Supplement CDC, applications, If NIH Clinical allowed unless your Revision application (or Resubmission of a Phase III FDA, Trial is Yes and NIH Revision) does not include the components that involve Clinical Trial AHRQ Defined Phase III clinical Phase III clinical trial. (Y/N) trial is not on all ‘Yes’ components of the application and the Overall NIH Phase III clinical trial is Yes, provide Warning PHS 398 Cover Disclosure 008.24 Page Permission Supplement Statement PHS 398 Cover Program N N Incl : V 2.0 Incl: Single Provide warning if checked Program income should not be marked as Yes for this W Page Income NIH, T01, T02, yes for Training grants application. Supplement CDC, T03, T14, applications FDA, T42, T90, AHRQ T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R PHS 398 Cover Program N Incl : V 2.0 Both Both If Program Anticipated If the answer to Program Income Anticipated question is E ‘No’, Page Income, NIH, question= N and Program no program income details may be entered. Supplement Budget Period CDC, Income data is provided, 1-5 FDA, give error. AHRQ PHS 398 Cover Program N Incl : V 2.0 Both Overall Y The number of program The Program Income Anticipated Amount has been provided for E Page Income, NIH, income budget periods <x> budget periods. Only <y> periods of budgets were provided Supplement Budget Period CDC, must be less than or equal for this application. 1-5 FDA, to the number of budgets AHRQ provided in the budget form. PHS 398 Cover Program 008.26 Page Income, Supplement Sources 1-5 PHS 398 Cover Program Y N Incl : V 2.0 Both Overall Must be less than The Program Income Anticipated Amount for budget period E
Supplement Phase III Clinical Trial (Y/N) CDC, FDA, AHRQ applications, If NIH Clinical Trial is Yes and NIH Defined Phase III clinical trial is not ‘Yes’ on all components of the application and the Overall NIH Phase III clinical trial is Yes, provide Warning allowed unless your Revision application (or Resubmission of a Revision) does not include the components that involve Phase III clinical trial. PHS 398 Cover Page Supplement Disclosure Permission Statement 008.24 PHS 398 Cover Page Supplement Program Income N N Incl : NIH, CDC, FDA, AHRQ V 2.0 Incl: T01, T02, T03, T14, T42, T90, T90/R90, TU2,T15, T32, T34, T35, T36, T37, K12, D43, D71, U2R Single Provide warning if checked yes for Training grants applications Program income should not be marked as Yes for this application. W PHS 398 Cover Page Supplement Program Income, Budget Period 1-5 N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Both If Program Anticipated question= N and Program Income data is provided, give error. If the answer to Program Income Anticipated question is ‘No’, no program income details may be entered. E PHS 398 Cover Page Supplement Program Income, Budget Period 1-5 N Incl : NIH, CDC, FDA, AHRQ V 2.0 Both Overall Y The number of program income budget periods must be less than or equal to the number of budgets provided in the budget form. The Program Income Anticipated Amount has been provided for <x> budget periods. Only <y> periods of budgets were provided for this application. E PHS 398 Cover Page Supplement Program Income, Sources 1-5 008.26 PHS 398 Cover Program Y N Incl : V 2.0 Both Overall Must be less than The Program Income Anticipated Amount for budget period E
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