Report Enrollment Type must be “Planned”. study title to message) PHS Report Enrollment Type 033.3.3 N N Incl: NIH, AHRQ Both If enrollment type is planned then no data should be entered in any unknown/not reported columns / rows of the data table. For <Study Title>, If you answered “Planned” to the Enrollment Type questions, then you should not provide values for any on the Unknown or Not Reportted cells in the data table. E Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Report Using an Existing Dataset or Resource 033.4.1 N N Incl: NIH, AHRQ Both Using an existing dataset or resource is required if answer to Delayed Onset Study question is “No”. For <Study Title>, An answer to the “Using an Existing Dataset or Resource” question must be provided if you answered “No” to the Delayed Onset Study question. E Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Report Enrollment Location 033.5.1 N N Incl: NIH, AHRQ Both Enrollment Location is required if answer to Delayed Onset Study question is “No”. For <Study Title>, An answer to the “Enrollment Location” question must be provided if you answered “No” to the Delayed Onset Study question. E Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Report Report Clinical Trial 033.6.1 N N Incl: NIH, AHRQ Both Clinical Trial is required if answer to Delayed Onset Study question is “No”. For <Study Title>, An answer to the “Clinical Trial” question must be provided if you answered “No” to the Delayed Onset Study question. E Forms D, March 2016 Release May 2016 Release (added study title to message) PHS NIH-Defined Phase III Clinical Trial 033.7.1 N N Incl: NIH, AHRQ Both NIH-Defined Phase III Clinical Trial is required if answer to Delayed For <Study Title>, An answer to the Phase III Clinical Trial” question must be E Forms D, March 2016 Release
Report Onset Study question is “No”. provided if you answered “No” to the Delayed Onset Study question. May 2016 Release (added study title to message) PHS Report NIH-Defined Phase III Clinical Trial 033.7.2 N N Incl: NIH, AHRQ Both If Clinical Trial is set to No, then NIH-Defined Phase III Clinical Trial cannot be set to Yes. For <Study Title>, The answer to NIH-Defined Phase III Clinical Trial question must be “No” if the answer to the Clinical Trial question is “No”. E Forms D, March 2016 Release May 2016 Release (added study title to message) PHS Report Comments 033.8.1 PHS Report Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Female 033.9.1 PHS Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Male 033.10.1
PHS Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Unknown 033.11.1 PHS Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Hispanic or Latino, Female 033.12.1 PHS Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Hispanic or Latino, Male 033.13.1 PHS Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Hispanic or 033.14.1
Latino, Unknown PHS Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Unknown, Female 033.15.1 PHS Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Unknown, Male 033.16.1 PHS Report Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Unknown, Unknown 033.17.1 PHS Report Racial Category: American Indian/ Alaska Native; Total 033.18.1
PHS Report Racial Category: Asian; Ethnic Category: Hispanic or Latino, Unknown 033.24.1 PHS Report Racial Category: Asian; Ethnic Category: Unknown, Female 033.25.1 PHS Report Racial Category: Asian; Ethnic Category: Unknown, Male 033.26.1 PHS Report Racial Category: Asian; Ethnic Category: Unknown, Unknown 033.27.1 PHS Report Racial Category: American Asian; Total 033.28.1
PHS Report Racial Category: Native Hawaiian /Pacific Islander; Ethnic Category: Not Hispanic or Latino, Female 033.29.1 PHS Report Racial Category: American Native Hawaiian /Pacific Islander; Ethnic Category: Not Hispanic or Latino, Male 033.30.1 PHS Report Racial Category: Native Hawaiian /Pacific Islander; Ethnic Category: Not Hispanic or Latino, Unknown 033.31.1 PHS Racial Category: Native Hawaiian /Pacific 033.32.1
Report Report Islander; Ethnic Category: Hispanic or Latino, Female PHS Report Racial Category: Native Hawaiian /Pacific Islander; Ethnic Category: Hispanic or Latino, Male 033.33.1 PHS Report Racial Category: Native Hawaiian /Pacific Islander; Ethnic Category: Hispanic or Latino, Unknown 033.34.1 PHS Report Racial Category: Native Hawaiian /Pacific Islander; Ethnic Category: Unknown, Female 033.35.1
PHS Report Racial Category: Native Hawaiian /Pacific Islander; Ethnic Category: Unknown, Male 033.36.1 PHS Report Racial Category: Native Hawaiian /Pacific Islander; Ethnic Category: Unknown, Unknown 033.37.1 PHS Report Racial Category: Native Hawaiian /Pacific Islander; Total 033.38.1 PHS Report Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Female 033.39.1 PHS Racial Category: Black 033.40.1
Report or African American; Ethnic Category: Not Hispanic or Latino, Male PHS Report Racial Category: Black or African American; Ethnic Category: Not Hispanic or Latino, Unknown 033.41.1 PHS Report Racial Category: Black or African American; Ethnic Category: Hispanic or Latino, Female 033.42.1 PHS Report Racial Category: Black or African American; Ethnic Category: Hispanic or Latino, Male 033.43.1 PHS Racial Category: Black 033.44.1
Report or African American; Ethnic Category: Hispanic or Latino, Unknown PHS Report Racial Category: Black or African American; Ethnic Category: Unknown, Female 033.45.1 PHS Report Racial Category: Black or African American; Ethnic Category: Unknown, Male 033.46.1 PHS Report Racial Category: Black or African American; Ethnic Category: Unknown, Unknown 033.47.1 PHS Racial Category: Black or 033.48.1
Report Hispanic or Latino, Male PHS Report Racial Category: White; Ethnic Category: Hispanic or Latino, Unknown 033.54.1 PHS Report Racial Category: White; Ethnic Category: Unknown, Female 033.55.1 PHS Report Racial Category: White; Ethnic Category: Unknown, Male 033.56.1 PHS Report Racial Category: White; Ethnic Category: Unknown, Unknown 033.57.1 PHS Racial Category: White; Total 033.58.1
Report PHS Report Racial Category: More than One Race; Ethnic Category: Not Hispanic or Latino, Female 033.59.1 PHS Report Racial Category: More than One Race; Ethnic Category: Not Hispanic or Latino, Male 033.60.1 PHS Report Racial Category: More than One Race; Ethnic Category: Not Hispanic or Latino, Unknown 033.61.1 PHS Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Female 033.62.1
PHS Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Male 033.63.1 PHS Report Racial Category: More than One Race; Ethnic Category: Hispanic or Latino, Unknown 033.64.1 PHS Report Racial Category: More than One Race; Ethnic Category: Unknown, Female 033.65.1 PHS Report Racial Category: More than One Race; Ethnic Category: Unknown, Male 033.66.1 PHS Racial Category: More than One Race; Ethnic 033.67.1
Report Category: Unknown, Male PHS Report Racial Category: More than One Race; Ethnic Category: Unknown, Unknown 033.68.1 PHS Report Racial Category: More than One Race; Total 033.69.1 PHS Report Racial Category: Unknown; Ethnic Category: Not Hispanic or Latino, Female 033.70.1 PHS Report Racial Category: Unknown; Ethnic Category: Not Hispanic or Latino, Male 033.71.1 PHS Racial Category: Unknown; 033.72.1
Report Category: Not Hispanic or Latino, Unknown PHS Report Racial Category: Unknown; Ethnic Category: Hispanic or Latino, Female 033.73.1 PHS Report Racial Category: Unknown; Ethnic Category: Hispanic or Latino, Male 033.74.1 PHS Report Racial Category: Unknown; Ethnic Category: Hispanic or Latino, Unknown 033.75.1 PHS Report Racial Category: Unknown; Ethnic Category: 033.76.1
Unknown, Female PHS Report Racial Category: Unknown; Ethnic Category: Unknown, Male 033.77.1 PHS Report Racial Category: Unknown; Ethnic Category: Unknown, Unknown 033.78.1 PHS Report Racial Category: Unknown; Total 033.79.1 PHS Report Ethnic Category; Not Hispanic or Latino, Female; Total 033.80.1 PHS Ethnic Category; Not Hispanic or 033.81.1
Form Field Rule# Rule Categories Validation Error Message Error/ Warning Comments Mandatory (Y/N) (Y/N) Agency Specific (Lists Form FOA Specific Activity Specific Lists Activity Code (Inclusion & to Multi or Both Applies to Com- ponent Type (Multi Project Only) Cross (Multi Project Only) PHS Indirect Costs DUNS 021.1.1 N N Incl : NIH, CDC, FDA, AHRQ, V 1.0 Multi Overall DUNS is required The Organization DUNS number is required. E PHS Indirect Costs DUNS PHS Indirect Costs DUNS 021.1.3 N N Incl : NIH, CDC, FDA, AHRQ, V 1.0 Multi Overall Y Provide error if PHS Additional Indirect Costs form is present in the Overall component and all other components are lead at the overall organization (based on the DUNS number). The PHS Additional Indirect Costs Form should not be included with the application, since the Organization is the same for the Overall and all components. E PHS Indirect Costs Name of Organization 021.2 PHS Indirect Costs Budget Type: Project or 021.3.1 N N Incl : NIH, CDC, FDA, AHRQ, V 1.0 Multi Overall Budget type must be marked as ‘Project’ The budget type must be marked as ‘Project’. E PHS Start Date 021.4.1 N N Incl : NIH, V 1.0 Multi Overall For budget year 1, for new applications and resubmissions, must be the same as the On the <Organization name> budget for Budget Period < Budget Year>, the start date should be equal E
Indirect Costs Indirect Cost Base PHS Indirect Costs Indirect Costs - Funds Requested 021.9 PHS Indirect Costs Indirect Costs - Total Indirect Costs 021.10.1 N N Incl : NIH, CDC, FDA, AHRQ, V 1.0 Multi Overall Must be equal to funds requested for all indirect cost types for each Budget period. On the <Organization name> budget for Budget Period < Budget Year>, the Total Indirect Costs does not equal the sum of individual indirect costs for each indirect cost type. E PHS Indirect Costs Budget Justification 021.10.2 PHS Indirect Costs Indirect Costs 021.11.1 N N Incl : NIH, CDC, FDA, AHRQ, V 1.0 Multi Overall Must be equal to funds requested for all indirect cost types for all budget periods. On the <Organization name> budget, the Total Indirect Costs does not equal the sum of individual indirect costs for each indirect cost type for all budget periods. E