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US: FDA unveils user fee rates for FY2016

2015/08/10

The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a more timely manner. The solution FDA proposed was to collect one-time fees from the companies it regulates for each new drug approval, which would provide the agency with a substantial source of funding to boost its staff and reduce review times.

Eventually, this led to the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, which authorized FDA to collect fees for its review activities in return for a speedier, more predictable review process.

Since then, Congress has enacted many other user fee acts covering medical devices, generic drugs, animal drugs and biosimilars, as well as related inspection and registration activities.

FY2016 Fees

Each year, FDA adjusts the rates of these fees to keep up with inflation and the agencys workload. The table below shows the rates to be charged for FY2016, which take effect on 1 October 2015.

**Activity**   **Prescription Drug User Fee Act (PDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18914/prescription-drug-user-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18113/prescription-drug-user-fee-rates-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18624/prescription-drug-user-fee-rates-for-fiscal-year-2014)**   New Drug Application (With Clinical Data) $2,374,200 $2,335,200 $2,169,100   New Drug Application (Without Clinical Data) $1,187,100 $1,167,600 $1,084,550   New Drug Application Supplement With Clinical Data $1,187,100 $1,167,600 $1,084,550   NDA Establishment $585,200 $569,200 $554,600   Annual Product Registration $114,450 $110,370 $104,060   **Medical Device User Fee Act (MDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18907/medical-device-user-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/07/30/2014-17902/medical-device-user-fee-rates-for-fiscal-year-2015?utm_campaign=pi+subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18623/medical-device-user-fee-rates-for-fiscal-year-2014)**   Premarket Application $261,388 $250,895 $258,520   Product Development Protocol $261,388 $250,895 $258,520   Biologics Licensing Application $261,388 $250,895 $258,520   Premarket Report $261,388 $250,895 $258,520   BLA Efficacy Supplement $261,388 $250,895 $258,520   Panel-Track Supplement $196,041 $188,171 $193,890   180-Day Supplement $39,208 $37,634 $38,778   Real-Time Supplement $18,297 $17,563 $18,096   510(k) Premarket Notification Submission $5,228 $5,018 $5,170   30-Day Notice $4,182 $4,014 $4,136   513(g) Request for Classification Information $3,529 $3,387 $3,490   Annual Fee for Class III Device $9,149 $8,781 $9,048   Annual Establishment Registration $3,845 $3,646 $3,313   **Generic Drug User Fee Act (GDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18915/generic-drug-user-fee-abbreviated-new-drug-application-prior-approval-supplement-drug-master-file)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18108/generic-drug-user-fee-abbreviated-new-drug-application-prior-approval-supplement-drug-master-file)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18625/generic-drug-user-fee-abbreviated-new-drug-application-prior-approval-supplement-drug-master-file)**   Abbreviated New Drug Application $76,030 $58,730 $63,860   Prior Approval Supplement $38,020 $29,370 $31,930   Drug Master File $42,170 $26,720 $31,460   Finished Dosage Form Facility (Domestic) $243,905 $247,717 $220,152   Finished Dosage Form Facility (Foreign) $258,905 $262,717 $235,152   Active Pharmaceutical Ingredient Facility (Domestic) $40,867 $41,926 $34,515   Active Pharmaceutical Ingredient Facility (Foreign) $55,867 $56,926 $49,515   **Biosimilar User Fee Act (BsUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18908/biosimilar-user-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18112/biosimilar-user-fee-rates-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18621/biosimilar-user-fee-rates-for-fiscal-year-2014)**   Biosimilar Application (Requiring Clinical Data) $2,374,200 $2,335,200 $2,169,100   Biosimilar Application (Not Requiring Clinical Data) $1,187,100 $1,167,600 $1,084,550   Biosimilar Supplement (Requiring Clinical Data) $1,187,100 $1,167,600 $1,084,550   Biological Product Development (Initial) $237,420 $233,520 $216,910   Biological Product Development (Annual) $237,420 $233,520 $216,910   Biological Product Development (Reactivation) $474,840 $467,040 $433,820   Establishment Fee $585,200 $569,200 $554,600   Product Fee $114,450 $110,370 $104,060   **Animal Drug User Fee Act (ADUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18913/animal-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18110/animal-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18619/animal-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2014)**   Animal Drug Application (New) $351,100 $400,600 $396,600   Animal Drug Application (Supplement) $175,550 $200,300 $198,300   Animal Drug Product Fee $7,790 $8,075 $9,075   Animal Drug Establishment Fee $105,950 $104,150 $105,800   Animal Drug Sponsor Fee $101,000 $94,450 $101,150   **Animal Generic Drug User Fee Act (AGDUFA)** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18909/animal-generic-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18178/animal-generic-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2015)** **[2014](https://www.federalregister.gov/articles/2013/08/02/2013-18620/animal-generic-drug-user-fee-rates-and-payment-procedures-for-fiscal-year-2014)**   Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) $233,300 $189,200 $177,900   Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) $116,650 $94,600 $88,950   Generic New Animal Drug Product Fee $8,705 $8,500 $8,035   Sponsor Fee (Seven or More Approved Products) $83,800 $80,900 $72,800   Sponsor Fee (Three or More Approved Products) $62,850 $60,675 $54,600   Sponsor Fee (One or Fewer Approved Products) $41,900 $40,450 $36,400   **Outsourcing Facility Fee** **[2016](https://www.federalregister.gov/articles/2015/08/03/2015-18916/outsourcing-facility-fee-rates-for-fiscal-year-2016)** **[2015](https://www.federalregister.gov/articles/2014/08/01/2014-18111/outsourcing-facility-fee-rates-for-fiscal-year-2015)** **2014**   Qualified Small Business Establishment Fee $5,203 $5,103 N/A   Non-Small Business Establishment Fee $16,465 $16,442 N/A   Reinspection Fee $15,610 $15,308 N/A

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