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

The Limited Competition: Specific Pathogen Free Macaque Colonies to Support HIV/AIDS Research (U42 Clinical Trial Not Allowed) funding opportunity is administered by the National Institutes of Health through the Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs, with participation from the Office of AIDS Research. The program is designed to provide continuing support for specific pathogen-free macaque breeding colonies that were previously funded under PAR-21-089 and PAR-18-669. These colonies are considered critical infrastructure for HIV/AIDS-related biomedical research because macaques provide highly relevant nonhuman primate models for studying HIV pathogenesis, vaccine development, immune response mechanisms, prevention technologies, and co-infections. The program specifically supports colonies that maintain animals free from Simian Immunodeficiency Virus, Simian Retrovirus, Simian T-cell Lymphotropic Virus 1, and herpes B virus, all of which could confound experimental outcomes or present biosafety risks. The funding opportunity supports the breeding, maintenance, testing, characterization, and distribution of specific pathogen-free rhesus and pigtail macaques for use in HIV/AIDS research. The colonies are also required to genetically characterize animals for major histocompatibility complex class I alleles because these genetic markers strongly influence immune responses to Simian Immunodeficiency Virus infection and vaccine efficacy studies. The NIH notes that these breeding colonies are effectively closed colonies that rely on existing breeding stock to sustain research populations. Applicants are expected to maintain colony operations, preserve pathogen-free status through ongoing viral testing, genotype animals for key MHC loci, allocate animals to qualified HIV/AIDS researchers, and provide long-term sustainability planning. The funding opportunity also allows expanded pathogen-free programs if applicants can justify excluding additional pathogens and explain how such expansion would benefit HIV/AIDS research. This opportunity uses the U42 cooperative agreement mechanism and only allows renewal, resubmission, and revision applications from organizations previously funded under the earlier SPF macaque colony announcements. Foreign organizations and foreign components are not eligible. Clinical trials are not permitted. The award budget is not capped, but applicants must justify costs based on actual project needs. Any applicant requesting more than $500,000 in direct costs in a year must contact NIH scientific staff at least six weeks prior to submission. The maximum project period is four years. Cost sharing is not required. Applicants are strongly encouraged to generate program income through animal sales, lease fees, per diem charges, and related operational revenue to support sustainability. NIH expects program income and other non-federal support sources to contribute approximately half or more of the colony operating costs over the renewal period. Applications must be submitted electronically through Grants.gov using ASSIST or institutional system-to-system solutions and tracked through eRA Commons. Required application components include an Overall component, a Husbandry and Management Core, a Viral Testing Core, and an MHC Genetic Typing Core. Each core has detailed instructions and page limitations. The Overall section requires colony management descriptions, allocation plans prioritizing NIH-funded HIV/AIDS researchers, conflict resolution procedures, and justification for any expanded pathogen-free programs. The Husbandry and Management Core requires sustainability planning, breeding protocols, veterinary care procedures, environmental enrichment descriptions, and financial strategies. The Viral Testing Core requires detailed descriptions of testing assays, outbreak validation procedures, and assay improvement plans. The MHC Genetic Typing Core requires descriptions of current and expanded MHC typing approaches and methods supporting rigor and reproducibility. Applications must also include institutional support letters, resource sharing plans, and all required registrations including SAM, UEI, Grants.gov, and eRA Commons. Applications are reviewed through NIH peer review processes using criteria related to significance, investigators, innovation, approach, and environment. Additional review factors include vertebrate animal protections, biohazard safeguards, resource sharing, and colony sustainability. Reviewers evaluate the scientific value of maintaining pathogen-free colonies, the applicants’ ability to manage breeding and distribution programs, the adequacy of viral testing and MHC characterization approaches, and plans to allocate at least 50 percent of animals to investigators outside the awardee institution. The cooperative agreement structure includes substantial NIH involvement, including participation from ORIP project scientists and program officers in colony coordination, allocation oversight, remediation planning, and consortium meetings. Awardees must maintain local electronic databases, submit annual colony reports, and participate in SPF Macaque Grantee Consortium coordination activities. The funding opportunity opened for submissions on April 7, 2024 and uses recurring AIDS-related application due dates through September 25, 2026. The next active due date after the current analysis date is September 25, 2026. Applications are due by 5:00 PM local time of the applicant organization. Review cycles occur several months after submission, with advisory council review and earliest project start dates tied to each cycle. The notice expiration date was updated to September 26, 2026. Key contacts include Yongjun Sui at ORIP, Elisabet V Caler at the Office of AIDS Research, and several grants administration and peer review contacts. The funding opportunity reflects NIH priorities related to HIV/AIDS infrastructure, nonhuman primate research resources, and long-term biomedical research capacity development.

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