Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed)

The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is a leading federal agency responsible for biomedical and public health research. Within NIH, the Division of Program Coordination, Planning and Strategic Initiatives, through the Office of Research Infrastructure Programs (ORIP), and in collaboration with the Office of AIDS Research (OAR), has released a Notice of Funding Opportunity (NOFO) titled “Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research.” This funding opportunity, designated under activity code U42, is a reissue of PAR-24-078 and is intended to provide continued support for Specific Pathogen Free (SPF) macaque colonies that play a vital role in HIV/AIDS research. The primary goal of this NOFO is to support existing SPF macaque colonies previously funded under PAR-21-089 and PAR-18-669. These colonies provide essential nonhuman primate (NHP) models, specifically SPF Indian-origin rhesus macaques and pigtail macaques, which are used in HIV/AIDS-related research. These animals are free of viruses such as Simian Immunodeficiency Virus (SIV), Simian T-cell Lymphotropic Virus (STLV-1), Type D simian retrovirus (SRV), and Herpes B virus. This pathogen-free status is critical to ensure that experimental results are not confounded and that animal care personnel are protected from potential health risks. Furthermore, the macaques are genetically characterized for their Major Histocompatibility Complex (MHC) class I alleles, which play a key role in immune response and are critical in evaluating vaccine efficacy. Funding under this NOFO supports the continued breeding and maintenance of these SPF colonies, as well as their allocation to HIV/AIDS researchers, prioritizing NIH-funded investigators. The colonies must ensure SPF status through rigorous viral testing, conduct MHC genotyping, and sustain operations through a mix of federal funding and program income derived from animal distribution fees. Notably, the NOFO requires that at least 50% of SPF macaques produced be allocated to external investigators outside of the awardee institution. The program also encourages development of expanded SPF colonies (eSPF), free of additional pathogens such as CMV and HSV, to support broader HIV/AIDS research objectives. The application process for this funding opportunity follows the NIH multi-project structure and must be submitted electronically via NIH ASSIST or an institutional S2S solution. Applications must include an Overall Component, as well as three required Core Components: Husbandry and Management, Viral Testing, and MHC Genetic Typing. The application must outline sustainability plans, financial strategies, animal allocation protocols, and methods for maintaining SPF status. Applications must also include letters of support and adhere strictly to NIH's application guide, including all relevant page limits and formatting requirements. Clinical trials are not permitted under this NOFO. Eligible applicants are limited to institutions previously awarded funding under PAR-21-089 or PAR-18-669, meaning this is a limited competition. Foreign organizations or components are not eligible. Matching funds are not required. While application budgets are not capped, applicants requesting $500,000 or more in direct costs in any year must obtain prior approval. The maximum project period is four years. Applications are accepted on standard NIH AIDS deadlines, including May 7 and September 7 in 2025 and 2026, and January 7 in 2026. The most current expiration date is September 26, 2026. Applications are evaluated based on scientific merit by a peer review group, with additional consideration given to the colony's significance, innovation, investigator expertise, and the strength of the approach and environment. The program requires coordination among grantees through an annual consortium and includes close federal oversight and involvement through cooperative agreements. Key contacts for technical and administrative inquiries are Yongjun Sui ([email protected]) and Elisabet Caler ([email protected]) for scientific questions, and Kenneth Holiness ([email protected]) and Felecia Bush ([email protected]) for grants management.

Emphasize prioritization of animal distribution to NIH-funded researchers and maintenance of SPF status; include strong financial and sustainability plans.