forecasted
Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
Food and Drug Administration · FOR-FD-24-004
$250,000 – $250,000
Not specified
City or township governments, Native American tribal governments (Federally recognized), Native American tribal organizations (other than Federally recognized tribal governments), Public and State controlled institutions of higher education, State governments, Public housing authorities/Indian housing authorities, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility", Others (see text field entitled "Additional Information on Eligibility" for clarification), Private institutions of higher education, Independent school districts, For profit organizations other than small businesses, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Small businesses, County governments, Special district governments
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
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 NIH or 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).
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Cooperative Agreement. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 351126
Source ↗ · id
opportunityNumber: FOR-FD-24-004
Source ↗ · opportunityNumber
opportunityTitle: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)
Source ↗ · opportunityTitle
revision: 2
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":415634,"opportunityId":351126,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
Source ↗ · cfdas
forecastDesc: <p><span style="color: black;">The purpose of this funding opportunity is to support the research and development necessary to advance non-invasive (e.g., quantitative tomography-based) technologies, including the development of apparatus, methods, study designs, and methods of data analysis, to characterize and compare the rate and extent to which a topically applied drug becomes available at or near a site of action within the skin in vivo. The expectation is that the funded work will produce an accurate, sensitive and reproducible approach that rapidly measures the (relative) amount of drug present in the skin at a series of depths below the skin surface, which can be utilized to monitor the cutaneous pharmacokinetics (PK) of the drug at selected depths (e.g., in the epidermis) by repeated, serial measurements over time. The intent is to support the eventual development of an alternative, scientifically valid, in vivo cutaneous PK-based approach that can be used to efficiently demonstrate the bioequivalence (BE) of topical products. </span></p>
Source ↗ · forecastDesc
applicantTypes: [{"id":"02","description":"City or township governments"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"00","description":"State governments"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"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)"},{"id":"20","description":"Private institutions of higher education"},{"id":"05","description":"Independent school districts"},{"id":"22","description":"For profit organizations other than small businesses"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"23","description":"Small businesses"},{"id":"01","description":"County governments"},{"id":"04","description":"Special district governments"}]
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 NIH or 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).
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: 250000
Source ↗ · awardFloor
awardCeiling: 250000
Source ↗ · awardCeiling
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: Nov 24, 2023 12:55:39 PM EST
Source ↗ · lastUpdatedDate
status: forecasted
Source ↗ · oppHits[id=351126].oppStatus
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