Generic Drug User Fee-Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, and Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year 2016, 46015-46019 [2015-18915]
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TABLE 2—FY 2016 FEE RATES—Continued
Fee rate for
FY 2016
Generic new animal drug user fee category
Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) ...........................................
Generic New Animal Drug Product Fee ..............................................................................................................................................
100 Percent Generic New Animal Drug Sponsor Fee 1 ......................................................................................................................
75 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................
50 Percent Generic New Animal Drug Sponsor Fee 1 ........................................................................................................................
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
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116,650
8,705
83,800
62,850
41,900
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
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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.
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.
B. Application Cover Sheet Procedures
Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Step One—Create a user account and
password. Log onto the AGDUFA Web
site at https://www.fda.gov/ForIndustry/
UserFees/AnimalGenericDrugUserFee
ActAGDUFA/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
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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.
[FR Doc. 2015–18909 Filed 7–31–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0007]
Generic Drug User Fee—Abbreviated
New Drug Application, Prior Approval
Supplement, Drug Master File, Final
Dosage Form Facility, and Active
Pharmaceutical Ingredient Facility Fee
Rates for Fiscal Year 2016
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates for abbreviated new drug
applications (ANDAs), prior approval
supplements to an approved ANDA
(PASs), drug master files (DMFs),
SUMMARY:
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generic drug active pharmaceutical
ingredient (API) facilities, and finished
dosage form (FDF) facilities user fees
related to the Generic Drug User Fee
Program for fiscal year (FY) 2016. The
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as amended by the
Generic Drug User Fee Amendments of
2012 (GDUFA), authorizes FDA to
assess and collect user fees for certain
applications and supplements for
human generic drug products, on
applications in the backlog as of October
1, 2012 (only applicable to FY 2013), on
FDF and API facilities, and on type II
active pharmaceutical ingredient DMFs
to be made available for reference. This
document establishes the fee rates for
FY 2016.
FOR FURTHER INFORMATION CONTACT:
Rachel Richter, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14216, Silver Spring, MD 20993–
0002, 301–796–7111.
SUPPLEMENTARY INFORMATION:
of applications and supplements for
human generic drug products; (3)
certain facilities where APIs and FDFs
are produced; and (4) certain DMFs
associated with human generic drug
products (see section 744B(a)(1)–(4) of
the FD&C Act).
For FY 2016, the generic drug fee
rates are: ANDA ($76,030), PAS
($38,020), DMF ($42,170), domestic API
facility ($40,867), foreign API facility
($55,867), domestic FDF facility
($243,905), and foreign FDF facility
($258,905). These fees are effective on
October 1, 2015, and will remain in
effect through September 30, 2016.
Fees for ANDA, PAS, and DMF will
increase in FY 2016 over the
corresponding fees in FY 2015 due to a
drop in the number of submissions in
each of those three categories over the
course of FY 2015. The fees for all types
of facilities will decrease in FY 2016
over the corresponding fees in FY 2015
due to an increase in the number of
facilities that self-identified for FY 2016.
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j–41 and 379j–42)
establish fees associated with human
generic drug products. Fees are assessed
on: (1) Certain applications in the
backlog as of October 1, 2012 (only
applicable to FY 2013); (2) certain types
II. Fee Revenue Amount for FY 2016
The base revenue amount for FY 2016
is $299 million, as set in the statute
prior to the inflation adjustment.
GDUFA directs FDA to use the yearly
revenue amount as a starting point to set
the fee rates for each fee type. For more
information about GDUFA, please refer
to the FDA Web site (https://
www.fda.gov/gdufa). The ANDA, PAS,
DMF, API facility, and FDF facility fee
calculations for FY 2016 are described
in this document.
Inflation Adjustment
GDUFA specifies that the $299
million is to be adjusted for inflation
increases for FY 2016 using two
separate adjustments—one for personnel
compensation and benefits (PC&B) and
one for non-PC&B costs (see section
744B(c)(1) of the FD&C Act).
The component of the inflation
adjustment for PC&B costs shall be one
plus the average annual percent change
in the cost of all PC&B paid per full-time
equivalent position (FTE) at FDA for the
first three of the four preceding fiscal
years, multiplied by the proportion of
PC&B costs to total FDA costs of the
review of human generic drug activities
for the first three of the preceding four
fiscal years (see section 744B(c)(1)(A)–
(B) of the FD&C Act).
Table 1 summarizes the actual cost
and total FTE for the specified fiscal
years, and provides the percent change
from the previous fiscal year and the
average percent change over the first
three of the four fiscal years preceding
FY 2016. The 3-year average is 2.2328
percent.
TABLE 1—FDA PERSONNEL COMPENSATION AND BENEFITS (PC&B) EACH YEAR AND PERCENT CHANGE
Fiscal year
2012
The statute specifies that this 2.2328
percent should be multiplied by the
proportion of PC&B expended for
human generic drug activities for the
first three of the preceding four fiscal
years. When FDA set fees in FY 2014,
2014
$1,824,703,000
13,382
$136,355
3.1843%
Total PC&B ......................................
Total FTE .........................................
PC&B per FTE .................................
% Change from Previous Year ........
2013
$1,927,703,000
13,974
$137,949
1.1690%
$2,054,937,000
14,555
$141,184
2.3451%
the 3-year average of PC&B costs for the
entire Agency was used because
information for GDUFA was not
available. Now that the first 2 years of
GDUFA have been completed, FDA will
use the data from FY 2013 and FY 2014
3-Year average
2.2328%
to calculate the PC&B and non-PC&B
proportions. Table 2 shows the amount
of PC&B and the total amount obligated
for human generic drug activities in FY
2013 and FY 2014.
TABLE 2—PC&B AS A PERCENT OF FEE REVENUES SPENT ON THE PROCESS OF HUMAN GENERIC DRUG APPLICATIONS
OVER THE LAST 3 YEARS
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Fiscal year
2012
PC&B ...........................................................
Non-PC&B ...................................................
Total Costs ...................................................
PC&B percent ..............................................
Non-PC&B percent ......................................
NA ......................
NA ......................
NA ......................
............................
............................
The payroll adjustment is 2.2328
percent multiplied by 44.1952 percent
(or 0.9868 percent).
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2013
2014
$117,576,760
$149,307,336
$266,884,096
44.0554%
55.9446%
The statute specifies that the portion
of the inflation adjustment for nonPC&B costs for FY 2016 is the average
annual percent change that occurred in
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$171,612,147
$215,469,133
$387,081,279
44.3349%
55.6651%
3-Year Average
44.1952%
55.8048%
the Consumer Price Index (CPI) for
urban consumers (WashingtonBaltimore, DC–MD–VA–WV; not
seasonally adjusted; all items; annual
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index) for the first three of the preceding
four years of available data multiplied
by the proportion of all costs other than
PC&B costs to total costs of human
generic drug activities (see section
744B(c)(1)(C) of the FD&C Act). Table 3
provides the summary data for the
percent change in the specified CPI for
the Baltimore-Washington area. The
data are published by the Bureau of
Labor Statistics and can be found on
their Web site at https://data.bls.gov/cgi-
bin/surveymost?cu by checking the box
marked ‘‘Washington-Baltimore All
Items, November 1996=100—
CUURA311SA0’’ and then clicking on
the ‘‘Retrieve Data’’ button.
TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR BALTIMORE-WASHINGTON AREA
Year
2012
Annual CPI .......................................
Annual Percent Change ..................
150.212
2.2024%
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To calculate the inflation adjustment
for non-pay costs, we multiply the 3year average percent change in the CPI
(1.7549 percent) by the proportion of all
costs other than PC&B to total costs of
human generic drug activities obligated.
Since 44.1952 percent was obligated for
PC&B as shown in table 2, 55.8048
percent is the portion of costs other than
PC&B. The non-pay adjustment is
1.7549 percent times 55.8048 percent, or
0.9793 percent.
To complete the inflation adjustment
for FY 2016, we add the PC&B
component (0.9868 percent) to the nonPC&B component (0.9793 percent) for a
total inflation adjustment of 1.9661
percent (rounded) for FY 2016.
GDUFA provides for this inflation
adjustment to be compounded after FY
2013 (see section 744B(c)(1) of the FD&
C Act). This factor for FY 2016 (1.9661
percent) is compounded by adding one
to it, and then multiplying it by the
compounded inflation adjustment factor
for FY 2015 (1.044228), as published in
the Federal Register of August 1, 2014
(79 FR 44797). The result of this
multiplication of the inflation factors for
the 3 years since FY 2013 (1.019661
times 1.044228 percent) becomes the
inflation adjustment for FY 2016. For
FY 2016, the inflation adjustment is
6.4759 percent (rounded). We then add
one, making 1.064759. Finally, we
multiply the FY 2016 base revenue
amount ($299 million) by 1.064759,
yielding inflation-adjusted target
revenue of $318,363,000 (rounded to the
nearest thousand dollars).
III. ANDA and PAS Fees
Under GDUFA, the FY 2016 ANDA
and PAS fees are owed by each
applicant that submits an ANDA or a
PAS, on or after October 1, 2015. These
fees are due on the receipt date of the
ANDA or PAS. Section 744B(b)(2)(B)
specifies that the ANDA and PAS fees
will make up 24 percent of the
$318,363,000, which is $76,407,000
(rounded to the nearest thousand
dollars), and further specifies that the
PAS fee is equal to half the ANDA fee.
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2013
2014
152.500
1.5232%
In order to calculate the ANDA fee,
FDA estimated the number of full
application equivalents (FAEs) that will
be submitted in FY 2016. This is done
by assuming ANDAs count as one FAE
and PASs (supplements) count as onehalf an FAE since the fee for a PAS is
one half of the fee for an ANDA. GDUFA
also requires, however, that 75 percent
of the fee paid for an ANDA or PAS
filing fee be refunded if the ANDA or
PAS is refused due to issues other than
failure to pay fees (section 744B(a)(3)(D)
of the FD&C Act). Therefore, an ANDA
or PAS that is considered not to have
been received by the Secretary due to
reasons other than failure to pay fees
counts as one-fourth of an FAE if the
applicant initially paid a full
application fee, or one-eighth of an FAE
if the applicant paid the supplement fee
(one half of the full application fee
amount).
FDA utilized data from ANDAs and
PASs submitted from October 1, 2012,
to May 31, 2015, to estimate the number
of new original ANDAs and PASs that
will incur filing fees in FY 2016. For FY
2016, the Agency estimates that
approximately 801 new original ANDAs
and 421 PASs will be submitted and
incur filing fees. Not all of the new
original ANDAs and PASs will be
received by the Agency, and some of
those not received will be resubmitted
in the same fiscal year. Therefore, the
Agency expects that the FAE count for
ANDAs and PASs will be 1,005 for FY
2016.
The FY 2016 application fee is
estimated by dividing the number of
FAEs that will pay the fee in FY 2016
(1,005) into the fee revenue amount to
be derived from application fees in FY
2016 ($76,407,000). The result, rounded
to the nearest $10, is a fee of $76,030 per
ANDA. The PAS fee is one-half that
amount, or $38,020, rounded to the
nearest $10.
The statute provides that those
ANDAs that include information about
the production of active pharmaceutical
ingredients other than by reference to a
DMF will pay an additional fee that is
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3-Year average
154.847
1.5390%
........................................
1.754867%
based on the number of such active
pharmaceutical ingredients and the
number of facilities proposed to
produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA
considers that this additional fee is
unlikely to be assessed often; therefore,
FDA has not included projections
concerning the amount of this fee in
calculating the fees for ANDAs and
PASs.
IV. DMF Fee
Under GDUFA, the DMF fee is owed
by each person that owns a type II active
pharmaceutical ingredient DMF that is
referenced, on or after October 1, 2012,
in a generic drug submission by an
initial letter of authorization. This is a
one-time fee for each individual DMF.
This fee is due no later than the date on
which the first generic drug submission
is submitted that references the
associated DMF. Under section
744B(a)(2)(D)(iii) of the FD&C Act, if a
DMF has successfully undergone an
initial completeness assessment and the
fee is paid, the DMF will be placed on
a publicly available list documenting
DMFs available for reference. Thus,
some DMF holders may choose to pay
the fee prior to the date that it would
otherwise be due in order to have the
DMF placed on that list.
In order to calculate the DMF fee,
FDA assessed the volume of DMF
submissions over time. The statistical
forecasting methodology of power
regression analysis was selected because
this model showed a very good fit to the
distribution of DMF submissions over
time. Based on data representing the
total paid DMFs from October 2012 to
May 2015 and projecting a 5-year
timeline (October 2012 to September
2017), FDA is estimating 453 fee-paying
DMFs for FY 2016.
The FY 2016 DMF fee is determined
by dividing the DMF target revenue by
the estimated number of fee-paying
DMFs in FY 2016. Section 744B(b)(2)(A)
specifies that the DMF fees will make
up 6 percent of the $318,363,000, which
is $19,102,000 (rounded up to the
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nearest thousand dollars). Dividing the
DMF revenue amount ($19,102,000) by
the estimated fee-paying DMFs (453),
and rounding to the nearest $10, yields
a DMF fee of $42,170 for FY 2016.
V. Foreign Facility Fee Differential
Under GDUFA, the fee for a facility
located outside the United States and its
territories and possessions shall be not
less than $15,000 and not more than
$30,000 higher than the amount of the
fee for a facility located in the United
States and its territories and
possessions, as determined by the
Secretary. The basis for this differential
is the extra cost incurred by conducting
an inspection outside the United States
and its territories and possessions. For
FY 2016, FDA has determined that the
differential for foreign facilities will be
$15,000. The differential may be
adjusted in future years.
VI. FDF Facility Fee
Under GDUFA, the annual FDF
facility fee is owed by each person that
owns a facility which is identified, or
intended to be identified, in at least one
generic drug submission that is pending
or approved to produce one or more
finished dosage forms of a human
generic drug. These fees are due no later
than the first business day on or after
October 1 of each such year. Section
744B(b)(2)(C) of the FD&C Act specifies
that the FDF facility fee revenue will
make up 56 percent of $318,363,000,
which is $178,283,000 (rounded to the
nearest thousand dollars).
In order to calculate the FDF fee, FDA
used data submitted by generic drug
facilities through the self-identification
process mandated in the GDUFA statute
and specified in a Notice of
Requirement published on October 2,
2012 (77 FR 60125). The total number
of FDF facilities identified through selfidentification was 705. Of the total
facilities identified as FDF, there were
283 domestic facilities and 422 foreign
facilities. The foreign facility fee
differential is $15,000. In order to
calculate the fee for domestic facilities,
we must first subtract the fee revenue
that will result from the foreign facility
fee differential. We take the foreign
facility differential ($15,000) and
multiply it by the number of foreign
facilities (422) to determine the total
fees that will result from the foreign
facility differential. As a result of that
calculation the foreign fee differential
will make up $6,330,000 of the total
FDF fee revenue. Subtracting the foreign
facility differential fee revenue
($6,330,000), from the total FDF facility
target revenue ($178,283,000) results in
a remaining fee revenue balance of
$171,953,000. To determine the
domestic FDF facility fee, we divide the
$171,953,000 by the total number of
facilities (705) which gives us a
domestic FDF facility fee of $243,905.
The foreign FDF facility fee is $15,000
more than the domestic FDF facility fee,
or $258,905.
VII. API Facility Fee
Under GDUFA, the annual API
facility fee is owed by each person that
owns a facility which produces, or
which is pending review to produce,
one or more active pharmaceutical
ingredients identified, or intended to be
identified, in at least one generic drug
submission that is pending or approved
or in a Type II active pharmaceutical
ingredient drug master file referenced in
such generic drug submission. These
fees are due no later than the first
business day on or after October 1 of
each such year. Section 744B(b)(2)(D) of
the FD&C Act specifies that the API
facility fee will make up 14 percent of
$318,363,000 in fee revenue, which is
$44,571,000 (rounded to the nearest
thousand dollars).
In order to calculate the API fee, FDA
used data submitted by generic drug
facilities through the self-identification
process mandated in the GDUFA statute
and specified in a Notice of
Requirement published on October 2,
2012. The total number of API facilities
identified through self-identification
was 826. Of the total facilities identified
as API facilities, there were 105
domestic facilities and 721 foreign
facilities. The foreign facility differential
is $15,000. In order to calculate the fee
for domestic facilities, we must first
subtract the fee revenue that will result
from the foreign facility fee differential.
We take the foreign facility differential
($15,000) and multiply it by the number
of foreign facilities (721) to determine
the total fees that will result from the
foreign facility differential. As a result
of that calculation, the foreign fee
differential will make up $10,815,000 of
the total API fee revenue. Subtracting
the foreign facility differential fee
revenue ($10,815,000) from the total API
facility target revenue ($44,571,000)
results in a remaining balance of
$33,756,000. To determine the domestic
API facility fee, we divide the
$33,756,000 by the total number of
facilities (826) which gives us a
domestic API facility fee of $40,867. The
foreign API facility fee is $15,000 more
than the domestic API facility fee, or
$55,867.
VIII. Fee Schedule for FY 2016
The fee rates for FY 2016 are set out
in table 4.
TABLE 4—FEE SCHEDULE FOR FY 2016
Fee rates for FY
2016
Fee category
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Applications:
Abbreviated New Drug Application (ANDA) ...........................................................................................................................
Prior Approval Supplement (PAS) to an ANDA .....................................................................................................................
Drug Master File (DMF) .................................................................................................................................................................
Facilities:
Active Pharmaceutical Ingredient (API)—Domestic ...............................................................................................................
API—Foreign ..........................................................................................................................................................................
Finished Dosage Form (FDF)—Domestic ..............................................................................................................................
FDF—Foreign .........................................................................................................................................................................
IX. Fee Payment Options and
Procedures
The new fee rates are effective
October 1, 2015. To pay the ANDA,
PAS, DMF, API facility, and FDF facility
fee, you must complete a Generic Drug
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User Fee Cover Sheet, available at
https://www.fda.gov/gdufa, and generate
a user fee identification (ID) number.
Payment must be made in U.S. currency
drawn on a U.S. bank by electronic
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$76,030
38,020
42,170
40,867
55,867
243,905
258,905
check, check, bank draft, U.S. postal
money order, or wire transfer.
FDA has partnered with the U.S.
Department of the Treasury to utilize
Pay.gov, a Web-based payment
application, for online electronic
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payment. The Pay.gov feature is
available on the FDA Web site after
completing the Generic Drug User Fee
Cover Sheet and generating the user fee
ID number.
Please include the user fee ID number
on your check, bank draft, or postal
money order and make payable to the
order of the Food and Drug
Administration. Your payment can be
mailed to: Food and Drug
Administration, P.O. Box 979108, St.
Louis, MO 63197–9000. If checks are to
be sent by a courier that requests a street
address, the courier can deliver checks
to: U.S. Bank, Attention: Government
Lockbox 979108, 1005 Convention
Plaza, St. Louis, MO 63101. (Note: This
U.S. Bank address is for courier delivery
only.) Please make sure that the FDA
post office box number (P.O. Box
979108) is written on the check, bank
draft, or postal money order.
If paying by wire transfer, please
reference your unique user fee ID
number when completing your transfer.
The originating financial institution
may charge a wire transfer fee. Please
ask your financial institution about the
wire transfer fee and include it with
your payment to ensure that your fee is
fully paid. The account information is
as follows: New York Federal Reserve
Bank, U.S. Department of Treasury,
TREAS NYC, 33 Liberty St., New York,
NY 10045, account number: 75060099,
routing number: 021030004, SWIFT:
FRNYUS33, Beneficiary: FDA, 8455
Colesville Rd., Silver Spring, MD
20993–0002. The tax identification
number of FDA is 53–0196965.
Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–18915 Filed 7–31–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–1997–D–0187]
Dissolution Testing and Specification
Criteria for Immediate-Release Solid
Oral Dosage Forms Containing
Biopharmaceutics Classification
System Class 1 and 3 Drugs; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
SUMMARY:
VerDate Sep<11>2014
18:35 Jul 31, 2015
Jkt 235001
guidance for industry entitled
‘‘Dissolution Testing and Specification
Criteria for Immediate-Release Solid
Oral Dosage Forms Containing
Biopharmaceutics Classification System
Class 1 and 3 Drugs.’’ This draft
guidance has been developed to provide
manufacturers with recommendations
for submission of new drug applications
(NDAs), investigational new drug
applications (INDs), and/or abbreviated
new drug applications (ANDAs), as
appropriate, for immediate-release (IR)
tablets and capsules that contain highly
soluble drug substances. The draft
guidance is intended to define when a
standard release test and criteria may be
used in lieu of extensive method
development and specification-setting
exercises. When final, this guidance will
supersede the guidance for industry on
‘‘Dissolution Testing of Immediate
Release Solid Oral Dosage Forms’’
(August 1997) for biopharmaceutics
classification system (BCS) class 1 and
3 drug substances that meet the criteria
in this draft guidance. For class 2 and
4 drug substances, applicants should
still refer to the August 1997 guidance
mentioned previously.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 2,
2015.
DATES:
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Richard Lostritto, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Avenue, Silver Spring, MD
20993, 301–796–1667.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
46019
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Dissolution Testing and Specification
Criteria for Immediate-Release Solid
Oral Dosage Forms Containing
Biopharmaceutics Classification System
Class 1 and 3 Drugs.’’ Drug absorption
from a solid dosage form after oral
administration depends on the release
of the drug substance from the drug
product, the dissolution or
solubilization of the drug under
physiological conditions, and the
permeation across the gastrointestinal
membrane. NDAs and ANDAs
submitted to FDA contain
bioavailability (BA) or bioequivalence
(BE) data and in vitro dissolution data
that, together with chemistry,
manufacturing, and controls (CMC)
data, characterize the quality and
performance of the drug product. In
vitro dissolution data are generally
obtained from batches that have been
used in pivotal clinical and/or
bioavailability studies and from other
human studies conducted during
product development. Knowledge about
the solubility, permeability, dissolution,
and pharmacokinetics of a drug product
is considered when defining dissolution
test specifications for the drug approval
process.
The BCS is a scientific framework for
classifying drug substances based on
their aqueous solubility and intestinal
permeability. The definitions of high
and low solubility and high and low
permeability are used as described in
FDA’s Biopharmaceutics Classification
System (BCS) Guidance. The different
classifications are:
Class 1: High Solubility—High
Permeability Drugs
Class 2: Low Solubility—High
Permeability Drugs
Class 3: High Solubility—Low
Permeability Drugs
Class 4: Low Solubility—Low
Permeability Drugs
This classification can be used as a
basis for determining when in vivo
bioavailability and bioequivalence
studies are needed and can be used to
determine when a successful in vivo-in
vitro correlation (IVIVC) is likely. The
BCS suggests that, for certain high
solubility drugs, dissolution testing can
be standardized or may not be needed.
Owing to their high solubility, BCS class
1 and 3 drugs are considered to be
relatively low risk regarding the impact
of dissolution on performance, provided
the in vitro performance meets or
exceeds the recommendations discussed
in the guidance.
E:\FR\FM\03AUN1.SGM
03AUN1
Agencies
[Federal Register Volume 80, Number 148 (Monday, August 3, 2015)]
[Notices]
[Pages 46015-46019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18915]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0007]
Generic Drug User Fee--Abbreviated New Drug Application, Prior
Approval Supplement, Drug Master File, Final Dosage Form Facility, and
Active Pharmaceutical Ingredient Facility Fee Rates for Fiscal Year
2016
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the rates
for abbreviated new drug applications (ANDAs), prior approval
supplements to an approved ANDA (PASs), drug master files (DMFs),
[[Page 46016]]
generic drug active pharmaceutical ingredient (API) facilities, and
finished dosage form (FDF) facilities user fees related to the Generic
Drug User Fee Program for fiscal year (FY) 2016. The Federal Food,
Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug
User Fee Amendments of 2012 (GDUFA), authorizes FDA to assess and
collect user fees for certain applications and supplements for human
generic drug products, on applications in the backlog as of October 1,
2012 (only applicable to FY 2013), on FDF and API facilities, and on
type II active pharmaceutical ingredient DMFs to be made available for
reference. This document establishes the fee rates for FY 2016.
FOR FURTHER INFORMATION CONTACT: Rachel Richter, Office of Financial
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14216, Silver Spring, MD 20993-0002, 301-796-7111.
SUPPLEMENTARY INFORMATION:
I. Background
Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42) establish fees associated with human generic drug products. Fees
are assessed on: (1) Certain applications in the backlog as of October
1, 2012 (only applicable to FY 2013); (2) certain types of applications
and supplements for human generic drug products; (3) certain facilities
where APIs and FDFs are produced; and (4) certain DMFs associated with
human generic drug products (see section 744B(a)(1)-(4) of the FD&C
Act).
For FY 2016, the generic drug fee rates are: ANDA ($76,030), PAS
($38,020), DMF ($42,170), domestic API facility ($40,867), foreign API
facility ($55,867), domestic FDF facility ($243,905), and foreign FDF
facility ($258,905). These fees are effective on October 1, 2015, and
will remain in effect through September 30, 2016.
Fees for ANDA, PAS, and DMF will increase in FY 2016 over the
corresponding fees in FY 2015 due to a drop in the number of
submissions in each of those three categories over the course of FY
2015. The fees for all types of facilities will decrease in FY 2016
over the corresponding fees in FY 2015 due to an increase in the number
of facilities that self-identified for FY 2016.
II. Fee Revenue Amount for FY 2016
The base revenue amount for FY 2016 is $299 million, as set in the
statute prior to the inflation adjustment. GDUFA directs FDA to use the
yearly revenue amount as a starting point to set the fee rates for each
fee type. For more information about GDUFA, please refer to the FDA Web
site (https://www.fda.gov/gdufa). The ANDA, PAS, DMF, API facility, and
FDF facility fee calculations for FY 2016 are described in this
document.
Inflation Adjustment
GDUFA specifies that the $299 million is to be adjusted for
inflation increases for FY 2016 using two separate adjustments--one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see section 744B(c)(1) of the FD&C Act).
The component of the inflation adjustment for PC&B costs shall be
one plus the average annual percent change in the cost of all PC&B paid
per full-time equivalent position (FTE) at FDA for the first three of
the four preceding fiscal years, multiplied by the proportion of PC&B
costs to total FDA costs of the review of human generic drug activities
for the first three of the preceding four fiscal years (see section
744B(c)(1)(A)-(B) of the FD&C Act).
Table 1 summarizes the actual cost and total FTE for the specified
fiscal years, and provides the percent change from the previous fiscal
year and the average percent change over the first three of the four
fiscal years preceding FY 2016. The 3-year average is 2.2328 percent.
Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2012 2013 2014 3-Year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B.......................................... $1,824,703,000 $1,927,703,000 $2,054,937,000
Total FTE........................................... 13,382 13,974 14,555
PC&B per FTE........................................ $136,355 $137,949 $141,184
% Change from Previous Year......................... 3.1843% 1.1690% 2.3451% 2.2328%
--------------------------------------------------------------------------------------------------------------------------------------------------------
The statute specifies that this 2.2328 percent should be multiplied
by the proportion of PC&B expended for human generic drug activities
for the first three of the preceding four fiscal years. When FDA set
fees in FY 2014, the 3-year average of PC&B costs for the entire Agency
was used because information for GDUFA was not available. Now that the
first 2 years of GDUFA have been completed, FDA will use the data from
FY 2013 and FY 2014 to calculate the PC&B and non-PC&B proportions.
Table 2 shows the amount of PC&B and the total amount obligated for
human generic drug activities in FY 2013 and FY 2014.
Table 2--PC&B as a Percent of Fee Revenues Spent on the Process of Human Generic Drug Applications Over the Last 3 Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2012 2013 2014 3-Year Average
--------------------------------------------------------------------------------------------------------------------------------------------------------
PC&B........................................ NA............................. $117,576,760 $171,612,147
Non-PC&B.................................... NA............................. $149,307,336 $215,469,133
Total Costs................................. NA............................. $266,884,096 $387,081,279
PC&B percent................................ ............................... 44.0554% 44.3349% 44.1952%
Non-PC&B percent............................ ............................... 55.9446% 55.6651% 55.8048%
--------------------------------------------------------------------------------------------------------------------------------------------------------
The payroll adjustment is 2.2328 percent multiplied by 44.1952
percent (or 0.9868 percent).
The statute specifies that the portion of the inflation adjustment
for non-PC&B costs for FY 2016 is the average annual percent change
that occurred in the Consumer Price Index (CPI) for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items;
annual
[[Page 46017]]
index) for the first three of the preceding four years of available
data multiplied by the proportion of all costs other than PC&B costs to
total costs of human generic drug activities (see section 744B(c)(1)(C)
of the FD&C Act). Table 3 provides the summary data for the percent
change in the specified CPI for the Baltimore-Washington area. The data
are published by the Bureau of Labor Statistics and can be found on
their Web site at https://data.bls.gov/cgi-bin/surveymost?cu by checking
the box marked ``Washington-Baltimore All Items, November 1996=100--
CUURA311SA0'' and then clicking on the ``Retrieve Data'' button.
Table 3--Annual and 3-Year Average Percent Change in CPI for Baltimore-Washington Area
--------------------------------------------------------------------------------------------------------------------------------------------------------
Year 2012 2013 2014 3-Year average
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annual CPI.......................................... 150.212 152.500 154.847 .......................
Annual Percent Change............................... 2.2024% 1.5232% 1.5390% 1.754867%
--------------------------------------------------------------------------------------------------------------------------------------------------------
To calculate the inflation adjustment for non-pay costs, we
multiply the 3-year average percent change in the CPI (1.7549 percent)
by the proportion of all costs other than PC&B to total costs of human
generic drug activities obligated. Since 44.1952 percent was obligated
for PC&B as shown in table 2, 55.8048 percent is the portion of costs
other than PC&B. The non-pay adjustment is 1.7549 percent times 55.8048
percent, or 0.9793 percent.
To complete the inflation adjustment for FY 2016, we add the PC&B
component (0.9868 percent) to the non-PC&B component (0.9793 percent)
for a total inflation adjustment of 1.9661 percent (rounded) for FY
2016.
GDUFA provides for this inflation adjustment to be compounded after
FY 2013 (see section 744B(c)(1) of the FD& C Act). This factor for FY
2016 (1.9661 percent) is compounded by adding one to it, and then
multiplying it by the compounded inflation adjustment factor for FY
2015 (1.044228), as published in the Federal Register of August 1, 2014
(79 FR 44797). The result of this multiplication of the inflation
factors for the 3 years since FY 2013 (1.019661 times 1.044228 percent)
becomes the inflation adjustment for FY 2016. For FY 2016, the
inflation adjustment is 6.4759 percent (rounded). We then add one,
making 1.064759. Finally, we multiply the FY 2016 base revenue amount
($299 million) by 1.064759, yielding inflation-adjusted target revenue
of $318,363,000 (rounded to the nearest thousand dollars).
III. ANDA and PAS Fees
Under GDUFA, the FY 2016 ANDA and PAS fees are owed by each
applicant that submits an ANDA or a PAS, on or after October 1, 2015.
These fees are due on the receipt date of the ANDA or PAS. Section
744B(b)(2)(B) specifies that the ANDA and PAS fees will make up 24
percent of the $318,363,000, which is $76,407,000 (rounded to the
nearest thousand dollars), and further specifies that the PAS fee is
equal to half the ANDA fee.
In order to calculate the ANDA fee, FDA estimated the number of
full application equivalents (FAEs) that will be submitted in FY 2016.
This is done by assuming ANDAs count as one FAE and PASs (supplements)
count as one-half an FAE since the fee for a PAS is one half of the fee
for an ANDA. GDUFA also requires, however, that 75 percent of the fee
paid for an ANDA or PAS filing fee be refunded if the ANDA or PAS is
refused due to issues other than failure to pay fees (section
744B(a)(3)(D) of the FD&C Act). Therefore, an ANDA or PAS that is
considered not to have been received by the Secretary due to reasons
other than failure to pay fees counts as one-fourth of an FAE if the
applicant initially paid a full application fee, or one-eighth of an
FAE if the applicant paid the supplement fee (one half of the full
application fee amount).
FDA utilized data from ANDAs and PASs submitted from October 1,
2012, to May 31, 2015, to estimate the number of new original ANDAs and
PASs that will incur filing fees in FY 2016. For FY 2016, the Agency
estimates that approximately 801 new original ANDAs and 421 PASs will
be submitted and incur filing fees. Not all of the new original ANDAs
and PASs will be received by the Agency, and some of those not received
will be resubmitted in the same fiscal year. Therefore, the Agency
expects that the FAE count for ANDAs and PASs will be 1,005 for FY
2016.
The FY 2016 application fee is estimated by dividing the number of
FAEs that will pay the fee in FY 2016 (1,005) into the fee revenue
amount to be derived from application fees in FY 2016 ($76,407,000).
The result, rounded to the nearest $10, is a fee of $76,030 per ANDA.
The PAS fee is one-half that amount, or $38,020, rounded to the nearest
$10.
The statute provides that those ANDAs that include information
about the production of active pharmaceutical ingredients other than by
reference to a DMF will pay an additional fee that is based on the
number of such active pharmaceutical ingredients and the number of
facilities proposed to produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA considers that this additional fee
is unlikely to be assessed often; therefore, FDA has not included
projections concerning the amount of this fee in calculating the fees
for ANDAs and PASs.
IV. DMF Fee
Under GDUFA, the DMF fee is owed by each person that owns a type II
active pharmaceutical ingredient DMF that is referenced, on or after
October 1, 2012, in a generic drug submission by an initial letter of
authorization. This is a one-time fee for each individual DMF. This fee
is due no later than the date on which the first generic drug
submission is submitted that references the associated DMF. Under
section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has successfully
undergone an initial completeness assessment and the fee is paid, the
DMF will be placed on a publicly available list documenting DMFs
available for reference. Thus, some DMF holders may choose to pay the
fee prior to the date that it would otherwise be due in order to have
the DMF placed on that list.
In order to calculate the DMF fee, FDA assessed the volume of DMF
submissions over time. The statistical forecasting methodology of power
regression analysis was selected because this model showed a very good
fit to the distribution of DMF submissions over time. Based on data
representing the total paid DMFs from October 2012 to May 2015 and
projecting a 5-year timeline (October 2012 to September 2017), FDA is
estimating 453 fee-paying DMFs for FY 2016.
The FY 2016 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2016. Section
744B(b)(2)(A) specifies that the DMF fees will make up 6 percent of the
$318,363,000, which is $19,102,000 (rounded up to the
[[Page 46018]]
nearest thousand dollars). Dividing the DMF revenue amount
($19,102,000) by the estimated fee-paying DMFs (453), and rounding to
the nearest $10, yields a DMF fee of $42,170 for FY 2016.
V. Foreign Facility Fee Differential
Under GDUFA, the fee for a facility located outside the United
States and its territories and possessions shall be not less than
$15,000 and not more than $30,000 higher than the amount of the fee for
a facility located in the United States and its territories and
possessions, as determined by the Secretary. The basis for this
differential is the extra cost incurred by conducting an inspection
outside the United States and its territories and possessions. For FY
2016, FDA has determined that the differential for foreign facilities
will be $15,000. The differential may be adjusted in future years.
VI. FDF Facility Fee
Under GDUFA, the annual FDF facility fee is owed by each person
that owns a facility which is identified, or intended to be identified,
in at least one generic drug submission that is pending or approved to
produce one or more finished dosage forms of a human generic drug.
These fees are due no later than the first business day on or after
October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act
specifies that the FDF facility fee revenue will make up 56 percent of
$318,363,000, which is $178,283,000 (rounded to the nearest thousand
dollars).
In order to calculate the FDF fee, FDA used data submitted by
generic drug facilities through the self-identification process
mandated in the GDUFA statute and specified in a Notice of Requirement
published on October 2, 2012 (77 FR 60125). The total number of FDF
facilities identified through self-identification was 705. Of the total
facilities identified as FDF, there were 283 domestic facilities and
422 foreign facilities. The foreign facility fee differential is
$15,000. In order to calculate the fee for domestic facilities, we must
first subtract the fee revenue that will result from the foreign
facility fee differential. We take the foreign facility differential
($15,000) and multiply it by the number of foreign facilities (422) to
determine the total fees that will result from the foreign facility
differential. As a result of that calculation the foreign fee
differential will make up $6,330,000 of the total FDF fee revenue.
Subtracting the foreign facility differential fee revenue ($6,330,000),
from the total FDF facility target revenue ($178,283,000) results in a
remaining fee revenue balance of $171,953,000. To determine the
domestic FDF facility fee, we divide the $171,953,000 by the total
number of facilities (705) which gives us a domestic FDF facility fee
of $243,905. The foreign FDF facility fee is $15,000 more than the
domestic FDF facility fee, or $258,905.
VII. API Facility Fee
Under GDUFA, the annual API facility fee is owed by each person
that owns a facility which produces, or which is pending review to
produce, one or more active pharmaceutical ingredients identified, or
intended to be identified, in at least one generic drug submission that
is pending or approved or in a Type II active pharmaceutical ingredient
drug master file referenced in such generic drug submission. These fees
are due no later than the first business day on or after October 1 of
each such year. Section 744B(b)(2)(D) of the FD&C Act specifies that
the API facility fee will make up 14 percent of $318,363,000 in fee
revenue, which is $44,571,000 (rounded to the nearest thousand
dollars).
In order to calculate the API fee, FDA used data submitted by
generic drug facilities through the self-identification process
mandated in the GDUFA statute and specified in a Notice of Requirement
published on October 2, 2012. The total number of API facilities
identified through self-identification was 826. Of the total facilities
identified as API facilities, there were 105 domestic facilities and
721 foreign facilities. The foreign facility differential is $15,000.
In order to calculate the fee for domestic facilities, we must first
subtract the fee revenue that will result from the foreign facility fee
differential. We take the foreign facility differential ($15,000) and
multiply it by the number of foreign facilities (721) to determine the
total fees that will result from the foreign facility differential. As
a result of that calculation, the foreign fee differential will make up
$10,815,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($10,815,000) from the total API
facility target revenue ($44,571,000) results in a remaining balance of
$33,756,000. To determine the domestic API facility fee, we divide the
$33,756,000 by the total number of facilities (826) which gives us a
domestic API facility fee of $40,867. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $55,867.
VIII. Fee Schedule for FY 2016
The fee rates for FY 2016 are set out in table 4.
Table 4--Fee Schedule for FY 2016
------------------------------------------------------------------------
Fee rates for FY
Fee category 2016
------------------------------------------------------------------------
Applications:
Abbreviated New Drug Application (ANDA).......... $76,030
Prior Approval Supplement (PAS) to an ANDA....... 38,020
Drug Master File (DMF)............................... 42,170
Facilities:
Active Pharmaceutical Ingredient (API)--Domestic. 40,867
API--Foreign..................................... 55,867
Finished Dosage Form (FDF)--Domestic............. 243,905
FDF--Foreign..................................... 258,905
------------------------------------------------------------------------
IX. Fee Payment Options and Procedures
The new fee rates are effective October 1, 2015. To pay the ANDA,
PAS, DMF, API facility, and FDF facility fee, you must complete a
Generic Drug User Fee Cover Sheet, available at https://www.fda.gov/gdufa, and generate a user fee identification (ID) number. Payment must
be made in U.S. currency drawn on a U.S. bank by electronic check,
check, bank draft, U.S. postal money order, or wire transfer.
FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a Web-based payment application, for online electronic
[[Page 46019]]
payment. The Pay.gov feature is available on the FDA Web site after
completing the Generic Drug User Fee Cover Sheet and generating the
user fee ID number.
Please include the user fee ID number on your check, bank draft, or
postal money order and make payable to the order of the Food and Drug
Administration. Your payment can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks
are to be sent by a courier that requests a street address, the courier
can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only.) Please make sure that the FDA
post office box number (P.O. Box 979108) is written on the check, bank
draft, or postal money order.
If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. The originating financial
institution may charge a wire transfer fee. Please ask your financial
institution about the wire transfer fee and include it with your
payment to ensure that your fee is fully paid. The account information
is as follows: New York Federal Reserve Bank, U.S. Department of
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, account
number: 75060099, routing number: 021030004, SWIFT: FRNYUS33,
Beneficiary: FDA, 8455 Colesville Rd., Silver Spring, MD 20993-0002.
The tax identification number of FDA is 53-0196965.
Dated: July 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18915 Filed 7-31-15; 8:45 am]
BILLING CODE 4164-01-P