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  1. Prescription Drug User Fee Amendments

Food and Drug Administration Reauthorization Act (FDARA) of 2017 Hiring Data

As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI) and the Biosimilar User Fee Act (BsUFA II), the Food and Drug Administration (FDA) committed to reporting quarterly updates on the progress made towards hiring goals for fiscal years (FY) 2018-2022. Tables will be added for each FY (2018-2022) below and updated quarterly.

FY19 Hiring Goals

PDUFA VI FY 2019 Hiring Goals Q1
Hires*
Q2
Hires*

Q3
Hires

(06/22/19)

Q4
Hires
Total Percentage complete
Center for Drug Evaluation and Research (CDER) 60 20     6 7   33 55%
Center for Biologics Evaluation and Research (CBER) 8 8 0 0   8 100%
Other FDA** 6 0 0       0%
TOTAL Full Time Equivalents (FTEs) 74 28 6 7   41 55%

Remaining Hires from FY18

The tables below represent the outstanding hiring goals from FY18 for PDUFA VI and BsUFA II and FDA’s completion percentage of those hiring goals as of June 22nd, 2019. See below for the complete table for FY18 quarterly goals and hires.

PDUFA VI FY 2018 Hiring Goal Total Hires Percentage complete
Center for Drug Evaluation and Research (CDER) 45 45 100%
BSUFA II FY 2018 Hiring Goal Total Hires Percentage complete
Center for Drug Evaluation and Research (CDER) 15 12 80%

*A hire is defined as someone who has been confirmed as on board by the date indicated in a full-time position at the noted Center. While some hires are recruited from outside the Center/FDA, in some cases a hire can also be a current Center/FDA employee who is changing positions within the agency.

**Please note for FY19 Hiring Goals: 4 positions from “Other FDA” were reallocated to CDER.

FY18 Hiring Goals

As part of the reauthorizations of the Prescription Drug User Fee Act (PDUFA VI) and the Biosimilar User Fee Act (BsUFA II), the Food and Drug Administration (FDA) committed to reporting quarterly updates on the progress made towards hiring goals for fiscal years (FY) 2018-2022.

PDUFA VI FY 2018 Hiring Goals Q1
Hires*
Q2
Hires
Q3
Hires**
Q4
Hires
 Total  Percentage Complete
Center for Drug Evaluation and Research (CDER) 45 3 1  12  21  37  82%
Center for Biologics Evaluation and Research (CBER) 16 11 0  5  0  16  100%
Other FDA*** 10 1 3  2  4  10  100%
TOTAL Full Time Equivalents (FTEs) 71 15 4  19  25  63  89%
BSUFA II FY 2018 Hiring Goals Q1 Hires Q2 Hires Q3 Hires** Q4 Hires Total Percentage Complete
CDER 15 1 1  2  4 8 53%
CBER 0 0 0  0  0 0  
OTHER FDA 0 0 0  0  0 0  
TOTAL FTE 15 1 1  2  4 8 53%

*A hire is defined as someone who has started a full-time position at the noted Center. While some hires are recruited from outside the Center/FDA, in some cases a hire can also be a current Center/FDA employee who is changing positions within the agency.

**As of June 30, 2018

***Please note, 2 FTE’s from “Other” FDA were reallocated to CDER.