This NCCIH grant invites applications for investigator-initiated mid-phase clinical trials focused on natural products. The purpose of this grant is to determine the optimal dose or formulation for future multi-site clinical trials, or to identify patient phenotypes that respond to the natural product, informing future efficacy studies. Successful applications require preliminary data demonstrating bioavailability and a measurable impact on a biological signature, though waivers may apply. Proposed trials must be hypothesis-based, milestone-driven, and directly align with NCCIH’s research mission. This funding explicitly excludes support for single or multi-site efficacy/effectiveness trials and trials for cancer treatment or prevention.
Opportunity ID: 327261
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-20-216 |
| Funding Opportunity Title: | NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 20, 2020 |
| Last Updated Date: | Mar 28, 2023 |
| Original Closing Date for Applications: | May 07, 2023 |
| Current Closing Date for Applications: | Sep 07, 2023 |
| Archive Date: | Oct 07, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Private institutions of higher education Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education State governments Special district governments For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-20-216.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| updated close date | Mar 28, 2023 | |
| May 20, 2020 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-20-216 |
| Funding Opportunity Title: | NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | May 20, 2020 |
| Last Updated Date: | Mar 28, 2023 |
| Original Closing Date for Applications: | May 07, 2023 |
| Current Closing Date for Applications: | Sep 07, 2023 |
| Archive Date: | Oct 07, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Private institutions of higher education Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education State governments Special district governments For profit organizations other than small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-20-216.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-20-216 |
| Funding Opportunity Title: | NCCIH Natural Product Mid Phase Clinical Trial Cooperative Agreement (U01 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 20, 2020 |
| Last Updated Date: | May 20, 2020 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | May 07, 2023 |
| Archive Date: | Jun 12, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Public and State controlled institutions of higher education For profit organizations other than small businesses Independent school districts State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Special district governments City or township governments Native American tribal governments (Federally recognized) Small businesses Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-20-216.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Related Documents
Folder 327261 Full Announcement-PAR-20-216 -> PAR-20-216-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00261811 | Jun 20, 2020 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270416 | Nov 18, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277938 | Nov 04, 2022 | Sep 07, 2023 | View |
Package 1
Mandatory forms
327261 RR_SF424_2_0-2.0.pdf
327261 PHS398_CoverPageSupplement_5_0-5.0.pdf
327261 RR_OtherProjectInfo_1_4-1.4.pdf
327261 PerformanceSite_2_0-2.0.pdf
327261 RR_KeyPersonExpanded_2_0-2.0.pdf
327261 PHS398_ResearchPlan_4_0-4.0.pdf
327261 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
327261 RR_Budget_1_4-1.4.pdf
327261 RR_SubawardBudget30_1_4-1.4.pdf
327261 PHS398_ModularBudget_1_2-1.2.pdf
327261 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
327261 RR_SF424_5_0-5.0.pdf
327261 PHS398_CoverPageSupplement_5_0-5.0.pdf
327261 RR_OtherProjectInfo_1_4-1.4.pdf
327261 PerformanceSite_4_0-4.0.pdf
327261 RR_KeyPersonExpanded_4_0-4.0.pdf
327261 PHS398_ResearchPlan_4_0-4.0.pdf
327261 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
327261 RR_Budget_3_0-3.0.pdf
327261 RR_SubawardBudget30_3_0-3.0.pdf
327261 PHS398_ModularBudget_1_2-1.2.pdf
327261 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
327261 RR_SF424_5_0-5.0.pdf
327261 PHS398_CoverPageSupplement_5_0-5.0.pdf
327261 RR_OtherProjectInfo_1_4-1.4.pdf
327261 PerformanceSite_4_0-4.0.pdf
327261 RR_KeyPersonExpanded_4_0-4.0.pdf
327261 PHS398_ResearchPlan_5_0-5.0.pdf
327261 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
327261 RR_Budget_3_0-3.0.pdf
327261 RR_SubawardBudget30_3_0-3.0.pdf
327261 PHS398_ModularBudget_1_2-1.2.pdf
327261 PHS_AssignmentRequestForm_3_0-3.0.pdf
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