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Regulatory Focus™ > News Articles > 2020 > 7 > FDA FY2021 user fee table

FDA FY2021 user fee table

Posted 31 July 2020 | By Michael Mezher 

FDA FY2021 user fee table

The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:
 
FDA User Fee Table FY2021
Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change
Applications:      
     Requiring clinical data $2,875,842 $2,942,965 -$67,123
     Not requiring clinical data $1,437,921 $1,471,483 -$33,562
Program fee $336,432 $325,424 $11,008
Generic Drug User Fee Amendments (GDUFA II) FY2021 FY2020 Change
Applications:      
     Abbreviated new drug application (ANDA) $196,868 $176,237 $20,631
     Drug master file (DMF) $69,921 $57,795 $12,126
Facilities:      
     Active pharmaceutical ingredient (API) – Domestic $41,671 $44,400 -$2,729
     API – Foreign $56,671 $59,400 -$2,729
     Finished dosage form (FDF) – Domestic $184,022 $195,662 -$11,640
     FDF – Foreign $199,022 $210,662 -$11,640
     Contract manufacturing organization (CMO) – Domestic $61,341 $65,221 -$3,880
     CMO – Foreign $76,341 $80,221 -$3,880
GDUFA program:      
     Large size operation generic drug applicant $1,542,993 $1,661,684 -$118,691
     Medium size operation generic drug applicant $617,197 $664,674 -$47,477
     Small business operation generic drug applicant $154,299 $166,168 -$11,869
Biosimilar User Fee Amendments (BSUFA II) FY2021 FY2020 Change
Initial biological product development (BPD) $102,494 $117,987 -$15,493
Annual BPD $102,494 $117,987 -$15,493
Reactivation $204,988 $235,975 -$30,987
Applications:      
     Requiring clinical data $1,746,745 $1,746,745 $0
     Not requiring clinical data $873,373 $873,373 $0
     Program $304,162 $304,162 $0
Medical Device User Fee Amendments (MDUFA IV) FY2021 (small business fee) FY2020 (small business fee) Change
Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act (21 U.S.C. 360e(f), or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) $365,657 ($91,414) $340,995 ($85,249) $24,662 ($6,165)
Premarket report (submitted under section 515(c)(2) of the FD&C Act) $365,657 ($91,414) $340,995 ($85,249) $24,662 ($6,165)
Efficacy supplement (to an approved BLA under section 351 of the PHS Act) $365,657 ($91,414) $340,995 ($85,249) $24,662 ($6,165)
Panel-track supplement $274,243 ($68,561) $255,747 ($63,937) $18,496 ($4,624)
De novo classification request $109,697 ($27,424) $102,299 ($25,575) $7,398 ($1,849)
180-day supplement $54,849 ($13,712) $51,149 ($12,787) $3,700 ($925)
Real-time supplement $25,596 ($6,399) $23,870 ($5,968) $1,726 ($431)
510(k) premarket notification submission $12,432 ($3,108) $11,594 ($2,899) $838 ($209)
30-day notice $5,851 ($2,926) $5,456 ($2,728) $395 ($198)
513(g) request for classification information $4,936 ($2,468) $4,603 ($2,302) $333 ($166)
Annual fee type:      
     Annual fee for periodic reporting on a Class III device $12,798 ($3,200) $11,935 ($2,984) $863 ($216)
     Annual establishment registration fee $5,546 ($5,546) $5,236 ($5,236) $310 ($310)
Outsourcing Facility Fees FY2021 FY2020 Change
Qualified small business establishment fee $5,695 $5,599 $96
Non-small business establishment fee $18,837 $18,288 $549
Re-inspection fee $17,085 $16,798 $287

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