FDA FY2019 User Fee Table

Applications:

     Requiring clinical data

$2,588,478

$2,421,495

     Not requiring clinical data

$1,294,239

$1,210,748

Program fee

$309,915

$304,162

Applications:

     Abbreviated new drug application (ANDA)

$178,799

$171,823

     Drug master file (DMF)

$55,013

$47,829

Facilities:

     Active pharmaceutical ingredient (API) – Domestic

$44,226

$45,367

     API – Foreign

$59,226

$60,367

     Finished dosage form (FDF) – Domestic

$211,305

$211,087

     FDF – Foreign

$226,305

$226,087

     Contract manufacturing organization (CMO) – Domestic

$70,435

$70,362

     CMO – Foreign

$85,435

$85,362

GDUFA program:

     Large size operation generic drug applicant

$1,862,167

$1,590,792

     Medium size operation generic drug applicant

$744,867

$636,317

     Small business operation generic drug applicant

$186,217

$159,079

Initial biological product development (BPD)

$185,409

$227,213

Annual BPD

$185,409

$227,213

Reactivation

$370,818

$454,426

Applications:

     Requiring clinical data

$1,746,745

$1,746,745

     Not requiring clinical data

$873,373

$873,373

     Program

$304,162

$304,162

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))

$322,147 ($80,537)

$310,764 ($77,691)         

Premarket report (submitted under section 515(c)(2) of the FD&C Act)

$322,147 ($80,537)

$310,764 ($77,691)         

Efficacy supplement (to an approved BLA under section 351 of the PHS Act)

$322,147 ($80,537)

$310,764 ($77,691)         

Panel-track supplement

$241,610 ($60,403)

$233,073 ($58,268)

De novo classification request

$96,644 ($24,161)

$93,229 ($23,307)

180-day supplement

$48,322 ($12,081)

$46,615 ($11,654)

Real-time supplement

$22,550 ($5,638)

$21,753 ($5,438)

510(k) premarket notification submission

$10,953 ($2,738)

$10,566 ($2,642)

30-day notice

$5,154 ($2,577)

$4,972 ($2,486)

513(g) request for classification information

$4,349 ($2,175)

$4,195 ($2,098)

Annual fee type

     Annual fee for periodic reporting on a class III device

$11,275 ($2,819)

$10,877 ($2,719)

Annual establishment registration fee

$4,884 ($4,884)

$4,624 ($4,624)

Qualified small business establishment fee

$5,461

$5,364

Non-small business establishment fee

$18,375

$17,364

Re-inspection fee

$16,382

$16,093