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NCCIH Clinical FOAs Required Application Elements – Natural Products

Applicants should follow instructions in the application package and use the PHS Human Subjects and Clinical Trial Information form to provide details about their clinical trial (see Annotated FORMS-E). NIH policy has eliminate most Appendix materials related to clinical trials (NOT-OD-18-126); however, investigators should follow instructions within the FOA and outlined below to provide additional attachments when required by the FOA. Please be sure to check the “Related Notices” section of the FOA for any changes to the required elements.

NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

PAR-18-829

Period of Award: Up to 2 years for R61 phase; up to 3 years for R33 phase (R61/R33 combined up to 5 years)

Budget: R61 phase: limited to $500,000 total in direct costs for up to 2 years; R33 phase: limited to $1,050,000 total in direct costs for up to 3 years


NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)

PAR-18-828

Period of Award: Up to 3 years

Budget: Limited to $1,050,000 total in direct costs for up to 3 years


NCCIH Natural Product Phase II Clinical Trial Cooperative Agreement (U01)

PAR-18-125

Period of Award: Up to 5 years

Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year


Clinical Coordinating Center for NCCIH Multisite Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3)

PAR-18-696

Period of Award: UG3 phase: 1 year planning; UH3 phase: up to 4 years implementation (up to 6 years with strong justification)

Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year


Natural Product Multisite Clinical Trial Data Coordinating Center (Collaborative U24)

PAR-18-697

Period of Award: Up to 5 years (up to 7 years with strong justification)

Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year