[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49669-49672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17811]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0007]
Animal Generic Drug User Fee Rates and Payment Procedures for
Fiscal Year 2017
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) 2017 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 2017.
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 (21 U.S.C.
379j-21(b)). Base revenue amounts established for fiscal years after FY
2014 are subject to adjustment for workload (21 U.S.C. 379j-21(c)). The
target revenue amounts for each fee category for FY 2017, after the
adjustment for workload, are as follows: For application fees the
target revenue amount is $2,835,000; for product fees the target
revenue amount is $4,253,000; and for sponsor fees the target revenue
amount is $4,253,000.
For FY 2017, the generic new animal drug user fee rates are:
$232,400 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)); $116,200 for each abbreviated
application for a generic new animal drug subject to the criteria in
section 512(d)(4); $10,200 for each generic new animal drug product;
$96,350 for each generic new animal drug sponsor paying 100 percent of
the sponsor fee; $72,263 for each generic new animal drug sponsor
paying 75 percent of the sponsor fee; and $48,175 for each generic new
animal drug sponsor paying 50 percent of the sponsor fee. FDA will
issue invoices for FY 2017 product and sponsor fees by December 31,
2016. These fees will be due by January 31, 2017. The application fee
rates are effective for all abbreviated applications for a generic new
animal drug submitted on or after October 1, 2016, and will remain in
effect through September 30, 2017. 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 (AGDUFA program).
II. Revenue Amount for FY 2017
A. Statutory Fee Revenue Amounts
AGDUFA II, Title II of Public Law 113-14, specifies that the
aggregate revenue amount for FY 2017 for abbreviated application fees
is $1,984,000 and each of the other two generic new animal drug user
fee categories, annual product fees and annual sponsor fees, is
$2,976,000 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 II 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, 2016.
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
[[Page 49670]]
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 42.9097 percent for FY 2017. This is the workload adjuster
for FY 2017.
Table 1--Workload Adjuster Calculation
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Column 1 Column 2 Column 3 Column 4 Column 5
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Application type 5-year average Latest 5-year Weighting Weighted
(base years) average Percent change factor percent change
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Abbreviated New Animal Drug 25.0 29.8 19.2000 0.3730 7.1620
Applications (ANADAs)..........
Manufacturing Supplements ANADAs 128.0 145.2 13.4375 0.2667 3.5837
Generic Investigational Study 23.0 48.0 108.6957 0.2411 26.2031
Submissions....................
Generic Investigational Protocol 17.2 25.8 50.0000 0.1192 5.9609
Submissions....................
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FY 2017 AGDUFA II Workload .............. .............. .............. .............. 42.9097
Adjuster...................
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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 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 2017 ($1,984,000 for application fees and $2,976,000 for both
product and sponsor fees) must now be increased by 42.9097 percent, for
a total fee revenue target in FY 2017 of $11,341,000 (rounded to the
nearest thousand dollars) for fees from all three categories. The
target for application fee revenue is $1,984,000 times 42.9097 percent,
for a total of $2,835,000, rounded to the nearest thousand. The target
for product fee revenue is $2,976,000 times 42.9097 percent, for a
total of $4,253,000, rounded to the nearest thousand dollars, and the
target for sponsor fee revenue is the same as for product fees
($4,253,000, rounded to the nearest thousand dollars).
III. Abbreviated Application Fee Calculations for FY 2017
A. Application Fee Revenues and Numbers of Fee-Paying Applications
Each person that submits an abbreviated application or a
supplemental abbreviated application for a generic new animal drug
shall be subject to an application fee, with limited exceptions (21
U.S.C. 379j-21(a)(1)). The term ``abbreviated application for a generic
new animal drug'' means an abbreviated application for the approval of
any generic new animal drug submitted under section 512(b)(2) (21
U.S.C. 379j-21(k)(1)). A ``supplemental abbreviated application for a
generic new animal drug'' is defined as a request to the Secretary to
approve a change in an approved abbreviated application (21 U.S.C.
379j-21(k)(11)). The application fees are to be set so that they will
generate $2,835,000 in fee revenue for FY 2017.
To set fees for abbreviated applications for generic new animal
drugs to realize $2,835,000, FDA must first make some assumptions about
the number of fee-paying abbreviated applications it will receive
during FY 2017.
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 (21 U.S.C. 379j-21(a)(1)(C)(ii)).
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 2017 will equal the average
number of submissions over the 5 most recently completed years of the
AGDUFA program (FY 2011-FY 2015). FDA believes that this is a
reasonable approach after 7 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 10 applications not subject to the criteria in
section 512(d)(4) of the FD&C Act and 4.4 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 that are subject
to such criteria results in a total of 12.2 anticipated full fees.
In prior years, FDA had estimated the number of reactivations of
abbreviated applications for generic new animal drugs that had been
originally submitted prior to July 1, 2008. Over the years, that number
has decreased 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.
[[Page 49671]]
Based on the previous assumptions, FDA is estimating that it will
receive a total of 12.2 fee-paying generic new animal drug applications
in FY 2017 (10 original applications paying a full fee and 4.4
applications paying a half fee).
B. Application Fee Rates for FY 2017
FDA must set the fee rates for FY 2017 so that the estimated 12.2
abbreviated applications that pay the fee will generate a total of
$2,835,000. To generate this amount, the fee for a generic new animal
drug application, rounded to the nearest hundred dollars, will have to
be $232,400, and for those applications that are subject to the
criteria set forth in section 512(d)(4) of the FD&C Act, 50 percent of
that amount, or $116,200.
IV. Generic New Animal Drug Product Fee Calculations for FY 2017
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 $4,253,000 in fee revenue for FY 2017.
To set generic new animal drug product fees to realize $4,253,000,
FDA must make some assumptions about the number of products for which
these fees will be paid in FY 2017. 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 2016, FDA estimates a total of 417 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 417 products will be subject to this fee in FY
2017.
In estimating the fee revenue to be generated by generic new animal
drug product fees in FY 2017, FDA is assuming that less than two
products invoiced will qualify for minor use/minor species fee waiver
(see 21 U.S.C. 379j-21(d)). FDA has kept this estimate at 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 417 products will
be subject to product fees in FY 2017.
B. Product Fee Rates for FY 2017
FDA must set the fee rates for FY 2017 so that the estimated 417
products that pay fees will generate a total of $4,253,000. To generate
this amount will require the fee for a generic new animal drug product,
rounded to the nearest $5, to be $10,200.
V. Generic New Animal Drug Sponsor Fee Calculations for FY 2017
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),
respectively). 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 $4,253,000 in fee revenue for FY 2017.
To set generic new animal drug sponsor fees to realize $4,253,000,
FDA must make some assumptions about the number of sponsors who will
pay these fees in FY 2017. FDA now has 7 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 recently completed years of the AGDUFA program
(FY 2011 through FY 2015), FDA estimates that in FY 2017, 13 sponsors
will pay 100 percent fees, 18 sponsors will pay 75 percent fees, and 38
sponsors will pay 50 percent fees. That totals the equivalent of 45.5
full sponsor fees (13 times 100 percent or 13, plus 18 times 75 percent
or 13.5, plus 38 times 50 percent or 19).
FDA estimates that about 3 percent of all of these sponsors, or
1.37, may qualify for a minor use/minor species fee waiver (see 21
U.S.C. 379j-21(d)). FDA has reduced the estimate of the percentage of
sponsors that will not pay fees from 4 percent to 3 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 44.13 full
sponsor fees (45.5 minus 1.37) are likely to be paid in FY 2017.
B. Sponsor Fee Rates for FY 2017
FDA must set the fee rates for FY 2017 so that the estimated
equivalent of 44.13 full sponsor fees will generate a total of
$4,253,000. To generate this amount will require the 100 percent fee
for a generic new animal drug sponsor, rounded to the nearest $50, to
be $96,350. Accordingly, the fee for those paying 75 percent of the
full sponsor fee will be $72,263, and the fee for those paying 50
percent of the full sponsor fee will be $48,175.
VI. Fee Schedule for FY 2017
The fee rates for FY 2017 are summarized in table 2 of this
document.
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Table 2--FY 2017 Fee Rates
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Fee rate for
Generic new animal drug user fee category FY 2017 ($)
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Abbreviated Application Fee for Generic New Animal Drug $232,400
except those subject to the criteria in section
512(d)(4)..............................................
Abbreviated Application Fee for Generic New Animal Drug 116,200
subject to the criteria in section 512(d)(4)...........
Generic New Animal Drug Product Fee..................... 10,200
100 Percent Generic New Animal Drug Sponsor Fee \1\..... 96,350
75 Percent Generic New Animal Drug Sponsor Fee \1\...... 72,263
50 Percent Generic New Animal Drug Sponsor Fee \1\...... 48,175
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\1\ An animal drug sponsor is subject to only one fee each fiscal year.
VII. Procedures for Paying FY 2017 Generic New Animal Drug User Fees
A. Abbreviated Application Fees and Payment Instructions
The FY 2017 fee established in the new fee schedule must be paid
for an abbreviated new animal drug application subject to fees under
AGDUFA II that is submitted on or after October 1, 2016. Payment must
be made in U.S. currency from a U.S. bank by check, bank draft, U.S.
postal money order payable to the order of the Food and Drug
Administration, wire transfer, or electronically using Pay.gov. The
preferred payment method is online using electronic check (Automated
Clearing House (ACH), also known as eCheck) or credit card (Discover,
VISA, MasterCard, American Express). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay or the Pay.gov payment option is available to you
after you submit a cover sheet. Once you search for your invoice, click
``Pay Now'' to be redirected to Pay.gov. Note that electronic payment
options are based on the balance due. Payment by credit card is
available for balances less than $25,000. If the balance exceeds this
amount, only the ACH option is available. Payments must be drawn on U.S
bank accounts as well as U.S. credit cards.
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 979033) 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., 14th Floor, 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, 2016, FDA will issue invoices and payment
instructions for product and sponsor fees for FY 2017 using this fee
schedule. Fees will be due by January 31, 2017. FDA will issue invoices
in November 2017 for any products and sponsors subject to fees for FY
2017 that qualify for fees after the December 2016 billing.
Dated: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17811 Filed 7-27-16; 8:45 am]
BILLING CODE 4164-01-P