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% |
|
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
