Value AD
CAN BE
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INVESTMENT
Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
FOR-FD-24-010
Terrin Brown Grantor
Funding Opportunity Number: FOR-FD-24-010
Opportunity Category: Discretionary
Expected Number of Awards: 1
CFDA Number(s): 93.103 -- Food and Drug Administration Research
Cost Sharing or Matching Requirement: No
Posted Date: Nov 24, 2023 12:00:00 AM EST
Closing Date: N/A
Award Ceiling: $2000000
Award Floor: $2000000
Eligible Applicants: Public and State controlled institutions of higher education,State governments,County governments,Special district governments,Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,Native American tribal governments (Federally recognized),For profit organizations other than small businesses,Others (see text field entitled "Additional Information on Eligibility" for clarification),Small businesses,Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility",City or township governments,Public housing authorities/Indian housing authorities,Private institutions of higher education,Native American tribal organizations (other than Federally recognized tribal governments),Independent school districts,Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
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).
Description:
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.
