Food and Drug Administration · Department of Health and Human Services
Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
Key facts
- Deadline
- Opening date not announced
- Award size
- Up to $2M
- Match ?
- Not required · Work out your budget and match
- Who can apply
- Tribal organization, Public college or university, Larger business, Tribal government, State government, Anyone (unrestricted), Special district (utility, fire, etc.), County government, Nonprofit without 501(c)(3), Private college or university, Nonprofit with 501(c)(3), School district, City or town government, Small business, and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Opening soon: the funder has announced this grant, but you can't apply yet. Use the time to get ready and check whether it fits.
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Get-ready checklist
How this fits you
- Available in Roane County (nationwide program)
- No match required
- Past Tennessee awards on file: 42
Tell us who you are to see whether you're eligible.
About this grant
The U.S. Food and Drug Administration (FDA) seeks applications to develop, implement, and evaluate a human abuse potential (HAP) study of botanical Kratom. FDA has previously warned consumers about the use of Kratom (Mitragyna speciosa), a plant indigenous to Southeast Asia. Kratom alkaloids have demonstrated both affinity and activity at receptor sites known to be associated with abuse, such as mu opioid receptors. Although Kratom use is prevalent, to date, clinical evaluations of its abuse potential have been limited.
The proposed HAP study should be performed in accordance with the guidance for industry, "Assessment of Abuse Potential of Drugs," including (but not limited to) the selection of an appropriate comparator(s) and outcome measures, statistical analyses etc. Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.
Who can apply, from the official notice
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submission of Resubmission Application. This means that the FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.•A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.•An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
Official notice: https://simpler.grants.gov/opportunity/7ef4b263-e6d5-4091-b2a5-9815fdf37ba1 · Printed from grantme.click/grants/7a4c0bff-09c7-497a-81f9-692d4af03d92
Writing the need statement? Roane County facts with citations.
Who in Tennessee has won this program
20 awards to Tennessee groups in 5 counties since 2016 · 0 in Roane County. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| University of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| State of Tennessee | Nashville | $2.7M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $2.4M | 2020 |
| University of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.9M | 2020 |
| University of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department of Health | Nashville, Davidson County | $1.3M | 2020 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2016 |
Source: USAspending.gov; Federal Audit Clearinghouse. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through a state agency or another organization
This federal money also reaches local groups as pass-through grants. 22 pass-through grants on file · 0 in Roane County. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Combinedbrain, Inc | Brentwood | Duke University | $538K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Harvard Pilgrim Health Care | $241K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $75K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $69K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic Hospital | $51K spent that year | 2025 |
| Volumetrix Inc. | Nashville, Davidson County | The Children's Hospital of Philadelphia | $50K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Cumberland Pharmaceuticals Inc | $42K spent that year | 2025 |
| Loch & Key Productions, LLC | Knoxville, Knox County | Association of Public Health Laboratories, Inc. (THE) | $33K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | The Queen's Medical Center | $32K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of California-San Francisco | $29K spent that year | 2025 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
More from Food and Drug Administration
- Rapid Response Team (RRT) Cooperative Agreement · The funder's estimated date (Dec 1, 2022) has passed. Check the official notice Estimate, not confirmed by the funder
- FDA OMHHE Convener for Racial & Ethnic minority Acceleration Consortium for Health Equity (REACH) · The funder's estimated date (Mar 3, 2023) has passed. Check the official notice Estimate, not confirmed by the funder
- FDA Support for Conferences and Scientific Meetings (R13 Clinical Trial Not Allowed) · The funder's estimated date (Apr 12, 2023) has passed. Check the official notice Estimate, not confirmed by the funder
- Data Standards for Tobacco Research and Scientific Review Phase 2 · The funder's estimated date (Dec 1, 2023) has passed. Check the official notice Estimate, not confirmed by the funder
- Minor Use Minor Species Development of Drugs (R01) · Due Jan 29, 2027 · 112 days left
- NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens · Due Apr 1, 2027 · 174 days left
About the federal program
Food and Drug Administration Research, also called “General Grant Funding”
Program number 93.103 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, Food and Drug Administration · Cooperative agreement (a grant with close agency involvement), project grant
How applications are judged
Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies.
Match
None required (federal program listing).