Sustained Release Innovation for HIV (SRI) (R61/R33 Clinical Trial Optional) | RFA AI 18 006

Opportunity Information: Apply for RFA AI 18 006

The Sustained Release Innovation for HIV (SRI) (R61/R33 Clinical Trial Optional) funding opportunity (RFA AI 18-006) is a National Institutes of Health (NIH) grant program focused on accelerating next-generation HIV prevention tools that last far longer than current options. Its central aim is to spur the creation and early development of new sustained-release or extended-release HIV prevention drugs and drug delivery systems (DDS) capable of protecting at-risk individuals for extended durations measured in months to years. In practical terms, the program is looking for innovations that could meaningfully reduce the burden of frequent dosing or clinic visits by enabling long-acting prevention approaches, potentially improving adherence, persistence, and real-world effectiveness.

The award uses a phased R61/R33 structure, which is designed for milestone-driven translational development rather than open-ended basic research. The R61 phase supports early, high-impact development work that is tied to clearly defined performance benchmarks. Progress is evaluated against pre-specified milestones, and continuation into the R33 phase depends on meeting those benchmarks through formal Go/No Go decision points. This structure is meant to push projects toward tangible product-like readiness by requiring teams to show evidence that the approach is working as planned, that key risks are being retired, and that the development path is credible.

A defining requirement of this FOA is the involvement of an industry partner, signaling a strong emphasis on manufacturability, product development expertise, regulatory readiness, and eventual commercialization or large-scale implementation pathways. The program also builds in an explicit regulatory expectation: by the time year 5 funding is relevant, applicants are expected to have engaged with the U.S. Food and Drug Administration (FDA), including communication with the agency and/or a pre-IND (Investigational New Drug) submission. This requirement underscores that funded projects should be moving toward clinical development readiness, with regulatory strategy and supporting data (such as formulation, stability, preclinical safety, and quality/manufacturing considerations) being treated as core components rather than afterthoughts.

The opportunity is listed as a discretionary grant in the health funding category and is associated with CFDA numbers 93.242 and 93.855. The FOA is designated "Clinical Trial Optional," meaning applicants may propose studies that do or do not meet the definition of a clinical trial, depending on the maturity and needs of the technology. The posted award ceiling is $800,000, indicating an upper limit on funding levels (as presented in the source summary), and the original closing date for applications was 2018-11-30, with a creation date of 2018-06-11.

Eligibility is broad and intentionally inclusive, spanning many types of organizations that can contribute to long-acting HIV prevention innovation. Eligible applicants include various levels of government (state, county, city/township, and special district governments), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, and Native American tribal organizations other than federally recognized governments. Nonprofits are eligible both with and without 501(c)(3) status (excluding institutions of higher education under that nonprofit category), as are public housing authorities/Indian housing authorities. The FOA also allows for-profit organizations (other than small businesses) and small businesses, reflecting the goal of engaging product developers and companies capable of translating technologies into real-world interventions.

In addition, the FOA explicitly highlights several categories of "other eligible applicants," reinforcing NIH interest in participation from diverse institutions and communities. These include Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, U.S. territories or possessions, regional organizations, and non-U.S. (foreign) entities. Taken together, the eligibility language indicates a desire to attract both traditional biomedical R&D groups and a wider set of organizations that may contribute specialized capabilities, community relevance, or global perspective, particularly important for HIV prevention implementation across varied settings.

Overall, this FOA is best understood as a product-development oriented NIH mechanism intended to move promising long-acting HIV prevention concepts toward a regulated development pathway. It emphasizes innovation in sustained-release drugs and delivery platforms, formal milestone accountability with Go/No Go decisions, mandatory industry engagement, and an expectation of meaningful FDA interaction by later-stage funding, all aimed at turning durable HIV prevention technologies into realistic candidates for future clinical development and impact.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Sustained Release Innovation for HIV (SRI) (R61/R33 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.855.
• This funding opportunity was created on 2018-06-11.
• Applicants must submit their applications by 2018-11-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $800,000.00 in funding.
• Eligible applicants include: 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.

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