Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed) | RFA HD 19 015

Opportunity Information: Apply for RFA HD 19 015

The NIH funding opportunity titled "Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed)" (Funding Opportunity Number: RFA-HD-19-015) is a discretionary grant program intended to accelerate early, multidisciplinary research that can lead to new, nonsteroidal contraceptive products for both men and women. The scientific focus is specifically on contraceptive approaches that act prior to fertilization, with the broader goal of generating the kind of rigorous, validated preclinical evidence needed to position these methods for later-stage clinical development. As stated in the title and mechanism, this program does not allow clinical trials, so projects are expected to remain in the non-clinical development space, emphasizing discovery-to-validation steps rather than testing in human participants.

This FOA uses the NIH R61/R33 phased innovation mechanism, which is designed to move projects through a milestone-driven development path. In practical terms, applicants typically propose an initial, shorter R61 phase that supports early feasibility work, optimization, and proof-of-concept, followed by an R33 phase that supports more advanced development once predefined milestones are met. The structure is meant to reduce risk and encourage translation by requiring clear, measurable technical objectives, decision points, and deliverables that demonstrate whether the approach is ready to move forward. The emphasis on "innovative and validated methods" signals that the NIH is looking for projects that do more than generate interesting basic findings; they should produce credible data packages, prototype candidates, or enabling evidence that would support subsequent clinical-stage planning outside the scope of this FOA.

Administratively, the opportunity is offered by the National Institutes of Health under CFDA 93.865 and falls within the Health, Income Security and Social Services activity category. The funding instrument is a grant, and the listed award ceiling is $500,000. The opportunity was created on June 15, 2018, with an original closing date of November 6, 2018. While the number of expected awards is not specified in the provided source data, the presence of a defined ceiling and a phased mechanism indicates the program is designed to support well-scoped development projects with clear go/no-go criteria rather than open-ended exploratory research.

Eligibility is broad and includes a wide range of domestic and non-domestic organizations. Eligible applicants include state, county, and local 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 that are not federally recognized governments; public housing authorities/Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities. The FOA also explicitly highlights additional eligible applicant types 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, regional organizations, U.S. territories or possessions, Indian/Native American tribal governments other than federally recognized, and non-U.S. entities (foreign organizations). This breadth reflects an interest in drawing on diverse scientific, engineering, clinical-development, and product-development expertise, including institutions and communities that are often underrepresented in federally funded biomedical R&D.

Taken together, the opportunity is best understood as an NIH-backed push to expand the pipeline of contraceptive options by supporting nonsteroidal, pre-fertilization methods at a stage where strong preclinical validation and development planning can de-risk future clinical translation. The program’s milestone-based R61/R33 structure and the explicit prohibition on clinical trials reinforce that funded work should concentrate on building credible, actionable evidence and development readiness, rather than initiating or conducting studies in human subjects.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - 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 2018-06-15.
• Applicants must submit their applications by 2018-11-06. (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 $500,000.00 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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