Today, the announcement of the User Fees for three FDA programs today were published in the Federal Register notice prepublication. PDUFA, animal and generic drug fees and medical device fees for FY 2021 start October 1, 2020 and are provided below. We await the GDUFA fee announcement, which we should see in a day or two.
PDUFA Fees for FY 2021
| Fee Category | Fee Rates for FY 2021 |
| Application | |
|
Requiring clinical data |
$2,875,842 |
|
Not requiring clinical data |
$1,437,921 |
| Program |
$336,432 |
Medical Device Fees for FY 2021
| Application Fee Type | Standard Fee (as a percent of the standard fee for a premarket application) | FY 2021
Standard Fee |
FY 2021
Small Business Fee |
| 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, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) |
Base fee specified in statute | $365,657 | $91,414 |
| Premarket report (submitted under section 515(c)(2) of the FD&C Act) | 100 | $365,657 | $91,414 |
| Efficacy supplement (to an approved BLA under section 351 of the PHS Act) | 100 | $365,657 | $91,414 |
| Panel-track supplement | 75 | $274,243 | $68,561 |
| De novo classification request | 30 | $109,697 | $27,424 |
| 180-day supplement | 15 | $54,849 | $13,712 |
| Real-time supplement | 7 | $25,596 | $6,399 |
| 510(k) premarket notification submission | 3.40 | $12,432 | $3,108 |
| 30-day notice | 1.60 | $5,851 | $2,926 |
| 513(g) request for classification information | 1.35 | $4,936 | $2,468 |
| Annual Fee Type | |||
| Annual fee for periodic reporting on a class III device | 3.50 | $12,798 | $3,200 |
| Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(14)) | Base fee specified in statute | $5,546 | $5,546 |
Animal Generic Drug User Fees for FY 2021
| Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4) |
$513,423 |
| Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4) |
$256,712 |
| Generic New Animal Drug Product Fee |
$17,235 |
| 100% Generic New Animal Drug Sponsor Fee1 |
$201,687 |
| 75% Generic New Animal Drug Sponsor Fee1 |
$151,265 |
| 50% Generic New Animal Drug Sponsor Fee1 |
$100,843 |
Animal Drug User Fee Rates for FY 2021
| Animal Drug User Fee Category | Fee Rate for FY 2021 |
| Animal Drug Application Fees: Animal Drug Application
Supplemental Animal Drug Application for Which Safety or Effectiveness Data are Required or Animal Drug Application Subject to the Criteria Set Forth in Section 512(d)(4) of the FD&C Act |
$574,810 $287,405 |
| Animal Drug Product Fee | $12,230 |
| Animal Drug Establishment Fee1 | $166,695 |
| Animal Drug Sponsor Fee2 | $142,881 |
PDUFA user fees decreased for application submission by $67,123 (-.2.3%), primarily because FDA estimated that they would receive more NDAs in the new FY, while the program fees jumped $11,008, (+3.3%) an indication that a number of products likely have been discontinued by innovators.
All medical device fees have increased In FY 2021 across the board by about 6.8% with the exception of the annual facility registration fee, which increased 5.6% from $5,236 to $5596.
Animal generic drug user fees rose with fee increases in the range of about 5%; however, for the sponsor fee a rise of 14.6% was noted for the full sponsor fee; however, as noted in the chart above, that fee is tiered.
Animal drug user fees went up about 23.4% for original applications and supplements, 7.2% for product fees and 4.6% for establishment fees but a decrease for animal drug sponsor fees of -1.6% were noted.
This is certainly an interesting year for adjustments. Look for the announcements of additional fee categories that will be revised over the next week.
