Notice of Intent to Publish a Funding Opportunity Announcement for Botanical Dietary Supplements Research Centers (U19 Clinical Trial Optional)

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Opportunity ID: 310198
Opportunity Number: NOT-OD-19-013
Opportunity Title: Notice of Intent to Publish a Funding Opportunity Announcement for Botanical Dietary Supplements Research Centers (U19 Clinical Trial Optional)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
CFDA Number(s): 93.213
93.321
Eligible Applicants: State governments
County governments
City or township governments
Special district governments
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
Private institutions of higher education
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility:
Agency Code: HHS-NIH11
Agency Name: Department of Health and Human Services
National Institutes of Health
Posted Date: Nov 05, 2018
Last Updated Date: Nov 05, 2018
Estimated Synopsis Post Date: Nov 14, 2018
Fiscal Year: 2020
Award Ceiling: $1,200,000
Award Floor:
Estimated Total Program Funding: $3,000,000
Expected Number of Awards: 3
Description: The Office of Dietary Supplements (ODS) and the National Center for Complementary and Integrative Health (NCCIH) with other NIH Institutes and Centers (ICs) to be determined, intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for research to further advance the Centers for Advancing Research on Botanicals and Other Natural Products (CARBON) Program by publishing a set of linked FOAs for cooperative agreement applications. The goal of this U19 , Botanical Dietary Supplements Research Centers (BDSRC) component of the CARBON.2 Consortium will be to support collaborative, trans-disciplinary research focused on obtaining information that will contribute significantly to the optimal design of future clinical trials of the effects on human resilience of orally consumed, complex botanical products. Products appropriate for applications responsive to the planned FOA will be limited to those for which there is rigorous, but not definitive, evidence supporting a clinically or public health significant, biologically and mechanistically plausible, and reproducible effect on, or relevant to, human biological or cognitive/behavioral resilience. Applications in which a purified phytochemical is the main focus will be considered unresponsive to the FOA. The BDSRC are expected to focus on developing the most critical data to inform the optimal design of future clinical trials of orally consumed complex botanical dietary supplements. Information acquired through achievement of the BDSRC specific aims is expected to signifiantly contribute to the design of optimally informative clinical trials, providing evidence for design decisions including, but not limited to, decisions about the appropriateness of the trial design (or of doing any trial with the product), as well as those regarding product formulations, doses, timing, eligibility criteria, participant characteristics to be collected, markers of proximal biological effect, outcome measures, etc. Applicants applying under this BDSRC FOA are encouraged to collaborate, as appropriate, with the NMR Open Data Exchange (NODE), the Center for Natural Product Technology, Methodology and Productivity Optimization (NP-TEMPO), and other NCCIH, ODS, and NIH supported grantees. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. The FOA is expected to be published in October, 2018, with an expected application due date in April, 2019. This FOA will utilize the U19 activity code. .NIH U19 cooperative agreements support multi-project research programs directed toward a specific major objective, basic theme or program goal, requiring a broadly based, multidisciplinary approach. Details of the planned FOA are provided below. As detailed in the ODS Strategic Plan, ODS’ goals include expanding the knowledge base relevant to dietary supplements by stimulating and supporting a full range of biomedical research, and enhancing the dietary supplement research workforce through training and career development. The NCCIH Strategic Plan incorporates advancing the understanding of basic biological mechanisms of action of natural products, and developing improved research methods for conducting rigorous studies of their integration into health care.
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