Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed) | PAR 19 261

Opportunity Information: Apply for PAR 19 261

The Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed) funding opportunity (PAR-19-261) is an NIH program run through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) that is designed to speed up the development of non-hormonal contraceptives for either men or women. Instead of primarily providing traditional research dollars to build a lab program from scratch, this opportunity gives investigators a formal mechanism to request access to a centralized, state-of-the-art chemical synthesis and optimization facility that NICHD already maintains. The core idea is to help promising contraception concepts move forward faster by pairing research teams with specialized, high-capacity preclinical development services that many individual laboratories do not have the infrastructure to perform efficiently on their own.

A key feature of the program is its emphasis on preclinical, translational work that supports product development readiness. The facility can contribute across multiple stages of early discovery and lead optimization, including protein generation, high-throughput screening to identify active compounds, structure-activity relationship work to refine potency and selectivity, hit-to-lead and lead optimization chemistry, and drug metabolism studies to better understand how candidate molecules behave in biological systems. In addition, the description highlights fertility studies and other development activities that can support IDE- or IND-enabling packages, meaning the generated data and materials can be aligned with the type of evidence typically needed before a contraceptive candidate is ready to approach regulatory pathways for devices or drugs. Even with that development orientation, the FOA clearly states "Clinical Trial Not Allowed," which signals that the supported activities are intended to remain on the preclinical side rather than funding clinical testing in humans under this mechanism.

The purpose of the FOA is straightforward: to let qualified investigators submit requests for specific services from the NICHD Chemical Synthesis and Optimization Facility that would materially advance a male or female non-hormonal contraception development program. Practically, that means applicants should already have a credible scientific rationale and a defined development need (for example, optimizing a chemical series, improving pharmacokinetic properties, validating activity through screening, or generating the preclinical data needed to move toward IND/IDE preparation). The program is structured to be service-oriented and milestone-driven in spirit, with the facility providing technical capabilities that complement, rather than replace, the applicant's underlying scientific and product-development strategy.

Eligibility for this opportunity is broad and spans many sectors. Eligible applicants include various levels of government (state, county, city/township, and special districts), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, and additional categories described as "Others." It also explicitly includes a wide range of mission- or community-focused and historically underrepresented institution types, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). Beyond domestic applicants, the FOA also lists non-U.S. entities (foreign organizations), regional organizations, faith-based or community-based organizations, and U.S. territories or possessions, as well as certain tribal governments and tribal organizations (including those other than federally recognized, as specified). This breadth reflects an intent to draw promising contraceptive innovations from academic, nonprofit, government, and industry pipelines and then connect them to specialized preclinical development capacity.

From an administrative standpoint, the opportunity is classified as a discretionary grant under NIH, within the Health, Income Security and Social Services activity area, and is associated with CFDA number 93.865. The original posting dates back to April 26, 2019, and the listed original closing date is December 14, 2022. The public summary does not specify an award ceiling or the expected number of awards, which is consistent with service-oriented mechanisms where the scope and resource use can vary depending on the nature of the requested facility support.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Chemical Screening and Optimization Facility (X01 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 2019-04-26.
• Applicants must submit their applications by 2022-12-14. (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.

Apply for PAR 19 261

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