FDA Unveils User Fee Rates for FY2016
Posted 04 August 2015 | By Michael Mezher
In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for FDA itself.
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 agency's 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 | 2015 | 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 | 2015 | 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 | 2015 | 2014 |
| 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 | 2015 | 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 | 2015 | 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 | 2015 | 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 | 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 |