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

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

ADUFA IV

Submission Type Average Standard Costs per Year ($ in thousands)
Drug Applications FY 2019 FY 2020
INAD - Human Food Safety $2,557 $3,389
INAD - Safety & Efficacy - Food Animals $533 $593
INAD - Safety & Efficacy - Non Food Animals $1,039 $1,194
INAD - Environmental $89 $80
INAD - Manufacturing $208 $198
Administrative NADA $251 $216
Supplement - Safety & Efficacy $147 $124
Supplement - Other $18 $19

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

 

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