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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices TABLE 3THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONSContinued FY 2018
actual
Application type Small Business
De Novo Classification Request
Small Business
180-Day Supplements
Small Business
Real-Time Supplements
Small Business
510ks
Small Business
30-Day Notice
Small Business
513g 21 U.S.C. 360cg Request for Classification Information
Small Business
Annual Fee for Periodic Reporting
Small Business 2
Establishment Registration

The information in table 3 is necessary to estimate the amount of revenue that will be collected based on the fee amounts. Table 4 displays the FY
2022 base fees set in statute column one and the inflation adjusted base fees
FY 2019
actual
5 27
29
133
27
169
34
2,122
1,385
1,058
98
84
33
624
74
27,544

per calculations in section III.A.
column two. Using the inflation adjusted fees and the 3-year averages of fee-paying submissions, collections are projected to total $262,694,460, which is $19,221,460 higher than the inflation
FY 2020
actual
4 12
37
124
23
213
43
2,069
1,558
925
111
75
54
629
96
27,734

6
11
18
126
21
175
29
2,049
1,667
867
105
96
57
420
68
41,409

3-Year average 5
17
28
128
24
186
35
2,080
1,537
950
105
85
48
558
79
32,229

adjusted total revenue amount in section II. The fees in column two are those we are establishing in FY 2022, which are the standard fees.

TABLE 4FEES NEEDED TO ACHIEVE NEW FY 2022 REVENUE TARGET

Application type
khammond on DSKJM1Z7X2PROD with NOTICES

FY 2022
Inflation adjusted statutory base fees standard fees
FY 2022
statutory fees base fees
3-Year average of fee-paying submissions
FY 2022
revenue from adjusted fees
Full Fee Applications
Small Business
Panel-Track Supplement
Small Business
De Novo Classification Request
Small Business
180-Day Supplements
Small Business
Real-Time Supplements
Small Business
510ks
Small Business
30-Day Notice
Small Business
513g Request for Classification Information
Small Business
Annual Fee for Periodic Reporting
Small Business
Establishment Registration

$329,000
82,250
246,750
61,688
98,700
24,675
49,350
12,338
23,030
5,758
11,186
2,797
5,264
2,632
4,442
2,221
11,515
2,879
4,978

$374,858
93,714
281,143
70,286
112,457
28,114
56,229
14,057
26,240
6,560
12,745
3,186
5,998
2,999
5,061
2,530
13,120
3,280
5,672

33
7 20
5 17
28
128
24
186
35
2,080
1,537
950
105
85
48
558
79
32,229

$12,370,303
656,001
5,622,865
351,429
1,911,774
787,201
7,197,267
337,372
4,880,647
229,600
26,509,934
4,897,328
5,697,837
314,880
430,149
121,454
7,320,970
259,120
182,798,329

Total

262,694,460

The standard fee adjusted base amount for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $374,858 for FY 2022. The fees set by reference to the standard fee for a premarket application are:
For a panel-track supplement, 75
percent of the standard fee;
For a de novo classification request, 30 percent of the standard fee;

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For a 180-day supplement, 15
percent of the standard fee;
For a real-time supplement, 7
percent of the standard fee;
For an annual fee for periodic reporting concerning a class III device, 3.5 percent of the standard fee;
For a 510k premarket notification, 3.4 percent of the standard fee;
For a 30-day notice, 1.6 percent of the standard fee; and
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For a 513g request for classification information, 1.35 percent of the standard fee.
For all submissions other than a 30day notice and a 513g request for classification information, the small business fee is 25 percent of the standard full fee for the submission see 21 U.S.C. 379jd2C and e2C. For a 30-day notice and a 513g request for classification information, the small business fee is 50

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