Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)

id: 351131
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opportunityNumber: FOR-FD-24-008
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opportunityTitle: Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01)
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revision: 1
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agencyDetails: {"code":"FDA","seed":"HHS-FDA","agencyName":"Food and Drug Administration","agencyCode":"HHS-FDA","topAgencyCode":"HHS"}
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owningAgencyCode: HHS-FDA
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cfdas: [{"id":415639,"opportunityId":351131,"cfdaNumber":"93.103","programTitle":"Food and Drug Administration Research"}]
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forecastDesc: <p>The Food and Drug Administration's (FDA), Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), is announcing this Funding Opportunity Announcement (FOA) for a Cooperative Agreement.</p><p><strong>&nbsp;</strong></p><p>The proposed work directly supports the U.S. FDA’s stated goal of protecting public health from unacceptable risks from nitrosamine impurities in human drugs. Although significant experimental and policy/regulatory initiatives have been undertaken in this area, there remains a need for further research into and development and refinement of translational and implementable practices that will protect the public against nitrosamine risks while ensuring continued safe access to critical therapeutic drugs. The aim is to improve the safety of human drugs with potential nitrosamine impurity liabilities.</p><p>&nbsp;</p><p>In addition to the work outlined above, the award recipient will assess how best to ensure that this research and practices development continues among industry members, non-profits, and/or academic institutions once the FDA funding for this cooperative agreement ends.</p>
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applicantTypes: [{"id":"01","description":"County governments"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"05","description":"Independent school districts"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"02","description":"City or township governments"},{"id":"23","description":"Small businesses"},{"id":"00","description":"State governments"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"20","description":"Private institutions of higher education"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"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":"22","description":"For profit organizations other than small businesses"},{"id":"04","description":"Special district governments"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"}]
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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. 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 statementfrom the review of the previous new (A0) application.
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fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
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fundingActivityCategories: [{"id":"AG","description":"Agriculture"},{"id":"CP","description":"Consumer Protection"},{"id":"FN","description":"Food and Nutrition"}]
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awardFloor: 350000
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awardCeiling: 350000
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costSharing: false
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lastUpdatedDate: Nov 30, 2023 04:02:24 PM EST
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status: forecasted
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