User-Based Design to Aid in Contraceptive Development by Small Business (R43 Clinical Trial Not Allowed) | RFA HD 22 019

Opportunity Information: Apply for RFA HD 22 019

The National Institutes of Health (NIH) issued this discretionary grant opportunity, RFA-HD-22-019, titled "User-Based Design to Aid in Contraceptive Development by Small Business (R43 Clinical Trial Not Allowed)." It is an SBIR-focused funding announcement intended for small businesses that can apply user-centered and human-centered design methods to contraception R&D. The core aim is not to run clinical trials or test clinical outcomes, but to generate practical, evidence-based insights about what prospective users actually want and will be willing to use. In other words, the NIH is looking to fund research that helps contraceptive products in the development pipeline become more acceptable, desirable, and even genuinely appealing to end-users, across products being developed for both women and men.

The work this FOA supports centers on studying and identifying user characteristics, preferences, and decision drivers that shape contraceptive uptake and sustained use. That can include factors tied to usability and product experience (for example, form factor, dosing or use schedule, privacy and discretion, perceived control, side effects concerns, ease of access, partner involvement, and cultural fit), as well as motivational and emotional dimensions (such as trust, stigma, novelty appeal, confidence in effectiveness, and perceived impact on intimacy). The emphasis on "acceptability, desirability, and excitement" signals that NIH is encouraging applicants to look beyond minimum viability and instead examine what features would make a new method compelling enough to compete with existing options in real-world settings. The expected output is actionable user-informed guidance that can be fed back into product design decisions for novel contraceptives already being developed.

This is an SBIR Phase I-style award mechanism (R43), meaning it is designed to support early-stage, feasibility-oriented research by small businesses. The award ceiling listed is $250,000, which is consistent with Phase I budget expectations and reinforces the focus on targeted studies that can produce clear design requirements, user insights, and development priorities within a limited scope. The funding instrument type is a grant, and the funding activity category is identified broadly within health, income security, and social services under CFDA 93.865.

Eligibility is limited to small businesses, which aligns with the SBIR goal of stimulating technological innovation and supporting commercialization-oriented research in the private sector. Foreign institutions and non-U.S. entities are explicitly not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, the announcement notes that "foreign components" as defined in the NIH Grants Policy Statement may be allowed, which typically means a U.S. applicant might be able to include certain elements of work performed abroad if properly justified, approved, and compliant with NIH policy, even though the applicant organization itself must be domestic and eligible.

The opportunity was created on March 29, 2021, and the original closing date was July 29, 2021. While the provided record does not specify the number of expected awards, the purpose statement makes clear that NIH wanted to attract multiple SBIR applicants capable of conducting rigorous user research that directly informs design choices for emerging contraceptive technologies. The key boundary condition is that this FOA is "Clinical Trial Not Allowed," so proposed studies must avoid clinical trial activities (such as prospective assignment to an intervention to evaluate health-related outcomes). Instead, the project scope should remain in the realm of user research and design-oriented investigation, such as qualitative and quantitative user studies, preference elicitation, usability research with prototypes where appropriate, and other non-clinical evaluations aimed at improving product-market fit and adoption potential.

Overall, the grant opportunity is essentially a call for small businesses to bring structured user-based design research into contraceptive development. The NIH objective is to reduce the common gap between promising contraceptive science and real-world adoption by funding early studies that clarify what different user groups value, what barriers they face, and what product attributes would make novel contraceptives more likely to be chosen, used correctly, and used consistently.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "User-Based Design to Aid in Contraceptive Development by Small Business (R43 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): 93.865.
• This funding opportunity was created on 2021-03-29.
• Applicants must submit their applications by 2021-07-29. (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 $250,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA HD 22 019

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