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  1. Prescription Drug User Fee Amendments

Standard Costs (in thousands of dollars) for Components of the Process for the Review of Human Drug Applications

FY 2014 - FY 2017

Estimates Made Pursuant to Section 736(d)(2) of the Federal Food, Drug, and Cosmetic Act

Excel Version (XLS - 24 KB)

Submission TypeFY 14FY 15Fy 16FY17
Drug Applications
IND$459.0$550.3$600.4$619.2
NDA Clinical Data - NME$5,646.4$5,250.5$5,929.1$5,340.6
NDA with Clinical Data - Non-NME$1,845.2$1,356.2$1,817.1$1,528.0
NDA without Clinical Data$757.6$975.8$1,161.6$849.2
Supplement with Clinical Data$337.8$384.6$473.6$349.0
Supplement without Clinical Data$75.9$55.4$59.4$49.8
Biologic Applications
IND$602.3$428.9$476.9$396.0
BLA$5,533.5$5,054.8$4,887.1$4,596.9
PLA    
ELA    
Supplement with Clinical Data$401.3$395.7$331.0$286.2
Supplement without Clinical Data$83.9$100.4$88.6$87.0

Revised to Incorporate FY 2012 Standard Costs                          

 FY 2003 - FY 2013

 Estimates Made Pursuant to Section 736(d)(2) of the Federal Food, Drug, and Cosmetic Act

 From Time Rpt.  
Submission TypeFY 03FY 04FY 05FY 06FY 07FY 08FY 09FY 10FY 11FY 12FY 13
Drug Applications     
IND$299$203.3$240$249.6$284.7$236.5$290.9$362.1$423.3$498.5$449.5
NDA with Clinical Data - NME$2,116$1,987.1$2,456.3$2,986.2$2,250.9$3,736.4$4,021.0$4,316.6$5,091.6$3,279.0$5,122.0
NDA with Clinical Data - Non-NME$746$760.1$684.6$777.1$804.9$1,320.9$1,313.1$1,863.6$2,368.5$1,936.1$1,474.7
NDA without Clinical Data$561$411.5$476.5$481$239.6$288.7$398.4$502.1$917.1$982.7$1,020.7
Supplement with Clinical Data$175$142.2$255.4$224.4$247.8$364.0$555.9$615.7$693.7$525.9$372.3
Supplement without Clinical Data$18$16.7$16.5$22.7$19.4$13.8$28.7$31.4$17.8$27.0$49.8
Biologic Applications  
IND$361$400.4$437.1$393.9$427.5$802.8$860.4$791.9$1,000.8$771.7$550.7
BLA$4,394$4,074.7$4,492.2$2,626.2$3,141.6$2,726.7$3,529.6$6,081.5$11,203.5$5,905.8$4,089.8
PLA           
ELA           
Supplement with Clinical Data$228$367.4$239.4$265.2$627.1$511.5$681.8$655.4$661.3$1,166.8$459.0
Supplement without Clinical Data$21$41$41.9$40.2$53$49.4$68.3$72.8$83.8$80.4$78.1
1 Standard costs include all costs associated with application review, including rent, overhead, and centrally funded costs. Method revised in FY 2001-2002 based on KPMG study, and in 2003 on time reporting data. Time reporting method revised with better allocation of indirect cost beginning in 2004.                                                                             

FY 1993 - FY 2002

Estimates Made Pursuant to Section 736(d)(2)of the Federal Food, Drug, and Cosmetic Act

Submission TypeFY 93FY 94FY 95FY 96FY 97FY 98FY 99FY 00FY 01FY 02
Drug Applications
IND$70$79$98$97$84$94$105$119$200$211.8
NDA with Clinical Data - NME$887$1,004$1,243$1,233$1,065$1,194$1,328$1,503$1,920$2,037.0
NDA with Clinical Data - Non-NME$298$337$417$414$358$401$446$505$929$985.9
NDA without Clinical Data$127$144$178$177$152$171$190$215$261$276.6
Supplement with Clinical Data$151$171$212$210$181$203$226$256$111$118.1
Supplement without Clinical Data$6$7$8$8$7$8$9$10$8$8.1
Biologic Applications
IND$184$230$234$266$204$173$243$175$287$278.9
BLA     $1,118$1,568$1,128$2,788$2,708.2
PLA$1,078$1,345$1,369$1,560$1,194$1,016$1,426$1,026  
ELA$177$221$225$256$196$167$234$168  
Supplement with Clinical Data$561$700$713$812$622$529$742$534$195$189.6
Supplement without Clinical Data$34$42$43$49$38$32$45$32$31$29.8
1 Standard costs include all costs associated with application review, including rent, overhead, and centrally funded costs. Method revised in FY 2001-2002 based on KPMG study, and in 2003 on time reporting data. Time reporting method revised with better allocation of indirect cost beginning in 2004.

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