The National Center for Complementary and Integrative Health (NCCIH) is offering funding for early phase clinical trials of natural products with strong scientific backing. This grant supports milestone-driven testing of bioavailability, pharmacokinetics, and effects on biological signatures. Successful R61 phase trials can receive additional support for replicating effects and assessing impact on patient outcomes in the R33 phase. The focus is on translating basic science findings about natural products into clinical testing to determine future research directions. Hypothesis-driven trials related to NCCIH priorities are encouraged. Applications should address optimizing natural product delivery, combination treatments, or responsive target populations. Efficacy studies are not supported. Closing date: Nov 04, 2019.
Opportunity ID: 306226
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-18-829 |
| Funding Opportunity Title: | NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/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: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Native American tribal governments (Federally recognized) Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses State governments Public and State controlled institutions of higher education Small businesses County governments Special district governments City or township governments Public housing authorities/Indian housing authorities 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 Private institutions of higher education 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 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 two years (R61 phase) of support for milestone-driven testing of bioavailability, pharmacokinetics, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a biological signature(s). If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded 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 R33 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 R61/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 effecti |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-18-829.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 | PKG00243058 | Jul 31, 2018 | Nov 04, 2019 | View |
Package 1
Mandatory forms
306226 RR_SF424_2_0-2.0.pdf
306226 PHS398_CoverPageSupplement_4_0-4.0.pdf
306226 RR_OtherProjectInfo_1_4-1.4.pdf
306226 PerformanceSite_2_0-2.0.pdf
306226 RR_KeyPersonExpanded_2_0-2.0.pdf
306226 RR_Budget_1_4-1.4.pdf
306226 PHS398_ResearchPlan_4_0-4.0.pdf
Optional forms
306226 RR_SubawardBudget30_1_4-1.4.pdf
306226 PHS_AssignmentRequestForm_2_0-2.0.pdf
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