Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
View forecast on Grants.gov →Forecasted — not yet open · no update since November 30, 2023
- Posted
- November 24, 2023
- Closes
- See announcement
- Award ceiling
- $2,000,000
- Award floor
- $2,000,000
- Expected awards
- 1
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
Program funding history
Awards made under Assistance Listing 93.103 across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $213M
- FY2026 obligated
- $215.3M
- FY2027 (to date) obligated
- $0
- Awards in window
- 849
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
Synopsis
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
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Independent school districts
- State governments
- 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
- Native American tribal organizations (other than Federally recognized tribal governments)
- Special district governments
- Small businesses
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- County governments
- Public and State controlled institutions of higher education
- Private institutions of higher education
- City or township governments
- Native American tribal governments (Federally recognized)
- For profit organizations other than small businesses
- Public housing authorities/Indian housing authorities
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).
How to apply
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