FDA Issues Generic Drug User/Backlog Fee Notices

This post was written by Jennifer Pike.

On October 25, 2012, the Food and Drug Administration (FDA) published in the Federal Register the fiscal year (FY) 2013 rates for certain filings under the Generic Drug User Fee Program. Specifically, the notice establishes the new annual rates for an abbreviated new drug application (ANDA) ($51,520), prior approval supplement ($25,760), and drug master file ($21,340). These fees are effective on October 1, 2012 and remain in effect through September 30, 2013. The fees for the ANDA and prior approval supplement are due by the applicant on the date of submission, or 30 days after the published notice (i.e. November 24, 2012), whichever is later. The drug master file (DMF) fee is owed by each person that owns a type II active pharmaceutical ingredient drug master file that is referenced, on or after the effective date in a generic drug submission by an initial letter of authorization. This one-time fee for each individual DMF 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 the published notice (i.e. November 24, 2012), whichever is later.

Also on October 25, 2012, FDA published the 2013 rate for the backlog fee related to generic drug user fees. The backlog fee of $17,434 is effective on October 1, 2012. Each person that owns a pending ANDA on October 1, 2012 -- i.e., an ANDA submission that has not received tentative FDA prior approval to the effective date -- is subject to the backlog fee for each such application. The backlog fee is a means for FDA to generate enough resources to process its backlog of ANDAs. FDA currently has an approximate backup of over 2,800 ANDAs. The backlog fee is due no later than 30 days after the published notice (i.e. November 24, 2012).

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