Opportunity Information: Apply for RFA HD 19 004

The funding opportunity titled "Male and Female Contraceptive Development (R43/R44 Clinical Trial Optional)" (Funding Opportunity Number: RFA-HD-19-004) is a Small Business Innovation Research (SBIR) grant program run by the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services. Its central aim is to fund small businesses that are developing new contraceptive products or meaningfully improving existing contraceptive options for both men and women. In practical terms, the announcement is focused on helping early-stage and growing companies move promising contraceptive technologies forward, including the kinds of development work needed to turn a concept, prototype, or candidate product into something that can be tested, manufactured, and eventually used in real-world healthcare settings.

This FOA uses the SBIR R43/R44 mechanism, which generally supports a staged approach to innovation: Phase I (R43) typically covers proof-of-concept and early feasibility work, while Phase II (R44) supports more advanced research and development as the product moves closer to commercialization. The "Clinical Trial Optional" designation indicates that applicants may propose projects that include clinical trials, but they are not required to do so; companies can apply with non-clinical development plans as well, such as formulation work, device engineering, preclinical testing, manufacturing scale-up planning, performance and safety studies in appropriate models, usability and human factors work, or other activities that directly de-risk the product and prepare it for later regulatory and market steps.

Eligibility is limited to small businesses, reflecting the SBIR program's emphasis on supporting U.S. small companies as engines of innovation. The activity category is listed under Health, Income Security and Social Services, and the opportunity is associated with CFDA number 93.865, which corresponds to NICHD-related research support. The announcement was created on February 14, 2018, with an original application closing date of April 16, 2018, and it anticipated making about six awards. The listed award ceiling is $225,000, which signals the approximate upper limit expected for an award under the terms provided in the source data, though actual budgets in SBIR programs can vary depending on phase, scope, and NIH-specific guidance in the full solicitation.

Overall, the opportunity is designed to accelerate contraceptive innovation by providing targeted federal support to small businesses working on male and female contraception. The emphasis on "new and/or improved" products suggests an openness to a broad range of approaches, from entirely novel methods to refinements that improve effectiveness, safety, side-effect profiles, reversibility, ease of use, adherence, acceptability, delivery method, or access and affordability. The NIH sponsorship also implies an expectation that funded projects will be grounded in rigorous biomedical and product development practices, with a clear pathway toward a viable contraceptive product that can ultimately reach users.

  • The Department of Health and Human Services, National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Male and Female Contraceptive Development (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 Feb 14, 2018.
  • Applicants must submit their applications by Apr 16, 2018. (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.
  • The number of recipients for this funding is limited to 6 candidate(s).
  • Eligible applicants include: Small businesses.
Apply for RFA HD 19 004

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