NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required)

The summary for the NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required) grant is detailed below. This summary states who is eligible for the grant, how much grant money will be awarded, current and past deadlines, Catalog of Federal Domestic Assistance (CFDA) numbers, and a sampling of similar government grants. Verify the accuracy of the data FederalGrants.com provides by visiting the webpage noted in the Link to Full Announcement section or by contacting the appropriate person listed as the Grant Announcement Contact. If any section is incomplete, please visit the website for the National Institutes of Health, which is the U.S. government agency offering this grant.

NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required): This Funding Opportunity Announcement (FOA) invites cooperative agreement applications for investigator-initiated mid-phase clinical trials of natural products. All applications submitted under this FOA must be supported by sufficient preliminary data of bioavailability and documentation that the natural product produces a replicable and measurable impact on a biological signature (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure a biological signature in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived. Applications submitted to this FOA should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site clinical trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy study. Clinical trials submitted under this FOA are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This FOA will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this FOA.

Federal Grant Title:	NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required)
Federal Agency Name:	National Institutes of Health (HHS-NIH11)
Grant Categories:	Health
Type of Opportunity:	Discretionary
Funding Opportunity Number:	PAR-20-216
Type of Funding:	Cooperative Agreement
CFDA Numbers:	93.213
CFDA Descriptions:	Information not provided
Current Application Deadline:	May 7th, 2023
Original Application Deadline:	May 7th, 2023
Posted Date:	May 20th, 2020
Creation Date:	May 20th, 2020
Archive Date:	June 12th, 2023
Total Program Funding:
Maximum Federal Grant Award:
Minimum Federal Grant Award:
Expected Number of Awards:
Cost Sharing or Matching:	No
Last Updated:	May 20th, 2020

Applicants Eligible for this Grant: 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 (see text field entitled "Additional Information on Eligibility" for clarification.)
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Link to Full Grant Announcement: http://grants.nih.gov/grants/guide/pa-files/PAR-20-216.html
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