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NCCIH Clinical FOAs Required Application Elements—Mind and Body

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 eliminated 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.

Fundamental Science Research on Mind and Body Approaches (R21)

PAR-18-322

Period of Award: Up to 2 years

Budget: Combined budget for direct costs for the two-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.

Fundamental Science Research on Mind and Body Approaches (R01)

PAR-18-323

Period of Award: Up to 5 years

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

Phased Innovation Award for Mechanistic Studies To Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R61/R33)

PAR-18-114

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: a limit of $300,000 per year in direct costs is recommended; R33 phase: a limit of $500,000 per year in direct costs is recommended

Innovation Award for Mechanistic Studies To Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R33)

PAR-18-115

Period of Award: Up to 3 years

Budget: A limit of $500,000 per year in direct costs is recommended

Exploratory Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34)

PAR-18-417

Period of Award: Up to 3 years (includes the optional administrative period)

Budget: Up to $450,000 total (includes optional administrative period budget of up to $100,000; and limited to $225,000 in direct costs per year)

NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01)

PAR-18-118

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 Mind and Body Interventions (Collaborative UG3/UH3)

PAR-18-662

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

Mind and Body Intervention Multisite Clinical Trial Data Coordinating Center (U24)

PAR-18-663

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. The combined budgets of the Clinical Coordinating Center and Data Coordinating Center will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied.