(Y/N) typically not allowed unless all components of the application and the your Revision application (or Overall NIH Resubmission of a Revision) Phase III clinical trial is does not include the Yes, provide Warning components that involve Phase III clinical trial. PHS 398 Cover Disclosure 008.24 Page Permission Supplement Statement PHS 398 Cover Program 008.25 Page Income Supplement PHS 398 Cover Program N Incl : V 2.0 Both Both E If Program Anticipated If the answer to Program Page Income, NIH, question= N and Income Anticipated question is Supplement Budget Period CDC, Program Income data is no program income ‘No’, 1-5 FDA, provided, give error. details may be entered. AHRQ, VA PHS 398 Cover Program N Incl : V 2.0 Both Overall Y The number of program The Program Income E Page Income, NIH, income budget periods Anticipated Amount has been Supplement Budget Period CDC, must be less than or provided for <x> budget 1-5 FDA, equal to the number of periods. Only <y> periods of AHRQ, budgets provided in the budgets were provided for this VA budget form. application. 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 E Page Income, NIH, 10,000,000,000 Anticipated Amount for budget Supplement Anticipated CDC, period <budget period> Amount 1-5 FDA, exceeds the allowable amount AHRQ, for the agency. VA PHS 398 Cover Human N N Incl : V 2.0 Both Both A response is required A response of or is E ‘Yes’ ‘No’ Page Embryonic NIH, for Human Embryonic required to the Human Supplement Stem Cells CDC, Stem Cells (HESC) Embryonic Stem Cells (HESC)
(Y/N) all components of the application and the Overall NIH Phase III clinical trial is Yes, provide Warning typically not 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 008.25 PHS 398 Cover Page Supplement Program Income, Budget Period 1-5 N Incl : NIH, CDC, FDA, AHRQ, VA 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, VA 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 Page Supplement Program Income, Anticipated Amount 1-5 Y N Incl : NIH, CDC, FDA, AHRQ, VA V 2.0 Both Overall Must be less than 10,000,000,000 The Program Income Anticipated Amount for budget period <budget period> exceeds the allowable amount for the agency. E PHS 398 Cover Page Supplement Human Embryonic Stem Cells N N Incl : NIH, CDC, V 2.0 Both Both A response is required for Human Embryonic Stem Cells (HESC) A response of ‘Yes’ or ‘No’ is required to the Human Embryonic Stem Cells (HESC) E
SVS-Validations-Single-and-Multi-Project-April-2015-tracked-PreRelease.docx