102212_GDUFA User Fees_Final

FDF:
80%
Facilities:
70%
Applications:
30%
FDF Fac:
56%
ANDA / PAS:
24%
API:
20%
API Fac:14%源自DMF:6%4
Target Revenue for FY13
Total Revenue (Dollars in millions): $299
Backlog Fee
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Backlog Fee
What is the backlog fee? A one-time application fee associated with a population of abbreviated new drug applications (ANDAs) that are submitted to FDA prior to October 1, 2012 which are pending* and have not received tentative approval. *ANDAs that have the following Application Status as of September 28, 2012 at 4:30pm are subject to the backlog fee:
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Backlog Fee (continued)
How are backlog applicants notified? Correspondence from Office of Generic Drugs (OGD) to alert applicants of backlog applications and provide instructions to withdraw ANDA. Federal Register Notices: • • June 14, 2012 (Notice to withdraw 364 applications) NLT October 31, 2012 (Notice of fee amount)
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Fee Collection Process (continued)
Who is entitled to a refund? After October 1, 2012, any ANDA/PAS not considered to have been received for scientific reasons is refunded 75% of the application fee.
Are companies refunded for overpayments and payments in error?
Yes - Refunds for overpayment and payments in error must be requested in writing within 180 days of payment.
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Backlog Fee (continued)
What is the effect for failure to pay the backlog fee? No new ANDAs or supplements submitted after October 1, 2012 from the applicant or its affiliates will be received. Outstanding fees are treated as a claim of the U.S. government and subject to collection activities. Applicant is placed on the arrears list.
Who processes the refunds?
The Office of Financial Management (OFM) processes the refunds. All inquires regarding refunds should be addressed by OFM.
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Timeline for FY2013 GDUFA Fees
Failure to Pay Failure to Pay (ANDA/PAS): (DMF): • DMF not available • RTR application for reference • RTR ANDA/PAS referencing DMF
Failure to Pay: • Arrears list • RTR generic drug submission referencing facility • FDFs/APIs of facility deemed misbranded
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Outline of the Agreement (continued)
• Critical splits: – 80% from finished dosage form manufacturers, 20% from API manufacturers – 70% from facility fees, 30% from application fees – In year 1, $50M from backlog fee, so above splits are slightly different
Can an applicant avoid the backlog fee?
Yes - Applicant must notify OGD in writing of its request to withdraw the ANDA prior to the September 28, 2012 deadline.
• • • • • Pending Application Integrity Policy Complete Response Incomplete Not Approvable
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Backlog Fee (continued)
How is the backlog fee calculated? Fee = $50 Million / # of ANDAs in backlog population (Ex. If backlog population = 2000 ANDAs, then fee = $25,000). One-time calculation for FY13 and remains in effect for FY14-17.
When is the backlog fee due?
No later than (NLT) 30 calendar days after fee amount is published in Federal Register Notice. The backlog fee will then be due between November 1st and November 30th, 2012.
Fee deadline
+150d
(e.g. Feb 28)
Fee deadline
+50d
(e.g. Dec 20)
End of grace period
+170d
(e.g. Mar 20)
End of grace period
Failure to Pay: • Arrears list • No new ANDA/PAS received from owner and/or any affiliate
Backlog fee: ANDA/PAS: DMF: API Facility: FDF Facility:
--24% 6% 14% 56%
$50 $59.8 $14.9 $34.9 $139.4
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Fee Collection Process
• • Industry initiates submission of user fees Industry will use iStore, an application within FDA’s User Fee System, to create the GDUFA cover sheet which calculates the fee amount • Specific information required for each fee type • PET drugs require cover sheet even though no fee is due • Fees should be paid after completion of cover sheet • Three options to submit payment: • (ACH direct deposit or Credit Card) • FedWire • Check • Refund criteria
User Fees
Donal Parks, MBA, MPM Director User Fee Collections Staff Office of Management
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Agenda for User Fees Presentation
• • • • • Outline of the Agreement Target Revenue for FY13 Timeline Fee Collection Process Fee Types
Deadline for Secretary’s FR notice
+60d
(e.g. Nov 30)
NLT Oct 31
Deadline for Secretary’s FR notice
+105d
(e.g. Jan 14)