
[Federal Register Volume 78, Number 149 (Friday, August 2, 2013)]
[Notices]
[Pages 46977-46980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-18625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-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 
2014

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the rate 
for the abbreviated new drug application (ANDA), prior approval 
supplement to an approved ANDA (PAS), drug master file (DMF), generic 
drug active pharmaceutical ingredient (API), and finished dosage form 
(FDF) facilities user fees related to the Generic Drug User Fee Program 
for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act 
(the FD&C Act), as amended by the Generic Drug User Fee Amendments of 
2012 (GDUFA), as

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further amended by the FDA User Fee Correction Act of 2012, 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. GDUFA directs FDA to establish each 
year the Generic Drug User Fee rates for the upcoming year, and publish 
those rates in the Federal Register 60 days before the start of the 
upcoming FY. This document establishes FY 2014 rates for an ANDA 
($63,860), PAS ($31,930), DMF ($31,460), domestic API facility 
($34,515), foreign API facility ($49,515), domestic FDF facility 
($220,152), and foreign FDF facility ($235,152). These fees are 
effective on October 1, 2013, and will remain in effect through 
September 30, 2014.

FOR FURTHER INFORMATION CONTACT: David Miller, Office of Financial 
Management (HFA-100), Food and Drug Administration, 1350 Piccard Dr., 
PI50, Rm. 210J, Rockville, MD 20850, 301-796-7103.

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 (section 744B(a) of the FD&C Act).

II. Fee Revenue Amount for FY 2014

    The base revenue amount for FY 2014 is $299,000,000, 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 (http://www.fda.gov/gdufa). The ANDA, PAS, DMF, API facility, and 
FDF facility fee calculations for FY 2014 are described in this 
document.

Inflation Adjustment

    GDUFA specifies that the $299,000,000 is to be further adjusted for 
inflation increases for FY 2014 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 3 of the 4 
preceding FYs, multiplied by the proportion of PC&B costs to total FDA 
costs of the review of human generic drug activities for the first 3 of 
the preceding 4 FYs (see section 744B(c)(1)(B) of the FD&C Act). The 
data on total PC&B paid and numbers of FTE paid, from which the average 
cost per FTE can be derived, are published in FDA's Justification of 
Estimates for Appropriations Committees.
    Table 1 of this document summarizes the actual cost and total FTE 
for the specified FYs, and provides the percent change from the 
previous FY and the average percent change over the first 3 of the 4 
FYs preceding FY 2014. The 3-year average is 2.05 percent.


              Table 1--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
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             Fiscal year                     2010               2011               2012          3-Year average
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Total PC&B..........................     $1,634,108,000     $1,761,655,000     $1,824,703,000  .................
Total FTE...........................             12,526             13,331             13,382  .................
PC&B per FTE........................           $130,457           $132,147           $136,355  .................
% Change from Previous Year.........              1.67%              1.30%              3.18%              2.05%
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    The statute specifies that this 2.05 percent should be multiplied 
by the proportion of PC&B expended for the review of human generic drug 
activities. Since the first year of the Generic Drug User Fee Program 
has not been completed and those costs are not yet available, costs for 
the entire Agency will be used. Table 2 of this document shows the 
total amount of expenditures made by FDA broken down by PC&B and Non-
PC&B for FYs 2010, 2011, and 2012.

           Table 2--PC&B and Non-PC&B as a Percent of Total Expenditures by FDA Over the Last 3 Years
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             Fiscal year                     2010               2011               2012          3-Year average
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PC&B................................     $1,634,108,000     $1,761,655,000     $1,824,703,000  .................
Non-PC&B............................     $1,536,502,000     $1,571,752,000     $1,725,793,000  .................
Total Costs.........................     $3,170,610,000     $3,333,407,000     $3,550,496,000  .................
PC&B percent........................                52%                53%                51%                52%
Non-PC&B percent....................                48%                47%                49%                48%
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    The payroll adjustment is 2.05 percent multiplied by 52 percent (or 
1.066 percent).
    The statute specifies that the portion of the inflation adjustment 
for non-PC&B costs for FY 2014 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 index) for the first 3 of the preceding 4 years of available 
data multiplied by the proportion of all costs of the process for the 
review of human generic drug activities other than PC&B (see section 
744B(c)(1)(C) of the FD&C Act). Table 3 of this document 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 http://
data.bls.gov/cgi-bin/

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surveymost?cu by checking the box marked ``Washington-Baltimore All 
Items, November 1996 = 100 - CUURA311SAO'' and then clicking on the 
``Retrieve Data'' button.

               Table 3--Annual and 3-Year Average Percent Change in Baltimore-Washington Area CPI
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                Year                         2010               2011               2012          3-Year average
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Annual CPI..........................            142.218            146.975            150.212  .................
Annual Percent Change...............              1.72%              3.34%              2.20%              2.42%
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    To calculate the inflation adjustment for non-pay costs, we 
multiply the 2.42 percent by the proportion of costs FDA obligated for 
costs other than PC&B. Since 52 percent was obligated for PC&B as shown 
in table 2 of this document, 48 percent is the portion of costs other 
than PC&B. The non-pay adjustment is 2.42 percent times 48 percent, or 
1.161 percent.
    To complete the inflation adjustment, we add the PC&B component 
(1.066 percent) to the non-PC&B component (1.161 percent) for a total 
inflation adjustment of 2.227 percent (rounded), and then add one, 
making 1.02227. We then multiply the base revenue amount for FY 2014 
($299,000,000) by 1.02227, yielding an inflation adjusted amount of 
$305,659,000 (rounded to the nearest thousand dollars).

III. ANDA and PAS Fees

    Under GDUFA, the FY 2014 ANDA and PAS fees are owed by each 
applicant that submits an ANDA or a PAS, on or after October 1, 2013. 
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 $305,659,000, which is $73,358,000 (rounded to the 
nearest thousand dollars).
    In order to calculate the ANDA fee, FDA estimated the number of 
full application equivalents (FAEs) that will be submitted in FY 2014. 
This is done by estimating the number of ANDAs and PASs that will incur 
the fee in FY 2014 and converting them into FAEs. Applications count as 
one FAE and supplements count as one-half an FAE since the fee for a 
PAS is one half of the fee for an ANDA. However, GDUFA requires that 75 
percent of the fees paid for an ANDA or PAS filing fee be refunded if 
its receipt 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).
    It was determined that approximately 911 ANDAs will incur an ANDA 
filing fee in FY 2014. This number is based on available data from the 
first 8 months of FY 2013 and estimating the last 4 months based on the 
current trend. In contrast to previous non-fee paying FYs, the first 
year of GDUFA implementation saw a significant increase in Changes 
Being Effected (CBE) submissions and a significant decrease in PAS 
submissions. Due to the trend of FY 2013 submissions, FDA utilized 
available FY 2013 data to estimate the number of such supplement 
submissions for FY 2014. The estimated number of PASs to be received in 
FY 2014 is 480, based on an annualized estimate of the number of 
receipts for FY 2013.
    After taking into account estimates of the number of ANDAs and PASs 
that are likely to be refused due to issues other than failure to pay 
fees, and the number that are likely to be resubmitted in the same 
fiscal year, FDA estimates that the total number of fee-paying FAEs 
that will be received in FY 2014 is 1,148.8.
    The FY 2014 application fee is estimated by dividing the number of 
full application equivalents that will pay the fee in FY 2014 (1,148.8) 
into the fee revenue amount to be derived from application fees in FY 
2014 ($73,358,000). The result, rounded to the nearest $10, is a fee of 
$63,860 per ANDA. Section 744B(b)(2)(B) of the FD&C Act states that the 
PAS fee is equal to half the ANDA fee; therefore the PAS fee is 
$31,930.
    We note that 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 the 8 
months of available data representing the total paid DMFs from FY 2013 
and projecting a 5-year timeline (October 2013 to October 2017), FDA is 
estimating 583 fee-paying DMFs for FY 2014.
    The FY 2014 DMF fee is determined by dividing the DMF revenue by 
the estimated number of fee-paying DMFs in FY 2014. Section 
744B(b)(2)(A) specifies that the DMF fees will make up 6 percent of the 
$305,659,000, which is $18,340,000 (rounded to the nearest thousand 
dollars). Dividing the DMF revenue amount ($18,340,000) by the 
estimated fee-paying DMFs (583), and rounding to the nearest $10, 
yields a DMF fee of $31,460 for FY 2014.

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

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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 
2014 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 or an 
active pharmaceutical ingredient used in 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 $305,659,000, 
which is $171,169,000 (rounded to the nearest thousand dollars).
    In order to calculate the FDF fee, FDA has used the 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 FDF facilities 
identified through self-identification was 748. Of the total facilities 
identified as FDF, there were 315 domestic facilities and 433 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 (433) 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 
$6,495,000 of the total FDF fee revenue. Subtracting the foreign 
facility differential fee revenue ($6,495,000) from the total FDF 
facility target revenue ($171,169,000) results in a remaining fee 
revenue balance of $164,674,000. To determine the domestic FDF facility 
fee, we divide the $164,674,000 by the total number of facilities (748) 
which gives us a domestic FDF facility fee of $220,152. The foreign FDF 
facility fee is $15,000 more than the domestic FDF facility fee, or 
$235,152.

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 $305,659,000 in fee 
revenue, which is $42,792,000 (rounded to the nearest thousand 
dollars).
    In order to calculate the API fee, FDA has used the data submitted 
by generic drug facilities through the self-identification process. The 
total number of API facilities identified through self-identification 
was 903. Of the total facilities identified as API, there were 128 
domestic facilities and 775 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 (775) 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 $11,625,000 of the total API 
fee revenue. Subtracting the foreign facility differential fee revenue 
($11,625,000) from the total API facility target revenue ($42,792,000) 
results in a remaining balance of $31,167,000. To determine the 
domestic API facility fee, we divide the $31,167,000 by the total 
number of facilities (903) which gives us a domestic API facility fee 
of $34,515. The foreign API facility fee is $15,000 more than the 
domestic API facility fee, or $49,515.

VIII. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2013. To pay the ANDA, 
PAS, DMF, API facility, and FDF facility fee, you must complete a 
Generic Drug User Fee cover sheet, available at http://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 
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 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, 1350 Piccard Dr., 
Rockville, MD 20850. The tax identification number of FDA is 53-
0196965.

    Dated: July 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18625 Filed 8-1-13; 8:45 am]
BILLING CODE 4160-01-P


