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Forecasted · Cooperative Agreement

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

National Institutes of Health, Department of Health and Human Services

Key facts

Copied from the official Grants.gov record. Last verified October 30, 2026.

Program name
Integrated Specific Pathogen Free Research Models and Human New Approach Methodologies to Advance HIV/AIDS Research (U42 Clinical Trial Not Allowed)
Issuing agency
National Institutes of Health (Department of Health and Human Services)
Opportunity number
PAR-28-019
Funding type
Cooperative Agreement
Funding purpose
Health
Status
Forecasted
Application deadline
Forecasted · estimated close January 25, 2027 (agency estimate)
Agency estimates
Estimated posting: November 24, 2026. Estimated award date: February 1, 2028. Estimates can change.
Published award range
$212,004 – $2,725,311
Expected number of awards
4
Cost sharing or match required
No
Eligible applicants (official categories)
  • State governments
  • County governments
  • City or township governments
  • Special district governments
  • Independent school districts
  • Public and State controlled institutions of higher education
  • Native American tribal governments (Federally recognized)
  • Public housing authorities/Indian housing authorities
  • 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
  • Private institutions of higher education
  • For profit organizations other than small businesses
  • Small businesses
  • Others (see Additional Information on Eligibility)
Relevant to
Businesses and NonprofitsHow we determined this: Grants.gov eligibility includes small businesses or for-profit organizations. Grants.gov eligibility includes nonprofit organizations.
Geographic restrictions
None stated in structured data (federal opportunities are often nationwide). Check the eligibility details and full announcement for any limits.
Assistance Listing (CFDA)
93.351
Official source
View on Grants.gov ↗
Application URL
www.grants.gov/search-results-detail/362488 ↗Apply through Grants.gov (Workspace) using the application package on the official listing, unless the full announcement names a different submission system.
Source identifier
Grants.gov opportunity ID 362488 · Funding opportunity number PAR-28-019
Posted
May 20, 2026 · Source last updated May 20, 2026
Last verified
October 30, 2026 (against Grants.gov)
Data completeness
100% of key fields published by the source
Record confidence
mediumforecast — dates and amounts are agency estimates.

Eligibility details (from the agency)

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).

Description (from the official listing)

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…

Read the full 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.

Agency contact

Division of Comparative Medicine, Office of Research Infrastructure Programs (ORIP)
ORIPDCM@mail.nih.gov

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