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

id: 351137
Source ↗ · id

opportunityNumber: FOR-FD-24-010
Source ↗ · opportunityNumber

opportunityTitle: Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required)
Source ↗ · opportunityTitle

revision: 1
Source ↗ · revision

agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
Source ↗ · agencyDetails

owningAgencyCode: HHS-FDA
Source ↗ · owningAgencyCode

cfdas: [{"id":415660,"opportunityId":351137,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
Source ↗ · cfdas

forecastDesc: <p>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.&nbsp;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.&nbsp;</p><p><br></p><p>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.&nbsp;Interested parties, will also complete the submission of an Investigational New Drug (IND) application and obtain Institutional Review Board (IRB) clearance.&nbsp;&nbsp;</p>
Source ↗ · forecastDesc

applicantTypes: [{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"00","description":"State governments"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"23","description":"Small businesses"},{"id":"02","description":"City or township governments"},{"id":"01","description":"County governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"20","description":"Private institutions of higher education"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"04","description":"Special district governments"},{"id":"05","description":"Independent school districts"},{"id":"99","description":"Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled \"Additional Information on Eligibility\""},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"}]
Source ↗ · applicantTypes

applicantEligibilityDesc: 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:&bull;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.&bull;A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.&bull;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).
Source ↗ · applicantEligibilityDesc

fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
Source ↗ · fundingInstruments

fundingActivityCategories: [{"id":"AG","description":"Agriculture"},{"id":"CP","description":"Consumer Protection"},{"id":"FN","description":"Food and Nutrition"}]
Source ↗ · fundingActivityCategories

awardFloor: 2000000
Source ↗ · awardFloor

awardCeiling: 2000000
Source ↗ · awardCeiling

costSharing: false
Source ↗ · costSharing

lastUpdatedDate: Nov 30, 2023 04:05:16 PM EST
Source ↗ · lastUpdatedDate

status: forecasted
Source ↗ · oppHits[id=351137].oppStatus