The National Center for Complementary and Integrative Health offers grants for investigator-initiated early phase clinical trials of natural products to evaluate their impact on biological signatures and clinical outcomes. The trials should provide valuable scientific information to determine further development or testing of the natural product. Projects can focus on optimizing delivery, combining treatments, or targeting specific populations. This funding opportunity aims to translate basic science findings into clinical research quickly, supporting hypothesis-based and milestone-driven trials aligned with NCCIH research priorities. Note that this grant does not fund efficacy trials or research on cancer treatment or prevention.
Opportunity ID: 306228
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-828 |
| 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: | Jun 13, 2018 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Nov 04, 2019 |
| Current Closing Date for Applications: | Nov 04, 2019 |
| Archive Date: | Dec 10, 2019 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $1,050,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | For profit organizations other than small businesses Private institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal governments (Federally recognized) County governments Public housing authorities/Indian housing authorities Special district 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) Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments City or township governments 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 can design studies to determine how to optimize the impact of the natural product on the biological signature by (1) optimizing the delivery of the natural product by dose or formulation; (2) combine the natural product with another treatment approach that is known to impact the same biological signature; or (3) 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-18-828.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 |
|---|---|---|
Related Documents
There are no related documents on this grant.
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-E | FORMS-E | PKG00243044 | Jul 31, 2018 | Nov 04, 2019 | View |
Package 1
Mandatory forms
306228 RR_SF424_2_0-2.0.pdf
306228 PHS398_CoverPageSupplement_4_0-4.0.pdf
306228 RR_OtherProjectInfo_1_4-1.4.pdf
306228 PerformanceSite_2_0-2.0.pdf
306228 RR_KeyPersonExpanded_2_0-2.0.pdf
306228 RR_Budget_1_4-1.4.pdf
306228 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
306228 RR_SubawardBudget30_1_4-1.4.pdf
306228 PHS_AssignmentRequestForm_2_0-2.0.pdf
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