FDA: New User Fees Begin Oct. 1, 2013, Increases Up to 10%

August 13, 2013

On Aug. 2, 2013, the FDA published its fiscal year 2014 user fee schedules in the Federal Register. The new user fees will be in effect Oct. 1, 2013, through Sept. 30, 2014. Although there has been industry concern of sequestration’s threat on the FDA User Fees, various industry trade groups and representatives have praised congressional efforts to pass legislation exempting those fees from sequestration. Below is a brief overview of the new rates for various types of User Fees in fiscal year 2014.

Application Name User Fee Notes
Prescription Drug User Fee Rates
New Drug Application Fee – clinical data $2,169,100 Fee increased by 10.7%
New Drug Application Fee – no clinical data required $1,084,500 Fee increased by 10.7%
New Drug Application Fee – supplement requiring clinical data $1,084,500 Fee increased by 10.7%
NDA Establishment Fee $554,600 Fee increased by 5.3%
Animal Product Registration Fee $104,060 Fee increased by 5.8%
Generic Drug User Fee Rates
Abbreviated New Drug Application Fee $63,860  
Master File Fee $31,460  
Generic Drug Active Pharmaceutical Ingredient (API) Fee – Domestic $34,515 The basis for the differential between the foreign and domestic fee is the extra cost incurred by conducting an inspection outside the United States.
API Fee – Foreign $49,515
Finished Dosage Form (FDF) Facility Fee – Domestic $220,152
FDF Fee – Foreign $235,152
Medical Device User Fee Rates
Standard Premarket Approval Fee $258,520 Fee increased by 4.2%
Premarket Notification (510(k)) Fee $5,170
Small Business Premarket Approval Fee $64,630 If an entity can qualify as a “small business” (i.e., the entity has gross receipts or sales of no more than $100 million for the most recent tax year) the entity is eligible for significant reductions in user fees (approximately a 75% discount) as well as a one-time waiver of the user fee for its first-ever premarket application, biologics license application, product development protocol or premarket report.
Premarket Notification (510(k)) Fee $2,585
Biosimilar User Fee Rates
Biological Product Development Fee – Initial $216,910 Fee increased by 10.7%
Biological Product Development Fee – Annual $216,910
Biological Product Development Fee – Reactivation $433,820
Animal Drug User Fee Rates and Generic Animal Drug User Fee Rates
Animal Drug Application Fee $396,600 Fee decreased by 8.9%
Animal Drug Establishment Fee $105,800 Fee increased by 1.1%
Animal Drug Sponsor Fee $101,150 Fee increased by 15.3%
Generic New Animal Drug Product Fee $8,035 Fee increased by 23.3%
Abbreviated Application Fee for a Generic New Animal Drug $177,900 Fee increased by 20%

If you have any question regarding FDA user fees or the proposed legislation, please contact one of the authors.