An official website of the United States governmentCompleteness, Compliance, and Responsiveness Tables
Unique Completeness Aspects for the Mind and Body NOFOs
| NOFO Title | Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High Priority Research Topics (R34 CT Required) | NCCIH Multisite Feasibility Clinical Trials of Mind and Body Interventions (R01 CT Required) | Investigator-Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 CT Required) | CCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 CT Required) | DCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 CT Required) |
|---|---|---|---|---|---|
| NOFO # | PAR-24-084 | PAR-24-083 | PAR-24-08 | PAR-24-090 | PAR-24-087 |
| Clinical Trial Experience | |||||
| Data and Safety Monitoring Plan | |||||
| Milestone Plan (Section 2.7 of PHS Human Subjects and Clinical Trials Information) | |||||
| Milestone Plan (Other Clinical Trial-Related Attachments) | |||||
| Project Management Plan | |||||
| Cover Letter Attachment | |||||
| DMS Plan (If Applicable) |
Key: CCC = Clinical Coordinating Center; CT = Clinical Trial; DCC = Data Coordinating Center; DMS = Data Management and Sharing; mHealth = Mobile Health; NCCIH = National Center for Complementary and Integrative Health; NOFO = Notice of Funding Opportunity; PAR = Program Announcement with Special Receipt, Referral, and/or Review Considerations; PHS = Public Health Service; R01: Research Project; R34: Planning Grants; U24: Resource-Related Projects—Cooperative Agreements; UG3/UH3: Exploratory/Developmental Cooperative Agreement
Unique Compliance Aspects for the Mind and Body NOFOs
| NOFO Title | Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High-Priority Research Topics (R34 CT Required) | NCCIH Multisite Feasibility Clinical Trials of Mind and Body Interventions (R01 CT Required) | Investigator-Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 CT Required) | CCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 CT Required) | DCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative U24 CT Required) |
|---|---|---|---|---|---|
| NOFO # | PAR-24-084 | PAR-24-083 | PAR-24-08 | PAR-24-090 | PAR-24-087 |
| Late Applications Allowable Under NOFO | |||||
| Application Types Allowed | New, Resubmission | New, Resubmission | New, Renewal, Resubmission, Revision | New, Renewal, Resubmission, Revision | New, Renewal, Resubmission, Revision |
| CT Required? | |||||
| Allowable Budget | $450,000 total direct costs; >$225,000 per year not allowed | Not limited, but <$350,000 per year recommended | Not limited, but should reflect project needs | Not limited, but should reflect project needs; $500,000 policy applies to both collaborative applications combined | Not limited, but should reflect project needs; $500,000 policy applies to both collaborative applications combined |
| Allowable Project Period | 3 years | 3 years recommended; up to 5 years allowed | Maximum project period is 5 years | UG3 phase is 1 year; UH3 phase is expected to be 4 years, but up to 6 years with strong justification | 5 years expected; up to 7 years with strong justification |
| Foreign Organizations | Foreign components only; no foreign CT sites | Foreign components only; no foreign CT sites | Foreign components only; no foreign CT sites | Foreign components only; no foreign CT sites | Foreign components only; no foreign CT sites |
| Allowable Post-Submission Material | Updates to FDA communication, if applicable | Updates to FDA communication, if applicable, or clinical trial experience table | Updates to FDA communication, if applicable, clinical trial experience table, or milestones plan | Updates to FDA communication, clinical trial experience table, CCC milestones plan, or CCC project management plan | Updates to FDA communication, if applicable, clinical trial experience table, DCC milestones plan, or DCC project management plan |
| Collaborative Application Required | |||||
| Permission to Submit Required (If $500,000 Direct Costs) |
Key: CCC = Clinical Coordinating Center; CT = Clinical Trial; DCC = Data Coordinating Center; DMS = Data Management and Sharing; FDA = U.S. Food and Drug Administration; mHealth = Mobile Health; NCCIH = National Center for Complementary and Integrative Health; NOFO = Notice of Funding Opportunity; PAR = Program Announcement with Special Receipt, Referral, and/or Review Considerations; R01: Research Project; R34: Planning Grants; U24: Resource-Related Projects—Cooperative Agreements; UG3/UH3: Exploratory/Developmental Cooperative Agreement
Unique Responsiveness Aspects for the Mind and Body NOFOs
| NOFO Title | Feasibility Clinical Trials of Mind and Body Interventions for NCCIH High-Priority Research Topics (R34 CT Required) | NCCIH Multisite Feasibility Clinical Trials of Mind and Body Interventions (R01 CT Required) | Investigator Initiated Clinical Trials of Complementary and Integrative Interventions Delivered Remotely or via mHealth (R01 CT Required) | CCC or DCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 or U24 CT Required) |
|---|---|---|---|---|
| NOFO # | PAR-24-084 | PAR-24-083 | PAR-24-08 | PAR-24-090 PAR-24-087 |
| Trial Design | No mechanistic study or waitlist control; cannot target treatment or prevention of cancer | |||
| Feasibility, acceptability, fidelity, and/or adherence of mind and body intervention | Efficacy or effectiveness of mind-body intervention (mechanistic if strong rationale) | Efficacy or effectiveness or pragmatic trial of mind-body intervention | ||
| Intervention Delivery | Not specified | No fully remote intervention delivery | Fully remotely delivered intervention within United States or Canada; intervention cannot include DEA-regulated natural product | No fully remote intervention delivery (remote recruitment okay) |
| Preliminary Data | Not required | Required (intervention safety/feasibility at single site/team experience) | Required | Required (intervention feasibility and collective team experience) |
| Sites | Single site/multisite | Multisite (at least two that are geographically diverse) | Recruit eligible participants nationwide utilizing remote methods | Multisite (at least three geographically diverse; two sites with justification) |
| Power Analysis | Assess feasibility and/or acceptability benchmarks; fully powered or preliminary tests of clinical outcomes not allowed | Fully powered to test clinical outcomes | Fully powered to test clinical outcomes | |
Key: CCC = Clinical Coordinating Center; CT = Clinical Trial; DCC = Data Coordinating Center; DEA: U.S. Drug Enforcement Administration; DMS = Data Management and Sharing; FDA = U.S. Food and Drug Administration; mHealth = Mobile Health; NCCIH = National Center for Complementary and Integrative Health; NOFO = Notice of Funding Opportunity; PAR = Program Announcement with Special Receipt, Referral, and/or Review Considerations; R01: Research Project; R34: Planning Grants; U24: Resource-Related Projects—Cooperative Agreements; UG3/UH3: Exploratory/Developmental Cooperative Agreement
Unique Completeness Aspects for the NP CT NOFOs
| NOFO Title | NCCIH Natural Product Early-Phase Clinical Trial Phased Innovation Award (R61/R33 CT Required) | NCCIH Natural Product Early-Phase Clinical Trial Award (R33 CT Required) | NCCIH Natural Product Mid-Phase Clinical Trial (R01 CT Required) | CCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 CT Required) | Natural Product Multisite Clinical Trial Data Coordinating Center (Collaborative U24 CT Required) |
|---|---|---|---|---|---|
| NOFO # | PAR-24-124 | PAR-24-116 | PAR-24-115 | PAR-24-123 | PAR-24-125 |
| Clinical Trial Experience | |||||
| Data and Safety Monitoring Plan | |||||
| Milestones and Go/No-Go Criteria Plan (Other Attachments) | |||||
| Milestone Plan (Section 2.7 of PHS Human Subjects and Clinical Trials Information) | |||||
| Milestone Plan (Other Clinical Trial-Related Attachments) | |||||
| Project Management Plan | |||||
| Cover Letter Attachment | |||||
| DMS Plan (If Applicable) |
Key: CCC = Clinical Coordinating Center; CT = Clinical Trial; DMS = Data Management and Sharing; NCCIH = National Center for Complementary and Integrative Health; NOFO = Notice of Funding Opportunity; NP = Natural Product; PAR = Program Announcement with Special Receipt, Referral, and/or Review Considerations; PHS: Public Health Service; R01: Research Project; R33: Exploratory/Developmental Grants Phase II; R61/R33: Exploratory/Developmental Grants; U24: Resource-Related Projects—Cooperative Agreements; UG3/UH3: Exploratory/Developmental Cooperative Agreement
Unique Compliance Aspects for the NP CT NOFOs
| NOFO Title | NCCIH Natural Product Early-Phase Clinical Trial Phased Innovation Award (R61/R33 CT Required) | NCCIH Natural Product Early-Phase Clinical Trial Award (R33 CT Required) | NCCIH Natural Product Mid-Phase Clinical Trial (R01 CT Required) | CCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 CT Required) | Natural Product Multisite Clinical Trial DCC (Collaborative U24 CT Required) |
|---|---|---|---|---|---|
| NOFO # | PAR-24-124 | PAR-24-116 | PAR-24-115 | PAR-24-123 | PAR-24-125 |
| Late Applications Allowable Under NOFO | |||||
| Application Types Allowed | New, Resubmission | New, Resubmission | New, Resubmission | New, Renewal, Resubmission, Revision | New, Renewal, Resubmission, Revision |
| CT Required? | |||||
| Allowable Budget | Up to $350,000 direct costs per year in both the R61 and R33 phases | Up to $1,050,000 in direct costs for the duration of the award | Not limited, but strongly recommended no more than $350,000 in direct costs per year | Not limited, but should reflect project needs; $500,000 policy applies to both collaborative applications combined | Not limited, but should reflect project needs; $500,000 policy applies to both collaborative applications combined |
| Allowable Project Period | Maximum project period of 5 years for both phases, with up to 3 years for each individual R61 or R33 phase | Up to 3 years | No more than 3 years recommended, but with strong rationale a maximum project period can be 5 years | UG3 phase is 1 year; UH3 phase is expected to be 4 years, but up to 6 years with strong justification | 5 years expected; up to 7 years with strong justification |
| Foreign Organizations | Foreign components only | Foreign components only | Foreign components only | Foreign components only | Foreign components only |
| Allowable Post-Submission Material | Revised information about FDA-regulated interventions, if applicable, or milestone plan | Revised information about FDA-regulated interventions, if applicable | Revised information about FDA-regulated interventions, if applicable, or clinical trial experience table | Revised clinical trial experience table, CCC milestones plan, CCC project management plan, or updates to Section 4.6 on communications with FDA | Revised clinical trial experience table, DCC milestones plan, or DCC project management plan |
| Collaborative Application Required | |||||
| Permission to Submit Required (If $500,000 Direct Costs) |
Key: CCC = Clinical Coordinating Center; CT = Clinical Trial; DCC = Data Coordinating Center; FDA = U.S. Food and Drug Administration; NCCIH = National Center for Complementary and Integrative Health; NOFO = Notice of Funding Opportunity; NP = Natural Product; PAR = Program Announcement with Special Receipt, Referral, and/or Review Considerations; R01: Research Project; R33: Exploratory/Developmental Grants Phase II; R61/R33: Exploratory/Developmental Grants; U24: Resource-Related Projects—Cooperative Agreements; UG3/UH3: Exploratory/Developmental Cooperative Agreement
Unique Responsiveness Aspects for the NP CT NOFOs
| NOFO Title | NCCIH Natural Product Early-Phase Clinical Trial Phased Innovation Award (R61/R33 CT Required) | NCCIH Natural Product Early-Phase Clinical Trial Award (R33 CT Required) | NCCIH Natural Product Mid-Phase Clinical Trial (R01 CT Required) | CCC or DCC for NCCIH Multisite Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 or U24 CT Required) |
|---|---|---|---|---|
| NOFO # | PAR-24-124 | PAR-24-116 | PAR-24-115 | PAR-24-123 PAR-24-125 |
| Trial Design | No waitlist control, cannot target treatment or prevention of cancer, and no animal studies | |||
| Mechanistic | Mechanistic | Intervention refinement or optimization; Phase 1/first-in-human trials not allowed | Efficacy or effectiveness or pragmatic trial | |
| Intervention Requirements | Must include a natural product or standardized nutritional regimen; natural compound may not be synthetically modified | -Must include a natural product or standardized nutritional regimen; natural compound may not be synthetically modified -No fully remote intervention delivery (remote recruitment okay) | ||
| Preliminary Data | Not required | Required | Required | Required |
| Sites | Not specified | Not specified | Not specified | Multisite (at least three geographically diverse; two sites with justification) |
| Power Analysis | -Fully powered to assess target engagement or mechanism of action in R61 phase, if applicable -Fully powered to assess replicability in the R33 phase and association between target engagement and clinical outcomes -Fully powered or preliminary tests of efficacy or estimating effect size not allowed | -Trials proposing to measure or replicate target engagement not allowed -Fully powered or preliminary tests of efficacy or estimating effect size not allowed | Fully powered to test clinical outcomes | |
Key: CCC = Clinical Coordinating Center; CT = Clinical Trial; DCC = Data Coordinating Center; NCCIH = National Center for Complementary and Integrative Health; NOFO = Notice of Funding Opportunity; NP = Natural Product; PAR = Program Announcement with Special Receipt, Referral, and/or Review Considerations; R01: Research Project; R33: Exploratory/Developmental Grants Phase II; R61/R33: Exploratory/Developmental Grants; U24: Resource-Related Projects—Cooperative Agreements; UG3/UH3: Exploratory/Developmental Cooperative Agreement