Generic Drug User Fee-Backlog Fee Rate for Fiscal Year 2013, 65199-65200 [2012-26257]

Download as PDF erowe on DSK2VPTVN1PROD with Federal Register / Vol. 77, No. 207 / Thursday, October 25, 2012 / Notices 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 feepaying FAEs, applications count as one FAE and supplements count as one-half an FAE, since the fee for a PAS is onehalf 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 (onehalf 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 VerDate Mar<15>2010 12:06 Oct 24, 2012 Jkt 229001 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 Frm 00034 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration To pay the ANDA, PAS, or DMF fee, you must complete a generic drug user fee cover sheet, available at https:// 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. PO 00000 65199 [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. The Food and Drug Administration (FDA) is announcing the SUMMARY: E:\FR\FM\25OCN1.SGM 25OCN1 65200 Federal Register / Vol. 77, No. 207 / Thursday, October 25, 2012 / Notices 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. erowe on DSK2VPTVN1PROD with 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 VerDate Mar<15>2010 18:14 Oct 24, 2012 Jkt 229001 GDUFA, please refer to the FDA Web site (https://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 (https://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. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 (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 DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS–R3–ES–2012–N247; FX3ES11130300000D2–123–FF03E00000] Information Collection Request Sent to the Office of Management and Budget (OMB) for Approval; Bald Eagle Postdelisting Monitoring Fish and Wildlife Service, Interior. ACTION: Notice; request for comments. AGENCY: We (U.S. Fish and Wildlife Service) have sent an Information Collection Request (ICR) to OMB for review and approval. We summarize the ICR below and describe the nature of the collection and the estimated burden and cost. This information collection is scheduled to expire on November 30, 2012. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. However, under OMB regulations, we may continue to conduct or sponsor this information collection while it is pending at OMB. DATES: You must submit comments on or before November 26, 2012. ADDRESSES: Send your comments and suggestions on this information collection to the Desk Officer for the SUMMARY: E:\FR\FM\25OCN1.SGM 25OCN1

Agencies

[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.

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

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 (https://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 (https://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

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