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