80 FR 46012 - Animal Generic Drug User Fee Rates and Payment Procedures 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		46012-46015
FR Document		2015-18909

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.

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

[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46012-46015]
From the Federal Register Online [www.thefederalregister.org]
[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.

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

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 cvmagdufa@fda.hhs.gov.

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

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
------------------------------------------------------------------------
Fee rate for
Generic new animal drug user fee category FY 2016
------------------------------------------------------------------------
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
------------------------------------------------------------------------
\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]
BILLING CODE 4164-01-P

46012 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices

on file in the public docket (docket SUPPLEMENTARY INFORMATION: II. Revenue Amount for FY 2016
number found in brackets in the
I. Background A. Statutory Fee Revenue Amounts
heading of this document) and will post
it at http://www.fda.gov/ Section 741 of the FD&C Act (21 AGDUFA II, Title II of Public Law
MedicalDevices/NewsEvents/ U.S.C. 379j–21) establishes three 113–14, specifies that the aggregate
WorkshopsConferences/default.htm. different types of user fees: (1) Fees for revenue amount for FY 2016 for
The deadline for submitting comments abbreviated application fees is
certain types of abbreviated applications
to this document for presentation at the $1,857,000 and each of the other two
for generic new animal drugs; (2) annual
public workshop is September 18, 2015, generic new animal drug user fee
fees for certain generic new animal drug
although comments related to this categories, annual product fees and
products; and (3) annual fees for certain
document can be made until September annual sponsor fees, is $2,786,000 each
sponsors of abbreviated applications for
28, 2015. (see 21 U.S.C. 379j–21(b)).
generic new animal drugs and/or
The Agencies will use the input from
investigational submissions for generic B. Inflation Adjustment to Fee Revenue
this workshop and public comments to
new animal drugs (21 U.S.C. 379j– Amount
determine appropriate next steps to
advance sematic interoperability of 21(a)). When certain conditions are met, The amounts established in AGDUFA
laboratory data. FDA will waive or reduce fees for II for each year for FY 2014 through FY
generic new animal drugs intended 2018 include an inflation adjustment;
Dated: July 28, 2015. solely to provide for a minor use or therefore, no further inflation
Leslie Kux, minor species indication (21 U.S.C. adjustment is required.
Associate Commissioner for Policy. 379j–21(d)).
[FR Doc. 2015–18910 Filed 7–31–15; 8:45 am] C. Workload Adjustment Fee Revenue
For FY 2014 through FY 2018, the Amount
BILLING CODE 4164–01–P
FD&C Act establishes aggregate yearly
base revenue amounts for each of these For each FY beginning after FY 2014,
fee categories. Base revenue amounts AGDUFA provides that statutory fee
DEPARTMENT OF HEALTH AND revenue amounts shall be further
HUMAN SERVICES established for fiscal years after FY 2014
may be adjusted for workload. The adjusted to reflect changes in review
Food and Drug Administration target revenue amounts for each fee workload. (See 21 U.S.C. 379j–21(c)(2).)
category for FY 2016, after the FDA calculated the average number of
[Docket No. FDA–2015–N–0007] each of the four types of applications
adjustment for workload, are as follows:
For application fees the target revenue and submissions specified in the
Animal Generic Drug User Fee Rates workload adjustment provision
and Payment Procedures for Fiscal amount is $2,426,000; for product fees
the target revenue amount is $3,639,000; (abbreviated applications for generic
Year 2016 new animal drugs, manufacturing
and for sponsor fees the target revenue
AGENCY: Food and Drug Administration, amount is $3,639,000. supplemental abbreviated applications
HHS. for generic new animal drugs,
For FY 2016, the generic new animal investigational generic new animal drug
ACTION: Notice.
drug user fee rates are: $233,300 for study submissions, and investigational
SUMMARY: The Food and Drug each abbreviated application for a generic new animal drug protocol
Administration (FDA) is announcing the generic new animal drug other than submissions) received over the 5-year
fee rates and payment procedures for those subject to the criteria in section period that ended on September 30,
fiscal year (FY) 2016 generic new 512(d)(4) of the FD&C Act (21 U.S.C. 2013 (the base years), and the average
animal drug user fees. The Federal 360b(d)(4)); $116,650 for each number of each of these types of
Food, Drug, and Cosmetic Act (the abbreviated application for a generic applications and submissions over the
FD&C Act), as amended by the Animal new animal drug subject to the criteria most recent 5-year period that ended on
Generic Drug User Fee Amendments of in section 512(d)(4); $8,705 for each June 30, 2015.
2013 (AGDUFA II), authorizes FDA to generic new animal drug product; The results of these calculations are
collect user fees for certain abbreviated $83,800 for each generic new animal presented in the first two columns in
applications for generic new animal drug sponsor paying 100 percent of the table 1. Column 3 reflects the percent
drugs, for certain generic new animal sponsor fee; $62,850 for each generic change in workload over the two 5-year
drug products, and for certain sponsors new animal drug sponsor paying 75 periods. Column 4 shows the weighting
of such abbreviated applications for percent of the sponsor fee; and $41,900 factor for each type of application,
generic new animal drugs and/or for each generic new animal drug reflecting how much of the total FDA
investigational submissions for generic sponsor paying 50 percent of the generic new animal drug review
new animal drugs. This notice sponsor fee. FDA will issue invoices for workload was accounted for by each
establishes the fee rates for FY 2016. FY 2016 product and sponsor fees by type of application or submission in the
FOR FURTHER INFORMATION CONTACT: Visit December 31, 2015. These fees will be table during the most recent 5 years.
FDA’s Web site at http://www.fda.gov/ due by January 31, 2016. The Column 5 is the weighted percent
ForIndustry/UserFees/AnimalGeneric application fee rates are effective for all change in each category of workload
DrugUserFeeActAGDUFA/default.htm, abbreviated applications for a generic and was derived by multiplying the
or contact Lisa Kable, Center for new animal drug submitted on or after weighting factor in each line in column
mstockstill on DSK4VPTVN1PROD with NOTICES

Veterinary Medicine (HFV–10), Food October 1, 2015, and will remain in 4 by the percent change from the base
and Drug Administration, 7519 Standish effect through September 30, 2016. years in column 3. At the bottom right
Pl., Rockville, MD 20855, 240–402– Applications will not be accepted for of table 1, the sum of the values in
6888. For general questions, you may review until FDA has received full column 5 is calculated, reflecting a total
also email the Center for Veterinary payment of related application fees and change in workload of 30.6305 percent
Medicine (CVM) at cvmagdufa@ any other fees owed under the Animal for FY 2016. This is the workload
fda.hhs.gov. Generic Drug User Fee program. adjuster for FY 2016.

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Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices 46013

TABLE 1—WORKLOAD ADJUSTER CALCULATION
Column 1 Column 2 Column 5
Column 3 Column 4
Application type 5-year average latest 5-year aver- weighted percent
percent change weighting factor
(base years) age change

Abbreviated New Animal Drug Applica-
tions (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 Submis-
sions ................................................... 23.0 39.2 70 0.2217 15.6183
Generic Investigational Protocol Sub-
missions .............................................. 17.2 24.6 43 0.1261 5.4252
FY 2016 AGDUFA Workload Adjuster .. .............................. .............................. .............................. .............................. 30.6305

Over the last year FDA has continued the statute (21 U.S.C. 379j–21(b)(1)) after recent completed years of AGDUFA (FY
to see more sponsors getting involved in applying the workload adjuster. 2010–FY 2014). FDA believes that this
the generic animal drug approval To set fees for abbreviated is a reasonable approach after 6
process including pioneer sponsors. applications for generic new animal complete years of experience with this
This has contributed to small sustained drugs to realize $2,426,000, FDA must program.
increases in the number of ANADAs, first make some assumptions about the The average number of original
manufacturing supplements, and number of fee-paying abbreviated submissions of abbreviated applications
protocols submitted. Additionally, more applications it will receive during FY for generic new animal drugs over the
sponsors continue to pursue drug 2016. 5 most recently completed years is 8.6
approvals that do not qualify for a The Agency knows the number of applications not subject to the criteria in
waiver of the requirement to conduct an applications that have been submitted section 512(d)(4) of the FD&C Act and
in vivo bioequivalence study. For this in previous years. That number 3.6 submissions subject to the criteria in
reason we are seeing a large sustained fluctuates from year to year. FDA is section 512(d)(4). Each of the
increase in the number of generic making estimates and applying different submissions described under section
investigational new animal drug study assumptions for two types of full fee 512(d)(4) of the FD&C Act pays 50
submissions. submissions: Original submissions of percent of the fee paid by the other
abbreviated applications for generic new applications and will be counted as one
As a result, the statutory revenue
animal drugs and ‘‘reactivated’’ half of a fee. Adding all of the
amount for each category of fees for FY
submissions of abbreviated applications applications not subject to the criteria in
2016 ($1,857,000 for application fees
for generic new animal drugs. Any section 512(d)(4) of the FD&C Act and
and $2,786,000 for both product and
original submissions of abbreviated 50 percent of the number which are
sponsor fees) must now be increased by
applications for generic new animal subject to such criteria results in a total
30.6305 percent, for a total fee revenue
drugs that were received by FDA before of 10.4 anticipated full fees.
target in FY 2016 of $9,705,000
July 1, 2008, were not assessed fees (21 Under AGDUFA I, FDA estimated the
(rounded to the nearest thousand
U.S.C. 379j–21(a)(1)(A)). Some of these number of reactivations of abbreviated
dollars) for fees from all three non-fee-paying submissions were later applications for generic new animal
categories. The target for application fee resubmitted on or after July 1 because drugs which had been originally
revenue is $1,857,000 times 30.6305 the initial submission was not approved submitted prior to July 1, 2008. That
percent, for a total of $2,426,000, by FDA (i.e., FDA marked the number has decreased over the years to
rounded to the nearest thousand. The submission as incomplete and requested the point that FDA no longer expects to
target for product fee revenue is additional non-administrative receive any reactivations of applications
$2,786,000 times 30.6305 percent, for a information) or because the original initially submitted prior to July 1, 2008,
total of $3,639,000, rounded to the submission was withdrawn by the and will include no provision for them
nearest thousand dollars, and the target sponsor. Abbreviated applications for in its fee estimates. Should such a
for sponsor fee revenue is the same as generic new animal drugs resubmitted submission be made, the submitter will
for product fees ($3,639,000, rounded to on or after July 1, 2008, are subject to be expected to pay the appropriate fee.
the nearest thousand dollars). user fees. In this notice, FDA refers to Based on the previous assumptions,
III. Abbreviated Application Fee these resubmitted applications as FDA is estimating that it will receive a
Calculations for FY 2016 ‘‘reactivated’’ applications. total of 10.4 fee-paying generic new
Also, under AGDUFA II, an animal drug applications in FY 2016
The term ‘‘abbreviated application for abbreviated application for an animal (8.6 original applications paying a full
a generic new animal drug’’ is defined generic drug subject to the criteria in fee and 3.6 applications paying a half
in 21 U.S.C. 379j–21(k)(1). section 512(d)(4) of the FD&C Act and fee).
A. Application Fee Revenues and submitted on or after October 1, 2013,
shall be subject to 50 percent of the fee B. Application Fee Rates for FY 2016
Numbers of Fee-Paying Applications
applicable to all other abbreviated FDA must set the fee rates for FY 2016
mstockstill on DSK4VPTVN1PROD with NOTICES

The application fee must be paid for applications for a generic new animal so that the estimated 10.4 abbreviated
abbreviated applications for a generic drug. applications that pay the fee will
new animal drug that is subject to fees Regarding original submissions of generate a total of $2,426,000. To
under AGDUFA and that is submitted abbreviated applications for generic new generate this amount, the fee for a
on or after July 1, 2008. The application animal drugs, FDA is assuming that the generic new animal drug application,
fees are to be set so that they will number of applications that will pay rounded to the nearest hundred dollars,
generate $2,426,000 in fee revenue for fees in FY 2016 will equal the average will have to be $233,300, and for those
FY 2016. This is the amount set out in number of submissions over the 5 most applications that are subject to the

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46014 Federal Register / Vol. 80, No. 148 / Monday, August 3, 2015 / Notices

criteria set forth in section 512(d)(4) of September 1, 2008. Based on this, FDA sponsor fee; and applicants with one or
the FD&C Act 50 percent of that amount, believes that a total of 418 products will fewer approved abbreviated
or $116,650. be subject to this fee in FY 2016. applications will pay 50 percent of the
In estimating the fee revenue to be sponsor fee (see 21 U.S.C. 379j–
IV. Generic New Animal Drug Product
generated by generic new animal drug 21(a)(3)(C)). The sponsor fees are to be
Fee Calculations for FY 2016
product fees in FY 2016, FDA is set so that they will generate $3,639,000
A. Product Fee Revenues and Numbers assuming that no products invoiced will in fee revenue for FY 2016, after
of Fee-Paying Products qualify for minor use/minor species fee workload adjustment ($2,786,000 times
The generic new animal drug product waiver (see 21 U.S.C. 379j–21(d)). FDA 1.306305, rounded to the nearest
fee (also referred to as the product fee) has changed the estimate of the thousand dollars).
must be paid annually by the person percentage of products that will not pay To set generic new animal drug
named as the applicant in an fees to zero percent this year, based on sponsor fees to realize $3,639,000, FDA
abbreviated application or supplemental historical data over the past 5 completed must make some assumptions about the
abbreviated application for a generic years of the AGDUFA program. number of sponsors who will pay these
new animal drug product submitted for Accordingly, the Agency estimates fees in FY 2016. FDA now has 6
listing under section 510 of the FD&C that a total of 418 products will be complete years of experience collecting
Act (21 U.S.C. 360), and who had an subject to product fees in FY 2016. these sponsor fees. Based on the number
abbreviated application or supplemental B. Product Fee Rates for FY 2016 of firms that meet this definition and the
abbreviated application for a generic average number of firms paying fees at
FDA must set the fee rates for FY 2016 each level over the 5 most recent
new animal drug product pending at
so that the estimated 418 products that completed years of AGDUFA (FY 2010
FDA after September 1, 2008 (see 21
pay fees will generate a total of through FY 2014), FDA estimates that in
U.S.C. 379j–21(a)(2)). The term ‘‘generic
$3,639,000. To generate this amount FY 2016, 12 sponsors will pay 100
new animal drug product’’ means each
will require the fee for a generic new percent fees, 17 sponsors will pay 75
specific strength or potency of a
animal drug product, rounded to the percent fees, and 41 sponsors will pay
particular active ingredient or
nearest $5, to be $8,705. 50 percent fees. That totals the
ingredients in final dosage form
marketed by a particular manufacturer V. Generic New Animal Drug Sponsor equivalent of 45.25 full sponsor fees (12
or distributor, which is uniquely Fee Calculations for FY 2016 times 100 percent or 12, plus 17 times
identified by the labeler code and 75 percent or 12.75, plus 41 times 50
A. Sponsor Fee Revenues and Numbers percent or 20.5).
product code portions of the national
of Fee-Paying Sponsors FDA estimates that about 4 percent of
drug code, and for which an abbreviated
application for a generic new animal The generic new animal drug sponsor all of these sponsors, or 1.81, may
drug or supplemental abbreviated fee (also referred to as the sponsor fee) qualify for a minor use/minor species
application for a generic new animal must be paid annually by each person fee waiver (see 21 U.S.C. 379j–21(d)).
drug has been approved (21 U.S.C. 379j– who: (1) Is named as the applicant in an FDA has changed the estimate of the
21(k)(6)). The product fees are to be set abbreviated application for a generic percentage of sponsors that will not pay
so that they will generate $3,639,000 in new animal drug, except for an fees to 4 percent this year, based on
fee revenue for FY 2016, after workload approved application for which all historical data over the past 5 completed
adjustment ($2,786,000 times 1.306305, subject products have been removed years of the AGDUFA program.
rounded to the nearest thousand from listing under section 510 of the Accordingly, the Agency estimates
dollars). FD&C Act, or has submitted an that the equivalent of 43.44 full sponsor
To set generic new animal drug investigational submission for a generic fees (45.25 minus 1.81) are likely to be
product fees to realize $3,639,000, FDA new animal drug that has not been paid in FY 2016.
must make some assumptions about the terminated or otherwise rendered
number of products for which these fees inactive and (2) had an abbreviated B. Sponsor Fee Rates for FY 2016
will be paid in FY 2016. FDA gathered application for a generic new animal FDA must set the fee rates for FY 2016
data on all generic new animal drug drug, supplemental abbreviated so that the estimated equivalent of 43.44
products that have been submitted for application for a generic new animal full sponsor fees will generate a total of
listing under section 510 of the FD&C drug, or investigational submission for a $3,639,000. To generate this amount
Act and matched this to the list of all generic new animal drug pending at will require the 100 percent fee for a
persons who FDA estimated would have FDA after September 1, 2008 (see 21 generic new animal drug sponsor,
an abbreviated new animal drug U.S.C. 379j–21(k)(7) and 379j–21(a)(3)). rounded to the nearest $50, to be
application or supplemental abbreviated A generic new animal drug sponsor is $83,800. Accordingly, the fee for those
application pending after September 1, subject to only one such fee each fiscal paying 75 percent of the full sponsor fee
2008. As of June 2015, FDA estimates a year (see 21 U.S.C. 379j–21(a)(3)(C)). will be $62,850, and the fee for those
total of 418 products submitted for Applicants with more than six approved paying 50 percent of the full sponsor fee
listing by persons who had an abbreviated applications will pay 100 will be $41,900.
abbreviated application for a generic percent of the sponsor fee; applicants
VI. Fee Schedule for FY 2016
new animal drug or supplemental with more than one and fewer than
abbreviated application for a generic seven approved abbreviated The fee rates for FY 2016 are
mstockstill on DSK4VPTVN1PROD with NOTICES

new animal drug pending after applications will pay 75 percent of the summarized in table 2 of this document.

TABLE 2—FY 2016 FEE RATES
Fee rate for
Generic new animal drug user fee category FY 2016

Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) ..................... $233,300

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Document Created: 2018-02-23 10:51:44
Document Modified: 2018-02-23 10:51:44

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.
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]
FR Citation		80 FR 46012

80 FR 46012 - Animal Generic Drug User Fee Rates and Payment Procedures 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