Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)

id: 362488
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opportunityNumber: PAR-28-019
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opportunityTitle: Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)
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revision: 0
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agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
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owningAgencyCode: HHS-NIH11
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cfdas: [{"id":433487,"opportunityId":362488,"cfdaNumber":"93.351","programTitle":"Research Infrastructure Programs"}]
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forecastDesc: <p>This NOFO is issued during a period of accelerating development, validation, and adoption of human new approach methodologies (NAMs). Accordingly, it has two integrated priorities for NIH-funded HIV/AIDS research: (1) implementation of a NAMs-enabled stewardship framework, including optional HIV-relevant human <i>in vitro</i> testing support and pilot benchmarking activities, to reduce or replace specific pathogen free (SPF) <i>in vivo</i> model use where scientifically appropriate without compromising rigor, reproducibility, or translational relevance; and (2) support for high-quality SPF colony resources for studies in which well-characterized <i>in vivo</i> models remain scientifically necessary.</p><p>Under the NAMs-enabled component, required elements include: (1) integration of a NAMs triage and consultation service within request intake and allocation workflows to identify NAM-feasible studies and document reductions or replacements in <i>in vivo</i> use; and (2) establishment of a formal referral pathway to NAM centers as well as human tissue and other human science based resources to facilitate collaborative HIV-relevant human NAM development, benchmarking, and refinement. Applicants may also propose optional NAMs-enabled HIV human <i>in vitro</i> testing support (research use only), including standardized operating procedures, quality control frameworks, and user guidance for viral load quantification, drug resistance assessment, and <i>ex vivo</i> susceptibility assays, as well as optional pilot benchmarking projects to define performance metrics, quality control benchmarks, and context-of-use statements for HIV-relevant human NAMs.</p><p>Under the SPF resource component, the award will support core colony operations, including colony management and husbandry; transparent, merit-based request intake and allocation; comprehensive virologic surveillance and rapid mitigation to preserve SPF status; and high-resolution immunogenetic characterization (e.g., MHC typing) to enable rigorous, genotype-informed study design and efficient stewardship of limited <i>in vivo</i> resources.</p>
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applicantTypes: [{"id":"22","description":"For profit organizations other than small businesses"},{"id":"02","description":"City or township governments"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"04","description":"Special district governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"00","description":"State governments"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"01","description":"County governments"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"20","description":"Private institutions of higher education"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"05","description":"Independent school districts"},{"id":"23","description":"Small businesses"}]
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applicantEligibilityDesc: Other Eligible ApplicantsIndian/Native American Tribal Governments (Other than Federally Recognized);Eligible Agencies of the Federal Government;U.S. Territory or Possession;Faith-based or Community-based Organizations;Regional Organizations;Non-domestic (non-U.S.) Entities (Foreign Institutions).
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fundingInstruments: [{"id":"CA","description":"Cooperative Agreement"}]
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fundingActivityCategories: [{"id":"HL","description":"Health"}]
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awardFloor: 212004
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awardCeiling: 2725311
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costSharing: false
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lastUpdatedDate: May 20, 2026 06:09:32 AM EDT
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status: forecasted
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