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Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)

US · MD Food and Drug Administration (HHS-FDA) grant unknown #FOR-FD-24-010

Summary

The Food and Drug Administration (FDA) is seeking a cooperative agreement (U01 mechanism) to support a human abuse potential (HAP) study of botanical kratom. This is a clinical trial-required opportunity, meaning the awardee must conduct a formal clinical trial examining the abuse potential of kratom in human subjects. The study is intended to generate scientific evidence to inform FDA's regulatory understanding of kratom's pharmacological and behavioral effects. This is a forecasted opportunity, meaning it has not yet been formally solicited.

What they want

The awardee will enter into a cooperative agreement with the FDA to design and conduct a Human Abuse Potential (HAP) clinical study of botanical kratom. The study must meet the definition of a clinical trial as required by the U01 cooperative agreement mechanism. Work includes study design, human subjects enrollment and testing, data collection, analysis, and reporting of kratom's abuse potential to the FDA. FDA will maintain substantial programmatic involvement throughout the performance period as is standard under cooperative agreement terms.
Technical requirements
  • Must conduct a Human Abuse Potential (HAP) study of botanical kratom
  • Must meet clinical trial requirements as defined under the U01 cooperative agreement mechanism
  • FDA will have substantial programmatic involvement throughout the award period

How they evaluate

Submission: Grants.gov federal grants portal (grants.gov)

Risks & flags

  • Opportunity is listed as 'forecasted' — no formal solicitation has been issued; timeline and requirements may shift significantly
  • Highly specialized scope (human abuse potential clinical trial for a specific botanical substance) may limit the eligible bidder pool to a small number of qualified research institutions or CROs

Market context

inferred from NAICS
Professional, Scientific & Technical Services
NAICS 541714
US market size
$2.0T
Typical award
$25K – $50M
Typical buyers
All federal civilianDoDStates
Commonly required
8(a)WOSBSDVOSBPE/PMP

Sector-level estimate — full code lookup not yet in catalog.

Health Care & Social Assistance
NAICS 621511
US market size
$2.7T
Typical award
$50K – $100M
Typical buyers
VAHHSDoD MHSIHS
Commonly required
Joint CommissionCMS

Sector-level estimate — full code lookup not yet in catalog.

Cooperative Agreement to Support a Human A…
$unknown
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