Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)

Key Facts

Status: Forecasted

Posted date: September 11, 2024

Archive date: August 19, 2026

Close date: July 14, 2026

Opportunity ID: 356395

Opportunity number: PAR-24-275

Opportunity category: Discretionary

Agency name: National Institutes of Health

Agency code: HHS-NIH11

Award floor: $0

Award ceiling: $0

Cost sharing required: No

Funding Instrument Types
  • Cooperative Agreement
Category of Funding Activity
  • Health
Eligible Applicants
  • City or township governments
  • County governments
  • For-profit organizations other than small businesses
  • Independent school districts
  • Native American tribal governments (Federally recognized)
  • Native American tribal organizations (other than Federally recognized tribal governments)
  • Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
  • Others
  • Private institutions of higher education
  • Public and State controlled institutions of higher education
  • Public housing authorities/Indian housing authorities
  • Small businesses
  • Special district governments
  • State governments
Tools
Categories (use these for quoted searches)
  • agency_code:hhs_nih11
  • category_of_funding_activity:health
  • cost_sharing_or_matching_requirement:false
  • eligible_applicants:city_or_township_governments
  • eligible_applicants:county_governments
  • eligible_applicants:for_profit_organizations_other_than_small_businesses
  • eligible_applicants:independent_school_districts
  • eligible_applicants:native_american_tribal_governments_federally_recognized
  • eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
  • eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
  • eligible_applicants:others
  • eligible_applicants:private_institutions_of_higher_education
  • eligible_applicants:public_and_state_controlled_institutions_of_higher_education
  • eligible_applicants:public_housing_authoritiesindian_housing_authorities
  • eligible_applicants:small_businesses
  • eligible_applicants:special_district_governments
  • eligible_applicants:state_governments
  • funding_instrument_type:cooperative_agreement
  • opportunity_category:discretionary
  • status:forecasted
Description

This notice of funding opportunity (NOFO) encourages applications for investigator-initiated multi site clinical trials (e.g., efficacy, effectiveness, or pragmatic trials) to study the effects of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions), and/or multicomponent interventions that include physical, psychological, and/or nutritional approaches in NCCIH- designated areas of high research priority. Clinical Coordinating Centers (CCC) should develop and implement the proposed fully powered multi-site clinical trial (Phase III and beyond). The objective of a CCC application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. CCC applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. CCC applications submitted under this NOFO will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center (DCC) application (U24), submitted under PAR-24-087 proposing a data analysis and data management plan for the clinical project is required. Both a CCC application and a corresponding DCC application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans). Applicants are encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.

Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)
This notice of funding opportunity (NOFO) encourages applications for investigator-initiated multi site clinical trials (e.g., efficacy, effectiveness, or pragmatic trials) to study the effects of complementary and integrative health approaches with physical and/or psychological therapeutic inputs (often called mind and body interventions), and/or multicomponent interventions that include physical, psychological, and/or nutritional approaches in NCCIH- designated areas of high research priority. Clinical Coordinating Centers (CCC) should develop and implement the proposed fully powered multi-site clinical trial (Phase III and beyond). The objective of a CCC application is to present the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. CCC applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. CCC applications submitted under this NOFO will utilize a two-phase, milestone-driven cooperative agreement (UG3/UH3) funding mechanism. In addition, an accompanying Data Coordinating Center (DCC) application (U24), submitted under PAR-24-087 proposing a data analysis and data management plan for the clinical project is required. Both a CCC application and a corresponding DCC application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans). Applicants are encouraged to contact the appropriate Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NOFO.
[Forecasted] Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3 Clinical Trial Required)
Forecasted
National Institutes of Health
Health
Cooperative Agreement
State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For-profit organizations other than small businesses
Small businesses
Others
2024-09-11