Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)
Status: Open
Posted date: May 20, 2026
Opportunity ID: 362488
Opportunity number: PAR-28-019
Opportunity category: Discretionary
Agency name: National Institutes of Health
Agency code: HHS-NIH11
Award floor: $212,004
Award ceiling: $2,725,311
Cost sharing required: No
Funding Instrument Types
- Cooperative Agreement
Category of Funding Activity
- Health
Eligible Applicants
- City or township governments
- County governments
- For-profit organizations other than small businesses
- Independent school districts
- Native American tribal governments (Federally recognized)
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education
- Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education
- Others
- Private institutions of higher education
- Public and State controlled institutions of higher education
- Public housing authorities/Indian housing authorities
- Small businesses
- Special district governments
- State governments
Categories (use these for quoted searches)
- agency_code:hhs_nih11
- category_of_funding_activity:health
- cost_sharing_or_matching_requirement:false
- eligible_applicants:city_or_township_governments
- eligible_applicants:county_governments
- eligible_applicants:for_profit_organizations_other_than_small_businesses
- eligible_applicants:independent_school_districts
- eligible_applicants:native_american_tribal_governments_federally_recognized
- eligible_applicants:native_american_tribal_organizations_other_than_federally_recognized_tribal_governments
- eligible_applicants:nonprofits_having_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:nonprofits_that_do_not_have_a_501_c_3_status_with_the_irs_other_than_institutions_of_higher_education
- eligible_applicants:others
- eligible_applicants:private_institutions_of_higher_education
- eligible_applicants:public_and_state_controlled_institutions_of_higher_education
- eligible_applicants:public_housing_authoritiesindian_housing_authorities
- eligible_applicants:small_businesses
- eligible_applicants:special_district_governments
- eligible_applicants:state_governments
- funding_instrument_type:cooperative_agreement
- opportunity_category:discretionary
- status:open
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.