Opportunity ID: 327246

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-20-217
Funding Opportunity Title: NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
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: $1,050,000
Award Floor:

Eligibility

Eligible Applicants: Native American tribal governments (Federally recognized)
Special district governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
City or township governments
County governments
State governments
For profit organizations other than small businesses
Small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits having 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
Independent school districts
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 not allowed.

Additional Information

Agency Name: National Institutes of Health
Description:

This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA will provide up to 3 years support for studies to replicate the impact of the natural product on the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on the biological signature by optimizing the delivery of the natural product by examining different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same biological signature; or study the impact of the natural product in a target population that is more responsive. 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 R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early stage clinical testing to determine whether continued clinical research is warranted. This FOA will not support efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.

Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-20-217.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-20-217
Funding Opportunity Title: NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
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: $1,050,000
Award Floor:

Eligibility

Eligible Applicants: Native American tribal governments (Federally recognized)
Special district governments
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public and State controlled institutions of higher education
Public housing authorities/Indian housing authorities
City or township governments
County governments
State governments
For profit organizations other than small businesses
Small businesses
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits having 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
Independent school districts
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 not allowed.

Additional Information

Agency Name: National Institutes of Health
Description:

This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA will provide up to 3 years support for studies to replicate the impact of the natural product on the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on the biological signature by optimizing the delivery of the natural product by examining different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same biological signature; or study the impact of the natural product in a target population that is more responsive. 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 R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early stage clinical testing to determine whether continued clinical research is warranted. This FOA will not support efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.

Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-20-217.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-20-217
Funding Opportunity Title: NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Grant
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: $1,050,000
Award Floor:

Eligibility

Eligible Applicants: County governments
Small businesses
Independent school districts
For profit organizations other than small businesses
State governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Public housing authorities/Indian housing authorities
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Native American tribal governments (Federally recognized)
Native American tribal organizations (other than Federally recognized tribal governments)
Special district governments
Private institutions of higher education
City or township governments
Public and State controlled 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 not allowed.

Additional Information

Agency Name: National Institutes of Health
Description: This Funding Opportunity Announcement (FOA) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. Under this FOA, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This FOA will provide up to 3 years support for studies to replicate the impact of the natural product on the biological signature(s) when used by humans and assess whether there is an association between the degree of the impact on the biological signature and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on the biological signature by optimizing the delivery of the natural product by examining different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same biological signature; or study the impact of the natural product in a target population that is more responsive. 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 R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early stage clinical testing to determine whether continued clinical research is warranted. This FOA will not support efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer.
Link to Additional Information: http://grants.nih.gov/grants/guide/pa-files/PAR-20-217.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

Folder 327246 Full Announcement-PAR-20-217 -> PAR-20-217-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 PKG00261812 Jun 20, 2020 Jan 24, 2022 View
FORMS-G Use for due dates on or before January 24, 2023 PKG00272333 Feb 28, 2022 Jan 24, 2023 View
FORMS-H Use for due dates on or after January 25, 2023 PKG00278261 Nov 10, 2022 Sep 07, 2023 View

Package 1

Mandatory forms

327246 RR_SF424_2_0-2.0.pdf

327246 PHS398_CoverPageSupplement_5_0-5.0.pdf

327246 RR_OtherProjectInfo_1_4-1.4.pdf

327246 PerformanceSite_2_0-2.0.pdf

327246 RR_KeyPersonExpanded_2_0-2.0.pdf

327246 RR_Budget_1_4-1.4.pdf

327246 PHS398_ResearchPlan_4_0-4.0.pdf

327246 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf

Optional forms

327246 RR_SubawardBudget30_1_4-1.4.pdf

327246 PHS_AssignmentRequestForm_3_0-3.0.pdf

Package 2

Mandatory forms

327246 RR_SF424_5_0-5.0.pdf

327246 PHS398_CoverPageSupplement_5_0-5.0.pdf

327246 RR_OtherProjectInfo_1_4-1.4.pdf

327246 PerformanceSite_4_0-4.0.pdf

327246 RR_KeyPersonExpanded_4_0-4.0.pdf

327246 RR_Budget_3_0-3.0.pdf

327246 PHS398_ResearchPlan_4_0-4.0.pdf

327246 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

327246 RR_SubawardBudget30_3_0-3.0.pdf

327246 PHS_AssignmentRequestForm_3_0-3.0.pdf

Package 3

Mandatory forms

327246 RR_SF424_5_0-5.0.pdf

327246 PHS398_CoverPageSupplement_5_0-5.0.pdf

327246 RR_OtherProjectInfo_1_4-1.4.pdf

327246 PerformanceSite_4_0-4.0.pdf

327246 RR_KeyPersonExpanded_4_0-4.0.pdf

327246 RR_Budget_3_0-3.0.pdf

327246 PHS398_ResearchPlan_5_0-5.0.pdf

327246 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

327246 RR_SubawardBudget30_3_0-3.0.pdf

327246 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-10T06:04:29-05:00

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