Next Generation Multipurpose Prevention Technologies (NGM) (R61/R33 Clinical Trial Optional) | RFA AI 17 028

Opportunity Information: Apply for RFA AI 17 028

The National Institutes of Health (NIH) funding opportunity titled "Next Generation Multipurpose Prevention Technologies (NGM) (R61/R33 Clinical Trial Optional)" (Funding Opportunity Number RFA AI 17 028) is a discretionary grant program designed to move forward new, innovative multipurpose prevention technologies (MPTs) for women that can simultaneously prevent unintended pregnancy and HIV infection. The emphasis is on products that fit the real-world expectations set by current long-acting reversible contraceptive (LARC) approaches, meaning the proposed MPT should be comparable in practical, user-facing terms such as look and feel, perceived comfort, ease of use, and importantly, the effectiveness, safety profile, and duration of protection that users and clinicians associate with established long-acting contraceptive methods. In other words, NIH is looking for next-generation products that are not only scientifically compelling, but also realistically adoptable and acceptable to end users, with physical and performance characteristics that align with what has made LARC strategies successful.

A central requirement of the FOA is that the proposed technology must be truly dual indication: it must prevent pregnancy and prevent HIV infection, not one or the other. To achieve this, the project must include a drug delivery system (DDS) capable of sustained or extended release of both active drugs over time. The sustained-release requirement is a major theme because it aligns with the "long-acting" expectation, reducing adherence burdens that can undermine effectiveness in daily or event-driven products. Another key constraint is that the contraceptive component must be a licensed contraceptive, which signals NIHs intent to reduce developmental uncertainty and accelerate translation by building the MPT around a contraceptive agent with an established regulatory and clinical history.

The mechanism uses an R61/R33 phased innovation structure. The R61 phase typically supports early, milestone-driven development and feasibility work, while the R33 phase supports the next stage of development once predefined performance benchmarks are met. This FOA is explicitly milestone-based, with Go/No Go decision points tied to those milestones, which means applicants are expected to propose clear, measurable technical and development targets and accept that continued funding depends on meeting them. A notable late-stage requirement is that receiving funding into year 5 is contingent on submitting a pre-IND package to the U.S. Food and Drug Administration (FDA). That detail makes the programs intent very clear: projects should be progressing toward a product that is plausibly on a regulatory path, not just generating early research findings.

The opportunity is labeled "Clinical Trial Optional," meaning a clinical trial is not automatically required under the FOA, but clinical trial-related activities may be allowable if they fit the aims and stage of development. Given the product-development focus and the pre-IND expectation, the practical intent is to support a pipeline that can mature from concept and formulation through the kinds of preclinical and translational work needed to engage FDA and prepare for later clinical evaluation, while leaving flexibility to tailor the workplan to the maturity of a given candidate technology.

Collaboration with industry is not optional here: the FOA requires an industry partner. This requirement reflects the reality that complex combination products and sustained-release delivery platforms often need manufacturing, formulation, quality systems, scale-up experience, and regulatory strategy capabilities that are commonly found in industry settings. Applicants should therefore anticipate that the partnership needs to be substantive and well integrated into the workplan, especially around product design, manufacturability, and regulatory readiness.

In terms of who can apply, eligibility is broad and spans public and private sectors. Eligible applicants include state, county, city or township governments; 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; tribal organizations other than federally recognized tribal governments; public housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations other than small businesses; and small businesses, along with certain other entities. The FOA also highlights additional eligible applicants and organizational types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). This breadth is consistent with the multidisciplinary nature of MPT development, which can span biomedical research, pharmaceutical sciences, materials science, device engineering, behavioral and user perception research, and implementation considerations.

Administrative details in the source include that the program is a grant under NIH, categorized under health, with CFDA numbers 93.242 and 93.855. The opportunity record lists an original closing date of 2018-03-19 and a creation date of 2017-09-12. The listing also indicates an award ceiling of 800,000. The number of expected awards is not specified in the provided record ("ExpectedAwards:" appears without a number), so applicants would typically interpret that as unknown or dependent on available funds and the quality of submissions.

Overall, this FOA is best understood as a product-development push for next-generation, long-acting style MPTs for women that combine a licensed contraceptive with an anti-HIV prevention drug in a sustained-release delivery platform, while also meeting practical user acceptability expectations. It is structured to reduce risk through staged funding and firm milestones, requires a real industry partnership, and is designed to culminate in concrete regulatory engagement through a required pre-IND submission to FDA as a condition for later-year support.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Next Generation Multipurpose Prevention Technologies (NGM) (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 2017-09-12.
• Applicants must submit their applications by 2018-03-19. (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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