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  5. Standard Costs (in thousands of dollars) for Components of the Process for the Review of Animal Drug Applications
  1. FDA User Fee Programs

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

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

ADUFA III

Submission Type Average Standard Costs per Year ($ in thousands)
Drug Applications FY 2014 FY 2015 FY 2016 FY 2017 FY 2018
INAD - Human Food Safety $2,066 $2,159 $2,272 $2,329 $2,415
INAD - Safety & Efficacy - Food Animals $475 $481 $499 $513 $518
INAD - Safety & Efficacy - Non Food Animals $909 $906 $927 $962 $1,003
INAD - Environmental $82 $83 $83 $82 $84
INAD - Manufacturing $246 $235 $219 $210 $209
Administrative NADA $263 $264 $256 $247 $252
Supplement - Safety & Efficacy $169 $156 $153 $150 $148
Supplement - Other $17 $18 $18 $18 $18

ADUFA II

Submission Type Average Standard Costs per Year ($ in thousands)
Drug Applications FY 2009 FY 2010 FY 2011 FY 2012 FY 2013
INAD - Human Food Safety $1,447 $1,548 $1,802 $1,922 $1,979
INAD - Safety & Efficacy - Food Animals $417 $440 $458 $451 $469
INAD - Safety & Efficacy - Non Food Animals $912 $976 $989 $966 $943
INAD - Environmental $96 $94 $88 $89 $85
INAD - Manufacturing $248 $264 $252 $249 $252
Administrative NADA $286 $286 $280 $269 $269
Supplement - Safety & Efficacy $226 $200 $202 $184 $182
Supplement - Other $19 $18 $18 $18 $17

ADUFA I

Submission Type Average Standard Costs per Year ($ in thousands)
Drug Applications FY 2004 FY 2005 FY 2006 FY 2007 FY 2008
INAD - Human Food Safety $1,291 $1,013 $1,248 $1,496 $1,283
INAD - Safety & Efficacy - Food Animals $1,056 $949 $722 $515 $380
INAD - Safety & Efficacy - Non Food Animals $542 $938 $1,029 $850 $882
INAD - Environmental $25 $27 $69 $104 $100
INAD - Manufacturing $249 $214 $210 $176 $213
Administrative NADA $85 $171 $231 $215 $265
Supplement - Safety & Efficacy $92 $93 $115 $113 $192
Supplement - Other $12 $15 $15 $16 $18