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Federal Register / Vol. 86, No. 155 / Monday, August 16, 2021 / Notices preceding 4 fiscal years, multiplied by the proportion of PC&B costs to total FDA costs of the process for the review of human drug applications for the first 3 of the preceding 4 fiscal years see
section 736c1A and B of the FD&C
Act.
Table 1 summarizes the actual cost and FTE data for the specified fiscal years and provides the percent changes
from the previous fiscal years and the average percent changes over the first 3
of the 4 fiscal years preceding FY 2022.
The 3-year average is 2.7383 percent.

TABLE 1FDA PERSONNEL COMPENSATION AND BENEFITS PC&B EACH YEAR AND PERCENT CHANGES
Fiscal year
2018

Total PC&B
Total FTE
PC&B per FTE
Percent Change From Previous Year

The statute specifies that this 2.7383
percent be multiplied by the proportion of PC&B costs to the total FDA costs of
2019

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

2020

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

the process for the review of human drug applications. Table 2 shows the PC&B and the total obligations for the
$2,875,592,000
17,535
$163,992
7.3063

3-Year average

2.7383

process for the review of human drug applications for the first 3 of the preceding 4 fiscal years.

TABLE 2PC&B AS A PERCENT OF TOTAL COST OF THE PROCESS FOR THE REVIEW OF HUMAN DRUG APPLICATIONS
Fiscal year
2018

Total PC&B
Total Costs
PC&B Percent

The payroll adjustment is 2.7383
percent from table 1 multiplied by 59.7496 percent or 1.6361 percent.
The statute specifies that the portion of the inflation adjustment for nonpayroll costs is the average annual percent change that occurred in the Consumer Price Index CPI for urban consumers Washington-Baltimore, DCMD-VA-WV; not seasonally adjusted; all items; annual index for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than PC&B costs to total costs of the process for the review of
2019

$792,900,647
$1,374,508,527
57.6861

2020

$872,087,636
$1,430,338,888
60.9707

human drug applications for the first 3
years of the preceding 4 fiscal years see section 736c1B of the FD&C Act.
As a result of a geographical revision made by the Bureau of Labor and Statistics in January 2018 1, the Washington-Baltimore, DC-MD-VA-WV
index was discontinued and replaced with two separate indices i.e., Washington-Arlington-Alexandria, DCVA-MD-WV and Baltimore-ColumbiaTowson, MD. In order to continue applying a CPI that best reflects the geographic region in which FDA is headquartered and that provides the
$891,395,106
$1,471,144,928
60.5919

3-Year average
59.7496

most current data available, the Washington-Arlington-Alexandria index will be used in calculating the relevant adjustment factors for FY 2020 and subsequent years. Table 3 provides the summary data for the percent changes in the specified CPI for the WashingtonArlington-Alexandria area. The data are published by the Bureau of Labor Statistics and can be found on its website at: https data.bls.gov/pdq/
SurveyOutputServlet?data_
tool=dropmap&series_id=
CUURS35ASA0,CUUSS35ASA0.

TABLE 3ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN CPI FOR WASHINGTON-ARLINGTON-ALEXANDRIA AREA
Year
2018

lotter on DSK11XQN23PROD with NOTICES1

Annual CPI
Annual Percent Change

261.445
2.0389

The statute specifies that this 1.4041
percent be multiplied by the proportion of all costs other than PC&B to total costs of the process for the review of human drug applications obligated.
Because 59.7496 percent was obligated for PC&B as shown in table 2, 40.2504
percent is the portion of costs other than PC&B 100 percent minus 59.7496
percent equals 40.2504 percent. The non-payroll adjustment is 1.4041

percent times 40.2504 percent, or 0.5652
percent.
Next, we add the payroll adjustment 1.6361 percent to the non-payroll adjustment 0.5652 percent, for a total inflation adjustment of 2.2013 percent rounded for FY 2022.
We then multiply the base revenue amount for FY 2022 $1,098,077,960 by 1.022013, yielding an inflation-adjusted amount of $1,122,249,950.

1 The Bureau of Labor Statistics announcement of the geographical revision can be viewed at https

www.bls.gov/cpi/additional-resources/geographicrevision-2018.htm.

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2019

2020

264.777
1.2745

267.157
0.8989

3-Year average
1.4041

B. FY 2022 Statutory Fee Revenue Adjustments for Capacity Planning The statute specifies that after $1,098,077,960 has been adjusted for inflation, the inflation-adjusted amount shall be further adjusted to reflect changes in the resource capacity needs for the process of human drug application reviews see section 736c2 of the FD&C Act. Following a process required in statute, the FDA

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