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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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Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

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This contract focuses on advancing HIV/AIDS research through two integrated priorities: the implementation of human new approach methodologies (NAMs) to reduce or replace the use of specific pathogen free (SPF) in vivo models where appropriate, and the support of high-quality SPF colony resources for studies that still require well-characterized in vivo models. The NAMs component requires establishing a triage and consultation service to identify studies suitable for NAMs, documenting reductions in animal use, and creating referral pathways to NAM centers and human science resources to foster collaborative development and benchmarking of HIV-relevant human NAMs. Optional elements include providing HIV human in vitro testing support involving standardized procedures and quality controls for viral load quantification, drug resistance assessment, and ex vivo susceptibility assays, alongside pilot projects to define performance metrics and usage guidelines for these methodologies. On the other hand, the SPF resource component supports the operational needs of SPF colonies, including colony management, husbandry, merit-based allocation processes, comprehensive virologic monitoring, and rapid response strategies to maintain SPF status. It also emphasizes high-resolution immunogenetic profiling such as MHC typing to facilitate rigorous, genotype-informed study designs and efficient management of limited in vivo resources. Overall, this contract aims to integrate NAMs and SPF resources to enhance scientific rigor, reproducibility, and translational relevance in NIH-funded HIV/AIDS research.

General Info

Advance HIV/AIDS research by integrating NAMs implementation and maintaining SPF colony resources.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressUS
Contacts
Division of Comparative Medicine Office of Research Infrastructure Programs (ORIP
contact@example.gov
+1 (555) 000-0000

Full Description

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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 in vitro testing support and pilot benchmarking activities, to reduce or replace specific pathogen free (SPF) in vivo 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 in vivo models remain scientifically necessary.

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 in vivo 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 in vitro testing support (research use only), including standardized operating procedures, quality control frameworks, and user guidance for viral load quantification, drug resistance assessment, and ex vivo 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.

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 in vivo resources.

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