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.Apply for RFA AI 18 006
- 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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Frequently Asked Questions (FAQs)
What is the Sustained Release Innovation for HIV (SRI) funding opportunity?
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 aimed at accelerating next-generation HIV prevention tools that can last much longer than current options. The program is designed to support the creation and early development of sustained-release or extended-release HIV prevention drugs and drug delivery systems (DDS) that could protect at-risk individuals for durations measured in months to years.
What is the main goal of this program?
The central goal is to spur innovation that reduces the burden of frequent dosing or repeated clinic visits by enabling long-acting HIV prevention approaches. By supporting technologies that last months to years, the program seeks to improve adherence, persistence, and real-world effectiveness of HIV prevention strategies.
What kinds of projects does the FOA prioritize?
The FOA prioritizes product-development oriented innovations in sustained-release or extended-release HIV prevention drugs and drug delivery systems (DDS). The emphasis is on approaches that can credibly move toward clinical development readiness and that address practical development issues such as manufacturability, regulatory strategy, and supporting data packages (for example, formulation, stability, preclinical safety, and quality/manufacturing considerations).
What does "sustained-release" or "extended-release" mean in this context?
In this FOA, sustained-release or extended-release refers to HIV prevention drugs and delivery systems intended to provide protective drug exposure over long durations, specifically aiming for timeframes measured in months to years, rather than requiring frequent dosing or frequent clinical visits.
What is the funding mechanism used by this opportunity?
This opportunity uses a phased R61/R33 structure. It is intended for milestone-driven translational development rather than open-ended basic research, with defined performance benchmarks and formal decision points that determine whether a project advances from the early phase (R61) into the later phase (R33).
How does the R61 phase work?
The R61 phase supports early, high-impact development work tied to clearly defined performance benchmarks. Progress is evaluated against pre-specified milestones, and the structure is designed to push projects toward tangible, product-like readiness.
How does the R33 phase work, and what is required to move from R61 to R33?
Continuation into the R33 phase depends on meeting the R61 benchmarks through formal Go/No Go decision points. The intent is that teams demonstrate their approach is working as planned, key risks are being retired, and the development path is credible before advancing.
What are "Go/No Go" decision points?
Go/No Go decision points are formal evaluations against pre-specified milestones. Based on whether the milestones are met, a project may be allowed to continue (Go) or may not advance (No Go), including whether it can transition from the R61 phase to the R33 phase.
Is an industry partner required?
Yes. A defining requirement of this FOA is the involvement of an industry partner. This signals a strong emphasis on manufacturability, product development expertise, regulatory readiness, and eventual commercialization or large-scale implementation pathways.
Why does the FOA require an industry partner?
Based on the FOA description, the industry partner requirement reflects the program's product-development focus, including attention to manufacturability, product development capabilities, regulatory readiness, and pathways toward commercialization or large-scale implementation.
Is this FOA focused on basic research or translational development?
This FOA is structured for milestone-driven translational development and early product-oriented work rather than open-ended basic research. The phased R61/R33 mechanism is used to drive tangible progress and accountability through benchmarks and decision points.
What does "Clinical Trial Optional" mean for this opportunity?
"Clinical Trial Optional" means applicants may propose studies that do or do not meet the definition of a clinical trial. Whether a clinical trial is proposed can depend on the maturity and needs of the technology being developed.
Does the program expect engagement with the FDA?
Yes. The FOA includes an explicit regulatory expectation that, 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.
What is a pre-IND submission in the context of this FOA?
A pre-IND (Investigational New Drug) submission is referenced as part of the expected engagement with the FDA by the later stage of the project (by the time year 5 funding is relevant). The FOA treats regulatory strategy and interaction as core components of development readiness.
What types of data or development components are implied to support regulatory readiness?
The FOA description highlights that regulatory strategy and supporting data should be treated as core components, including areas such as formulation, stability, preclinical safety, and quality/manufacturing considerations.
What is the maximum award amount listed for this opportunity?
The posted award ceiling is $800,000 (as presented in the source summary), indicating an upper limit on funding levels for this opportunity.
What agency is offering this grant opportunity?
The opportunity is a National Institutes of Health (NIH) grant program.
What is the FOA number for this opportunity?
The FOA is identified as RFA AI 18-006.
What is the funding category and award type?
The opportunity is listed in the health funding category and is identified as a discretionary grant.
What are the CFDA numbers associated with this opportunity?
The opportunity is associated with CFDA numbers 93.242 and 93.855.
When was this opportunity created and when did it close?
The creation date listed is 2018-06-11, and the original closing date for applications was 2018-11-30.
Who is eligible to apply?
Eligibility is broad. Eligible applicants include 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). Public housing authorities/Indian housing authorities are eligible. The FOA also allows for-profit organizations (other than small businesses) and small businesses.
Are for-profit organizations allowed to apply?
Yes. The FOA allows for-profit organizations (other than small businesses) and also allows small businesses, reflecting the goal of engaging product developers and companies positioned to translate technologies into real-world interventions.
Are nonprofit organizations eligible even without 501(c)(3) status?
Yes. The FOA states that nonprofits are eligible both with and without 501(c)(3) status (excluding institutions of higher education under that nonprofit category).
Are tribal entities eligible to apply?
Yes. Eligible applicants include federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized governments.
Are institutions of higher education eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are community-based or faith-based organizations eligible?
Yes. The FOA explicitly highlights faith-based or community-based organizations among the "other eligible applicants."
Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA explicitly highlights 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), and Tribally Controlled Colleges and Universities (TCCUs).
Are U.S. territories or non-U.S. entities eligible?
Yes. The FOA explicitly includes U.S. territories or possessions and also lists non-U.S. (foreign) entities among the "other eligible applicants."
Are federal agencies eligible to apply?
Yes. The FOA includes eligible federal agencies among the "other eligible applicants."
What makes this FOA different from a traditional research grant?
This FOA is positioned as product-development oriented and milestone-driven, using the R61/R33 phased structure with Go/No Go decision points. It also requires an industry partner and includes an expectation of meaningful FDA engagement by later-stage funding, all of which reinforce a translational, development-ready focus.
What is the intended long-term impact of projects funded under this FOA?
The FOA aims to move durable HIV prevention technologies into realistic candidates for future clinical development and impact by accelerating innovations in long-acting drugs and delivery platforms, enforcing milestone accountability, and emphasizing industry partnership and regulatory readiness.
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