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 | FY 2021 |
| INAD - Human Food Safety | $2,557 | $3,389 | $3,402 |
| INAD - Safety & Efficacy - Food Animals | $533 | $593 | $617 |
| INAD - Safety & Efficacy - Non Food Animals | $1,039 | $1,194 | $1,207 |
| INAD - Environmental | $89 | $80 | $87 |
| INAD - Manufacturing | $208 | $198 | $204 |
| Administrative NADA | $251 | $216 | $217 |
| Supplement - Safety & Efficacy | $147 | $124 | $129 |
| Supplement - Other | $18 | $19 | $20 |
ADUFA III
| Submission Type | Average Standard Costs per Year ($ 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 |