
[Federal Register Volume 77, Number 207 (Thursday, October 25, 2012)]
[Notices]
[Pages 65199-65200]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-26257]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Generic Drug User Fee--Backlog Fee Rate 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

[[Page 65200]]

rate for the backlog fee related to generic drug 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), 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 (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 the FY 2013 rate for the 
backlog fee ($17,434). This fee is effective on October 1, 2012.

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 and744B 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 (Public Law 112-144), which was signed by the 
President on July 9, 2012), establish user fees associated with human 
generic drug products. Fees are assessed on the following: (1) 
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 APIs and FDFs are produced; (4) 
certain type II API DMFs associated with human generic drug products. 
This notice focuses solely on the backlog fee.

II. Fee Revenue Amount for FY 2013

    The total fee revenue amount for FY 2013 is $299,000,000, as set in 
the statute (section 744B(b)(1)(A) of the FD&C Act). Under that 
provision, FDA uses the yearly revenue amount as a starting point to 
set the fees. The GDUFA statute states that the backlog fee will make 
up $50,000,000 of the total revenue collected for FY 2013 (section 
744B(b)(1)(A)(i) of the FD&C Act). For more information about GDUFA, 
please refer to the FDA Web site (http://www.fda.gov/gdufa). The 
backlog fee calculation for FY 2013 is described in this document.

III. Backlog Fee

    Under GDUFA, each person that owns an abbreviated new drug 
application that is pending on October 1, 2012, and that has not 
received a tentative approval prior to that date, shall be subject to a 
backlog fee for each such application (section 744B(a)(1)(A) of the 
FD&C Act). The backlog fee is due no later than 30 days after 
publication of this notice (section 744B(a)(1)(D) of the FD&C Act). The 
backlog fee is assessed one time only, for FY 2013, and no backlog fee 
will be assessed in subsequent years. Once incurred, the backlog fee 
obligation can only be discharged by payment in full.
    Under section 744B(a)(1)(B) of the FD&C Act, FDA calculates the 
backlog fee by taking the exact number of pending abbreviated new drug 
applications in the backlog that have not received tentative approval 
as of October 1, 2012, and dividing $50,000,000 by that number. Since 
there are 2,868 applicable applications in the backlog, the backlog fee 
is calculated to be $17,434 ($50,000,000 divided by 2,868 rounded to 
the nearest dollar).

IV. Fee Payment Options and Procedures

    To make a payment of the backlog 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 backlog 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. 2012-26257 Filed 10-24-12; 8:45 am]
BILLING CODE 4160-01-P


