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.