Regulatory Focus™ > News Articles > 2021 > 8 > FDA FY2022 user fee table

FDA FY2022 user fee table

Posted 13 August 2021 | By Michael Mezher 

FDA FY2022 user fee table

The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2022 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program.

Each year, FDA adjusts its user fees based on factors such as inflation and the number of applications or establishments expected to pay the various fees. For FY2022, FDA’s fee for new drug applications (NDAs) and biologics license applications (BLAs) requiring clinical data will surpass $3 million for the first time, up from $$2,875,842 in FY2021.

Medical device user fees will see a more modest increase of about 2.5% across the board. On the other hand, biosimilar developers will get some relief in FY2022, with application fees frozen at the FY2021 level and fees for biological product development (BPD) and reactivation cut nearly in half from the previous year.
 
FDA User Fee Table FY2022
Prescription Drug User Fee Act (PDUFA VI) FY2022 FY2021 Change
Applications:      
     Requiring clinical data $3,117,218 $2,875,842 $241,376
     Not requiring clinical data $1,558,609 $1,437,921 $120,688
Program fee $369,413 $336,432 $32,981
Generic Drug User Fee Amendments (GDUFA II) FY2022 FY2021 Change
Applications:      
     Abbreviated new drug application (ANDA) $225,712 $196,868 $28,844
     Drug master file (DMF) $74,952 $69,921 $5,031
Facilities:      
     Active pharmaceutical ingredient (API) – Domestic $42,557 $41,671 $886
     API – Foreign $57,557 $56,671 $886
     Finished dosage form (FDF) – Domestic $195,012 $184,022 $10,990
     FDF – Foreign $210,012 $199,022 $10,990
     Contract manufacturing organization (CMO) – Domestic $65,004 $61,341 $3,663
     CMO – Foreign $80,004 $76,341 $3,663
GDUFA program:      
     Large size operation generic drug applicant $1,536,856 $1,542,993 -$6,137
     Medium size operation generic drug applicant $614,742 $617,197 -$2,455
     Small business operation generic drug applicant $153,686 $154,299 -$613
Biosimilar User Fee Amendments (BSUFA II) FY2022 FY2021 Change
Initial biological product development (BPD) $57,184 $102,494 -$45,310
Annual BPD $57,184 $102,494 -$45,310
Reactivation $114,368 $204,988 -$90,620
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) FY2022 (small business fee) F2021 (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)) $374,858
($93,714)                               
$365,657
($91,414)
$9,201
($2,300)
Premarket report (submitted under section 515(c)(2) of the FD&C Act) $374,858
($93,714)
$365,657
($91,414)
$9,201
($2,300)
Efficacy supplement (to an approved BLA under section 351 of the PHS Act) $374,858
($93,714)
$365,657
($91,414)
$9,201
($2,300)
Panel-track supplement $281,143
($70,286)
$274,243
($68,561)
$6,900
($1,725)
De novo classification request $112,457
($28,114)
$109,697
($27,424)
$2,760
($690)
180-day supplement $56,229
($14,057)
$54,849
($13,712)
$1,380
($345)
Real-time supplement $26,240
($6,560)
$25,596
($6,399)
$644
($161)
510(k) premarket notification submission $12,745
($3,186)
$12,432
($3,108)
$313
($78)
30-day notice $5,998
($2,999)
$5,851
($2,926)
$147
($73)
513(g) request for classification information $5,061
($2,530)
$4,936
($2,468)
$125
($62)
Annual fee type:      
     Annual fee for periodic reporting on a Class III device $13,120
($3,280)
$12,798
($3,200)
$322
($80)
     Annual establishment registration fee $5,672
($5,672)
$5,546
($5,546)
$126
($126)
Outsourcing Facility Fees FY2022 FY2021 Change
Qualified small business establishment fee $5,824 $5,695 $129
Non-small business establishment fee $18,999 $18,837 $162
Re-inspection fee $17,472 $17,085 $387

 

© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe