs and ``reactivated''
submissions of abbreviated applications for generic new animal drugs.
Any original submissions of abbreviated applications for generic new
animal drugs that were received by FDA before July 1, 2008, were not
assessed fees (21 U.S.C. 379j-21(a)(1)(A)). Some of these non-fee-
paying submissions were later resubmitted on or after July 1 because
the initial submission was not approved by FDA (i.e., FDA marked the
submission as incomplete and requested additional non-administrative
information) or because the original submission was withdrawn by the
sponsor. Abbreviated applications for generic new animal drugs
resubmitted on or after July 1, 2008, are subject to user fees. In this
notice, FDA refers to these resubmitted applications as ``reactivated''
applications.
Also, under AGDUFA II, an abbreviated application for an animal
generic drug subject to the criteria in section 512(d)(4) of the FD&C
Act and submitted on or after October 1, 2013, shall be subject to 50
percent of the fee applicable to all other abbreviated applications for
a generic new animal drug.
Regarding original submissions of abbreviated applications for
generic new animal drugs, FDA is assuming that the number of
applications that will pay fees in FY 2016 will equal the average
number of submissions over the 5 most recent completed years of AGDUFA
(FY 2010-FY 2014). FDA believes that this is a reasonable approach
after 6 complete years of experience with this program.
The average number of original submissions of abbreviated
applications for generic new animal drugs over the 5 most recently
completed years is 8.6 applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and 3.6 submissions subject to the
criteria in section 512(d)(4). Each of the submissions described under
section 512(d)(4) of the FD&C Act pays 50 percent of the fee paid by
the other applications and will be counted as one half of a fee. Adding
all of the applications not subject to the criteria in section
512(d)(4) of the FD&C Act and 50 percent of the number which are
subject to such criteria results in a total of 10.4 anticipated full
fees.
Under AGDUFA I, FDA estimated the number of reactivations of
abbreviated applications for generic new animal drugs which had been
originally submitted prior to July 1, 2008. That number has decreased
over the years to the point that FDA no longer expects to receive any
reactivations of applications initially submitted prior to July 1,
2008, and will include no provision for them in its fee estimates.
Should such a submission be made, the submitter will be expected to pay
the appropriate fee.
Based on the previous assumptions, FDA is estimating that it will
receive a total of 10.4 fee-paying generic new animal drug applications
in FY 2016 (8.6 original applications paying a full fee and 3.6
applications paying a half fee).
B. Application Fee Rates for FY 2016
FDA must set the fee rates for FY 2016 so that the estimated 10.4
abbreviated applications that pay the fee will generate a total of
$2,426,000. To generate this amount, the fee for a generic new animal
drug application, rounded to the nearest hundred dollars, will have to
be $233,300, and for those applications that are subject to the
[[Page 46014]]
criteria set forth in section 512(d)(4) of the FD&C Act 50 percent of
that amount, or $116,650.
IV. Generic New Animal Drug Product Fee Calculations for FY 2016
A. Product Fee Revenues and Numbers of Fee-Paying Products
The generic new animal drug product fee (also referred to as the
product fee) must be paid annually by the person named as the applicant
in an abbreviated application or supplemental abbreviated application
for a generic new animal drug product submitted for listing under
section 510 of the FD&C Act (21 U.S.C. 360), and who had an abbreviated
application or supplemental abbreviated application for a generic new
animal drug product pending at FDA after September 1, 2008 (see 21
U.S.C. 379j-21(a)(2)). The term ``generic new 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 abbreviated application for a generic new animal drug or
supplemental abbreviated application for a generic new animal drug has
been approved (21 U.S.C. 379j-21(k)(6)). The product fees are to be set
so that they will generate $3,639,000 in fee revenue for FY 2016, after
workload adjustment ($2,786,000 times 1.306305, rounded to the nearest
thousand dollars).
To set generic new animal drug product fees to realize $3,639,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2016. FDA gathered data on all generic
new 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 FDA estimated would have an abbreviated new animal drug application
or supplemental abbreviated application pending after September 1,
2008. As of June 2015, FDA estimates a total of 418 products submitted
for listing by persons who had an abbreviated application for a generic
new animal drug or supplemental abbreviated application for a generic
new animal drug pending after September 1, 2008. Based on this, FDA
believes that a total of 418 products will be subject to this fee in FY
2016.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2016, FDA is assuming that no products invoiced
will qualify for minor use/minor species fee waiver (see 21 U.S.C.
379j-21(d)). FDA has changed the estimate of the percentage of products
that will not pay fees to zero percent this year, based on historical
data over the past 5 completed years of the AGDUFA program.
Accordingly, the Agency estimates that a total of 418 products will
be subject to product fees in FY 2016.
B. Product Fee Rates for FY 2016
FDA must set the fee rates for FY 2016 so that the estimated 418
products that pay fees will generate a total of $3,639,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest $5, to be $8,705.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2016
A. Sponsor Fee Revenues and Numbers of Fee-Paying Sponsors
The generic new 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 abbreviated application for a generic new animal
drug, 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 submission for a generic new animal
drug that has not been terminated or otherwise rendered inactive and
(2) had an abbreviated application for a generic new animal drug,
supplemental abbreviated application for a generic new animal drug, or
investigational submission for a generic new animal drug pending at FDA
after September 1, 2008 (see 21 U.S.C. 379j-21(k)(7) and 379j-
21(a)(3)). A generic new animal drug sponsor is subject to only one
such fee each fiscal year (see 21 U.S.C. 379j-21(a)(3)(C)). Applicants
with more than six approved abbreviated applications will pay 100
percent of the sponsor fee; applicants with more than one and fewer
than seven approved abbreviated applications will pay 75 percent of the
sponsor fee; and applicants with one or fewer approved abbreviated
applications will pay 50 percent of the sponsor fee (see 21 U.S.C.
379j-21(a)(3)(C)). The sponsor fees are to be set so that they will
generate $3,639,000 in fee revenue for FY 2016, after workload
adjustment ($2,786,000 times 1.306305, rounded to the nearest thousand
dollars).
To set generic new animal drug sponsor fees to realize $3,639,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2016. FDA now has 6 complete years of experience
collecting these sponsor fees. Based on the number of firms that meet
this definition and the average number of firms paying fees at each
level over the 5 most recent completed years of AGDUFA (FY 2010 through
FY 2014), FDA estimates that in FY 2016, 12 sponsors will pay 100
percent fees, 17 sponsors will pay 75 percent fees, and 41 sponsors
will pay 50 percent fees. That totals the equivalent of 45.25 full
sponsor fees (12 times 100 percent or 12, plus 17 times 75 percent or
12.75, plus 41 times 50 percent or 20.5).
FDA estimates that about 4 percent of all of these sponsors, or
1.81, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has changed the estimate of the percentage of
sponsors that will not pay fees to 4 percent this year, based on
historical data over the past 5 completed years of the AGDUFA program.
Accordingly, the Agency estimates that the equivalent of 43.44 full
sponsor fees (45.25 minus 1.81) are likely to be paid in FY 2016.
B. Sponsor Fee Rates for FY 2016
FDA must set the fee rates for FY 2016 so that the estimated
equivalent of 43.44 full sponsor fees will generate a total of
$3,639,000. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $83,800. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $62,850, and the fee for those paying 50
percent of the full sponsor fee will be $41,900.
VI. Fee Schedule for FY 2016
The fee rates for FY 2016 are summarized in table 2 of this
document.
Table 2--FY 2016 Fee Rates
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Fee rate for
Generic new animal drug user fee category FY 2016
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Abbreviated Application Fee for Generic New Animal Drug $233,300
except those subject to the criteria in section
512(d)(4)..............................................
[[Page 46015]]
Abbreviated Application Fee for Generic New Animal Drug 116,650
subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee..................... 8,705
100 Percent Generic New Animal Drug Sponsor Fee \1\..... 83,800
75 Percent Generic New Animal Drug Sponsor Fee \1\...... 62,850
50 Percent Generic New Animal Drug Sponsor Fee \1\...... 41,900
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\1\ An animal drug sponsor is subject to only one fee each fiscal year.
VII. Procedures for Paying FY 2016 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2016 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA that is submitted on or after October 1, 2015. Payment must be
made in U.S. currency from a U.S. bank by check, bank draft, or U.S.
postal money order payable to the order of the Food and Drug
Administration, by wire transfer, or by automatic clearing house 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, U.S. or postal money order, please write your application's
unique Payment Identification Number, beginning with the letters
``AG'', from the upper right-hand corner of your completed Animal
Generic 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 Generic Drug
User Fee Cover Sheet can be mailed to: Food and Drug Administration,
P.O. Box 979033, St. Louis, MO 63197-9000.
If payment is made via wire transfer, send payment to U. S.
Department of the Treasury, TREAS NYC, 33 Liberty St., New York, NY
10045, Account Name: Food and Drug Administration, Account No.:
75060099, Routing No.: 021030004, Swift No.: FRNYUS33, Beneficiary:
FDA, 8455 Colesville Rd., Silver Spring, MD 20993-0002. 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, the courier may deliver
the check and printed copy of the cover sheet to: U.S. Bank, Attn:
Government Lockbox 979033, 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 phone 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 abbreviated application arrives at FDA's Center for
Veterinary Medicine (CVM). FDA records the official abbreviated
application receipt date as the later of the following: The date the
application was received by CVM, or the date U.S. Bank notifies FDA
that your payment in the full amount has been received, or when the
U.S. Department of the Treasury notifies FDA of payment. U.S. Bank and
the United States Treasury are required to notify FDA within 1 working
day, using the Payment Identification Number described previously.
B. Application Cover Sheet Procedures
Step One--Create a user account and password. Log onto the AGDUFA
Web site at http://www.fda.gov/ForIndustry/UserFees/AnimalGenericDrugUserFeeActAGDUFA/ucm137049.htm and scroll down the
page until you find the link ``Create AGDUFA User Fee Cover Sheet.''
Click on that link and follow the directions. 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 Generic Drug User Fee 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 Generic Drug User Fee Cover Sheet. One cover sheet is needed
for each abbreviated animal drug application. 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 Payment Identification Number.
Step Three--Send the payment for your application as described in
Section VII.A of this document.
Step Four--Please submit your application and a copy of the
completed Animal Generic 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 and Sponsor Fees
By December 31, 2015, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2016 using this fee
schedule. Fees will be due by January 31, 2016. FDA will issue invoices
in November 2016 for any products and sponsors subject to fees for FY
2016 that qualify for fees after the December 2015 billing.
Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18909 Filed 7-31-15; 8:45 am]
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