Thursday, October 25, 2012

GDUFA - USFDA fixes ANDA , PAS and DMF fees

The Food and Drug Administration (FDA) has announced  the rate for the Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) fees related to the Generic Drug User Fee Program for fiscal year (FY) 2013.
The total fee revenue amount to be raised for FY 2013 is $299million. As per GDUFA the backlog fee will make up $50m of the total revenue collected for FY 2013.  Therefore, the fees collected from ANDA / PAS and DMF application should together constitute $249m.

The ANDA and PAS fees would be owed by each applicant that  submits, on or after October 1, 2012, an ANDA or a PAS. These fees are due on the date of submission of the ANDA or PAS or 30 days after the publication date of this notice, whichever is later

ANDA and PAS fees will make up 24 percent of the $249m, which is $59.7million.  In calculating the ANDA and PAS fees the  USFDA  has estimated  that the total number of fee-paying FAEs (Full Application equivalent ) that will be received in FY 2013 is 1,160.  In estimating the number of fee paying FAEs, ANDA applications count as one FAE and PAS count as one-half an FAE, since the fee for a PAS is one half of the fee for an ANDA.

FY 2013 rates for an ANDA ($51,520), PAS ($25,760), and DMF ($21,340). These fees are effective
on October 1, 2012, and will remain in effect through September 30, 2013.

Each year thereafter the GDUFA fee rates will be published 60 days before the start of the FY

DMF Fees
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.

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

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