Development of Fertility Regulation Methods by Small Business (R43/R44 Clinical Trial Optional) | RFA HD 21 007

Opportunity Information: Apply for RFA HD 21 007

The grant opportunity titled "Development of Fertility Regulation Methods by Small Business (R43/R44 Clinical Trial Optional)" (Funding Opportunity Number RFA HD-21-007) is a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) funding announcement designed to push forward practical, product-focused advances in contraception. The central goal is to help small businesses develop new or improved non-hormonal fertility regulation methods for both women and men. In other words, the emphasis is on contraceptive approaches that do not rely on hormones, which can be important for reducing side effects, expanding user choice, and meeting the needs of people who cannot or prefer not to use hormonal methods.

A notable aspect of the scientific scope is that the NIH is also interested in contraceptives that include anti-infective properties. That points to products that could potentially provide dual protection: preventing pregnancy while also helping reduce the risk of certain infections. The announcement frames these as "contraceptives with anti-infective properties," suggesting that applicants can propose technologies that combine fertility regulation with infection prevention or infection-limiting mechanisms, so long as the work aligns with the overall contraceptive development mission.

This opportunity uses the SBIR R43/R44 mechanism, which typically corresponds to a phased innovation pathway for small companies: an early-stage feasibility and proof-of-concept phase (commonly associated with R43/Phase I) and a later-stage development and commercialization-oriented phase (commonly associated with R44/Phase II). The listing states "Clinical Trial Optional," meaning applicants may propose projects that include clinical trial activities if appropriate, but they are not required to do so. That flexibility allows companies to propose work anywhere along the development pipeline, from preclinical development and prototyping through later-stage validation, depending on what is justified by their product maturity and aims.

Eligibility is narrowly focused on small businesses, consistent with SBIR rules. The opportunity explicitly states that non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply. It also clarifies that non-domestic components of U.S. organizations are not eligible to apply, which is important for companies that may have overseas subsidiaries, labs, or significant foreign operational components tied directly to the proposed work. At the same time, the announcement leaves room for certain "foreign components" as defined in the NIH Grants Policy Statement, which may be allowed in some cases. In practical terms, that language often means that while the applicant organization must be a qualifying U.S. small business and the project must meet NIH requirements regarding domestic performance, there may be limited, well-justified circumstances where specific foreign elements are permitted under NIH policy (for example, specialized resources or collaborations), subject to approval and compliance with NIH rules.

Administratively, this is a discretionary grant under the health-related federal assistance umbrella (CFDA 93.865) and is managed by the NIH. The original closing date listed is 2020-07-30, and the funding opportunity record shows an award ceiling of $225,000. The source information provided does not specify the number of expected awards, but the intent is clearly to fund product-driven R&D that can lead to real-world contraceptive options, especially those that broaden non-hormonal choices and potentially integrate anti-infective benefits. The opportunity was created on 2020-04-10, indicating it was issued as a time-bounded call aligned with NIH priorities in fertility regulation and contraceptive technology development.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Development of Fertility Regulation Methods by Small Business (R43/R44 Clinical Trial Optional)" 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 2020-04-10.
• Applicants must submit their applications by 2020-07-30. (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 $225,000.00 in funding.
• Eligible applicants include: Small businesses.

Apply for RFA HD 21 007

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