Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3 Clinical Trial Required)
Status: Forecasted
Posted date: October 29, 2024
Archive date: August 19, 2026
Close date: July 14, 2026
Opportunity ID: 356904
Opportunity number: PAR-24-312
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
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
This Notice of Funding Opportunity (NOFO) encourages cooperative agreement applications for investigator-initiated, multi-site, clinical trials (Phase III and beyond) to study the effects of natural products (i.e. botanicals, probiotics, and products marketed as dietary supplements) in NCCIH designated areas of high research priority. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Applicants should describe plans for a Clinical Coordinating Center to develop and implement the proposed multi-site clinical trial. The objective of the Clinical Coordinating Center application is to provide the scientific rationale and a comprehensive scientific and operational plan for the clinical trial. Clinical Coordinating Center applications are expected to describe plans for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Clinical Coordinating Center 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 application, submitted under PAR-24-125, proposing a data analysis and data management plan for the clinical project is required. Both a Clinical Coordinating Center application and a corresponding Data Coordinating Center (DCC) application need to be submitted simultaneously for consideration by NCCIH. For additional information about the mission, strategic vision, and research priorities of the NCCIH, applicants are encouraged to consult the NCCIH website: (https://nccih.nih.gov/about/plans).