Opportunity Information: Apply for PAR 21 298

The grant opportunity "Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R41/R42 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR 21 298) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding program designed to push forward new multipurpose prevention technologies (MPTs) aimed at adolescent and young women. The central goal is to accelerate the development of innovative products that can simultaneously help prevent HIV infection and unintended pregnancy, with an emphasis on approaches that are long-acting and practical for real-world use. The FOA is focused on both systemic options (products that act throughout the body) and non-systemic options (products designed to act locally or through other non-systemic mechanisms), reflecting an interest in expanding the range of viable prevention choices beyond what is currently available.

A major theme of this announcement is the development of MPTs that combine protection against HIV with contraception, including both hormonal and non-hormonal pregnancy prevention strategies. This means applicants can propose technologies that integrate antiretroviral-based HIV prevention with contraceptive agents, or they can explore non-hormonal contraceptive concepts paired with HIV prevention components. The intent is to support prevention tools that fit the needs of adolescent and young adult women, especially in contexts where a single product that addresses multiple risks could reduce barriers to consistent use and improve overall health outcomes.

The FOA makes clear that a wide range of early-stage and translational development activities are considered relevant, particularly those needed to prepare a candidate product for later-stage testing and eventual implementation. Projects may include pharmacokinetic (PK) studies to understand how a drug or active agent is absorbed, distributed, metabolized, and eliminated; pharmacodynamic (PD) studies to examine biological effects and dose-response relationships; safety studies to assess tolerability and potential adverse effects; and drug-drug interaction (DDI) studies, which are especially important for combination products or for individuals who may use other medications concurrently. In practice, this creates room for applicants to tackle the key scientific and product-development uncertainties that commonly block progress between proof-of-concept and readiness for more advanced evaluation.

In addition to biomedical and formulation development, the announcement explicitly encourages biobehavioral and behavioral/social research components that help ensure the resulting technologies match end-user needs and preferences. This includes studies to identify what potential users prioritize in an MPT, such as look and feel, ease and comfort of use, perceived and actual effectiveness, safety concerns, and preferred duration of action. The FOA is essentially signaling that technical performance alone is not enough; adoption and sustained use depend heavily on acceptability, trust, convenience, and the social realities influencing decision-making for adolescent and young women. Projects that incorporate methods to better understand these factors, and to translate that understanding into product design requirements, align with the program's intent to promote higher uptake and consistent use once technologies become available.

This is an SBIR R41/R42 opportunity, which generally supports a phased small business research and development pathway, with early feasibility work typically occurring in Phase I (R41) and more advanced development in Phase II (R42). The eligible applicants listed for this FOA are small businesses, meaning proposals must be led by a qualifying small business concern rather than a university or nonprofit serving as the primary applicant (although collaborations and subcontracting arrangements are often used in SBIR projects). The funding instrument is a discretionary grant, administered by NIH, and the activity category is listed under Health, Income Security and Social Services. The CFDA numbers associated with this opportunity are 93.242 and 93.865, which correspond to NIH program areas that support relevant research and development activities.

A key boundary condition is stated in the title: "Clinical Trial Not Allowed." That typically means the FOA does not support applications proposing clinical trials as defined by NIH, so applicants should focus on preclinical development, non-clinical testing, product optimization, and other studies that do not meet the NIH definition of a clinical trial. The aim is to fund enabling work that de-risks candidate MPTs and strengthens the evidence base needed for later clinical evaluation through other mechanisms or future opportunities that allow clinical trials.

The opportunity was created on 2021-08-31, with an original closing date listed as 2023-12-09. Applicants considering similar opportunities should verify current submission dates and any reissued or updated FOAs, since NIH announcements can have multiple receipt dates across cycles or may be replaced by newer versions. Overall, PAR 21 298 is positioned to help small businesses develop next-generation MPTs that are long-acting, acceptable to users, and grounded in both rigorous biomedical development and realistic understanding of user preferences and behavioral factors that drive adoption among adolescent and young women.

  • The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R41/R42 Clinical Trial Not Allowed)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.865.
  • This funding opportunity was created on 2021-08-31.
  • Applicants must submit their applications by 2023-12-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses.
Apply for PAR 21 298

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