[Federal Register Volume 78, Number 12 (Thursday, January 17, 2013)]
[Notices]
[Pages 3900-3901]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-00851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0007]


Generic Drug User Fee--Active Pharmaceutical Ingredient and 
Finished Dosage Form Facility Fee Rates for Fiscal Year 2013

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 generic drug active pharmaceutical ingredient (API) and 
finished dosage form (FDF) facilities user fees 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), 
enacted the Food and Drug Administration Safety and Innovation Act, as 
further amended by the FDA User Fee Corrections Act of 2012, authorizes 
FDA to assess and collect user fees for certain applications and 
supplements associated with 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 API drug master files (DMF) 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 fiscal year. This document establishes the FY 2013 rate 
for API and FDF facility fees. These fees are due on March 4, 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, as added by GDUFA (21 
U.S.C. 379j-41 and 379j-42), establish user fees associated with human 
generic drug products. Fees are assessed on: (1) Certain applications 
in the backlog as of October 1, 2012; (2) certain types of applications 
and supplements associated with human generic drug products; (3) 
certain facilities where human generic drug APIs and FDFs are produced; 
and (4) certain Type II API DMFs associated with human generic drug 
products. This notice focuses on the API and FDF facility 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 fees. 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 fee revenue. For more information 
about GDUFA, please refer to the FDA Web site (http://www.fda.gov/gdufa). The API and FDF facility fee calculations for FY 2013 are 
described in this document.

III. Foreign 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 
2013 FDA has determined that the differential for foreign facilities 
will be $15,000. The differential may be adjusted in future years.

[[Page 3901]]

IV. 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 the human generic drug. 
These fees are due no later than 45 days after the publication of this 
notice. Section 744B(b)(2)(C) of the FD&C Act specifies that the FDF 
facility fee revenue will make up 56 percent of the remaining 
$249,000,000, which is $139,440,000.
    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 758. Of the total facilities 
identified as FDF, there were 325 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 ($139,440,000) results in a remaining fee 
revenue balance of $132,945,000. To determine the domestic FDF facility 
fee, we divide the $132,945,000 by the total number of facilities (758) 
which gives us a domestic FDF facility fee of $175,389. The foreign FDF 
facility fee is $15,000 more than the domestic FDF facility fee, or 
$190,389.

V. 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 45 days after the publication of this notice. 
Section 744B(b)(2)(D) of the FD&C Act specifies that the API facility 
fee will make up 14 percent of the remaining $249,000,000 fee revenue, 
which is $34,860,000.
    In order to calculate the API fee, FDA has used the data submitted 
by generic drug facilities through the self-identification process. Of 
the total facilities identified as API, there were 122 domestic 
facilities and 763 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 (763) 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 $11,445,000 of the total API 
fee revenue. Subtracting the foreign facility differential fee revenue 
($11,445,000) from the total API facility target revenue ($34,860,000) 
results in a remaining balance of $23,415,000. To determine the 
domestic API facility fee, we divide the $23,415,000 by the total 
number of facilities (885) which gives us a domestic API facility fee 
of $26,458. The foreign API facility fee is $15,000 more than the 
domestic API facility fee, or $41,458.

VI. Fee Payment Options and Procedures

    To make a payment of the facility fee, you must complete a Generic 
Drug User Fee Cover Sheet, available on the FDA Web site (http://www.fda.gov/gdufa) and generate a user fee payment 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 payment ID number.
    Please include the user fee payment 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 the user fee payment 
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 facility 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: January 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-00851 Filed 1-16-13; 8:45 am]
BILLING CODE 4160-01-P