Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)
Can you apply?
This grant is for research institutions and organizations supporting HIV/AIDS research through integrated pathogen-free animal models and human new approach methodologies. Eligible applicants include academic medical centers, research institutions, and nonprofits with capacity to operate SPF animal colonies and/or develop validated human-based testing systems. The award supports two integrated priorities: implementing NAMs stewardship frameworks to reduce animal model use, and maintaining high-quality specific pathogen-free colony resources where in vivo studies remain necessary. Geographic scope is national; applicants from across the United States may apply.
Key dates
- May 20, 2026 Applications open
- Jan 25, 2027 Application deadline in 226 days
- Feb 1, 2028 Award announced
- Feb 1, 2028 Project start
Program description
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.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (Application for Federal Assistance)
- Project Narrative (specific page limit not stated; check NOFO for guidance)
- Detailed Budget and Budget Justification
- Institutional commitment letters demonstrating animal care facility or NAM resource partnerships
- Organizational capacity documentation (AAALAC accreditation, if applicable)
- Biographical sketches of key personnel
- Research strategy and specific aims
Program contact
- 👤 Division of Comparative Medicine, Office of Research Infrastructure Programs (ORIP)
- 📧 ORIPDCM@mail.nih.gov
- 📞 301-435-0744
Funding track record
Recent awards under CFDA 93.351 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$191,271,017
-
$189,307,929
-
$188,853,963
-
$156,271,917
-
$140,230,629
-
$133,830,113
-
$122,234,337
-
$37,946,246
-
$37,475,785
-
$33,218,050
Top States by Funding
- OR 7 awards $273.8M
- CA 8 awards $266.7M
- TX 10 awards $224.3M
- WA 2 awards $219.0M
- LA 5 awards $184.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.351). How funding has trended year over year.
| 2024 | $279,889,905 | |
| 2025 | $284,089,258 | |
| 2026 est. | $283,084,958 |
FAQ
Who is eligible to apply for this grant?
Domestic research institutions, academic medical centers, and nonprofits with capacity to operate SPF animal facilities or develop validated human-based testing methodologies. For-profit entities may be eligible if they collaborate with qualifying institutions.
What are the main funding priorities?
The grant supports two integrated components: establishing NAMs stewardship frameworks with consultation services to reduce animal model use, and maintaining high-quality SPF colony resources for HIV research where in vivo studies remain scientifically necessary.
Can I propose only the NAMs component without animal colony operations?
Yes. The grant has two integrated but distinct components. You may focus on implementing NAMs triage services, human in vitro testing support, and benchmarking activities if your organization lacks animal facility capacity.
What is a "Cooperative Agreement" vs. a traditional grant?
Cooperative agreements include substantial federal involvement in project oversight and performance. Expect ongoing collaboration with NIH program staff, not just funding and reporting.
What budget range should I target?
Awards range from approximately $212,000 to $2.7 million depending on project scope. Smaller awards typically focus on NAMs components; larger awards support full colony operations and integrated services.
💡 Tips for applicants
- Clearly distinguish whether you are applying for the NAMs stewardship component, the SPF colony resource component, or both integrated priorities. NIH reviewers need clarity on your institution's core capacity.
- If proposing animal colony operations, demonstrate existing SPF expertise, transparent allocation procedures, and robust virologic surveillance protocols. NIH expects high standards for animal resource stewardship.
- For NAMs components, emphasize partnerships with human tissue banks, cell culture providers, and other NAM centers. Integration with external resources strengthens your application competitively.
- Include specific metrics for animal model reduction or replacement outcomes. Document baseline use and realistic targets to show how your NAMs framework will advance the 3Rs principle (replacement, reduction, refinement).
- Budget for comprehensive quality control and validation activities. NIH prioritizes rigor and reproducibility for both animal colonies and human-based testing platforms.
⚠️ Common mistakes
Failing to demonstrate institutional commitment to animal welfare and the 3Rs principles. Proposing NAMs support without documented partnerships or integration pathways to external NAM resources. Underestimating the operational and quality control costs required for SPF colony maintenance and virologic surveillance.
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