Opportunity Information: Apply for PAR 21 297
The National Institutes of Health (NIH) funding opportunity titled "Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R43/R44 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-21-297) is a discretionary grant program aimed at pushing forward new, innovative multipurpose prevention technologies (MPTs). The central goal is to support development work on products that can simultaneously prevent HIV infection and unintended pregnancy, with a strong emphasis on meeting the real-world needs of adolescent and young adult women. The FOA is focused on advancing both long-acting systemic approaches (where prevention is delivered through the body over time) and non-systemic options (approaches that work locally or do not rely on sustained systemic drug levels). Both hormonal and non-hormonal pregnancy prevention strategies are within scope, as long as the overall concept is an MPT that addresses HIV and pregnancy together.
From a research and development standpoint, the announcement supports a range of early-stage and translational activities that are typical of product development, but it explicitly excludes clinical trials under this mechanism. Applicants can propose studies that generate the kinds of data needed to move an MPT concept forward responsibly, including pharmacokinetic (PK) work (how the body absorbs, distributes, metabolizes, and eliminates an agent), pharmacodynamic (PD) studies (what the agent does biologically and how it produces its effect), safety assessments, and drug-drug interaction (DDI) evaluations. In practice, this means the FOA is designed to help teams de-risk a candidate technology, optimize formulation or delivery approaches, understand dosing and durability for long-acting concepts, and establish foundational safety and interaction profiles that would be needed before later-stage clinical testing through other pathways.
A notable feature of this opportunity is that it encourages research that goes beyond laboratory and preclinical performance alone by including biobehavioral and behavioral/social studies. NIH is signaling that successful MPTs for young women will depend heavily on acceptability and sustained use, not just technical efficacy. Projects are therefore encouraged to examine end-user preference factors such as product look and feel, perceived and actual effectiveness, safety concerns, and preferred duration of action. The FOA also invites investigation into broader behavioral and social drivers that influence uptake and continued use, recognizing that adherence, stigma, relationship dynamics, access, and community context can determine whether a prevention technology succeeds outside of controlled settings.
This opportunity is offered as an NIH grant under the small business-oriented R43/R44 framework, which is typically used to support phased innovation and product development by small businesses, while still allowing a wide ecosystem of partners to participate. Eligibility is broad and includes not only small businesses, but also many types of organizations that can apply or collaborate depending on the application structure and NIH rules. Eligible applicants listed for this FOA 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; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); and for-profit organizations (including those other than small businesses). The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, non-U.S. entities (foreign organizations), regional organizations, tribal governments other than federally recognized tribes, and U.S. territories or possessions. This breadth reflects an intention to support a diverse pipeline of innovators and to encourage partnerships with institutions that have strong connections to communities most impacted by HIV and unintended pregnancy.
The opportunity falls under NIH CFDA numbers 93.242, 93.855, and 93.865 and was created on 2021-08-31, with an original closing date listed as 2023-12-09. While the award ceiling and expected number of awards are not specified in the provided source data, the overall structure and content make the intent clear: NIH wants to accelerate the development of next-generation, long-acting and user-centered MPT options for adolescent and young women, pairing biomedical development (PK/PD/safety/DDI) with acceptability and behavioral research to improve the likelihood that resulting products are not only scientifically sound but also genuinely usable and desirable for the intended end users.Apply for PAR 21 297
- 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 (R43/R44 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, 93.855, 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: 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 title and funding opportunity number for this NIH program?
The opportunity is titled "Multipurpose Prevention Technology: Novel Systemic Options for Young Adults (R43/R44 Clinical Trial Not Allowed)" and the Funding Opportunity Number is PAR-21-297.
What is the main goal of this funding opportunity?
The central goal is to advance new multipurpose prevention technologies (MPTs) that can simultaneously prevent HIV infection and unintended pregnancy, with a strong emphasis on meeting the real-world needs of adolescent and young adult women.
What types of prevention technologies are in scope?
The FOA supports innovative MPT concepts that address both HIV prevention and pregnancy prevention together. It is focused on advancing long-acting systemic approaches (prevention delivered through the body over time) as well as non-systemic options (approaches that work locally or do not rely on sustained systemic drug levels).
Are both hormonal and non-hormonal pregnancy prevention strategies allowed?
Yes. Both hormonal and non-hormonal pregnancy prevention strategies are within scope, as long as the overall concept is an MPT that addresses HIV prevention and pregnancy prevention together.
What does "systemic" mean in the context of this FOA?
In this FOA, systemic approaches are those where prevention is delivered through the body over time, typically relying on sustained drug levels in the body to provide longer-acting protection.
What does "non-systemic" mean in the context of this FOA?
Non-systemic options are approaches that work locally or do not rely on sustained systemic drug levels. The FOA explicitly includes these alongside long-acting systemic concepts.
What grant mechanism is used for this opportunity?
This opportunity is offered under the NIH small business-oriented R43/R44 framework, which is typically used to support phased innovation and product development.
Are clinical trials allowed under this funding opportunity?
No. Clinical trials are explicitly excluded under this mechanism ("Clinical Trial Not Allowed"). Applicants can propose product development and translational studies, but not clinical trials within this FOA.
What kinds of research activities does the FOA support?
The announcement supports early-stage and translational activities typical of product development aimed at responsibly moving an MPT concept forward. This includes generating data to de-risk candidates, optimize formulation or delivery approaches, and build foundational evidence needed before later-stage clinical testing through other pathways.
What is pharmacokinetic (PK) work, and is it supported?
Yes, PK work is supported. Pharmacokinetics refers to how the body absorbs, distributes, metabolizes, and eliminates an agent, and the FOA allows studies to generate PK data to inform dosing, durability, and performance for long-acting concepts.
What is pharmacodynamic (PD) work, and is it supported?
Yes, PD work is supported. Pharmacodynamics refers to what the agent does biologically and how it produces its effect. The FOA supports PD studies that help demonstrate biological activity and inform product development decisions.
Are safety assessments included as allowable activities?
Yes. The FOA allows safety assessments as part of the development work needed to move an MPT candidate forward responsibly.
Are drug-drug interaction (DDI) evaluations supported?
Yes. Drug-drug interaction (DDI) evaluations are explicitly included as allowable studies, supporting the establishment of foundational interaction profiles.
What does NIH mean by "de-risking" a candidate technology in this FOA?
Based on the FOA description, de-risking refers to generating key PK/PD, safety, and DDI information (and related development data) that reduces uncertainty about the feasibility and readiness of an MPT candidate before later-stage testing.
Does this FOA support formulation or delivery optimization?
Yes. The FOA is designed to support development work that can include optimizing formulation or delivery approaches, including understanding dosing and durability for long-acting concepts.
Why does the FOA emphasize adolescent and young adult women?
The FOA places strong emphasis on developing MPTs that fit the real-world needs of adolescent and young adult women, recognizing that successful prevention products must be usable and desirable for the intended end users.
Does the FOA support behavioral or social science research?
Yes. A notable feature is the inclusion of biobehavioral and behavioral/social studies, reflecting NIH's focus on acceptability and sustained use in real-world settings, not just technical or preclinical performance.
What kinds of end-user preference factors are encouraged for study?
Projects are encouraged to examine factors such as product look and feel, perceived and actual effectiveness, safety concerns, and preferred duration of action, as these can influence acceptability and continued use.
What broader behavioral and social drivers does the FOA suggest may be important?
The FOA points to drivers such as adherence, stigma, relationship dynamics, access, and community context, acknowledging that these can determine whether a prevention technology succeeds outside controlled settings.
Who is eligible to apply or participate?
Eligibility is broad. The FOA lists many eligible applicant types and also reflects an intention to support diverse innovators and partnerships, including organizations with strong connections to communities most impacted by HIV and unintended pregnancy.
Which government entities are listed as eligible applicants?
Eligible applicants include state, county, city or township governments; special district governments; independent school districts; federally recognized Native American tribal governments; tribal governments other than federally recognized tribes; U.S. territories or possessions; and eligible federal agencies.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education. The FOA also highlights categories such as HBCUs, TCCUs, Hispanic-serving Institutions, AANAPISIs, and Alaska Native and Native Hawaiian Serving Institutions.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education) are listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations are listed as eligible applicants, including entities other than small businesses, even though the mechanism is described as small business-oriented (R43/R44).
Are community-based and faith-based organizations mentioned?
Yes. The FOA highlights faith-based or community-based organizations among eligible applicant categories.
Are non-U.S. entities eligible?
Yes. The FOA includes non-U.S. entities (foreign organizations) among the eligible applicant categories.
Are tribal organizations that are not federally recognized eligible?
Yes. Native American tribal organizations that are not federally recognized are explicitly listed as eligible applicants, and tribal governments other than federally recognized tribes are also highlighted.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
What CFDA numbers are associated with this opportunity?
The opportunity falls under NIH CFDA numbers 93.242, 93.855, and 93.865.
When was this opportunity created?
The opportunity was created on 2021-08-31.
What is the closing date listed in the provided information?
The original closing date listed in the provided source data is 2023-12-09.
Does the provided information specify an award ceiling or number of awards?
No. The provided source data does not specify the award ceiling or the expected number of awards.
What is NIH trying to accelerate through this FOA?
NIH is aiming to accelerate next-generation, long-acting and user-centered MPT options for adolescent and young women by pairing biomedical development work (PK/PD/safety/DDI) with acceptability and behavioral research to improve real-world usability and desirability.
What kind of evidence is this FOA designed to help teams build before later-stage clinical testing?
It is designed to help teams establish foundational PK/PD, safety, and drug-drug interaction profiles, along with other development data (such as dosing and durability for long-acting concepts), that would be needed prior to pursuing later-stage clinical testing through other pathways.
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