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.Apply for PAR 21 298
- 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.
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Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R41/R42 Clinical Trial Not Allowed)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PAR 21 298.
Which agency is offering this funding?
This is a National Institutes of Health (NIH) funding opportunity.
What type of funding program is this?
This is a Small Business Innovation Research (SBIR) opportunity using the R41/R42 mechanism, which supports phased small business R&D (Phase I and Phase II).
What is the main goal of the program?
The central goal is to accelerate development of innovative multipurpose prevention technologies (MPTs) intended to help prevent both HIV infection and unintended pregnancy, with emphasis on approaches that are long-acting and practical for real-world use.
Who is the target population for the technologies supported by this FOA?
The FOA is aimed at technologies for adolescent and young adult women, with particular emphasis on meeting the needs of adolescent and young women.
What is a multipurpose prevention technology (MPT) in the context of this announcement?
In this FOA, an MPT refers to a product concept intended to address multiple prevention needs in a single technology, specifically combining protection against HIV with contraception (prevention of unintended pregnancy).
Does the FOA focus only on systemic options?
No. While the title references systemic options (products that act throughout the body), the FOA description indicates interest in both systemic options and non-systemic options (products designed to act locally or through other non-systemic mechanisms).
What kinds of contraception approaches are in scope?
The FOA includes both hormonal and non-hormonal pregnancy prevention strategies, as long as they are paired with HIV prevention components consistent with the program intent.
Are antiretroviral-based HIV prevention approaches allowed?
Yes. The FOA indicates applicants can propose technologies that integrate antiretroviral-based HIV prevention with contraceptive agents, and also encourages exploration of non-hormonal contraceptive concepts paired with HIV prevention components.
What kinds of research and development activities are considered relevant?
The FOA highlights early-stage and translational development activities intended to prepare a candidate product for later-stage testing and eventual implementation, including studies that address key uncertainties between proof-of-concept and readiness for more advanced evaluation.
Are pharmacokinetic (PK) studies allowed under this opportunity?
Yes. The FOA explicitly lists pharmacokinetic (PK) studies as an example of relevant work to understand how an active agent is absorbed, distributed, metabolized, and eliminated.
Are pharmacodynamic (PD) studies allowed?
Yes. The FOA explicitly includes pharmacodynamic (PD) studies to examine biological effects and dose-response relationships.
Does the FOA support safety studies?
Yes. Safety studies are specifically called out as relevant, including work to assess tolerability and potential adverse effects.
Are drug-drug interaction (DDI) studies in scope?
Yes. The FOA notes that DDI studies may be important, especially for combination products or for individuals who may use other medications concurrently.
Does this FOA encourage behavioral or social science components?
Yes. The FOA explicitly encourages biobehavioral and behavioral/social research components to help ensure technologies match end-user needs and preferences.
What kinds of user-preference factors does the FOA mention?
The FOA mentions factors such as look and feel, ease and comfort of use, perceived and actual effectiveness, safety concerns, and preferred duration of action.
Why does the FOA emphasize acceptability and real-world use?
The FOA signals that technical performance alone is not enough; adoption and sustained use depend on acceptability, trust, convenience, and social realities that influence decision-making for adolescent and young women.
What SBIR phases does this opportunity use?
This opportunity uses the R41/R42 pathway, generally aligning with Phase I (R41) for early feasibility work and Phase II (R42) for more advanced development.
Who is eligible to apply as the primary applicant?
The eligible applicants listed are small businesses. The proposal must be led by a qualifying small business concern as the primary applicant.
Can universities or nonprofits apply as the lead applicant?
Based on the information provided, the FOA is an SBIR opportunity and specifies small businesses as eligible applicants, meaning a university or nonprofit would not be the primary applicant under this program (though collaboration arrangements may be used).
Are collaborations or subcontracting allowed?
The FOA description notes that collaborations and subcontracting arrangements are often used in SBIR projects, even though the small business must be the primary applicant.
What is the funding instrument for this opportunity?
The funding instrument is a discretionary grant administered by NIH.
What is the listed activity category?
The activity category is listed under Health, Income Security and Social Services.
What CFDA numbers are associated with this opportunity?
The CFDA numbers associated with this opportunity are 93.242 and 93.865.
Are clinical trials allowed under this FOA?
No. The title states "Clinical Trial Not Allowed," which indicates the FOA does not support applications proposing clinical trials as defined by NIH.
If clinical trials are not allowed, what kinds of studies does NIH want funded here?
The FOA is positioned to support enabling work such as preclinical development, non-clinical testing, product optimization, and other studies intended to de-risk candidate MPTs and strengthen the evidence base for later clinical evaluation through other mechanisms.
When was this opportunity created?
The opportunity was created on 2021-08-31.
What was the original closing date listed for this opportunity?
The original closing date listed was 2023-12-09.
Should applicants verify current submission dates?
Yes. The information provided notes that NIH announcements can have multiple receipt dates across cycles or be replaced by newer versions, so applicants should verify current submission dates and whether an updated or reissued FOA applies.
What is the overall intended impact of PAR 21 298?
Overall, the FOA is positioned to help small businesses develop next-generation MPTs that are long-acting, acceptable to users, and informed by both biomedical development work and realistic understanding of user preferences and behavioral factors affecting adoption among adolescent and young women.
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