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  1. Prescription Drug User Fee Amendments

Center for Drug Evaluation and Research & Center for Biologics Evaluation and Research Net Hiring Data

Though the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI) and the Biosimilar User Fee Act (BsUFA II) commits FDA to report quarterly hiring updates under the respective user fee programs, that data does not represent or capture the entirety of the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research (CBER’s) hiring progress or status.

In an effort to provide a more comprehensive overview of CDER’s and CBER’s hiring progress and status, FDA is providing these tables that display total hires which include what is reported under PDUFA VI and BsUFA II. FDA plans to update this table concurrently with the FDARA quarterly hiring data page.

FY21 Quarterly Net Hiring for CDER (as of 3/27/2021)

CDER Employees On Board
Beginning of Quarter*
Gains ** Losses ** Employees On Board
End of Quarter***
Net Gains
FY21 - Q1 5293 87 50 5330 37
FY21 - Q2 5330 129 96 5363 33
FY21 - Q3          
FY21 - Q4          
Total FY21 5293 216 146 5363 70

* Numbers are based on data pulled on a particular date and could fluctuate slightly due to corrections in the underlying data if pulled on another day.
** External to CDER Gains and Losses
*** Numbers for each month/quarter are based on the last full pay period of the month. Q4 reflects through 09/30

FY21 Quarterly Net Hiring for CBER (as of 3/27/2021)

CBER Employees On Board
Beginning of Quarter*
Gains ** Losses ** Employees On Board
End of Quarter***
Net Gains
FY21 - Q1 1147 29 8 1168 21
FY21 - Q2 1168 33 19 1182 14
FY21 - Q3          
FY21 - Q4          
Total FY21 1147 62 27 1182 35

* Numbers are based on data pulled on a particular date and could fluctuate slightly due to corrections in the underlying data if pulled on another day.
** External to CBER Gains and Losses
*** Numbers for each month/quarter are based on the last full pay period of the month. Q4 reflects through 09/30

FY20 Quarterly Net Hiring for CDER (as of 9/30/2020)

CDER Employees On Board
Beginning of Quarter*
Gains ** Losses ** Employees On Board
End of Quarter***
Net Gains
FY20 - Q1 5112 106 70 5148 36
FY20 - Q2 5148 115 92 5171 23
FY20 - Q3 5171 90 57 5204 33
FY20 - Q4 5204 168 79 5293 89
Total FY20 5112 479 298 5293 181

* Numbers are based on data pulled on a particular date and could fluctuate slightly due to corrections in the underlying data if pulled on another day.
** External to CDER Gains and Losses
*** Each month/quarter is based on the last full pay period of the month
*** Numbers for each month/quarter are based on the last full pay period of the month. Q4, however, reflects through 09/30.
NOTE: Adjusted the FY20 Q1 beginning number based on an FY19 late gain and FY20 through 09/30/20.

 

FY20 Quarterly Net Hiring for CBER (as of 9/30/2020)

CBER Employees On Board
Beginning of Quarter*
Gains ** Losses ** Employees On Board
End of Quarter***
Net Gains
FY20 - Q1 1126 29 20 1135 9
FY20 - Q2 1135 23 31 1127 -8
FY20 - Q3 1127 27 14 1140 13
FY20 - Q4 1140 34 27 1147 7
Total FY20 1126 113 92 1147 21

* Numbers are based on data pulled on a particular date and could fluctuate slightly due to corrections in the underlying data if pulled on another day. (Q1 and Q3 adjustments made after previous submissions – 1 late loss in Q1 and 1 late loss in Q3).
** External to CBER Gains and Losses
*** Numbers for each month/quarter are based on the last full pay period of the month. Q4, however, reflects through 09/30.

FY19 Quarterly Net Hiring for CDER

CDER Employees On Board
Beginning of Quarter
Gains * Losses * Employees On Board
End of Quarter**
Net Gains
FY19 - Q1 5043 84 62 5065 22
FY19 - Q2 5065 93 99 5059 -6
FY19 - Q3 5059 90 73 5076 17
FY19 - Q4 5076 146 111 5111 35
Total FY19 5043 413 345 5111 68

* Numbers are based on data pulled on a particular date and could fluctuate slightly due to corrections in the underlying data if pulled on another day.
* External to CDER Gains and Losses
** Each month/quarter is based on the last full pay period of the month

FY19 Quarterly Net Hiring for CBER

CBER Employees On Board
Beginning of Quarter
Gains * Losses * Employees On Board
End of Quarter**
Net Gains
FY19 - Q1 1084 34 11 1107 23
FY19 - Q2 1107 20 26 1101 -6
FY19 - Q3 1101 30 21 1110 9
FY19 - Q4 1110 43 27 1126 16
Total FY19 1084 127 85 1126 42

* Numbers are based on data pulled on a particular date and could fluctuate slightly due to corrections in the underlying data if pulled on another day.
* External to CBER Gains and Losses
** Each month/quarter is based on the last full pay period of the month

 

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