Grants / Department of Health and Human Services / Food and Drug Administration

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

Forecast Forecast, no dates yet Opportunity FOR-FD-24-010

• Award ceiling$2.0 million
• Award floor$2.0 million
• Expected awards1
• Total fundingnot stated
• Cost sharingNot required
• Funding typeCooperative Agreement

Key dates

Who can apply

This opportunity is open to any type of organization.

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities/Indian housing authorities
• Native American tribal organizations (other than Federally recognized tribal governments)
• Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
• Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
• Private institutions of higher education
• For profit organizations other than small businesses
• Small businesses
• Others (see text field entitled "Additional Information on Eligibility" for clarification)
• Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"

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).

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses, individuals.

Is this a realistic fit?

• No cost sharing or match is required.

What the grant funds

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.

Category: Agriculture, Consumer Protection, Food and Nutrition.

How to apply

1. Read the full notice and attachments on Grants.gov. The notice is the official source for deadlines and requirements.
2. Make sure your organization has an active SAM.gov registration and Unique Entity ID; registration can take several weeks.
3. Register on Grants.gov and submit through Workspace before the deadline and time given in the notice. Our application guide walks through each step.

Questions go to Terrin Brown, Grantor, terrin.brown@fda.hhs.gov, (240) 402-7610.

Open the official notice