Activity to Specific Applies Lists to Activity Com- Cross Agency Code ponent Specific (Inclusion Multi Type (Lists Form & (Multi (Multi Mandatory FOA or Project Project (Y/N) (Y/N) Specific Both Only) Only) Planned Study Title X of 017.1.1 N N Incl : V 1.0 Both Provide Warning if Human Subjects are involved W NIH, Y Planned Enrollment but no Planned Enrollment CDC, Report(s) for inclusion has Report form is not part FDA, Report been included. of the application AHRQ, when HS = Y and VA Exemption not E4 Planned Study Title X of 017.1.2 N N Incl : V 1.0 Both Provide warning if Planned Enrollment Report(s) W NIH, Y Planned Enrollment was submitted with no data. If CDC, Report is submitted with not a Delayed Onset study, is FDA, Report all zeros planned enrollment data AHRQ, needed? VA 017.2 Planned Study Title: Report Planned 017.3 Report Planned Comments: 017.4 Report Planned Racial 017.5 Category: American Report Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Female 017.6 Planned Racial Category:
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) Planned Report Study Title X of Y 017.1.1 N N Incl : NIH, CDC, FDA, AHRQ, VA V 1.0 Both Provide Warning if Planned Enrollment Report form is not part of the application when HS = Y and Exemption not E4 Human Subjects are involved but no Planned Enrollment Report(s) for inclusion has been included. W Planned Report Study Title X of Y 017.1.2 N N Incl : NIH, CDC, FDA, AHRQ, VA V 1.0 Both Provide warning if Planned Enrollment Report is submitted with all zeros Planned Enrollment Report(s) was submitted with no data. If not a Delayed Onset study, is planned enrollment data needed? W Planned Report Study Title: 017.2 Planned Report 017.3 Planned Report Comments: 017.4 Planned Report Racial Category: American Indian/ Alaska Native; Ethnic Category: Not Hispanic or Latino, Female 017.5 Planned Racial Category: 017.6