
[Federal Register Volume 77, Number 207 (Thursday, October 25, 2012)]
[Notices]
[Pages 65198-65199]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26256]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0007]


Generic Drug User Fee--Abbreviated New Drug Application, Prior 
Approval Supplement, and Drug Master File Fee Rates for Fiscal Year 
2013

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the rate 
for the Abbreviated New Drug Application (ANDA), Prior Approval 
Supplement (PAS), and Drug Master File (DMF) fees related to the 
Generic Drug User Fee Program for fiscal year (FY) 2013. The Federal 
Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic 
Drug User Fee Amendments of 2012 (GDUFA), as 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, on 
finished dosage form (FDF) and active pharmaceutical ingredient (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. In the first 
year of GDUFA (FY 2013), some rates will be published in separate 
Federal Register notices because of the timing specified in the 
statute. Each year thereafter the GDUFA fee rates will be published 60 
days before the start of the FY. This document establishes FY 2013 
rates for an ANDA ($51,520), PAS ($25,760), and DMF ($21,340). These 
fees are effective on October 1, 2012, and will remain in effect 
through September 30, 2013.

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), as added by GDUFA (Title III of the Food and Drug Administration 
Safety and Innovation Act (Pub. L. 112-144), which was signed by the 
President on July 9, 2012), as further amended by the FDA User Fee 
Correction Act of 2012 (Pub. L. 112-193) (signed by the President on 
October 5, 2012), establish fees associated with human generic drug 
products. Fees are assessed on the following: (1) Certain applications 
in the backlog as of October 1, 2012; (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). This 
notice will focus on the ANDA, PAS, and DMF fees.

II. Fee Revenue Amount for FY 2013

    The total fee revenue amount for FY 2013 is $299,000,000, as set in 
the statute. GDUFA directs FDA to use the yearly revenue amount as a 
starting point to set the fee rates for each fee type. GDUFA states 
that the backlog fee will make up $50,000,000 of the total revenue 
collected for FY 2013. Therefore, the rest of the fees will make up a 
percentage of the remaining $249,000,000 of the total revenue. For more 
information about GDUFA, please refer to the FDA Web site (http://www.fda.gov/gdufa). The ANDA, PAS, and DMF fee calculations for FY 2013 
are described in this document.

III. ANDA and PAS Fees

    Under GDUFA, the ANDA and PAS fees are owed by each applicant that 
submits, on or after October 1, 2012, an ANDA or a PAS. These fees are 
due on the date of submission of the ANDA or PAS or 30 days after the 
publication date of this notice, whichever is later. Section 
744B(b)(2)(B) specifies that the

[[Page 65199]]

ANDA and PAS fees will make up 24 percent of the $249,000,000, which is 
$59,760,000.
    In order to calculate the ANDA fee, FDA needed to estimate the 
number of full application equivalents (FAEs) that will be submitted in 
FY 2013. Over the past 4 years, the average number of ANDAs that would 
have been subject to the fee was approximately 850. Because the number 
of prior approval supplements submitted in FY 2012 is significantly 
lower than the number submitted in the 2 previous years, FDA has 
utilized available data concerning FY 2012 to estimate the number of 
such supplements for FY 2013. The estimated number of PASs to be 
received in FY 2013 is 576 based on an annualized estimate of the 
number of receipts for FY 2012.
    In estimating the number of fee-paying 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. GDUFA requires that 75 percent 
of the fees paid for an ANDA or PAS 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 application or supplement 
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 initially paid the supplement fee (one-half 
of the full application fee amount).
    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 2013 is 1,160.
    The FY 2013 application fee is estimated by dividing the number of 
full application equivalents that will pay the fee in FY 2013 (1,160) 
into the fee revenue amount to be derived from application fees in FY 
2013 ($59,760,000). The result, rounded to the nearest $10, is a fee of 
$51,520 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 
$25,760. 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 this 
additional fee to be 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 drug master file 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, or 30 
days after publication of this notice, whichever is later. (Under 
section 744B(a)(2)(D)(iii) of the FD&C Act, if the DMF successfully 
undergoes 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 DMFs 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.) Section 744B(b)(2)(A) of the FD&C Act 
specifies that the DMF fee will make up 6 percent of the remaining 
$249,000,000, which is $14,940,000.
    In order to calculate the DMF fee, FDA must estimate the number of 
DMFs that will be referenced by an initial letter of reference in FY 
2013. This number will include DMFs that have been referred to in ANDAs 
prior to FY 2013, but that are first referred to in an initial letter 
of reference in an ANDA during that year. Based on the numbers of DMFs 
referenced by ANDAs and PASs in 2011, the last full calendar year for 
which DMF information is available, FDA is estimating that 700 DMFs 
will be referenced by an initial letter of reference in FY 2013. 
Dividing the DMF revenue of $14,940,000 by the estimated number of 
first-referenced DMFs (700), and rounding to the nearest $10, yields a 
DMF fee of $21,340 for FY 2013.

V. Fee Payment Options and Procedures

    To pay the ANDA, PAS, or DMF fee, you must complete a generic drug 
user fee cover sheet, available at http://www.fda.gov/gdufa starting in 
October 2012, 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 the 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 the Food and Drug 
Administration is 53-0196965.

    Dated: October 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-26256 Filed 10-24-12; 8:45 am]
BILLING CODE 4160-01-P


