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Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices TABLE 1FDA PC&BS EACH YEAR AND PERCENT CHANGE
Fiscal year
2018

Total PC&B
Total FTE
PC&B per FTE
Percent change from previous year

The payroll adjustment is 2.7383
percent multiplied by 60 percent, or 1.6430 percent. The statute specifies that the component of the inflation adjustment for non-payroll costs for FY
2022 is the average annual percent change that occurred in the Consumer Price Index CPI for urban consumers Washington-Baltimore, DC-MD-VAWV; Not Seasonally Adjusted; All Items;
Annual Index for the first 3 of the preceding 4 years of available data multiplied by 0.40, or 40 percent see 21
U.S.C. 379jc2C. As a result of a
2019

$2,690,678,000
17,023
$158,061
4.2206%

2020

$2,620,052,000
17,144
$152,826
3.3120%

geographical revision made by the Bureau of Labor and Statistics in January 2018,1 the WashingtonBaltimore, DC-MD-VA-WV index was discontinued and replaced with two separate indices i.e., WashingtonArlington-Alexandria, DC-VA-MD-WV
and Baltimore-Columbia-Towson, MD. In order to continue applying a CPI that best reflects the geographic region in which FDA is headquartered and that provides the most current data available, the Washington-ArlingtonAlexandria index has been used since
3-Year average
$2,875,592,000
17,535
$163,992
7.3063%

2.7383%

FY 2020 and will be used in calculating the relevant adjustment factors for FY
2022 and subsequent years.
Table 2 provides the summary data and the 3-year average percent change in the specified CPI for the WashingtonArlington-Alexandria area. These data are published by the Bureau of Labor Statistics and can be found on their website under series Id CUURS35ASA0
at: https data.bls.gov/pdq/Survey OutputServlet?data_
tool=dropmap&series_
id=CUURS35ASA0,CUUSS35ASA0.

TABLE 2ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN WASHINGTON-ARLINGTON-ALEXANDRIA AREA CPI
Fiscal year
2018

2019

2020

3-Year average
Annual CPI
Annual Percent Change
3-Year Average Percent Change in CPI

261.445
2.0389%

264.777
1.2745%

267.157
0.8989%

1.4041%

The non-payroll adjustment is 1.4041
percent multiplied by 40 percent, or 0.5616 percent. Next, the payroll adjustment 1.6430 percent or 0.016430
is added to the non-payroll adjustment 0.5616 percent or .005616, for a total of 2.2046 percent or 0.022046. To complete the inflation adjustment, 1
100 percent or 1.0 is added for a total base inflation adjustment of 1.022046
for FY 2022.
MDUFA IV provides for this inflation adjustment to be compounded for FY
2022 and each subsequent fiscal year see 21 U.S.C. 379jc2Bii. To complete the compounded inflation adjustment for FY 2022, the FY 2021
compounded adjustment 1.114808 is multiplied by the FY 2022 base inflation adjustment 1.022046 to reach the applicable inflation adjustment of 1.139385 rounded for FY 2022. We then multiply the total revenue amount for FY 2022 $213,687,660 by 1.139385,
fees of $374,858 premarket application and $5,672 establishment registration.

yielding an inflation adjusted total revenue amount of $243,473,000
rounded to the nearest thousand dollars.

B. Further Adjustments
III. Fees for FY 2022
Under the FD&C Act, all submission fees and the periodic reporting fee are set as a percent of the standard full fee for a premarket application see 21
U.S.C. 379ja2A.
A. Inflation Adjustment MDUFA specifies that the base fees of $329,000 premarket application and $4,978 establishment registration are to be adjusted for FY 2022 using the same methodology as that for the total revenue inflation adjustment in section II see 21 U.S.C. 379jc2Di.
Multiplying the base fees by the compounded inflation adjustment of 1.139385 yields inflation adjusted base
After the applicable inflation adjustment to fees is done, FDA may increase, if necessary to achieve the inflation adjusted total revenue amount, the base fee amounts on a uniform proportionate basis see 21 U.S.C.
379jc2Dii. If necessary, after this adjustment, FDA may further increase the base establishment registration fees to generate the inflation adjusted total revenue amount see 21 U.S.C.
379jc3.
C. Calculation of Fee Rates Table 3 provides the last 3 years of fee-paying submission counts and the 3year average. These numbers are used to project the fee-paying submission counts that FDA will receive in FY
2022.

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TABLE 3THREE-YEAR AVERAGE OF FEE-PAYING SUBMISSIONS
FY 2018
actual
Application type Full Fee Applications
Small Business
Panel-Track Supplement
1 The Bureau of Labor Statistics Announcement of the geographical revision can be viewed at
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FY 2019
actual 38
7 23

FY 2020
actual 32
8 14

https www.bls.gov/cpi/additional-resources/
geographic-revision-2018.htm.

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3-Year average 30
6 22

33
7 20