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

Submission Type	FY 14	FY 15	Fy 16	FY17
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 Type	FY 03	FY 04	FY 05	FY 06	FY 07	FY 08	FY 09	FY 10	FY 11	FY 12	FY 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 Type	FY 93	FY 94	FY 95	FY 96	FY 97	FY 98	FY 99	FY 00	FY 01	FY 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

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