Opportunity Information: Apply for PAR 23 193
The Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed), funding opportunity number PAR 23-193 (CFDA 93.865), is a discretionary NIH grant mechanism run through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It is centered on giving research teams access to NICHDs in-house, state-of-the-art chemical synthesis and optimization capabilities to move promising ideas in contraception and reproductive health toward a credible preclinical development package. The emphasis is on non-hormonal contraceptive development, but the scope also includes other reproductive health related product concepts where there is a plausible path to a safe therapeutic option. The program is explicitly not for clinical trials, and instead focuses on the kind of preclinical work that helps determine whether a concept is strong enough, safe enough, and well-characterized enough to justify later IND or IDE planning.
A key feature of this opportunity is that it is designed as a facility-enabled pathway for translation, meaning the value is not only in direct funding but in access to specialized services and infrastructure that can be difficult for many academic or early-stage groups to build on their own. The NICHD Chemical Synthesis and Optimization Facility supports a broad range of IND- or IDE-enabling preclinical activities, which can include protein generation to support assay development and target validation, X-ray crystallography to clarify binding interactions and guide rational design, high throughput screening to identify initial hits, structure-activity relationship work to systematically improve potency and selectivity, hit-to-lead generation to turn early screening results into more viable lead series, and drug metabolism-related studies to understand stability, exposure, and other properties that influence whether a molecule can realistically become a drug candidate. In practical terms, the program is meant to help applicants answer the development-critical questions: what is the best chemical series to pursue, what modifications improve performance, what liabilities emerge as compounds are optimized, and what data are needed to credibly support a next-stage regulatory path.
The long-term objective described in the announcement is to enable at least one preclinical candidate that is suitable for IND and/or IDE study planning, with the ultimate goal of delivering a safe therapeutic option in contraception and/or reproductive health indications. That goal is framed with realistic constraints: actual project support is dependent on contractor availability and available funding, which signals that timelines and the exact services performed may be shaped by facility capacity and prioritization. Even so, the intent is clearly to reduce the technical and resource barriers between early discovery and a development-ready preclinical candidate by pairing applicants with a dedicated optimization and screening environment.
Eligibility is broad and includes a wide range of domestic and international organizations. Eligible applicants listed include state, county, and city or township 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; other Native American tribal organizations (including those other than federally recognized governments); public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations other than small businesses; small businesses; and other entities. The opportunity also calls out additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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, and non-domestic (non-U.S.) entities and foreign organizations. Taken together, that eligibility language signals an interest in drawing from diverse institutional types and geographies, including organizations that may be closer to community needs, public health priorities, or under-resourced research ecosystems.
Administratively, the sponsor agency is the National Institutes of Health, and the opportunity remains open with an original closing date of 2026-04-03. The posting information indicates this opportunity was created on 2023-05-19. While the notice does not specify an award ceiling or expected number of awards in the provided text, the overall structure suggests that the main deliverable is progress toward a rigorously supported preclinical candidate through the facilitys screening, synthesis, and optimization pipeline rather than a traditional open-ended research project.Apply for PAR 23 193
- 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 2023-05-19.
- Applicants must submit their applications by 2026-04-03. (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.
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Frequently Asked Questions (FAQs)
What is the Chemical Screening and Optimization Facility (X01 Clinical Trial Not Allowed) opportunity?
This opportunity (PAR 23-193, CFDA 93.865) is a discretionary NIH grant mechanism run through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). It is designed to give research teams access to NICHD's in-house chemical synthesis and optimization capabilities to advance promising contraception and reproductive health concepts toward a credible preclinical development package.
What is the main purpose of this program?
The program is intended to help applicants move from early discovery toward a development-ready preclinical position by using NICHD facility resources for screening, synthesis, and optimization. The focus is on generating the kind of evidence that supports later IND and/or IDE study planning, rather than running open-ended basic research.
Is this opportunity focused on contraception only?
The emphasis is on non-hormonal contraceptive development. However, the scope also includes other reproductive health-related product concepts where there is a plausible path to a safe therapeutic option.
Are hormonal contraceptive projects in scope?
The information provided highlights a strong emphasis on non-hormonal contraceptive development. It also notes the scope includes other reproductive health-related product concepts with a plausible path to a safe therapeutic option.
Are clinical trials allowed under this opportunity?
No. The opportunity is explicitly labeled "Clinical Trial Not Allowed" and is described as not being for clinical trials. It focuses on preclinical work that helps determine whether a concept is strong enough, safe enough, and well-characterized enough to justify later IND or IDE planning.
What kind of work does the program support if it does not allow clinical trials?
The program supports IND- or IDE-enabling preclinical activities that help answer development-critical questions such as: which chemical series is best to pursue, what modifications improve performance, what liabilities arise during optimization, and what data are needed to credibly support a next-stage regulatory path.
What facility resources or services are available through NICHD?
The NICHD Chemical Synthesis and Optimization Facility supports a broad range of services, including protein generation (to support assay development and target validation), X-ray crystallography (to clarify binding interactions and guide rational design), high throughput screening (to identify initial hits), structure-activity relationship (SAR) work (to improve potency and selectivity), hit-to-lead generation (to create more viable lead series), and drug metabolism-related studies (to understand stability, exposure, and other properties relevant to drug candidacy).
What does "facility-enabled pathway for translation" mean in practical terms?
It means the value of the opportunity is not limited to direct funding. A major component is access to specialized infrastructure and services (screening, synthesis, optimization, and related capabilities) that many academic or early-stage groups may not be able to build internally. The facility helps reduce technical and resource barriers between early discovery and a development-ready preclinical candidate.
What are "development-critical questions" this program aims to help answer?
Based on the description, the program is structured to help applicants determine: (1) what the best chemical series is to pursue, (2) which chemical modifications improve performance, (3) what liabilities or weaknesses emerge during compound optimization, and (4) what supporting preclinical data are needed to justify future IND or IDE study planning.
What is the long-term objective of the announcement?
The long-term objective is to enable at least one preclinical candidate suitable for IND and/or IDE study planning, with the ultimate goal of delivering a safe therapeutic option for contraception and/or other reproductive health indications.
Does the opportunity guarantee that all proposed work will be supported by the facility?
No. The description states that actual project support depends on contractor availability and available funding. This indicates that timelines and the specific services performed may be shaped by facility capacity and prioritization.
Who is the sponsoring agency for this opportunity?
The sponsor agency is the National Institutes of Health (NIH), and the program is run through NICHD (Eunice Kennedy Shriver National Institute of Child Health and Human Development).
What is the funding opportunity number and CFDA number?
The funding opportunity number is PAR 23-193, and the CFDA number provided is 93.865.
What is the application deadline (closing date) based on the information provided?
The opportunity remains open with an original closing date of 2026-04-03.
When was this opportunity created or posted?
The posting information indicates the opportunity was created on 2023-05-19.
Is the program limited to U.S.-based applicants?
No. Eligibility is described as broad and includes domestic and international organizations, including non-domestic (non-U.S.) entities and foreign organizations.
What types of organizations are eligible to apply?
Eligible applicants include a wide range of domestic and international organizations, such as state, county, and city or township 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; other Native American tribal organizations (including those other than federally recognized governments); public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations other than small businesses; small businesses; and other entities.
Are minority-serving institutions and community-based organizations explicitly included in eligibility?
Yes. The eligibility language specifically calls out categories including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.
Are U.S. territories or federal agencies eligible?
Yes. The eligibility list includes eligible federal agencies as well as U.S. territories or possessions, and regional organizations.
What is the program trying to deliver as an outcome or deliverable?
Based on the description, the main deliverable is progress toward a rigorously supported preclinical candidate by using the facility's screening, synthesis, and optimization pipeline, with the longer-term aim of reaching a position suitable for IND and/or IDE study planning.
Does the provided information state an award ceiling or expected number of awards?
No. The provided text does not specify an award ceiling or an expected number of awards.
How is this different from a traditional research grant?
The structure described suggests the core value is access to NICHD's specialized facility services and infrastructure for screening, synthesis, and optimization, rather than a traditional open-ended research project. The intent is to accelerate translation from early discovery to a credible preclinical package.
What kinds of scientific capabilities are emphasized in the facility work?
The described capabilities emphasize chemical synthesis and optimization and related preclinical activities: screening for hits, improving compounds through SAR and hit-to-lead work, using crystallography to guide design, generating proteins to support assays and validation, and conducting drug metabolism-related studies to evaluate properties that affect drug candidacy.
What does the program say about safety and characterization of concepts?
The program is described as focusing on preclinical work to determine whether a concept is strong enough, safe enough, and well-characterized enough to justify later IND or IDE planning.
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