Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)
Forecasted Federal grant Posted
- Opportunity number
- PAR-28-019
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications expected due
- Award size
- $212,004 to $2,725,311
Opportunity facts
- Expected posting
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- State Governments
- Public or Indian Housing Auth.
- County Governments
- City/Township Governments
- Higher Education Inst. (Private)
- Tribal Governments (Federally Recognized)
- Non-501(c)(3) Nonprofits
- Independent School Districts
- Small Businesses
- 501(c)(3) Nonprofits
- Other
- Higher Education Inst. (Public)
- Tribal Organizations (Not Federally Recognized)
- For Profit Organizations
- Special District Governments
- Points of contact
-
- Oleg Mirochnitchenko oripdcm@mail.nih.gov (301) 435-0744
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institutes of Health is soliciting applications for a cooperative agreement to advance HIV/AIDS research through integrated specific pathogen free (SPF) research models and human new approach methodologies (NAMs), with eligible applicant types spanning state and local governments, higher education institutions (public and private), tribal governments and organizations, nonprofits (including 501(c)(3) and non-501(c)(3)), small businesses, for-profit organizations, and other entity categories including faith-based and community-based organizations, regional organizations, non-domestic entities, and U.S. territories.
The NOFO establishes two integrated priorities: implementation of a NAMs-enabled stewardship framework to reduce or replace SPF in vivo model use where scientifically appropriate, and support for high-quality SPF colony resources for studies requiring well-characterized in vivo models. Required elements under the NAMs component include integration of a triage and consultation service within request intake workflows to identify NAM-feasible studies and document reductions in in vivo use, and establishment of a formal referral pathway to NAM centers and human tissue resources to facilitate collaborative HIV-relevant human NAM development and benchmarking. Applicants may propose optional elements including NAMs-enabled HIV human in vitro testing support with standardized operating procedures and quality control frameworks for viral load quantification, drug resistance assessment, and ex vivo susceptibility assays, and pilot benchmarking projects to define performance metrics and context-of-use statements. Under the SPF resource component, awards support core colony operations including management, husbandry, transparent merit-based request allocation, virologic surveillance to preserve SPF status, and high-resolution immunogenetic characterization such as MHC typing.
The opportunity falls under the NIH Office of Research Infrastructure Programs (CFDA 93.351). No application deadline, award ceiling, award floor, or period of performance dates are specified in the source material.
Forecast synopsis
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.
Eligibility
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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